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1. Manufacturer Model Description A Humidifier Published Com Volume Setting pressible for SST mL Volume Empty mL Fisher amp Payke MR225 Infant Ped dispos 300 300 able Manual Feed Fisher amp Payke MR290 Neo Adult Dispos 380 380 able Autofeed Fisher amp Payke MR250 Adult Disposable 480 480 Manual Feed Fisher amp Payke MR210 Adult Disposable 480 480 Manual Feed Fisher amp Payke MR370 Adult Reusable 725 725 Manual Feed Fisher amp Payke MR340E Infant Reusable 310 310 Manual Feed Teleflex Concha 382 60 Standard compli 296 296 ance Teleflex Concha 382 30 Low compliance 300 300 Teleflex Concha 385 40 Minimal compli 164 164 ance SST Results SST reports results for each individual test Three status indicators identify the SST results and actions to take for each e Pass The individual SST test has met its requirements e Alert Alerts occur when the ventilator detects one or more non critical faults e Fail The individual SST test did not meet its requirements 3 50 Operator s Manual Product Connectivity Table 3 5 Individual SST Results Test status Meaning Response PASS Individual SST test passed No need to do anything unless prompted by the ventilator ALERT The test result is not ideal but is not When the system prompts touch one critical of these buttons A if SST is in progress it halts further e
2. Gesture Description Used for How to Use Double tap Rapidly touch the Maximizing or minimizing Double tapping maximizes the viewable screen surface the viewable area of a waveform area or shows the long descrip twice with one dialog control or wave tion of a tooltip Double tapping again min finger form expanding or collaps imizes the viewable waveform area or ing tooltips shows the short description of a tooltip If the control is configurable double tapping produces the configuration pop up menu Drag Move the finger Changing x and y axis Touch the axis and drag to the right to tip over the scales moving the wave increase the waveform x axis scale and to screen surface form cursor moving scroll the left to decrease Touch the axis and without losing bars scrolling lists Scrolling drag upward to increase the y axis scale and contact speed varies depending downward to decrease upon how far outside the list To move the cursor when the waveform is boundary the finger is posi paused touch the cursor and drag it right tioned or left The graph responds similarly Scroll a list by dragging the scrollbar right or eft or up or down The list scrolls according to the direction of the finger movement An automatic scrolling feature starts if the finger is dragged from the inside of a list to outside its boundary The farther outside the boundary the finger is dragged the faster the list scrolls Touch and
3. cceeeeeeeeeee 10 21 Spontaneous Breath Delivery Characteristics 10 23 Maximum Pressure Adjustments cceeee eee eeee 10 26 Inspiratory and Expiratory Pause Events 10 51 Values for Vz Based on Circuit Type sees e eee eee 10 58 Peak Flow and Circuit Type Leak Sync Disabled 10 59 Modes and Breath Types 0c cece cence cence eeeenee 10 60 Safety PCV Settings cece cece eee e cence waaa 10 72 Inspiratory Backup Ventilation Settings 10 75 Performance Verification Equipment Uncertainty 11 1 Physical CharacteristicS 0 cece cece cence cence eens 11 2 Pneumatic Specifications cc aaa 11 3 Technical Specifications 0 c cece a 11 3 Electrical Specifications 0 ccc cece aaa 11 6 Interface Pin Designations aaa 11 6 Nurse Call Pin Designations ce aaa 11 7 Environmental Specifications aa 11 7 Ventilator Settings Range and Resolution 11 8 Alarm Settings Range and Resolution 11 17 Patient Data Range and Resolution e eee e ee 11 19 Delivery ACCUIACY 2 2 08 cas ees edaatniiecaid eaeentvease 11 26 Monitoring Patient Data Accuracy cece eee 11 27 Computed Value Accuracy cece cece cece ence ences 11 28 Electromagnetic Emissions aaa 11 30 Electromagnetic Immu
4. Ventilator breathing circuit Neonatal dispos 780 06 able Hudson RCI Teleflex Ventilator breathing circuit Neonatal dispos RT235 able Fisher amp Paykel e9 Ventilation Features E 9 E 9 2 Ventilation using NeoMode 2 0 is performed exactly as described in Chapter 4 of this manual Reference Ventilator Operation p 4 7 If using a Puritan Ben nett 980 Neonatal Ventilator NeoMode 2 0 is already in use and a neonatal patient circuit is the only choice available when performing SST If using a Puritan Bennett 980 Pediatric Adult Ventilator or Puritan Bennett 980Uni versal Ventilator the NeoMode 2 0 software option must be installed and SST must be run using a neonatal patient circuit WARNING Always run SST prior to patient ventilation ensuring that all accessories used during ventilation are in the ventilator breathing system when SST is run This ensures correct calculation of compliance and resistance Reference SST Short Self Test p 3 46 for more information Predicted Body Weight PBW vs Patient Length Reference Predicted Body Weight PBW Calculation in Chapter 4 of this manual for tables of PBW values associated with patient length in centimeters and inches respectively Elevate O In NeoMode 2 0 the elevate O control works exactly as described in Chapter 3 of this manual except when the ventilator is in stand by or circuit disconnect states If the elevate O fun
5. 2 00 cee eee Service Personnel Preventive Maintenance Safety Checks 265545 ama eeeseabeyeeeew amass 7 9 Inspection and Calibration 00 eee eee eee 7 25 7 10 Documentation 200 e eee eee 7 25 7 11 Storage for Extended Periods 7 26 8 Troubleshooting 8 1 OVEIVIEW 35228 6048405024 she ee wentsecanestaccsnse 8 1 8 2 Problem Categories 53 4 eee eee eee ees 8 1 8 3 How to Obtain Ventilator Service a 8 1 8 4 Used Part Disposal 200 cece e eee eee 8 1 8 5 Ventilator LOGS waaa eed AG Ke wee AA DA 8 2 8 6 Diagnostic Codes 1 ee 8 4 9 Accessories 9 1 OVETVIEW lt checceeeese laws eee sed eeeede wen AA 9 1 9 2 General Accessory Information 20 55 9 2 10 Theory of Operations 10 1 OVENIEW zax awa NEGRA NAA AA KAG bu HAKA KANAN 10 1 10 2 Theoretical Principles 20 ce eee eee eee 10 3 10 3 Applicable Technology 200 e0eeeee eens 10 3 10 4 Inspiration Detection and initiation 10 4 10 4 1 Pressure Triggering sagana ia we eee ended feu n ose de 10 5 10 4 2 Flow Triggering sie nae PP eases 10 6 10 4 3 Time Triggers 7a ka Tamaan 4ceadd cached tbeenses abae 10 8 10 4 4 Operator initiated Triggers 00 0002 0 eee eee 10 8 10 4 5 IE Sync Trigger n n anaana wend ase be ete d ee ees 10 8 10 5 Exhalation Detection and Initiation 10 9 10 5 1 Airway Pressure Method sc ssccdaccdar av ka
6. Note Refer to the patient circuit s instructions for use IFU for information on proper use and handling and care and maintenance of the circuit A list of breathing system components and accessories is provided Reference Covidien Accessories and Options p 9 4 Use only Covidien components and accessories in the patient circuit Follow your institution s protocol for safe disposal of the patient circuit Follow the patient circuit s instructions for use IFU for cleaning and disinfec tion information for reusable circuits Orient the patient circuit by hanging the patient circuit on the circuit manage ment supports provided with the flex arm Operator s Manual 3 15 Installation Figure 3 7 Connecting the Adult or Pediatric Patient Circuit DO 9 0D 4 3 2 1 VEN 11168 A 1 Humidifier 6 From Patient port 2 Inspiratory limb 7 Expiratory filter 3 Circuit wye 8 To Patient port 4 Expiratory limb 9 Inspiratory filter 5 Condensate vial 3 16 Operator s Manual Product Connectivity Figure 3 8 Connecting the Neonatal Patient Circuit DO 9 UI aaa CEN Tie a 2 7 6 R MO DD MSD 4 1 Humidifier 6 2 Patient circuit inspiratory limb 7 3 Circuit wye 8 4 Patient circuit expiratory limb 9 5 Condensate vial Operator s Manual VEN 11169 A From patient port Neonatal expiratory filter installed in adapter door To patient port Inspiratory filter 3 17 Install
7. 10 cmH30 0 1 cmH20 when 2 10 cmH 20 PAV based intrinsic PEEP PEEP pay The estimated intrinsic PEEP during a PAV breath Intrin sic PEEP is an estimate of the pressure above PEEP at the end of every pause exhala tion Range O to 130 cmH 70 Resolution 0 1 cmH O for values lt 10 cmH 0 1cmH 0 for values gt 10 cmH 0 PAV based lung compliance Cpay The calculated change in pul monary volume for an applied change in patient airway pressure when measured under conditions of zero flow during a PAV plateau maneuver When PAV is selected the ventilator dis plays the current filtered value for patient compliance and updates the display at the successful completion of each estimation Cpay can be dis played in the vital patient data banner Reference Vital Patient Data p 3 42 Range 2 5 mL cmH20 to 200 mL cmH30 Resolution 0 1 mL cmH50O for values lt 10 mL cmH50 1 cmH430 for values gt 10 mL cmH30 Operator s Manual Performance Specifications Table 11 11 Patient Data Range and Resolution Continued Data Value PAV based lung elastance Epay Description For a PAV breath Epay is cal culated as the inverse of Cpay see above Epay can be dis played in the vital patient data banner Reference Vital Patient Data p 3 42 Range and Resolution Range 5 0 cmH 0O L to 400 cmH zO L Resolution 0 1 cmH O L for values lt 10 cmH O L 1 cmH
8. NO O SUPPLY e LOW DELIVERED 05 10596 e HIGH DELIVERED 07 102 Ventilator setup for alarms tests 1 Disconnect the patient circuit from the ventilator and turn the ventilator off for at least five minutes 2 Turn the ventilator or on The ventilator runs POST Operator s Manual 6 9 Performance On the GUI select NEW PATIENT Set up new patient using the following settings PBW 70 kg Vent type INVASIVE Mode A C Mandatory type VC Trigger type V TRIG Set the following new patient settings f 6 0 1 min Vq 500 mL Vmax 30 L min Tp Os Flow pattern SQUARE Vsens 3 L min 05 21 PEEP 5 cmH 0 Set the following apnea settings Ta 10s f 6 0 1 min 02 21 Vq 500 mL Set the following alarm settings TPpeax 70 cmH 70 ftor OFF LVe tot 1 L min TVE Tot 3 5 L min Ve MAND 300 mL TV7e MAND OFF LVTE spont OFF TV7e spont OFF Operator s Manual Ventilator Settings s Set the graphics display to a volume time plot for use in the APNEA alarm test 9 Connect an Adult patient circuit to the ventilator and attach a test lung to the patient wye Note To ensure proper test results do not touch the test lung or patient circuit during the CIRCUIT DISCONNECT alarm test CIRCUIT DISCONNECT alarm test 1 Allow the ventilator to deliver at least four breaths During the inspiratory phase of a breath disconnect the inspiratory filter from the To Patient port The ve
9. Range 0 mL to 500 mL Resolution 0 1mL for values 0 mL to 9 9 mL 1 mL for values 10 mL to 500 mL Proximal exhaled total minute volume VE TOTY For neonatal patients the exhaled minute volume mea sured by the Proximal Flow Sensor Range 0 00 to 99 9 L min Resolution 0 01 L min for 0 00 to 9 99 L min 0 1 L min for 10 0 to 99 9 L min Proximal inspired tidal volume Viy For neonatal patients the inspired volume of the previ ous breath measured by the Proximal Flow Sensor if installed Range 0 mL to 500 mL Resolution 1 mL Spontaneous inspiratory time Ti sPonT The duration of the inspirato ry phase of a spontaneous breath Range Os to 10s Resolution 0 01 s Operator s Manual Performance Specifications Table 11 11 Patient Data Range and Resolution Continued Data Value Spontaneous inspiratory time ratio T TtoT Spontaneous rapid shallow breathing index f V 7 Description The fraction of the total spon taneous breath time used by inspiration A calculated value using exhaled spontaneous tidal volume High values indicate the patient is breathing rapid ly but with little volume breath Low values indicate the inverse scenario Range and Resolution Range 0 to 1 Resolution 0 01 Range 0 1 1 min L to 600 1 min L Resolution 0 1 1 min L for values lt 10 1 min L 1 1 min L for values gt 10 1 min L Static compliance
10. Reference the table below for a summary of Dcgns settings when Leak Sync is enabled Note that it is possible to set Dsgys below maximum Leak Sync flow Table B 3 Degns settings Breathing circuit type Dsgns setting Maximum total flow Neonatal Range 1 to 15 L min 50 L min Default 2 L min INVASIVE ven tilation 5 L min NIV Pediatric Range 1 to 40 L min 120 L min Default 20 L min Adult Range 1 to 65 L min 200 L min Default 40 L min WARNING With significant leaks pressure targets may not be reached due to flow limitations WARNING Setting Dsens higher than necessary may prevent timely detection of inadvertent extubation 8 62 Monitored Patient Data When Leak Sync is enabled three additional parameters are displayed on the More Patient Data screen and updated for each breath Display the More Patient Data screen by swiping the tab on the patient data banner These leak parameters may also be configured on the patient data banner and the large font patient data panel Operator s Manual Technical Discussion Figure B 3 Leak Sync Monitored Patient Data TOT Vie mano P Vie Wor Puean v 18 398 10 1 7 1 51 396 398 VEN_11367_D 1 Leak Sync Parameters Reference the table Patient Data Range and Resolution in Chapter 17 of this manual for information regarding the following monitored patient data parameters e VLEAK e Yo LEAK e LEAK Displayed values for Exhaled
11. 3 Turn the device on The appearance of the GUI now displays on the external display device Service Port The Service port is used by service personnel only ss Retrieving Stored Data ms Ventilator data are stored in various logs accessible using the logs icon Some logs may be accessed during normal ventilation and some are only available to Covidien personnel when the ventilator is in Service mode Reference Ven tilator Logs p 8 2 for more information on data stored in various logs s7 Display Configurability The operator can configure some ventilator parameters according to personal preference Reference Ventilator Configuration p 3 35 for a table showing which parameters are configurable and by whom 5 20 Operator s Manual Data Transfer Reference Preparing the Ventilator for Use p 3 37 for information on config uring each display item ss Printing Data or Screen Captures The ventilator cannot be connected directly to a printer Save screen captures to an external storage device such as a USB flash drive then print from a PC Reference GU Screen Capture p 5 2 for instructions on using the screen capture feature s9 Connectivity to External Systems The ventilator is compatible with the Philips Medical IntelliVue MP50 and Spacelabs Ultraview patient monitoring systems Note Not all patient monitors are compatible with the Puritan Bennett 980 Series Ventilator Operator s Manual 5 21 Prod
12. 7 26 Surface Cleaning of Ventilator Exterior Surfaces 4 7 4 symbols BDU rear panel label symbols and descriptions 2 11 safety symbol definitions 1 3 shipping label symbols and descriptions 1 2 System Related Problems 10 73 T TC alarms 10 28 monitored patient data 10 28 PBW and tube ID 10 28 technical description 10 27 tube type tube ID humidification 4 14 technical assistance 1 15 Technical Services 1 15 Ty T ratio BiLevel 10 67 Tidal Volume 10 62 Tube compensation TO 10 27 U Used Part Disposal 8 1 Using Battery Power 3 3 V VC maximum pressure adjustments 10 21 startup 10 20 10 21 ventilating a new patient 4 9 ventilating the same patient 4 9 ventilator alarm log 8 2 available languages 5 1 BDU controls and indicators 2 25 BDU front view 2 8 BDU rear label symbols and descriptions 2 11 2 13 BDU rear view 2 10 BDU right side view 2 14 2 15 Components List 2 5 connectors 2 35 Description 2 2 EST SST status log 8 3 function 4 1 gas flow overview 10 2 general event log 8 3 GUI front view 2 6 GUI rear view 2 7 Indications For Use 2 4 Operation 4 7 4 21 patient data log 8 2 service log 8 3 settings log 8 2 system diagnostic log 8 3 Ventilator Logs 8 2 Ventilator Operating Modes 3 30 3 34 ventilator operating modes Normal mode 3
13. Product Connectivity WARNING When changing any accessories in the patient circuit or changing the patient circuit itself run SST to check for leaks and to ensure the correct circuit compliance and resistance values are used in ventilator calculations When a patient is not attached to the ventilator run SST to check the patient circuit for e Gas leaks e Circuit compliance and resistance calculations SST is a five minute test and must be run under any of the following condi tions e Prior to ventilating a new patient e When replacing the patient circuit and expiratory filter e When connecting a different patient circuit to the ventilator e When changing the patient circuit type e When installing a new or sterilized expiratory filter e When changing the humidification device type e When adding or removing accessories to the breathing system such as a humidi fier or water trap No external test equipment is required and SST requires minimal operator par ticipation Humidification type and volume can be adjusted after running SST however the ventilator makes assumptions when calculating resistance and compliance if these changes are made without re running SST For optimal breath delivery run SST after changing humidification type and humidifier volume SST results are recorded in the SST results log viewable in Service mode and in Normal mode using the configuration wrench icon Required Equipment e Proposed
14. SST Opbons Comm Prox Manual Purge YE To begin touch the Start button A s PEEP 25 3 0 VEN_11432_E Note If the Proximal Flow Option has been disabled or enabled SST does not have to be re run unless the breathing circuit or other breathing system accessories have been changed removed or added e11 Using the Proximal Flow Sensor Review and follow all warnings prior to patient ventilation with the Proximal Flow Sensor Reference Safety Information p F 2 and ensure the Proximal Flow Sensor option is enabled To connect the Proximal Flow Sensor to the ventilator 1 Verify the Proximal Flow Sensor pneumatic lines and connector are not damaged in any way 2 Open the connector panel door and firmly attach the sensor connector to the right most receptacle in the BDU s front connector port labeled Prox Reference Attaching Proximal Flow Sensor to Ventilator p F 11 Operator s Manual F 13 Proximal Flow Option Appendix To attach the Proximal flow sensor between the endotracheal tube and patient circuit 1 Connect the larger end of the sensor marked with UP and an arrow to the endotracheal tube Reference the figure below Do not force the connection when the sensor is oriented correctly insertion requires little effort Note If using a Heat Moisture Exchanger HME on the endotracheal tube place the Proximal Flow Sensor between the HME and the breathing circuit wye Figure F
15. Table 1 2 Safety Symbol Definitions Symbol Definition WARNING A Warnings alert users to potential serious outcomes death injury or adverse events to the patient user or environment Caution Cautions alert users to exercise appropriate care for safe and effective use of the product Note Notes provide additional guidelines or information 1 3 2 Warnings Regarding Fire Hazards WARNING Explosion hazard Do not use in the presence of flammable gases An oxygen rich environment accelerates combustibility Operator s Manual 1 3 Introduction WARNING To avoid a fire hazard keep all components of the system away from all sources of ignition such as matches lighted cigarettes flammable medical gases and or heaters Oxygen rich environments accelerate combustibility WARNING In case of fire or a burning smell immediately take the following actions if it is safe to do so disconnect the patient from the ventilator and disconnect the ventilator from the oxygen supply facility power and all batteries Provide alternate method of ventilatory support to the patient if required WARNING Replacement of batteries by inadequately trained personnel could result in an unacceptable risk such as excessive temperatures fire or explosion WARNING To minimize fire hazard inspect and clean or replace as necessary any damaged ventilator parts that come into contact with oxygen WARNIN
16. e Prior to initial installation and first time usage of the ventilator e Every six months e Before any preventive maintenance e Following ventilator service or repair e As part of the ventilator s routine performance verification During EST the ventilator displays the current EST status including the test currently in progress results of completed tests and measured data where applicable The ventilator logs EST results and that information is available fol lowing a power failure The ventilator disables several offscreen keys located on the bezel of the GUI during EST e Alarm silence Operator s Manual 3 53 Installation e Alarm reset e Manual inspiration e Inspiratory pause e Expiratory pause Run tests either as a group or as single tests for troubleshooting purposes Equipment for EST e Covidien gold standard test circuit e Number one stopper e Air and oxygen sources both at 35 to 87 psi 241 to 599 kPa e An adult sized expiratory filter Note Attempts to run EST with a Neonatal filter can cause some EST tests to fail 9 Note If using Air Liquide Dr ger and SIS air oxygen hose assemblies certain EST tests may fail when using supply pressures less than50 psi 345 kPa based on excessive hose restriction 3 9 3 EST Test Sequence Note If the ventilator has not reached normal operating temperature from recent usage allow it to warm up for at least 15 minutes in Service Mode prior t
17. p 5 5 Protection Against Hazard PAV software is designed to reduce the risk that hyperinflation may occur The potential for hyperinflation could arise if the software were to overesti mate actual patient resistance or underestimate actual patient lung thorax compliance that is to overestimate actual elastance If the software cannot generate valid estimates of Rpay and Cpay PAV cannot start If after startup the values of Rpay and Cpay cannot be updated with valid new values the pre vious values become less reliable The stability of PAV is primarily determined by the relationship between the true lung elastance E true and the true lung volume V true Although P wye resistive also plays a part the following discussion focuses on the elastic component At all lung volumes the true state of the lung and thorax is expressed by Operator s Manual D 19 PAV Appendix D 20 i i P recoil V true x E true Pl recoil True lung recoil pressure EL true True lung elastance vi true True instantaneous volume of the lung Over inflation will not occur as long as P elastic lt Pi recoil Which is equiv alent to the inequality S V estimated x K3 lt Vi true x E true where K Epay 1 see equations 2 and 4 As long as Epay estimated Epay true and V estimated V true then Pl ccoil Pwe even at high values of Supp i e between 85 and 95 This means t
18. 1 5 L min neo natal Gas flow Controlled by pressure in the mix accumulator During inspiratory BUV the delivery PSOL is disabled but gas delivery is achieved via an inspiratory BUV solenoid valve the gas flow being created by pressure in the mix accumulator Exhalation BUV is invoked if problems with the Exhalation Valve driver are detected A backup analog circuit is enabled to control the exhalation valve Operator s Manual 10 75 Theory of Operations 10 17 10 76 though the more advanced control features active exhalation valve control are not functional Note During Mix and Inspiratory BUV gas supply to installed options is disabled Entry into BUV is logged in the alarm log and system diagnostic log and the Status display provides an indicator that the ventilator is in BUV and which sub system is affected When in BUV a high priority alarm is annunciated and the GUI displays an alarm banner indicating BUV blanks patient data and a displays a pressure waveform If the ventilator cannot provide any degree of reliable ventilatory support and fault monitoring then the ventilator alarms and enters the safety valve open SVO emergency state During SVO the ventilator de energizes the safety expiratory and inspiratory valves annunciates a high priority alarm and turns on the SVO indicator During SVO a patient can spontaneously inspire room air if able to do so and exhale Check valves on the inspirat
19. 2 Touch Large Font Patient Data Defaults Five layout presets appear along with a list of parameters and descriptions 3 Touch a preset button and individually select a parameter for each of the desired patient data values 4 Choose the desired scalar and loop waveforms for the large font patient data dis play Waveform thumbnails appear in the three right most cells of the large font data panel 5 Touch any of the padlock icons along the right most edge of the selected layout to prevent operator configurability of the selected row Operator s Manual 3 43 Installation 6 Touch Accept or Accept ALL when finished 7 If factory defaults are desired for a preset touch Defaults s If done configuring parameters exit Service Mode by touching Exit To display the large font patient data panel 1 Swipe the vital patient data banner tab downward or touch the vital patient data tab The additional patient data panel appears 2 Swipe the additional patient data banner s tab downward or touch the additional patient data banner s tab Patient data appear in a larger font 3 Swipe the large font patient data panel tab upward or touch the tab to return to the banner to its normal font size The large font patient data parameters are configured in the same way as described in the patient data configuration section above Waveforms Green waveforms denote a mandatory inspiration yellow waveforms denote exhalation and orange w
20. 2 3 1 l T LI T LI i 6 6 VEN_11342_A 1 Peirc CmH20 4 Py 2 Ty 5 PL 3 TL 6 Spontaneous breaths BiLevel resembles SIMV mode except that BiLevel establishes two levels of pos itive airway pressure Cycling between the two levels can be triggered by BiLevel timing settings or by patient effort A 1 BiLevel 2 0 Appendix Figure A 2 BiLevel Mode 23 4 5 6 7 VEN_10251_C 1 Pressure y axis 5 Synchronized transitions 2 PL 6 Pressure support 3 Py 7 Time based transitions 4 Spontaneous breath NOTE The Pressure support level is always referenced to P The two pressure levels are called Low Pressure P and High Pressure Pp At either pressure level patients can breathe spontaneously and spontaneous breaths can be assisted with tube compensation or pressure support BiLevel monitors mandatory and spontaneous tidal volumes separately Inspiratory time and expiratory time in BiLevel become Time high Th and Time low T respectively During these inspiratory and expiratory times Py is main tained during Ty and P is maintained during T a2 Intended Use BiLevel is intended for adult pediatric and neonatal patients a3 Safety Symbol Definitions This section contains safety information for users who should always exercise appropriate caution while using the ventilator A 2 Operator s Manual Technical Description Table A 1 Safety Symb
21. An inspiratory pause maneuver closes the inspiration and exhalation valves and extends the inspiratory phase of a single mandatory breath for the purpose of measuring end inspiratory circuit pressure in order to calculate inspiratory Plateau Pressure Pp lung Static Compliance Csrar and Static Resistance Rstar of the respiratory system Pressures on either side of the artificial airway are allowed to equilibrate which determines the pressure during a no flow State A request for an inspiratory pause is rejected during apnea ventilation safety PCV OSC BUV and in Stand by state Inspiratory pauses are allowed in A C SIMV BiLevel and SPONT modes If an inspiratory pause maneuver has already occurred during the breath a second inspiratory pause maneuver is not allowed Inspiratory pauses can be classified as automatic or manual The automatic inspiratory pause lasts at least 0 5 second but no longer than three seconds A manual inspiratory pause starts by pressing and holding inspiratory pause key The pause lasts for the duration of the key press up to seven seconds To perform an automatic inspiratory pause 1 Press and release the inspiratory pause key on the GUI bezel or touch and release Start if performing an inspiratory pause from the GUI screen as shown above The ventilator performs the inspiratory pause maneuver and displays Pp Cstat and Rstat along with the date and time 2 Touch Accept or Reject to save or dismiss re
22. Cor GP age P V Compliance volume C wye Compliance of the patient circuit P C Pressure at the patient wye at the end of the current inspiration Pressure at the end of the current exhala tion pt ckt Without automated compliance compensation practitioners would have to compute V to estimate the loss of volume in the patient circuit then increase the V7 setting by that amount Increasing the tidal volume by a single incre ment to compensate for compliance volume provides only partial compensa tion and requires extra effort and understanding by the practitioner Additionally Pwye and P can change with time Operator s Manual 10 15 Theory of Operations An iterative algorithm in the ventilator automatically computes the compliance volume and compensates for it Compliance compensation does not change inspiratory time T It is achieved by increasing flow increasing the amplitude of the selected flow pattern Keeping T constant maintains the original I E ratio There is a maximum compliance volume to reduce the potential for overinfla tion due to an erroneous compliance volume calculation The maximum com pliance volume is determined by the selected patient circuit type and predicted body weight PBW and is summarized by this equation Voomp max Factor x Tidal volume where Vcomp max Maximum compliance volume Factor linear interpolation of the values in the following table for adult pedi atri
23. Leak Percent leak Por Plateau pressure Tp Plateau time Pcomp Compensation pressure Operator s Manual 2 10 4 Audible Indicators A tone sounds when a button on the GUI is touched and also when settings are accepted Audible indicators include pitched tones beeps and key clicks Key clicks sound whenever a key on the GUI is pressed Various tones annun ciate patient alarms Operator s Manual GUI Controls and Indicators Table 2 7 Symbols and Abbreviations Continued Symbol or Abbreviation Definition Psens Pressure sensitivity Psypp Pressure support level P TRIG Pressure triggering Viy Proximal inspired tidal volume VIEY Proximal exhaled tidal volume VI MANDY Proximal mandatory inspired tidal volume VII SPONTY Proximal spontaneous inspired tidal volume VIY Proximal inspired tidal volume with Leak Sync enabled f Respiratory rate or apnea respiratory rate FP Rise time percent fN Spontaneous rapid shallow breathing index Ti SPONT Spontaneous inspiratory time T TTtoT Spontaneous inspiratory time ratio Cstat Static compliance Rstat Static Resistance VT Tidal Volume PEEPror Total PEEP ftot Total Respiratory Rate monitored VC Vital Capacity VS Volume support 2 23 Product Overview Note Pressing ALARM SILENCE mutes alarms for the two minute alarm silence duration period Caregivers may choose to silence alarms by pressing
24. Note When utilizing a closed suction catheter system the suctioning procedure can be executed using existing mode breath type and settings To reduce potential for hypoxemia during the procedure elevated delivered oxygen can be enabled using the Elevate O control Reference To adjust the amount of elevated O delivered for two minutes p 3 40 Obtaining Technical Assistance Technical Services For technical information and assistance to order parts or to order an Opera tor s Manual or Service Manual contact Covidien Technical Services at 1 800 255 6774 or a local Covidien representative Reference the following table for service centers in the USA and other countries The Puritan Bennett 980 Series Ventilator Service Manual includes information necessary to service or repair the ventilator when used by qualified factory trained personnel When calling Covidien Technical Services or a local Covidien representative have the BDU and GUI serial numbers available as well as the firmware version number of the ventilator system The ventilator s configuration is available by touching the wrench icon on the GUI screen then touching the Options tab Have this information available whenever requesting technical assistance Information on obtaining the Operator s and Service Manuals are available on the Internet at http www covidien com The following table lists Covidien Service Centers addresses telephone and Fax n
25. Short Self Test SST Figure 10 22 Apnea Ventilation in SIMV 1 1 1 424 bi 3 I I VEN_10768_B 2 Last breath PIM 6 Tm If Ta elapses during Tm ventilator delivers a VIM rather than beginning apnea ventilation 3 VIM 7 Ts 4 Tm max 10 12 Phasing in New Apnea Intervals How a new apnea interval is phased in depends on whether or not apnea ven tilation is active If apnea ventilation is active the ventilator accepts and imple ments the new setting immediately During normal ventilation that is apnea ventilation is not active these rules apply e f the new apnea interval setting is shorter than the current or temporarily extend ed apnea interval the new value is implemented at the next inspiration e f the new apnea interval setting is longer than the current or temporarily extend ed apnea interval the old interval is extended to match the new interval immedi ately 10 13 Detecting Occlusion and Disconnect 10 13 1 Occlusion The ventilator detects severe patient circuit occlusions in order to protect the patient from excessive airway pressures or from receiving little or no gas Occlusions require immediate attention to remedy The ventilator detects a severe occlusion if Operator s Manual 10 45 Theory of Operations e The inspiratory or expiratory limb of the breathing circuit is partially or completely occluded condensate or secretions collected in a gravity dependent loop kinked or crim
26. To clean parts 1 Wash parts in warm water using a mild soap solution 2 Thoroughly rinse parts in clean warm water tap water is acceptable and wipe dry 3 Clean or disinfect ventilator surfaces and component parts per the procedures listed for each component Reference Surface Cleaning Agents p 7 5 Reference Component Cleaning Agents and Disinfection Procedures p 7 6 for acceptable cleaning and disinfecting agents 4 Visually inspect the components for cracks or other damage prior to use 5 Dispose of damaged parts according to the institution s policy Whenever replacing or reinstalling a component run SST before ventilating a patient 7 5 Condensate Vial Cleaning Reference Condensate Vial p 7 9 when following the condensate vial clean ing instructions Note The o ring 1 should remain in place during cleaning To clean the condensate vial 1 Un cap 2 the drain port from the condensate vial but do not detach the retainer 3 7 8 Operator s Manual Service Personnel Preventive Maintenance 2 Rinse the condensate vial in water to remove any accumulations prior to cleaning 3 Wipe the condensate vial assembly with the suggested cleaning solution to remove any accumulated material The vial assembly may be fully immersed in the cleaning solution Reference Component Cleaning Agents and Disinfection Proce dures p 7 6 for the proper condensate vial cleaning solution 4 Rinse the via
27. Ventilator On Battery 35 cmH Meaning On battery power Alerts the operator there is insufficient AC power to operate the ventilator Ventilator is operating on battery power with greater than ten minutes of capacity remaining Note the appearance of the battery icon 35 PEEP F 3 gt 5 cmH Low battery Identifies that the ventilator s primary battery right most slot is discharging and there are ten minutes or less of battery capacity remaining A percentage indicator shows the remaining battery capacity If an extended battery is installed the image would show a similar representation in the extended battery location left most slot Ventilator Battery Low Minutes remaining 5 Ma K n Ns mem 35 PEEP 3 5 cmHj0 Critically low battery Identifies that the ventila tor s primary battery has less than five minutes of battery capacity remaining A percentage indica tor shows the remaining battery capacity If an extended battery is installed the image would show a similar representation in the extended battery location JI Danger Power Failure Power failure Alerts the user that the ventilator s battery is depleted or depletion is imminent Replace primary or extended battery with a fully charged batter or connect ventilator to AC power 2 32 Operator s Manual GUI Controls and Indicators Table 2 9 Status Display Indicators and Descriptions Continued
28. ep L min 3 4 VEN_10757_B 1 Exhalation 4 Event B Patient triggered inspiration begins 2 Inspiration 5 A B interval 3 Event A patient inspires 6 Operator set pressure sensitivity 10 4 2 Flow Triggering If flow triggering V_tpic is selected the BDU provides a constant gas flow through the ventilator breathing circuit called base flow during exhalation The base flow is 1 5 L m greater than the value selected for flow sensitivity Vcens Reference nspiration Using Flow Sensitivity p 10 7 where the top graphic represents expiratory flow and the bottom graphic represents inspira tory flow The ventilator s breath delivery flow sensor measures the base flow delivered to the circuit and the exhalation valve flow sensor measures the flow entering the exhalation valve The ventilator monitors patient flow by measuring the dif ference between the inspiratory and exhaled flow measurements If the patient is not inspiring any difference in measured flows is due to leaks in the breathing system or flow sensor inaccuracy The clinician can compensate for leaks in the breathing system by increasing Vseysto a value equal to desired VsENS leak flow Operator s Manual Short Self Test SST As the patient begins the inspiratory effort and inspires from the base flow less exhaled flow is measured while the delivered flow remains constant Refer ence the figure below event A As the patient continues to inspire the differ
29. sssssssssssssesssssssccssssseeesssssee 10 6 Inspiration Using Flow Sensitivity s ssssssesreseesersersersersessesreesessee 10 7 Breath Activity During Time triggered Inspiration 10 8 Exhalation via the Airway Pressure Method ssesseseeceeeseees 10 10 Exhalation via the Percent Peak Flow Method cesses 10 11 Square Flow Pattern ccodscccscycwaciseccseanicrnrcacitsccaoevonsitaciiecesetne 10 13 Descending Ramp Flow Pattern sssssssssssesssssssseeceeesssssnsssesseeseessssssss 10 14 Ideal Waveform Using Square Flow Pattern esssssssssssseesesssssssss 10 18 Ideal Waveform Using Descending Ramp Flow Pattern 10 19 Ideal Waveform Using Pressure Control Ventilation 10 20 ET Tube Target Pressure vs FIOW scssessssscssssssesecsecsssncssseseesssesees 10 30 Tracheostomy Tube Target Pressure VS FIOW sssssecssecseeceeseees 10 31 No Patient Inspiratory Effort Detected 0 eesesseccssecseecseeceessees 10 32 Patient Inspiratory Effort Detected wu ssssscsseecseccssccssecseccseessees 10 33 Combined VIM and PIM Breaths cccssssssccsecsseccssccecssecssceseecseeeeee 10 33 Mandatory and Spontaneous Intervals ccssccscsseecseececseceneeess 10 34 PIM Delivered Within Mandatory Interval scssssccsseseeceeseees 10 35 Figure 10 18 PIM Not Delivered Within Mandatory Interval sescssesseecees 10 35 Figure 10 19 Apnea Interval Equals Breath Period sssssss
30. support setting of 75 WARNING The ventilator accuracies listed in this chapter are applicable under the operating conditions identified in the table Environmental Specifications on Reference p 11 7 Operation outside specified ranges cannot guarantee the accuracies listed in the tables above and may supply incorrect information 11 8Regulatory Compliance The ventilator complies with the following standards e IEC 60601 1 2005 Medical Electrical Equipment Part 1 General Requirements for Basic safety and essential performance e EN 60601 1 2006 Medical Electrical Equipment Part 1 General Requirements for Basic safety and essential performance 28 Operator s Manual Operator s Manual Regulatory Compliance ANSI AAMI ES 60601 1 2005 Medical Electrical Equipment Part 1 General Requirements for Basic safety and essential performance CSA C22 2 No 60601 1 2008 Medical Electrical Equipment Part 1 General Requirements for Basic safety and essential performance IEC 60601 1 8 2006 Medical electrical equipment Part 1 8 General require ments for basic safety and essential performance Collateral Standard General requirements tests and guidance for alarm systems in medical electrical equip ment and medical electrical systems EN 60601 1 8 2007 Medical electrical equipment Part 1 8 General require ments for basic safety and essential performance Collateral Standard General requirements tests an
31. 1 0 L min estimated leak flow at PEEP Inspired Tidal Volume V7 Accuracy During Leak Sync Reference Patient Data Range and Resolution p 11 19 Vq parameter for V7 accuracy For readings lt 100 mL accuracy ranges apply when the percentage of inspi ratory leak volume is lt 80 where the percentage of leak volume is Leak volume during inspiration total delivered inspiratory volume x 100 Note Inspired tidal volume is labeled as V7 when Leak Sync is enabled and as V when Leak Sync is disabled 8 7 2 Exhaled Tidal Volume Ve Accuracy During Leak Sync Reference Patient Data Range and Resolution p 11 19 Vtg parameter for accuracy when Leak Sync is enabled where T time to exhale 90 of volume actually exhaled by the patient Operator s Manual Technical Discussion For readings lt 100 mL accuracy ranges apply when the percentage of inspi ratory leak volume is lt 80 where the percentage of leak volume is Leak volume during inspiration total delivered inspiratory volume x 100 8 7 3 LEAK Calculation Reference Patient Data Range and Resolution p 11 19 LEAK parameter for specifications 8 7 4 Circuit Disconnect Alarm During Leak Sync The Circuit Disconnect alarm is activated if the overall leak volume during the whole breath exceeds the maximum leak volume derived from the Dggns set ting During VC the Circuit Disconnect alarm is also activated if the end inspi ratory pressur
32. 1 800 255 6774
33. 2 0 1 min to 40 1 min Resolution 0 1 1 min for 2 0 to 9 9 1 1 min for 10 1 min to 40 1 min Range NEONATAL 3 mL to 315 mL PEDIATRIC ADULT 25 mL to 2500 mL Resolution 0 1 mL lt 5 mL 1 mL for 5 mL to 100 mL 5 mL for100 mL to 395 mL 10 mL for values gt 400 mL Apnea constant during rate change Apnea mandatory type Specifies which of the three operator adjustable breath timing variables remains constant when respiratory rate is changed during apnea ventilation The type of mandatory breath delivered during apnea ventilation Range T Range PC VC Circuit type Specifies the circuit for which compliance and resistance values during SST have been calculated Range NEONATAL PEDIATRIC ADULT Specifications 10 Table 11 9 Ventilator Settings Range and Resolution Continued Setting Constant during rate change Description Specifies which of the three operator adjustable breath timing variables remains constant when respiratory rate is changed Range and Resolution Range E ratio Tj Tg for PC or VC breaths Ty T ratio Ty T in BiLevel Disconnect sensitivity Dsens Expiratory sensitivity Esens The percentage of returned volume lost above which the ventilator declares a circuit discon nect alarm when Leak Sync is not enabled or installed The percentage of Vmax that when reached causes the ventilator to cycle from inspiration t
34. 5 Occlusion is detected Operator s Manual 10 51 Theory of Operations 10 52 Table 10 5 Inspiratory and Expiratory Pause Events Continued Event Identifier Event 6 Apnea is detected 7 72 seconds have elapsed without an inspiratory pause after one has been requested 8 INSPIRATION TOO LONG alarm is detected 9 High inspired tidal volume TV alarm is detected 10 High compensation pressure TPcomp alarm is detected 11 Cancel is touched if maneuver is initiated from the GUI screen 12 Safety Valve Open SVO is detected 13 Patient trigger effort causes circuit pressure to go below sensitivity The sensitivity level is the setting value for pressure trigger or the backup pressure value for flow trigger 14 BUV is entered 15 Expiratory pause key is pressed Inspiratory pause key if maneuver is an expiratory pause During a manual inspiratory pause the maneuver is terminated if any of events 1 3 5 6 12 or 13 occur Reference nspiratory and Expiratory Pause Events p 10 51 An inspiratory pause maneuver is ignored if the ventilator is in Apnea ventila tion safety PCV OSC SVO BUV or Stand by state An active automatic inspiratory pause maneuver is terminated and exhalation begun if any of events1 12 or 14 occur Reference nspiratory and Expiratory Pause Events p 10 51 The active automatic inspiratory pause maneuver is considered complete if the pause d
35. After VS Startup the ventilator makes adjustments to the target pressure in order to deliver the set volume V7 supp In order to reach the desired volume promptly the maximum allowed pressure adjustments for an Adult or Pediatric patient will be greatest during the first five breaths following Startup or a change in V sypp The values of the maximum pressure adjustments for each patient type are summarized in the table below Table 10 4 Maximum Pressure Adjustments Conditions Maximum change in target pressure PBW gt 25 kg 15 kg lt PBW lt 25 kg 10 0 cmH 20 6 0 cmH20 PBW lt 15 kg Less than five breaths after VS startup or Change in V7 supp 3 0 cmH20 Five breaths or more after VS startup 3 0 cmH 20 3 0 cmH70 3 0 cmH20 Reference Non technical Alarm Summary p 6 18 for details on the following VS alarms e VOLUME NOT DELIVERED e COMPLIANCE LIMITED V e HIGH INSPIRED TIDAL VOLUME 1V7 10 26 Operator s Manual Short Self Test SST Monitored Patient Data Reference Patient Data Range and Resolution p 11 19 for details on the Spon taneous inspired tidal volume patient data parameter available during VS breaths 10 8 3 Tube Compensation Tube Compensation TC is a pressure supported spontaneous breath type available in SIMV SPONT and BiLevel modes When TC is enabled the patient s respiratory muscles are not required to work as hard to draw gase
36. After performing SST remove the assembly and place it into a protective bag or similar covered container 76 Component Sterilization To sterilize parts 1 Sterilize per the component s instructions for use or the steam sterilization proce dure described Reference Sterilization Parameters p 7 25 and Component Ster ilization Procedures on page 7 25 2 After the components are sterilized visually inspect them for cracks or other damage 3 Dispose of damaged parts according to the institution s policy 7 24 Operator s Manual Service Personnel Preventive Maintenance Table 7 4 Sterilization Parameters Autoclave sterilization Effective sterilization occurs by pre vac sterilization of wrapped goods 132 C for 4 minutes Refer to pre vac system manufacturer s program parameters or follow the steam sterilizer manufacturer s instructions 1 Disassemble the component 2 Clean the component 3 Wrap each component in a legally marketed sterilization wrap that has been cleared by FDA for use in pre vac sterilization using the parameters described above 4 Sterilize the wrapped parts 5 Inspect the sterilized parts for damage and discard if damaged 6 Reassemble the component 7 Install the component on the ventilator 8 Run SST Follow pre vac system manufacturer s instructions for use IFU Table 7 5 Component Sterilization Procedures Part Procedure Comments Cautions Re
37. Example of Freestanding Ventilator Placement VEN 10308 C 35 Product Connectivity 3 5 1 Connecting the Ventilator to AC Power e Note Power outlet access and power cord position Ensure that the power outlet used for the ventilator is easily accessible disconnection from the outlet is the only way to completely remove power from the ventilator To connect the power cord to AC power 1 Plug the ventilator into a properly grounded power outlet rated for at least 15 A Operator s Manual 3 5 Installation 3 6 2 Verify the connection by checking the AC indicator below the power switch on the front of the BDU Reference Ventilator Power Switch and AC Indicator p 2 26 for the power switch and AC indicator locations To connect the power cord to the ventilator 1 Remove the power cord retainer and connect the female end of the power cord to the ventilator s power cord receptacle Reference Power Cord Retainer on BDU p 3 7 2 Replace the power cord retainer Use the power cord hook located at the back of the ventilator for power cord storage WARNING For proper ventilator operation and to avoid the risk of electric shock connect the ventilator to a grounded hospital grade AC electrical outlet Operator s Manual Product Connectivity Figure 3 2 Power Cord Retainer on BDU 5 OX KA NY NO YS OSS IN KSI I NNN w RAK SOX x QO XX KA NOO KINS
38. S breath indi cators glow orange each appearing in inverse video where the indicator appears black surrounded by the colored glow Reference Areas of the GUI p 4 3 During the expi ratory phase the breath indicators appear as solid colors green during assist or control breaths and orange during spontaneous breaths Vital Patient data banner Located across the top of the GUI screen The patient data banner displays monitored patient data and can be configured to show desired patient data Reference Vital Patient Data p 3 42 for information on configuring patient data for display Alarm banners Located on the right side of the GUI screen Indicates to the operator which alarms are active and shown in a color corresponding to priority high is red and flashing medium is yellow and flashing low is yellow and steady Constant access icons Located at the lower right of the GUI screen This area allows access to home house configure wrench logs clipboard elevate oxygen percentage O and help question mark icon These icons are always visible regardless of the function selected on the GUI Constant access area Consists of the Current Settings area and the Constant access icons This area allows access to any of the patient setup variables shown in these areas Touching an icon causes the particular menu for that variable to appear Current settings area Located at the lower center of the GUI screen The
39. Status Display Indicator or Message Ventilator Hours 1000 PEEP je cmH Ventilator Hours 1000 Meaning Battery inoperative This image appears on the status display when a battery fault renders the battery inoperative Battery not installed This image appears when there is no primary battery installed and renders ventilator inoperative This image displays when the primary battery is removed during ventilator operation cmHj0 Display Ventilating as set Failed Replace ventilator Loss of GUI Indicates a loss of communication between the BDU and the GUI where the GUI cannot reliably display or receive ventilator infor mation This loss of communication could be caused by problems such as a GUI hardware fail ure faulty Ethernet or GUI reset If the indicator is visible ventilation continues as currently set Replace the ventilator as soon as it is appropriate to do so Service the ventilator prior to returning it for use on patients Ventilator Inoperative Replace Ventilator Ventilator inoperative Vent Inop Indicates the ventilator is no longer capable of ventilating a patient and requires service The alarm reset key cannot be used to restore function to the ventila tor during a ventilator inoperative condition Provide alternate means of ventilation immedi ately Note the display of the Safety Valve Open indicator Operator s Manual 2 33 Product Overview Table 2 9 S
40. Table Glossary 1 Glossary of Ventilation Terms Glossary 1 Table Glossary 2 Units of Measure aaa ee ence ences Glossary 9 Table Glossary 3 Technical Abbreviations e ee eee Glossary 10 XV xvi Page Left Intentionally Blank List of Figures Figure 2 1 Figure 2 2 Figure 2 3 Figure 2 4 Figure 2 5 Figure 2 6 Figure 2 7 Figure 2 8 Figure 2 9 Figure 2 10 Figure 2 11 Figure 2 12 Figure 3 1 Figure 3 2 Figure 3 3 Figure 3 4 Figure 3 5 Figure 3 6 Figure 3 7 Figure 3 8 Figure 3 9 Figure 3 10 Figure 3 11 Figure 3 12 Figure 3 13 Figure 3 14 Figure 3 15 Figure 4 1 Figure 4 2 Figure 4 3 Figure 4 4 Figure 4 5 Figure 4 6 Figure 4 7 Figure 4 8 Figure 4 9 Figure 4 10 Figure 4 11 Figure 4 12 GUNETONTI NEN aaa Ala a an 2 6 GUI Rear VIEW Gawaan makan RAOA 2 7 BDU Front ViEW a kaa Aa ae eo neo 2 8 BDU Rear View aga aaa an kaa Am eacauataicace 2 10 Installed Software Options ssssesssssseeessssssssssssseseessnsssssseosrerssssssssesse 2 11 Ventilator Right Side View un cccssssssssssssssccssssesssscsssssseessssessncencensess 2 14 Ventilator Left Side View ssssssssssssseessssssssssssceesossssssossereserssossesseeeseee 2 15 Ventilator Power Switch and AC Indicator ssssssssseeesessssssssseeeseee 2 26 Service Mode Button TEST sssssssssscssesssecssccssecsscensesscessccescesseesseessees 2 27 Sample Status Displa
41. The proximal Flow Sensor is used to measure low flows and pressures associated with neonatal ventilation If the ventilator is configured with this option Reference Appendix F for more infor mation Operator s Manual 2 35 Product Overview 213 Color Definitions Reference the following figures to view the ventilator s pneumatic diagram during inspiration with various colors representing the gases as shown below Table 2 11 Color Legend Color or Symbol Description High pressure Oxygen NFPA 99 designation High pressure Air NFPA 99 designation Mixed gases including air Atmosphere Vacuum 214 Pneumatic Diagrams The following figures illustrate the ventilator s pneumatics with and without the optional Proximal Flow System The Proximal Flow System is only for use with neonatal patients Operator s Manual 43 42 41 40 39 38 37 36 10 11 Operator s Manual GUI Controls and Indicators Figure 2 11 Pneumatic Diagram 3433 32 31 Pressure switch mix accumulator PS1 Solenoid Valve options supply SOL2 Pressure sensor mix accumulator Pux Accumulator mix ACCm Tube mix Ty Proportional solenoid valve patient gas delivery PSOLp Solenoid valve BUV SOL3 Safety valve SV Pressure Sensor safety valve Psy Solenoid valve inspiratory pressure sensor autozero SOL4 Pressure Sensor inspiratory Pj 12 13 14 15
42. Touch an item Displaying a tooltip dialog N A hold and hold for at on whatever item is least 0 5 seconds touched The tooltip appears to glow indicating the touch and hold action Drag and Touch and drag Dragging help icon to Drag the help icon located at the lower drop an item to describe an onscreen item right of the GUI screen to the item in ques another location tion and drop If a blue glow appears a and lift finger to tooltip is available and appears with infor drop mation about that item for example a control or symbol as Ventilator Operation Caution Do not set containers filled with liquids on the ventilator as spilling may occur Operator s Manual Operation 4 8 After turning on the ventilator it will display a Covidien splash screen and run Power On Self Test POST After the splash screen appears the ventilator gives a choice to ventilate the same patient or a new patient or run SST Ventilation parameters are entered via the graphical user interface GUI using the following general steps 1 Touch the setting displayed on the GUI 2 Turn the knob to the right to increase or to the left to decrease the value 3 Touch Accept to apply the setting or Accept ALL to apply several settings at once Note Quick Start allows for rapid setup and initiation of mechanical ventilation Review Quick Start parameters and ensure they are consistent with institutional practice before using this
43. Ventilator Settings Guidance 1 we ee es D 10 Specified performance cee ee eee ee D 11 Graphics Displays in PAV a eve Bea ad D 11 WOB Terms and Definitions 20 004 D 12 Technical Description PA D 14 Protection Against Hazard 2 4 44 see Pi ee beer dese D 19 NeoMode 2 0 Appendix ONEIVIEW ismo ie aT i 4444500 u0sdeuews LAT E 1 Intended Use 0 cee eee E 1 Safety Symbol Definitions 200220eeee E 1 Safety Information 00 cece eee eee E 2 Description PAPA E 3 Neonatal Door and Filter Installation E 3 Xi xii E 7 E 8 E 9 E 9 1 E 9 2 E 9 3 E 9 4 E 9 5 E 9 6 EO J F F 1 F 2 F 3 F 4 F 5 F 6 F 6 1 F 7 F 8 F 9 F 9 1 F 10 F 11 F 11 1 F 12 F 13 F 13 1 F 14 Glossary How to Empty the Condensate Vial E 5 Connecting the Breathing Circuit E 6 Ventilation Features es E 8 Predicted Body Weight PBW vs Patient Length E 8 Ale RA AP AA AA E 8 CPAP Mode a dann BRA hh GA HAKA BA ddd eke Me E 9 Entering CPAP From Other Ventilation Modes E 10 Exiting CPAP Mode 7a eure MAMA dees dean es E 11 Compliance Compensation 0 02002 e eee E 11 Settings Alarms and Monitored Patient Data E 11 Proximal Flow Option Appendix OVEIVIEW 45544005 6eae donna dd KAKA BA MANAKAWAN F 1 Intended Use 4am Sh base sane GWA AA F 1 Safety Symbol Definitions 20
44. b VEN 11163 B 3 5 2 Connecting the Gas Supplies The ventilator can be connected to hospital grade wall or bottled air and oxygen Reference Connecting the Ventilator to the Gas Supplies p 3 9 Both air and O supply pressure ranges must be between 35 and 87 psig 241 3 kPa to 599 8 kPa and the average flow requirement for both gases is 60 L min at 40 61 psi The transient will not exceed 200 L min for gt three 3 s Operator s Manual 3 7 Installation 3 8 WARNING Due to excessive restriction of the Air Liquide SIS and Drager hose assemblies reduced ventilator performance levels may result when oxygen or air supply pressures lt 50 psi 345 kPa are employed Gas cross flow from one high pressure input port of one type of gas to another high pressure input port of a different gas will not exceed 100 mL h under normal or single fault conditions If during a single fault condition cross flow exceeds 100 mL h an audible alarm annunciates WARNING Use of only one gas source could lead to loss of ventilation and or hypoxemia if that one gas source fails and is not available Therefore always connect at least two gas sources to the ventilator to ensure a constant gas supply is available to the patient in case one of the gas sources fails The ventilator has two connections for gas sources air inlet and oxygen inlet Reference Non technical Alarm Summary p 6 18 for alarms that occur due to a loss of eith
45. breath As defined by international standards organizations an abnormal condi tion that requires prompt attention to ensure the safety of the patient When a medium priority alarm is active the yellow medium priority LED indicator flashes the medium priority audible alarm a repeating sequence of three tones sounds and the GUI screen shows an alarm banner with the symbol Ventilatory mode The algorithm that determines type and sequence of breath delivery Non interchangeable screw thread A standard for high pressure gas inlet fittings Patient ventilation without the use of an endotracheal tube instead using interfaces such as masks nasal prongs or uncuffed endotracheal tubes An alarm caused due to a fault in the patient ventilator interaction or a fault in the electrical or gas supplies that the practitioner may be able to alleviate The state of the ventilator when breathing is in progress and no alarms are active Operator s Manual Operator s Manual Table Glossary 1 Glossary of Ventilation Terms Continued 07 OIM ongoing background checks OSC OVERRIDDEN patient circuit patient data alarm patient problems PBW PC PE PEEP Both a ventilator setting and a monitored variable The O2 setting determines the percentage of oxygen in the delivered gas The 07 monitored data is the percentage of oxygen in the gas delivered to the patient measured at the ventilator outlet upstrea
46. breath triggering and cycling but only indicates where in the patient s breath cycle an inspiration and expiration would have started if IE Sync were active cs Setting Up IE Sync To set up IE Sync 1 At the ventilator setup screen enter the patient s gender and height or PBW 2 Touch the Invasive vent type button C 2 Operator s Manual Technical Description 3 Touch SPONT mode 4 Touch PAV VS PS or TC to choose the spontaneous type 5 Touch IE Sync as the trigger type 6 Set the inspiratory triggering threshold Ices 7 Set the expiratory sensitivity threshold Esens s Continue setting up the ventilator as described in Chapter 4 of this manual Figure C 1 Setup Screen Preag Vie troy re a T 26 35 13 1 46 31 45 2 14 256 Ventilation Type Invasive NIV Mode 1101b OR VEN 11362 D Note If Leak Sync is currently enabled it becomes disabled when IE Sync is selected as the trigger type Leak Sync cannot be selected if using IE Sync as the trigger type Conversely If IE Sync is disabled then Leak Sync becomes selectable A message appears on the GUI stating IE Sync Startup until the IE Sync startup period completes The startup period takes three 3 breaths to reach a steady state after which it triggers and cycles the ventilator breaths During the startup period the default ventilator settings are e Trigger type P RIG PSENS 2 cmH 0 Operator s Manual C 3 IE Sync
47. changes as pressure changes Selected pressure units Measured PEEP During Service mode the status display supplies Operator s Manual Ventilator serial number s Ventilator operational time EST and SST history Power On Self Test POST status Hours until next preventive maintenance is due Gas pressure at the manifold inlets 2 29 Product Overview 2 30 Reference the table below for status display possibilities Typical Status Display Indicators and Messages The following table lists indicators and messages that appear on the status dis play Table 2 9 Status Display Indicators and Descriptions Status Display Indicator or Message Puritan Bennett 980 Ventilator EJ covinien Meaning Splash screen Appears when the ventilator s power switch is turned on When this image appears press and release the TEST button at the back of the ventilator to enter Service mode Puritan Bennett 980 Ventilator EJ coven LP0125 POST Failed Primary Battery Not Installed POST failure This image appears if a POST error occurs at ventilator start up along with the error code in this case a missing primary battery Ventilator Hours 1000 Prior to patient connection The status display appears as shown when the patient has not been connected to the ventilator Note the absence of Ppeax and PEEP values Operator s Manual GUI Controls and Indicators Table 2 9 Status
48. e Spontaneous SPONT mode allows the patient to control ventilation The patient must be able to breathe independently and exert the effort to trigger ventilator support e Synchronous Intermittent Mandatory Ventilation SIMV is a mixed mode that allows a combination of mandatory and spontaneous interactions In SIMV the breaths can be spontaneous or mandatory mandatory breaths are synchronized with the patient s inspiratory efforts and breath delivery is determined by the f setting e BiLevel is a mixed mode that combines both mandatory and spontaneous breath types Breaths are delivered in a manner similar to SIMV mode with PC selected but providing two levels of pressure The patient is free to initiate spontaneous breaths at either pressure level during BiLevel Changes to the mode are phased in at the start of inspiration Mandatory and spontaneous breaths can be flow or pressure triggered or IE Sync triggered if the IE Sync software option is installed The ventilator automatically links the mandatory type setting to the mode set ting During A C or SIMV modes once the operator has specified volume or pressure the ventilator displays the appropriate breath parameters Changes in the mandatory type are phased in at the start of inspiration 10 15 5 Respiratory Rate f The f setting determines the minimum number of mandatory breaths per minute for ventilator initiated mandatory breaths in A C SIMV and BiLevel modes If t
49. flow sensor assembly Caution Use specified cleaning disinfecting and sterilization agents and procedures for the appropriate part as instructed 74 Surface Cleaning of Exterior Surfaces External surfaces of the GUI BDU and ventilator base may become soiled and should be cleaned periodically To clean the GUI BDU and ventilator base surfaces da Moisten a soft cloth with one of the surface cleaning agents listed or use Sani Cloths PDI Inc Reference Surface Cleaning Agents p 7 5 Wipe the GUI BDU and ventilator base removing any dirt or foreign substances Dry all components thoroughly If necessary vacuum any cooling vents on the GUI and BDU with an electrostatic discharge ESD safe vacuum to remove any dust Operator s Manual Table 7 2 Surface Cleaning Agents Service Personnel Preventive Maintenance Part Ventilator exterior including touch screen and flex arm Procedure Wipe clean with a cloth damp ened with one of the cleaning agents listed below or equiva lent Use a damp cloth and water to rinse off chemical residue as necessary Comments Cautions Do not allow liquid or sprays to penetrate the ventilator open ings or cable connections Mild dish washing detergent solution Do not attempt to sterilize the ventilator by exposure to eth ylene oxide ETO gas Isopropyl alcohol 70 solu tion Bleach 10 solution Do not use pressurized air to clea
50. if appropriate 4 7 7 NIV Apnea Setup Set the patient s apnea parameters as described Reference Apnea Settings p 4 15 NIV does not change the way apnea parameters are set 4 7 8 NIV Alarm Settings The system initially sets most alarm settings based on the patient s PBW Review all alarm settings and change as necessary but startup does not require confirmation of the settings Figure 4 11 Default NIV Alarm Settings Waiting for patient connect Setup Alarms Preax frot Ve TOT Vre MAND Vre SPONT Vin THO Umir L mil mil mi OFF 10 300 44 0 0 N VEN 11355 D Touch the Alarms tab at any time during ventilation to show the current limits and the monitored patient value shown in white on the indicating arrows for each alarm If an alarm is occurring the indicator LED color changes based on alarm priority Reference Alarm Prioritization p 6 16 for colors and meanings Operator s Manual 4 27 Operation of alarms and their priorities e Note The upper and lower limits of an alarm cannot conflict with each other o LAP Note The upper limits for the spontaneous exhaled tidal volume and mandatory exhaled tidal volume alarms are always the same value Changing the upper limit of one alarm automatically changes the upper limit of the other ss Manual Inspiration A manual inspiration is an operator initiated mandatory OIM inspiration KIN When the operator presses the Manual inspiration key the ventilato
51. or computed T volume ventilation lapses 10 5 4 IE Sync Cycling IE Sync detects the end of inspiration when a real time estimate of the time derivative of intra pleural pressure Ps Psync drops below the set Esens threshold Operator s Manual 10 11 Theory of Operations 10 5 5 Backup Methods There are four backup methods for preventing excessive duration or pressure during inspiration e Time limit e High circuit pressure limit e High ventilator pressure limit e High inspired tidal volume limit 10 5 6 Time Limit For adult and pediatric patients the time limit method ends inspiration and begins exhalation when the duration of a spontaneous inspiration is greater than or equal to 1 99 s 0 02 x PBW kg s 10 5 7 High Circuit Pressure Limit During any type of inspiration inspiration ends and exhalation begins when the monitored airway pressure Pcjpc is greater than or equal to the set high circuit pressure limit 10 5 8 High Ventilator Pressure Limit The ventilator transitions from inspiration to exhalation if the high ventilator pressure TPyenr limit of 110 cmH30 is reached 10 5 9 High Inspired Tidal Volume Limit The high inspired tidal volume limit terminates inspiration and commences exhalation during VC VS tube compensated TC or proportionally assisted PAV breaths if the delivered volume is greater than or equal to TV Note The ventilator does not generate subatmospheric airway pre
52. or vice versa To avoid breath stacking a manual inspiration is not delivered during inspi ration or during the restricted phase of exhalation Reference Manual Inspiration p 10 22 for information on the restricted phase of exhalation The Manual inspiration key can be used to deliver mandatory breaths to the patient or to run an inspiratory pause maneuver in SPONT mode The manual inspiration key cannot be used to run an expiratory pause maneuver in SPONT mode Inspiratory pause key Initiates an inspiratory pause which closes the inspiratory and exhalation valves and extends the inspiratory phase of a mandatory breath for the purposes of measuring end inspiratory pressure Pj eyp for calculation of plateau pressure Pp static compliance Cstaq and static resistance Rstaz L A EN E E Expiratory pause key Initiates an expiratory pause which extends the expiratory phase of the current breath in order to measure total PEEP PEEPyo7 Alarm reset key Clears active alarms or resets high priority alarms and cancels an active alarm silence An alarm reset is recorded in the alarm log if there is an active alarm DEVICE ALERT alarms cannot be reset RR Alarm silence key Silences alarms for two minutes Cancel the alarm silence function by touching the on screen Cancel button 2 10 2 Visual Indicators The table below shows the GUl s visual indicators Reference Areas of the GUI
53. p 3 48 A WARNING Check for leaks in the ventilator breathing system by running SST prior to ventilating a patient WARNING Lock the ventilator s casters during use to avoid the possibility of extubation due to inadvertent ventilator movement A WARNING The ventilator accuracies listed in the Ventilator Settings Alarm Settings and Patient Data tables in Chapter 11 are applicable only under specified operating conditions Reference Environmental Specifications p 11 7 If the ventilator is operated outside specified ranges the ventilator may supply incorrect information and the accuracies listed in the aforementioned tables do not apply A hospital Biomedical Technician must verify the ventilator is operated in the environmental conditions specified 1 3 6 Warnings Regarding Electrical Power WARNING To avoid the risk of electrical shock e Use only Covidien branded batteries adapters and cables e Do not use batteries adapters or cables with visible signs of damage e Do not touch internal components 1 8 Operator s Manual Safety Information 1 3 7 Warnings Regarding Ventilator Settings WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of t
54. p 4 3 for area names The alarm silence function has two visual indicators the alarm silence key on the GUI bezel glows yellow during an alarm silence interval and a visual count Operator s Manual Product Overview down timer appears showing the amount of time the alarm silence interval has remaining Table 2 6 GUI Visual Indicators Symbol Description Ventilator Setup Vent Setup button Located at the lower left corner of the GUI Touch this button to open the ventilator setup screen Adult patient circuit indicator Indicates adult circuit type tested during SST and in use Appears above the Vent Setup button Pediatric Pediatric patient circuit indicator Indicates pedi atric circuit type tested during SST and in use Appears above the Vent Setup button Neonate Neonatal patient circuit indicator Indicates neo natal circuit type tested during SST and in use Appears above the Vent Setup button z Home icon A constant access icon Reference Areas of the GUI p 4 3 Touch this icon to dismiss all open dialogs on the GUI screen The display resumes showing the ventilator wave forms Alarms icon A constant access icon Reference Areas of the GUI p 4 3 Touch this icon to display the alarm settings screen which allows alarm limits to be changed Logs icon A constant access icon Reference Areas of the GUI p 4 3 Touch this icon to display the
55. parameter alarm settings items 2 and 3 recent range of patient data values for the last 200 breaths item 4 If an alarm occurs the slider and correspond ing limit button show a color matching the alarm s priority Reference Alarm Screen During Operation p 4 19 Operator s Manual Ventilator Shutdown Figure 4 8 Alarm Screen During Operation Pres Vre fror KE PEEP Nieman Preno 20 116 30 1 1 8 49 100 20 Setup Alarms Ppeax fror Ve ToT Vie MAND Vre SPONT Vin mf Vere yi OFF o 1290 1290 2 230 3 fi 4 0 050 1 P Ti Pure 20 0 50 15 VEN 11448 A 1 Pointers show current value of patient 3 Low alarm setting in this case data corresponding to the alarm LVE spont parameter 2 High alarm setting in this case 4 Range of patient data values for the particular parameter during the last TVre spon baha reaths 4 5 5 Making Ventilator Settings Changes If during ventilation settings changes are necessary that don t involve changes to PBW Mode Breath types or Trigger types the current settings area located at the lower portion of the GUI screen can be used Reference Areas of the GUI p 4 3 for the location of the current settings area Operator s Manual 4 19 Operation To change a ventilator setting using the current settings area 1 In the current settings area touch the parameter whose value needs to be changed A dialog appears containing buttons for all ventilator settings with the selected se
56. patient Medium data alarm Measured 07 gt set for gt 30s but lt 2 min High Measured 07 gt set for gt 2 min Check patient gas sources O analyz er amp ventilator The O2 measured during any phase of a breath cycle is 7 12 during the first hour of opera tion or more above the O2 setting for at least 30 seconds These percentages increase by 5 for four minutes fol lowing a decrease in the O2 setting Operator s Manual 6 21 Performance 6 22 Table 6 5 Non technical Alarm Summary Continued Analysis message Remedy message Comments 402 patient High Measured O2 Check patient gas The O2 measured data alarm lt set 07 sources O2 analyz during any phase of er amp ventilator a breath cycle is 7 12 during the first hour of opera tion or more below the O2 setting for at least 30 seconds or below 18 These percentages increase by 5 for four minutes fol lowing an increase in the O2 setting TV re patient Low Last 2 breaths gt Check settings Exhaled tidal data alarm set limit changes in volume gt set limit patient s R amp C Alarm updated Medium Last 4 breath s gt whenever exhaled set limit tidal volume is High aco armor ee Possi breaths gt set S dependent imit alarm VE TOT We tor patient Low Vg tor 2 set limit Check patient and Expiratory minute data alarm forz 30s settin
57. retention of particles 0 3 um nominal at 100 L min flow lt 0 58 cmH30 at 2 5 L min NEONATAL lt 0 25 mL cmH 20 to gt 3 0 mL cmH 20 PEDIATRIC 1 05 mL cmH 30 to 9 mL cmH 20 ADULT 1 05 mL cmH 0 to 12 mL cmH 0 Inspiratory limb circuit resistance NEONATAL 0 2 cmH5 0 L s to 3 5 cmH O L s PEDIATRIC 0 2cmH 0 to 7 5 cmH2O L s ADULT 0 2cmH530 to 12 5 cmH O L s Expiratory limb circuit resistance NEONATAL 0 2 cmH O L s to 3 5 cmH2O L s PEDIATRIC 0 2cmH30 to 7 5 cmH 0 ADULT 0 2cmH20 to 12 5 cmH 20 Alarm volume primary Measurement uncertainty 3 dBA High priority alarm volume range dBA 58 volume setting 1 to 86 volume setting 10 Medium priority alarm volume range dBA 52 volume setting 1 to 78 volume setting 10 Low priority alarm volume range dBA 50 volume setting 1 to 76 volume setting 10 Measured 1 m from front rear and sides of ven tilator Reference Alarm Volume Key p 6 8 for alarm volume behavior during an alarm condition Alarm volume secondary Measurement uncertainty 3 dBA Minimum 64 dBA measured 1 m from front rear and sides of ventilator Operator s Manual Specifications 11 4Electrical Specifications Table 11 5 Electrical Specifications Electrical ratings 100V 50 60 Hz 2 25A 120V 50 60 Hz 1 5A 220 240 V 50 60 Hz 0 75A Mains overcurrent release CB1 4A Earth leakage current 300 pA Touch current 100 pA
58. than ten minutes of battery power remaining The ventilator annunciates a high priority LOW BATTERY alarm when less than five minutes of battery power are estimated available 6 5 10 Apnea Alarm The APNEA alarm indicates neither the ventilator nor the patient has triggered a breath for the operator selected apnea interval Ta Ta is measured from the start of an inspiration to the start of the next inspiration and is based on the ventilator s inspiratory detection criteria Ta can only be set via the apnea ven tilation settings The APNEA alarm autoresets after the patient initiates two successive breaths and is intended to establish the patient s inspiratory drive is reliable enough to resume normal ventilation To ensure the breaths are patient initiated and not due to autotriggering exhaled volumes must be at least half the inspired V7 this avoids returning to normal ventilation if there is a disconnect 6 5 11 CIRCUIT DISCONNECT Alarm The CIRCUIT DISCONNECT alarm indicates the patient circuit is disconnected at the ventilator or the patient side of the patient wye or a large leak is pres ent The methods by which circuit disconnects are detected vary depending on breath type Time pressure flow delivered volume exhaled volume and the Dsens setting may be used in the circuit disconnect detection algorithms Ref erence Disconnect p 10 47 for a complete discussion of the CIRCUIT DISCON NECT detection methods The CIRC
59. the individual sensor uncertainties are combined and applied as applicable to determine the accep tance limits 11 3Physical Characteristics Table 11 2 Physical Characteristics Weight 113 Ib 51 26 kg including BDU GUI standard base and primary battery BDU only 69 Ib 31 3 kg Dimensions Ventilator 12 5 width x 11 5 depth x 43 5 height 32 cm x 30 cm x 111 cm not including GUI screen Ventilator 12 5 width x 11 5 depth x 58 height 32 cm x30 cm x 148 cm including GUI screen Standard base 22 5 width x 26 depth 58 cm x 66 cm A weighted sound pressure level ventilator average At a distance of one 1 meter does not exceed 48 dBA at 5 L min A weighted sound power level ventilator Does not exceed 58 dBA below 500 mL min Connectors Inspiratory and expiratory limb connectors are 22 mm OD conical fittings compliant with ISO 5356 1 Inspiratory Expiratory filters Reference filter Instructions For Use for complete specifications Pressure units chosen by oper ator Hectopascal hPa centimeters of water cmH 0 Displayed weight units Kilograms kg or Pounds Ib user selectable Displayed length units Centimeters cm or Inches in user selectable Operator s Manual Physical Characteristics Table 11 3 Pneumatic Specifications Oxygen and air inlet supplies Pressure 241 to 600 kPa 35 psi to 87 psi Flow Maximum of 2
60. value Reference Ventilator Settings Range and Resolution p 11 8 Operator s Manual 4 25 Operation 4 7 6 High Spontaneous Inspiratory Time Limit Setting NIV includes a setting in SIMV or SPONT modes for High Spontaneous Inspira tory Time limit TT spon When a patient s inspiratory time reaches or exceeds the set limit the ventilator transitions from inspiration to exhalation and the TT spont symbol appears at the lower left on the GUI screen indicating the ventilator has truncated inspiration shown below The TT sponr setting does not restrict changes to PBW if the PBW is decreased TT spont May decrease automatically to remain within its allowable limits Figure 4 10 TT sponr Indicator Vie mano Pre Vie troy KE PEEP Pana Devas 12 253 AD Mise 6 6 3 09 253 gt 10 39o 44 50 0 0 VEN 11354 D WARNING No audible alarm sounds in conjunction with the visual TT sponr indicator nor does the indicator appear in any alarm log or alarm message It is possible the target inspiratory pressure may not be reached if the TT spont setting is not long enough or if system leaks are so large as to cause the ven tilator to truncate the breath at the maximum allowableTT sponr setting 4 26 Operator s Manual Ventilator Shutdown Note To reduce the potential for not reaching the target pressure minimize the leaks in the system and increase the Rise time Yo and or decrease the Esgyg setting
61. ventilator s current active settings display here Touching any of the current set tings buttons causes a dialog to appear allowing changes using the knob Vent Setup Button Located at the lower left of the GUI screen Touching this button allows access to the ventilator setup screen Adjusting GUI Viewing Properties 4 4 Operator s Manual Ventilator Shutdown Screen Opacity The opacity control enables the operator to adjust the opacity of the displayed information between 50 and 100 At 50 the displayed image is semi transparent and at 100 the displayed image is opaque The opacity value remains as set if power is cycled and if the same patient is ventilated If a new patient is ventilated the opacity defaults to 85 Reference To adjust the ia screen opacity p 3 46 for instructions on adjusting this feature Pushpin Feature The pushpin feature prevents a dialog from closing under certain conditions when it is pinned Like the opacity control the pushpin appears on the settings screen after a new patient starts ventilation Figure 4 2 Pushpin Icon oO o 1 Pushpin icon unpinned state 2 Pushpin icon pinned state To use the pushpin 1 When a dialog is open for example if Accept or Accept ALL buttons are available touch the unpinned pushpin icon to pin the dialog and hold it open 2 Touch Close to close the dialog Display Brightness Display brightness can be controlled manually
62. when managing a patient s treatment Some of the logs are accessible during ventilation and some logs are only available to Covidien personnel when the ventilator is in Service mode The Puritan Bennett 980 Series Ventilator Service Manual gives more details regarding logs available to qualified service personnel When New Patient is selected during ventilator setup patient data ventilator settings and alarm logs are cleared but this information is available for Service personnel review following New Patient selection when the ventilator is set up e Alarms Log The alarm log records up to 1000 alarms that have occurred whether they have been reset or autoreset the priority level and their analysis messages The alarm log is accessible during normal ventilation and in Service mode A date and time stamped entry is made in the log whenever an alarm is detected escalated reset or auto reset An entry is also made when an alarm silence interval begins ends or is canceled If one or more alarms have occurred since the last time the alarm log was viewed a triangular icon appears on the GUI A indicating there are unread items The alarm log is stored in non volatile memory NVRAM and may be re displayed after the ventilator s power is cycled If the ven tilator enters BUV for any reason this is also entered into the alarm log The alarm log is cleared by setting the ventilator up for a new patient e Settings Log The setting
63. 00 lands Belgium Croatia Turkey Russia Slovenia Serbia Bul garia Romania Air hose assembly United Kingdom Ireland Switzerland 4 074713 00 Hungary Slovakia Czech Oxygen hose assembly Norway Sweden Finland Denmark 4 074697 00 Greece France Oxygen hose assembly Canada 4 074710 00 Oxygen hose assembly Italy Switzerland Spain Belarus 4 074705 00 Kazakhstan Oxygen hose assembly Japan Israel 10001766 Oxygen hose assembly Poland Portugal South Africa 4 074705 00 Oxygen hose assembly Switzerland 4 074708 00 Oxygen hose assembly United States Latin America 4 001474 00 Oxygen hose assembly Germany Luxembourg Austria 4 074715 00 Netherlands Belgium Croatia Turkey Russia Slovenia Serbia Bulgaria Romania Oxygen hose assembly United Kingdom Ireland Switzer 4 074698 00 land Hungary Slovakia Czech For countries not identified contact your local Covidien representative for the proper air and oxygen hose part numbers 10 Cylinder mount for compressed Air and O gas 10086050 11 Flex arm assembly 4 032006 00 12 Rechargeable Lithium lon battery 10086042 Operator s Manual Item number Table 9 1 Covidien Accessories and Options Continued Accessory or option description Humidifier bracket General Accessory Information Part number 10086049 Drain Bag Clip 10087137 Inspiratory bacterial filter reusable Re Flex 4 074600 00 Inspiratory bacterial filter dispo
64. 1 IEC classification 2 3 Inspiration Detection and Initiation 10 4 10 8 Inspiratory Pause 10 50 10 53 Inspiratory pause maneuvers 4 30 10 50 Inspiratory Pressure P 10 64 Inspiratory Time T 10 65 Installation Testing testing prior to ventilating a patient 3 46 3 51 L Leak Sync option B 1 Low Pressure BiLevel 10 66 Low Time BiLevel 10 67 M Mandatory Breath Delivery 10 17 Manual Inspiration 4 28 10 22 Manufacturer 1 20 MISCA response 5 6 MISCF response 5 10 Mode and Breath Type 10 60 Monitored Patient Data 6 42 N NeoMode 2 0 option E 1 NIV alarm settings 4 27 apnea settings 4 27 high spontaneous inspiratory time limit setting 4 26 setup 4 23 Non invasive ventilation NIV 4 22 4 28 O Occlusion a 10 45 Omni directional LED 3 30 On screen Help 1 18 On screen Symbols and Abbreviations 2 20 2 23 Operation Verification 3 58 oxygen sensor calibration 4 34 calibration test 4 34 function 4 32 P Po Maneuver 10 55 Patient Data Parameters 6 43 6 50 patient data range and resolution 11 19 11 26 PAV option D 1 Peak Inspiratory Flow Vmax 10 62 PEEP pa aha tesa a aha 10 67 PEEP restoration 10 67 Percent Support PAV 1
65. 1 1 pos pass Introduction Overview This manual contains information for operating the Puritan Bennett 980 Series Ventilators Before operating the ventilator system thoroughly read this manual The latest version of this manual is available on the Internet at http www covidien com To order an additional copy of this manual contact Covidien Customer Service or your local representative Related Documents Documentation is available online at the URL above Covidien makes available all appropriate information relevant to use and service of the ventilator For further assistance contact your local Covidien representative e The Puritan Bennett 980 Series Ventilator Operator s Manual Provides basic information on operating the ventilator and troubleshooting errors or mal functions Before using the ventilator thoroughly read this manual e The Puritan Bennett 980 Series Ventilator Service Manual Provides infor mation to Covidien trained service technicians for use when testing troubleshoot ing repairing and upgrading the ventilator This chapter contains the following e Symbol definitions e Safety Information including Warnings Cautions and Notes e Technical assistance information e How to access on screen Help e How to access warranty information e Serial number interpretation e Information regarding Electromagnetic susceptibility 1 1 Introduction 12 Global Symbol Definiti
66. 10 66 extended battery installation 3 22 Extended Self Test EST 10 77 F Filter Installation 3 10 Flow Pattern 10 63 Flow Sensitivity Vsens PTEE 10 63 G gas failure cross flow 3 8 Gestures 4 6 4 7 double tap 4 7 drag and drop 4 7 touch and hold 4 7 gestures Drag 4 7 swipe 4 6 Graphical User Interface GUI 2 16 GUI Control Keys 2 16 GUl control keys 2 16 GUI indicators audible 2 23 visual 2 17 2 20 GUI screen capture 5 2 H hard bound 4 3 4 4 High Pressure BiLevel 10 66 High Spontaneous Inspiratory Time Limit FT SPONT Pr era er ae et ere eer ae er 10 70 High Time BiLevel 10 66 how to enter Service mode 3 33 How to Install Accessories 3 18 3 30 how to use the ventilator system 4 7 4 21 how to use the ventilator s user interface 4 25 leis bel i ee eee ee 4 7 how to view ventilator logs 8 3 Humidification Type 10 71 humidifier installation 3 27 Humidifier Volume 10 71 l I E Ratio iior na ai ia 10 66 icons configure 2 19 elevate O 2 19 grid lines 2 20 help 2 19 high priority alarm 2 20 logs 2 18 low priority alarm 2 20 maximize waveform 2 20 medium priority alarm 2 20 pause 2 19 restore waveform 2 20 screen capture 2 19 unread items 2 19 ventilator setup 2 18 waveform layout 2 19 IE Sync option C
67. 1000 charge discharge cycles were used for this data the run time can be expected to be approximately 55 minutes 3 6 4 Battery Life Battery life for both primary and extended batteries is approximately three 3 years Actual battery life depends on the history of use and ambient conditions As the batteries age with use the time the ventilator will operate on battery power from a fully charged battery will decrease Replace the battery every three 3 years or sooner if battery operation time is insufficient for your usage 3 6 5 Battery Disposal The battery is considered electronic waste and must be disposed of according to local regulations Follow local governing ordinances and recycling plans regarding disposal or recycling of the battery 3 6 6 Flex Arm Use the flex arm to support the patient circuit between the patient and the ventilator Reference Flex Arm Installation p 3 26 which illustrates flex arm installation into the sockets provided Operator s Manual 3 25 Installation Figure 3 12 Flex Arm Installation VEN 10330 B To attach or remove the flex arm 1 Locate the threaded inserts in the ventilator s handle 2 Fasten the flex arm into one of the inserts 3 Hang the patient circuit using the circuit management supports included with the flex arm 4 Remove the flex arm by first removing the patient circuit then un fastening the flex arm from the threaded fastener in the handle 3 26 Operator
68. 15 Ib Software controls prevent inadvertent mismatching of patient size and breathing circuit type A neonatal breathing circuit connects to a neonatal expiratory filter which must be used with the neonatal adapter door assembly Note To enable NeoMode 2 0 select the neonatal breathing circuit type in Short Self Test SST Breathing circuit type can only be changed during SST NeoMode 2 0 software restricts the circuit type selection to neonatal es Neonatal Door and Filter Installation WARNING Removing the expiratory filter while the patient is connected to the ventilator can cause a loss of circuit pressure ventilator autotriggering or direct contact with liquid Caution Do not pull on door while expiratory filter latch is closed as damage to the ventilator can result Operator s Manual E 3 NeoMode 2 0 Appendix E 4 Note Reference the Inspiratory filter and expiratory filter instructions for use IFU for information on filtration efficiency and filter resistance To install the neonatal adapter door 1 Remove expiratory limb of patient circuit from expiratory filter 2 Lift expiratory filter latch Reference Installing Neonatal Filter and Door p E 4 3 Remove existing expiratory filter door by lifting it off of pivot pins 4 Fit neonatal adapter door onto pivot pins To install neonatal expiratory filter assembly 1 With the door still open push the neonatal filter straight up into the adapter 2
69. 351 21 445 05 88 Covidien Puerto Rico Palmas Industrial Park Road 869 Km 2 0 Bdlg 1 Cata o PR 00962 Tel 787 993 7250 Ext 7222 amp 7221 Fax 787 993 7234 Covidien Russia 53 bld 5 Dubininskaya StreetMoscow RUSSIA 119054 Tel 70 495 933 64 69 Fax 70 495 933 64 68 Covidien Saglik A S Maslak Mahallesi Bilim Sokak No 5 Sun Plaza Kat 2 3 Sisli Istanbul 34398 Turkey Tel 90 212 366 20 00 Fax 90 212 276 35 25 Covidien South Africa Corporate Park North 379 Roan Crescent RandjesparkMidrand South Africa Tel 27 115 429 500 Fax 27 115 429 624 Operator s Manual Introduction Soh wledge base Covidien Spain S L C Fructuds Gelabert 6 8 Planta 08970 Sant JoanDespi Barcelona Spain Tel 34 93475 86 10 Fax 34 93 477 10 17 Covidien Sverige AB Hemvarnsgatan 9 Box 54 SE 171 74 Solna Sweden Tel 46 0 8517 615 73 Fax 46 0 8 517 615 79 Covidien Switzerland Roosstrasse 53 Ch 8832 Wollerau Switzerland Tel 41 0 44 786 50 50 Fax 41 0 44 78650 10 Covidien Thailand 319 Chamchuri Square 17th Floor Unit 1 8 Phayathai Road Pathumwan Bangkok 10330 Thailand Tel 66 2 207 3 100 Fax 66 2 207 3101 Covidien UK 4500 Parkway Whiteley Fareham Hampshire PO157NY United Kingdom Tel 44 0 1329 2240002 Fax 44 0 1329 ER bas Covidien USA 2101 Faraday Ave Carlsbad CA 92008 Phone 1 800 255 6774 option 4 Email V
70. 6 RSET lt CR gt 5 4 6 SNDA Command The SNDA command instructs the ventilator to send information on ventilator settings and monitored patient data to the host system Enter the SNDA command exactly as shown SNDA lt CR gt When the ventilator receives the command SNDA lt CR gt it responds with the code MISCA followed by ventilator settings and monitored patient data infor mation The MISCA response follows this format MISCA 706 97 lt STX gt FIELD 5 FIELD 101 lt ETX gt lt CR gt 1 2 3 4 5 6 7 1 Response code to SNDA command 5 Data field left justified and padded with spaces 2 Number of bytes between lt STX gt and 6 End of transmission 03 hex lt CR gt 3 Number of data fields between lt STX gt 7 Terminating carriage return and lt ETX gt 4 Start of transmission 02 hex Fields not available are marked as Not used Underscores represent one or more spaces that pad each character string The table below lists MISCA responses to SNDA commands Table 5 1 MISCA Response MISCA Response to SNDA command 5 characters 706 The number of bytes between lt STX gt and lt CR gt 3 characters 97 The number of fields between lt STX gt and lt ETX gt 2 characters lt STX gt Start of transmission character 02 hex Operator s Manual Component Data Transfer Table 5 1 MISCA Response Continued Ventilator time HH MM_ 6 characters Ventilator ID to allow external
71. 6 Attaching Proximal Flow Sensor VEN_10359_A 1 Endotracheal tube 2 Breathing circuit wye 2 Connect the smaller end of the sensor to the breathing circuit wye 3 Ensure the sensor tubing is positioned in an upward direction as shown in the figure above If the sensor needs repositioning DO NOT rotate it by pulling on the tubing Reposition as follows a Grasp the sensor s plastic body with one hand and the breathing circuit wye with the other hand b Rotate the sensor body and wye towards each other until the sensor tubing is upright c Confirm a tight connection between the sensor and breathing circuit wye F 14 Operator s Manual Part numbers 4 Use the three cable management clips provided with the sensor to attach the sensor tubing to the breathing circuit tubing Space the clips evenly along the length of the sensor tubing Twist the ends of each clip to close Note When the ventilator is set up for Proximal Flow Option operation the Proximal Flow Sensor can be switched as necessary There is no need to run SST after switching sensors unless the breathing circuit or other ventilator accessories have been changed F 11 1 How to Perform a Manual Purge A manual purge may be performed any time the sensor lines contain excessive condensation moisture or secretions To perform a manual purge 1 Touch the Configure icon on the in the constant access icons area of the GUI 2 Touch the Options tab A screen a
72. A 1 Pressure CmH 0 2 Flow L min 10 8 4 Proportional Assist Ventilation PAV PAV is another type of spontaneous breath which is available only if the PAV option is installed For detailed description of the operating theory ref erence Appendix D in this manual 10 9 A C Mode When the ventilator is in assist control A C mode only mandatory breaths are delivered These mandatory breaths can be PC VC or VC breaths Refer ence Mandatory Breath Delivery p 10 17 for a more detailed explanation of VC breaths As for any mandatory breath the triggering methods can be P_tric V tric time triggered or operator initiated If the ventilator senses the patient initiating the breath a PIM or assist breath is delivered Otherwise VIM breaths control breaths are delivered based on the set respiratory rate The length of the breath period is defined as Operator s Manual 10 31 Theory of Operations where Tb 60 f Tb breath period s f set respiratory rate breaths per minute The inspiratory phase length is determined by the current breath delivery set tings At the end of the inspiratory phase the ventilator enters the expiratory phase as determined by the following equation Ny ty ll where Te length of the expiratory phase s T length of inspiratory phase s including plateau time Tp The figure shown below illustrates A C breath delivery when there is no patient inspiratory effort detec
73. Alarm Summary p 6 18 for details of the TPcomp TPyent and TV alarms associated with TC Monitored Patient Data Reference Patient Data Range and Resolution p 11 19 for details of the inspired tidal volume V monitored patient data parameter a associated with TC Tube Inside Diameter ID The ventilator uses soft bound and hard bound values for estimated tube inside diameter ID based on PBW Soft bounds are ventilator settings that have reached their recommended high or low limits When adjusting the tube size if the inside diameter does not align with a valid predicted body weight a Continue button appears Setting the ventilator beyond these soft bounds requires the operator to acknowledge the prompt by touching the Continue button before continuing to adjust the tube size The limit beyond which the tube ID cannot be adjusted is called a hard bound and the ventilator emits an invalid entry tone when a hard bound is reached Operator s Manual Short Self Test SST WARNING Greater than expected ventilatory support leading to unknown harm can result if the specified tube type or tube ID is smaller than the actual tube type or tube ID Ventilator Settings Guidelines The estimation of settings to use with TC is aided by an understanding of the ventilator settings the data used for determination of the compensation values and the specified performance or accuracy of the TC function The setting for TPpra
74. Because the PAV algorithm does not know the patient s mechanics when the PAV breath type is selected the software performs a startup routine to obtain initial data At startup PAV software delivers four consecutive PAV breaths each of which includes an end inspiratory pause maneuver that yields esti mates of the patient s resistance and compliance The first breath however is delivered using the predicted resistance for the artificial airway and conserva tive estimates for patient resistance and compliance based on the patient s PBW Each of the next three PAV breaths averages stepwise decreased physiologic values with the estimated resistance and compliance values from the previous breath weighting earlier estimates less with each successive breath and yield ing more reliable estimates for resistance and compliance The fifth PAV breath the first non startup breath is delivered using the final estimates with the clinician set Supp setting Once startup is complete the PAV software randomly applies a maneuver breath every four to ten breaths after the last maneuver breath to re estimate patient resistance and compliance New values are always averaged with former values The PAV option graphically displays estimates of patient lung pressure intrin sic PEEP patient compliance patient resistance total resistance total work of inspiration patient work of inspiration inspiratory elastic work an indicator of lung thorax
75. Bennett 980 Series Ventilator Service Manual for instructions on downloading ventilator logs s6 Diagnostic Codes Refer to the diagnostic log for the codes generated during patient ventilation For a more information on the diagnostic codes reference the Puritan Ben nett 980 Series Ventilator Service Manual or contact Covidien Technical Sup port 8 4 Operator s Manual 9 Accessories 91 Overview This chapter includes accessories that can be used with the Puritan Bennett 980 Series Ventilator Reference Covidien Accessories and Options p 9 4 for part numbers of any items available through Covidien The following commonly available accessories from the listed manufacturers can be used with the ventilator system e Filters DAR Covidien Puritan Bennett e Heated Humidification Systems Hudson RCl Teleflex Fisher amp Paykel e Patient Circuits commonly available breathing circuits with standard ISO 15 mm 22 mm connection for neonatal pediatric and adult patients Manufacturers include Fisher amp Paykel DAR and Hudson RC I Teleflex e Masks ResMed Respironics Fisher amp Paykel e Patient Monitoring Systems Reference Connectivity to External Systems p 5 21 for information on which systems can be used with the ventilator e Nasal Interfaces Hudson RCI Teleflex Fisher amp Paykel Argyle e Compressed air filter and water trap Covidien A WARNING The Puritan Bennett 980
76. Chapter 11 the internal Lithium ion battery of the device is considered to be Dangerous Goods DG Class 9 Miscellaneous when transported in commerce As such the Puritan Bennett 980 Ventilator and or the associated Lithium ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport IATA International Air Transport Association International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by Road ADR for Europe Private individuals who transport the device are excluded from these regulations although for air transport some requirements may apply A WARNING To avoid the risk of fire explosion electric shock or burns do not short circuit puncture crush heat above 60 C incinerate disassemble the battery or immerse the battery in water LA Note Reference Battery Charging p 3 4 for battery charging information when batteries are installed in ventilator 3 22 Operator s Manual Product Connectivity 3 6 2 Battery Testing To test the batteries 1 Push the battery charge level button located on the battery A series of LEDs illu minates indicating the charge level of the battery When the bottom LED is illu minated there is 5 10 of full battery capacity The next LED illuminates when there is gt 25 capacity the third lamp illuminates when there is gt 50 capacity available The fourth
77. Description Rx US federal law restricts this device to sale by or on the order of a phy sician ONLY obstruct labels on both left and right sides of the ventilator and on User must consult instructions for use Symbol is also found on Do not label indication supply gas connections Keep away from fire or flame Oxygen rich environments accelerate combustibility 106 kPa D Atmospheric pressure limitations The operational atmospheric pres its sure range 70 kPa to 106 kPa 10 2 psi to 15 4 psi Atmospheric pressure limitations 95 E Humidity limitations The operational humidity limit range 10 to ND paang 95 Humidity limitations io Temperature limitations The operational temperature limit range nina 50 F to 104 F 10 C to 40 C 10 C Operator s Manual 2 11 Product Overview 2 12 Table 2 3 BDU Rear Label or Panel Symbols and Descriptions Continued Nn lt 3 5 2 gt gt Description Type BF applied part N IEC Ingress protection classification Protected against ingress of fingers or similar objects and protected from condensation El Explosive hazard Do not use in the presence of flammable gases oO O ee n cg Authorized to bear the CSA certification mark signifying the product has been evaluated to the applicable ANSI Underwriters Laboratories Inc UL and CSA standards for use in the US and Canada o
78. EXHALED SPONTANEOUS TIDAL VOLUME alarm test 4 5 Make the following patient and alarm settings changes Trigger type P 1c TPeens 4 cmH 0 VIE SPONT 2500 mL Press the alarm reset key to reset the apnea alarm Slowly squeeze the test lung to simulate spontaneous breaths The ventilator annunciates a LOW EXHALED SPONTANEOUS TIDAL VOLUME V5g spon alarm at the start of the fourth consecutive spontaneous inspiration Make the following patient settings changes Mode A C LVTE spont OFF Press the alarm reset key to reset the 4V spont alarm NO O SUPPLY alarm test 1 2 Disconnect the oxygen inlet supply The ventilator annunciates a NO O gt SUPPLY alarm within one breath Connect the oxygen inlet supply The NO O SUPPLY alarm autoresets within two breaths after oxygen is reconnected LOW DELIVERED O and HIGH DELIVERED O2 alarms tests 1 Operator s Manual Make the following patient and alarm settings changes Pcens 2 cmH 0 07 100 Make the following apnea settings changes Ta 60s Attach the ventilator s oxygen gas hose to a known air supply for example a medical grade air cylinder or a wall air outlet 6 13 Performance 4 attach the ventilator s air gas hose to a known medical oxygen supply 5 Observe the GUI screen The delivered 05 display should decrease and the ven tilator should annunciate a medium priority 402 alarm within 60 s and a high priority 402 alarm wit
79. Exhaled Total Minute Volume Ve tor Alarm 6 41 6 5 26 PROCEDURE ERROR Alarm gd aM ay alang oe ek sya Sa 6 42 6 5 27 Severe Occlusion Alarm tran NA GRAE Ak ag eimai va NGA 6 42 Monitored Patient Data eee eee 6 42 6 6 1 Total Exhaled Minute Volume Vg oT 6 43 6 6 2 Exhaled Spontaneous Minute Volume Ve spon 6 43 6 6 3 Exhaled Tidal Volume Vje 4a paa Payag a tare aay 6 43 6 6 4 Proximal Exhaled Minute Volume Vetoty 6 44 6 6 5 Proximal Exhaled Tidal Volume Vypy 00 200 eee eee 6 44 6 6 6 Exhaled Spontaneous Tidal Volume Vtg spont 6 44 6 6 7 Exhaled Mandatory Tidal Volume VTE MAND 6 44 6 6 8 Exhaled mL kg Volume es duvieis on NLA eg aye Kaw NG ha acess 6 44 6 6 9 Inspired Tidal Volume Vp osanaan naaa 6 44 6 6 10 Proximal Inspired Tidal Volume Viy ee ee 6 45 6 6 11 Delivered mL kg Volume 7 20 6 45 vi 7 1 7 2 7 3 7 4 7 5 7 6 7 7 7 8 GG PANA AA AA AA ew a 6 6 13 Mean Circuit Pressure PMEAaN 00002 aah eee ee eee 6 6 14 Peak Circuit Pressure Ppgak 2 2 0000 6 6 15 End Inspiratory Pressure Pj Exp ooo ee aaa 6 6 16 End Expiratory Pressure PEEP 2 0 a a a bka Ka GG 66 17 Intrinsic PEEP PEEP apa ha A ANG NGA PG GA AAO 6 6 18 PAV based Intrinsic PEEP PEEP pay aa 6 6 19 Total PEEP PEEProp 0 cee teens 6 6 20 Plateau Pressure Pp awww ay bo 4a ade eee es dees ee wpe 6 6 21 Total Respiratory
80. IEC 60601 test level 3 Vrms 150 kHz to 80 MHz Compliance level 1 Vrms 159 kHz to 80 MHz Electromagnetic environment guid ance Portable and mobile RF communications equipment should be used no closer to any part of the ventilator system including cables than the sepa ration distance calcu lated from the equation applicable to the frequency of the transmitter Recommended sepa ration distance d 3 5 P 10 Vrms in ISM bands 1 Vrms in ISM bands Recommended sepa ration distance d 12 P Operator s Manual Manufacturer s Declaration Table 11 16 Electromagnetic Immunity Continued The ventilator is intended for use in the electromagnetic environment specified below The customer or the operator of the ventilator should assure that it is used in such an environ ment Immunity Test IEC 60601 test level Compliance level Electromagnetic environment guid ance Radiated RF IEC EN 10 V m 10 V m Modulation of 61000 4 3 80 MHz to 2 5 GHz 80 AM 2 Hz 80 MHz to 2 5 GHz d 1 2 P 80 MHz to 800 MHz d 2 3 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W according to the trans mitter manufacturer and d is the separation distance in meters m Field strengths from fixed trans mitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range In
81. If SST fails check the patient circuit and flow sensor connections for leaks or occlusions and replace the Proximal Flow Sensor if necessary Replace the Proximal Flow Option hardware if SST continues to fail then repeat SST to determine circuit compliance and resistance Reference the Puritan Bennett 980 Series Ventilator Hardware Options Installation Instructions p n 10084704 for instructions on replacing the Proximal Flow Option hardware r10 Disabling Enabling the Proximal Flow Option The Proximal Flow Sensor can function in the ENABLED state only if the circuit type is NEONATAL Assuming the Proximal Flow Option is available and the vent type is INVASIVE the New Patient default value is ENABLED If the vent type is NON INVASIVE the Proximal Flow Option is DISABLED The system becomes ENABLED again if the vent type is changed to INVASIVE After SST has been performed the clinician may disable the Proximal Flow Option if desired To disable or enable the Proximal Flow Option 1 In the constant access icons area touch the configure icon A menu containing tabs appears 2 Touch the Options tab A screen appears containing the Installed Options and Prox tabs 3 Touch Enabled or Disabled to enable or disable the Prox Flow option F 12 Operator s Manual Part numbers Figure F 5 Enabling disabling Proximal Flow Sensor Ppeax View troy Ke PEEP Puean 18 26 20 1 6 5 33 31 PA Prox Setup Configure Ve rota Vre manon
82. LED illuminates when there is gt 75 capacity and when the top LED is illuminated it represents gt 90 capacity Reference Proper Battery Ori entation p 3 20 to view the battery test button and LEDs 3 6 3 Battery Performance Test Results Performance testing on a sample of new batteries and batteries charged and discharged at least 1000 times was completed to demonstrate that the venti lator s LOW BATTERY alarms remain effective Testing demonstrated that the batteries have a minimum of ten 10 minutes time remaining from the activa tion of the low battery alarm and a minimum of five 5 minutes time remain ing from the critically low battery alarm until ventilator shutdown Reference Status Display Indicators and Descriptions p 2 30 for images of the Status Display during low battery and critically low battery conditions Performance testing on a sample of new batteries and batteries charged and discharged at least 1000 times was completed to demonstrate the expected run time of the ventilator on battery This testing was performed for both typical ventilator settings and adult high demand ventilator settings The typical ventilator settings used were e Ventilator settings Assist Control Ventilation with Volume Control VC mandatory type Tidal volume V7 500 mL Peak flow Vmax 30 L min Respiratory rate f 20 1 min PEEP 8cmH O Oxygen concentration FiO gt 60 Flow trigger V trig 3 L m
83. LOW BATTERY NO AIR SUPPLY NO O gt SUPPLY PROCEDURE ERROR alarms and active battery alarms If the cause of the alarm still exists after the Alarm Reset key is pressed the alarm becomes active again The ventilator logs all actuations of the alarm reset key 6 5 3 Alarm Silence Key LA The alarm silence feature temporarily mutes the audible portion of an alarm for two minutes After the two minute period if the alarm condition still exists the alarm sounds again Pressing the alarm silence key again re starts the two minute interval during which an alarm is muted An LED within the key illumi nates and a count down timer appears on the GUI next to an alarm silence indicator symbol indicating an active alarm silence function The alarm silence feature does not allow the audible alarm to be turned off the audible portion of the alarm is temporarily muted for two minutes The GUI s omni directional LED flashes during an active alarm state and during an alarm silence period and its appearance changes with the priority if the alarm escalates Pressing the Alarm Reset key cancels an Alarm Silence If the condition that caused the alarm still exists the alarm activates again 6 5 4 Alarm Volume Key 6 8 An alarm volume key is available for setting the desired alarm volume The alarm volume is automatically set to the factory default setting of 10 maxi mum or to the institutional default setting based on circuit type if it has been s
84. MISCF Response Continued Low exhaled spontaneous tidal volume YVr_ spont alarm 6 characters Low O2 alarm 6 characters Reserved Low air supply pressure alarm 6 characters Low O gt supply pressure alarm 6 characters Disconnect alarm 6 characters Severe occlusion alarm 6 characters Inspiration too long alarm 6 characters Procedure error 6 characters Compliance limited tidal volume V7 alarm 6 characters High inspired spontaneous tidal volume LT sponr alarm 6 characters High inspired volume TV alarm 6 characters High compensation limit TPcomp alarm 6 characters PAV startup too long alarm 6 characters PAV R and C not assessed alarm 6 characters Volume not delivered VC alarm 6 characters Volume not delivered VS alarm 6 characters ction Low inspiratory pressure 4Ppg ag alarm 6 characters A5 6 characters ction A10 6 characters ction A15 6 characters ction A20 6 characters ction A25 6 characters Ka Field 143 Technical malfun ction ction A30 6 characters A35 6 characters Field 144 Technical malfun ction A40 6 characters Possible responses are NORMAL LOW MEDIUM HIGH or RESET Operator s Manual Data Transfer Table 5 2 MISCF
85. Mode ses oo ctonahsbay coma ay GAS 10 34 10 10 SIMY Moder naaa aa ts MATER cokes aa e ee Pees 10 34 10 10 1Changing to SIMV Mode n c5 654 arman ana cake man 10 37 10 11 Spontaneous SPONT Mode 10 39 10 11 1Changing to SPONT Mode xa ga naa Aa b gand 10 40 10 12 Apnea Ventilation 0c eee eee 10 41 10 12 1Apnea Detection gt 873 aa kaa Kalan ead owes an AKA NANG 10 41 10 12 2Transition to Apnea Ventilation 2 10 43 10 12 3Settings Changes During Apnea Ventilation 10 43 10 12 4Resetting Apnea Ventilation 20 004 10 44 10 12 5Apnea Ventilation in SIMV 2 paka 45459008 wee des 10 44 10 12 6Phasing in New Apnea Intervals 2 0205 10 45 10 13 Detecting Occlusion and Disconnect 10 45 LOASRPOCEIUSIONS maha exten cation tea ea oe tee ee hea 10 45 PORTS 7A DISCOMMECI Naawa aba Wa lei MAAN gee all Sal ht eh O WA 10 47 10 13 3Annunciating Occlusion and Disconnect Alarms 10 49 10 14 Respiratory Mechanics eee eeeee 10 49 10 14 1lnspiratory Pause haaa aka pat ahhahaha cesta KG 10 50 10 14 2Expiratory Pause Hah KAG GN oe thee NGA 10 53 10 14 3Negative Inspiratory Force NIF Maneuver 10 54 10 14 4P Maneuver Occlusion Pressure 10 55 10 14 5Vital Capacity VC Maneuver 0 000008 10 56 10 15 Ventilator Settings eee eee eee ees 10 57 10 15 1Apnea Ventilation n a wis dco are
86. Patient Data Patient data are displayed in the Vital Patient Data banner The operator can configure the banner for displaying the desired patient data Reference Areas of the GUI p 4 3 A total of 14 values may be configured at one time with eight 8 values visible and six 6 more visible by scrolling the values using the left and right pointing arrows in the patient data area Two pages of additional patient data may be viewed by touching or swiping down on the patient data tab at the top of the GUI Choose the respective buttons to view page one or page two Additional patient data values may not be changed Reference Patient Data Range and Resolution p 11 19 for default patient data values To institutionally configure patient data displayed on the GUI 1 Enter Service mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode 2 Touch Patient Data Defaults Five 5 layout preset buttons appear along with a list of parameters and descriptions 3 Touch a preset button and individually select a parameter from the scrollable list below to appear in that preset s vital patient data banner Use the right and left pointing arrows to configure default values for all available parameters Addition ally touch the padlock icon above each patient data parameter on the data banner to allow unlocked or restrict locked operator configurablity
87. Puritan Bennett 980 Series Ventilator Service Manual for instructions on replacing the O sensor New patient default O2 settings are as follows e O sensor enabled e Neonatal 40 O e Pediatric adult 100 O gt Operator s Manual Ventilator Shutdown Note The oxygen sensor has three states Enabled Disabled and Calibrate The oxygen sensor is enabled at ventilator startup regardless if New Patient or Same Patient setup is selected To enable or disable the O sensor 1 Touch Vent Setup 2 Touch the More Settings tab The more settings screen appears Figure 4 14 More Settings Screen with O Sensor Enabled Waiting for patient connect Setup More Settings Vuax 10 300 4 VEN_11357_D 3 Touch the button corresponding to the desired O sensor function Enable or Dis able 4 Touch Accept 4 10 1 Oxygen Sensor Life The 05 setting can range from room air 21 O up to a maximum of 100 oxygen The sensor reacts with oxygen to produce a voltage proportion al to the partial pressure of the mixed gas Since ambient atmosphere contains approximately 21 oxygen the sensor constantly reacts with oxygen and Operator s Manual 4 33 Operation 4 10 2 4 10 3 always produces a voltage The useful life of the cell can also be shortened by exposure to elevated temperatures and pressures During normal use in the ICU the oxygen sensor lasts for approximately one year the interv
88. Response Continued function A45 6 characters function A50 6 characters function A55 6 characters function A60 6 characters function A65 6 characters ield 150 Techni function A70 6 characters ield 151 Technica function A75 6 characters ield 152 Technica function A80 6 characters ield 153 Technica function A85 6 characters ield 154 Spontaneous tidal volume Ve spon in liters 6 characters ield 155 Total work of breathing WOByo7 in Joules L 6 characters ield 156 Leak Sync state 9 characters ON or OFF ield 157 LEAK 6 characters ield 158 LEAK 6 characters ield 159 Vieak 6 characters ield 160 Prox Inop alarm ALARM or NORMAL ield 161 171 Reserved TX gt End of transmission character 03 hex Terminating carriage return Possible responses are NORMAL LOW MEDIUM HIGH or RESET ss Communication Ports WARNING To avoid possible injury only connect devices that comply with IEC 60601 1 standard to any of the ports at the rear of the ventilator with the exception of passive memory storage devices flash drives and serial to USB adapter cables If a serial to USB adapter cable is used it must be connected to an IEC 60601 1 compliant device Operator s Manual 5 17 Product Data Output WARNING To avoid possible injury do not connect a device
89. Response nasan KAKA NENA AG AG 5 6 MISCF Response saan tp B Ah GERA vases kA BADA GANA Npa GS 5 11 Alarm Descriptions and Symbols asaan 6 6 Alarm Prioritization 43 4 254444000444 ANAKAN eee aes 6 16 Technical Alarm Categories cc cece cect ence eee ees 6 17 Technical Alarms 2884K KK NGANGA LEA BNG AGA 6 18 Non technical Alarm Summary eeeee cece ee eeee 6 18 Non Technical Alarms and Suggested Responses 6 29 Operator Preventive Maintenance Frequency 7 2 Surface Cleaning Agents c cece eee eee eee een eenee 7 5 Component Cleaning Agents and Disinfection Procedures 7 6 Sterilization Parameters aa 7 24 Component Sterilization Procedures 7 24 xiii xiv Table 9 1 Table 10 1 Table 10 2 Table 10 3 Table 10 4 Table 10 5 Table 10 6 Table 10 7 Table 10 8 Table 10 9 Table 10 10 Table 11 1 Table 11 2 Table 11 3 Table 11 4 Table 11 5 Table 11 6 Table 11 7 Table 11 8 Table 11 9 Table 11 10 Table 11 11 Table 11 12 Table 11 13 Table 11 14 Table 11 15 Table 11 16 Table 11 17 Table 11 18 Table A 1 Table B 1 Table B 2 Table B 3 Table C 1 Table D 1 Table D 2 Table D 3 Table D 4 Table E 1 Table E 2 Table E 3 Covidien Accessories and Options c ccc e eee e ees 9 4 Compliance Volume Factors ccc ec ec cece ence eenee 10 16 Maximum Pressure Adjustments
90. and immediate service A setting that determines the gas flow pattern of mandatory volume controlled breaths Test circuit designed for use with EST Graphical user interface The ventilator s touch screen used to enter patient settings and alarm settings including off screen keys soft keys and knobs A ventilator setting that has reached its minimum or maximum limit As defined by international standards organizations an alarm that requires immediate attention to ensure patient safety When a high pri ority alarm is active the red high priority LED indicator flashes and the high priority audible alarm sounds a repeating sequence of five tones that repeats twice pauses then repeats again and the alarm banner on the GUI screen shows an alarm message with the symbol Heat moisture exchanger A humidification device also called an artificial nose Hectopascal A unit of pressure approximately equal to 1 cmH 0 A setting for the type of humidification system HME non heated expi ratory tube or heated expiratory tubing in use on the ventilator The ratio of inspiratory time to expiratory time Also the operator set timing variable that applies to PC and VC mandatory breaths An operator initiated maneuver that closes the inspiration proportional solenoid and exhalation valves at the end of the inspiratory phase of a mandatory breath The maneuver can be used to determine static com pliance Cstaq and
91. and not for neonatal patients c3 Safety Symbol Definitions This section contains safety information for users who should always exercise appropriate caution while using the ventilator C 1 IE Sync Appendix Table C 1 Safety Symbol Definitions Symbol Definition WARNING Warnings alert users to potential serious outcomes death injury or adverse events to the patient user or environment Caution Cautions alert users to exercise appropriate care for safe and effective use of the product Note Notes provide additional guidelines or information Q gt gt WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs calE Sync Description IE Sync is a triggering and cycling algorithm based on the estimated patient intra pleural pressure It is only available in SPONT mode with the following breath types PAV PS VS and TC A PBW 25 kg is recommended IE Sync can also be used in monitoring mode where it does not control the patient s
92. and ventila torsettings e Check for leaks tube type ID and Supp settings and patient agitation VOLUME NOT DELIVERED patient data alarm Insp target pressure gt Pprag PEEP 3 cmH gt 0 when sponta neous type is VS or when man datory type is VC Check patient and TPprax setting PAV STARTUP TOO LONG occurs only if PAV option is in use Unable to assess resistance and or compliance during PAV startup Check for leaks shallow breathing and settings for PAV R amp C NOT ASSESSED occurs only if PAV option is in use Unable to assess resistance and or compliance during PAV steady state Check for leaks shallow breathing and settings for tube ID TV and TPpeag PROX INOPERATIVE A malfunction occurred with the Proximal Flow Sensor or the pneumatic lines are occluded Replace the Proximal Flow Sensor or purge its pneumatic lines Does not affect data from the ventilator s delivery or exha lation valve flow sensors The next sections provide detailed descriptions of selected alarms Operator s Manual Ventilator Settings 6 5 9 AC POWER LOSS Alarm The AC POWER LOSS alarm indicates the ventilator power switch is on and the ventilator is being powered by the battery and an alternate power source may soon be required to sustain normal ventilator operation The ventilator annun ciates a medium priority LOW BATTERY alarm when the ventilator has less
93. artificial airway and the patient s own airways plus the work to inflate the patient s elastic lung thorax WOBpr Patient Work of Breathing That part of WOByor per formed by the patient WOBpr ELASTIC Inspiratory Elastic Work That part of WOBp7 attributed to inflating the patient s elastic lung thorax WO Bp7 RESISTIVE Inspiratory Resistive Work That part of the WOBp7 attributed to moving breathing gas through resistive elements in the gas path Operator s Manual D 13 PAV Appendix Figure D 2 Graphics displays in PAV Puean Ve TO 2A WAR Ae WW 9 180 30 VEN_11371_D 1 Total work of breathing WOByo7 3 Shadow trace 2 Patient s work of breathing WOBp7 p 5 4 Technical Description When PAV is selected the ventilator acts as an inspiratory amplifier propor tionally assisting the pressure generating capability of the inspiratory muscles Pmus Pressure Gradient Equation of Motion During spontaneous breathing Pyys generates a pressure gradient that drives breathing gas through the artificial airway and the patient s airways and into the elastic lung thorax and is described by the equation of motion D 14 Operator s Manual Puus Pmus Pressure generating capability of patient s inspiratory muscles Vi Flow through the resistance ele ments and into the lungs VL Insufflation volume of the lung Operator s Manual Ventilator Settings G
94. base flow is not user selectable When the patient inhales and their inspiratory flow exceeds the Vcens setting a trigger occurs and the ventilator delivers a breath Reductions to Vsens are phased in immediately while increases are phased in at the start of exhalation When Ven is active it replaces pressure sensitivity Pcgys The Veens setting has no effect on the Psgns setting Vsens can be active in any ventilation mode including pressure supported volume controlled pressure controlled and apnea ventilation When Vsens is active a backup Psens setting of 2 cmH 0 is in effect to detect the patient s inspiratory effort even if the flow sensors do not detect flow Although the minimum Vsgns setting of 0 2 L min adult pediatric circuit types or 0 1 L min neonatal circuit type can result in autotriggering it can be appro priate for very weak patients The maximum setting of 20 L min adult pediatric circuit types or 10 L min neonatal circuit type is intended to avoid autotrig gering when there are significant leaks in the patient circuit 10 15 11Pressure Sensitivity Pcenys The Pseys setting selects the pressure drop below baseline PEEP required to begin a patient initiated breath either mandatory or spontaneous Changes to Pcens are phased in immediately The Pceys setting has no effect on the Vcens setting and is active only if the trigger type is P_tpic Lower Psens settings provide greater patient comfort and
95. biomedcentral com 147 1 2431 3 13 2 Hamill PV V 1977 NCHS growth curves for children birth to 18 years for the United States National Center for Health Stat Vital and Health Statistics Series 11 Data from the National Health Survey no 165 DHEW publication PHS 78 1650 1977 3 Kuczmarski RJ Ogden CL Guo SS et al 2000 CDC growth charts for the United States Methods and development National Cen ter for Health Statistics Vital Health Stat 11 246 2002 Operator s Manual Ventilator Shutdown WARNING Use only non vented patient interfaces with NIV Leaks associated with vented interfaces could result in the ventilator s inability to compensate for those leaks even if Leak Sync is employed WARNING Full face masks used for non invasive ventilation should provide visibility of the patient s nose and mouth to reduce the risk of emesis aspiration WARNING When Using NIV the patient s exhaled tidal volume Vp could differ from the ventilator s monitored patient data Vg reading due to leaks around the interface To avoid this ensure Leak Sync is installed 4 7 3 NIV Setup NIV can be initiated from either the New Patient Setup screen during Vent start up or while the patient is being ventilated invasively Reference the table below for using NIV patient setup information Table 4 2 Setting Up a Patient for NIV To set up a new patient To set up a patient currently being ventilated 1 Turn the ven
96. by the ventilator s background diagnostic system Technical alarms cannot be reset by pressing the Alarm Reset key Reference Background Diagnostic System p 10 74 Technical alarms fall into eight categories shown in the table below Table 6 3 Technical Alarm Categories System Response Ventilator goes to safe state Reference Ventila tor Protection Strategies p 4 35 Backup ventilation Backup ventilation Backup ventilation Ventilator goes to safe state Reference Ventila tor Protection Strategies p 4 35 Ventilation continues as set Ventilation continues as set Category Name Priority Vent Inop High Exh BUV High Insp BUV High Mix BUV High SVO High Caution High Warning Medium Notification Low Ventilation continues as set not displayed on alarm banner Reference the table below for a list of ventilator technical alarms their mean ing and what to do if they occur Operator s Manual Performance Reference Alarm Settings Range and Resolution p 11 17 for the settings ranges resolutions new patient default values and accuracies of all the ven tilator alarms Table 6 4 Technical Alarms Alarm message Meaning What to do gory is described Reference Technical Alarm Categories p 6 17 More information for the particular technical alarm can be found in the System diag nostic log a link to which is provided on the ex
97. by the patient Reference Appendix D for more information on PAV The inspiratory trigger methods for spontaneous breaths are e Pressure Trigger P_tpig Same as described for mandatory inspiration trig gers Operator s Manual 6 3 Performance Flow Trigger Vp Same as described for mandatory inspiration triggers e IE Sync Trigger When this software option is installed and the IE Sync trigger type is selected triggering and cycling of spontaneous breaths occur based on the patient s intra pleural pressure e Operator Trigger OIM Since the operator can only initiate a mandatory breath by pressing the Manual inspiration key spontaneous mode allows OIMs but the breath delivered is based on the current apnea breath settings Reference nspiration Detection and initiation p 10 4 for details on the dif ferent trigger methods 6s Alarms 6 5 6 4 This manual uses the following conventions when discussing alarms A description or name of an alarm without specifying the alarm setting is denoted with an upward or downward pointing arrow t or preceding the specific alarm name An alarm setting is denoted as an upward or downward pointing arrow with an additional horizontal limit symbol 7 or preceding the specific alarm Some alarm conditions actually limit breath delivery such as 1Ppgak and tV by truncating inspiration and transitioning to the exhalation phase These alarm conditions are d
98. cmH530 L s for values 10 cmH O L s Operator s Manual 23 Specifications 24 Table 11 11 Patient Data Range and Resolution Continued Data Value PAV based work of breathing WOByo7 Description The estimated effort needed for patient inspiration includ ing both patient and ventila tor Range and Resolution Range 1 0 J L to10 0 J L Resolution 0 1 J L Peak expiratory flow PEF The maximum speed of exha lation Range 0 to 150 L min Resolution 0 1 L min for PEF lt 20 L min 1 L min for PEF gt 20 L min Peak circuit pressure Pprax The maximum pressure during the previous breath relative to the patient wye including inspiratory and expiratory phases Range 20 0 cmH 0 to 130 cmH 0 Resolution 0 1 cmH 0 for values 20 0 cmH50 to 9 9 cmH 0 1 0 cmH530 for values 10 cmH70 to 130 cmH20 Peak spontaneous flow PSF The maximum flow rate sampled during a sponta neous inspiration Range O to 200 L min Resolution 0 1 L min for values lt 20 L min 1L min for values gt 20 L min Plateau pressure Pp The pressure measured during an inspiratory pause maneuver Range 20 0 cmH 0 to 130 cmH 0 Resolution 0 1 cmH 0 for values 20 0 to 9 9 cmH 30 1 0 cmH50 for values gt 10 cmH 0 Proximal exhaled tidal volume Vtey For neonatal patients the exhaled volume of the previ ous breath measured by the Proximal Flow Sensor if installed
99. commands Ethernet Port The Ethernet port is used by Service personnel for accessing various logs and updating ventilator software Nurse Call Port A remote alarm or nurse call interface is available on the ventilator system which can be used to remotely annunciate the alarm status of the ventilator Medium and high priority alarms are remotely annunciated The nurse call con nector is located at the back of the ventilator as shown Reference Port Loca tions p 5 18 Reference the remote alarm manufacturer s instructions for use for informa tion regarding proper nurse call connection Operator s Manual 5 19 Product Data Output USB Ports The USB ports are used for screen captures or receiving serial data when a USB port has been configured as a serial port This is also known as transferring data via a serial over USB protocol Reference Communication Setup p 5 3 for Comm setup configuration Screen captures require an external USB memory storage device flash drive for screen captures Instructions for using this port for screen captures are given Reference To capture GUI screens p 5 2 HDMI Port An external display can be used via connection with the HDMI port To use the HDMI port with an external display 1 Connect one end of an HDMI cable to the HDMI port at the back of the ventilator item 6 above 2 Connect the other end of the cable to the external display An HDMI to DVI adapter may be used
100. control a mandatory mode allowing volume controlled VC pressure controlled PC or VC breath types SPONT allows the patient to initiate the breath Applicable SPONT breath types are pressure support PS volume support VS tube com pensated TC or PAV if the PAV option is installed SIMV Synchronized Intermittent Mandatory Ventilation a mixed ven ilatory mode providing mandatory breaths and lowing a patient sponta neous breaths during the breath cycle BiLevel a mixed ventila tory mode combining the attributes of both manda tory and spontaneous breaths incorporating two pressure levels Py and P ev Range and Resolution Range A C SPONT SIMV BiLevel if option installed but not available when vent type is NIV CPAP only available when circuit type is NEO NATAL and vent type is NIV O2 delivered Percentage of delivered oxygen in the gas mixture Range 21 to 100 Resolution 1 Peak inspiratory flow The maximum rate of tidal Range When mandatory type is VC ratory pressure defined as the pressure targeted in the patient circuit during exhalation Vax volume delivery during NEONATAL 1 L min to 30 L min mandatory volume based PEDIATRIC 3 0 L min to 60 L min breaths ADULT 3 0 L min to 150 L min Resolution 0 1 L min for values lt 20 L min BTPS 1 L min for values 20 L min BTPS PEEP Sets the positive end expi Ran
101. damage to pneumatic lines use supplied cable management clips Operator s Manual Part numbers Caution Use only Covidien branded Proximal Flow Sensors with the Proximal Flow Option rs Proximal Flow Option Description The Proximal Flow Option measures pressure flow and volume at the patient wye A Printed Circuit Board Assembly PCBA containing the electronics and pneumatics for the Proximal Flow Option is installed in the ventilator on the Option Host Card Data measured by the Proximal Flow Sensor are displayed on the GUI for monitoring purposes not for ventilator control When the ven tilator has a Proximal Flow Sensor installed both proximal flow and proximal pressure measurements are obtained and displayed on the GUI A manual purge control is also provided to clear pneumatic lines for accurate pressure measurements When a manual purge is requested the ventilator will not allow another purge for at least 30 seconds Reference Sensor Calibration and Sensor Line Purging p F 8 for more information on the purge function F 6 1 Proximal Flow Option components The Proximal Flow Option consists of the following components Proximal Flow Option PCBA Installed on the Option Host Card in the BDU this printed circuit board assembly contains a pressure sensor to measure the pressure difference between the flow sensor lines and the interfaces required to convert analog measurements from the Proximal Flow Sensor into digital da
102. declared e Communications with the GUI is lost e A manual inspiration is requested e The maneuver as been active for 15 s and inspiration is not detected e The Cancel is touched Operator s Manual Short Self Test SST When an active VC maneuver ends successfully the calculated expiratory volume displays on the waveforms screen and on the maneuver panel and a PEEP restoration breath is delivered 10 15 Ventilator Settings 10 15 1 Apnea Ventilation Apnea ventilation is a backup mode and starts if the patient fails to breathe within the apnea interval Ta set by the operator Ta defines the maximum allowable length of time between the start of inspiration and the start of the next inspiration Available settings include mandatory type PC or VC For PC breaths the allowable settings are e Apnea interval Ta e Inspiratory pressure P e Inspiratory time T e Respiratory rate f For VC breaths the allowable settings are e Apnea interval Ta e Flow pattern e O Yo e Peak inspiratory flow Vmax e Respiratory rate f e Tidal Volume V During apnea ventilation with PC selected as the mandatory type rise time is fixed at 50 and the constant parameter during a rate change is inspiratory time T If apnea is possible that is if 60 f gt Ta increasing the non apnea O2 setting automatically changes apnea ventilation O2 if it is not already set higher than the new non apnea 07 Apnea ventilation O2
103. does not auto matically change by decreasing the non apnea 05 Whenever there is an Operator s Manual 10 57 Theory of Operations 10 58 automatic change to an apnea setting a message appears on the GUI and the apnea settings screen appears During apnea ventilation changes to all non apnea ventilation settings are allowed but the new settings do not take effect until the ventilator resumes normal ventilation Being able to change T during apnea ventilation can avoid immediately re entering apnea ventilation once normal ventilation resumes Because the minimum value for T4 is ten 10 s apnea ventilation cannot take place when non apnea f is greater than or equal to 5 8 min The ventilator does not enter apnea ventilation if Ta is equal to the breath period interval Set Ta to a value less than the expected or current breath period interval as a way of allowing the patient to initiate breaths while protecting the patient from the consequences of apnea 10 15 2 Circuit Type and Predicted Body Weight PBW Together circuit type and PBW displayed in lb or kg provide the basis for new patient values and absolute limits on various ventilator settings such as tidal volume V7 and Peak flow Vmax Run SST in order to change the circuit type The table below gives the minimum maximum and new patient default values for Vy based on circuit type Table 10 6 Values for Vy Based on Circuit Type Circuit Type New Patient Default
104. eee eeee sey 2 25 7m BAGO pla PP AA AT 2 35 2 12 Special Features 22 2 35 2 13 Color Definitions cece eee eee eee 2 36 2 14 Pneumatic Diagrams ee eee eee ees 2 36 3 Installation 3 1 Overview shaman EN DERSINENNA coos ee veeres see AETA 3 1 3 2 Safety Reminders 2 eee eee e eee ees 3 1 3 3 Product Assembly 2002 eee eee eee 3 2 3 3 1 How to Assemble Ventilator Components 3 2 3 3 2 Product Power SOUICES ah NAG vehscanarce NAE LANANG 3 2 3 4 Product Placement 2 unsa DANG KANA AA ewes 3 4 3 5 Product Connectivity eee eee eee eee 3 5 3 5 1 Connecting the Ventilator to AC Power 3 5 3 5 2 Connecting the Gas Supplies 000000 008 3 7 3 5 3 Filter Installation 2caeereelie ewan LO ANA NAKAW ees 3 10 3 5 4 Connecting the Patient Circuit a 3 14 3 6 How to Install Accessories aan 3 18 3 6 1 Batteries 14 40 oye paa GANA DA BANG NAKAKA 3 18 3 6 2 Battery Testing ag aa hace edb hard WAN ae eee as he 3 23 3 6 3 Battery Performance Test Results a 3 23 36 4 Battery Life KABAN BAG KG AA NN ALA pra ee ee eas 3 25 3 6 5 Battery Disposal nnana annaa 3 25 3 6 6 Flex Arm PP PA PAA 3 25 3 6 7 Humidifier 14 bes conn dens a AE ead UG ewan ok aus 3 27 3 7 Ventilator Operating Modes 22 005 3 30 3 7 1 Normal Mode sds vad hese ee bbias Sexadae vs earn 3 30 3 7 2 ICR uma wane AA 3 30 3 7 3 3 7 4 3 8 3 8
105. ence between the delivery and exhalation valve flow sensor measurements increases The ventilator initiates an inspiration when the difference between the two flow measurements is greater than or equal to the operator set flow sensitivity value Reference nspiration Using Flow Sensitivity p 10 7 event B As with pressure triggering the time delay between onset of the patient s effort and actual gas delivery depends on e How quickly the exhaled flow declines that is the aggressiveness of the inspira tory effort The more aggressive the inspiratory effort the shorter the interval and e the flow sensitivity value The smaller the value the shorter the delay During flow triggering a backup pressure sensitivity of 2 cmH5O is present to detect a breath trigger in the event that the flow trigger fails Figure 10 2 Inspiration Using Flow Sensitivity i 6 0 L min 4 os oe bh L min 4 VEN_10758_8 1 Software set base flow L min 5 Operator set flow sensitivity 2 Start of patient effort 6 1 5 L min 3 Event A flow is decreasing 7 Flow delivered to patient 4 Event B Gas delivery begins Operator s Manual Theory of Operations 10 4 3 Time Triggers The ventilator measures the time interval for each breath and breath phase If the ventilator is in Assist Control A C mode where the ventilator delivers breaths based on the breath rate setting a VIM or ventilator initiated manda tory breath is delivered after the appro
106. environ ment Operator s Manual GUI Controls and Indicators 25 Components List Note No parts of the ventilator system contain latex LAP Note The components in the gas pathway that can become contaminated with bodily fluids or expired gases during both normal and single fault conditions are e External inspiratory filter e Internal inspiratory filter e Expiratory filter and condensate vial e Exhalation valve assembly The typical ventilator system ships with the following packing list Depending upon the ventilator system purchased your list may vary Table 2 1 Typical Packing List Quantity Item 1 Graphical User Interface 1 Breath Delivery Unit 1 Inspiratory filter 1 Expiratory filter 1 Condensate vial 2 Gas hoses air and oxygen 1 Standard caster base 1 Power cord 1 Operator s Manual CD 1 Puritan Bennett 980 Series Ventilator Installation Instructions 1 Flex arm 1 Drain bag 1 Gold standard circuit for running EST Operator s Manual 2 5 Product Overview 26 Product Views 2 6 1 GUI Front View Figure 2 1 GUI Front View ES covioien Pur i 2 3 A 5 6 7 8 39 1 Display brightness key 6 Inspiratory pause key 2 Display lock key 7 Expiratory pause key 3 Alarm volume key 8 Alarm reset key 4 Manual Inspiration key 9 Alarm silence key 5 Rotary encoder knob 2 6 Operator s Manual GUI Controls and Indicators 2 6 2 GUI Rear View F
107. equivalents These values appear in the patient data panel if so config ured Reference Vital Patient Data on page 3 42 and the figure above Operator s Manual Part numbers F 7 Proximal Flow Option Appendix F 8 Table F 2 Proximal Flow Option Patient Data Symbols Data Symbol Description Viy Inspired tidal volume mandatory or spontaneous at patient circuit wye VIEY Exhaled tidal volume at patient circuit wye VTE SPONTY Exhaled spontaneous tidal volume at patient circuit wye VTE MANDY Exhaled mandatory tidal volume at patient circuit wye Ve TOTY Exhaled total minute volume at patient circuit wye Vy Flow throughout the breath cycle at patient circuit wye VILY Inspired tidal volume at patient circuit wye with Leak Sync enabled Note In the patient data symbols shown above the Y appears in inverse video as shown Reference Sample GUI screen Showing Proximal Flow Data p F 7 Note When the Proximal Flow and Leak Sync options are enabled the following parameters are available for display e Vry and Vy e LEAK and LEAKy When only the Proximal Flow option is enabled Vry and V5 are available for display When a Y appears in the symbol the data are measured with the proximal flow sensor When a Y is absent from the symbol the data are measured by the ventilator s internal flow sensors rs Sensor Calibration and Sensor Line Purging To ensure accu
108. has triggered a breath for the operator selected Apnea Interval Ta When the Apnea alarm condition is true the ventilator invokes mandatory ventilation as specified by the operator Range 10 s to 60s or OFF in CPAP Resolution 1 s High circuit pressure setting TPpeak The TPprag alarm indicates the patient s airway pressure gt the set alarm level Range 7 cmH20 to 100 cmH20 Resolution 1 cmH30O Low circuit pressure setting LPpEAK The 4Pprag alarm indicates the measured airway pres sure lt the set alarm limit during an NIV or VC inspira tion Range NIV OFF or 2 0 5 cmH50 to lt 100 cmH 0 Resolution 0 5 cmH 0 for values lt 20 0 cmH 0 1 cmH50 for values gt 20 cmH j0 High exhaled minute volume alarm setting TVE ton The TV tor alarm indicates the measured total minute volume the set alarm limit Range OFF and NEONATAL 0 1 L min to 10 L min PEDIATRIC 0 1 L min to 30 L min ADULT 0 1 L min to 100 L min Resolution 0 005 L min for values lt 0 50 L min 0 05 L min for values 0 5 L min to lt 5 0 L min 0 5 L min for values gt 5 0 L min 17 Specifications 18 Table 11 10 Alarm Settings Range and Resolution Continued Setting High exhaled tidal volume alarm setting T V7 High inspired tidal volume alarm limit TVn Description The 1V5galarm indicates that the measured exhaled tidal volume gt the set alarm limit fo
109. icon appears over laid on another icon or tab the logs icon for example it indicates there are unread items at this location Configure icon A constant access icon Refer ence Areas of the GUI p 4 3 Touch this icon to display the configure screen Tabs with SST results options Comm setup and date time change are displayed l Pause icon Located above the constant access icons Touch this icon to pause the waveform graph Waveform layout icon Located above the con stant access icons area Touch this icon to open the waveform layout dialog Operator s Manual 2 19 Product Overview Table 2 6 GUI Visual Indicators Continued Symbol Description Grid lines icon Located above the constant access icons area Touch this icon to turn wave form grid lines ON or OFF Maximize waveform icon Located at the upper right portion of each waveform Touch this icon to enlarge the waveform to its maximum size Restore waveform icon Restores waveform to its EG original size Located at the upper right of the maximized waveform Pushpin icon pinned state When in the pinned state prevents a dialog from closing under certain conditions Located in the upper right corner of the GUI on the vent setup screen Ref erence Pushpin Icon p 4 5 Pushpin icon unpinned state When the o unpinned icon is touched the pinned state becomes active Located in the upper right corne
110. in a PAV breath at which the ventilator cycles from inspiration to exhalation for spontaneous breaths Low settings will result in longer spontaneous inspirations In an IE Sync triggered breath when the Psync signal drops below the Esens setting the ventilator cycles to exhalation Extended self test A comprehensive test of ventilator function intended to be run by qualified service personnel Operator s Manual Operator s Manual Table Glossary 1 Glossary of Ventilation Terms Continued expiratory pause exhalation valve EV f fror FAILURE flow pattern gold standard test circuit GUI hard bound high priority alarm HME hPa humidification type I E ratio inspiratory pause an operator initiated maneuver that closes the inspiration proportional solenoid and exhalation valves during the exhalation phase of a manda tory breath The maneuver can be used to determine intrinsic auto PEEP PEEP The valve in the expiratory limb of the ventilator breathing system that controls PEEP Respiratory rate as a setting f in A C SIMV and BiLevel the minimum number of mandatory breaths the patient receives per minute As a mon itored value ftor the average total number of breaths delivered to the patient A category of condition detected during SST or EST that causes the ven tilator to enter the safety valve open state A ventilator experiencing a FAILURE requires removal from clinical use
111. inspiration A 10 Operator s Manual B Leak Sync Appendix 8 1 Overview This appendix describes the operation of the Puritan Bennett 980 Series Ven tilator Leak Sync option The Leak Sync option enables the ventilator to com pensate for leaks in the breathing circuit while accurately detecting the patient s effort to trigger and cycle a breath Because Leak Sync allows the ven tilator to differentiate between flow due to leaks and flow due to patient respi ratory effort it provides dynamic compensation and enhances patient ventilator synchrony Reference Chapter 4 in this manual for general parame ter and operational information s2 Intended Use Leak Sync is designed to compensate for leaks in the breathing circuit during noninvasive or invasive ventilation Leak Sync accurately quantifies instanta neous leak rates therefore detecting patient respiratory phase transitions cor rectly and may affect work of breathing Leak Sync is intended for neonatal pediatric and adult patients B 1 Leak Sync Appendix B 2 s 3 Safety Symbol Definitions This section contains safety information for users who should always exercise appropriate caution while using the ventilator Table B 1 Safety Symbol Definitions Symbol Definition WARNING A Warnings alert users to potential serious outcomes death injury or adverse events to the patient user or environment Caution Cautions alert users to exercise approp
112. inspiratory pause is allowed per breath An inspiratory pause cannot occur during apnea venti lation safety PCV Stand by state Occlusion and SVO An automatic inspiratory pause begins when the inspiratory pause key is pressed momentarily or the maneuver is started from the GUI screen Refer ence To access respiratory mechanics maneuvers p 4 28 for more information on performing respiratory mechanics maneuvers from the Menu tab on the GUI rather than using the keys on the GUI The pause lasts at least 0 5 second but no longer than three 3 s A manual inspiratory pause starts by pressing and holding the inspiratory pause key The pause lasts for the duration of the key press up to seven 7 5 An active manual inspiratory pause is considered complete if any of the fol lowing occur e The inspiratory pause key is released and at least two seconds of inspiratory pause have elapsed or pressure stability conditions have been detected for not less than 0 5 s e Pause duration reaches seven 7 s A manual inspiratory pause maneuver request if the maneuver is not yet active will be canceled if any of events1 10 occur Reference nspiratory and Expiratory Pause Events Table 10 5 Inspiratory and Expiratory Pause Events Event Identifier Event 1 There is a loss of communications with the GUI 2 High ventilator pressure limit TPyent is reached 3 High circuit pressure limit TPpeax is reached 4 A disconnect is detected
113. mode of ventilation when there is insufficient breath delivery to the patient over a specified period of time Apnea ventilation can be reset to normal ventilation by the operator by press ing the Alarm Reset key or the patient autoreset It is also reset when a rate change is made that renders apnea ventilation inapplicable If the patient regains inspiratory control the ventilator returns to the operator selected mode of non apnea ventilation The ventilator determines whether the patient has regained respiratory control by monitoring triggered inspira tions and exhaled volume If the patient triggers two consecutive inspirations and the exhaled volume is equal to or greater than 50 of the delivered volume including any compliance volume the ventilator resets to non apnea ventilation Exhaled volume is monitored to avoid resetting due to autotrigger ing caused by large leaks in the patient circuit Apnea Ventilation in SIMV The following strategy is designed to allow SIMV to avoid triggering apnea ventilation if a VIM breath can be delivered instead e Ifthe apnea interval Ta elapses at any time during the mandatory interval the ventilator delivers a VIM rather than beginning apnea ventilation e If Ta elapses during the spontaneous interval apnea ventilation begins The following figure shows an illustration of how SIMV is designed to deliver a VIM rather than trigger apnea ventilation when possible Operator s Manual
114. not make unauthorized modifications to the ventilator WARNING To prevent injury and avoid interfering with ventilator operation do not insert tools or any other objects into any of the ventilator s openings or ports WARNING The audio alarm volume level is adjustable The operator should set the volume at a level that allows the operator to distinguish the audio alarm above background noise levels Reference To adjust alarm volume p 3 41 for instructions on alarm volume adjustment WARNING Do not silence disable or decrease the volume of the ventilator s audible alarm if patient safety could be compromised WARNING If increased pressures are observed during ventilation it may indicate a problem with the ventilator Check for blocked airway circuit occlusion and or run SST Operator s Manual 1 5 Introduction WARNING The LCD panel contains toxic chemicals Do not touch broken LCD panels Physical contact with a broken LCD panel can result in transmission or ingestion of toxic substances A WARNING If the Graphical User Interface GUI display LCD panel is blank or experiences interference and cannot be read check the patient then verify via the status display that ventilation is continuing as set Because breath delivery is controlled independently from the GUI problems with the display will not by themselves affect ventilation The ventilator however should be replaced as soon as possible and repaire
115. of the selected layout If factory defaults are desired for a preset touch Defaults If done configuring parameters exit Service Mode by touching Exit To configure waveforms and loops ub Touch Waveform Layout located below the displayed waveforms or the vent setup screen The icon glows and a menu of various waveform layouts appears Touch the desired waveform s icon to display The selected waveform s appear on the GUI screen and the dialog closes To change the axis scaling 1 Touch the desired waveform axis Turn the knob to change the value For each axis turn the knob to the right to decrease the values and turn to the left to increase the values To pause waveforms JJ f 2 Touch the pause icon located below the waveforms area The icon glows yellow and allows the breath to complete A cursor appears and travels along the wave form while turning the knob displaying the x and y axis values Touch the pause icon again to re activate the waveform Reference To capture GUI screens p 5 2 for information on storing wave forms Opacity To institutionally configure screen opacity f Operator s Manual Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode Touch the Opacity icon Turn the knob to increase or decrease the opacity 3 45 Installation 4 Touch the padlock icon at t
116. on the ventilator after servicing it at the intervals specified in the table above Reference the Puritan Bennett 980 Series Ventilator Service Manual for details on performing EST 79 Inspection and Calibration Ventilator inspection and calibration should be performed by Covidien factory trained service personnel at the intervals specified in the table above 710 Documentation Covidien factory trained service personnel should manually enter the service date time and nature of repair preventive maintenance performed into the log using a keyboard on the GUI 7 26 Operator s Manual Service Personnel Preventive Maintenance To manually document a service or preventive maintenance activity 1 Enter Service Mode 2 Select the Logs tab 3 Select the Service Log tab 4 Select Add Entry and using the buttons to the right of each line complete the entry 5 Touch Accept when complete 7 1 pass Storage for Extended Periods To store the ventilator 1 Clean the unit thoroughly 2 Remove any batteries and accessories To return the ventilator to service 1 Replace batteries 2 Recharge batteries prior to patient ventilation If batteries are older than three 3 years use new batteries 3 Perform EST and SST prior to patient ventilation Operator s Manual 7 27 Preventive Maintenance Page Left Intentionally Blank 7 28 Operator s Manual 8 Troubleshooting 3 1 Overview This chapter contai
117. operation of breath delivery hardware including pressure and flow sensors checks the patient circuit including tubing humidification device and filters for leaks and measures the circuit compliance and resistance SST also checks the resistance of the expiratory filter SST in normal mode can only be performed at start up prior to initiation of ventilation Covidien recommends running SST every 15 days between patients and when changing the patient circuit or its configuration including changing circuit type adding or removing in line water traps or using a different type or style of patient circuit Reference To run SST p 3 48 The ventilator does not allow access to SST if it senses a patient is connected 10 19 Extended Self Test EST EST verifies the integrity of the ventilator s subsystems using operator partici pation EST requires a gold standard test circuit and a stopper to block the patient wye All test resources including the software code to run EST exist in the ventilator EST testing excluding tests of optional equipment such as the extended battery takes about ten 10 minutes Reference EST Extended Self Test p 3 52 WARNING Do not enter Service mode with a patient attached to the ventilator Serious injury could result Operator s Manual 10 77 Theory of Operations Page Left Intentionally Blank 10 78 Operator s Manual 11 Specifications 11 1Overview This chapter contains
118. or replace the battery or install an extended battery Ve MAND patient data alarm The patient s exhaled mandato ry tidal volume is lt alarm setting for the last two manda tory breaths e Check the patient e Check for leaks in the patient circuit e Check for changes in the patient s resistance or neous breaths compliance We spont patient data alarm The patient s exhaled sponta e Check the patient neous tidal volume is lt alarm setting for the last two sponta e Check the ventilator set tings Operator s Manual Ventilator Settings Table 6 6 Non Technical Alarms and Suggested Responses Continued Alarm message We tor patient data alarm Meaning The minute volume for all breaths is lt alarm setting Response e Check the patient e Check the ventilator set tings NO AIR SUPPLY The air supply pressure is less than the minimum pressure required for correct ventilator operation The ventilator deliv ers 100 O if available If an oxygen supply is not available the safety valve opens The ven tilator displays the elapsed time without ventilator support This alarm cannot be set or disabled e Check the patient e Check the air and oxygen sources e Obtain alternative ventila tion if necessary NO O SUPPLY The oxygen supply pressure is less than the minimum pressure required for correct ventilator operation The v
119. other accessories used during ventilation Reference To run SST in Chapter 3 of this manual There is also a table listing the general SST test sequence located in that section Ref Operator s Manual F 9 Proximal Flow Option Appendix erence the table below for a listing of the test sequence when running SST with the Proximal Flow Option Note Failure of the Proximal Flow Option to pass SST does not prevent ventilation but will prevent measurement with the Proximal Flow Option The ventilator will use its internal flow sensors for measurement instead of the Proximal Flow Option Table F 3 Proximal Flow Option SST test Sequence Test Step SST Flow Sensor Cross Check Function Tests O and Air Flow Sensors Comments N A SST EV Performance Calibrates the exhalation valve and creates a table for use during calculations N A SST Circuit Pressure SST Leak SST Exhalation Filter SST Circuit Resistance Exercises delivery PSOL Checks inspiratory and expira tory autozero solenoids Cross checks inspiratory and expiratory pressure transducers at various pressures Tests ventilator breathing system for leaks Checks for exhalation filter occlusion and exhalation com partment occlusion Checks for inspiratory and expi ratory limb occlusions and cal culates and stores the inspiratory and expiratory limb resistance parameters N A N A Ventilator prompts the user to block the p
120. p 10 74 for a full description of the Backup Ventilation strategies Note Do not confuse BUV with Safety PCV which occurs when a patient is connected before ventilator setup is complete or with Apnea ventilation which occurs in response to patient apnea Safety Valve Open SVO In the event of a serious fault occurring that cannot be safely bypassed the ventilator as a last resort reverts to a Safe State In Safe State the ventilator opens the Safety Valve and the Exhalation Valve allowing the patient to breathe room air if able to do so provided the patient circuit is not occluded and the inspiratory PSOL valve is closed During SVO the patient if connected can breathe room air through the safety valve after it releases pressure in the patient circuit The patient exhales through the exhalation valve with minimal resistance and the exhalation valve also acts like a check valve limiting gas from being drawn in through the expiratory filter or expiratory limb of the cir cuit SVO conditions are logged into the event and alarm logs as are the events leading to the SVO condition If the condition causing SVO clears the ventila tor clears the SVO state Patient data do not display on the GUI but graphics are still plotted During SVO the ventilator ignores circuit occlusions and dis Operator s Manual Ventilator Shutdown connects If the condition causing SVO can only be corrected by servicing the ventilator the SVO
121. reject the maneuver data 10 14 3 Negative Inspiratory Force NIF Maneuver The Negative Inspiratory Force NIF maneuver is a coached maneuver where the patient is prompted to draw a maximum inspiration against an occluded airway the inspiratory and exhalation valves are fully closed A NIF maneuver is canceled if e Disconnect is detected e Occlusion is detected Operator s Manual Short Self Test SST e SVO is detected e TPprax alarm is declared e TPyenr alarm is declared e 1V alarm is declared e Communications with the GUI is lost e The maneuver has been active for 30 s and an inspiration is not detected e INSPIRATION TOO LONG alarm is declared e A manual inspiration is requested When a NIF maneuver is activated a single pressure time waveform grid is automatically displayed During a NIF maneuver the circuit pressure displays on the waveforms screen and is regularly updated producing a real time dis play When an active NIF maneuver ends successfully the calculated NIF result appears on the waveforms screen and on the maneuver panel The NIF value displayed represents the maximum negative pressure from PEEP When a NIF maneuver ends a PEEP restoration breath is delivered to the patient then normal breath delivery resumes 10 14 43 Pp Maneuver Occlusion Pressure Po 1 is the negative airway pressure delta pressure change generated during the first 100 ms of an occluded inspiration It is an esti
122. require less patient effort to initiate a breath However fluctuations in system pressure can cause autotriggering at very low settings The maximum Ps_ns setting avoids auto triggering under worst case conditions if patient circuit leakage is within spec ified limits 10 15 12Inspiratory Pressure Pj The P setting determines the pressure at which the ventilator delivers gas to the patient during a PC mandatory breath The P setting only affects the deliv ery of PC mandatory breaths The selected P is the pressure above PEEP For example if PEEP is set to five cmH O and P is 20 cmH70 the ventilator deliv 10 64 Operator s Manual Short Self Test SST ers gas to the patient at 25 cmH5 0 Changes to the P setting are phased in at the start of inspiration The sum of PEEP P 2 cmH 30 cannot exceed the high circuit pressure TPpeax limit To increase this sum of pressures first raise the TPpgak limit before increasing the settings for PEEP or P The minimum value for P is 5 cmH50O and the maximum value is 90 cmH50 10 15 13INspiratory Time T The T setting determines the time during which an inspiration is delivered to the patient for PC mandatory breaths The ventilator accepts a setting as long as the resulting I E ratio and Tr settings are valid Changes to T phase in at the start of inspiration Directly setting T in VC mandatory breaths is not allowed The ventilator rejects settings that result in an
123. run SST to calculate the compliance and resistance with all items included in the patient circuit Reference To run SST p 3 48 sa User Interface Management The user interface is structured with a GUI and a status display The GUI provides access to ventilator controls and patient data The status display is a small LCD panel which acts as a back up to the GUI in the event of a GUI failure Reference Status Display p 2 28 for more information about the status display The status display is not interactive During normal ventilator operation the following information appears on the Status display Current power state AC or DC e Batteries installed charge status e Visual indication of audible alarm volume e Circuit pressure graph displaying Ppea PEEP and pressure related alarm settings 4 2 Operator s Manual Ventilator Shutdown Reference Status Display p 2 28 for information about displayed items during Service mode Using the GUI The GUI is used to interact with the ventilator while it is ventilating a patient or in any of its operating modes Caution Do not lean on the GUI or use it to move the ventilator Doing so could break the GUI its locking mechanism or tip the ventilator over The GUI is divided into several areas Figure 4 1 Areas of the GUI Veror Vr P ly TOT P MAND 4 1 30 28 VEN_11149_D 1 Prompt area Located beneath the waveforms Any prompts or messages display here Examp
124. sensor body tubing or connector are damaged occluded or broken A WARNING Do not use the Proximal Flow Sensor if there are kinks in the tubing WARNING Prior to patient ventilation with the Proximal Flow Option run SST with the exact configuration that will be used on the patient This includes a neonatal patient circuit Proximal Flow Sensor and all accessories used with the patient circuit If SST fails any Proximal Flow Sensor test check the patient circuit and the Proximal Flow sensor for leaks or occlusions and replace the flow sensor if necessary If SST continues to fail it may indicate a malfunction or a leak within the Proximal Flow hardware which could compromise accuracy or increase the likelihood of cross contamination thus replace the Proximal Flow hardware A WARNING Changing ventilator accessories can change the system resistance and compliance Do not add or remove accessories after running SST A WARNING If the Proximal Flow Option fails to respond as described in this appendix discontinue use until correct operation is verified by qualified personnel WARNING The Proximal Flow Sensor measures gas flow at the patient wye The actual volume of gas delivered to the patient may be affected by system leaks between the patient and the Proximal Flow Sensor such as a leak that could occur from the use of an uncuffed endotracheal tube WARNING Position the Proximal Flow Sensor exactly as described in
125. software described herein without notice In the absence of an express written agreement to the contrary Covidien has no obligation to furnish any such revisions changes or modifications to the owner or user of the equipment including its software described herein Table of Contents 1 1 4 mb md ma 00 NG O ul 2 1 2 2 2 3 2 4 2 5 2 6 Introduction OvervieW PP AA AA AA AAP 1 1 1 1 1 Related Documents ad dacwyis bie IIAAK NG KA dew Rs AA pd 1 1 Global Symbol Definitions aa 1 2 Safety Information 00 eee eee eee eee 1 3 1 3 1 Safety Symbol Definitions 02 00000020 e 1 3 1 3 2 Warnings Regarding Fire Hazards 5 a 1 3 1 3 3 General AA 1 4 1 3 4 Warnings Regarding Environment of Use 1 7 1 3 5 Warnings Before Using Equipment 1 8 1 3 6 Warnings Regarding Electrical Power 1 8 1 3 7 Warnings Regarding Ventilator Settings 1 9 1 3 8 Warnings Regarding Hoses Tubing and Accessories 1 9 1 3 9 Warnings Regarding Gas Sources 1 ee eee 1 11 1 3 10 Warnings Regarding Infection Control 1 12 1 3 11 Warnings Regarding Ventilator Maintenance 1 13 PAG AA AA 1 13 LUTO 2A MANA aks eee a NG er eee eee 1 14 Obtaining Technical Assistance 1 15 1 4 1 Technical Services kit dees bn eee Dede hea ANA KAKAW 1 15 1 4 2 On Scree Help ona a Bsr Bee Seda gad ad NG Na AG
126. the ALARM SILENCE key A two minute countdown timer appears on the GUI during the alarm silence interval Cancel the alarm silence function by touching Cancel Click each icon below to listen to a sample of the corresponding tones Note To hear the tones Adobe Acrobat Reader version 10 or higher must be installed on your computer Get Adobe Acrobat Reader free here Table 2 8 GUI Audible Indicator Functions Function Description Low priority alarm tone A series of two tones Sounds when a low priority alarm occurs 4 Medium priority alarm tone A repeating series of three tones Sounds when a medium priority alarm occurs 4 High priority alarm tone A repeating series of five tones Sounds when a high priority alarm occurs 4 Soft bound tone One tone Sounds when a soft bound is reached when making changes to ventilator settings A soft bound is a selected value that exceeds or K goes below its limit and requires acknowledg ment to continue Hard bound tone invalid entry The invalid entry sound occurs when a hard bound is reached when making changes to ven tilator settings A hard bound defines the upper K or lower limit of the setting where the setting cannot be adjusted higher or lower 2 24 Operator s Manual GUI Controls and Indicators The clinician enters ventilation parameters via the GUI s touch screen Refer ence GUI Front View p 2 6 The keys activate other ve
127. the PBW tube ID range pairs listed in the following table touch the continue button to override the tube ID setting If attempts are made to choose a tube ID less than 6 0 mm or greater than 10 mm a hard bound limit is reached as PAV is not intended for use with tubes smaller than 6 0 mm or larger than 10 0 mm When touching Dismiss the setting remains at the last tube ID selected Touch Accept or Accept ALL to accept changes or touch Cancel to cancel changes Continue setting up the ventilator as described in Chapter 4 of this manual Note If Leak Sync is currently enabled it becomes disabled when PAV is selected D 5 PAV Appendix Figure D 1 Ventilator Setup Screen Waiting for patient connect Setup Vent Ventilation Type Invasive NIV Mode Vseus O Pprax Tube I 0 3 6 100 40 mer cmH Essua PEEP TVn miO Match to Patent 10 300 44 Ramp o0 N VEN_11370_D Note When the ventilator is used on the same patient previously ventilated using PAV the GUI displays an attention icon and the tube type and tube ID previously used as a reminder to the clinician to review those settings during ventilator setup to 0 4 2 PBW and Tube ID The ventilator uses soft bound and hard bound values for estimated tube inside diameters based upon PBW Soft bounds are ventilator settings that have reached their recommended high or low limits When adjusting the tube size if the inside diameter does not al
128. the following specifications for the Puritan Bennett 980 Series Ventilator e Physical e Electrical e Interface e Environmental e Performance Ranges resolution and accuracies for ventilator settings alarm set tings and patient data e Regulatory Compliance A WARNING Due to excessive restriction of the Air Liquide SIS and Drager hose assemblies reduced ventilator performance levels may result when oxygen or air supply pressures lt 50 psi 345 kPa are employed 11 2Measurement Uncertainty Table 11 1 Performance Verification Equipment Uncertainty Measured Parameter Offset Gain Flow 0 1001 SLPM 2 7642 reading Pressure 0 121594 cmH20 0 195756 reading Oxygen Concentration 0 0168 O 0 0973 reading Temperature 0 886041 C 0 128726 reading Atmospheric Pressure 1 76 cmH20 Specifications During breath delivery performance verification for flow and pressure based measurements the equipment inaccuracy is subtracted from the acceptance specification as follows Net Acceptance Gain Requirement Specification Gain Measurement Uncer tainty Gain Net Acceptance Offset Requirement Specification Offset Measurement Uncer tainty Offset Acceptance Limit Net Acceptance Offset Net Acceptance Gain x Set ting Setting Acceptance Limit lt Measurement lt Setting Acceptance Limit For derived parameters such as volume compliance etc
129. this appendix or the Instructions for Use IFU provided with the sensor Operator s Manual F 3 Proximal Flow Option Appendix F 4 WARNING Do not position the Proximal Flow Sensor cables or tubing in any manner that may cause entanglement strangulation or extubation which could lead to hypercarbia or hypoxemia Use the cable management clips supplied to mitigate this risk WARNING To reduce the risk of extubation or disconnection do not apply tension to or rotate the Proximal Flow Sensor by pulling on the Proximal Flow Sensor s tubing WARNING Do not install the Proximal Flow Sensor in the patient circuit if the sensor is not also connected to the BDU WARNING Excessive moisture in the Proximal Flow Sensor tubing may affect the accuracy of the measurements Periodically check the sensor and tubing for excessive moisture or secretion build up WARNING The Proximal Flow Sensor is intended for single use only Do not re use the sensor Attempts to clean or sterilize the sensor may result in bioincompatibility infection or product failure risks to the patient WARNING Install the Proximal Flow Sensor as shown Reference Attaching Proximal Flow Sensor p F 14 Improper orientation of the flow sensor could lead to misinterpretation of data or incorrect ventilator settings Q Caution Do not use aerosolized medications with the Proximal Flow Sensor Such medications may damage the sensor Caution To prevent
130. to 106 105 0 to 15 10 to 121 8 3 to 100 115 0 to 15 11 to 133 7 5 to 91 125 O to 14 2 to 144 6 9 to 83 135 O to 14 13to 156 6 4 to 77 145 O to 14 4 to 167 6 0 to 71 150 O to 14 15 to 173 5 8 to 67 Operator s Manual D 9 PAV Appendix v 43 PAV Alarms D ul Reference Non technical Alarm Summary in Chapter 6 of this manual for a summary of the following alarms associated with PAV High circuit pressure TPpr px High ventilator pressure TPyenr PAV STARTUP TOO LONG PAV R amp C NOT ASSESSED Wy Ventilator Settings Guidance WARNING For optimal performance of PAV it is important to select the humidification type tube type and tube size that match those in use on the patient The instantaneous pressure generated at the patient wye during inspiration is a function of the patient effort Supp setting tube type and size patient resistance and elastance and the instantaneously measured gas flow and lung volume Set TPprax to a safe circuit pressure above which truncation and alarm annunciation are appropriate Note PAV has a built in high pressure compensation TP omp limit that is determined by theTPprax setting minus 5 cmH 30 or 35 cmH50 whichever is less If the inspiratory pressure at the patient wye P wye reaches the TPcopp limit the inspiration is truncated and the ventilator transitions to exhalation Reference p D 21 for more details regarding TPcomp and TPoeak Op
131. to line s 2 kV line s to earth Mains power quality should be that of a typical hospital envi ronment Voltage dips short interruptions and voltage variations on power supply input lines IEC EN 61000 4 11 Power frequency 50 60 Hz magnetic field IE EN 61000 4 8 lt 5 Ur gt 95 dip in Uy for 0 5 cycle 40 Ur 60Y6 dip in Ur for 5 cycles 70 U7 30 dip in Uy for 25 cycles lt 5 Ur gt 95 dip in Uy for 5s 3 A m lt 5 Uy gt 95 dip in Uy for 0 5 cycle 40 Ur 60Y6 dip in Ur for 5 cycles 70 U7 30 dip in Uy for 25 cycles lt 5 Uy gt 95 dip in U for 5s 3 A m Mains power should be that of a typical hospital environment If the operator of the ventilator requires continuous operation during power mains interruptions it is rec ommended that the ventilator be powered from an uninterrupt ible power supply or a battery Power frequency mag netic fields should be at levels characteristic of a typical hospital environment NOTE Uz is the AC mains voltage prior to application of the test level Operator s Manual 31 Specifications 32 Table 11 16 Electromagnetic Immunity Continued The ventilator is intended for use in the electromagnetic environment specified below The customer or the operator of the ventilator should assure that it is used in such an environ ment Immunity Test Conducted RF IEC EN 61000 4 6
132. work and inspiratory resistive work The Supp setting ranges from a minimum of 5 the ventilator performs 5 of the work of inspiration and the patient performs 95 to a maximum of 95 the ventilator performs 95 of the work and the patient performs 5 adjustable in 5 increments The PAV option also includes alarm limits safety checks and logic checks that reject non physiologic values for patient resistance and compliance as well as inappropriate data Humidification type and volume can be adjusted after running SST however the ventilator makes assumptions when calculating resistance and compliance if these changes are made without re running SST For optimal breath delivery run SST after changing humidification type and humidifier volume Operator s Manual Ventilator Settings Guidance p 4 1 Setting Up PAV To set up PAV 1 Operator s Manual At the ventilator setup screen enter the patient s gender and height or the patient s PBW Touch INVASIVE vent type Touch SPONT mode Touch PAV to select Spontaneous type Touch the desired trigger type P_tricg V trig or IE Sync if the IE Sync option is installed Select tube type Select the tube ID Initially a default value is shown based on the PBW entered at ventilator startup If this ID is not correct for the airway in use turn the knob to adjust the ID setting Note If the operator selects an internal diameter that does not correspond to
133. wye pressure cal culated in Equation 4 equals the TPcoyyp for 500 ms the inspiration is truncated and exhalation begins Further when Phe TPcomp ae is limited to TPcomp PAV Appendix Although this freezes the value of Pee patient activity such as coughing could drive Pye to FPpeax Causing inspiration to end The rapid rise of Paw to the TP omp limit would likely occur in the first third of inspiration and only if Rpay were overestimated and Supp were set above 85 The TPcomp condition guards against over inflation due to overestimation of Repay 6 The Yo Supp setting ranges from 5 to 95 in 5 increments Reducing the level of support decreases the possibility of over inflation A significant decrease could produce a sensation of inadequate support and the patient would absorb the additional work of inspiration or require an increase in the level of support A significant increase could cause a surge in the ventilator generated value for Pwye Which in turn could cause Piy to reach TPcomp and lead to temporary patient ventilator disharmony To minimize this possibility PAV software limits the actual increase in support to increments of 1096 every other breath until the new setting is reached 7 Spirometry remains active during PAV operation TV can be set high enough to allow spontaneous sigh breaths while 4Vg tor and TV tor remain active to reveal changes in minute ventilation Because PAV cannot operate wi
134. 0 11 38 3 8 7 3 100 35 120 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in meters m can be estimated using the equation applicable to the frequency of the trans mitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE 1 At 80 MHz and 800 MHz the separation distance for the higher frequency range applies NOTE 2 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people WARNING The use of accessories and cables other than those specified with the exception of parts sold by Covidien as replacements for internal components may result in increased emissions or decreased immunity of the ventilator system Operator s Manual Table 11 18 Part number and description Cable length 10087151 Power cord 10A RA ANZ 10 ft 3 m 10087159 Power cord 10A RA UK 10 ft 3 m 10087155 Power cord 10A RA EU 10 ft 3 m 10087157 Power cord 10A RA Japan 10 ft 3 m 10087152 Power cord 10A RA British 10 ft 3 m 10087154 Power cord 10A RA Swtzrlnd 10 ft 3 m 10081056 Power cord 10A RA USA 10 ft 3 m 10087156 Power cord 10A RA Israel 10 ft 3 m 10087160 Power cord 10A RA Brazil 10 ft 3 m 10087153 Power cord 10A RA China 10 ft 3 m
135. 0 68 Percent Support TC 10 68 Plateau Pressure Pp 6 46 Plateau Time Tp 10 63 Pneumatic Diagram 2 36 Power On Self Test POST 10 76 Preparing the Ventilator for Use 3 37 Pressure Sensitivity Pseys 10 64 Pressure Support P5ypp 10 68 primary battery installation 3 19 Primary display 2 16 Product Assembly 3 2 proximal flow option F 1 pushpin iarsin eee eee 4 5 Q quick start use 4 8 R respiratory maneuvers expiratory pause maneuver 10 53 inspiratory pause maneuver 10 50 NIF maneuver 10 54 respiratory mechanics maneuvers Negative Inspiratory Force maneuver NIF 10 54 Po 1 maneuver 10 55 vital capacity maneuver VC 10 56 Respiratory Rate f 10 61 Rise Time a 10 69 RS 232 commands RSET 5 5 SNDA 5 6 SNDF 5 10 S Safety Net 10 71 Serial commands 5 5 serial number interpretation 1 19 settings alarm 4 16 apnea 4 15 return to previous 4 20 ventilator 4 10 Short Self Test SST 10 77 SIMM 25 225 eke Se Reed BANA DAG lee 10 34 SINING cous sd EE oe ae oh 10 39 soft bound 4 3 Spontaneous SPONT Mode 10 39 10 41 Spontaneous Breath Delivery 10 22 SST how to run 3 48 outcomes 3 51 results 3 50 test sequence 3 48 Status Display 2 28 2 34 Storage for Extended Periods
136. 00 L min Oxygen sensor life Up to one year Operating life varies depending on oxygen usage and ambient temperature Gas mixing system Range of flow from the mixing system Up to 150 L min for Adult patients Additional flow is available peak flow to 200 L min for compliance compensation Up to 80 L min for pediatric circuit type Up to 30 L min for neonatal circuit type Leakage from one gas system to another Meets IEC 80601 2 12 standard Operating pressure range 35 psi to 87 psi 241 to 600 kPa Table 11 4 Technical Specifications Maximum limited pressure Pi jumax A fixed pressure limit to the safety valve limits circuit pressure to lt 125 cmH30 123 hPa at the patient wye Maximum working pressure Pyymax Pwmax Is ensured by the high pressure limit FPpE ak when P is 125 cmH 0 98 07 hPA Response time to change in FiO setting from lt 18 s for volumes gt 150 mL 21 to 90 O measured at the patient wye lt 19 s for volumes 2 30 mL but lt 150 mL lt 20s for volumes 2 2 mL but lt 30 mL Measuring devices Pressure measurements Type Solid stated differential pressure transducer Sensing position Inspiratory module expiratory module Mean circuit pressure Pyyean 20 cmH 0 20 hPa to 130 cmH30 127 hPa Peak circuit pressure PpeaK 20 CMH 20 20 hPa to 130 cmH 30 127 hPa Volume Measurements Type Hot film anemometer Sensing position Inspiratory module expir
137. 0220eeee F 1 Software Hardware Requirements F 2 Safety Information cece eee eee F 2 Proximal Flow Option Description F 5 Proximal Flow Option components 20 F 5 On screen symbols 200 e eee eee eee eee F 6 Sensor Calibration and Sensor Line Purging F 8 SST Requirements 200 c eee eee eee eee F 9 Attaching the Proximal Flow Sensor for SST U F 11 Disabling Enabling the Proximal Flow Option F 12 Using the Proximal Flow Sensor F 13 How to Perform a Manual Purge 000 0a F 15 MELO PR PAA beeen i a E ete a a a a F 16 Ranges Resolutions and Accuracies 5 F 17 Proximal Flow Sensor Specifications F 17 Part Numbers swertceseueane KABAN ANA NE R ARAMA awed F 18 List of Tables Table 1 1 Table 1 2 Table 2 1 Table 2 2 Table 2 3 Table 2 4 Table 2 5 Table 2 6 Table 2 7 Table 2 8 Table 2 9 Table 2 10 Table 2 11 Table 3 1 Table 3 2 Table 3 3 Table 3 4 Table 3 5 Table 3 6 Table 3 7 Table 3 8 Table 3 9 Table 4 1 Table 4 2 Table 4 3 Table 4 4 Table 5 1 Table 5 2 Table 6 1 Table 6 2 Table 6 3 Table 6 4 Table 6 5 Table 6 6 Table 7 1 Table 7 2 Table 7 3 Table 7 4 Table 7 5 Shipping Carton Symbols and Descriptions 1 2 Safety Symbol Definitions aaa 1 3 Typical Packing List ic0ced lt tadeu
138. 1 3 8 2 3 9 3 9 1 3 9 2 3 9 3 3 9 4 3 10 4 1 4 2 4 3 4 4 4 5 4 5 1 4 5 2 4 5 3 4 5 4 4 5 5 4 5 6 4 6 4 7 4 7 1 4 7 2 4 7 3 4 7 4 4 7 5 4 7 6 4 7 7 4 7 8 4 8 4 9 4 9 1 4 9 2 4 9 3 4 10 Stand By State Laue an pw arian Mee eee eee eee er ore cS 3 31 Service Mode PEPE OP 3 33 Product Configuration eee eee 3 35 Preparing the Ventilator for Use nananana ee 3 37 Configuring the GUI anc ett eae Xu Res bowers nts RR ewes 3 37 Installation Testing cece eee eee eee 3 46 SST Sh rt Self TES a cate cas NA KAGAD an NG chee eee 3 46 EST Extended Self AASA 3 52 EST Test Sequence Lain chewed od edad Ok en daw ae RORY 3 54 EST Test Results nonn chanodcs 2 da abhadebachsotdeads 3 57 Operation Verification eee ees 3 58 Operation Overview ccscanttececin see ceed KANAN KE LB AE enced 4 1 Ventilator Function 2 2 0200s 2eeeececee ee eedecue ds 4 1 Ventilator Setup 4 c lt eis wine NGA AG 4 2 User Interface Management 220 eee eee 4 2 Ventilator Operation 2c cee es 4 7 Ventilator Settings casa Ana KAG PAS haha ada 4 10 Apnea Settings waka KA GLAD oe dagen nee KA 4 15 Alarm Settings AA AE 4 16 Alarm Screen During Operation 0200005 4 18 Making Ventilator Settings Changes 4 19 Constant Timing Variable During Respiratory Rate Changes 4 20 Predicted Body Weight PBW Calculation 4 21 Non invasive Ventilation N
139. 11 10Safety Tests All safety tests should be performed by qualified Service personnel at the inter val specified Reference Service Preventive Maintenance Frequency p 1 2 in the Operator s Manual Addendum on Preventive Maintenance 11 11Essential Performance Requirements Per ISO EN 80601 2 12 2011 Medical electrical equipment Part 2 12 Partic ular requirements for basic safety and essential performance of critical care ventilators the ventilator s essential performance requirements are given in Ventilator Settings Alarm Settings and Patient Data tables earlier in this chap ter Alarms including Oxygen level alarms and gas failure alarms are identified in Chapter 6 AC and battery backup power information is given in Chapter 3 and gas failure cross flow information is given in Chapter 3 Operator s Manual Safety Tests 35 Specifications Page Left Intentionally Blank 36 Operator s Manual A BiLevel 2 0 Appendix a1 Overview This appendix describes the operation of the BiLevel 2 0 ventilation mode on the Puritan Bennett 980 Series Ventilator BiLevel is a mixed mode of ventilation that combines attributes of mandatory and spontaneous breathing with the breath timing settings determining which breath type is favored In BiLevel Mode mandatory breaths are always pressure controlled and spontaneous breaths can be pressure supported PS or tube compensated TC Figure A 1 Spontaneous Breathing at PL
140. 11 7Performance Specifications 11 7 1Ranges and Resolutions Reference the table below for ranges resolutions accuracies new patient default values and dependencies where applicable for ventilator settings Reference Alarm Settings Range and Resolution p 11 17 for alarm settings and Reference Patient Data Range and Resolution p 11 19 for displayed patient data parameters Table 11 9 Ventilator Settings Range and Resolution Setting Apnea ventilation Description A safety mode of ventila tion that starts if the patient does not receive a breath for an elapsed time exceeding the apnea inter val Range and Resolution See individual apnea settings Apnea expiratory time T For mandatory PC apnea breaths the time interval between the end of inspi ration and the beginning of the next inspiration Range 0 20 s to 59 8 s Resolution 0 01 s Apnea I E ratio Apnea flow pattern In PC breath types speci fies the ratio of apnea inspiratory time to apenea expiratory time The flow shape of the delivered mandatory volume based VC apnea breath Range E lt 1 00 1 Resolution 0 01 for values gt 1 10 0 0 1 for values lt 1 10 and gt 1 100 1 for values lt 1 100 Range SQUARE descending ramp Apnea inspiratory pres sure Pj The pressure above PEEP at which gas is delivered to the patient during manda tory PC apnea breaths Range 5 cmH20 to 90 PEEP c
141. 16 17 18 19 20 21 22 8 9 10 m 12 l VEN_11426_B Pressure Sensor barometric P4 Vial exhalation condensate ECV Filter expiratory F4 Flow sensor assembly exhalation valve Exhalation valve EV Filter exhalation pressure line F5 Solenoid valve exhalation pressure autozero SOL5 Pressure sensor exhalation Pe Humidifier Filter External bacterial Fp Filter Internal bacterial Fp 2 37 Product Overview 23 24 25 26 27 28 29 30 31 32 33 Check valve patient gas delivery CVp Sensor oxygen OS Restrictor breath delivery bypass R2 Flow sensor patient gas delivery FSp Check valve Oxygen CVO gt Check valve Air CV air Proportional solenoid valve Oxygen PSOLO Flow sensor Air FS air Proportional solenoid valve Air PSOL pir Pressure sensor air gas inlet Pair Restrictor Wall air bleed outlet R1 34 35 36 37 38 39 40 41 42 43 44 Check valve compressor air inlet CVcair Filter bowl assembly Air WT2 mn ilter element Air F2 a heck valve wall Air inlet CVyair Filter Oxygen Impact F1 mn ilter element Oxygen F3 Pressure sensor Oxygen gas inlet PO Flow sensor Oxygen FSO Restrictor Prox Flow R4 Relief Valve mix accumulator RVma Solenoid Valve mix accumulator purge SOL1 Figure 2 12 Pneumatic Diagram Optional Proximal Flow S
142. 3 Product Overview 2 6 5 Ventilator Side Views Figure 2 6 Ventilator Right Side View VEN_10308_C 2 14 Operator s Manual GUI Controls and Indicators Figure 2 7 Ventilator Left Side View VEN 10331 A 27 Mounting Configurations The ventilator system can be mounted as a free standing unit standing at the patient s bedside the BDU with the GUI is mounted on a base with casters and includes a handle for ease of movement 2s Battery Backup The ventilator system uses a battery to provide backup power in case AC power is lost When operating on battery power the status display shows the On Battery Power image and the GUI displays a representation of battery charge levels Reference Typical Status Display Indicators and Messages p 2 30 to for a description of the status display images and messages An optional extended battery is available to lengthen the amount of time the ventilator can operate on battery power Reference Using Battery Power p 3 3 Operator s Manual 2 15 Product Overview 29 Graphical User Interface There are two displays on the ventilator the primary display GUI and the Status display 2 9 1 Primary Display The GUl incorporates a 15 display that rotates throughout a 170 angle about a vertical axis in either direction The GUI can also be tilted up to 45 from ver tical The clinician enters ventilation parameters via the GUI s touch screen also known as th
143. 30 Quick Start mode 3 30 Service mode 3 33 Stand By state 3 31 Ventilator Protection Strategies 4 35 4 37 ventilator settings apnea ventilation 10 57 circuit type and PBW 10 59 configuration 3 37 3 46 disconnect sensitivity Dsens 10 70 flow pattern 10 63 flow sensitivity Vsens 10 64 high inspiratory time limit TT spont 10 71 high pressure BiLevel 10 66 high time BiLevel 10 66 humidification type 10 71 humidifier volume 10 71 I E ratio 10 66 inspiratory pressure P 10 65 inspiratory time Tj 10 65 low pressure BiLevel 10 66 low time BiLevel 10 67 mode and breath type 10 61 peak inspiratory flow 10 62 peak inspiratory flow Vmax 10 62 PEEP 10 67 PEEP restoration 10 67 percent support PAV 10 68 percent support TC 10 68 plateau time Tp 10 63 pressure sensitivity Psens 10 64 pressure support 10 68 pressure support Psypp 10 68 range and resolution 11 8 11 16 respiratory rate f 10 62 rise time 10 69 Ty T ratio 10 67 tidal volume 10 62 vent type 10 59 volume support V7 supp 10 68 Ventilator Setup 4 2 VentType a 10 59 Volume Support V7 supp 10 68 VS maximum pressure adjustments 10 26 startup 10 26 W Warranty Information 1 19 waveform axis scaling 3 45 Rx ONLY Part No 10077893 A 2014 10 2014 Covidien ual Covidien Ilc 15 Hampshire Street Mansfield MA 02048 USA www covidien com T
144. 33 Pediatric Adult Expiratory Filtration System carton of 12 10043551 6 980 FRU Exhalation valve flow sensor 10097468 7 Wall air water trap 10086051 Operator s Manual Table 9 1 Covidien Accessories and Options Continued General Accessory Information Item Accessory or option description Part number number Power cord 10A RA ANZ 0087151 Power cord 10A RA UK 0087159 Power cord 10A RA EU 0087155 Power cord 10A RA Japan 0087157 Power cord 10A RA British 0087152 Power cord 10A RA Switzerland 0087154 Power cord 10A RA USA 0081056 Power cord 10A RA Israel 0087156 Power cord 10A RA Brazil 0087160 Power cord 10A RA China 0087153 Air hose assembly Norway Sweden Finland Denmark 4 074696 00 Greece France Operator s Manual Accessories Table 9 1 Covidien Accessories and Options Continued Item Accessory or option description Part number number Air hose assembly Australia New Zealand 4 074712 00 Air hose assembly Canada 4 074709 00 Air hose assembly Italy Switzerland Spain Belarus Kazakh 4 074706 00 stan Air hose assembly Japan Israel 10001777 Air hose assembly Poland Portugal South Africa 4 074703 00 Air hose assembly Switzerland 4 074707 00 Air hose assembly United States Latin America 4 006541 00 Air hose assembly Germany Luxembourg Austria Nether 4 074714
145. 38400 bits s and the operator selected stop bits and parity A sample of pressure and flow readings is taken every 20 ms This sample of readings is transmitted on the selected serial port at the end of each breath at breath rates of 10 min and higher For longer duration breaths at least the first eight seconds of the breath is transmitted The format of the data is as follows The beginning of inspiration is indicated by BS S nnn lt LF gt where BS identifies the Breath Start S nnn is a sequence number incremented at every breath and lt LF gt is a line feed charac ter The fff and ppp fields show the breath flow and pressure data The end of exhalation is indicated by BE lt LF gt where BE indicates Breath End and lt LF gt is a line feed character 5 4 4 Serial Commands The ventilator system offers commands that allow communication to and from the ventilator using a Comm port Commands to the ventilator from a remote device include e RSET Reference RSET Command p 5 5 e SNDA Reference SNDA Command p 5 6 e SNDF Reference SNDF Command p 5 10 Note The ventilator responds only if it receives a carriage return lt CR gt after the command string 5 4 5 RSET Command The RSET command clears data from the ventilator receive buffer The ventila tor does not send a response to the host system Enter the RSET command exactly as shown Operator s Manual 5 5 Product Data Outpt o o o ooe 5
146. A WARNING One primary battery must be installed at all times in the BDU s primary battery slot for proper ventilator operation The ventilator will not complete the startup process without the primary battery installed Reference Battery Compartment Locations p 3 21 for identification of battery slots The ventilator s primary battery must be installed by qualified service personnel as it is shipped separately before patient use The ventilator will not complete Power on Self Test POST if the battery is not present and ventilation is pro hibited Ensure the battery is fully charged before placing the ventilator into service The ventilator employs a battery backup system if AC power becomes unavail able or drops below approximately 90 volts A new fully charged battery pro vides at least one hour of power to the ventilator assuming ambient temperature of 20 C 68 F to 25 C 77 F PBW 70 kg and at factory default ventilator settings The battery back up system for the ventilator contains one primary battery Backup power is supplied to the ventilator in the event of an AC power loss One extended battery slot is available for the ventilator If both primary and extended ventilator batteries are present these batteries can power the venti lator for two hours one hour for the primary battery and one hour for the extended battery under the environmental conditions described above When using battery power the ventilator o
147. Appendix e Esens 25 if IE Sync has not been used previously otherwise default Esens setting for the currently active breath type If IE Sync is enabled while in transition from a different trigger type then the trigger type Psens and Eseng settings from the prior breath type shall be used during startup instead of those stated above ce Setting Up IE Sync for Monitoring Only To set up IE Sync for monitoring only 1 At the Vent Setup screen change the trigger type to a type other than IE Sync 2 Touch Accept 3 Swipe the Menu tab on the left side of the GUI Figure C 2 Monitoring Setup PEEP 38 37 Mi nao 3 VEN 11363 D 4 Touch IE Sync A dialog appears allowing enabling ON or disabling OFF of IE Sync monitoring C 4 Operator s Manual Technical Description Figure C 3 Monitoring Dialog PEEP Vie mano BB 37 44 170 32 Fi 058 388 IE Syne Monitoring oft On VEN_11392_D 5 Touch ON 6 Set the inspiratory trigger threshold Isens 7 Set the expiratory sensitivity threshold Ecens 8 Touch Close c7 IE Sync Monitoring Display The waveforms screen shows the Psync intra pleural pressure signal and the lE signal during the delivery of a spontaneous breath Reference Technical Description p C 7 for details regarding Psync Note IE Sync related signals are not displayed during Apnea ventilation IE Sync monitoring displays a waveform indicator marking where in the bre
148. Backup Venti lation BUV state An emergency state the ventilator enters if it detects a hardware failure or a critical software error which could compromise safe ventilation During a ventilator inoperative condition the safety valve opens to allow the patient to breathe room air if able to do so unassisted by the venti lator Qualified service personnel must power up the ventilator and run EST before normal ventilation can resume Ventilator initiated mandatory breath A breath that is delivered at a time determined by the ventilator Peak flow A setting of the peak maximum flow of gas delivered during a VC mandatory breath Combined with tidal volume flow pattern and plateau constant peak flow defines the inspiratory time To correct for compliance volume the ventilator automatically increases the peak flow Flow sensitivity A setting that determines the rate of flow inspired by the patient that triggers the ventilator to deliver a mandatory or spontaneous breath when flow triggering is selected Tidal volume A setting that determines the volume inspired and expired with each breath The Vy delivered by some Puritan Bennett ventilators is an operator set variable that determines the volume delivered to the patient during a mandatory volume based breath Vy is compliance compensated and corrected to body temperature and pressure saturat ed BTPS Flow triggering A method of recognizing patient inspiratory eff
149. Close the door 3 Lower the expiratory filter latch a Re attach expiratory limb of patient circuit to filter Figure E 1 Installing Neonatal Filter and Door VEN_11162_A 1 Neonatal expiratory filter 3 Expiratory filter latch 2 Neonatal adapter door 4 Filter door pivot pin Operator s Manual Ventilation Features WARNING e To ensure all breathing circuit connections are leak tight perform a circuit leak test by running SST every time the filter is installed The circuit leak test can be performed as an individual test from the SST startup screen but after the leak test is performed the entire suite of SST tests must be performed without a failure before ventilation can begin e Empty the condensate vial before fluid reaches the maximum fill line Con densate vial overflow can enter the filter or the breathing circuit and can cause increased expiratory flow resistance Change the filter if it appears to be saturated e The neonatal expiratory filter and condensate vial is a single unit and is for single patient use only Do not attempt to sterilize the filter assembly WARNING Adding accessories to the ventilator can change the pressure gradient across the ventilator breathing system VBS and affect ventilator performance Ensure any changes to the recommended ventilator circuit configurations do not exceed the specified values for inspiratory and expiratory pressure drop Reference the table Technical Specificati
150. Comin alee ace ate kts 6 4 o5 Alarm Messages 22 0 acai kek Da nG DI ORO GEES 6 4 6 5 2 Alarm Reset Key yaaa vue es ea eee eek 6 8 6 5 3 Alarm Silence Key aie rein KA KAG PAGA GM 6 8 6 5 4 Alarm Volume Key 5 2a sale ain dn AKA edema ad An kaban 6 8 65 5 NENA SU AA AA 6 9 6 5 6 Viewing Alarms sma pistes Kalam ALA MAD NG AG oh KA NGO 6 14 6 5 7 Alarm Delay Ga aNG Pad ee LS PA NA 6 15 65 3 Alarm Handling xau GANA Fetch bh mna aaa 6 15 6 5 9 AG POWER LOSS Alarm 06 Dna a keV ka ITNA AnG MG RA Sed 6 35 6 5 10 Apnea Alarm maa ee ee pa ech ae ae eae tees 6 35 6 5 11 CIRCUIT DISCONNECT Alarm co s kang Ie a gece arb heer ood 6 35 6 5 12 Loss of Power Alarm accu sumed ed deve Gn ne eeated mae se 6 36 6 5 13 DEVICE ALERT T AlarM Kalag oii eceus oh bounce vias 6 36 6 5 14 High Circuit Pressure TPpgax Alarm ws we ee 6 36 6 5 15 High Delivered 05 10596 Alarm ee ee 6 37 6 5 16 High Exhaled Minute Volume Wg qor Alarm 6 38 6 5 17 High Exhaled Tidal Volume tVy_ Alarm ws we ee ee 6 38 6 5 18 High Inspired Tidal Volume Vp Alarm 6 38 6 5 19 High Respiratory Rate NMAfo7 Alarm ww ee ee ee 6 39 6 5 20 INSPIRATION TOO LONG Alarm 20 csebs baa WADA HA vais 6 39 6 5 21 Low Circuit Pressure 4Ppr ap Alarm ww we eee 6 39 6 5 22 Low Delivered 07 107 Alarm aaa 6 40 6 5 23 Low Exhaled Mandatory Tidal Volume LVt manp Alarm 6 41 6 5 24 Low Exhaled Spontaneous Tidal Volume 4V spont Alarm 6 41 6 5 25 Low
151. Cstaz Resistance Rstaq An estimate of the patient s lung thorax static compliance or elasticity An estimate of the restrictive ness of the patient s lungs and the artificial airway Range O mL cmH20 to 500 mL cmH70 Resolution 0 1 mL cmH50O for values lt 10 mL 1 mL cmH 0 for values gt 10 mL cmH30 Range O cmH 2O L s to 500 cmH70 L s Resolution 0 1 cmH O L s for values lt 10 cmH gt O L s 1 cmH gt O L s for values 10 cmH O L s Total PEEP PEEPro1 The estimated pressure at the circuit wye during an expira tory pause maneuver Range 20 0 cmH 0 to 130 cmH 0 Resolution 0 1 cmH 0 for values lt 10 cmH 30 1 cmH 0 for values lt 10 cmH 0O and 2 10 cmH30 Total respiratory rate fror The number of mandatory or spontaneous breaths min delivered to the patient Range 1 to 200 1 min Resolution 0 1 1 min for values lt 10 1 min 1 1 min for 10 1 min to 200 1 min Vital capacity VC The maximum amount of air that can be exhaled after a maximum inhalation Range 0 mL to 6000 mL Resolution 0 1 mL for values lt 10 mL 1 mL for values gt 10 mL VLEAK Inspiratory leak volume the total volume delivered during inspiration to compensate for the leak Range 0 to 9000 mL Resolution 1 mL Operator s Manual 25 Specifications 26 Table 11 11 Patient Data Range and Resolution Continued Data Value Description Range and Resol
152. Display Indicators and Descriptions Continued Status Display Indicator or Message Meaning Stand by state The status display appears as shown when the ventilator is in stand by state Ventilator Hours 1000 Battery charged The ventilator s primary battery in the right most slot is shown fully charged The percentage indicator shows 100 Ppeax 3 PEEP 3 o cmH Ventilator Hours 1000 Battery charging discharging Identifies that the ventilator s primary battery and or extended battery is charging or discharging This icon is animated orange bars scroll upward indicating 3b i the battery is charging and downward when the battery is discharging If the orange bars are absent the battery is neither charging nor dis charging A percentage indicator shows the TRO remaining battery capacity If an extended battery is installed the image shows a similar rep resentation in the extended battery location left most slot PEEP ye Battery icon Denotes the ventilator is operating lid on battery power when this image appears on b any status display indicator Alerts the operator ly there is insufficient AC power to operate the ven tilator The indicator is replaced by the on AC power indicator when adequate AC power is restored Operator s Manual 2 31 Product Overview Table 2 9 Status Display Indicators and Descriptions Continued Status Display Indicator or Message
153. Ed COVIDIEN Operator s Manual Puritan Bennett 980 Series Ventilator Copyright Information COVIDIEN COVIDIEN with logo and positive results for life are U S and internationally regis tered trademarks of COVIDIEN AG All other brands are trademarks of a Covidien company or of their respective owners 2014 COVIDIEN The information contained in this manual is the sole property of Covidien and may not be duplicated without permission This manual may be revised or replaced by Covidien at any time and without notice Ensure this manual is the most current applicable version If in doubt contact Covidien s technical support department or visit the Puritan Bennett product manual web page at http Awww covidien com Click Our Products gt Respiratory amp Monitoring Products gt Brands gt Puritan Bennett Click Sales and Support Center gt Product Manuals and Directions for Use then follow the prompts to select the desired manual While the information set forth herein is believed to be accurate it is not a substitute for the exercise of professional judgement The ventilator should be operated and serviced only by trained professionals Covidien s sole responsibility with respect to the ventilator and software and its use is as stated in the limited warranty provided Nothing in this document shall limit or restrict in any way Covidien s right to revise or otherwise change or modify the equipment including its
154. Exhaled tidal volume ESENS Expiratory sensitivity TE Expiratory time Flow pattern ramp Flow pattern square VsENs Flow sensitivity VARIG Flow triggering Py High pressure setting in BiLevel Ty High pressure time in BiLevel Ty Ty High pressure time to Low pressure time ratio in BiLevel LE Inspiratory Time to Expiratory Time I E Co C Inspiration compliance ratio VLEAK Inspiratory leak T Inspiratory time 2 21 2 22 Product Overview Table 2 7 Symbols and Abbreviations Continued Symbol or Abbreviation Definition Pi Inspiratory pressure Vi Inspired tidal volume VIL Inspired tidal volume when Leak Sync is enabled PEEP Intrinsic PEEP auto PEEP PEEP pay PAV based intrinsic PEEP PL Low pressure setting in BiLevel TL Low pressure time in BiLevel PMEAN Mean circuit pressure NIF Negative inspiratory force 07 Oxygen percentage Po 4 Airway occlusion pressure at 100 ms Cpay PAV based lung compliance Epay PAV based lung elastance Supp Percent support setting for Tube Compensation and PAV Repay PAV based patient resistance RTOT PAV based total airway resistance WOByot PAV based work of breathing of patient and ventilator during inspiration Ppeak Peak circuit pressure PEF Peak expiratory flow VMAX Peak inspiratory flow PSF Peak spontaneous flow PEEP Set or monitored positive end expiratory pressure
155. G To prevent electrostatic discharge ESD and potential fire hazard do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system 1 3 3 General Warnings 1 4 WARNING To ensure proper operation and avoid the possibility of physical injury only qualified medical personnel should attempt to set up the ventilator and administer treatment with the ventilator WARNING In case of ventilator failure the lack of immediate access to appropriate alternative means of ventilation can result in patient death An alternative source of ventilation such as a self inflating manually powered resuscitator as specified in ISO 10651 4 with mask should always be available when using the ventilator Operator s Manual Safety Information WARNING Patients on mechanical ventilation should be monitored by clinicians for proper patient ventilation WARNING The ventilator system is not intended to be a comprehensive monitoring device and does not activate alarms for all types of conditions For a detailed understanding of ventilator operations be sure to thoroughly read this manual before attempting to use the ventilator system WARNING To prevent patient injury do not use the ventilator if it has a known malfunction Never attempt to override serious malfunctions Replace the ventilator and have the faulty unit repaired by trained service personnel WARNING To prevent patient injury do
156. I E ratio greater than 4 00 1 a T greater than eight 8 s or less than 0 2 s or a Tg less than 0 2 s to ensure the patient has adequate time for exhalation Setting f and T automatically determines the value for I E and Tr IA f a T This equation summarizes the relationship between T I E Te and breath period time T Dao LE If the f setting remains constant any one of the three variables Tj I E or T can define the inspiratory and expiratory intervals If the f setting is low and additional spontaneous patient efforts are expected T can be a more useful variable to set than I E As the f setting increases and the fewer patient trig gered breaths are expected the I E setting becomes more relevant Regardless of which variable is chosen a breath timing bar always shows the interrelation ship between T 1 E TE and f Operator s Manual 10 65 Theory of Operations 10 15 14Expiratory Time TE The T setting defines the duration of exhalation for PC and VC mandatory breaths only Changes to the T setting are phased in at the start of exhala tion Setting f and Te automatically determines the value for I E ratio and T Reference nspiratory Time T p 10 65 for an explanation of the interdepen dencies of f Tj Te and KE 10 15 151 E Ratio The I E ratio setting is available when I E is selected as the constant during rate change The LE setting determines the ratio of inspiratory time to expirato
157. IMV breath period Figure 10 16 Mandatory and Spontaneous Intervals SN pt E VEN 10765 B 1 Tb SIMV breath period includes Tm and T 3 Ts Spontaneous interval VIM delivered if no PIM delivered during Tm 2 Tm Mandatory interval reserved for a PIM breath 10 34 Operator s Manual Short Self Test SST The first part of the period is the mandatory interval T which is reserved for a PIM If a PIM is delivered the T interval ends and the ventilator switches to the second part of the period the spontaneous interval T which is reserved for spontaneous breathing for the remainder of the breath period At the end of an SIMV breath period the cycle repeats If a PIM is not delivered during the mandatory interval the ventilator delivers a VIM at the end of the mandatory interval then switches to the spontaneous interval The following figure shows an SIMV breath period where a PIM is delivered within the mandatory interval Any subsequent trigger efforts during T yield spontaneous breaths As shown Tm transitions to T when a PIM is delivered Figure 10 17 PIM Delivered Within Mandatory Interval Nan 2 3 o _ VEN_10766_B 1 PIM 3 Ts subsequent trigger efforts during Ts yield spontaneous breaths 2 Tm Tm transitions to Ts when a 4 Tb PIM is delivered The following figure shows an SIMV breath period where a PIM is not delivered within the mandatory interval Figure 10 18 PIM Not Delivered
158. IV 2 eee eee 4 22 NIV Intended Use a aman Bank dah Oe Oe ah ee tah NG 4 22 NIV Breathing Interfaces akma maam bah dees 4 22 NIV Setup sissa chapaa madai aoe aia dwodad anda cae 4 23 Conversion from INVASIVE to NIV Vent Type 4 24 Conversion from NIV to INVASIVE Vent Type 4 25 High Spontaneous Inspiratory Time Limit Setting 4 26 NIV Apnea Setup ciedetetibide BABA saru BAGGAGE DANG 4 27 NIV Alarm Settings 24 0 davis NA NAA Dara ha ee oes 4 27 Manual Inspiration eee eee eee eee 4 28 Respiratory Mechanics Maneuvers 4 28 Inspiratory Pause Maneuver 000 eee eee 4 30 Expiratory Pause Maneuver 0 0000 cee ee eee 4 31 Other Respiratory Maneuvers 0 0000 ce eee ee 4 32 Oxygen Sensor Function eee 4 32 4 10 1 Oxygen Sensor Life aaa AKA tinge aY ng oul 4 33 4 10 2 Oxygen Sensor Calibration lt 2s5x40 paha ewes ee eead ou 4 34 4 10 3 Oxygen sensor calibration testing 204 4 34 4 11 Ventilator Protection Strategies 4 35 4 11 1 Power on Self Test POST 0 00 0 0 000 000 0 0000040 4 35 4 11 2 Technical Fault oi KABAN contd tienda dhe eae ta Gan AG 4 35 AVS Th aida amas a dee Heed Knee ANA o NAG NG GG ANAND 4 35 4 11 4 Procedure Error 44a da e sow AA ds dot ews 4 36 4 11 5 Ventilation Assurance ww eee 4 36 4 11 6 Safety Valve Open SVO 2 2a debe eval ebeenesidands 4 36 4 11 7 Ventilator Inoperative
159. LEDs Reference p 3 79 for information on interpreting the battery capacity Green LED bars do not scroll if the battery is not charging or is in use If a battery fault occurs the fault is annunciated charging of the faulty battery discontinues but charging of any other non faulty battery continues A faulty battery will cause annunciation of the error and battery power will not be avail able for the ventilator The ventilator status display indicates the charge level of the installed batteries the presence of one or more battery faults and which battery is being charged The ventilator operates no differently when its batteries are charging than it does when the batteries are fully charged The ventilator continues operating as set when the ventilator switches from AC power to battery power and illuminates an indicator on the status display alert ing the operator that the ventilator is now operating on battery power and AC POWER LOSS alarm annunciates A medium priority alarm annunciates when the remaining run time for the ventilator drops to ten 10 minutes and a high priority alarm annunciates when the remaining time drops to five 5 minutes 34 Product Placement The ventilator is positioned standing on its casters next to the patient s bed side as shown below 3 4 Operator s Manual Product Connectivity Move the ventilator using the handle encircling the BDU and roll the ventilator to the desired location Figure 3 1
160. MAL ALARM_ or RESET_ 6 characters Inspiratory component of I E ratio or High component of H L BiLevel setting 6 characters Expiratory component of 1 E ratio setting or Low component of H L BiLevel 6 characters eld 98 Inspiratory component of apnea I E ratio setting 6 characters Field 99 Expiratory component of apnea I E ratio setting 6 characters Operator s Manual 5 9 Product Data Output Table 5 1 MISCA Response Continued Field 100 Constant during rate setting change for pressure control mandatory breaths I TIME or I E___ or 6 characters where represents Te or PCV not active Field 101 Monitored value of 1 E ratio 6 characters lt ETX gt End of transmission character 03 hex lt CR gt Terminating carriage return 5 4 7 SNDF Command SNDF is a command sent from an external host device to the ventilator system instructing it to transmit all ventilator settings data monitored patient data and alarm settings and occurrences Enter the SNDF command exactly as shown SNDF lt CR gt When the ventilator receives the command SNDF lt CR gt it responds with the code MISCF followed by ventilator settings monitored patient data and alarm information The MISCF response follows this format MISCF 1225 169 lt STX gt FIELD 5 FIELD 169 lt ETX gt lt CR gt 1 2 3 4 5 6 7 1 Response code to SNDF command 5 Data field left justified and padded with spaces 2 Numbe
161. Mandatory breaths are delivered by the ventilator are either assisted if patient initiated or PIM or controlled if ventilator initiated or VIM or initiated by the operator OIM In A C mode the breath period Tb is calculated using the breath rate f according to the equation P6077 If during Tb patient effort is detected a PIM breath is initiated and a new breath period starts If no patient effort is detected before Tb lapses the next breath delivered is a VIM and a new breath period starts Reference Ventilator Settings Range and Resolution p 11 8 for details on the following VC settings e Expiratory time T e E ratio e Inspiratory time T Operator s Manual 10 17 Theory of Operations e Rise time Yo e Target or tidal volume V7 VC and PC breath types require no initialization A VC breath is based on meeting a delivered volume target and a PC breath is based on meeting a spe cific pressure target VC breaths however go through a startup routine 10 7 1 Volume Control VC Volume Control is the control scheme that controls the flow with for the purpose of supplying a predetermined volume set by the practitioner to the patient There are two basic flow wave forms to administer this volume the square that guarantees a constant flow during the inspiration time or the descending ramp whose slope and initial value are determined to provide the required volume target Reference dea
162. Minimum V Maximum V Neonatal When mandatory type is 2 mL if NeoMode 2 0 315 mL VC MAX 2 mL mL kg software option is Ratio x PBW mL installed When mandatory type is VC MAX 3 mL mL kg Ratio PBW mL Pediatric mL kg ratio x PBW mL 25 mL 1590 mL Adult mL kg ratio x PBW mL 25 mL 2500 mL Reference Ventilator Settings Range and Resolution p 11 8 Vz setting for more information on V7 calculations based on PBW and circuit type Operator s Manual Short Self Test SST Table 10 7 Peak Flow and Circuit Type Leak Sync Disabled Circuit Type Maximum peak flow Vmax setting Neonatal 30 L min Pediatric 60 L min Adult 150 L min PBW determines constants for breath delivery algorithms some user settable alarms the high spontaneous inspiratory time limit setting TTi spon in NIV and the non settable INSPIRATION TOO LONG alarm 10 15 3 Vent Type There are two Vent Type choices INVASIVE and NIV non invasive INVASIVE ventilation is conventional ventilation used with endotracheal or tracheostomy tubes All installed software options breathing modes breath types and trigger types are available during INVASIVE ventilation NIV interfaces include non vented full faced or nasal masks or nasal prongs Reference NIV Breathing Interfaces p 4 22 for a list of interfaces that have been successfully tested with NIV NIV enables the ventilator to handle large s
163. Mode ensure a patient is not connected to the ventilator Ventilatory support is not available in Service Mode Service Mode is used for Extended Self Test EST ventilator calibration con figuration software upgrades option installation all of which must be per formed by Covidien factory trained service personnel and for making adjustments to institutional settings All information stored in the individual logs is available in Service Mode Service Mode logs include e System diagnostic Log e System Comm Log e EST SST Diagnostic log e Settings Log e Alarms Log e General Event Log e Service log e Patient data Log Reference the Puritan Bennett 980 Series Ventilator Service Manual for details about Service Mode logs A patient must not be attached to the ventilator when entering Service Mode Specific actions must be performed to enter this mode prior to POST comple tion To access Service Mode 1 Remove the ventilator from patient usage 2 Turn the ventilator s power switch ON 3 Press and release the Service Mode button TEST at the back of the ventilator when the Covidien splash screen appears on the status display after powering on the ventilator Reference Service Mode Button TEST p 3 34 Reference Status Display Indicators and Descriptions p 2 30 for an image of the splash screen The ventilator prompts to confirm no patient is attached Operator s Manual 3 33 Installation Figure 3 15 Servic
164. NAAT na 1 18 Warranty Information eee eee eee 1 19 Manufacture Date 21 ee ee 1 19 Manufacturer siace sabe we eee eased ee eee ee 1 20 Electromagnetic Compatibility 1 20 Product Overview O HA RAPSA AA PAA 2 1 Ventilator Description eee eee eee eee 2 2 Indications For Use 2 eee ee 2 4 Contraindications 20 cece eee ee 2 4 Components List sawsaw aED ENG eee dbase ee neues ced 5 2 5 Product Views naa deceit read da Km eK eee ees ewe Rw 2 6 2 6 1 GUI Front View uta natn ns KG aaa KAG dane KK eS ee BEE 2 6 2 6 2 GUI Rear View arman DBA Ka LAWS oe opiate anew 2 7 2 6 3 BDU Front View Leng ey eens KKK AA KA wes oo uiee 2 8 2 6 4 BDU Rear View aaa DE ENLA ND deaucees BAG KAKELANLAY 2 10 2 6 5 Ventilator Side Views 00 ccc eee nee e een eae 2 14 2 7 Mounting Configurations 20 20ee eee ee 2 15 2 8 Battery Backup ses ede ewe AA ee a Oe AA 2 15 2 9 Graphical User Interface 0 0 0 eee eee ees 2 16 2 9 1 Primary Display 3 45 csSae eared eka a edad LANG NG 2 16 2 10 GUI Controls and Indicators 22000005 2 16 2 10 1 Control REVS aa antes heeded KA DAKDG DU KG GNG DADANG 2 16 2 10 2 Visual Indicators Kaawa wary AE RATAN KAANAK AA LK eS 2 17 2 10 3 On screen Symbols and Abbreviations 2 20 2 10 4 Audible Indicators 2ancaeso545e02es hbebacn esare4 2 23 2 11 Breath Delivery Unit 2 25 2 11 1 BDU Controls and Indicators waa N ANDA
165. PAR APANG NA a Caalss 10 57 10 15 2Circuit Type and Predicted Body Weight PBW 10 58 TO BVENLTYPET KAKAIN Napala Pa GA KANOR ATA NLA HA 10 59 10 15 4Mode and Breath Type 0 a 10 60 10 15 5Respiratory Rate f taunan hahaah mee Rees 10 61 10 15 6Tidal Volume V cai Bak ka ARKA NAL KA BAGA aw ea es 10 62 10 15 7Peak Inspiratory Flow Vijay sawa ee nakaka 10 62 10 15 8Plateau Time Tp mema papang ALA DAY taacetseeaes 10 63 10 15 9Flow Pareto estes ena a He aes DAG NG ee we KA 10 63 10 15 10Flow Sensitivity NENA apakan Km BA Aha nA NA 10 63 10 15 11Pressure Sensitivity Pseys 0 0 10 64 10 15 12Inspiratory Pressure P o oo naaa dee aGetoedadeaGas 10 64 10 15 13Inspiratory Time T ak eke te rae eee doa aw 10 65 10 15 14Expiratory Time T pawang ea in eo ee hd Oe YG 10 66 TOTS AS5LEERatO maa t4eceb5oons ded eee el PERA APA ADD 10 66 10 15 16High Pressure Pp in Bilevel 0000 000 10 66 10 15 17Low Pressure P in Bileve aves dcas ae VET daa ewe ox 10 66 10 15 18High Time Ty in BiLevel 6 22 eee 10 66 10 15 19Low Time T1 in BiLevel sidvasanecdeas adeeseatons 10 67 10 15 20Tp T Ratio in BiLevel AA SAGANA WG maa 10 67 WONG IEE and ma GA AN ee eed kG a ee eg A as 10 67 10 15 22Pressure Support Psupp sossar ae eeaveeesdusedesns 10 68 10 15 23Volume Support VT sUPP e eaea eaaa 10 68 10 15 24 Supp in TE seretii essa GA DAKAG ates OOE EES 10 68 10 15 25 Supp in PAV 24444004 44 denen 8G Bk P
166. PIM or VIM is delivered all successful patient efforts yield soontaneous breaths until the cycle interval ends The ventilator delivers one mandatory breath during the mandatory interval regardless of the number of successful patient efforts detected during the spontaneous interval An OIM delivered during the mandatory interval satisfies the mandatory breath requirement and causes Tm to transition to T The maximum mandatory interval for any valid respiratory rate setting in SIMV is defined as the lesser of e 0 6 x the SIMV interval period Tb or e tens There is no minimum value for Tm In SIMV the interval from mandatory breath to mandatory breath can be as long as 1 6 x the SIMV period interval but no longer than the period interval Operator s Manual Short Self Test SST ten 10 s At high respiratory rates and too large tidal volumes breath stacking the delivery of a second inspiration before the first exhalation is complete is likely In volume ventilation breath stacking during inspiration and early exhalation leads to hyperinflation and increased airway and lung pressures which can be detected by a high pressure limit alarm In pressure control ventilation with inspiratory pressure remaining constant breath stacking leads to reduced tidal volumes which can be detected by the low tidal volume and minute ventilation alarms In SIMV mode it is possible for the respiratory rate to drop temporarily below the
167. PONT spontaneous ventilation BiLevel if the BiLevel option is installed or CPAP CPAP is only available when circuit type is neonatal and vent type is NIV Reference Ventilator Settings Range and Resolu tion p 11 8 Mode setting e Mandatory type Select PC pressure control VC volume control or VC volume control plus Operator s Manual Ventilator Shutdown e Spontaneous type If SIMV or BiLevel was selected as the Mode specify PS pressure support or TC tube compensation If SPONT was selected as the Mode specify PS Pressure Support TC Tube Compensation VS Volume Support or PAV Proportional Assist Ventilation if the PAV software option is installed Note VS PAV and TC are only available during INVASIVE ventilation e Trigger type Select pressure triggering P_tpic flow triggering V_qpic or IE Sync triggering if the IE Sync option is installed and only in SPONT mode Ref erence Appendix C in this manual for detailed information on the IE Sync software option Pressure triggering and IE Sync triggering are not available when vent type is NIV If ventilating a neonatal patient only flow triggering is available Other ways to access the vent setup screen NG e Touch Vent Setup at the bottom left of the GUI display 50 6 00 300 e Swipe the menu tab on the left side of the GUI and touch Setup Figure 4 4 Open Menu Tab PEEP TO 29 10 1 79 32 VEN 11349 D 1 Setup b
168. Patient Leakage current 100 uA maximum 11 5Interface Requirements Table 11 6 Interface Pin Designations Pin Signal Name 1 N C Not connected 2 RxD Receive data 3 TxD Transmit data 4 N C Not connected 5 GND Ground 6 N C Not connected 7 RTS Request to send 8 CTS Clear to send 9 N C Mot connected The pin out for the nurse call interface is as follows Operator s Manual Environmental Specifications Table 11 7 Nurse Call Pin Designations Pin Configuration 1 Normally closed NC 2 Relay common 3 Normally open NO 4 Not connected 11 6Environmental Specifications Table 11 8 Environmental Specifications Specification Operation Storage Temperature 10 C to 40 C 50 F to 104 F Ventilator 20 C to 70 C 68 F to 158 F 10 C to 35 C 50 F to 95 F Internal Battery Charger Atmospheric Pressure 70kPa to 106 kPa 10 15 psi to 15 37 50 kPa to 106 kPa 7 25 psi to psi 15 37 psi Altitude 411 5 m to 3048 m 1350 ft to 10000 6096 m max 20000 ft max ft Relative Humidity 10 to 95 non condensing 10 to 95 non condensing Note The limits marked on the device label represent out of box storage conditions as follows e Temperature 10 C to 40 C 50 F to 104 F e Pressure 70kPa to 106 kPa 10 15 psi to 15 37 psi e Relative Humidity 10 to 95 non condensing Operator s Manual 7 Specifications
169. Rate fo u Aa 6 6 22 PAV based Lung Compliance Cpay ee eee ee 6 6 23 PAV based Patient Resistance Rpay 6 6 24 PAV based Lung Elastance Epay 0 eee eee eee 6 6 25 Spontaneous Rapid Shallow Breathing Index f V 6 6 26 Spontaneous Inspiratory Time Ratio T Tro1 6 6 27 Spontaneous Inspiratory Time Tj spont 6 6 28 PAV based Total Airway Resistance Rtp7 6 6 29 Static Compliance Csrat and Static Resistance Rstaq 6 6 30 Dynamic Compliance Cay lt s204 a4 d0tu au ead ew ads 6 6 31 Dynamic Resistance Rpyn s444e4 4eeceeoeendaa nat sin CA 6 6 33 End Expiratory Flow EEF a aaa KAG dotecca ngewe 6 6 34 Peak Spontaneous Flow PSF 00 0A 6 6 35 Displayed O2 lt acanaedhen KA BAG ad DO BAKA NANASL Preventive Maintenance OVEIVIEW PP PAPA PAR ARA AA AA AA Ventilator Operational Time aa Preventive Maintenance Intervals Surface Cleaning of Exterior Surfaces Component Cleaning and Disinfection 7 5 1 Condensate Vial Cleaning 0 0000 e eee ee 7 5 2 Expiratory Filter Cleaning lt 4 lt 9223siveceuseeesia ad 7 5 3 Exhalation Valve Flow Sensor Assembly Disinfection 7 5 4 Exhalation Valve Flow Sensor Assembly Reassembly 7 5 5 Exhalation Valve Flow Sensor Assembly Replacement Poe Storage cerctasce rage ventas AA Component Sterilization
170. Repeat Test testing and prompts for decision e Next Test e Exit SST FAIL The ventilator has detected a critical Eliminate leaks in the ventilator problem and SST cannot complete breathing system and re run SST Oth ay until the ventilator passes the failed erwise service the ventilator and re test run SST SST Outcomes WARNING Choose to override the ALERT status and authorize ventilation only when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards When SST completes all of the tests analyze the results Table 3 6 Overall SST Outcomes Final Outcome Meaning Response PASS All SST tests passed Touch Patient Setup to set up the patient for ventilation ALERT The ventilator detected one or more To override the alert touch Override faults Choose to override the ALERT SST then touch Accept status and authorize ventilation only To exit SST touch Exit SST when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards FAIL One or more critical faults were Check the patient circuit to determine detected The ventilator enters the the problem or restart SST with a dif SVO state and cannot be used for ferent patient circuit normal ventilation until SST passes Touch Repeat Test Run All SST or Exit SST then touch Accept Operator s Manual 3 51 Installation If touching Override SST ob
171. SST p 10 77 10 19 Extended Self Test EST p 10 77 10 1 Theory of Operations WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs The gas supplies to which the ventilator are connected must be capable of delivering 200 L min flow with the supply pressure between 35 psig and 87 psig 241 8 kPa to 599 8 kPa These supplies may be compressed air from an external source wall or bottled air or oxygen Air and oxygen hoses connect directly to fittings at the rear of the breath deliv ery unit BDU The flow of each gas is metered by a Proportional Solenoid PSOL valve to achieve the desired mix in the Mix Module The flow through each PSOL is monitored by separate flow sensors to ensure the accuracy of the mix The mixed gases then flow to the Inspiratory Module The blended gas in the Inspiratory Module is metered by the Breath Delivery PSOL and monitored by the Breath Delivery Flow Sensor to ensure that the gas is delivered to the patient according to the s
172. Series Ventilator contains phthalates When used as indicated very limited exposure to trace amounts of phthalates may occur There is no clear clinical evidence that this degree of exposure increases clinical risk However in order to minimize risk of phthalate exposure in children and nursing or pregnant women this product should only be used as directed 9 1 Accessories 9 2 s2 General Accessory Information The patient circuit support arm flex arm can be fastened to the ventilator handle on either the right or left side Flex arms used on the Puritan Bennett 840 Ventilator System can also be used on the Puritan Bennett 980 Ventila tor System Operator s Manual General Accessory Information Figure 9 1 Ventilator with Accessories 1716 15 14 13 VEN_10310_E Operator s Manual 9 3 Accessories Figure 9 2 Additional Accessories 20 21 19 a es 677 Reference Ventilator with Accessories p 9 3 and the figure above for the parts listed in the following table Note Occasionally part numbers change If in doubt about a part number contact your local Covidien representative Table 9 1 Covidien Accessories and Options Accessory or option description Part number Test lung 10005490 Drain Bag Tubing package of 10 4 048493 00 Drain Bag package of 25 4 048491 00 Drain Bag Tubing Clamp reusable package of 5 4 048492 00 Pediatric Adult Expiratory Filter 100630
173. Switching to A C mode from any other mode causes the ventilator to phase in a VIM and set the start time for the beginning of the next A C breath period Following this VIM and before the next A C period begins the ventilator responds to the patient s inspiratory efforts by delivering mandatory breaths The first A C breath VIM breath is phased in while following these rules e The breath is not delivered during an inspiration e The breath is not delivered during the restricted phase of exhalation e The ventilator ensures the apnea interval elapses at least five 5 s after the begin ning of exhalation e Any other specially scheduled event for example a respiratory mechanics maneu ver or any pause maneuver is canceled and rescheduled at the next interval When the first VIM of the new A C mode is delivered depends on the mode and breath type active when the mode change is requested 10 10 SIMV Mode Synchronous Intermittent Mandatory Ventilation SIMV mode is a mixed ven tilation mode allowing both mandatory and spontaneous breaths using pres sure or flow triggering The mandatory breaths can be PC VC or VC and the spontaneous breaths are pressure assisted with either PS or TC SIMV guar antees one mandatory breath per SIMV breath period which is either a PIM or VIM OIM breaths are allowed in SIMV and are delivered at the setting selected for Mandatory Type Reference the figure below which shows the two parts of the S
174. Tests Hana RAR KA NAKAKA KAKAI aa NAK EA KA 11 35 11 11 Essential Performance Requirements 11 35 A BiLevel 2 0 Appendix A 1 OVEIVIEW saa paR BANSA ANAN NAA DADA KG AN A 1 A 2 Intended Use ppa G AA RAEREA KA days Seb eee GANG PENA A 2 A 3 Safety Symbol Definitions Aa A 2 A 4 Setting Up BiLevel 2 4n A 3 A 5 Using Pressure Support with BiLevel A 4 A 6 Manual Inspirations in BiLevel Mode A 5 A 7 Respiratory Mechanics Maneuvers in BiLevel A 6 A 8 Specifications A 6 A 9 Technical Description 200 e eee eee eee A 6 A 9 1 Synchrony in BiLevel 2 2 2 0 00 eee A 7 A 9 2 Patient Monitoring in Bilevel 00 4 A 8 A 9 3 APRV Strategy in Bilevel a A 9 A 9 4 Technical Structure of Bilevel 0A Aa A 10 A 10 Mode Changes 22 2222 aan A 10 B Leak Sync Appendix B 1 OVEIVIEW oicciteneccGeinkdancesdcteeetececeeunen lt B 1 B 2 Intended Use wviveesetewebedua KAWANG NIDA ewe B 1 B 3 Safety Symbol Definitions 20 2000s B 2 B 4 Leak SUNG sais cude aw BUENA KAINAN ew are NENG B 2 B 5 Setting Up Leak Sync ama aka KANA YAN ee sede KANA B 3 B 6 When Leak Sync is Enabled 2 aan B 4 B 6 1 Adjusting Disconnect Sensitivity Dseys lt eo raaraa B 5 B 6 2 Monitored Patient Data wawa paa ANA NG Nah AKA PANGGA B 6 B 7 Technical Discussion 2000 eee eee eee eee B 8 B 7 1 Inspired Tidal Volume V Acc
175. This feature is institutionally configurable Reference Screen Brightness and Keyboard Backlight Light Set tings p 3 39 The brightness range is from 1 to 100 with 1 resolution The default value is 80 To manually adjust display brightness 1 Press the display brightness key 2 Slide the brightness slider to the right to increase the brightness level or to the left to decrease the brightness level Alternatively turn the knob to increase or decrease the brightness level The control disappears from the screen in approxi mately five 5 seconds Operator s Manual 4 5 Operation Display Lock The primary display provides a display lock key to prevent inadvertent changes to settings When active the display lock disables the touch screen knob and off screen keys other than the display lock key and illuminates an LED on the display bezel An image of the display lock icon appears transparently over any thing displayed on the GUI should the operator attempt to use the GUI Any new alarm condition disables the display lock and enables normal use of the GUI To lock and unlock the display 1 Press the display lock key on the GUI The keyboard LED illuminates and a trans parent locked icon appears on the screen indicating display lock The icon shortly disappears but if the operator tries to activate any of the touch screen controls the icon re appears 2 To unlock the display press the display lock key again The dis
176. This pro vides enough pressure sensitivity to avoid autotriggering but will still allow the ventilator to trigger with acceptable patient effort The exhalation valve controls Positive End Expiratory Pressure PEEP using feedback from the expiratory pressure transducer PE The valve controller also cycles the ventilator into the exhalation phase if the PE measurement equals or exceeds the operator set high circuit pressure limit The PE measure ment also controls when the safety valve SV opens If PE measures 110 cmH gt 0 or more in the ventilator breathing circuit the safety valve opens allowing the patient to breathe room air if able to do so through the valve 22 Ventilator Description 2 2 The ventilator system is available in three models All ventilators provide con tinuous ventilation to patients requiring respiratory support e Puritan Bennett 980 Pediatric Adult Ventilator The Pediatric Adult model ventilates Pediatric or Adult patients with predicted body weights from 3 5 kg to 150 kg and with tidal volumes from 25 mL to 2500 mL Operator s Manual GUI Controls and Indicators Puritan Bennett 980 Neonatal Ventilator The Neonatal model venti lates Neonatal patients with predicted body weights from 0 3 kg to 7 0 kg and with tidal volumes for mandatory volume controlled breaths from 2 mL to 320 mL Puritan Bennett 980 Universal Ventilator The Universal model ventilates Neonatal Pediatr
177. Tidal Volume Vg and Inspired Tidal Volume V1 are leak compensated and indicate the estimated inspired or exhaled lung volume The accuracies for Vtg and Vy also change when Leak Sync is enabled see Technical Discussion for more information Graphic displays of flow during Leak Sync indicate estimated lung flows Operator s Manual B 7 Leak Sync Appendix B 8 e7 Technical Discussion Managing breathing circuit leaks is important to ensure appropriate breath triggering and cycling ventilation adequacy and valid patient data Detecting and monitoring leaks can improve treatment reduce patient work of breath ing and provide more accurate information for clinical assessments Leak Sync recognizes that changing pressures lead to varying deflection of interface materials and leak sizes The Leak Sync leak model includes a rigid leak orifice whose size remains constant under changing pressures combined with an elastic leak source whose size varies as a function of applied pressure This algorithm provides a more accurate estimate of instantaneous leak to improve patient ventilator synchrony under varying airway pressures Leak Sync allows the ventilator to determine the leak level and allows the oper ator to set the flow trigger and peak flow sensitivities to a selected threshold The base flow during exhalation is set to e Flow triggering 1 5 L min estimated leak flow at PEEP flow sensitivity e Pressure triggering
178. Tube ID and Humidification A WARNING To prevent inappropriate ventilation with TC select the correct Tube Type ET or Tracheostomy and tube inner diameter ID for the patient s ventilatory needs Inappropriate ventilatory support leading to over or under ventilation could result if an ET tube or trach tube setting larger or smaller than the actual value is entered EEES To select new settings for the tube follow these steps 1 Touch Vent Setup on the GUI screen to display the Ventilator setup screen 2 Touch Tube Type or Tube ID for the value to be changed 3 Turn the knob to change the setting 4 Make other tube settings as necessary 5 Touch Accept or Accept ALL to apply the new settings or Cancel to cancel all changes and dismiss the dialog Note The tube type and tube ID indicators flash if TC is a new selection indicating the a need for entry of the correct tube type and tube ID To select new settings for the humidifier follow these steps 1 From the Ventilator setup screen touch the More Settings tab A dialog appears containing selections for humidifier type and volume A Humidifier Volume button appears below the selection only if Non Heated Expiratory Tube or Heated Expiratory Tube is selected as the humidifier type 2 Turn the knob to enter a value equal to the dry volume of the humidifier chamber being used 3 Touch Accept or Accept ALL to apply the new settings or Cancel to canc
179. UIT DISCONNECT alarm sensitivity is adjusted via the Dcens setting During a CIRCUIT DISCONNECT condition the ventilator enters an idle state and delivers a base flow of oxygen to detect a reconnection When the ventilator determines the patient circuit is reconnected the CIRCUIT DISCONNECT alarm autoresets and normal ventilation resumes without having to manually reset the alarm for example following suctioning Operator s Manual 6 35 Performance A disconnected patient circuit interrupts gas delivery and patient monitoring Notification of a patient circuit disconnect is crucial particularly when the patient cannot breathe spontaneously The ventilator does not enter apnea ventilation when a disconnect is detected to avoid changing modes during a routine suctioning procedure Note When utilizing a closed suction catheter system the suctioning procedure can be executed using existing mode breath type and settings To reduce potential for hypoxemia during the procedure elevate the oxygen concentration using the Elevate O control Reference To adjust the amount of elevated O delivered for two minutes p 3 40 6 5 12 Loss of Power Alarm This alarm alerts the operator that there is insufficient battery power and no AC power to support ventilator operation The alarm annunciates as long as the ventilator s power switch is in the ON position and lasts for at least 120 seconds 6 5 13 DEVICE ALERT Alarm A DEVICE ALERT alar
180. Vent Inop 2 eee 4 37 4 12 Ventilator Shutdown ee 4 37 5 Product Data Output 5 1 OVEIVIEW lt csicedaie iw naaus ESKARA a e a st 5 1 5 2 LANGUAGE cscri AA AAP AASA 5 1 5 3 Data Display 0002004 JGRE NEA ADEN AA DAA NEGA 5 1 5 4 Data Transfer aaa KI NIAN AGE EE EK NANANG 5 1 5 4 1 GUI Screen Capture 2a Ama mama KAABG PAG KAGAGAWA KUALA 5 2 5 4 2 Communication Setup a aa eerie ce ee eee nee een wen 5 3 5 4 3 Comm Port Configuration n saaana ee ere DAANG 5 4 5 4 4 Serial Commands mapa LANG a 5 5 5 4 5 RSET Command 2 2052 aed nin KAKA Kawa aa 5 5 5 4 6 SNDA Command waa deus otoureeiesseandse deed ews 5 6 se PAP BEC NA AE 5 10 5 5 Communication Ports an 5 17 aah POUSA Canaman LAG BEWANG nag KAG En eee ee Ki NG 5 19 5 6 Retrieving Stored Data aaa 5 20 5 7 Display Configurability a 5 20 5 8 Printing Data or Screen Captures 5 21 5 9 Connectivity to External Systems 5 21 6 Performance 6 1 Overview an c4unaeenar cnn NN GL BERAA ees sca ds 6 1 6 2 System ODUONS ok ove panebaa kaha eee beset AN ee ses 6 1 6 3 Environmental Considerations 5 6 1 6 4 Ventilator Settings cece eee eee eee 6 1 6 4 1 Ventilation Type pcvadavawerees toile han KARA KA wees es 6 2 642 MODO aerea mera vie coun KUA KAMAKRS BAG meee he NAA 6 2 6 5 6 6 OA Breath TYPE Gana KAKA RANG Hee ea sod Ce BG as 6 2 Alarms oa ieee ecclesia ate Ne AA caw Ga
181. Ventilator Shutdown 3 Connect the ventilator oxygen hose to another known 100 O source for example a second medical grade oxygen cylinder 4 Set O2 to each of the following values and allow one minute after each for the monitored value to stabilize 21 40 90 s Watch the GUI screen to ensure the value for O delivered 0396 is within 3 of each setting within one minute of selecting each setting a1 Ventilator Protection Strategies The ventilator incorporates a number of strategies to support patient safety These include Power On Self Test POST SST and a new Strategy called Ven tilation Assurance which provides alternate means of ventilation in the case of certain serious faults in the breath delivery system The descriptions below detail the system response to potential failures 4 11 1 Power on Self Test POST The first strategy is to detect potential problems before the ventilator is placed on a patient POST checks the integrity of the ventilator s electronics and pre vents ventilation if a critical fault is found Reference the Puritan Bennett 980 Series Ventilator Service Manual for a complete description of POST POST may detect major or minor system faults which manifest themselves as Device Alerts Reference DEVICE ALERT Alarm p 6 36 for more information 4 11 2 Technical Fault A technical fault occurs if a POST or background test has failed Reference Power On Self Test POST p 10 76 Based on t
182. WARNING In order to reduce the risk of infection always use the ventilator with inspiratory and expiratory bacteria filters WARNING Do not attempt to use inspiratory or expiratory filters designed for use with ventilators other than the Puritan Bennett 980 Series Ventilator Reference Covidien Accessories and Options p 9 4 for relevant part numbers WARNING Refer to the filter s instructions for use for details such as cleaning and sterilization requirements filtration efficiency proper filter usage and maximum filter resistance particularly when using aerosolized medications Caution Ensure both inspiratory and expiratory filters are properly attached to the ventilator To install the inspiratory filter 1 Attach the inspiratory filter to the To Patient port 2 Ensure the direction of flow arrow is pointing outward toward the patient cir cuit s inspiratory limb Note Refer to the inspiratory filter IFU for information on proper use and handling of the filter Operator s Manual Product Connectivity WARNING Refer to the expiratory filter instructions for use IFU for information on reusable filter cleaning and sterilization and filter efficiency Note Refer to the expiratory filter IFU for information on proper use and handling of the filter and for emptying the condensate vial for adult and pediatric patients Reference Appendix E for information on emptying the condensate vial when using neonatal exp
183. Waveform Using Square Flow Pat ternand Ideal Waveform Using Descending Ramp Flow Pattern The inspiration time is determined indirectly by the characteristics of the selected flow wave Figure 10 8 Ideal Waveform Using Square Flow Pattern o t 0 3 6 100 6 2 0 100 i o t 600 3 0 t 0 3 6 VEN 11505 A 1 Pressure CmH 0 Inspiration phase 2 Flow L min Expiration phase 3 Volume mL Constant flow 10 18 Operator s Manual Short Self Test SST Figure 10 9 Ideal Waveform Using Descending Ramp Flow Pattern 4 20 1 wl Pi o a t 0 3 6 100 6 2 0 10E L L t 0 3 6 600 r 3 D t 0 3 6 VEN_11506_A 1 Pressure CmH 0 4 Inspiration phase 2 Flow L min 5 Expiration phase 3 Volume mL 6 Descending ramp 10 7 2 Pressure Control PC Pressure Control is the control scheme by which the pressure is controlled at the circuit wye to reach a constant level set by the practitioner during inspi ration and a PEEP level during exhalation Reference Ideal Waveform Using Pressure Control Ventilation on page 10 20 This level is maintained for a time given by the set inspiration time following followed by an exhalation regulat ed by the exhalation valve until the PEEP level is reached As flow is not prede termined the supplied volume varies depending on the patient s pulmonary response Operator s Manual 10 19 Theory of Operations 10 20 Figure 10 10 Ideal Waveform Using Pressure Control Ve
184. Within Mandatory Interval VEN 10767 B 1 VIM 3 Ts Operator s Manual 10 35 Theory of Operations 10 36 2 Tm VIM delivered atendofTm 4 Tb if no PIM delivered during Tm In SIMV mandatory breaths are identical to those in A C mode if the ventila tor s respiratory rate setting is greater than the patient s natural respiratory rate Spontaneous breaths are identical to those in SPONT mode if the ventila tor setting for respiratory rate is significantly below the patient s natural respi ratory rate Patient triggering must meet the requirements for pressure and flow sensitivity The procedure for setting the respiratory rate in SIMV is the same as in A C mode Once the respiratory rate f is set the SIMV interval period Tb in seconds is Tb 60 f During the mandatory interval if the patient triggers a breath according to the current setting for pressure or flow sensitivity the ventilator delivers a PIM Once a mandatory breath is triggered Tm ends T begins and any further trigger efforts yield spontaneous breaths During the spontaneous interval the patient can take as many spontaneous breaths as allowed If no PIM or OIM is delivered by the end of the mandatory interval the ventilator delivers a VIM and transitions to the spontaneous interval at the beginning of the VIM The SIMV breathing algorithm delivers one mandatory breath each period interval regardless of the patient s ability to breathe spontaneously Once a
185. aged e Run SST to check for leaks when reinstalling the circuit or when installing a new components Disposable drain bag and tubing single unit Discard when filled to capacity or when changing patient cir cuit N A Inlet air filter bowl Wash the bowl with mild soap solution if needed e Avoid exposing the inlet air filter bowl to aromatic sol vents especially ketones e Replace if cracks or crazing are visible Battery Wipe with a damp cloth using one of the cleaning agents listed Reference Surface Clean ing Agents p 7 5 Do not immerse the battery or get the contacts wet Cooling fan filter Clean every 250 hours or as necessary Wash in mild soap solution rinse and air dry Expiratory filter Reference Expiratory Filter Cleaning p 7 9 for cleaning instructions e Metrizyme Metrex Research Corporation ENZOL ASP Reference expiratory filter instructions for use IFU for sterilization instructions Operator s Manual 7 7 Preventive Maintenance Table 7 3 Component Cleaning Agents and Disinfection Procedures Continued Part Cleaning Agent Procedure Comments Cautions Condensate vial Reference Condensate Vial Clean condensate vial Cleaning p 7 8 for cleaning instructions e Metrizyme Metrex Research Corporation ENZOL ASP Other accessories Follow manufacturer s instruc N A tions for use
186. al for routine preventive maintenance Because the oxygen sensor constantly reacts with oxygen it requires periodic calibration to prevent inaccurate O2 alarm annunciation Once a calibrated oxygen sensor and the ventilator reach a steady state operating temperature the monitored 05 will be within three percentage points of the actual value for at least 24 hours To ensure the oxygen sensor remains calibrated recali brate the oxygen sensor at least once every 24 hours Typically the clinician uses an O gt analyzer in conjunction with the information given by the ventilator If a NO O SUPPLY alarm occurs compare the O ana lyzer reading with the ventilator s O reading for troubleshooting purposes The ventilator automatically switches to delivering air only 21 oxygen Oxygen Sensor Calibration The oxygen sensor should be calibrated every 24 hours and before use The cal ibration function provides a single point O sensor calibration To calibrate the O sensor 1 Touch Vent Setup 2 Touch More Settings 3 Touch the Calibrate for the O sensor The oxygen sensor calibrates within two minutes Reference More Settings Screen with O Sensor Enabled p 4 33 Oxygen sensor calibration testing To test the O sensor calibration 1 Connect the ventilator s oxygen hose to a known 100 O source for example a medical grade oxygen cylinder 2 Calibrate the oxygen sensor as described above Operator s Manual
187. alarm cannot be reset by pressing the alarm reset key 4 11 7 Ventilator Inoperative Vent Inop Vent Inop occurs when the ventilator detects a catastrophic error which pre vents all other safety states from operating Vent Inop limits pressure to the patient as the ventilator enters the SVO state disables closes the gas mixing PSOL valves and purges the gas mixing system accumulator The safety valve is opened and a Vent Inop indicator illuminates and a high priority alarm annunciates from the primary alarm and the secondary alarm continuous tone is activated The ventilator can only exit the Vent Inop state by power cycling and successfully passing EST The Vent Inop alarm cannot be reset with the alarm reset key All detection and annunciation of patient data alarm con ditions is suspended During a Vent Inop condition the inspiratory and expiratory pressure drop measured at the patient wye does not exceed 6 0 cmH50O at 30 L min 412 Ventilator Shutdown When the ventilator power switch is turned OFF the ventilator executes an orderly shutdown routine saving patient data before removing power If the ventilator detects a patient connected when the power switch is turned OFF a high priority alarm is annunciated and a banner on the display requires the operator to confirm that a power down was requested Only after the operator confirms will the ventilator execute the shutdown command All logs are retained in the ventilator s m
188. alid non existent or unreasonable based on current ventila tor settings or purge lines are occluded Alarm resets when condi tion is corrected Data for real time waveforms and monitored volumes are obtained from internal sensors INADVERTENT High POWER OFF Ventilator switched OFF with patient connected to breathing cir cuit Return power switch to ON posi tion and discon nect patient before turning power off User must acknowl edge turning the power OFF by touching Power Off on the GUI Table 6 6 Non Technical Alarms and Suggested Responses Alarm message AC POWER LOSS Meaning The ventilator is running on battery power Response Monitor the battery charge level to ensure there is enough power remaining to operate the ventilator APNEA patient data alarm The time between patient breaths exceeds the set apnea interval Check patient and settings Operator s Manual 6 29 Performance 6 30 Table 6 6 Non Technical Alarms and Suggested Responses Continued Alarm message CIRCUIT DISCONNECT Compliance limited V patient data alarm Meaning The patient circuit has become disconnected or there is a large leak in the patient circuit Compliance volume required to compensate delivery of a VC VC or VS breath exceeds the maximum allowed for three of the last four breaths Response Re connect the patient circuit o
189. ang heed 10 68 10 15 26Rise Time bs kei Bea doe Soe Phe ewe we oe DAG 10 69 10 15 27 Expiratory Sensitivity Esgys 2xae x dere ds kukrawabaka 10 69 10 15 28Disconnect Sensitivity Dsgys ee ee 10 70 10 15 29High Spontaneous Inspiratory Time Limit TT sont 10 70 10 15 30Humidification Type oecrtewsdadaves seeketedx oes 10 71 10 15 31Humidifier Volume 4 c08uk sande deter ten ane eed es 10 71 10 16 Safety NEL EP tots cea PT PPT 10 71 10 16 1User Error nee dee beta ee dpe aie dos Se Mee ee Ses Sa 10 72 10 16 2Patient Related Problems 0 20000000 10 73 10 16 3System Related Problems 00200 00000 10 73 10 16 4Background Diagnostic System nananana eee 10 74 10 17 Power On Self Test POST an 10 76 10 18 Short Self Test SST eee eee 10 77 10 19 Extended Self Test EST eee eee 10 77 11 Specifications 11 1 OVEIVIEW EE FT TE 11 1 11 2 Measurement Uncertainty eee eee ee eee 11 1 11 3 Physical Characteristics eee eee eee eee 11 2 11 4 Electrical Specifications 20 a 11 6 11 5 Interface Requirements eee eee eee 11 6 11 6 Environmental Specifications 11 7 11 7 Performance Specifications 2 200020eeee 11 8 11 7 1 Ranges and Resolutions 2 2 00 0 cece eee eee teens 11 8 11 8 Regulatory Compliance 20 2ee ee eeee 11 28 11 9 Manufacturer s Declaration Aa 11 30 11 10 Safety
190. ange Changes in rise time are phased in at the start of inspiration e When Pcypp O the rise time setting determines how quickly the ventilator drives circuit pressure to PEEP 1 5 cmH 0 10 15 27Expiratory Sensitivity Esens The Esgns setting defines the percentage of the measured peak inspiratory flow at which the ventilator cycles from inspiration to exhalation in all sponta neous breath types unless IE Sync has been selected for inspiratory and expira tory detection When inspiratory flow falls to the level defined by Esens exhalation begins Esgns is a primary setting and is accessible from the GUI screen Changes to Eseys are phased in at the next patient initiated sponta neous inspiration Esens Complements rise time Rise time Yo should be adjusted first to match the patient s inspiratory drive and then the Ecens setting should cause ventila tor exhalation to occur at a point most appropriate for the patient The higher the Ecens setting the shorter the inspiratory time Generally the most appro priate Eseng is compatible with the patient s condition neither extending nor shortening the patient s intrinsic inspiratory phase Operator s Manual 10 69 Theory of Operations Esens in a PAV breath is expressed in L min instead of percent 10 15 28 Disconnect Sensitivity Dens Disconnect sensitivity Dsens is defined as the percentage of returned volume lost due to a leak above which the ventilator decl
191. ansanaasansasawsaa 4 12 Apnea Setup Screen e sssssssseeseeceesoosessrossssreeesssssesesssnsseecsseeeecoressssossssse 4 15 Alarms S ttings Sireen snssssssssniiisininennnnonennis 4 17 Alarm Screen During Operation sssessssessssseeeseeresersersereeessesesrrsseeres 4 19 Vent Setup Button NIV Indicating NIV vent type 4 25 TT SPONT NAGA haka bahin Bano rat aI sa tapad 4 26 Default NIV Alarm Settings ccccssscsssssssscsncsessscsesnsssecsssseessesesses 4 27 RMin MENU Tanga Ama Ga 4 29 Xvii xviii Figure 4 13 Figure 4 14 Figure 5 1 Figure 5 2 Figure 6 1 Figure 7 1 Figure 7 2 Figure 7 3 Figure 7 4 Figure 7 5 Figure 7 6 Figure 7 7 Figure 7 8 Figure 7 9 Figure 7 10 Figure 7 11 Figure 7 12 Figure 7 13 Figure 7 14 Figure 7 15 Figure 7 16 Figure 8 1 Figure 9 1 Figure 9 2 Figure 10 1 Figure 10 2 Figure 10 3 Figure 10 4 Figure 10 5 Figure 10 6 Figure 10 7 Figure 10 8 Figure 10 9 Figure 10 10 Figure 10 11 Figure 10 12 Figure 10 13 Figure 10 14 Figure 10 15 Figure 10 16 Figure 10 17 Respiratory Maneuver Tabs ssssssssssccsecssecseccssesssccssesscessseseesecses 4 29 More Settings Screen with O Sensor Enabled ou sess 4 33 Comm Setup Screen s ssseessssesesssessssessssecsssscesssceesseerssseeessseeessseossseossssessssee 5 4 POR LOCATIONS eend E NAAN 5 18 Alarm Message Format e ssssssssseesssssssseoseeessssssssosseeeseessnsssss
192. anual 3 37 Installation urable parameters they remain in memory during a ventilator power cycle as long as the same patient is set up when returned to ventilation If a new patient is set up the factory configured values or institutionally configured values if the parameter has been configured are used No alarm settings are institutionally configurable which prevents changes to factory default alarm settings However the default mL kg ratio is institutionally configurable which can affect the default alarm setting values Always review the alarm defaults prior to beginning ventilation and set appropriately Date and Time Format The date and time may be configured to the institution s preference The time can be specified as 12 hour or 24 hour time in HH MM SS format with one hour and one minute resolutions respectively The date formats are e DD MMM YYYY where DD is a two digit day format MMM is a three letter abbreviation for the month and YYYY is a four digit representation of the year or e MM DD YYYY where MM is a two digit month format DD is a two digit day format and YYYY is a four digit representation of the year The settable date corresponds to the number of days in the set month and accounts for leap years To institutionally configure the ventilator s date and time settings 1 Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions o
193. applies to the maximum base flow compensation during exhalation During pressure based inspirations the total delivered flow leak flow plus inspiratory flow is limited by the maximum total flow The following table shows the maximum leak rates at set PEEP pressure that Leak Sync will compensate based on patient type Table B 2 Leak Compensation Volumes Based on Patient Type Patient type Maximum Leak compensation flow Neonatal 15 L min Pediatric 40 L min Adult 65 L min es Setting Up Leak Sync For more information on setting up the ventilator Reference Chapter 4 of this manual To enable Leak Sync At the ventilator setup screen touch the More Settings tab 1 2 3 Operator s Manual Touch Enabled in the Leak Sync area Touch Accept ALL to enable Leak Sync B 3 Leak Sync Appendix Figure B 1 Enabling Leak Sync Waiting for patient connect Setup More Settings 10 300 44 Ramp 00 N VEN_11365_D J Note The default value for Leak Sync is Disabled when the circuit type is Pediatric or Adult and the Vent Type is Invasive Otherwise the default value for Leak Sync is Enabled 8 LAP Note Leak Sync is not allowed for tube compensated TC and Proportional Assist Ventilation PAV breath types s s When Leak Sync is Enabled Reference GUI Screen when Leak Sync is Enabled p B 5 for an example showing the GUI screen when Leak Sync is enabled e The Vent Setup button on
194. ares a CIRCUIT DISCONNECT alarm when Leak Sync is not enabled When Degps is set to its lowest value 20 it has the highest sensitivity for detecting a leak or disconnect Con versely when Degns is set to its highest value 95 the ventilator is least sen sitive to a leak or disconnect because greater than 95 of the returned volume must be lost before the alarm annunciates During NIV the Dsgys value is automatically set to OFF which is means that returned volume loss is not considered and the alarm will not sound Dsgns with Leak Sync enabled is expressed in L min instead of percent O Note If Dcens is set to OFF during NIV the ventilator is still capable of declaring a CIRCUIT DISCONNECT alarm e Note Dsens cannot be turned OFF if Leak Sync is enabled Changes to Degng are phased in at the start of inspiration 10 15 29High Spontaneous Inspiratory Time Limit TT spon The high spontaneous inspiratory time limit setting T spon is available only in SIMV or SPONT modes during NIV and provides a means for setting a maximum inspiratory time after which the ventilator automatically transitions to exhalation The default TT sponr setting is based upon circuit type and PBW For pediatric adult circuit types the new patient default value is 1 99 0 02 x PBW s For neonatal circuit types the new patient default value is 1 00 0 10 x PBW s The TT sponr indicator appears on the primary display at the b
195. ase flow indicating the patient is ini tiating an inspiration Another term autotriggering is used to describe a condition where the ven tilator triggers a breath in the absence of the patient s breathing effort Auto triggering can be caused by inappropriate ventilator sensitivity settings water in the patient circuit or gas leaks in the patient circuit 10 4 1 Pressure Triggering If pressure triggering P_tpic is selected the ventilator transitions into inspira tion when the pressure at the patient circuit wye drops below positive end expiratory pressure PEEP minus the operator set sensitivity level P ens Ref erence the figure below As the patient begins the inspiratory effort and breathes gas from the circuit event 5 the A B interval in the figure below pressure decreases below PEEP When the pressure drops below PEEP minus Pcens event 6 the ventilator delivers a PIM breath The pressure decline time interval between events A and B determines how aggressive the patient s inspiratory effort is A short time interval signifies an aggressive breathing effort The A B interval is also affected by Pcens A smaller Psens setting means a shorter A B time interval The minimum Pens setting is limited by autotrig gering and the triggering criteria include filtering algorithms that minimize the probability of autotriggering Operator s Manual 10 5 Theory of Operations Figure 10 1 Inspiration Using Pressure Sensitivity
196. at would result in an LE ratio that exceeds 4 00 1 or a T greater than eight 8 s or less than 0 2 s or a T less than 0 2 s For the I E ratio calculation Tp is considered part of the inspiration phase 10 15 9 Flow Pattern The flow pattern setting defines the gas flow pattern of volume controlled VC mandatory breaths only The selected values for Vy and Vmax apply to both the square or descending ramp flow patterns If Vz and Vmax and are held constant T approximately halves when the flow pattern changes from descending ramp to square and approximately doubles when flow pattern changes from square to descending ramp and corresponding changes to the lE ratio also occur Changes in flow pattern are phased in at the start of inspi ration The settings for flow pattern Vz f Tp and Vmax are interrelated If any setting change would cause any of the following the ventilator does not allow that change e LE ratio gt 4 1 e T gt 8 0sorl lt 025 e Te lt 02s 10 15 10Flow Sensitivity VsEns The Vseys setting defines the rate of flow inspired by a patient that triggers the ventilator to deliver a mandatory or spontaneous breath When V_ypic is select ed a base flow of gas 1 5 L min travels through the patient circuit during the Operator s Manual 10 63 Theory of Operations ventilator s expiratory phase Once a value for flow sensitivity is selected the ventilator delivers a base flow equal to Vseys 1 5 L min
197. ath cycle the ventilator would have triggered an inspiration or expiration and started an expiration if IE Sync were in use Operator s Manual C 5 IE Sync Appendix When using IE Sync monitoring the waveform displays an indication of missed breath triggers if applicable missed triggers per minute and the percent of missed triggers Note IE Sync related signals are not displayed during Apnea ventilation When using IE Sync monitoring the screen appears as shown below Figure C 4 Monitoring Waveform 13 382 20 1 34 29 81 812 3i7 gt IE Sync Monitoring in Progress 0 0 VEN 11364 D 1 The points at which the actual inspiration and expiration took place under pressure trigger or flow trigger 2 LE signal The points in the breath where IE Sync would have triggered an inspiration and expiration if not in monitoring Note In the Pepe waveform above red indicates the current breath trigger and cycle timing and blue indicates where IE Sync would have triggered inspiration and exhalation had IE Sync been the chosen trigger type C 6 Operator s Manual Technical Description cs Technical Description IE Sync uses a real time estimate p Psync of the time derivative of intra pleural pressure for determining breath phase transitions Psyyc is computed every five 5 ms based on a proprietary algorithm that uses the ventilator s pressure and flow sensor readings as its inputs IE Sync detects the start of i
198. atient without BiLevel 10 15 21 PEEP This setting defines the positive end expiratory pressure PEEP also called baseline airway pressure PEEP is the positive pressure maintained in the patient circuit during exhalation Changes to the PEEP setting are phased in at the start of exhalation The sum of e PEEP 7 cmH50 or e PEEP P 2 cmH30Q if PC is active or e PEEP Psupp cmH 0 if PS is on cannot exceed the TPpea limit To increase the sum of pressures first raise the TPprak limit before increasing the settings for PEEP Pj or Psypp If there is a loss of PEEP from occlusion disconnect Safety Valve Open or loss of power conditions PEEP is re established when the condition is corrected by the ventilator delivering a PEEP restoration breath The PEEP restoration breath is a 1 5 cmH20 pressure supported breath with exhalation sensitivity of 25 and rise time of 50 A PEEP restoration breath is also delivered at the conclusion of Vent Startup After PEEP is restored the ventilator resumes breath delivery at the current settings Note PEEP restoration breath parameters are not user adjustable Operator s Manual 10 67 Theory of Operations 10 15 22Pressure Support Pcypp The Pcypp setting determines the level of positive pressure above PEEP applied to the patient s airway during a spontaneous breath Psypp is only available in SIMV SPONT and BiLevel in which spontaneous breaths are allowed The Pcypp s
199. ation WARNING Do not attempt to sterilize single patient use circuits 36 How to Install Accessories 3 6 1 Batteries WARNING Use only Covidien branded batteries Using other manufacturer s brands or remanufactured batteries could result in the batteries operating the ventilator for less than the specified amount of time or could cause a fire hazard WARNING To reduce the risk of infection due to cross contamination using a damp cloth disinfect the batteries with one of the solutions listed before installation and whenever transferring to or from another ventilator During use clean external surfaces of batteries as necessary Reference Surface Cleaning Agents p 7 5 Do not spray disinfectant directly onto the battery or its connector Reference Ventilator Battery p 3 19 item 1 Caution Ensure the batteries are oriented properly Reference Proper Battery Orientation p 3 20 3 18 Operator s Manual Product Connectivity Figure 3 9 Ventilator Battery VEN 11449 A 1 Battery connector Primary Batteries The ventilator s primary battery is located in the rearward battery receptacle on the right side of the BDU Reference Battery Compartment Locations p 3 21 The primary battery may be hot swapped that is it can be replaced while the ventilator is operating To install or replace the primary battery in the BDU 1 With the battery not installed in the ventilator or if the ventilator is turned of
200. atory module Oxygen measurement Type Galvanic cell Sensing position Inspiratory module Minute volume Vp ror capability ventilator Up to 75 L min Results of ventilator testing using circuits identified for use with the ventilator system Operator s Manual 3 Specifications Table 11 4 Technical Specifications Continued Internal Inspiratory filter bacterial viral filtration efficiency Internal Inspiratory filter particle filtration effi ciency Internal Inspiratory filter resistance gt 99 999 gt 99 97 retention of particles 0 3 um nomina at 100 L min flow 0 2 cMH20 lt resistance lt 2 2 cmH 0 at 30 L min flow 0 2 cmH 20 lt resistance lt 1 7 cmH 70 at 15 L min flow External Inspiratory filter resistance 0 2 cmH70 lt resistance lt 2 2 cmH 0 at 30 L min flow 0 2 cmH 20 lt resistance lt 2 2 cmH 70 at 15 L min flow Combined inspiratory filter resistance 0 2 cmH20 lt resistance lt 5 5 cmH 0 at 30 L min flow 0 2 cmH30 lt resistance lt 1 7 cmH30 at 15 L min flow External Inspiratory filter resistance 0 2 cmH 20 lt resistance lt 2 2 cmH30 at 30 L min flow 0 2 cmH20 lt resistance lt 1 7 cmH20 at 15 L min flow External Inspiratory filter bacterial viral filtration efficiency reusable gt 99 999 External Inspiratory filter particle filtration effi ciency reusable gt 99 97 retention of particles 0 3 um no
201. available breath type in non invasive ventilation NIV Do not use non invasive patient interfaces such as masks nasal prongs uncuffed ET tubes etc as leaks associated with these interfaces may result in over assist and patient discomfort WARNING Breathing circuit and artificial airway must be free from leaks Leaks may result in ventilator over assist and patient discomfort Operator s Manual Ventilator Settings Guidance WARNING Ensure high and low tidal volume alarm thresholds are set appropriately because an overestimation of lung compliance could result in an under support condition resulting in the delivery of smaller than optimal tidal volumes vp PAV A WARNING Ensure that there are no significant leaks in the breathing circuit or around the artificial airway cuff Significant leaks can affect the performance of the PAV option and the accuracy of resistance R and elastance E estimates A WARNING Do not use silicone breathing circuits with the PAV option the elastic behavior of a silicone circuit at the beginning of exhalation can cause pressure flow oscillations that result in underestimates of patient resistance The act of inspiration requires the patient s inspiratory muscles to develop a pressure gradient between the mouth and the alveoli sufficient to draw in breathing gas and inflate the lungs Some of this pressure gradient is dissipated as gas travels through the artificial airway and the pat
202. aveforms denote a spontaneous inspiration The GUI can be configured to display up to three waveforms and two loops simultaneously in the waveform area Reference Areas of the GUI p 4 3 The allowable waveforms include flow vs time pressure vs time volume vs time and Pcync vs time if IE Sync is installed and in IE Sync Monitoring Reference Appendix C for more information on IE Sync Allowable loops include pressure vs volume and flow vs volume The waveforms display 60 seconds of infor mation and can be shown in a redrawing format or paused with the ability to enable a cursor to trace the waveform by turning the knob To institutionally configure waveforms and loops 1 Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode 2 Touch Graph Defaults Five 5 layout presets appear along with a list of parame ters and descriptions 3 Touch a layout preset button The parameter s button outline glows signifying that it can be changed If more than one parameter can be changed touch that parameter to make its outline glow 3 44 Operator s Manual 8 Product Connectivity Select the parameter from the list whose waveform is desired to appear on the waveforms screen Configure each of the graphic display layouts as described above Touch the padlock icon above each graphic layout to prevent operator configura tion
203. ay 50 La Auroa de Heredia Costa Rica Tel 506 2239 5386 Fax 506 2239 5319 Covidien ECE Prosecka 851 64 190 00 Prague Czech Republc Tel 42 024 109 57 35 Fax 42 02 3900 0437 Covidien Danmark A S Langebrogade 6E 4 th DK 1411 K benhavn K Danmark Tel 45 4368 2171 Fax 45 4368 2172 Covidien Deutschland GmbH Gewerbepark 1r D 93333 Neustadt Donau Germany Tel 49 0 9445 9590 Fax 49 0 9445 95 9 155 Covidien ECE Galvahiho 7 A 82104 Bratislava Slova kia Tel 420 2 41 095 735 Fax 420 2 39 000 437 Covidien Finland Oy Pursimiehenkatu 26 39C PL407 FIN 00151 Helsinki Finland Te 358 9725 192 88 Fax 358 9725 192 89 Covidien France SAS 2 Rue Denis Diderot 78990 Elancourt France Tel 33 0 13079 80 00 Fax 33 0 130 79 80 30 Covidien Hong Kong Unit 12 16 18 F BEA Tower Millennium City 5 4187 Kwun Tong Road Kwum Tong Kowloon Hong Kong Tel 852 3157 7299 Fax 852 2838 0749 Covidien India 10th Floor Building No 9B DLF Cyber City Phase Ill Gurgaon Haryana 122002 India Tel 91 1244 709800 Fax 91 1244 206850 Covidien ECE Mariassy u 7 1095 Budapest Hungary Tel 36 1880 7975 Fax 36 1777 4932 Operator s Manual Safety Information Covidien Ireland Block G Ground Floor Cherrywood Business Park Loughlinstown County Dublin Ireland Tel 353 0 1 4073173 Fax 353 0 1 4073174 Covidien Israe
204. be accessed via USB or RS 232 connectors The following data are available for downloading via connection to a remote device or flash drive e Waveform images screen capture function USB port 5 1 Product Data Output 5 2 5 4 1 o e Waveform data RS 232 port USB port with USB to serial conversion capability per Comm port configuration e Results from DCI commands RS 232 port USB port with USB to serial conversion capability per Comm port configuration GUI Screen Capture Caution The USB interface should be used for saving screen captures and interfacing with an external patient monitor It should not be used to provide power to other types of devices containing a USB interface Covidien recommends a minimum 128 MB flash drive storage device format ted in the 32 bit file format To capture GUI screens 1 Navigate to the desired screen from which you wish to capture an image for example the waveforms screen There is no need to pause the waveform before performing the screen capture 2 Touch the screen capture icon in the constant access icons area of the GUI screen If desired navigate to another screen and repeat steps 1 and 2 for up to ten 10 images If another image is captured increasing the queue to eleven images the newest image overwrites the oldest image so there are always only ten images available Note If the camera icon appears dim it means that the screen capture function is currentl
205. bezel key function Follow prompts Ventilator Battery Tests ventilator battery and power distribution Follow prompts 3 9 4 EST Test Results Table 3 8 Individual EST Results Test Status Meaning Response PASS Individual EST test passed No need to do anything unless prompted by the ventilator ALERT The test result is not ideal but is not When the system prompts select critical REPEAT TEST A If EST is in progress it halts further NEXT TEST or testing and prompts for decision STOP then touch ACCEPT FAIL EST not successfully passed Select REPEAT TEST pu NEXT TEST or STOP then touch ACCEPT NEVER RUN Test still requires successful PASS Run all EST tests When EST completes all of the tests analyze the results Operator s Manual 3 57 Installation Table 3 9 Overall EST Outcomes Final Outcome Meaning Response PASS ALERT A All EST tests passed The ventilator detected one or more faults The test result is not ideal but is not critical EST successfully completed Select other SERVICE MODE functions or prepare for SST tests prior to return ing the ventilator for patient usage When the system prompts select REPEAT TEST NEXT TEST or STOP then touch ACCEPT FAIL Ay One or more critical faults were detected The ventilatorenters the SVO state and cannot be used for normal ventilation until SST passes Service is required Wh
206. bly if the previous lockable alarm was silenced The following rules define how alarm messages are displayed 6 6 Primary alarms precede any dependent alarms The system adds dependent alarms to the analysis messages of each active primary alarm with which they are associated If a dependent alarm resets the system removes it from the analysis message of the primary alarm The priority level of a primary alarm is equal to or greater than the priority level of any of its active dependent alarms An alarm cannot be a dependent alarm of any alarm that occurs subsequently If a primary alarm resets any active dependent alarms become primary unless they are also dependent alarms of another active primary alarm This is due to different reset criteria for primary and dependent alarms The system applies the new alarm limit to alarm calculations from the moment a change to an alarm limit is accepted The priority level of a dependent alarm is based solely on its detection conditions not the priority of any associated alarms When an alarm causes the ventilator to enter OSC or safety valve open SVO the patient data display including waveforms is blanked The elapsed time without ventilatory support that is since OSC or SVO began appears on the GUI screen If the alarm causing OSC or SVO is autoreset the ventilator resets all patient data alarm detection algorithms Table 6 1 Alarm Descriptions and Symbols Alarm descri
207. c and neonatal circuit types Factor is calculated as MIN 10 MAX 2 5 1 0 2 0 0 3 x kg PBWV Table 10 1 Compliance Volume Factors Adult patient circuit type Pediatric patient circuit type PBW kg Factor PBW kg Factor Note Compliance compensation calculations are also in effect during exhalation to ensure spirometry accuracy 10 16 Operator s Manual Short Self Test SST If the patient s compliance decreases beyond the limits of compliance compen sation the ventilator relies on the TPpgag alarm setting to truncate the breath and switch to exhalation 10 6 2 BTPS Compensation in Volume based Breaths Volumes and flows are BTPS compensated that is they are reported by the ventilator at existing barometric pressure 37 C 98 6 F and fully saturated with water vapor 1 7 Mandatory Breath Delivery Three mandatory breath types are offered in the ventilator volume control VC which bases breath delivery on the delivered inspiratory tidal volume pressure control PC which bases breath delivery on achieving and sustaining a pressure target for a set period of time and volume control plus VC which is a pressure controlled breath based on a target tidal volume VC can be used in situations where a patient s lungs become more compliant due to treatment as it reduces the target pressure lessening the forces on the alveoli to achieve the target tidal volume
208. c or electrically conductive hoses or tubing in or near the ventilator breathing system 3 1 Installation WARNING Use only gas supply hoses approved by Covidien Other hoses may be restrictive and may cause improper ventilator operation WARNING To avoid possible injury lock the ventilator s casters prior to installing or removing ventilator components Caution To ensure optimum performance Covidien recommends preventive maintenance be performed by factory trained Biomedical Engineers per the schedule specified Reference Service Preventive Maintenance Frequency p 1 2 in the Operator s Manual Addendum in this manual Note US federal law restricts this device to sale by or on the order of a physician 33 Product Assembly 3 3 1 How to Assemble Ventilator Components Ventilator setup should have already been completed by factory trained service personnel including successfully passing EST This manual does not include ventilator assembly instructions 3 3 2 Product Power Sources Using AC Power The ventilator is normally AC powered Reference Connecting the Ventilator to AC Power p 3 5 to connect the ventilator to AC power 3 2 Operator s Manual Product Connectivity Using Battery Power A WARNING Use only Covidien branded batteries Using other manufacturer s brands could result in the batteries operating the ventilator for less than the specified amount of time or could cause a fire hazard
209. cansaeeees 10 9 10 5 2 Percent Peak Flaw Method 3223 0a ea ba abu ees nev ewes 10 10 10 5 3 Time cycling Method 0 0000 e eee eee 10 11 10 5 4 1E Sync Cycling ivi peuhesasone Rs aes KAN AIAI SKI 10 11 TOSS Backup Methods haccdwe ws AG ek tea eae YA ws 10 12 paa NIMC sorer ARA LANA NAA AA ae hE NA NAG cae a EE 10 12 10 5 7 High Circuit Pressure Limit dts ac 204 cadteae oda doe KAI 10 12 10 5 8 High Ventilator Pressure Limit aa 10 12 10 5 9 High Inspired Tidal Volume Limit 10 12 10 6 Compliance and BTPS Compensation 10 13 10 6 1 Compliance Compensation in Volume based Breaths 10 13 vii viii 10 6 2 BTPS Compensation in Volume based Breaths 10 17 10 7 Mandatory Breath Delivery aaa 10 17 10 7 1 Volume Control VC manggang Ade ha DI bw aaah 10 18 10 7 2 Pressure Control PC a es ete Gng NA Waa Bas Yan 10 19 OI NGE pik AKA BN GAAN KAP AA 10 20 10 74 RISE TIMES OD 35Nang Da BA ale RA ENO Shane DAA Aa ala 10 21 10 7 5 Manual Inspiration aces capa sic bees oak aot amnea estes 10 22 10 8 Spontaneous Breath Delivery 2 225 10 22 10 8 1 Pressure Support PS Laan ATE a AT Laan he ars ens 10 25 10 8 2 Volume Support VS nu ede eat ow KALA Gh eee 10 25 10 8 3 Tube Compensation aaa Tawa whe pace eee 10 27 10 8 4 Proportional Assist Ventilation PAV 2 2 0 ee 10 31 10 9 AICMOdG ppa GNG NN TY ce eee ge ees 10 31 10 9 1 Changing to A G
210. ce is not a concern during volume based ventilation because the tidal volume is fixed by the clini cian s choice and the ventilator s compliance compensation algorithm 6 5 18 High Inspired Tidal Volume TV 7 Alarm The high inspired tidal volume alarm indicates the patient s inspired volume exceeds the set limit When this condition occurs the breath terminates and the alarm sounds The ventilator displays monitored inspired tidal volume values in the patient data area on the GUI screen When Vent Type is NIV there is no high inspired tidal volume alarm or setting available but the monitored inspired tidal volume Vq may appear in the patient data area on the GUI screen 6 38 Operator s Manual Ventilator Settings 6 5 19 High Respiratory Rate 1 fro7 Alarm The Mr 7 alarm indicates the measured breath rate is greater than or equal to the Troy alarm setting The Tfo7 alarm is updated whenever a new total mea sured respiratory rate is available The Tfo7 alarm can detect tachypnea which could indicate the tidal volume is too low or the patient s work of breathing has increased The ventilator phases in changes to the T ftor limit immediately to ensure prompt notification of a high respiratory rate condition 6 5 20 INSPIRATION TOO LONG Alarm The INSPIRATION TOO LONG alarm active only when Vent Type is INVASIVE indicates the inspiratory time of a spontaneous breath exceeds the following time limit 1 99 0 02 x PBW s
211. cept All to apply the changes or Cancel to cancel PAV Ventilator Settings Reference the table Ventilator Settings Range and Resolution in Chapter 11 of this manual for a summary of PAV ventilator settings for the following param eters supp e Expiratory sensitivity Esens e Tube type e Tube ID e Trigger type PAV Alarm Settings Reference the table Alarm Settings Range and Resolution in Chapter 11 of this manual for a summary of the following alarm settings available when PAV is active Operator s Manual Ventilator Settings Guidance e High inspired tidal volume limit TV7 e Low exhaled spontaneous tidal volume Vt _ sponr p 4 7 Monitored Data Reference Patient Data Range and Resolution in Chapter 11 of this manual for the following monitored data associated with PAV e PAV based lung compliance Cpay e PAV based lung elastance Epay e PAV based lung resistance Rpay e PAV based total airway resistance Rror e Inspired tidal volume V Reference the table below for monitored data absolute limits Table D 2 Absolute limits for PAV Monitored Data PBW kg Rpay CmH3O L s Cpay mL cmH 0 Epay cmH20 L 25 0 to 50 2 5 to 29 34 to 400 35 0 to 44 3 5 to 41 24 to 286 45 0 to 31 4 5 to 52 19 to 222 55 O to24 5 5 to 64 6 to 182 65 0 to 20 6 4 to 75 13 to 156 75 0 to 18 7 4 to 87 1 to 135 85 O to 17 8 4 to 98 10 to 119 95 0 to 16 9 4 to 110 9 1
212. ch an environment Emissions Test Compliance Electromagnetic environ ment guidance Radiated RF emissions Group 1 The ventilator uses RF energy CISPR 11 Class A only for its internal functions The ventilator is intended to be used only in hospitals and not be connected to the public mains network Harmonic emissions IEC 61000 3 2 Class A The ventilator is intended to be used only in hospitals and not be connected to the public mains network Voltage fluctuations flicker Complies IEC 61000 3 3 30 Operator s Manual Table 11 16 Electromagnetic Immunity Manufacturer s Declaration The ventilator is intended for use in the electromagnetic environment specified below The customer or the operator of the ventilator should assure that it is used in such an environ ment Immunity Test Electrostatic discharge ESD IEC 61000 4 2 IEC 60601 test level 6 kV contact 8kVair Compliance level 6 kV contact 8 kV air Electromagnetic environment guid ance Floors should be wood concrete or ceramic tile If floors are covered with syn thetic material the rel ative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s
213. changes to the ventilator circuit configurations do not exceed the specified values for circuit compliance and for inspiratory or expiratory limb total resistance Reference Technical Specifications p 11 3 If adding accessories to the patient circuit always run SST to establish circuit compliance and resistance prior to ventilating the patient WARNING Use of a nebulizer or humidifier can lead to an increase in the resistance of inspiratory and expiratory filters Monitor the filters frequently for increased resistance or blockage WARNING During transport the use of breathing tubing without the appropriate cuffed connectors may result in the circuit becoming detached from the ventilator WARNING The added gas from an external pneumatic nebulizer can adversely affect spirometry delivered 05 delivered tidal volumes and breath triggering Additionally aerosolized particulates in the ventilator circuit can lead to an increase in expiratory filter resistance WARNING Carefully route patient tubing and cabling to reduce the possibility of patient entanglement or strangulation WARNING Always use filters designed for use with the Puritan Bennett 980 Series Ventilator Do not use filters designed for use with other ventilators Reference Covidien Accessories and Options p 9 4 for relevant filter part numbers WARNING To avoid liquid entering the ventilator empty the expiratory condensate vial before fluid reaches the
214. cise appropriate care for safe and effective use of the product Note Notes provide additional guidelines or information r4 Software Hardware Requirements The Proximal Flow Option requires installation of the NeoMode 2 0 software option or a Puritan Bennett 980 Neonatal Ventilator must be used Details regarding NeoMode 2 0 can be found in the NeoMode 2 0 Appendix rs Safety Information WARNING The Puritan Bennett 980 Series Ventilator contains phthalates When used as indicated very limited exposure to trace amounts of phthalates may occur There is no clear clinical evidence that this degree of exposure increases clinical risk However in order to minimize risk of phthalate exposure in children and nursing or pregnant women this product should only be used as directed A WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs F 2 Operator s Manual Part numbers WARNING Inspect the Proximal Flow Sensor prior to use and do not use it if the
215. clean de ionized water in the same manner used for the disinfection step 2 Drain and repeat rinsing three times with clean de ionized water A WARNING Rinse according to manufacturer s instructions Avoid skin contact with disinfecting agents to prevent possible injury 3 After rinsing in de ionized water immerse in a clean isopropyl alcohol bath for approximately 15 seconds Slowly agitate and rotate to empty air pockets Operator s Manual 7 19 Preventive Maintenance Q Drying 1 Dry in a low temperature warm air cabinet designed for this purpose Covidien recommends a convective drying oven for this process with temperature not exceeding 60 C 140 F Caution Exercise care in placement and handling in a dryer to prevent damage to the assembly s flow sensor element Inspection Reference Exhalation Valve Flow Sensor Components p 7 15 while inspecting the exhalation valve flow sensor assembly 1 Inspect the plastic body diaphragm sealing surface filter grommet and the seal groove on the bottom side for any visible damage degradation or contamination 2 Inspect electrical contacts for contaminating film or material Wipe clean with a soft cloth if necessary 3 Inspect the hot film wire and thermistor in the center port for damage and for con tamination DO NOT ATTEMPT TO CLEAN EITHER OF THESE If contamination exists rinse again with de ionized water If rinsing is unsuccessful or hot film wire or th
216. con glows and a dialog appears with a countdown timer Elev O button highlighted and ready for changes and Extend Stop and Close buttons Turn the knob to increase or decrease the amount of oxygen by the amount shown on the button The allowable range is 1 to 100 oxygen Touch Extend to extend the two minute interval Touching Extend restarts the two minute countdown timer Touch Stop to stop additional oxygen from being delivered and dismiss the count down timer The Elevate O function follows these rules Operator s Manual Product Connectivity e f the current O setting is 80 or above and the selected delivery increment is gt 20 the ventilator will deliver 100 O for two 2 minutes after which the oxygen sensor will be calibrated as long as the full two minute interval elapses without a change in O delivery e f apnea ventilation occurs during the two minute interval the apnea O deliv ery also increases by the configured amount e During LOSS OF AIR SUPPLY or LOSS OF QO SUPPLY alarm conditions the Elevate O function is canceled if in progress and is temporarily disabled until the alarm condition no longer exists e During Safety PCV the Elevate O control has no effect During circuit disconnect and stand by states when the ventilator is turned on but not ventilating the Elevate O function affects the currently delivered oxygen concentration not the set oxygen concentration Alarm Vo
217. cters Pressure sensitivity setting in cmH 0 6 characters PEEP CPAP in cmH50 6 characters Plateau setting in seconds 6 characters Apnea interval setting in seconds 6 characters Apnea tidal volume setting in L 6 characters Field 23 Apnea respiratory rate setting in breaths min 6 characters Apnea peak flow setting in L min 6 characters Operator s Manual Product Data Output Component Table 5 2 MISCF Response Continued Apnea O setting 6 characters PCV apnea inspiratory pressure setting in cmH 0 6 characters PCV Apnea Inspiratory Time setting in seconds 6 characters Apnea flow pattern setting SQUARE or RAMP 6 characters Apnea mandatory type setting PC or VC 6 characters Inspiratory component of Apnea I E ratio if apnea mandatory type is PC 6 characters Expiratory component of Apnea I E ratio if apnea mandatory type is PC 6 characters Support pressure setting cmH 0 Flow pattern setting SQUARE or RAMP 6 characters Elevate O state ON or OFF 6 characters High inspiratory pressure alarm setting TPprax in cmH 0 6 characters Low inspiratory pressure alarm setting 4Ppzax in cmH O or OFF 6 characters High exhaled minute volume TV Tot alarm setting in L min or OFF 6 characters Low exhaled minute volume LV_ Tor alarm setting in L min or OFF 6 characters High exhaled mandatory ti
218. ction is used during these conditions Operator s Manual Ventilation Features the value chosen for elevate O applies to the currently delivered oxygen con centration which is 40 O in these cases and not the set oxygen concentra tion E 9 3 CPAP Mode When using NeoMode 2 0 and ventilating with non invasive ventilation NIV a separate CPAP mode allows spontaneous breathing with a desired PEEP level In order to limit inadvertent alarms associated with the absence of returned volumes in nasal CPAP breathing CPAP does not make available exhaled minute volume and exhaled tidal volume alarm settings Since some neonates don t trigger breaths the default apnea interval Ta is set to OFF Also some settings changes will initiate a PEEP restoration breath before phasing in those changes Note In CPAP Apnea Time Ta can be adjusted if desired It merely defaults to OFF to avoid inadvertent alarms The message APNEA DETECTION DISABLED is displayed at the bottom of the GUI screen The attention icons are also displayed To set the ventilator for CPAP 1 Select New Patient from the ventilator s startup screen or touch Vent Setup to 2 Touch PBW and turn the knob to set the PBW 3 Select NIV as the Vent type 4 Touch CPAP 5 Touch each ventilator setting and turn the knob to select appropriate ventilator settings When finished touch Accept or Accept ALL 6 Complete the setup by setting the apnea parameters and a
219. d by qualified service personnel A WARNING The Puritan Bennett 980 Series Ventilator contains phthalates When used as indicated very limited exposure to trace amounts of phthalates may occur There is no clear clinical evidence that this degree of exposure increases clinical risk However in order to minimize risk of phthalate exposure in children and nursing or pregnant women this product should only be used as directed WARNING Even though the 980 Series Ventilator meets the standards listed in Chapter 11 the internal Lithium ion battery of the device is considered to be Dangerous Goods DG Class 9 Miscellaneous when transported in commerce The 980 Series Ventilator and or the associated Lithium ion battery are subject to strict transport conditions under the Dangerous Goods Regulation for air transport IATA International Air Transport Association International Maritime Dangerous Goods code for sea and the European Agreement concerning the International Carriage of Dangerous Goods by Road ADR for Europe Private individuals who transport the device are excluded from these regulations although for air transport some requirements may apply 1 6 Operator s Manual Safety Information 1 3 4 Warnings Regarding Environment of Use WARNING Do not position the ventilator next to anything that blocks or restricts the gas inlet or cooling air circulation openings gas exhaust port fan intake or alarm speaker as this
220. d guidance for alarm systems in medical electrical equip ment and medical electrical systems IEC 60601 2 12 2001 Medical electrical equipment Part 1 2 General require ments for basic safety and essential performance Collateral standard Safety requirements for medical electrical systems EN 60601 2 12 2005 Medical electrical equipment Part 2 12 Particular require ments for the safety of lung ventilators Critical care ventilators ISO EN 80601 2 12 2011 Medical electrical equipment Part 2 12 Particular requirements for basic safety and essential performance of critical care ventilators ISO 80601 2 55 2011 and EN ISO 80601 2 55 2012 Medical electrical equip ment Part 2 55 Particular requirements for the basic safety and essential perfor mance of respiratory gas monitors First Edition ISO 5356 1 2004 Anesthetic and respiratory equipment Conical connectors Part 1 Cones and sockets IEC 60601 1 4 2000 Medical Electrical Equipment Part 1 4 General Require ments for Safety Collateral Standard Programmable Electrical Medical Systems IEC 60601 1 6 2010 Medical electrical equipment Part 1 6 General require ments for basic safety and essential performance Collateral Standard Usability IEC 62366 2007 Medical devices Application of usability engineering to medical devices ANSI AAMI HE75 2009 Human Factors Engineering Design of Medical Devices IEC EN 60601 1 2 2007 Medical electrical equipment Part 1 2 G
221. d of the breath yield spontaneous breaths SPONT Not allowed PC or VC INVASIVE Pressure support All spontaneous except for manual allowed only for ed PS Tube compensated inspirations manual inspirations TC Volume supported VS Proportionally assisted PAV NIV PS BiLevel PC PS TC Combines mandatory and sponta INVASIVE neous breathing modes Reference vent type Appendix A for more information on only BiLevel ventilation CPAP VC or PC allowed only N A All spontaneous except for manual for OIM breaths inspirations Reference Appendix E NeoMode 2 0 for more information on CPAP Breath types must be defined before settings can be specified There are only two categories of breath type mandatory and spontaneous Mandatory breaths are volume controlled VC or pressure controlled PC or VC The ventilator currently offers spontaneous breaths that are pressure supported PS volume supported VS tube compensated TC or proportionally assisted PAV if the PAV option is installed The figure below shows the modes and breath types available on the ventilator Operator s Manual Short Self Test SST Re VC VC PS TC VS PAV The mode setting defines the interaction between the ventilator and the patient e Assist control A C mode allows the ventilator to control ventilation within boundaries specified by the practitioner All breaths are mandatory and can be PC VC or VC
222. d with either endotracheal ET or tracheostomy Trach tubes of internal diameter ID 6 0 mm to 10 0 mm Patients must have satisfactory neural ventilatory coupling and stable sustainable inspiratory drive x Proportional Assist and PAV are registered trademarks of The University of Manitoba Canada Used under license D 1 PAV Appendix D 2 p3 Safety Symbol Definitions This section contains safety information for users who should always exercise appropriate caution while using the ventilator Table D 1 Safety Symbol Definitions Symbol A Definition WARNING Warnings alert users to potential serious outcomes death injury or adverse events to the patient user or environment Caution Cautions alert users to exercise appropriate care for safe and effective use of the product Q Note Notes provide additional guidelines or information WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs A WARNING PAV is not an
223. dal volume TV re manp alarm setting in mL or OFF 6 charac Low exhaled mandatory tidal volume 4Vre manp alarm setting in mL or OFF 6 charac High exhaled spontaneous tidal volume TVre sponr alarm setting in mL or OFF 6 charac Low exhaled spontaneous tidal volume 4V e spon alarm setting in mL or OFF 6 charac Field 42 High respiratory rate Tfror alarm setting in breaths min or OFF 6 characters Field 43 High inspired tidal volume TV alarm setting in mL 6 characters Field 44 Base flow setting in L min 6 characters Field 45 Flow sensitivity Vsens setting in L min 6 characters Operator s Manual Component Data Transfer Table 5 2 MISCF Response Continued PCV inspiratory pressure P setting in cmH O 6 characters PCV inspiratory time Tj setting in seconds 6 characters Inspiratory component of I E ratio setting or High component of H L ratio setting 6 characters Expiratory component of I E ratio setting or Low component of H L ratio setting 6 characters Constant during rate change setting I time I E or E time 6 characters Tube ID setting in mm 6 characters Tube Type setting ET or TRACH 6 characters Humidification type setting Non heated exp tube Heated exp tube or HME 18 characters Humidifier volume setting in L 6 characters O sensor setting Enabled or Disabled 9 characters Disconnect sensiti
224. de of the artificial airway are allowed to equalize by closing the inspiratory and exhalation valves Expiratory pause is available in A C SIMV and BiLevel modes For A C and SIMV the expiratory pause maneuver is scheduled for the next end of exhalation prior to a mandatory breath In BiLevel the expiratory pause occurs at the next end of exhalation prior to a transition from P to Py Only one expiratory pause per breath is allowed and the expiratory pause request is rejected if an inspiratory pause has already taken place during the same breath A request for an expiratory pause maneuver is ignored in apnea ventilation safety PCV SPONT OSC BUV and Stand by Reference To access respiratory mechanics maneuvers p 4 28 for more information on performing these maneuvers from the GUI screen rather than using the keys on the GUI Either manual or automatic expiratory pause maneuvers can occur A momentary press of the expiratory pause key begins an automatic expiratory pause which lasts at least 0 5 s but no longer than 3 0 s A manual expiratory pause starts by pressing and holding the expiratory pause key and lasts for the duration of the key press up to 15 Operator s Manual 10 53 Theory of Operations 10 54 An active manual expiratory pause is terminated if any of events1 12 occur Reference Reference nspiratory and Expiratory Pause Events p 10 51 An active manual expiratory pause is complete if the expiratory pause ke
225. dent central processing units CPUs Reference Pneumatic Diagram p 2 37 and its associated reference designa tors when reading the following paragraphs Gas delivery starts with the ventilator connected to wall or bottled air and oxygen Gas travels to the mix module where gas pressures are regulated by their respective proportional solenoid valves PSOLs The PSOLs meter the gases according to the ventilator settings entered then the gases flow through individual air and oxygen flow sensors into the mix manifold and accumulator for mixing The individual gas pressures are continuously monitored both before and after they are mixed in the mix manifold and accumulator assem blies The mixed gas then flows to the inspiratory pneumatic system where it flows through the breath delivery flow sensor and then the inspiratory PSOL for delivery to the patient Before the gas reaches the patient it passes through an internal inspiratory bacteria filter then through an external inspiratory bacteria filter attached to the ventilator s gas outlet the To patient port where the breathing circuit is attached When the gas returns from the patient it flows through the expira tory limb of the breathing circuit to the From patient port on the expiratory bacteria filter which includes a condensate vial before flowing through the exhalation valve flow sensor and exhalation valve EV A gas exhaust port allows exhaled gas to exit the ventilator and f
226. designed for use on patient population sizes from Neonatal NICU through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0 3 kg 0 66 Ib It is suitable for service in hospital institutions and intra hospital transport to provide continuous positive pressure ventilatory support delivered invasively or noninvasively to patients who require the following types of ventilator sup port e Positive Pressure Ventilation delivered invasively via endotracheal tube or trach tube or non invasively via mask or nasal prongs e Assist Control SIMV or Spontaneous modes of ventilation Note Intended typical usage may be defined to include the following for the ventilator system Hospital Use Typically covers areas such as general care floors GCFs operating rooms special procedure areas intensive and critical care areas within the hospital and in hospital type facilities Hospital type facilities include physician office base facilities sleep labs skilled nursing facilities surgicenters and sub acute centers Intra hospital transport Includes transport of a patient within the hospital or hospital type facility All external hospital transportation i e ambulance or air craft is excluded Note Federal law USA restricts the sale of this device except by or on the order of a physician 24 Contraindications 2 4 Do not operate the ventilator in a magnetic resonance imaging MRI
227. dialog and touch the Alarms tab on the left side of the GUI screen or touch the alarm icon in the constant access icons area of the GUI screen The alarms screen appears with the default alarm set tings Reference Alarms Settings Screen p 4 17 Review and adjust the alarm settings appropriately for the patient Note If Quick Start is chosen the alarms tab on the dialog shows a yellow triangle indicating the alarm settings have not been reviewed Note Reference Alarm Settings Range and Resolution p 11 17 for new patient default alarm values These defaults cannot be changed The clinician can adjust alarm settings by following the procedure below The alarm settings are retained in memory when the ventilator s power is cycled and same patient is selected Otherwise current settings revert to new patient defaults when a new patient is selected Operator s Manual Ventilator Shutdown Figure 4 7 Alarms Settings Screen Waiting for patient connect Setup Alarms Pprax frot Ve ToT Vre MAND Vre SPONT Vn nh Nmir L mil ni mi OFF 10 300 44 Te Ramp 0 0 N VEN_11352_D To adjust the alarm settings 1 Touch each alarm setting slider of the alarm s to change Alarm settings are avail able for Peak fror Ve tot Vte MAND VTE spont and Vy parameters 2 Turn the knob clockwise to increase the value or counter clockwise to decrease the value 3 Continue until all desired alarms are set as necessary 4 Touc
228. dialog appears instructing the clinician to disconnect the patient circuit A timer starts which allows 30 s to disconnect the patient 3 Disconnect the patient circuit and confirm the disconnection by touching Confirm A timer starts which allows 30 s for confirmation of disconnect To exit Stand by state 1 Reconnect the patient circuit The ventilator resumes ventilation at the settings in use before the disconnection The following ventilator settings become active during Stand by state e Base flow is set to ten 10 L min e 100 O for adult pediatric patients e 40 O for neonatal patients During Stand by state Operator s Manual 3 31 Installation e The exhalation valve is open e Current ventilator settings are retained in memory e Flow sensors are monitored to detect patient reconnection e Patient related alarms are temporarily suppressed as described below e Ventilator settings can be changed if desired and will be applied upon patient reconnection e The ventilator displays an indicator that it is in Stand by State and a timer indicat ing the elapsed time the ventilator has been in Stand by state e Ventilator background checks continue to be made The ventilator automatically exits Stand by state when patient reconnection is detected the clinician completes patient setup if ventilation was mistakenly started before setup was complete or the ventilator power is cycled Prior to entering Stand by
229. difier volume are correct Operator s Manual Table 6 5 Non technical Alarm Summary Continued PAV R amp C NOT ASSESSED patient data alarm occurs only if PAV is in use Low Medium Analysis message R and or C over 15 minutes old R and or C over 30 minutes old Remedy message Check for leaks shallow breathing amp settings for tube ID Wy and TPpEak Ventilator Settings Comments Unable to assess resistance and or compliance during PAV steady state Startup was suc cessful but later assessments were unsuccessful Cor rective action Check patient Patient s inspirato ry times may be too short to evaluate resistance and com pliance Check that selected humidifica tion type and empty humidifier volume are correct LOSS OF POWER Immediate N A N A The ventilator power switch is ON and there is insuffi cient power from AC and the battery There may not be a visual indicator for this alarm but an independent audio alarm sounds for at least 120 seconds Alarm annuncia tion can be reset by turning power switch to OFF posi tion LOW BATTERY Medium Operating on battery Ventila tor battery oper ational time lt 10 minutes Replace or allow ventilator battery to recharge Resets when battery has gt ten minutes of opera tional time remain ing or when AC power is restored Operator s Manual 6 25 Performanc
230. ding a general description of the ventilator s components and how they work togeth er to manage breath delivery 10 3 Applicable Technology The ventilator s control is provided by Breath Delivery BD and Graphical User Interface GUI Central Processing Units CPUs The BD CPU manages all breath delivery functions and provides background checks on the subsystems required for breath delivery The GUI CPU controls the primary display opera tor input devices and the alarm system The status display a small non inter active LCD display located on the Breath Delivery Unit BDU is controlled by its own processor Reference Status Display p 2 28 for more information USB Ethernet and HDMI interfaces are provided on the ventilator The USB interface supports items such as transferring data to an external monitor via a serial over USB protocol and saving screen captures to a memory storage device or flash drive Reference To configure Comm ports p 5 4 for informa tion on serial over USB data transfer The Ethernet interface is used by quali fied service personnel for accessing ventilator logs and performing software options installation and the HDMI interface provides the ability to display the GUI screen on an external video display device Pressure and flow sensors in the inspiratory and expiratory modules to manage breath delivery processes Sensor signals are used as feedback to the breath delivery PSOL and exhalation valve controll
231. dragging to another item to dismiss the last tooltip and display another tooltip Other Resources Additional resources for information about the ventilator can be found in the Puritan Bennett 980 Series Ventilator Service Manual and appendices in this manual for BiLevel 2 0 IE Sync Leak Sync PAV NeoMode 2 0 and Proximal Flow Sensor options s Warranty Information To obtain warranty information for a covered product contact Covidien Tech nical Services at 1 800 255 6774 or call a local Covidien representative 16 Manufacture Date on The graphical User Interface GUI and Breath Delivery Unit BDU each possess a specific year of manufacture applicable only for that assembly These dates are contained in the serial numbers for each assembly or option Serial numbers for the 980 Ventilator final units consist of ten digits in the following format 357YYXXXXX where e 35 signifies the unit was manufactured in Galway Ireland e Zrepresents the product code B breath delivery unit G GUI P Proximal Flow Monitoring option The product codes shown here are typically the most common There may be other product codes shown in the serial number depend ing upon the particular option s purchased e YY is a two digit year code that changes with each year e XXXXX is a sequential number that resets at the beginning of each new year Operator s Manual 1 19 Introduction Serial numbers are located on labels on the back
232. e Table 6 5 Non technical Alarm Summary Continued LOW BATTERY Analysis message Operating on battery Ventila tor battery oper ational time lt 5 minutes Remedy message Replace or allow ventilator battery to recharge Comments Resets when battery has gt five minutes of opera tional time remain ing or when AC power is restored WE MAND patient data alarm Last 2 mand breaths lt set imit Medium Last 4 mand breaths lt set imit Last 10 or more mand breaths lt set limit Check for leaks changes in patient s R amp C Exhaled mandatory tidal volumes set limit Alarm updated whenever exhaled mandatory tidal volume is recalculated Possi ble dependent alarms JVE ToT Trot 4VTE SPONT patient data alarm Last 4 spont breaths lt set imit Medium Last 7 spont breaths lt set imit High Last 10 or more spont breaths lt set limit Check patient amp settings Exhaled sponta neous tidal volume lt set limit Alarm updated whenever exhaled sponta neous tidal volume is recalculated Pos sible dependent alarms 4V Tor Trot 6 26 Operator s Manual Table 6 5 Non technical Alarm Summary Continued Ventilator Settings Base message Priority Analysis Remedy Comments message message TV patient data Low Last spont In TC VS or Delivered inspirato alarm breath gt s
233. e Compensation Reference Compliance Compensation in Volume based Breaths in Chapter 10 of this manual for a complete discussion of compliance compensation Com pliance compensation in NeoMode 2 0 is implemented exactly as described in the aforementioned reference Note If the patient s compliance decreases beyond the limits of compliance compensation the ventilator relies on the TPprax alarm setting to truncate the breath and switch to exhalation E 9 7 Settings Alarms and Monitored Patient Data WARNING Monitor the patient closely if alarms are disabled there are no audible or visual annunciations for out of range conditions when volume pressure or apnea alarms are disabled turned OFF Reference the tables for Ventilator Settings Alarm Settings and Patient Data in Chapter 11 of this manual for the ranges for each ventilator setting or data value Most settings however are also limited by other settings or conditions for example a low alarm limit is always limited by the corresponding high alarm limit Review the prompt area when making settings changes Operator s Manual E 11 NeoMode 2 0 Appendix Volume Accuracy Volume accuracy testing in VC was conducted to demonstrate performance of delivered and monitored parameters The following tables provide a summary of the actual results obtained within the range of two 2 mL to 25 mL collected during test execution The first column Set Tidal Volume represents th
234. e Mode Button TEST VEN 11246 D 1 Service Mode button 4 Wait to enter Service Mode 5 Confirm a patient is not connected to the ventilator by touching the correspond ing button The message SERVICE MODE VENTILATION SUPPORT IS NOT AVAIL ABLE appears on the graphical user interface 6 Perform required service 7 Touch Exit or turn off the ventilator to exit Service Mode Reference the Puritan Bennett 980 Series Ventilator Service Manual for information on which keys are disabled during EST In addition to allowing SST to be run Service Mode also allows configuration of various items Reference Ventilator Configuration p 3 35 for a list of insti tutionally and operator configurable items Operator s Manual Product Connectivity 3s Product Configuration The ventilator is shipped configured with factory defaults for new patient parameters which can be configured to suit institutional preferences The operator may configure any desired parameter as long as this option has not been locked out and rendered unavailable When configuring the ventilator it displays the parameters associated with the operator s last configuration The following table lists the factory configured settings the institutionally config urable settings and the operator configurable settings WARNING If the ventilator fleet in your institution uses multiple institutionally configured presets and or defaults there can be risks of inapprop
235. e artifi cial airway TC causes the sensation of breathing through an artificial airway to diminish because the TC algorithm instructs the ventilator to develop just the correct amount of forward pressure to offset cancel the back pressure developed across the artificial airway during the inspiratory phase The degree Operator s Manual 10 27 Theory of Operations 10 28 of cancellation can be set by the clinician and is adjustable between 10 an 100 in increments of 5 Tube Compensation can support all unsupported spontaneous breaths for patients with predicted body weights gt 7 0 kg 15 4 Ib and for endotracheal tracheostomy tubes with an inside diameter ID of 5 4 5 mm TC can be used within SPONT BiLevel if this option is installed or SIMV all of which permit unsupported spontaneous breaths With BiLevel selected TC supports sponta neous breaths at both pressure levels Tube Compensation checks the flow rate every 5 ms using an internal lookup table which contains the flow to pressure relationship of the selected artificial airway and is used to calculate the amount of pressure needed to overcome all or part of the resistance of the artificial airway Based on the TC setting and the instantaneous flow measurement the ventilator s PSOL valves are contin ually adjusted adjusting the circuit pressure to match the changing tube pres sure compensation requirements Tube Compensation Alarms Reference Non technical
236. e artificial airway In PAV specifies the per centage of total inspirato ry work of breathing WOB performed by the ventilator Range 10 to 100 Resolution 5 Range 5 to 95 Resolution 5 Ty time high The duration of the insuf flation phase during BiLevel ventilation Range 0 2 s to 30s Resolution 0 01 s ratio of insufflation time to expiratory time T time low The duration of the expira Range 5 0 20 s tory phase during BiLevel Resolution 0 01 s ventilation Ty T ratio In BiLevel specifies the Range 1 299 to 4 1 in BiLevel Ty T Resolution 0 01 for lt 10 00 1 and gt 1 10 00 0 1for x 100 0 1 and gt 10 0 1 or s 1 10 0 and gt 1 100 0 1 for lt 1 100 0 or 100 1 15 Specifications 16 Table 11 9 Ventilator Settings Range and Resolution Continued Setting Tidal volume V7 Description The volume of gas deliv ered to the patient during a mandatory volume based breath V7 compen sates for body tempera ture and pressure saturated BTPS and circuit compliance Appli cable for volume based breaths Range and Resolution Range NEONATAL 2 mL to 315 mL PEDIATRIC 25 mL to 1590 mL ADULT 25 mL to 2500 mL Resolution 0 1 mL lt 5 mL 1 mL for gt 5mLand lt 100 mL 5 mL for 100 mL to 395 mL 10 mL for values gt 400 mL Volume support V7 supp or VS The volume of gas deliv ered to the patient during spontaneous v
237. e desired volume setting in milliliters mL The second column represents the total number of test points for test cases executed at that specific setting The third column is the mean Mean Value of the ventilators and test cases executed for the setting listed The fourth column represents the standard deviation of measurements taken for the ventilators and test cases executed at the setting listed The measurements were taken using instrumentation located at the patient connection port Accessories such as filters and humidifiers were in the circuit during the test Values were BTPS and compliance compensated A sample size of five 5 ventilators was used to conduct the testing Testing was conducted at 22 C 5 C Table E 3 Delivered Volume Accuracy Set Tidal Volume Number of Test Mean Value STD mL Points 2 150 2 067 0 198 5 270 4 853 0 324 15 240 15 108 0 383 25 270 24 608 0 607 Table E 4 Monitored Inspired Volume V Accuracy Set Tidal Volume Number of Test Mean Value STD mL Points 2 150 2 055 0 192 5 270 4 872 0 346 15 240 15 235 0 379 25 265 24 633 0 566 E 12 Operator s Manual Table E 5 Monitored Exhaled Tidal Volume Vtg Accuracy Ventilation Features Set Tidal Volume Number of Test Mean Value STD mL Points 2 150 2 212 0 274 5 270 5 892 0 607 15 240 16 145 0 851 25 265 25 492 0 819 Operator s Man
238. e falls below set PEEP 1 cmH50 for three consecutive breaths The screen shows this alarm message Figure B 4 Circuit Disconnect During VC Circuit Disconnect Adult mms 10 30044 3d 100 oo K 3 0 VEN_11368_D Normal operation resumes if the ventilator detects a patient connection Operator s Manual B 9 Leak Sync Appendix Page Left Intentionally Blank B 10 Operator s Manual C IE Sync Appendix c1 Overview This appendix describes the operation of the Puritan Bennett 980 Ventilator IE Sync option When a mechanically ventilated patient is capable of some degree of ventila tory effort it is essential that the ventilator be as responsive as possible to the patient s efforts In most modes and breath types this is done by clinicians esti mating Psens Vsens and Esens IE Sync is a ventilator triggering and cycling algorithm based on real time esti mation of the patient s intra pleural pressure The algorithm processes ventila tor pressure and flow measurements in a way that accounts for the variability of respiratory parameters of the patient population In a bench top model sim ulating patients with flow limitation incomplete exhalation or weak sponta neous efforts IE Sync triggering has been shown to decrease the number of missed breaths when compared to flow triggering c2 Intended Use IE Sync is intended for invasively ventilated spontaneously breathing pediatric and adult patients only
239. e font patient data 3 43 mL kg ratio 3 40 new patient setup defaults 3 40 O2 3 40 patient data 3 42 PBW 3 40 pressure units 3 39 screen brightness and keyboard backlight 3 39 screen opacity 3 45 waveforms 3 44 Connect the Ventilator to AC Power 3 5 Connecting the Gas Supplies 3 7 Connecting the Patient Circuit 3 14 Connectivity to External Patient Monitoring Systems 5 21 Constant Timing Variable for Rate Changes 4 20 Covidien Technical Services list of International Service Centers 1 15 phone number 1 15 Solv IT Center Knowledge Base 1 18 Covidien URL 1 1 1 15 D Detecting Occlusion and Disconnect 10 45 10 49 Disconnect 2 055 10 47 Disconnect Sensitivity Dsens 10 70 Display brightness adjustment 4 5 lock 4 6 E EMC compatibility 1 20 emissions 11 30 immunity 11 31 recommended separation distances 11 34 exhalation airway pressure method 10 9 high circuit pressure limit backup method 10 12 high inspired tidal volume limit backup method 10 12 high ventilator pressure limit backup method 10 12 percent peak flow method 10 10 time cycling method 10 11 time limit backup method 10 12 Exhalation Detection and Initiation 10 9 10 12 expiratory module EVQ removal disinfection reassembly 7 12 7 23 Expiratory Pause 10 53 10 54 Expiratory Pause Maneuvers 4 31 Expiratory Sensitivity Esens 10 69 Expiratory Time TE
240. e of the entire inspiration Range 0 to 1 00 Resolution 0 01 Operator s Manual Intrinsic PEEP PEEP A calculated estimate of the pressure above PEEP at the end of exhalation Range 20 0 cmH50 to 130 cmH70 Resolution 0 1 cmH 0 between 9 9 and 9 9 cmH 0 1 cmH70 lt 10 cmH 0 and 10 cmH70 21 Specifications 22 Table 11 11 Patient Data Range and Resolution Continued Data Value Mean circuit pressure Pyyean Description The calculated average circuit pressure for an entire breath cycle including both inspirato ry and expiratory phases whether the breath is man datory or spontaneous Range and Resolution Range 20 0 cmH 0 to 100 cmH 70 Resolution 0 1 cmH30 for 20 0 to 9 9 cmH 30 1 cmH 0 for 10 to 100 cmH 0 Negative inspiratory force NIF The negative pressure gener ated during a maximally forced inspiratory effort against an obstruction to flow Range lt 0 cmH 0 to 2 50 cmH 0 Resolution 1 cmH 0 for values lt 10 cmH 0 0 1 cmH 0 for values gt 10 cmH 0 O2 monitored The monitored percentage of oxygen in the gas delivered to the patient measured at the ventilator outlet upstream of the inspiratory filter Range 0 to 103 Resolution 1 The inspiratory depression of airway pressure after 100 ms of occlusion Pg is an indica tor of respiratory drive Range 20 cmH20 to O cmH 30 Resolution 1 cmH3O when lt
241. e target 4 200 ms 2 Pressure target incremental value n 5 Tn 3 Start breath 10 5 2 Percent Peak Flow Method For spontaneous breath types including PS pressure supported TC tube compensated and VS volume supported the ventilator captures the value of the delivered peak inspiratory flow then monitors the inspiratory flow decline until the value of current flow to peak flow expressed as a percentage is less than or equal to the set Eseng value The ventilator then cycles from inspiration into exhalation Reference Exhalation via the Percent Peak Flow Method p 10 11 for an example of exhalation using this method 10 10 Operator s Manual Short Self Test SST Figure 10 5 Exhalation via the Percent Peak Flow Method PLAN ee t VEN_10760_B 1 Inspiratory flow 0 L min 5 Event B Ventilator initiates exhalation 2 Inspiration 6 Inspiratory flow L min without expi ratory trigger 3 Trigger 7 Vmax X Esens 100 4 Event A delivered flow begins to decrease Vmax Note PAV uses a flow based cycling method also called Esens but it is expressed in L min rather than in of Vmax 10 5 3 Time cycling Method In pressure ventilation the set inspiratory time T defines the duration of the inspiratory phase In volume ventilation T depends on the tidal volume V setting peak flow Vmax flow pattern and plateau time Tp The ventilator cycles into exhalation when the set T pressure ventilation
242. e ventilator s primary display The GUl s keys activate other venti lator functions including screen brightness display lock alarm volume manual inspiration inspiratory pause expiratory pause alarm reset and alarm silence The GUI displays the following information depending on the state of the ven tilator e Ventilator apnea and alarm settings e Patient data e Waveforms e Current alarm banners 210 GUI Controls and Indicators 2 10 1 Control Keys The GUI bezel has eight off screen control keys as shown below Table 2 5 GUI Control Keys Key symbol Description so ly Brightness control key Adjusts the GUI screen brightness Press the key and turn C the knob to adjust the brightness 7 T x aad Operator s Manual Key symbol A aad GUI Controls and Indicators Table 2 5 GUI Control Keys Continued Description Display lock key Actuates a lock to prevent inadvertent settings changes to the ventilator including the knob function while the display is locked The display lock is useful when cleaning the touch screen Press the key again to unlock the display Alarm volume key Adjusts the alarm volume The alarm volume cannot be turned OFF Manual inspiration key In A C SIMV and SPONT modes delivers one manual breath to the patient in accordance with the current mandatory breath parameters In BiLevel mode transitions from low pressure P to high pressure Py
243. east the operator set value for flow sensitivity Vsens the ventilator delivers a breath e Time Trigger The ventilator delivers a Ventilator Initiated Mandatory VIM breath after a specific amount of time elapses e Operator Trigger OIM The operator presses the Manual inspiration key An operator initiated mandatory breath is also called an OIM breath During an OIM breath the breath delivered is based on the current settings for a mandatory breath Spontaneous breathing modes such as SIMV BiLevel and SPONT include the following breath types called Spontaneous Types e PS Pressure Support The ventilator delivers an operator set positive pres sure above PEEP or P in BiLevel during a spontaneous breath If SIMV is selected as the mode PS is automatically selected for spontaneous type e VS Volume Support The ventilator delivers an operator set positive pres sure above PEEP during a spontaneous breath and automatically adjusts the pres sure level from breath to breath to consistently deliver the set tidal volume e TC Tube Compensation Additional positive pressure delivered to the patient during spontaneous breaths to overcome resistance of the artificial airway e PAV Proportional Assist Ventilation A software option that allows the ventilator to reduce the work of breathing WOB by assisting the patient s inspi ration by an operator set amount proportional to the breathing effort generated
244. eclared 10 14 Respiratory Mechanics Reference Respiratory Mechanics Maneuvers p 4 28 for instructions on how to perform these maneuvers In addition to Inspiratory Pause and Expiratory Pause maneuvers the ventilator can provide other respiratory maneuvers including Negative Inspiratory Force NIF Occlusion Pressure Po 1 and Vital Capacity VC as well as automatic cal culations of lung function and performance such as Dynamic Compliance Cpyn and Dynamic Resistance Rpyn Peak Expiratory Flow PEF End Expira tory Flow EEF C3o C and Peak Spontaneous Flow PSF Respiratory maneuvers can be performed in all breathing modes except as noted below but are not available during the following conditions e Apnea ventilation e Safety PCV e Occlusion Status Cycling OSC Operator s Manual 10 49 Theory of Operations 10 14 1 10 50 e Non invasive ventilation NIV e When the circuit type is neonatal e SVO e Ventilator is in Stand by state e When any other respiratory maneuver has already taken place during the same breath The GUI also displays any maneuver request distinguishing between requests that are accepted or rejected and any maneuver that has begun ended or has been canceled When a maneuver is selected a GUI information panel is opened displaying the maneuver name user prompts and controls and recent calculated results Any maneuver is canceled automatically upon declaration of any of t
245. econds adult and pediatric circuits 1 00 0 10 x PBW seconds neonatal circuits where PBW is the current setting for predicted body weight in kg When the ventilator declares an INSPIRATION TOO LONG alarm the ventilator terminates inspiration and transitions to exhalation The INSPIRATION TOO LONG alarm applies only to spontaneous breaths and cannot be set or dis abled Because leaks in the patient circuit around the endotracheal tube cuff or through chest tubes and patient ventilator mismatch can affect accurate exhalation detection the INSPIRATION TOO LONG alarm can act as a backup method of safely terminating inspiration If the INSPIRATION TOO LONG alarm occurs frequently check for leaks and ensure Esgys and rise time Yo are prop erly set 6 5 21 Low Circuit Pressure 4Pprax Alarm The 4Ppgax alarm indicates the measured maximum airway pressure during the current breath is less than or equal to the set alarm level during a non invasive inspiration or during a VC inspiration Operator s Manual 6 39 Performance The J4Pprag alarm is active for mandatory and spontaneous breaths and is present only when Vent Type is NIV or Mandatory Type is VC During VC the 4Ppr ng alarm can be turned OFF The JPpr ag alarm can always be turned OFF during NIV The 4Ppg ag alarm limit cannot be set to a value greater than or equal to the TPpgeax alarm limit A WARNING Because the VC pressure control algorithm does not allow t
246. ect a leak in the patient circuit or a change in the patient s respiratory drive during a single breath The 4V e cponr alarm is based on the current breath rather than on an average to detect changes as quickly as possible There are separate alarms for mandatory and spontaneous exhaled tidal volumes for use during SIMV and BiLevel if this software option is installed The ventilator phases in a change to the V e sponr alarm limit immediately to ensure prompt notification of a low exhaled tidal volume con dition 6 5 25 Low Exhaled Total Minute Volume vg tot Alarm The Je tor alarm indicates the measured minute volume for mandatory and spontaneous breaths is less than or equal to the VE tor alarm setting The We tor alarm updates with each new calculation for exhaled minute volume Operator s Manual 6 41 Performance 6 5 26 6 5 27 6 6 The ve tor alarm can detect a leak or obstruction in the patient circuit a change in compliance or resistance or a change in the patient s breathing pat tern The Jv tor alarm can also detect too small tidal volumes which could lead to hypoventilation and hypoxia oxygen desaturation The ventilator phases in changes to the Jvg tor alarm limit immediately to ensure prompt notification of prolonged low tidal volumes PROCEDURE ERROR Alarm The ventilator declares a PROCEDURE ERROR alarm if it is powered up either by turning on the power switch or if power is regained following a
247. ect the pause With this approach maneuver breaths are delivered randomly so that their occurrence is neither consciously recognized nor predictable A PAV breath begins after the recognition of a trigger signal with flow detection at the patient wye The sample and control cycle of the ventilator the value of in Equation 2 is frequent enough to yield essentially constant tracking of patient inspiration At every ith interval the software identifies instantaneous lung flow V which is impeded by the resistances of the arti ficial airway and patient airways and integrates this flow to yield an estimate of instantaneous lung volume Vi which is impeded by the elastic recoil of the lung and thorax Operator s Manual D 17 PAV Appendix Using the values for instantaneous lung flow and lung volume PAV software calculates each of the pressure elements in Equation 2 which gives the value of Pyys at each ith interval At this point Equation 2 and the subsequent analysis identifies that an appro priate patient supported by PAV and with an active Pyys an absolute requirement will within a few breaths enable the algorithm to obtain reason able estimates of Rpay and Epay Once these physiologic data are captured and over a relatively brief time as they are improved and stabilized the PAV algorithm mirrors the patient s respiratory mechanics which then allows the ventilator to harmoniously amplify Pyys The key point t
248. ectronics consist of the hot film wire and the thermistor Since it is protected by the expiratory filter it does not require or need replacement or disinfection on a regular basis It is however removable and may be disinfected Expected service life is 25 disin fection cycles Caution To avoid damage to the expiratory flow sensor element e Do not touch the hot film wire or thermistor in the center port e Do not vigorously agitate fluid through the center port while immersed e Do not forcefully blow compressed air or any fluid into the center cavity e Do not drop or handle roughly during disinfection or storage Operator s Manual 7 13 Preventive Maintenance WARNING Damaging the flow sensor s hot film wire or thermistor in the center port can cause the ventilator s spirometry system to malfunction 7 14 Operator s Manual Service Personnel Preventive Maintenance Figure 7 5 Exhalation Valve Flow Sensor Assembly Bao VEN 10286 A 2 VEN_10287_A 1 Top view 2 Bottom view Figure 7 6 Exhalation Valve Flow Sensor Components VEN_10293_A 1 Hot film wire and thermistor 3 Electrical contacts 2 Diaphragm sealing surface 4 Filter grommet Removal To remove the exhalation valve flow sensor assembly 1 Lift up on the expiratory filter latch and open the expiratory filter door 2 With thumb inserted into the plastic exhalation port and four 4 fingers under the exhalation valve flow sensor assembly pull i
249. edy message The base message describes the primary alarm The analy sis message describes the likely cause of the alarm and may include alarm aug mentations The remedy message provides information on what to do to correct the alarm condition Alarm banners when dragged leftward from the right side of the GUI display messages for the indicated active alarms The figure below shows the alarm message format Figure 6 1 Alarm Message Format Last 4 or more breaths setlimit II PreaK 1 Check patient circuit amp ET tube Higl Circuit pressure 10 300 44 VEN_11359_D 1 Base message 3 Remedy message 2 Analysis message A latched alarm is one whose visual alarm indicator remains illuminated even if the alarm condition has autoreset Latched alarm indicators are located on the sides of the omni directional LED A latched alarm can be manually reset by pressing the alarm reset key If no alarms are active the highest priority Operator s Manual 6 5 Performance latched alarm appears on the omni directional LED on the GUI A lockable alarm is one that does not terminate an active alarm silence function it does not sound an audible alert during an active alarm silence function while a non lockable alarm cancels the alarm silence period and sounds an audible alert All patient data alarms and the CIRCUIT DISCONNECT alarm are lockable alarms Note When a new lockable alarm occurs the alarm will not start to sound audi
250. eginning of a ventilator initiated exhalation and remains visible for as long as the ventilator 10 70 Operator s Manual Short Self Test SST truncates breaths in response to the TT sponr setting The TT sponr indicator disappears when the patient s inspiratory time returns to less than the TT sponT Setting or after 15 seconds has elapsed after the beginning of exhalation of the last truncated breath Changes to TT spon are phased in at the start of inspiration 10 15 30 Humidification Type The humidification type setting sets the type of humidification system heated expiratory tube non heated expiratory tube or heat moisture exchanger HME used on the ventilator and can be changed during normal ventilation or short self test SST Changes in humidification type phase in at the start of inspiration SST calibrates spirometry partly based on the humidification type Changing the humidification type without rerunning SST can affect the accuracy of spi rometry and delivery The accuracy of the exhalation valve flow sensor varies depending on the water vapor content of the expiratory gas which depends on the type of humidifica tion system in use Because the temperature and humidity of gas entering the expiratory filter differ based on the humidification type being used spirometry calculations also differ according to humidification type For optimum accura cy rerun SST to change the humidification type 10 15 31 Humidifi
251. el all changes and dismiss the dialog 4 14 Operator s Manual Ventilator Shutdown 4 5 2 Apnea Settings After making the necessary changes to the ventilator settings touch the Apnea tab on the left side of the Setup dialog Although changing the apnea settings is not required confirm the default settings are appropriate for the patient Apnea ventilation allows pressure control or volume control breath types Parameters in pressure controlled apnea breaths include f P T 02 and Ta Volume controlled apnea breath parameters are f Vt Vmax Flow pattern 05 and Ty Note If QUICK START is chosen the apnea tab on the Vent Setup screen shows a yellow triangle indicating the apnea settings have not been reviewed Figure 4 6 Apnea Setup Screen Waiting for patient connect Setup Apnea Ventilation Type Invasive Mode Apnea 19 300 44 0 0 10 3d0 44 30 100 0 0 N VEN_11351_D To set apnea parameters 1 Select the desired apnea breath type PC or VC 2 Enter the desired apnea settings in the same manner as for the ventilator settings 3 Touch Accept or Accept ALL to confirm apnea settings Operator s Manual 4 15 Operation During apnea pressure ventilation apnea rise time is fixed at 50 and the constant parameter during a respiratory rate change is T 4 5 3 Alarm Settings After accepting the apnea settings the display returns once more to show the waveforms Return to the Vent Setup
252. emory upon ventilator shutdown When the logs reach the maximum number of entries the oldest values are overwritten with new values Reference Ventilator Logs p 8 2 for information on ventilator logs Operator s Manual Operation Page Left Intentionally Blank 4 38 Operator s Manual 5 Product Data Output 51 Overview This chapter describes the features of the Puritan Bennett 980 Series Venti lator designed to provide output to the clinician This includes language methods of displaying and transferring data types of displayed data and types of external device ports Connectivity to an external patient monitoring system is also included 52 Language The language used on the ventilator is configured at the factory s3 Data Display Displayed data are updated in real time The practitioner can display up to 60 seconds of waveform data and pause and capture up to two loops using the screen capture function The operator can pause the displays and when the displays are paused a cursor appears with the relevant numeric values for the intersecting points of the cursor and waveform or loop The scalar waveform contains a single value but loops contain both x and y axis data The operator can move the cursor along the waveform or loop using the knob and read the corresponding data Reference Waveforms p 3 44 for details regarding con figuring and displaying waveforms sa Data Transfer Data from the ventilator can
253. en the system prompts select REPEAT TEST NEXT TEST or STOP then touch ACCEPT OVERRIDDEN ALERT status overridden by user Select next desired test Touching Override Est results in the following warning WARNING Choose to override the ALERT status and authorize ventilation only when absolutely certain this cannot create a patient hazard or add to risks arising from other hazards 310 Operation Verification Before ventilating a patient you must perform SST and alarms tests with passing results Reference To run SST p 3 48 and Reference Alarm Testing p 6 9 as well 3 58 Operator s Manual 4 Operation 41 Overview This chapter describes Puritan Bennett 980 Series Ventilator operation and includes the following sections e Setting up the ventilator e How to use the ventilator e How to use the ventilator s graphical user interface GUI e How to set or change main alarm or apnea settings e How to test alarms e How to calibrate enable or disable the O sensor e How to perform inspiratory and expiratory pause maneuvers e How to use non invasive ventilation NIV 42 Ventilator Function Air and oxygen from wall sources or cylinders enter the ventilator and flow through individual oxygen and air flow sensors The gases are then mixed in the mix module s accumulator A pressure relief valve in the mix module s accumu lator prevents over pressurization The mix module als
254. eneral require ments for basic safety and essential performance Collateral standard Electro magnetic compatibility Requirements and tests ISO 14971 2007 EN ISO 14971 2012 Medical devices Application of risk man agement to medical devices 29 Specifications 11 9Manufacturer s Declaration The following tables contain the manufacturer s declarations for the ventilator system electromagnetic emissions electromagnetic immunity separation dis tances between ventilator and portable and mobile RF communications equip ment and a list of compliant cables WARNING Portable and mobile RF communications equipment can affect the performance of the ventilator system Install and use this device according to the information contained in this manual WARNING The ventilator system should not be used adjacent to or stacked with other equipment except as may be specified elsewhere in this manual If adjacent or stacked used is necessary the ventilator system should be observed to verify normal operation in the configurations in which it will be used Caution This equipment is not intended for use in residential environments and may not provide adequate protection to radio communication services in such environments Table 11 15 Electromagnetic Emissions The ventilator is intended for use in the electromagnetic environment specified below The cus tomer or the operator of the ventilator should assure that it is used in su
255. enoted as alarm limits Reference Alarm Descriptions and Symbols p 6 6 Alarm Messages Alarms are visually annunciated using an indicator on the top of the GUI which has a 360 field of view If an alarm occurs this indicator flashes at a frequency and color matching the alarm priority The alarms also appear as colored banners on the right side of the GUI screen If an alarm occurs this indicator appears in the color matching the alarm priority yellow for low and medium priority red for high priority For technical alarm and non technical alarm details reference the respective tables on p 6 78 and p 6 29 An alarm is defined as a primary alarm if it is the initial alarm A dependent alarm arises as a result of conditions that led to the primary alarm This is also referred to as an augmentation An augmentation strategy is built into the ven tilator software to handle occurrences where the initial cause of the alarm has the potential to precipitate one or more additional alarms When an alarm occurs any subsequent alarm related to the cause of this initial alarm aug Operator s Manual Ventilator Settings ments the initial alarm instead of appearing on the GUI as a new alarm The initial alarm s displayed analysis message is updated with the related alarm s information and the Alarm Log Event column shows the initial alarm as Aug mented A primary alarm consists of a base message analysis message and a rem
256. ent s PBW or gender and height are entered and Quick Start is touched to begin ventilation Operator s Manual Product Connectivity 3 7 3 Stand By State Stand By state can be used when the clinician needs to disconnect the patient for any reason prior to a suction procedure for example The ventilator enters Stand By state if a request is made by the clinician a patient is disconnected within a fixed time period determined by the ventilator software and the cli nician confirms the patient has been disconnected intentionally If a patient becomes disconnected from the patient circuit after the time period elapses an alarm sounds and the patient disconnect sequence is initiated In Stand by state gas output is reduced to ten 10 L min to limit gas consumption and to allow for detection of patient reconnection and O concentration becomes 100 for adult and pediatric circuit types and 40 for neonatal circuit types Stand by state is available in all ventilation modes except during Inspiratory and Expiratory BUV Occlusion Status Cycling OSC Safety Valve Open SVO or Ventilator Inoperative Vent Inop conditions Note Do not block patient circuit wye while in Stand By state If the wye is blocked the ventilator detects a patient connection and will attempt to resume normal ventilation To enter Stand By state 1 Touch the Menu tab on the left side of the GUI The menu appears 2 Touch Stand By A Stand By state pending
257. ent Data p 3 42 to change the displayed patient data parameters or the order in which they are displayed If any patient data values are displayed continuously blinking it means their values are shown clipped to what has been defined as their absolute limits If the values are displayed in parentheses it means they are clipped to their variable limits Variable limits are calculated values derived from the set PBW and ventilator settings Displayed patient data values that have been clipped should be viewed as suspect Dashes are displayed if the patient data value is not applicable based on mode breath type combinations Note If no value is displayed then the ventilator is in a state where the value cannot be measured The following sections contain descriptions of all patient data parameters shown in the patient data displays Note All displayed patient volume data represent lung volumes expressed under BTPS conditions 6 6 1 Total Exhaled Minute Volume ve ToT The BTPS and compliance compensated sum of exhaled gas volumes from both mandatory and spontaneous breaths for the previous one minute inter val 6 6 2 Exhaled Spontaneous Minute Volume ve spont The BTPS and compliance compensated sum of exhaled spontaneous volumes for the previous minute 6 6 3 Exhaled Tidal Volume V7 The volume of the patient s exhaled gas for the previous mandatory or spon taneous breath Displayed V p is both comp
258. entTechSup port covidien com For online Technical support visit the Solvi www covidien com The SolvIT Center provides answers to frequently asked TSM 220213 Center Knowledge Base at questions about the ventilator system and other Puritan Bennett products 24 hours a day seven days a week 1 4 2 On Screen Help The ventilator is equipped with an on screen help system that enables users to select an item on the screen and display a description of that item Follow the procedure below to access and use on screen help Accessing On screen Help Topics Help topics on the ventilator are called tooltips If a tooltip is available a glowing blue outline appears around the item in question To access tooltips 1 Touch the item in question for a period of at least 0 5 s or drag the help icon the question mark icon appearing at the lower right of the GUI screen to the item in ques tion A tooltip appears with a short description of the item Most screen items have tooltips associated with them providing the operator with access to a multitude of help topics 2 Touch more on the dialog to display an expanded description Operator s Manual Safety Information 3 Touch close to close the dialog or let it fade away after five 5 seconds Note e Dragging the help icon causes the tooltip to display in its unexpanded state e Dragging the help icon and pausing causes a tooltip to display Continue
259. entilate the patient as set A constant flow of gas through the patient circuit during the latter part of exhalation during flow triggering V_tpig The value of this base flow is 1 5 L min greater than the operator selected value for flow sensitivity A message given by the ventilator during an alarm condition identifying the alarm Changes to multiple settings that go into effect at the same time The system for supplying battery back up power to a device The ventila tor s battery back up system consists of a single primary battery to provide up to one 1 hour of battery power to the ventilator An optional extended battery with the same characteristics as the primary battery is available Breath delivery or breath delivery unit The ventilator component that includes inspiratory and expiratory pneumatics and electronics Glossary 1 Table Glossary 1 Glossary of Ventilation Terms Continued BiLevel mode BOC breath stacking BTPS cmH 20 compliance volume constant during rate change control breath CPU dependent alarm Dsens DISS EsENS EST A mixed ventilation mode combining mandatory and spontaneous breaths where two levels of pressure are delivered P and Py corre sponding to expiratory and inspiratory times T and Ty British Oxygen Company A standard for high pressure gas inlet fittings The delivery of a second inspiration before the previous exhalation is complete Body tempera
260. entilator deliv ers 100 air if available If an air supply is not available the safety valve opens The ventila tor displays the elapsed time without ventilatory support This alarm cannot be set or dis abled e Check the patient e Check the air and oxygen sources e Obtain alternative ventila tion if necessary TPcome Target pressure TPprax 5 cmH 20 In TC e Check for leaks and tube type l D setting In PAV e Limit target pressure to PROCEDURE ERROR The patient is attached before ventilator startup is complete Safety ventilation is active e Provide alternate ventila tion if necessary e Complete ventilator startup procedure Operator s Manual 6 33 Performance 6 34 Table 6 6 Non Technical Alarms and Suggested Responses Continued Alarm message SEVERE OCCLUSION Meaning The patient circuit is severely occluded The ventilator enters occlusion status cycling The elapsed time without ventilato ry support appears Response e Check the patient e Obtain alternative ventila tion if necessary e Check patient circuit for bulk liquid crimps blocked filter e If problem persists remove ventilator from use and obtain service TV patient data alarm Delivered inspiratory volume 3 high inspiratory volume limit Ventilator transitions to exhala tion e Check for leaks and tube type ID setting e Check patient
261. ept Predicted Body Weight PBW Calculation 4 a Many default ventilator and alarm settings are based on patient PBW Either through the entry of height and gender or directly via setting PBW the PBW range spans at least 0 3 kg 0 66 Ib through at least the 155 kg 342 Ib male and the 150 kg 331 Ib female Understanding how the ventilator operates at the very low end of the range of PBW requires awareness that an entry or pre diction for PBW drives the value of a delivered volume which has a lower limit of 2 0 mL if using the NeoMode 2 0 option Data for adult male and female PBW as a function of height were calculated by applying the equations pre sented on www ards net Assume the ventilator via direct height or PBW entry registered a PBW of 0 3 kg If a delivered volume of 4 mL kg PBW was specified the required volume would equal only 1 2 mL which is less than the ventilator minimum of 2 0 mL At a desired 4 mL kg the infants PBW would need to be at least 0 5 kg or the desired volume must be reset to greater than 4 mL kg PBW Once the PBW of the premature infant approaches 1 0 kg 2 2 Ib this restriction disappears After entering PBW review and change all settings as needed The correlation function PBW height was derived from the sources refer enced For subjects whose body weight height data define the range of PBWs Operator s Manual 4 21 Operation that include the 20 to 23 week gestational age ne
262. er gas supply To connect the gas sources 1 Connect the oxygen hose to the oxygen inlet fitting item 1 as shown Ensure use of a medical grade oxygen source 2 Connect the air hose to the air inlet fitting item 2 Reference Connecting the Ven tilator to the Gas Supplies p 3 9 Operator s Manual Product Connectivity Figure 3 3 Connecting the Ventilator to the Gas Supplies VEN_11164_ 1 Ov gas connection 2 Air gas connection WARNING To prevent a potential fire hazard and possible damage to the ventilator ensure the connections to the gas supplies are clean and unlubricated and there is no water in the supply gas If water is suspected use an external wall air water trap to prevent damage to the ventilator or its components The ventilator system can be purchased with the following gas inlet fittings for both air and O gt BOC DISS female NIST Air Liquide SIS and Dr ger Operator s Manual 3 9 Installation Reference Covidien Accessories and Options p 9 4 for part numbers of gas hoses For countries outside the USA contact your local Covidien representa tive for the proper gas hoses 3 5 3 Filter Installation The ventilator is shipped with internal and external inspiratory filters Reference Covidien Accessories and Options p 9 4 for the part numbers of expiratory fil ters To prevent infection and contamination both inspiratory and expiratory filters must be used with the ventilator
263. er Volume The dry compressible volume in mL of the humidification chamber for the humidification type entered during SST Only applies if a humidifier is used 10 16 Safety Net While the ventilator is designed to be as safe and as reliable as possible Covi dien recognizes the potential for problems to arise during mechanical ventila tion either due to user error patient ventilator interactions or because of problems with the ventilator itself Safety Net is a broad term that includes strategies for handling problems that arise in the patient ventilator system patient problems as well as strategies to minimize the impact of system faults on patient safety In these scenarios The ventilator is designed to alarm and to Operator s Manual 10 71 Theory of Operations 10 72 10 16 1 provide the highest level of ventilation support possible in case of ventilator malfunction If the ventilator is not capable of ventilatory support it opens the patient circuit and allows the patient to breathe from room air if able to do so this emergency state is called Safety Valve Open SVO Safety mechanisms are designed to be verified periodically or to have redundancy The ventilator is designed to ensure that a single point failure does not cause a safety hazard or affect its ability to annunciate a high priority audible alarm User Error The ventilator is designed to prevent the operator from implementing settings that are clearly i
264. erator s Manual Ventilator Settings Guidance D 5 1 Specified performance Performance using PAV is 0 5 Joules liter J L compared to measured work during inspiration at the 75 support Supp level Work is computed over the entire inspiratory interval In ventilation terms work W is expressed as i kx P x V dt W il f V dt ith sample interval 5 ms V Flow L s W Work J L k conversion constant 0 098 J cmH 0 x L P Synchronous and combined pres sures developed by the ventilator and by the patient Pyus cmH 20 p 5 2 Graphics Displays in PAV When PAV is active the mode is SPONT and the spontaneous breath type is PAV a work of breathing WOB graphic is automatically displayed Refer ence Graphics displays in PAV p D 14 which shows e estimates of work of breathing relative to normal subnormal and above normal values including the estimated work of breathing in Joules L during inspiration WOBp7 and the estimated total work of breathing in Joules L of the patient and ventila tor during inspiration WOByo7 Operator s Manual D 11 PAV Appendix e an indicator showing the proportion of patient inspiratory work to overcome the elastance E of the lung thorax and the combined resistance R of the artificial airway and the patient Additional information in the graphics screen includes e a shadow trace of the estimated lung pressure shown as a solid area su
265. ergency state in which the ventilator opens the safety valve so the patient can breathe room air unassisted by the venti lator if able to do so An SVO state does not necessarily indicate a ven tilator inoperative condition The ventilator enters an SVO state if a hardware or software failure occurs that could compromise safe ventila tion with the loss of the air and oxygen supplies or if the system detects an occlusion A definition used by the ventilator s safety net System faults include hardware faults those that originate inside the ventilator and affect its performance soft faults faults momentarily introduced into the ventila tor that interfere with normal operation inadequate supply AC power or external gas pressure and patient circuit integrity blocked or discon nected circuit Apnea interval the operator set variable that defines the breath to breath interval which if exceeded causes the ventilator to declare apnea and enter apnea ventilation Breath time cycle during mechanical ventilation Expiratory time The expiratory interval of a breath Also the operator set timing variable that determines the expiratory period for pressure con trolled PC or VC mandatory breaths An alarm occurring due to a violation of any of the ventilator s self mon itoring conditions or detected by background checks Inspiratory time the inspiratory interval of a breath Also the operator set timing variable that determ
266. ermistor is damaged replace the exhalation valve flow sensor assembly Operator s Manual Service Personnel Preventive Maintenance 7 5 4 Exhalation Valve Flow Sensor Assembly Reassembly The following illustration shows the reprocessing kit Figure 7 12 Exhalation Valve Flow Sensor Assembly Reprocessing Kit 1 2 3 VEN_11391_A 1 Diaphragm 3 Expiratory filter seal 2 Pressure sensor filter 1 After drying the exhalation valve flow sensor assembly remove the pressure sensor filter from the reprocessing kit and install its large diameter into the filter grommet with a twisting motion until flush with the plastic valve body as shown The narrow end faces out Figure 7 13 Installing the Pressure Sensor Filter VEN_10295_A VEN_10294_A 2 Remove the expiratory filter seal from the kit and turn the assembly so its bottom is facing up 3 Install the seal into the recess with the flat side facing outward away from the recess Reference nstalling the Expiratory Filter Seal p 7 22 Operator s Manual 7 21 Preventive Maintenance Figure 7 14 Installing the Expiratory Filter Seal VEN_10296_A 1 Flat side of seal 4 Remove the diaphragm from the kit and install it The outer seal bead rests in the outer groove 7 22 Operator s Manual Service Personnel Preventive Maintenance Figure 7 15 Installing the Diaphragm VEN 10289 A VEN 10299 A 1 Diaphragm bead located in exhalation valve flow sensor asse
267. ers Figure F 8 Alarm Message Prox Inoperative PEEP tot Vre mano Sa a TE AD ab 0GS 3S VEN 11431 D 13 Ranges Resolutions and Accuracies Reference Patient Data Range and Resolution in Chapter 11 of this manual for Proximal exhaled tidal volume Proximal inspired tidal volume Proximal exhaled minute volume and Proximal flow patient data parameters F 13 1 Proximal Flow Sensor Specifications Table F 4 Proximal Flow Sensor Volume Accuracy Measurement Accuracy Exhaled tidal volume 1 0 mL 10 of reading Inspired tidal volume 1 0 mL 10 of reading 1 The conditions under which the accuracy values apply are as follows Sensor is used as described in this appendix and or the Instructions for Use provided with the sensor Operator s Manual F 17 Proximal Flow Option Appendix Table F 5 Proximal Flow Sensor Specifications Parameter Specification Weight 6 69 Dead space c1 mL Pressure drop 1 5 cmH20 at 10 L min r14 Part Numbers The table below lists the part numbers for the Proximal Flow Option Kit and individual components Table F 6 Proximal Flow Option Component Part Numbers Item Part Number Proximal Flow Option Kit 10084331 Includes Installation hardware and accessories Proximal Flow Sensor Neonatal package of 10 10047078 NOTE Includes 3 cable management clips Proximal Flow Sensor module 10087622 Intercon
268. ers Additional flow and pressure sensors are used in the mix module to control the breathing gas composition In addition gas temperature is measured for temperature compensation of flow readings Atmospheric pressure is measured in the inspiratory module and used for BTPS compensation The sensor signals are filtered using anti aliasing filters and sampled with A D converters Additional low pass filters precondition the signals the signals are then used for controls and display pur poses Closed loop control is used to maintain consistent pressure and flow wave forms in the face of changing patient system conditions This is accomplished by using the output as a feedback signal that is compared to the operator set input The difference between the two is used to drive the system toward the Operator s Manual 10 3 Theory of Operations desired output For example pressure control modes use airway pressure as the feedback signal to control gas flow from the ventilator Reference the figure below This diagram shows a schematic drawing of a general feedback control system The input is a reference value e g operator preset inspiratory pressure that is compared to the actual output value e g instantaneous value of airway pressure The difference between those two values is the error signal The error signal is passed to the controller e g the software control algorithm The controller converts the error signal into a signal that ca
269. es 10 cmH O L s End expiratory flow EEF End expiratory pressure PEEP The rate of expiratory flow occurring at the end of exha lation The pressure at the end of the expiratory phase of the previ ous breath also applies in BiLevel Range 0 to 150 L min Resolution 0 1 L min for values lt 20 L min 1 L min for values gt 20 L min Range 20 0 cmH 0 to 130 cmH 0 Resolution 0 5 cmH O between 10 0 and 10 0 cmH gt 0 1 cmH50 for values lt 10 cmH20 and 10 cmH70 End inspiratory pressure Pi END The pressure at the end of the inspiratory phase of the current breath also applies in BiLevel Range 20 0 cmH 0 to 130 cmH 0 Resolution 0 1 cmH 0 for 20 0 cmH70 to 9 9 cmH 20 1 0 cmH gt 0 for values 10 cmH50 to 130 cmH20 Exhaled mandatory tidal volume VE MAND The exhaled volume of the last mandatory breath When the mode is SPONT and no mandatory breaths have occurred for a time period gt 2 minutes the Vte manp indica tor is hidden Mandatory breaths can occur during SPONT mode via manual inspiration Range 0 mL to 6000 mL Resolution 0 1 mL for O mL to 9 9mL 1 mL for 10 mL to 6000 mL Operator s Manual Performance Specifications Table 11 11 Patient Data Range and Resolution Continued Data Value Exhaled minute volume VE ToT Description A calculated sum of the volumes exhaled by the patient for mandatory and spontaneous brea
270. ess telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the 980 Series Ventilator is used exceeds the applicable RF compliance level above the 980 Series Ventilator should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the ventilator 4 Over the frequency range 150 kHz to 80 MHz field strengths should be less than 10 V m Table 11 17 Recommended Separation Distances for RF The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled The customer or the operator of the ventilator can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the ventilator as recommended below according to the maximum output power of the communications equipment Rated 150 kHz to 80 150 kHz to 80 80MHz to 800 800 MHz to 2 5 maximum MHz outside of MHz inside of MHz GHz output power ISM bands ISM bands of transmitter W d 12JP d 234P d 3 5 P d 124P 0 01 0 35 1 2 0 12 0 23 0 1 1 1 3 8 0 38 0 73 1 3 5 12 1 2 2 3 1
271. essessscsssssscscsssssecsscssccssssscsssssecsnceneensess C 6 Figure D 1 Ventilator Setup Screen ou ml lana nngannansnnaaawsawaanananaanasassassansanasasaanasnasa D 6 Figure D 2 Graphics displays in PAV esssssssssssccssesseccnecssecssccsseeseecsesseesueesseens D 14 Figure D 3 Use of Default Lung Resistance s sssessssssssseecseessssssssseoscessessnsssesse D 23 Figure E 1 Installing Neonatal Filter and Door uu ecesssssessssssessssseesssssessnceneessees E 4 Figure E 2 How to Connect the Breathing Circuit sesssssseeessesessssssseoseessssssssseese E 7 Figure E 32 CPAP Setup Streel acdeccssseccascccsscceassvastorecseivesansteesuvectancenstssrugcvcuccvcbnuecnece E 10 Figure F 1 Proximal Flow Sensor esssssssssessssssessscssssssssscsssssesssccscesscsecsesssessncencensess F 6 Figure F 2 Sample GUI screen Showing Proximal Flow Data ssesseseeee F 7 Figure F 3 Message During Autozero and Purge Processes ul JJ F 9 Figure F 4 Attaching Proximal Flow Sensor to Ventilator csesssesssseseeees F 11 Figure F 5 Enabling disabling Proximal Flow Sensor sssssscssessseeseecssceneese F 13 Figure F 6 Attaching Proximal Flow Sensor sssssssssssssessnsssessscscsssssecsnseneenes F 14 Figure F 7 Manual Purge a scumdinaiiianncindinensiinosasnncmiamabariiones F 16 Figure F 8 Alarm Message Prox Inoperative ssessssseeeseesssssssscocsessssssssseseee F 17 xix XX Page Left Intentionally Blank 1
272. ests complete review test results by pressing each individual test listed on the left side of the GUI 17 Touch EXIT EST 18 Touch ACCEPT The ventilator reruns POST and then displays the ventilator startup screen Table 3 7 EST Test Sequence EST Test Step Function Required User Interaction Zero Offset Tests inspiratory and expiratory pressure transducers Follow prompts and flow sensors at ambient pressure Operator s Manual 3 55 Installation 3 56 EST Test Step Function Leak Test Table 3 7 EST Test Sequence Continued Dete rmines ability of system to hold pressure Required User Interaction Follow prompts Mix Leak Verif ies integrity of the mix system Follow prompts Mix PSOL Mix Accumulator Verif Verif ies mix PSOL function ies mix accumulator pressure sensor and over pressure switch function None None Circuit Pressure Checks inspiratory and expiratory autozero sole noids Cross checks safety valve inspiratory and expira tory pressure transducers at various pressures Verify the autozero solenoid s function None Flow Sensor Cross Check Test Verif ies all flow sensors and PSOLs at specified flow volumes Delivery PSOL Verif ies delivery PSOL current function Exhalation Valve EV Loopback Verif ies exhalation valve current and loopback current are within range Exhalation Valve EV Pre
273. et PAV ry volume gt inspira imit tory limit Ventilator transitions to exha Medium Last 3 spont i lation Possible breaths 2 set 9 dependent alarms Na VTE spont VE TOT High Last 4 or more ror spont breaths gt set limit Corrective action Check for leaks Check for the correct tube type Check the Vy or Vy setting In PAV check for patient agitation which can cause miscalcu lation of Rpay and Cpay Consider reducing Supp setting Check TV We Tot patient Low Vetor lt setlimit Check patient amp Total minute data alarm for lt 30s settings volume lt set limit Alarm updated Medium Ve Tot lt set limit whenever exhaled for gt 30s minute volume is 3 recalculated Possi High Ve tor lt set limit ble dependent for gt 120s alarms4Vv7p MAND Wyre spont Tor Operator s Manual 6 27 Performance Table 6 5 Non technical Alarm Summary Continued Analysis Remedy Comments message message VOLUME NOT Low Last 2 spont or Check patient and Insp target pressure DELIVERED not mand breaths setting for TPprax gt Pprak PEEP 3 adjustable pressure gt max cmH30 when os data allowable level spontaneous type is alarm Medium Last 10 or more or Mie spont or mand nag PANDAY paa a breaths pres ator oe ae sure gt max Ki ata oe allowable level Secs alarms For VC breaths JVE MAND WE TOT Mror For VS breaths 4Vre spont YVE T
274. etting is maintained as long as the patient inspires and patient demand determines the flow rate Changes to the Psypp setting are phased in at the start of inspiration The pressure support setting affects only spontaneous breaths The sum of PEEP Pcypp 2 cmH gt O cannot exceed the TPpgak limit To increase the sum of pressures first raise the TPpgak limit before increasing the settings for PEEP or Pcypp Since the TPpr ag limit is the highest pressure considered safe for the patient a Psypp setting that would cause a TPpr a alarm requires re evaluating the maximum safe circuit pressure 10 15 23 Volume Support Vr SUPP Volume support V7 supp is defined as the volume of gas delivered to the patient during spontaneous VS breaths Changes to the to the V supp setting are phased in at the start of inspiration 10 15 24 Supp in TC In TC the Supp setting represents the amount of the imposed resistance of the artificial airway the TC breath type will eliminate by applying added pres sure at the patient circuit wye For example if the Supp setting is 100 TC eliminates 100 of the extra work imposed the by the airway At 50 TC eliminates 50 of the added work from the airway TC is also used with BiLev el and is available during both Py and P phases 10 15 25 Supp in PAV In PAV the Supp setting represents the percentage of the total work of breathing provided WOB by the ventilator Higher inspiratory demand yield
275. ettings specified by the operator Delivered tidal volumes are corrected to standard respiratory conditions BTPS to ensure consistent interpretation by the clinician The Inspiratory Module also incorporates the Safety Valve which opens to vent excess pressure and allows the patient to breathe room air if able to do so in the event of a serous mal function Breathing gas exits the Inspiratory Module passes through an internal bacteria filter leaving the ventilator via the To Patient port The ventilator breathing cir cuit including the external bacteria filter and humidification means carries the breathing gas to the patient Exhaled gas leaves the expiratory limb of the breathing circuit through the From Patient port The gas is conducted through a condensate vial the expi ratory bacteria filter and the exhalation valve assembly EVQ which includes a pressure sensing port a flow sensor and the exhaust port The gas then flows through the exhalation valve which actively controls PEEP while minimizing pressure overshoot and relieving excess pressures Pressure transducers in the inspiratory pneumatic system PI and exhalation compartment PE monitor pressures for accurately controlling breath delivery Operator s Manual Short Self Test SST 1 2 Theoretical Principles This theory of operations is described mainly from a clinical standpoint discuss ing how the ventilator responds to various patient inputs but also inclu
276. f and not connected to AC power check the charge level by pressing the charge level button on the battery and verifying the charge level LEDs illuminate Reference Proper Battery Orientation p 3 20 for the location of the charge level button Five green LED segments illuminate indicating gt 90 battery capacity From bottom to top the first LED indicates gt 10 capacity the second LED indicates gt Operator s Manual 3 19 Installation 25 capacity the third LED indicates gt 50 capacity and the fourth LED indi cates gt 75 capacity An illuminated red LED at the top of the battery indicates a battery fault If no LEDs illuminate it means there is lt 10 battery capacity remaining 2 If the charge level is sufficient orient the battery as shown Reference Proper Battery Orientation p 3 20 face the front of the ventilator and locate the battery compartments on the right side of the BDU Reference Battery Compartment Locations p 3 21 The receptacle towards the rear of the ventilator houses the primary battery while the receptacle towards the front of the ventilator houses the extended battery 3 The primary battery is fastened in place with a thumbscrew item 3 Loosen the thumbscrew approximately four to five turns to allow battery installation 4 Insert the battery and push into its receptacle all the way until it clicks indicating it is latched The battery will only fit into the slot one way Figure 3 10 Pr
277. f setting unlike A C mode in which f7o7 is always greater than or equal to the f setting If the patient triggers a breath at the beginning of a breath period then does not trigger another breath until the maximum mandatory interval for the following breath has elapsed a monitored respiratory rate less than the respiratory rate setting can result If a spontaneous breath occurs toward the end of the spontaneous interval inspiration or exhalation can still be in progress when the SIMV interval ends No VIM PIM or OIM is allowed during the restricted phase of exhalation In the extreme one or more expected mandatory breaths could be omitted When the expiratory phase of the spontaneous breath ends the ventilator reverts to its normal criteria for delivering mandatory breaths If an OIM is detected during the mandatory interval the ventilator delivers the currently specified mandatory breath then closes Tm and transitions to T If an OIM is detected during the spontaneous interval the ventilator delivers the currently specified mandatory breath but the SIMV cycle timing does not restart if OIM breaths are delivered during T 10 10 1 Changing to SIMV Mode Switching the ventilator to SIMV from any other mode causes the ventilator to phase in a VIM and set the start time for the next SIMV period Following this VIM but before the next SIMV period begins the ventilator responds to successful patient inspiratory efforts by delivering spon
278. f the operator changes to SPONT mode during an A C or SIMV inspiration mandatory or spontaneous the inspiration is completed unaffected by the mode change Because SPONT mode has no special breath timing require Operator s Manual Short Self Test SST ments the ventilator then enters the exhalation phase and waits for the detec tion of patient inspiratory effort a manual inspiration or apnea detection 1012 Apnea Ventilation When a patient stops breathing or is no longer being ventilated it is called apnea When apnea is detected by the ventilator the ventilator alarms and delivers apnea ventilation according to the current apnea ventilation settings 10 12 1 Apnea Detection The ventilator declares apnea when no breath has been delivered by the time the operator selected apnea interval elapses plus a small increment of time 350 ms This increment allows time for a patient who has begun to initiate a breath to trigger inspiration and prevent the ventilator from declaring apnea when the apnea interval is equal to the breath period The apnea timer resets whenever an inspiration begins regardless of whether the inspiration is patient triggered ventilator triggered or operator initiated The ventilator then sets a new apnea interval beginning from the start of the current inspiration To hold off apnea ventilation another inspiration must be delivered before the current apnea interval 350 ms elapses Apnea detec tion i
279. feature WARNING Prior to patient ventilation select the proper tube type and tube ID To use Quick Start 1 Touch New Patient 2 Touch the highlighted PBW button or Gender Height 3 Turn the knob to adjust the patient s PBW or gender and height if gender is selected the height selection becomes available 4 Touch Quick Start 5 Connect the circuit wye adapter to the patient s airway or interface connection The patient is ventilated with the institutionally configured or factory configured QUICK START defaults according to the PBW or gender height entered and circuit type used during SST There is no prompt to review the settings and the wave forms display appears Note Connecting the circuit wye adapter to the patient s airway or interface connection prior to making the ventilation settings causes the ventilator to begin ventilation using Safety Pressure Control Ventilation Safety PCV and annunciate a PROCEDURE ERROR alarm As soon as the ventilator receives confirmation of its settings by touching Accept or Accept ALL it transitions out of safety PCV resets the alarm and delivers the chosen settings Reference Safety PCV Settings p 10 72 for a listing of Operator s Manual Ventilator Shutdown these settings To resume ventilating the same patient 1 Touch Same Patient on the GUI screen The previous ventilator settings are dis played on the screen for review prior to applying the settings to
280. for values lt 1 100 Displayed as XX 1 when I E gt 1 dis played as 1 XX when I E lt 1 Inspiratory pressure P The pressure above PEEP at which gas is delivered to the patient during manda tory PC breaths Range 5 cmH 0 to 90 cmH20 Resolution 1 cmH 0 11 Specifications 12 Table 11 9 Ventilator Settings Range and Resolution Continued Setting Inspiratory time T Description The time during which an inspiration is delivered to the patient during manda tory PC or VC breaths Range and Resolution Range 0 2 s to 8 s for mandatory PC and VC breaths Tp 0 2 sto 8 sin VC Resolution 0 01 s for PC or VC breaths 0 02 s for VC breaths Leak Sync leak compen sation Compensates for leaks during INVASIVE or non invasive NIV ventilation Range Enabled or Disabled Mandatory type The type of mandatory breath delivered in A C SPONT or SIMV modes SPONT mode allows man datory type selection for operator initiated manda tory OIM breaths Range PC VC VC mL kg ratio The default tidal volume PBW ratio only adjustable in Service Mode Range 5 0 mL kg to 10 mL kg Resolution 0 5 mL kg Operator s Manual Performance Specifications Table 11 9 Ventilator Settings Range and Resolution Continued Setting Mode Description The ventilation mode The mode determines the allowable breath types A C assist
281. ft bound SPONT spontaneous type SST The time period during the exhalation phase where an inspiration trigger is not allowed The restricted phase of exhalation is defined as the first 200 ms of exhalation OR the time it takes for expiratory flow to drop to lt 50 of the peak expiratory flow OR the time it takes for the expiratory flow to drop to lt 0 5 L min whichever is longest The restricted phase of exhalation will end after five 5 seconds of exhalation have elapsed regardless of the measured expiratory flow rate A setting that determines the rise time to achieve the set inspiratory pres sure in pressure controlled PC VC BiLevel or pressure supported PS breaths The larger the value the more rapid the rise of pressure The ventilator s strategy for responding to patient problems and system faults A valve residing in the ventilator s inspiratory module designed to limit pressure in the patient circuit When open it allows the patient to breathe room air if able to do so A mode of ventilation active if the patient circuit is connected before ven tilator startup is complete or when power is restored after a loss of five 5 minutes or more A ventilator mode providing a set of services tailored to the needs of testing and maintenance personnel When in the service mode the ven tilator does not provide ventilation Synchronous intermittent mandatory ventilation A ventilatory mode in which the venti
282. ge O cmH gt 0 to 45 cmH 0O Resolution 0 5 cmH20 from 0 0 to 19 5 cmH 0 1 cmH gt 0 from 20 to 45 cmH50 Operator s Manual 13 Specifications 14 Table 11 9 Ventilator Settings Range and Resolution Continued Setting Description Range and Resolution Py The positive pressure Range 5 cmH 0 to 90 cmH 0 during the insufflation Resolution 1 cmH 0 phase in BiLevel ventila tion PL The positive pressure in Range O cmH20 to 45 cmH20 Plateau time Tp Predicted Body Weight PBW the patient circuit during the expiratory phase of BiLevel ventilation The amount of time inspi ration is held in the patient s lungs after inspi ratory flow ceases for volume based mandatory breaths Considered part of inspiratory phase for I E ratio calculations Indicates an approxima tion of the patient s ideal body weight based upon their gender and height or length for neonatal patients PBW determines default limits and limits for breath deliv ery parameters Resolution 0 5 cmH20 from 0 0 to 19 5 cmH30 1 cmH 0 from 20 to 45 cmH20 Range 0s to 2 s Resolution 0 1 s Range NEONATAL 0 3kg 0 66 Ib to 7 0 kg 15 Ib when NeoMode 2 0 option is installed PEDIATRIC 3 5 kg 7 7 Ib to 35 kg 77 Ib ADULT gt 25 kg 55 12 Ib Resolution 0 01 kg for weights lt 1 kg 0 1 kg for weights gt 1 kg and lt 10 kg 1 kg for weights gt 10 kg Pressure sensitivity Psens For pressure tr
283. gs 6 6 10 Proximal Inspired Tidal Volume Vrjy The inspired tidal volume for a mandatory or spontaneous breath measured by the Proximal Flow Sensor for neonatal patients only Vry is updated at the beginning of the following expiratory phase and is displayed when data are available 6 6 11 Delivered mL kg Volume The delivered gas volume in mL kg PBW 6 6 12 LE Ratio The ratio of inspiratory time to expiratory time for the previous breath regard less of breath type Updated at the beginning of the next inspiration When I E ratio is gt 1 1 it is displayed as XX 1 Otherwise it is displayed as 1 XX o LAP Note Due to limitations in setting the I E ratio in PC ventilation the monitored data display may not exactly match the I E ratio setting 6 6 13 Mean Circuit Pressure Pmean The average circuit pressure for a complete breath period including both inspi ratory and expiratory phases whether mandatory or spontaneous The dis played value can be either positive or negative 6 6 14 Peak Circuit Pressure Pprax The maximum circuit pressure at the patient wye during the previous breath including both inspiratory and expiratory phases 6 6 15 End Inspiratory Pressure P enp The pressure at the end of the inspiratory phase of the current breath Operator s Manual 6 45 Performance 6 6 16 End Expiratory Pressure PEEP The pressure at the end of the expiratory phase of the previous breath updated at t
284. gs volume gt set limit Alarm updated Medium Vt tor set limit whenever an for gt 30s exhaled minute volume is recalcu High Ve tor 2 set limit lated Possible for gt 120s dependent alarm Tfrot patient Low fror set limit Check patient amp Total respiratory data alarm for lt 30s settings rate gt set limit Alarm updated at Medium fror 2 set limit the beginning of for gt 30s each inspiration Reset when mea High fror 2 set limit sured respiratory for gt 120s rate falls below the alarm limit Possible dependent alarms JVE MAND We spont YVE ToT Operator s Manual Table 6 5 Non technical Alarm Summary Continued TP VENT patient data alarm INOPERATIVE BATTERY Low Analysis message 1 breath gt limit Medium 2 breaths limit High Low 3 or more breaths gt limit Inadequate charge or non functional venti lator s primary battery Remedy message Check patient circuit amp ET tube Service replace ventilator s primary battery Ventilator Settings Comments Inspiratory pressure gt 100 cmH30 and mandatory type is VC or spontaneous type is TC or PAV Ventilator trun cates current breath unless already in exhalation Possible dependent alarms WTE MAND We tor tror Corrective action 1 Check patient for agitation Agitated breathing combined with high Supp setting in PAV can cause over a
285. h Accept ALL to confirm the alarm settings Note There is an additional alarm setting for TC PAV VS and VC breath types High inspired tidal volume TV This alarm condition occurs when the inspired tidal volume is larger than the setting value A TV7 alarm will also cause breath delivery to transition to the exhalation phase to avoid delivery of excessive inspiratory volumes WARNING Prior to initiating ventilation and whenever ventilator settings are changed ensure the alarm settings are appropriate for the patient Operator s Manual Operation 4 18 WARNING Setting any alarm limits to OFF or extreme high or low values can cause the associated alarm not to activate during ventilation which reduces its efficacy for monitoring the patient and alerting the clinician to situations that may require intervention Reference To adjust alarm volume p 3 41 to ensure alarm volume is adjusted properly Note A sample alarm tone sounds for verification at each volume level change Re adjust the alarm volume by moving the alarm volume slider to increase or decrease the alarm volume Note Do not block the patient wye while the ventilator is waiting for a patient connection Otherwise the blockage could imitate a patient connection 4 5 4 Alarm Screen During Operation During ventilator operation the alarm screen appears with indicators to let the operator know the current patient data value for each parameter item 1 the
286. h small pulses as the ventilator delivers trial pressure based breaths Press the alarm reset key to reset all the alarms AC POWER LOSS alarm test 1 Allow the ventilator to deliver at least four breaths then disconnect the power cord from AC facility power If any battery is charged the GUI annunciates an AC POWER LOSS alarm If less than ten minutes of battery backup are available the GUI annunciates a LOW BATTERY alarm If no battery power is available the BDU annunciates a LOSS OF POWER alarm Connect the power cord to AC facility power The AC POWER LOSS or LOW BATTERY alarm autoresets APNEA alarm test i Make the following alarm settings changes TPPEAK 70 cmH20 Mode SPONT Spontaneous type PS Note To avoid triggering a breath during the apnea interval do not touch the test lung or patient circuit Note For the apnea alarm test the exhaled tidal volume V7 displayed in the patient data area must be greater than half the delivered volume shown on the volume time plot in the graphics display in order for apnea to autoreset Reference Apnea Ventilation p 10 41 for a technical description of apnea ventilation The GUI annunciates an APNEA alarm within 10 s after touching Accept Operator s Manual 3 4 Ventilator Settings Squeeze the test lung twice to simulate two subsequent patient initiated breaths The APNEA alarm autoresets Let the ventilator return to apnea ventilation LOW
287. hange in target pressure PBW gt 25 kg 15 lt PBW lt 25 kg 10 0 cmH 0 6 0 cmH70 PBW lt 15 kg Less than five breaths after VC startup or Change in V7 3 0 cmH 20 Five breaths or more after VC startup 3 0 cmH20 3 0 cmH20 3 0 cmH20 Reference Non technical Alarm Summary p 6 18 for details on the following VC alarms e VOLUME NOT DELIVERED e HIGH INSPIRED TIDAL VOLUME 1V7 e LOW CIRCUIT PRESSURE 1Pp ap e COMPLIANCE LIMITED V7 During VC inspiratory target pressure cannot be lower than PEEP 3 cmH3O and cannot exceed Pprag 3 cmH50 10 7 4 Rise time 26 If PC or VC is selected as the Mandatory type adjust rise time Yo for optimum flow delivery into the lungs Patients with high impedance low compliance high resistance may benefit from a lower rise time whereas patients with low impedance may better tolerate a more aggressive rise time setting The rise time Yo setting specifies the speed at which the inspiratory pressure reaches Operator s Manual 10 21 Theory of Operations 95 of the target pressure The rise time setting applies to PS including a setting of O cmH 0 PC or VC breaths To match the flow demand of an actively breathing patient observe simultaneous pressure time and flow time curves and adjust the rise time to maintain a smooth rise of pressure to the target value A rise time setting reaching the target value well before the end of
288. harge is inade quate after 6 hours of attempt ed charge time or the battery system is non functional Replace the battery or install an extended battery Operator s Manual 6 31 Performance 6 32 Table 6 6 Non Technical Alarms and Suggested Responses Continued Alarm message INSPIRATION TOO LONG patient data alarm Meaning The PBW based inspiratory time for the last two spontaneous breath exceeds the ventilator set limit Active only when Vent Type is INVASIVE Response e Check the patient e Check the patient circuit for leaks e Check Rise time and Esens settings LOSS OF POWER The ventilator power switch is ON but there is insufficient power from the mains AC and the battery There may not be a visual indicator for this alarm but an independent audio alarm immediate priority sounds for at least 120 sec onds e Check the integrity of the AC power and battery connections e Obtain alternative ventila tion if necessary e Install an extended battery If the loss of power event has been resolved turn the power switch OFF and back ON again to reset the alarm LOW BATTERY Medium priority alarm indicat ing lt ten 10 minutes of battery power remaining to operate the ventilator High priority alarm indicating lt five 5 minutes of battery power remain to operate the ventilator Recharge the battery by plug ging the ventilator into AC power
289. hat if the pressure applied to the lung thorax is never greater than Ej true x V lung volume will collapse if wye flow vanishes As long as Epay estimated lt Ej true V estimated lt V true and Rpay estimated lt Ri true Pmus is the modulator of P wye Hyperinflation could occur if the estimated Epa were greater than the true value of Ej At a high Supp setting P elastic could exceed Phe pede causing a self generating flow at the patient wye which in turn would cause a self generating inflation of the lungs This is part of the reason that the Supp setting is limited to 95 Likewise if the estimated Rpay were to exceed the true value of R at a high Supp setting P wye resistive could exceed the value necessary to compen sate for pressure dissipation across the artificial and patient airways resulting in early hyperinflation of the lungs As flow declines after the first third of inspi ration however the hyperinflating effect would most likely disappear Operator s Manual Ventilator Settings Guidance PAV software includes these strategies to minimize the possibility of hyperin flation of the lungs 1 Operator s Manual The maximum Supp setting is limited to 95 The raw data for Rpay and Cpay are checked for graph math logic and estimated mechanics values are checked against PBW based physiologic boundaries These checks reduce the possibility of overestimating patient res
290. he beginning of the next inspiration During an expiratory pause the displayed value includes any active lung PEEP 6 6 17 Intrinsic PEEP PEEP PEEP is an estimate of the pressure above the PEEP level at the end of an exha lation PEEP is determined during an Expiratory Pause maneuver 6 6 18 PAV based Intrinsic PEEP PEEP pay PEEP is an estimate of intrinsic PEEP updated at the end of a spontaneous PAV breath 6 6 19 Total PEEP PEEP7o7 PEEPy 97 is the estimated pressure at the circuit wye during the Expiratory Pause maneuver 6 6 20 Plateau Pressure Pp Pp is the pressure measured and displayed during an Inspiratory Pause maneu ver 6 6 21 Total Respiratory Rate ftot The total number of mandatory and spontaneous breaths per minute delivered to the patient 6 6 22 PAV based Lung Compliance Cpay For a PAV breath Cpay is the change in pulmonary volume for an applied change in patient airway pressure measured under zero flow conditions and 6 46 Operator s Manual Ventilator Settings updated upon successful completion of each calculation Cpay is displayed on the waveform screen 6 6 23 PAV based Patient Resistance Rpay For a PAV breath Rpay is the change in pulmonary pressure for an applied change in patient lung flow and updated upon successful completion of each calculation Rpay is displayed on the waveform screen 6 6 24 PAV based Lung Elastance Epay For a PAV breath Epay is t
291. he bracket clamp to the bracket with four 4 5 32 inch hex screws capturing the railing between the bracket and the clamp Ensure the humidifier mounting slots are facing outward from the ventilator Operator s Manual 3 27 Installation Figure 3 13 Bracket Installation on Rail VEN_11221_B To install the humidifier 1 Slide the rear of the humidifier into the corresponding slot on the humidifier bracket until it is fully seated Reference Humidifier Installation to Ventilator p 3 29 Some humidifiers slide into the narrow slot in the humidifier bracket and some humidifiers use the wide slot Operator s Manual Product Connectivity Figure 3 14 Humidifier Installation to Ventilator VEN 11220 B 2 Fill the humidifier with water to the desired fill volume 3 Install the chamber to the humidifier connect the patient circuit then run SST Operator s Manual 3 29 Installation 3 3 7 3 7 N N 4 Plug the humidifier into a grounded hospital grade electrical outlet 5 Turn the humidifier on Note Complete instructions for the humidifier bracket and humidifier installation are given in the Puritan Bennett 980 Series VentilatorHumidifier Bracket Installation Instructions which includes humidifier bracket part numbers and descriptions Ventilator Operating Modes Normal Mode Normal mode is the default mode used for patient ventilation The ventilator enters N
292. he breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs WARNING Avoid nuisance alarms by applying appropriate alarm settings WARNING To prevent inappropriate ventilation select the correct Tube Type ET or Tracheostomy and tube inner diameter ID for the patient s ventilatory needs Inappropriate ventilatory support leading to over or under ventilation could result if an ET tube or trach tube setting larger or smaller than the actual value is entered WARNING Setting expiratory volume alarms to OFF increases the risk of not detecting a low returned volume WARNING Setting any alarm limits to OFF or extreme high or low values can cause the associated alarm not to activate during ventilation which reduces its efficacy for monitoring the patient and alerting the clinician to situations that may require intervention 1 3 8 Warnings Regarding Hoses Tubing and Accessories WARNING To prevent electrostatic discharge ESD and potential fire hazard do not use antistatic or electrically conductive hoses or tubing in or near the ventilator breathing system Operator s Manual 1 9 Introduction gt gt WARNING Adding accessories to the ventilator can change the pressure gradient across the ventilator breathing system VBS and affect ventilator performance Ensure that any
293. he condensate vial Replace the condensate vial by carefully sliding the vial into position lifting it upward to the filter assembly and turning counterclockwise until it reaches the stop Note Condensate vial removal may cause the loss of system pressure and a disconnect alarm es Connecting the Breathing Circuit WARNING Use one of the ventilator breathing circuits listed Reference Recommended Breathing Circuits p E 8 or their equivalent This ensures that maximum pressure flow values specified by EN794 1 are not exceeded Using a circuit with a higher resistance does not prevent ventilation but can cause an SST fault or compromise the patient s ability to breathe through the circuit Reference How to Connect the Breathing Circuit p E 7 to connect the breath ing circuit E 6 Operator s Manual Ventilation Features Figure E 2 How to Connect the Breathing Circuit 9 Jj a D 1 Humidifier 2 Patient circuit inspiratory limb 3 Patient circuit wye 4 Patient circuit expiratory limb 5 Condensate vial Operator s Manual DO 9 oO maamuum yy Dy 3 2 1 VEN 11169 A From Patient port Neonatal expiratory filter installed in adapter door To Patient port Inspiratory filter E 7 NeoMode 2 0 Appendix E 8 Table E 2 Recommended Breathing Circuits Patient Circuit Part number Ventilator breathing circuit Neonatal disposable 3078447 DAR not available in USA
294. he follow ing alarms TPpEAK alarm TPVENT alarm e Vy The following Respiratory Mechanics maneuvers are not available in BiLevel ventilation e Occlusion Pressure e NIF Negative Inspiratory Force e VC Vital Capacity Inspiratory Pause Note Inspiratory pause and expiratory pause maneuvers can be performed directly by pressing the respective keys on the GUI or by swiping the Menu tab on the left side of the GUI For more information on how to perform Respiratory Mechanics Maneuvers from the Menu tab Reference Respiratory Mechanics Maneuvers p 4 28 An inspiratory pause extends the inspiratory phase of a single mandatory breath for the purpose of measuring end inspiratory circuit pressure which is used to calculate static compliance of the patient s lungs and thorax Cstaq Operator s Manual Short Self Test SST static resistance of the respiratory system Rsrar and inspiratory plateau pres sure Pp To calculate these pressures the inspiratory and exhalation valves are closed allowing pressures on both sides of the artificial airway to equalize revealing the actual lung inflation pressure during a no flow condition An inspiratory pause can be either automatically or manually administered and is only available during the next mandatory breath in A C SIMV BiLevel or SPONT modes In BiLevel an inspiratory pause maneuver is scheduled for the next inspiration prior to a transition from Py to P Only one
295. he inverse of Cpay and is updated upon successful completion of each calculation 6 6 25 Spontaneous Rapid Shallow Breathing Index f V7 An indication of the patient s ability to breathe spontaneously High values generally mean the patient is breathing rapidly but with low tidal volumes Low values generally indicate the inverse 6 6 26 Spontaneous Inspiratory Time Ratio T Tyo7 In SPONT mode the percentage of a spontaneous breath consumed by the inspiratory phase Updated at the successful completion of a spontaneous breath 6 6 27 Spontaneous Inspiratory Time Ti spon The duration of the inspiratory phase of a spontaneous breath and updated at the end of each spontaneous breath Tj spony is only calculated when the breathing mode allows spontaneous breaths and the breaths are patient initi ated 6 6 28 PAV based Total Airway Resistance R707 For a PAV breath Rroz is the change in pulmonary pressure for an applied change in total airway flow and updated upon the successful completion of Operator s Manual 6 47 Performance each calculation If the Rpay value appears in parentheses as described at the beginning of this section the Rro7 value also appears in parentheses 6 6 29 Static Compliance Cstar and Static Resistance Roza Cstat Is an estimate of the elasticity of the patient s lungs expressed in mL cmH50 It is computed during a mandatory breath Rsrar is the total inspiratory resistance across the a
296. he mode is A C or SIMV and VC is the breath type specifying Vmax and flow pattern determines Tj Te and I E In PC breaths specifying T auto Operator s Manual 10 61 Theory of Operations matically determines the other timing variables Reference Inspiratory Time T p 10 65 for an explanation of the interdependencies of f Tj Te and KE Changes to the f setting are phased in at the start of inspiration The ventilator does not accept a proposed f setting if it would cause the new T or Te to be less than 0 2 second the T to be greater than eight 8 s or I E ratio greater than 4 00 1 The ventilator also applies these restrictions to a pro posed change to the apnea respiratory rate except that apnea I E cannot exceed 1 00 1 An exception to this rule occurs in BiLevel ventilation where the proposed f setting will allow the I E ratio to be greater than 4 00 1 only until the minimum T is reached 10 15 6 Tidal Volume V7 The V setting determines the volume of gas delivered to the patient during a VC mandatory breath The delivered V is compensated for BTPS and patient circuit compliance Changes to the Vy setting are phased in at the start of inspi ration The V7 setting only affects the delivery of mandatory breaths When proposing a change to the V setting the ventilator compares the new value with the settings for f Vmax flow pattern and Tp If the proposed setting would result in an I E ratio that exceeds 4 00 1 o
297. he right side of the screen to allow or prevent operator adjustment of the screen opacity 5 Touch Accept to close the dialog To adjust the screen opacity 1 Touch the opacity control icon The icon glows when the opacity can be changed 2 Turn the knob to increase or decrease the opacity Note The opacity icon can be found on the vent setup screen and on any of the respiratory mechanics maneuvers screens 39 Installation Testing Fully charge the batteries before placing the ventilator into clinical use Refer ence Battery Charging p 3 4 for information on battery charging Reference p 3 19 for the meaning of battery charge status LEDs and Reference p 3 20 for the location of battery test switch and status LEDs Prior to connecting a patient to the ventilator for the first time a qualified service technician must have calibrated the ventilator s exhalation valve flow sensors and atmospheric pressure transducer and performed and successfully passed EST Reference the Puritan Bennett 980 Ventilator Service Manual for instructions In addition the clinician must also perform SST 3 9 1 SST Short Self Test WARNING Always disconnect the patient from the ventilator prior to running SST or EST If SST or EST is performed while a patient is connected patient injury may occur A WARNING Check for circuit occlusion and or run SST if increased pressures are observed during ventilation Operator s Manual
298. he setting The ventilator automatically adjusts the TO alarm limit when O changes due to 100 O apnea ventilation occlusion circuit disconnect or a NO AIR Operator s Manual 6 37 Performance O gt SUPPLY alarm The ventilator checks the TO3 alarm limit against the mea sured oxygen percentage at one second intervals 6 5 16 High Exhaled Minute Volume Tvg rot Alarm The Tvg tor alarm indicates the measured exhaled total minute volume for spontaneous and mandatory breaths is equal to or greater than the alarm set ting The Tvg tor alarm is effective immediately upon changing the setting to ensure prompt notification of prolonged high tidal volumes The Ng tot alarm can be used to detect a change in a patient s breathing pat tern or a change in compliance or resistance The Tvg tor alarm can also detect too large tidal volumes which could lead to hyperventilation and hypocarbia 6 5 17 High Exhaled Tidal Volume TV7 Alarm The 1V5g alarm indicates the measured exhaled tidal volume for spontaneous and mandatory breaths is equal to or greater than the set TVy alarm The TV7 alarm is updated whenever a new measured value is available The TVy alarm can detect increased exhaled tidal volume due to greater com pliance and lower resistance and prevent hyperventilation during pressure control ventilation or pressure support Turn the TV alarm OFF to avoid nui sance alarms Hyperventilation due to increased complian
299. he target inspiratory pressure to fall below PEEP 3 cmH 0O attempting to set the 4Pprax alarm limit at or below this level will turn the alarm off In VC whenever PEEP is changed 4Ppgak is set automatically to its New Patient value PEEP 4 cmH 0 when PEEP 16 cmH 20 or PEEP 3 5 cmH30 when PEEP lt 16 cmH50 There are no alarms dependent upon 4Ppgag and the JPpz ag alarm does not depend on other alarms 6 5 22 Low Delivered 05 40 96 Alarm The 405 alarm indicates the measured O2 during any phase of a breath is at or below the error percentage below the 05 setting or less than or equal to 18 for at least 30 seconds Although the ventilator automatically sets the 405 alarm replace if necessary or disable the oxygen sensor to avoid nui sance alarms The error percentage is 12 below setting for the first hour of ventilator operation following a reset 7 below setting after the first hour of operation and an additional 5 below setting for the first four minutes fol lowing an increase in the setting The ventilator automatically adjusts the 402 alarm limit when O2 changes due to apnea ventilation circuit disconnect or a NO O AIR SUPPLY alarm The 405 alarm is disabled during a safety valve open SVO condition The venti lator checks the 402 alarm against the measured oxygen percentage at one second intervals The 405 alarm can detect malfunctions in ventilator gas delivery or the oxygen monitor a
300. he test that failed the ventila tor will either ventilate with current settings ventilate with modified settings or enter the Vent Inop state A technical fault cannot be cleared by pressing the alarm reset key It can only be cleared by correcting the fault that caused it or if alarm reset criteria have been met 4 11 3 SST In addition to characterizing the ventilator breathing circuit SST performs basic checks on the ventilator s pneumatic system including the breath delivery Operator s Manual 4 35 Operation 4 11 4 4 11 5 4 11 6 PSOL the Flow Sensors and the Exhalation Valve Faults detected during SST must be corrected before ventilation can be started Procedure Error A procedure error occurs when the ventilator senses a patient connection before ventilator setup is complete The ventilator provides ventilatory support using default Safety Pressure Controlled Ventilation Safety PCV settings Ref erence Safety PCV Settings p 10 72 Ventilation Assurance During ventilation the ventilator performs frequent background checks of its breath delivery sub system Reference Safety Net p 10 71 In the event that certain critical components in the pneumatics fail Ventilation Assurance pro vides for continued ventilatory support using one of three Backup Ventilation BUV strategies bypassing the fault to maintain the highest degree of ventila tion that can be safely delivered Reference Background Diagnostic System
301. hin two 2 minutes 6 Set the O2 to 21 7 Observe the GUI screen The delivered O2 display should increase and the ven tilator should annunciate a a medium priority TO3Y6 alarm within 60 s and a high priority t02 alarm within two 2 minutes s Remove the air gas hose from the oxygen supply and reconnect the hose to a known medical air supply 9 Remove the oxygen gas hose from the air supply and reconnect the hose to a known oxygen supply to Press the alarm reset key to clear all alarms A WARNING Before returning the ventilator to service review all settings and set appropriately for the patient to be ventilated 6 5 6 Viewing Alarms When an alarm occurs the omni directional LED at the top of the GUI flashes in a color corresponding to the alarm priority an audible series of tones sounds and an alarm banner displays on the GUI Reference Areas of the GUI p 4 3 When the alarm banner appears it displays its base message Touching the individual alarm causes an expanded explanation to appear containing analysis and remedy messages and may contain a link to the alarm log or the alarms settings screen Touch the link to display requested information The omni directional LED remains steadily lit and may appear multicolored meaning that multiple alarms with varying priority levels have occurred During an event that causes multiple alarms the ventilator simultaneously displays the two highest priority active alarm
302. hosts to uniquely identify each Puritan Bennett 980 Ventilator 18 characters Room number 6 characters Date MMM_DD_YYYY_ 12 characters Mode CMV__ SIMV__ CPAP__ or BILEVL CMV A C setting 6 characters Respiratory rate setting in breaths per minute 6 characters Tidal volume setting in liters 6 characters Peak flow setting in liters per minute 6 characters 05 setting 6 characters Pressure sensitivity setting in cmH320 6 characters PEEP or P in BiLevel setting in cmH 0 6 characters Plateau time in seconds 6 characters Not used 6 characters ield 22 Apnea interval in seconds 6 characters Apnea tidal volume setting in liters 6 characters ield 23 Apnea respiratory rate setting in breaths per minute 6 characters ield 24 Apnea peak flow setting in liters per minute 6 characters ield 25 Apnea O setting 6 characters ield 26 Pressure support setting in cmH O 6 characters ield 27 Flow pattern setting SQUARE or RAMP__ 6 characters ield 28 29 Not used 6 characters ield 30 Elevate O state ON or OFF__ 6 characters ield31 33 Not used 6 characters ield 34 Total respiratory rate in breaths per minute 6 characters ield 35 Exhaled tidal volume in liters 6 characters ield 36 Exhaled minute volume in liters 6 characters ield 37 Sponta
303. ic and Adult patients with predicted body weights from 0 3 kg to 150 kg and with tidal volumes for mandatory volume controlled breaths from 2 mL to 2500 mL To ventilate Neonatal patients on the Pediatric Adult or Universal models the NeoMode 2 0 software option is required For details regarding the NeoMode 2 0 software option Reference Appendix E in this manual The estimated service life of the ventilator is approximately 10 years provided the preventive maintenance schedule stated in the Puritan Bennett 980 Series Ventilator Service Manual is followed however service life of individual units may vary The ventilator s IEC 60601 1 EN 60601 1 classification is Protection class Type BF Mobile Internally powered IP 21 equipment Continuous operation Not suitable for use with flammable medical gases not AP or APG Reference BDU Rear Label or Panel Symbols and Descriptions p 2 11 for a description of the meaning of the IP classification The ventilator system uses a graphical user interface GUI and breath delivery unit BDU for entering patient settings and delivering breaths to the patient The GUI contains electronics capable of transferring the clinician s input by touching the screen to the BDU where pneumatic and electronic sys tems respectively generate the breathing parameters Operator s Manual 2 3 Product Overview 23 Indications For Use The Puritan Bennett 980 Ventilator System is
304. ient s conducting air ways and some of the pressure gradient is dissipated in the inflation of the lungs and thorax Each element of pressure dissipation is characterized by a measurable property the resistance of the artificial and patient airways and the compliance or elastance of the lung and thorax PAV software uses specific information including resistance of the artificial airway resistance of the patient s airways lung thorax compliance instanta neous inspiratory flow and lung volume and the Supp setting to compute the instantaneous pressure to be applied at the patient connection port patient wye PAV software randomly estimates patient resistance and com pliance approximately every four to ten breaths Every five 5 ms the software estimates lung flow based on an estimate of flow at the patient wye and lung volume based on the integral of the value of estimated lung flow PAV begins to assist an inspiration when flow generated by the patient s inspiratory muscles appears at the patient wye If the patient ceases inspira tion the assist also ceases Once inspiratory flow begins PAV software mon itors instantaneous flow and volume every 5 ms and applies the pressure Operator s Manual D 3 PAV Appendix D 4 calculated to overcome a proportion determined by the Supp setting of the pressure losses dissipated across the resistances of the artificial and patient airways and lung thorax compliance
305. ies and Options Continued Accessory or option description NeoMode 2 0 Software Part number 0086743 Not shown NeoMode 2 0 Software Upgrade 0096526 Not shown PAV Software 0086283 Not shown PAV Software Upgrade 0096530 Not shown BiLevel 2 0 Software 0086682 1 Not shown BiLevel 2 0 Software Upgrade 0096527 Reusable filtration system does not include condensate vial Reusable condensate vial must be ordered separately Operator s Manual 10 Theory of Operations 10 1 Overview This chapter provides specific details on breath delivery functions of the Puritan Bennett 980 Series Ventilator The chapter is organized as shown below Section Number Title Page 10 1 Overview p 10 1 10 2 Theoretical Principles p 10 3 10 3 Applicable Technology p 10 3 10 4 Inspiration Detection and initiation p 10 4 10 5 Exhalation Detection and Initiation p 10 9 10 6 Compliance and BTPS Compensation p 10 13 10 7 Mandatory Breath Delivery p 10 17 10 8 Spontaneous Breath Delivery p 10 22 10 9 A C Mode p 10 31 0 10 SIMV Mode p 10 34 10 11 Spontaneous SPONT Mode p 10 39 0 12 Apnea Ventilation p 10 41 0 13 Detecting Occlusion and Disconnect p 10 45 10 14 Respiratory Mechanics p 10 49 0 15 Ventilator Settings p 10 57 10 16 Safety Net p 10 71 0 17 Power On Self Test POST p 10 76 10 18 Short Self Test
306. iggered breaths determines the amount of pressure below PEEP required to begin a mandatory or sponta neous patient initiated breath Range 0 1 cmH 0 to 20 0 cmH 70 Resolution 0 1 cmH O Pressure support Psypp or PS The positive pressure above PEEP or P in BiLev el during a spontaneous breath Range O cmH 20 to 70cmH20 Resolution 1 cmH 0 Respiratory rate f Sets the number of volume or pressure based breaths per minute for ventilator initiated manda tory VIM breaths in A C SIMV and BiLevel modes Range NEONATAL 1 0 1 min to 150 1 min PEDIATRIC ADULT Resolution 0 1 from 1 0 1 min to 9 9 1 min 1 1 min from 10 1 min to 150 1 min Operator s Manual Operator s Manual Performance Specifications Table 11 9 Ventilator Settings Range and Resolution Continued Setting Rise time Description Sets the speed at which inspiratory gas delivered to the patient reaches the pressure target in BiLevel PC VC VS or PS Higher percentages of rise time produce inspiratory pres sure trajectories with shorter time to the target value Range and Resolution Range 1 to 100 Resolution 1 Spontaneous type The breath type for patient initiated soontaneous breaths in SIMV SPONT and BiLevel modes Range PS TC PAV or VS Supp Supp In Tube Compensation specifies the additional positive pressure desired to overcome resistance of th
307. ign with a valid predicted body weight a Continue button appears Setting the ventilator beyond these soft bounds requires the operator to acknowledge the prompt by touching Continue button before continuing to adjust the tube size The limit beyond which the tube ID cannot be adjusted is called a hard bound and the ventilator emits an invalid entry tone when a hard bound is reached A WARNING Ensure that the correct artificial airway ID size is entered Because PAV amplifies flow entering a smaller than actual airway ID causes the flow D 6 Operator s Manual Ventilator Settings Guidance based pressure assistance to over support the patient and could lead to transient over assist at high values of Supp Conversely entering a larger than actual ID results in under support PAV software monitors the settings for the PBW and artificial airway If the PBW and tube ID settings do not correspond to the above PBW tube ID range pairs confirm or correct the settings Confirming or correcting the actual ID size minimizes the likelihood that PAV will over support or under support To apply new settings for the artificial airway follow these steps 1 Touch Vent Setup at the lower left of the GUI screen 2 Touch Tube Type and turn the knob to select Trach or ET to set the tube type 3 Touch tube ID and turn the knob to set the tube ID 4 Touch Accept or Accept ALL to apply the new settings or Cancel to cancel To apply new hu
308. igure 2 2 GUI Rear View VEN_10320_A Reference Common Symbols Found on GUI or BDU Labels p 2 13 for symbols found on the GUI or BDU The Do Not Push symbol found on the GUI only is shown in this table Operator s Manual 2 7 Product Overview 2 6 3 BDU Front View Figure 2 3 BDU Front View Condensate vial Expiratory filter Expiratory filter latch AC power indicator VEN_10321_C Power switch Status display Internal inspiratory filter Option connector panel door Operator s Manual Operator s Manual Table 2 2 BDU Front Label Symbols and Descriptions GUI Controls and Indicators Symbol TAN Description To Patient port SON From Patient port of 61 Expiratory filter latch locked down unlocked up Product Overview 2 6 4 BDU Rear View Figure 2 4 BDU Rear View VEN_11418_A 1 Standard base 5 Service mode button 2 Air inlet 6 Remote alarm port 3 Oxygen inlet 7 Cylinder mount optional 4 Labels indicating installed software options Software option labels are applied to the grid located on the back of the ven tilator as shown below and in the previous image item 4 2 10 Operator s Manual GUI Controls and Indicators Figure 2 5 Installed Software Options VEN_10284_A The following table lists the symbols and descriptions found on BDU or base labels Table 2 3 BDU Rear Label or Panel Symbols and Descriptions Symbol
309. ilation Opening the latch during ventilation will result in a patient disconnect condition and corresponding alarm Figure 3 4 Adult Pediatric Filter Installation VEN 11155 A Condensate drain port 5 Condensate drain port cap Condensate vial 6 Expiratory filter latch Expiratory filter 7 Expiratory filter door Condensate vial gasket To install the neonatal expiratory filter adapter door di 2 3 If necessary remove expiratory limb of patient circuit from expiratory filter Lift expiratory filter latch Reference installing the Neonatal Filter p 3 13 item 3 Remove existing expiratory filter door by lifting it off of the pivot pins Operator s Manual Product Connectivity 4 Fit neonatal adapter door onto pivot pins Figure 3 5 Installing the Neonatal Filter VEN_11162_A 1 Neonatal expiratory filter 3 Expiratory filter latch 2 Neonatal adapter door 4 Filter door pivot pin Note Unlike the pediatric adult expiratory filter and condensate vial the neonatal filter and condensate vial assembly is provided assembled The condensate vial is removable for discarding accumulated liquid by turning the vial clockwise to remove and counterclockwise to install To install the neonatal expiratory filter assembly 1 With the door still open push the neonatal filter assembly straight up into the adapter 2 Close the door 3 Lower the expiratory filter latch a Re attach expiratory limb of pa
310. ilator incorporates the following connectors e Ventilator outlet port To patient A coaxial 15 mm ID 22 mm OD conical connection to which the external inspiratory bacteria filter attaches e Exhalation port From patient port The expiratory limb of the patient circuit attaches to the inlet of the expiratory bacteria filter This port is compatible with a standard 22mm OD conical connection e Proximal Flow sensor A keyed pneumatic connector for the Proximal Flow Sensor is provided with a locking feature to prevent inadvertent disconnection The proximal flow sensor measures flow and pressure at the patient wye The Proximal Flow Sensor is an optional sensor Details on operation are provided in the appendix in this manual Reference Appendix F e Standard interface connectors USB HDMI and Ethernet connectors are provided The USB connector allows images to be captured on an external USB storage device and allows communication with an external patient monitor via serial over USB protocol and the HDMI connector allows the GUI image to be dis played on an external video display device The Ethernet connector is used by Service Personnel to upload new software and options Reference Port Use p 5 19 for more information Reference To configure Comm ports p 5 4 for informa Do on serial over USB data transfer when configuring Comm ports for external evices 212 Special Features A Proximal Flow option is available
311. ime it takes for the expiratory flow to drop to lt 0 5 L min whichever is longest The restricted phase of exhalation will end after five 5 s of exhalation have elapsed regardless of the measured expiratory flow rate 1 8 Spontaneous Breath Delivery The modes allowing spontaneous breaths are SIMV SPONT and BiLevel The spontaneous breath type setting determines which type of pressure assist will be applied to the patient s spontaneous breaths PS TC VS or PAV 10 22 Operator s Manual Short Self Test SST After selecting the spontaneous breath type choose the level of pressure support Pcypp for PS Support volume V7 supp for VS or percent support for TC and PAV if the PAV option is installed and specify the rise time and Esens Where available Changes to the spontaneous breath type setting phase in at the start of the next inspiration Note In any delivered spontaneous breath either INVASIVE or NIV there is always a target inspiratory pressure of at least 1 5 cmH 3O applied During spontaneous breathing the patient s respiratory control center rhyth mically activates the inspiratory muscles The support type setting allows selec tion of pressure assist to supplement the patient s pressure generating capability Table 10 3 Spontaneous Breath Delivery Characteristics Characteristic Implementation Inspiratory detection Pcens Vsens or IE Sync depending on the trigger type selected Press
312. in Operator s Manual 3 23 Installation e Approximate respiratory monitored parameters during simulation Peak pressure Ppr ag 27 CMH 7O Plateau pressure Pp during manual inspiratory pause 23 cmH O Exhaled tidal volume Vg 442 mL BTPS Total respiratory rate Rror 20 1 min IE ratio 1 2 PEEP 8 cmH 0 Total PEEP PEEPror during expiratory pause 8 cmH30Q Exhaled minute volume Veror 8 84 L min e Adult high demand ventilator settings Assist Control Ventilation with Pressure Control PC mandatory type Inspiratory pressure Pj 55 cmHz0 Inspiratory time T 0 55 s Respiratory rate f 60 1 min PEEP 35 cmH 0 Oxygen concentration FiOz 60 Flow trigger V trig 20 L min e Approximate respiratory monitored parameters during adult high demand simu lation Peak pressure Pprak 90 cmH 0 Plateau pressure Pp during manual inspiratory pause 79 cmH3OQ Exhaled tidal volume Vg 900 mL BTPS Total respiratory rate Rror 60 1 min Eratio 1 1 3 24 Operator s Manual Product Connectivity PEEP 39 cmH50 Total PEEP PEEPy 7 during expiratory pause 49 cmH 0 Exhaled minute volume Vetor 52 L min The run time does not vary significantly between typical and heavy load set tings The ventilator can be expected to run approximately 75 minutes at typical settings with new batteries When running batteries nearing end of life batteries with
313. ine indicates a PIM to avoid 9 Tb Ta lt Tb apnea 5 Apnea VIM 10 12 2 Transition to Apnea Ventilation When apnea is declared the ventilator delivers apnea ventilation according to the current apnea ventilation settings and displays the apnea settings on the graphical user interface GUI Regardless of the apnea interval setting apnea ventilation cannot begin until inspiration of the current breath is complete and the restricted phase of exhalation has elapsed 10 12 3 Settings Changes During Apnea Ventilation All apnea and non apnea settings remain active on the GUI during apnea ven tilation Both non apnea and apnea settings changes are phased in according to the applicable rules If apnea ventilation is active new settings are accepted but not implemented until non apnea ventilation begins Allowing key entries after apnea detection allows adjustment of the apnea interval at setup regard less of whether apnea has been detected During apnea ventilation the Manual Inspiration key is active but Expiratory Pause and Inspiratory Pause keys are not active The increase O control is active during apnea ventilation because apnea detection is likely during suctioning Operator s Manual 10 43 Theory of Operations The apnea respiratory rate must be gt 60 T Additionally apnea settings cannot result in an I E ratio gt 1 00 1 10 12 Resetting Apnea Ventilation 10 12 5 10 44 Apnea ventilation is intended as an auxiliary
314. ines the inspiratory interval for pressure controlled PC or VC mandatory breaths Mandatory interval portion of SIMV breath cycle it is reserved for a PIM Plateau time The amount of time the inspiration phase of a mandatory breath is extended after inspiratory flow has ceased and exhalation is blocked Increases the residence time of gas in the patient s lungs Spontaneous interval portion of SIMV breath cycle it is reserved for spon taneous breathing throughout the remainder of the breath cycle Minute volume the expiratory tidal volume normalized to unit time L min The displayed value is compliance and BTPS compensated Ventilator breathing system Includes the gas delivery components of the ventilator the patient circuit with tubing filters humidifier and other accessories and the ventilator s expiratory metering and measurement components Operator s Manual Table Glossary 1 Glossary of Ventilation Terms Continued VC Ventilation Assurance Ventilator Inoperative vent inop VIM Vmax Vsens VRG cm ft Hz kg Operator s Manual Volume control a mandatory breath type in which the ventilator delivers an operator set tidal volume peak flow and flow pattern Available in A C and SIMV modes and for operator initiated mandatory OIM breaths in SPONT mode A feature on the 980 Series Ventilator which enables ventilation to con tinue when a critical system error occurs by entering the
315. ing a special pause maneuver at the end of selected inspirations provides the information the software needs to estimate patient resistance Rpay and compliance Cpay which is converted to elastance Epay Immediately follow ing the end of the pause event software captures simultaneous values for PLUNG Pwye and Ve which yield an estimate for Roy at the estimated flow All raw data are subjected to logic checks and the estimates of Rpay and Cpay are further subjected to physiologic checks The estimates of Rpay and Cpay are discarded if any of the logic or physiologic checks fail If Cpay is rejected Rpay is also rejected Valid estimates of Rpay and Cpay are required for breath delivery and are con stantly updated by averaging new values with previous values This averaging process smooths data and avoids abrupt changes to breath delivery If new values for Rpay and Cpay are rejected the previous values remain active until valid new values are obtained PAV software monitors the update process and generates an escalating alarm condition if the old values do not refresh Maneuver Breaths and Supp During PAV maneuver breaths are randomly performed every four to ten breaths after the last maneuver breath A maneuver breath is a normal PAV inspiration with a pause at end inspiration Because muscle activity is delayed for at least 300 ms following the end of neural inspiration the patient s respi ratory control center does not det
316. ing appears in white font and changes to yellow italics to note the new value is pending Touch Accept or Accept ALL to confirm a single change or a batch of changes Once the settings are accepted their appearance changes to white font Note Selecting QUICK START Accept Accept ALL or Start from the Setup dialog implements all settings in ALL four Setup tabs Vent Setup Apnea Alarms and More Settings and dismisses the Setup dialog Tube Compensation Tube Compensation is a spontaneous breath type selected during ventilator setup It allows the ventilator to deliver additional positive pressure to over come the resistance imposed by the patient s artificial airway Reference p 4 72 for more information on setting up the ventilator Reference Ventilator Settings Range and Resolution p 11 8 for details of specific tube compensation settings To enable TC 1 Touch the VENT tab on the GUI screen Reference New Patient setup Screen p 4 12 2 Touch SPONT for the mode selection 3 Touch TC for Spontaneous type 4 Finish setting up the ventilator as described reference p 4 12 for information on entering ventilator settings 5 Select the tube type either endotracheal or tracheostomy and set the tube ID to correspond to patient settings e After making the changes touch Accept to apply the new settings or Cancel to cancel all changes and dismiss the dialog Operator s Manual 4 13 Operation Adjust Tube Type
317. ining an elevated mean airway pressure to promote oxygenation the P level is set along with the T to control the expiratory release volume of mandatory breaths to help manage CO and alveolar venti lation and the f setting controls the number of releases per minute which are used to help manage the patient s CO levels The f setting also impacts the mean airway pressure Operator s Manual A 9 BiLevel 2 0 Appendix In APRV the operator can configure the BiLevel settings to allow direct control of T to assure that changes in the f setting will not inadvertently lengthen the T period resulting in destabilization of end expiratory alveolar volume With the T period locked changes in set f will change the Ty period to accommo date the new f setting while maintaining the set T period a 9 Technical Structure of BiLevel In BiLevel the ventilator establishes two levels of baseline pressure One level is essentially the same as the standard PEEP level set for all common modes of ventilation The second pressure level is the level established at Ty Both pres sure levels permit CPAP TC and PS breaths The breath timing settings deter mine whether the patient can initiate any of these breath types a1o Mode Changes Changing to BiLevel mode from other modes follows the general guidelines for mode changes e The change is made as soon as possible without compromising inspiration or exhalation e Breaths are not stacked during
318. inspiration can cause the ventilator to supply excess flow to the patient Whether this oversupply is clinically beneficial must be evaluated for each patient Generally the optimum rise time for gently breathing patients is less than or equal to the default 50 while optimum rise time for more aggressively breathing patients can be 50 or higher A WARNING Under certain clinical circumstances such as stiff lungs or a small patient with a weak inspiratory drive a rise time setting above 50 could cause a transient pressure overshoot and premature transition to exhalation or pressure oscillations during inspiration Carefully evaluate the patient s condition before setting the rise time above the default setting of 50 KAN 10 7 Manual Inspiration When pressed the Manual Inspiration key delivers one OIM breath to the patient using set breath delivery parameters The ventilator will not allow a manual inspiration during the restricted phase of exhalation or when the ven tilator is in the process of delivering a breath whether mandatory or sponta neous All manual inspiration attempts are logged in the General Event log The restricted phase of exhalation is the time period during the exhalation phase where an inspiration trigger is not allowed The restricted phase of exha lation is defined as the first 200 ms of exhalation OR the time it takes for expi ratory flow to drop to lt 50 of the peak expiratory flow OR the t
319. ion The breath phase indicator displays the breath delivery phase inspiration or exhala tion currently being delivered to the patient Range and Resolution Range Control C Assist A Spontaneous S Inspired tidal volume V7 during Leak Sync The volume inspired for each breath when Leak Sync is enabled Range 0 mL to 6000 mL Resolution 0 1 mL for values lt 10mL 1 mL for values 10 mL to 6000 mL Inspired tidal volume V7 The volume inspired for a pressure based breath Range 0 mL to 6000 mL Resolution 0 01 mL for 0 mL to 9 9 mL 1 mL for values 10 mL to 6000 mL Inspired tidal volume Vr during Leak Sync The volume inspired for each breath when Leak Sync is enabled Range O mL to 6000 mL Resolution 1 mL for values lt 10 mL 1 mL for values 10 mL to 6000 mL Operator s Manual 19 Specifications 20 Table 11 11 Patient Data Range and Resolution Continued Data Value Dynamic compliance Cpyn Description The result of dividing the delivered tidal volume by the peak airway pressure Range and Resolution Range O mL cmH20 to 200 mL cmH70 Resolution 0 1 mL cmH5O for values lt 10 mL cmH50 1 mL cmH 0O for values gt 10 mL cmH 0 Dynamic resistance Rpyn The change in pressure per unit change in flow Range 0 0 cmH O L s to 100 cmH O L s Resolution 0 1 cmH O L for values lt 10 cmH O L s 1 cmH gt O L s for valu
320. ion and contamination always ensure inspiratory and expiratory bacteria filters are installed before ventilating the patient WARNING Never attempt to re use single patient use components or accessories Doing so increases risk of cross contamination and re processing of single patient use components or accessories may compromise functionality leading to possible loss of ventilation Operator s Manual Safety Information 1 3 11 Warnings Regarding Ventilator Maintenance WARNING To ensure proper operation and avoid the possibility of physical injury this ventilator should only be serviced by qualified technicians who have received appropriate Covidien provided training for the maintenance of this ventilator WARNING Follow preventive maintenance according to specified intervals listed in these tables Reference Operator Preventive Maintenance Frequency p 7 2 Reference Service Preventive Maintenance Frequency p 1 2 in the Operator s Manual Addendum on Preventive Maintenance 1 3 12 Cautions Caution To prevent possible equipment damage ensure the casters are locked to prevent inadvertent movement of the ventilator during routine maintenance or when the ventilator is on an incline Caution Do not use sharp objects to make selections on the display or keyboard Caution To ensure optimal performance keep the GUI touch screen and keyboard clean and free from foreign substances Reference Surface Cleaning Agents
321. ional patient data banner A total of ten 10 parameters are stored here consisting of date and time of the entry recorded every minute patient data name and the patient data value during ventilator operation e Diagnostic Log The Diagnostic Log is accessible during normal ventilation and Service modes and contains tabs for the System Diagnostic Log default the System Communication Log and the EST SST Diagnostic Log The diagnostic log contains tabs for the following e System Diagnostic Log The System Diagnostic Log contains the date and time when an event occurred the type of event the diagnostic code s asso ciated with the event and any notes Reference the Puritan Bennett 980 Series Ventilator Service Manual 10078090 for specific information con tained in the System Diagnostic Log The diagnostic log is not cleared when the ventilator is set up for a new patient e System Communication Log This log contains diagnostic information gen erated by the ventilator s communication software Reference the Puritan Bennett 980 Series Ventilator Service Manual 10078090 for specific infor mation contained in the System Communication Log e EST SST Diagnostic Log The EST SST diagnostic log displays the time date test event system code reference the Puritan Bennett 980 Series Ventilator Service Manual type and notes e EST SST status log The EST and SST status log displays the time date test te
322. iratory filters A WARNING Do not re use disposable inspiratory or expiratory filters and dispose according to your institution s policy for discarding contaminated waste The condensate vial must be assembled to the reusable expiratory filter prior to installing the assembly to the ventilator To assemble the Adult Pediatric reusable expiratory filter and condensate vial 1 Seat the filter to the condensate vial ensuring alignment of the condensate vial s seal with the mating edge of the expiratory filter 2 Twist the condensate vial in a counterclockwise direction until the stops on the vial and expiratory filter meet To install the Adult Pediatric expiratory filter 1 If necessary remove expiratory limb of patient circuit from expiratory filter Raise the expiratory filter latch to unlock item 6 Reference Adult Pediatric Filter Installation p 3 12 This raises the exhalation valve assembly and allows the filter door to swing away from the ventilator ae P 5 Insert the new filter by sliding the filter along the tracks in the door Ensure the From Patient port aligns with the cutout in the door and points away from the ventilator N w Open the expiratory filter door Remove the existing filter 6 Close the expiratory filter door 7 Lower the expiratory filter latch to secure the filter Operator s Manual 3 11 Installation A WARNING Do not operate the expiratory filter latch during patient vent
323. iratory phase begins when the ventilator detects patient effort during the ventilator s exhalation phase Breath delivery during the inspiratory phase is determined by the settings for pressure support PEEP rise time and expi ratory sensitivity unless the breath is an OIM breath If Tube Compensation TC or Proportional Assist Ventilation PAV if the PAV option is installed is selected as the spontaneous type breath delivery during the inspiratory phase is determined by the settings for support Supp expiratory sensitivity tube ID and tube type Note Given the current ventilator settings if PAV would be an allowable spontaneous type except that tube ID lt 6 mm then PAV becomes selectable If selected tube ID is set to its New Patient default value based on the PBW entered An attention icon for tube ID appears If Volume Support VS is selected as the spontaneous type breath delivery during the inspiratory phase is determined by rise time volume support level V7 supp expiratory sensitivity and PEEP Inspiratory pauses are only possible during OIM breaths and expiratory pauses are not allowed during SPONT Expiratory trigger methods include e Esens flow deceleration from peak inspiratory flow e PBW based time limit T too long e TPprak e Inspiratory tidal volume limit for VS only e TE Sync if the IE Sync option is installed e Airway Pressure Cycling method Changing to SPONT Mode I
324. istance or underestimat ing patient compliance which could lead to potential over inflation The high inspiratory tidal volume limit TV7 places an absolute limit on the inte gral of lung flow including leak flow which equals lung volume If the value of Vy reaches this limit the ventilator truncates inspiration and immediately transi tions to exhalation The TV setting places an upper limit on the value of the PYOLUME PATIENT COMPO nent of Pave see Equations 3 and 4 At the beginning of each new inspiration PAV software calculates a value for PYOLUME as follows PATIENT Powe elastic threshold limit 0 75x Vy X Epay where P wye is the unique value for the elastic threshold limit of P that will cause the lung volume to expand to 75 of TVt When Pie elastic P yy elastic threshold limit the software stops increasing Pliye elastic This means that any further increase in lung volume must be accomplished by the patient which tends to hasten the conclusion of inspiratory effort and avoid truncation due to lung volume reaching the TV limit The high inspiratory pressure limit TPpeax applies to all breaths and is used by PAV software to detect the high compensation pressure condition 1P 6mp TPcomp TPprak 5 CMH5O or 35 cmH20 whichever is less If the user adjustable TPprax limit is reached the ventilator truncates inspiration and immediately transitions to exhalation If Page the targeted
325. ix subsys tem the inspiratory subsystem or the expiratory subsystem Each subsystem has a Backup Ventilation strategy that allows ventilation to continue by bypass ing the suspect components giving the operator time to replace the ventilator Operator s Manual Short Self Test SST Mix BUV is invoked if the measured gas mix is significantly different from the set mix if the accumulator pressure is out of range or if a fault is indicated in the mix PSOLs or flow sensors During MIX BUV the normal mix controller is bypassed and ventilation continues as set except that the gas mix reverts to 100 Oxygen or Air depending on where the fault indication was detected Backup circuits then control the pressure in the accumulator to keep it in the proper range for the Inspiratory Module Inspiratory BUV is invoked if Background Diagnostics detect a problem in the inspiratory module PSOL and or flow sensor signal out of range In inspiratory BUV ventilation continues with the following settings Table 10 10 Inspiratory Backup Ventilation Settings Backup Ventilation parameter Setting PBW Previously used setting during Vent Startup Mode A C Mandatory type PC f Neonatal 25 1 min Pediatric 16 1 min Adult 16 1 min Ti Neonatal 0 3 s Pediatric 0 7 s Adult 1 s P 15 cmH 0 above PEEP 07 100 21 if O not available PEEP 3 cmH 0 Tp Os Trigger type V trigi 2 L min adult pediatric
326. l 5 Shasham St North Industrial Park POB3069 Caesarea 38900 Tel 972 4 627 73 88 Fax 972 4 627 76 88 Covidien Italia S p A Via Rivoltana 2 D I 20090 Segrate Mi Italy Tel 39 02 703 173 1 Fax 39 02 71740584 Covidien Japan Inc Technical Support Center 83 1 Takashimadaira 1 Chome Itabashi ku Tokyo 175 0082 Japan Tel 81 0 3 6859 0120 Fax 81 0 3 6859 0142 Covidien Korea 5F Hibrand Living Gwan 215 Yangjae Dong Seocho Gu Seoul Korea Tel 822 570 5459 Fax 822 570 5499 Covidien Mexico Insurgentes Sur 863 Piso 16 Col Napoles Del Benito Juarez Mexico D F 03810 Mexico Tel 5255 5804 1524 Fax 5255 5536 1326 Covidien Nederland BV Hogeweg 105 NL5301 LL ZaltbommelNederland Tel0418 57 66 00 Fax 0418 57 67 91 Covidien New Zealand Cnr Manu Tapu Dr amp Joseph Hammond PI Auckland Airport New Zealand Phone 64 508 489 264 Covidien Norge AS Bankveinen 1 Postboks 343 N 1372 Askerr Norway Tel 47 2415 98 87 Fax 47 2415 15 98 88 Covidien Panama Parque Industrial Costa del Esta Calle Primera Edifio 109 Panama City Panama Tel 507 264 7337 Fax 507 236 7408 Covidien Polska Al Jerozolimskie 162 02 342 Warszawa Polska Tel 48 22 312 20 00 Fax 48 22 312 20 20 Covidien Portugal Lda Produtos De Sa de Ida Est Outeiro Polima Lote 10 1 Piso Aboboda P 2785 521 S Domingos de Rana Portugal Tel 351 21 448 10 00 Fax
327. l or according to the institu tion s policy Disposable inspiratory Filter After 15 days of continuous use discard Discard according to the institu tion s protocol Disposable expiratory Filter After 15 days of continuous use discard Discard according to the institu tion s protocol Operator s Manual 7 3 Preventive Maintenance Table 7 1 Operator Preventive Maintenance Frequency Continued Part Frequency Maintenance Battery When transferring battery toor Disinfect by wiping with a from another ventilator damp cloth using one of the solutions listed Reference Surface Cleaning Agents p 7 5 for approved cleaning agents Battery Every three 3 years Replace Exhalation valve flow sensor assembly When contamination is sus pected NOTE The exhalation valve flow sensor assembly is remov able and may be disinfected DO NOT STERILIZE the exhala tion valve flow sensor assembly Reference Component Clean ing and Disinfection p 7 6 and Reference Exhalation Valve Flow Sensor Assembly Disinfec tion p 7 13 Exhalation valve flow sensor assembly Every 25 disinfection cycles A disinfection cycle is defined as one disinfection event as described Reference Exhala tion Valve Flow Sensor Assem bly Disinfection p 7 13 Replace Run flow sensor cali bration exhalation valve cali bration EST and SST after replacing the exhalation valve
328. l volume alarm setting 4Vre MAND The WV MAND alarm indi cates the measured manda tory tidal volume lt the set alarm limit Range OFF and NEONATAL 1 mL to 300 mL PEDIATRIC 1 mL to 1000 mL ADULT 1 mL to 2500 mL Resolution 1 0 mL for values lt 100 mL 5 mL for values gt 100 mL and lt 400 mL 10 mL for values 5 400 mL Operator s Manual Performance Specifications Table 11 10 Alarm Settings Range and Resolution Continued Setting Low exhaled minute volume alarm setting 4VE ton Description The 4V ror alarm indicates the measured exhaled minute volume sx the set alarm limit for mandatory and sponta neous breaths Range and Resolution Range OFF when vent type NIV and NEONATAL 0 01 L min to 10 L min PEDIATRIC 0 05 L min to 30 L min ADULT 0 05 L min to 60 L min Resolution 0 005 L min for values lt 0 50 L min 0 05 L min for values gt 0 50 L min and lt 5 0 L min 0 5 L min for values gt 5 0 L min Low exhaled spontaneous tidal volume alarm setting LV7E spont The 4V e spont alarm indi cates the measured sponta neous tidal volume lt the set alarm limit Range OFF and NEONATAL 1 mL to 300 mL PEDIATRIC 1 to 1000 mL ADULT 1 to 2500 mL Resolution 1 mL for values lt 100 mL 5 mL from 100 mL to lt 400 mL 10 mL for values gt 400 mL Table 11 11 Patient Data Range and Resolution Data Value Breath phase Descript
329. l as two mixed modes SIMV and BiLevel A C Assist Control A C mode guarantees delivery of a minimum number of mandatory breaths based on the frequency f set by the clinician Breaths in A C can be patient initiated PIM or ventilator initiated VIM e SPONT Spontaneous SPONT mode delivers only spontaneous breaths which are all patient initiated e SIMV Synchronized Intermittent Mandatory Ventilation SIMV is a mixed mode allowing both mandatory and spontaneous breaths SIMV guaran tees at least one mandatory breath per set breath cycle which is either patient initiated or ventilator initiated The mandatory type of an SIMV breath can be PC VC or VC e BiLevel BiLevel is also a mixed mode which overlays the patient s sponta neous breaths onto the breath structure for PC mandatory breaths Two levels of pressure P and Py are employed The breath cycle interval for both SIMV and BiLevel modes is 60 f where f is the respiratory rate set by the operator e CPAP CPAPis available only when circuit type is neonatal and vent type is NIV CPAP mode allows spontaneous breathing with a desired PEEP level In order to limit inadvertent alarms associated with the absence of returned volumes in nasal CPAP breathing CPAP does not make available exhaled minute volume and exhaled tidal volume alarm settings Breath Type Mandatory breath types for A C and SIMV modes include volume controlled VC pressure co
330. l assembly with clean water The assembly may be fully immersed to rinse 5 Wipe the condensate vial dry Figure 7 1 Condensate Vial G 3 VEN_11622_A 1 O ring 3 Retainer 2 Drain cap 7 5 2 Expiratory Filter Cleaning Reference the photos in this section when cleaning the expiratory filter Operator s Manual 7 9 liquid To avoid retaining harmful residues do not immerse housing or filter medium in liquid or sterilize using ethylene oxide ETO Preventive Maintenance Caution Do not immerse the expiratory filter in liquid cleaning agent Use care to prevent the cleaning agent from making contact with the filter media inside the filter housing LAP Note Follow the institution s protocol for handling storage and disposal of potentially biocontaminated waste To clean the expiratory filter 1 Spray or wipe down surfaces of the exterior housing and housing bottom with cleaning solution Reference Component Cleaning Agents and Disinfection Proce dures p 7 6 for appropriate cleaning solutions Use care to prevent the solution from contacting the filter media via the filter outlet or entering the filter intake opening or from patient port 7 10 Operator s Manual Service Personnel Preventive Maintenance Figure 7 2 Filter Top and Bottom Views 4 5 VEN_11623_A 1 Filter outlet top 4 External housing 2 Filter intake opening bottom 5 From patient port 3 Housing bottom 2 Wipe the i
331. lank Operator s Manual D D 1 D 2 PAV Appendix Overview This appendix describes the operation of the PAV software option for the Puritan Bennett 980 Ventilator Proportional Assist Ventilation PAV is designed to improve the work of breathing of a spontaneously breathing patient by reducing the patient s increased work of breathing when pulmonary mechanics are compromised The PAV breath type differs from the pressure support PS breath type in the following way PAV acts as an inspiratory amplifier the degree of amplification is set by the Support setting Supp PAV software continuously monitors the patient s instantaneous inspiratory flow and instantaneous lung volume which are indicators of the patient s inspiratory effort These signals together with ongoing estimates of the patient s resistance and compliance allow the soft ware to instantaneously compute the necessary pressure at the patient wye to assist the patient s inspiratory muscles to the degree selected by the Supp setting Higher inspiratory demand yields greater support from the ventilator PAV software reduces the risk of inadvertent entry of incompatible settings such as small predicted body weight PBW paired with a large airway Intended Use PAV is intended for use in spontaneously breathing adult patients whose ven tilator predicted body weight PBW setting is at least 25 0 kg 55 Ib Patients must be intubate
332. larm limits from their respective tabs Operator s Manual E 9 NeoMode 2 0 Appendix Figure E 3 CPAP Setup Screen Ventilation Type Invasive Mode VEN_11369_D E 9 4 Entering CPAP From Other Ventilation Modes Entering CPAP mode from other ventilation modes or vent types requires using the NIV Vent type The section Non invasive Ventilation NIV in Chapter 4 of this manual explains how the ventilator transitions from INVASIVE TO NIV vent type To enter CPAP mode for an existing patient 1 Touch Vent Setup at the lower left of the GUI screen 2 Touch NIV Vent type CPAP is only allowed during NIV 3 Touch CPAP The ventilator enters CPAP mode 4 Set an apnea interval Ta if appropriate as it defaults to OFF in CPAP Note Exhaled minute volume Vg tor exhaled tidal volume VE spont and inspired tidal volume V5 alarms are disabled upon entry into CPAP E 10 Operator s Manual Ventilation Features E 9 5 Exiting CPAP Mode When changing the mode from CPAP to any other mode several transition rules take effect e The Ve tor Vte mann VTE spont and Vr alarms are set to their respective new patient defaults e When transitioning from apnea interval set to OFF to an apnea interval of time Ta the new setting is phased in immediately e The Ve TOT VTE MAND VJE SPONT and VA alarm sliders appear in the alarm settings screen according to their applicability to the selected Mode E 9 6 Complianc
333. lator delivers one mandatory breath per breath cycle and as many spontaneous breaths as the patient can trigger during the remainder of the breath cycle Sleeved index system A standard for high pressure gas inlet fittings A ventilator setting that has reached its recommended high or low limit accompanied by an audible tone Setting the ventilator beyond this limit requires the operator to acknowledge a visual prompt to continue Spontaneous A ventilatory mode in which the ventilator delivers only spontaneous breaths In SPONT mode the patient triggers all breaths delivered by the ventilator with no set mandatory respiratory rate The patient controls the breath variables potentially augmented by support pressure A setting that determines whether spontaneous breaths are pressure supported PS tube compensated TC volume supported VS or pro portionally assisted PAV Short self test A test that checks circuit integrity calculates circuit com pliance and filter resistance and checks ventilator function Operator should run SST at specified intervals and with any replacement or alter ation of the patient circuit Glossary 7 STPD SVO system fault technical alarm Ts Ve TOT VBS Table Glossary 1 Glossary of Ventilation Terms Continued Standard temperature and pressure dry Defined as dry gas at a standard atmosphere 760 mmHg 101 333 kPa approximately 1 0 bar and 0 C Safety valve open An em
334. ld GF 2 CRC algorithms are the basis for data integrity checks Direct current The movement of electrical charge flowing in a single direction Electromagnetic compatibility European norm referring to the European Common Market Ethylene oxide International Electrotechnical Commission A standards organization International Standards Organization A standards organization Liquid crystal display A type of visual equipment operator Interface Light emitting diode A means of providing visual indications Magnetic resonance imaging Operator s Manual Operator s Manual Table Glossary 3 Technical Abbreviations Continued NVRAM also NovRam Non volatile random access memory Memory that is kept active across resets and power cycles and is not normally initialized at startup POST Power on self test Software algorithms to verify the integrity of appli cation software and the hardware environment Power on self test generally occurs at power on after power loss or when the device resets due to a detected fault RAM Random access memory Glossary 11 Page Left Intentionally Blank Glossary 12 Operator s Manual A A C mode 10 31 10 34 AC power operation 3 2 accessory compatibility 9 1 part numbers 9 4 adjusting waveform layout 3 45 alarm AC POWER LOSS 6 35 Apnea 6 35 CIRCUIT DISCONNECT 6 35 dependent 6 4 DEVICE ALERT 6 36 High circuit pressure 6 36 High delive
335. le Humidification type Set value or NON HEATED EXP TUBE if none available Humidifier volume Last set value or 480 mL if none available Note In Safety PCV expiratory pauses are not allowed 10 16 2 Patient Related Problems In case of patient problems the ventilator remains fully operative and annun ciates the appropriate alarm The detection response and priority of each patient related alarm is determined by the actual patient problem Reference Alarms p 6 4 for a comprehensive description of the patient alarm system 10 16 3 System Related Problems The ventilator is designed to prevent system faults Its modular design allows the breath delivery unit BDU to operate independently of the graphical user Operator s Manual 10 73 Theory of Operations 10 74 interface GUI and several modules of the breath delivery sub system have redundancy that if certain faults occur provides for ventilatory support using settings that do not depend on the suspect hardware System faults include the following e Hardware faults those that originate inside the ventilator and affect its perfor mance e Soft faults faults momentarily introduced into the ventilator that interfere with normal operation e Inadequate supply AC power or external gas pressure e Patient circuit integrity occluded or disconnected circuit 10 16 4 Background Diagnostic System The ventilator has an extensive sys
336. les include soft and hard bound messages PAV and IE Sync startup messages Oxygen sensor calibration in progress and various other infor mational messages Note A soft bound is a selected value that exceeds its recommended limit and requires acknowledgment to continue Hard bounds have minimum and maximum limits Operator s Manual 4 3 Operation beyond which values cannot be selected however if the desired value is equal to a settings hard bound then it is allowable Menu tab Located on the left side of the GUI screen Swiping the tab to the right and touching Setup causes the Vent Apnea Alarm and More Settings tabs to appear Touching those tabs opens screens so that changes to ventilator set tings apnea settings and alarm settings can be made Waveform area Located in the center of the GUI screen Shows various breath waveforms Reference To configure waveforms and loops p 3 45 for information on how to configure graphics Breath Phase Indicator During normal ventilation the GUI displays a breath indicator in the upper left corner which shows the type of breath Assist A Control O or Spontaneous S currently being delivered to the patient and whether it is in the inspiratory or expiratory phase The breath indicator Is updated at the beginning of every inspiration and persists until the next breath type update During inspiration assist A and control C breath indicators glow green and spontaneous
337. liance and BTPS compensated and updates at the next inspiration Operator s Manual 6 43 Performance 6 6 4 Proximal Exhaled Minute Volume vg tory The BTPS and compliance compensated sum of exhaled spontaneous volumes for the previous minute 6 6 5 Proximal Exhaled Tidal Volume V7gy The exhaled tidal volume for the previous breath measured by the Proximal Flow Sensor for neonatal patients only Vrey is updated at the beginning of the next inspiration 6 6 6 Exhaled Spontaneous Tidal Volume V E spont The exhaled volume of the last spontaneous breath updated at the beginning of the next inspiration following a spontaneous breath 6 6 7 Exhaled Mandatory Tidal Volume Vte mann The exhaled volume of the last mandatory breath updated at the beginning of the next inspiration following a mandatory breath If the mode is SPONT and the ventilator has not delivered mandatory breaths in a time period of greater than two minutes for example via a manual inspiration the Vte manp patient data indicator becomes hidden The indicator reappears when the value updates 6 6 8 Exhaled mL kg Volume The patient s exhaled volume displayed in mL kg PBW 6 6 9 Inspired Tidal Volume V7 The BTPS and compliance compensated volume of inspired gas for all pres sure based or NIV breaths updated at the beginning of the following expira tory phase V is displayed when data are available 6 44 Operator s Manual Ventilator Settin
338. light levels 4 Touch Accept to apply the changes or Cancel to revert to original settings 5 If done configuring parameters exit Service Mode To adjust display brightness 1 Press the display brightness key 2 Slide the brightness slider or turn the knob to adjust the brightness level 3 Dismiss the slider by touching anywhere on the GUI screen or allow to time out in five 5 s Operator s Manual 3 39 Installation New Patient Setup Defaults To institutionally configure new patient default settings 4 9 Touch the button corresponding to adult pediatric or neonatal New Patient Defaults Touch the Vent type Mode Mandatory type and Trigger type buttons corre sponding to the desired parameters Configure the default PBW and mL kg ratio Elevate O and O2 by touching its button and turning the knob Repeat for each patient type by selecting the corresponding button Touch Accept or Accept ALL when the default configuration is complete If done configuring parameters exit Service Mode Elevate O Note The Elevate O control adds a percentage of O to the breathing mixture for two minutes The additional percentage is shown on the icon in the constant access icon area The allowable range is 1 to 100 To adjust the amount of elevated O delivered for two minutes 1 In the vent setup dialog in Normal mode touch the Elevate O icon in the constant access icons area of the GUI screen The i
339. logs screen which contains tabs for Alarms Settings Patient Data Diagnostics EST SST status General Event and Service logs Operator s Manual GUI Controls and Indicators Table 2 6 GUI Visual Indicators Continued Symbol Description Elevate O control A constant access icon Refer ence Areas of the GUI p 4 3 Touch this icon to increase the set the elevated oxygen concentra tion to the institutional default O configuration if institutional default has been configured for two minutes or allows the operator to determine the additional percentage of oxygen to increase The O concentration for the two minute increase can be set to any value between 1 and 100 O If the Elevate O function is active touching Extend re starts the two minute inter val The Elevate O function can be terminated prior to completion of the two minute interval by touching Stop Any time the Elevate O control is activated an entry is made to the patient data log Screen capture icon A constant access icon Ref erence Areas of the GUI p 4 3 Touch this icon to capture the image displayed on the GUI screen Reference To capture GUI screens p 5 2 to read the complete procedure for capturing screen images Help icon A constant access icon Reference Areas of the GUI p 4 3 Drag this icon to the item in question and release A tooltip will appear describing the item s function Unread items icon When this
340. low omni directional LED located on the top of the GUI yellow alarm banner on GUI screen and yellow bar next to alarm setting icon on Alarms screen Medium priority audible alarm a repeating sequence of three tones LED indicator turns off and autoreset is entered into the alarm log Low A change in the patient ventilator system has occurred Steadily illuminated yellow omni direction al LED located on the top of the GUI yellow alarm banner on GUI screen and yellow bar next to alarm setting icon on Alarms screen Low priority audible alarm two tone non repeating LED indicator turns off and autoreset is entered into the alarm log Operator s Manual Normal Normal venti lator operation Immediate Table 6 2 Alarm Prioritization Continued Priority Level Visual indicator Steadily illuminated green omni directional LED located on the top of the GUI no alarm banner and white values next to alarm setting icon on Alarms screen Status display shows the GUI has failed Audible indicator None The secondary alarm annunciates a repeat ing sequence of single tones since the primary alarm part of the GUI has failed Ventilator Settings Autoreset characteristics None None A technical alarm is one that is caused by a violation of any of the ventilator s self monitoring conditions such as failure of POST or a fault detected
341. low to the room 2 1 Product Overview The ventilator recognizes the patient s breathing effort using pressure trigger ing P_rpig flow triggering V 1p g or IE Sync triggering if the IE Sync Option is installed Reference Appendix C for more information on the IE Sync Option During pressure triggering as the patient inhales the airway pressure decreas es and the inspiratory pressure transducer PI monitors this pressure decrease When the pressure drops to at least the value of the pressure sensi tivity Psens setting the ventilator delivers a breath During flow triggering the difference between inspiratory and expiratory flows is monitored As the patient inhales the exhalation valve flow sensor measures less flow while the delivery flow sensor measurement remains constant When the difference between the two measurements is at least the value of the operator set flow sensitivity Vsews the ventilator delivers a breath If the patient is not inhaling any difference between delivered flow and expiratory flow is due to flow sensor inaccuracy or leaks in the ventilator breathing circuit To compensate for leaks which can cause autotriggering the clinician can increase the Vegns setting or enable Leak Sync if available Note Leak Sync is a software option Details on its operation are provided in the Leak Sync appendix in this manual Reference Appendix B A backup pressure triggering threshold of 2 cmH30 is also in effect
342. lues are stabilized indicating the maneuver can be ended Operator s Manual 4 31 Operation To perform an automatic expiratory pause 1 Press and release the expiratory pause key on the GUI or touch and release Start if performing the expiratory pause from the GUI screen The ventilator performs the expiratory pause maneuver and displays a circuit pressure graph PEEPr 7 and PEEP along with the date and time To perform a manual expiratory pause 1 Press and hold the expiratory pause key on the GUI bezel or touch and hold Start if performing the expiratory pause from the GUI screen The ventilator prompts that the maneuver has started and to release the button to end the maneuver The ventilator performs the expiratory pause maneuver and displays a circuit pres sure graph PEEP 6y and PEEP along with the date and time 2 Accept or reject the pause results To cancel an expiratory pause maneuver 1 Touch Cancel on the GUI screen 4 9 3 Other Respiratory Maneuvers To perform other respiratory maneuvers touch the corresponding tab on the desired maneuver and follow the prompts on the GUI screen 410 Oxygen Sensor Function The ventilator s oxygen sensor monitors O3Yh This cell is mounted in the inspi ratory module in the BDU and monitors the percentage of oxygen in the mixed gas delivered to the breathing circuit it may not reflect the actual oxygen con centration in the gas the patient inspires Reference the
343. lume A WARNING The audio alarm volume level is adjustable The operator should set the volume at a level that allows the operator to distinguish the audio alarm above background noise levels To institutionally configure the alarm volume 1 Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode 2 Touch Alarm Volume Defaults A screen appears allowing configuration of the alarm volume by circuit type 3 Slide the alarm slider for each circuit type adult pediatric or neonatal or turn the knob to configure the alarm volume The volume settings range from 1 minimum to 10 maximum 4 lf done configuring the alarm volume exit Service Mode a00 To adjust alarm volume 1 Set the alarm volume by pressing the alarm volume key then sliding the alarm volume slider or turning the knob The alarm values range from 1 minimum to 10 maximum Operator s Manual 3 41 Installation Note A sample alarm tone sounds for verification at each volume level change If necessary re adjust the alarm volume by moving the alarm volume slider to increase or decrease the volume LA Note The alarm volume reverts to the institutionally configured default alarm volume or factory default if the ventilator s power is cycled 2 Dismiss the slider by touching anywhere on the GUI screen or allow to time out in five 5 seconds Vital
344. m I v Contains components manufactured with phthalates The ventilator contains components manufactured with phthalates MR unsafe Unsafe to use the ventilator in magnetic resonance imaging environ ments G Potential equalization point ground on AC panel CB1 BDU Circuit Breaker on AC panel CB2 Compressor Circuit Breaker on AC panel USB port at rear of ventilator HDMI port at rear of ventilator MNA gIMWU 20T h Service port at rear of ventilator Operator s Manual GUI Controls and Indicators Table 2 3 BDU Rear Label or Panel Symbols and Descriptions Continued Symbol Description Service mode button at rear of ventilator ANMA Remote alarm port at rear of ventilator SSS ad ae Ethernet connector at rear of ventilator Serial port at rear of ventilator lOlO Table 2 4 Common Symbols Found on GUI or BDU Labels Symbol Description Do Not Push Do not push on the GUI Manufacturer Name of the ventilator manufacturer Serial number Manufacture date The manufacture date is contained in the serial number Reference Manufacture Date p 1 19 for details regarding interpretation of the serial number WEEE Proper waste disposal Follow local governing ordinances regarding disposing of waste labeled with the WEEE symbol EHE Operator s Manual 2 1
345. m indicates a background test or Power On Self Test POST has failed Depending on which test failed the ventilator either contin ues to ventilate according to current settings or ventilates with modified set tings or enters the ventilator inoperative state The DEVICE ALERT alarm relies on the ventilator s self testing and notifies the clinician of an abnormal condi tion requiring service Reference Background Diagnostic System p 10 74 6 5 14 High Circuit Pressure TPprax Alarm The TPpeax alarm indicates the currently measured airway pressure is equal to or greater than the set limit The TPpgak limit is active during all breath types and phases to provide redundant patient protection for example to detect air flow restrictions downstream of the pressure sensing device The TPpgak limit is active in all normal ventilation modes The 7 Ppgax alarm new patient default values are separately configurable for neonatal pediatric and adult patients The Poe ax limit is not active during a SEVERE OCCLUSION alarm 6 36 Operator s Manual Ventilator Settings The TPprag alarm truncates inspiration and transitions the ventilator into the exhalation phase and the limit cannot be set less than e PEEP 7 cmH50 or e PEEP Pi 2 cmH70 or PEEP Psupp 2 cmH20 nor can it be set less than or equal to 4Pprag The TPpgak limit cannot be disabled The ventilator phases in changes to the TPpgak limit immediately to allow promp
346. m of the inspiratory filter Operator initiated mandatory breath A breath delivered when the oper ator presses the MANUAL INSP key Continuously running tests during ventilation that assess the ventilator s electronics and pneumatics hardware Occlusion status cycling A state invoked during a severe occlusion In this mode the ventilator periodically attempts to deliver a pressure based breath while monitoring the inspiration and expiration phases for the continuing existence of the occlusion The final status of an SST or EST run in which the operator used the over ride feature The ventilator must have ended the test with an ALERT con dition Failures cannot be overridden The entire inspiratory expiratory conduit including tubing humidifier and water traps An alarm condition associated with an abnormal condition of the patient s respiratory status A definition used by the ventilator s safety net Patient problems are declared when patient data are measured equal to or outside of alarm thresholds and are usually self correcting or can be corrected by a prac titioner The alarm monitoring system detects and announces patient problems Patient problems do not compromise the ventilator s perfor mance Predicted body weight a ventilator setting that specifies the patient s body weight assuming normal fat and fluid levels Determines absolute limits on tidal volume and peak flow and allows appropriate matching of ventila
347. mH 70 Resolution 1 cmH 0 Apnea inspiratory time Tj Same as inspiratory time for non apnea ventilation Range 0 20 s to 8 s Resolution 0 01 s in PC or VC 0 02 sin VC Operator s Manual Operator s Manual Performance Specifications Table 11 9 Ventilator Settings Range and Resolution Continued Setting Apnea interval Ta Description The time after which the ventilator transitions to apnea ventilation Ta 2 60 fa Range and Resolution Range 10 s to 60 s or OFF in CPAP Resolution 1 s Apnea O Yo Determines the oxygen concentration in a stan dard mixture of air and oxygen Range 21960 to 100 O Resolution 1 Apnea peak inspiratory The maximum rate of tidal volume delivery during mandatory volume based apnea breaths Range When mandatory type is VC NEONATAL 1 L min to 30 L min PEDIATRIC 3 0 L min to 60 L min ADULT 3 0 L min to 150 L min Resolution 0 1 L min for flows lt 20 L min BTPS 1 L min for flows 20 L min BTPS Apnea respiratory rate fa Apnea tidal volume V7 Sets the number of volume or pressure based breaths per minute for ventilator initiated manda tory VIM apnea breaths Sets the volume of gas delivered to the patient s lungs during a mandatory volume controlled apnea breath Apnea tidal volume is compensated for body temperature and pressure saturated BTPS and the compliance of the patient circuit Range
348. mate of the neuromus cular drive to breathe When a Po maneuver ends successfully the calculated airway pressure dis 0 1 plays on the waveforms screen and on the maneuver panel A Pg maneuver is terminated if seven 7 s elapse and a trigger has not been detected to acti vate the maneuver A Po 1 maneuver is canceled if e Disconnect is detected e Occlusion is detected e SVO is detected Operator s Manual 10 55 Theory of Operations 10 56 10 14 5 e TPprax alarm is declared o TPypnr alarm is declared e 1V alarm is declared e INSPIRATION TOO LONG alarm is declared e Communications with the GUI is lost e A manual inspiration is requested Vital Capacity VC Maneuver The Vital Capacity VC maneuver is a coached maneuver where the patient is prompted to draw a maximum inspiration regardless of the current settings and then to slowly and fully exhale When the Vital Capacity maneuver becomes active the ventilator delivers a spontaneous inspiration in response to patient effort with Psupp O Rise time 50 and Ecens O and then allows for a full exhala tion effort When a Vital Capacity maneuver is requested a single Volume Time waveform grid is automatically displayed A Vital Capacity maneuver is canceled if e Disconnect is detected e Occlusion is detected e SVO is detected e TPpgax alarm is declared TPygnr alarm is declared e V7 alarm is declared e INSPIRATION TOO LONG alarm is
349. maximum fill line Operator s Manual Safety Information WARNING Accessory equipment connected to the analog and digital interfaces must be certified according to IEC 60601 1 Furthermore all configurations shall comply with the system standard IEC 60601 1 1 Any person who connects additional equipment to the signal input part or signal output part of the ventilator system configures a medical system and is therefore responsible for ensuring the system complies with the requirements of the system standard IEC 60601 1 1 If in doubt consult Covidien Technical Services at 1 800 255 6774 or your local representative 1 3 9 Warnings Regarding Gas Sources WARNING Do not use nitric oxide helium or mixtures containing helium with the ventilator It has not been validated for use with these gas mixtures WARNING To avoid the risk of ventilator malfunction do not use the ventilator with anesthetic gases WARNING For proper ventilator operation use only clean dry medical grade gases when ventilating a patient A WARNING Use of only one gas source could lead to loss of ventilation and or hypoxemia if that one gas source fails and is not available Therefore always connect at least two gas sources to the ventilator to ensure a constant gas supply is available to the patient in case one of the gas sources fails The ventilator has two connections for gas sources air inlet and oxygen inlet A WARNING Use of the ventilat
350. may e limit the air circulation around the ventilator potentially causing over heating e limit the ventilator s ability to exhaust patient exhaled gas leading to potential harm limit the clinician s ability to hear ventilator alarms WARNING To avoid injury do not position the ventilator in a way that makes it difficult to disconnect the patient WARNING To ensure proper operation do not position the ventilator in a way that makes it difficult to access the AC power cord WARNING Do not use the ventilator in a hyperbaric chamber It has not been validated for use in this environment WARNING Do not use the ventilator in the presence of strong magnetic fields Doing so could cause a ventilator malfunction WARNING Do not use the ventilator during radiotherapy i e cancer treatment using ionizing radiation as doing so could cause a ventilator malfunction WARNING To avoid the risk of ventilator malfunction operate the ventilator in an environment that meets specifications Reference Environmental Specifications p 11 7 Operator s Manual 1 7 Introduction WARNING Do not use the ventilator as an EMS transport ventilator It has not been approved or validated for this use 1 3 5 Warnings Before Using Equipment WARNING Before activating any part of the ventilator be sure to check the equipment for proper operation and if appropriate run SST as described in this manual Reference To run SST
351. mbly s groove 5 Carefully inspect component placement and the complete assembly 7 5 5 Exhalation Valve Flow Sensor Assembly Replacement 1 Replace the exhalation valve flow sensor assembly any time if cracked or damaged in use or if a malfunction occurs during SST or EST 2 Replace the assembly if damage is noted to the hot film wire and thermistor in the center port 3 Perform required calibrations Reference Operator Preventive Maintenance Fre quency p 7 2 To install the exhalation valve flow sensor assembly into the ventilator 1 With the expiratory filter door open insert the assembly directly under the exha lation valve and push straight up until it snaps into place Reference nstalling the Exhalation Valve Flow Sensor Assembly p 7 24 To avoid damaging the hot film wire do not insert fingers into any opening 2 Install the expiratory filter by sliding it onto the tracks in the door and orienting the filter s From Patient port through the hole in the door 3 Close expiratory filter door and lower expiratory filter latch Operator s Manual 7 23 Preventive Maintenance Figure 7 16 Installing the Exhalation Valve Flow Sensor Assembly VEN_10300_A 4 Run EST after disinfection 7 5 6 Storage 1 Pre test the exhalation valve flow sensor assembly before storage by installing it into the ventilator and running SST to test the integrity of the breathing system Reference To run SST p 3 48 2
352. midifier settings 1 Touch the More Settings tab 2 Touch the appropriate button for Humidification Type 3 For non HME humidification types touch Humidifier Volume then turn the knob to adjust the empty humidifier volume 4 Touch Accept ALL to apply the changes A WARNING To ensure the accuracy of PAV breaths and spirometry measurements run SST following any change to the humidification type or humidification volume settings Ensure that the intended circuit is used with the SST p 4 3 Apnea Parameters Adjustment After accepting the PAV settings touch the Apnea Setup screen Adjust the Apnea parameters as required Operator s Manual D 7 PAV Appendix D 8 p 4 4 Alarm Settings Adjustment D 4 5 D 4 6 PAV includes the high inspired tidal volume TV and low exhaled sponta neous tidal volume alarm 4Vrg spon alarm limit settings Reference PAV Alarms p D 10 Note Because of the breathing variability that PAV allows the Vg spony alarm by default is turned OFF to minimize nuisance alarms To monitor adequate ventilation use the 4V tor alarm condition instead To adjust alarm settings 1 Touch the Alarm tab to view the current alarm settings 2 Touch the button for each alarm limit requiring a change 3 Turn the knob to adjust the value of the alarm limit Proposed values are highlight ed You can change more than one alarm limit before applying the changes 4 Touch Accept or Ac
353. minal at 100 L min flow External Inspiratory filter resistance reusable 0 2 cmH 0 lt resistance lt 4 2 cmH 0 at 60 L min 0 2 cmH 0 lt resistance lt 2 2 cmH 0 at 30 L min 0 2 cmH70 lt resistance lt 1 7 cmH 0 at 15 L min External Inspiratory filter bacterial viral filtration efficiency disposable gt 99 999 External Inspiratory filter particle filtration effi ciency disposable inspiratory filter gt 99 97 retention of particles 0 3 um nominal at 100 L min flow Expiratory filter particle filtration efficiency reus able gt 99 97 retention of particles 0 3 um nominal at 100 L min flow Expiratory filter bacterial viral filtration efficiency reusable gt 99 999 Expiratory filter resistance pediatric adult reus able and disposable lt 2 5 cmH5 0 at 30 L min when new lt 1 7 cmH 0 at 15 L min Operator s Manual Physical Characteristics Table 11 4 Technical Specifications Continued Expiratory filter bacterial viral filtration efficiency disposable Expiratory filter particle filtration efficiency dis posable Expiratory filter bacterial viral filtration efficiency neonatal disposable Expiratory filter particle filtration efficiency neo natal disposable Expiratory filter resistance neonatal disposable Circuit compliance gt 99 999 gt 99 97 retention of particles 0 3 um nominal at 100 L min flow gt 99 999 gt 99 97
354. mini mize the potential for introduction of particles Operator s Manual Service Personnel Preventive Maintenance Table 7 1 Operator Preventive Maintenance Frequency Continued Part Reusable expiratory filter Frequency e Before every use e After 15 days of continu ous use in the exhalation limb replace e Yearly or after 50 auto clave cycles replace e Whenever excess resis tance is suspected Maintenance e Inspect and replace if cracked crazed or dam aged Sterilize between patients and circuit chang es or according to the institution s policy Steril ize before non destructive disposal or dispose of filter according to the insti tution s policy e Run SST to check resis tance of the expiratory limb and filter e Use care when changing expiratory filter to avoid filter damage and mini mize the potential for introduction of particles Condensate vial e Several times a day or as required by the institu tion s policy e Before every use e After 15 days of continu ous use with the expiratory filter replace e Check and empty as needed e Inspect and replace if cracked crazed or dam aged e Clean and sterilize between patients and circuit changes Reference Condensate Vial Cleaning p 7 8 for instructions Ref erence Component Steril ization p 7 24 for sterilization requirements e Sterilize before non destructive disposa
355. n drive the actuator e g the hardware drivers and valves to cause a change in the manipulated variable e g inspiratory flow Disturbances Error Controller Netiatot Manipulated Controlled Input gt Plant signal software hardware Variable Variable Note In the diagram above the plant is the patient and the connected breathing circuit Feedback Signal 1 4 Inspiration Detection and initiation When ventilator inspiration occurs it is called triggering Breaths are delivered to the patient based on ventilator settings the practitioner has entered and are determined by pressure flow or time measurements or operator action The ventilator uses the following methods to trigger an inspiration e Pressure triggering P_tpic e Flow triggering V 11G e Time triggered e Operator initiated e TE Sync triggered if the IE Sync option is installed in SPONT mode only 10 4 Operator s Manual Short Self Test SST Note Reference Appendix C in this manual for more information on IE Sync If the ventilator detects a drop in pressure at the circuit wye or when there is a decrease in base flow measured at the exhalation valve the patient is said to trigger the breath Mandatory breaths triggered by the patient are referred to as PIM or patient initiated mandatory breaths All spontaneous breaths are patient initiated and are also triggered by a decrease in circuit pressure or measured b
356. n entering Service Mode 2 Touch Date and Time 3 Touch the button corresponding to 12 hour or 24 hour time 4 Touch Hour and turn the knob to enter the correct hour 5 Repeat for the minutes and am or pm 6 Touch the button corresponding to the date format desired DD MM YYYY or MM DD YYYY 7 Touch Accept to confirm the date and time s If done configuring parameters exit Service Mode 3 38 Operator s Manual Product Connectivity Pressure Units The ventilator s pressure units can be configured for hPa or cmH50 To institutionally configure pressure units 1 Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode 2 Touch Vent Setup 3 Touch the button corresponding to the desired pressure units 4 lf done configuring parameters exit Service Mode by touching Exit Screen Brightness and Keyboard Backlight Light Settings To institutionally configure screen brightness and keyboard backlight 1 Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode 2 Touch Light Settings Sliders appear to adjust the screen brightness and keyboard backlight 3 Move the sliders to increase or decrease the brightness and backlight levels Alter natively turn the knob to increase or decrease the brightness and back
357. n or dry the ventilator including the GUI cooling vents Do not submerge the ventilator or pour cleaning solutions over or into the ventilator Window cleaning solution iso propyl alcohol and ammonia Ammonia 15 solution Hydrogen peroxide 3 solu tion Formula 409 cleaner Clorox Company CaviCide surface disinfectant Metrex Research Corporation Control Ill germicide Maril Products Inc Virox spray or pre wipes Virox Technologies Inc Mr Muscle Window 8 Glass SC Johnson Sani Cloths PDI Inc Propan 2 ol Isopropanol Iso propyl Alcohol Operator s Manual 7 5 Preventive Maintenance Table 7 2 Surface Cleaning Agents Continued Part Ventilator cooling vents Procedure Vacuum the vents at the back of the GUI and BDU to remove dust Comments Cautions N A 1 Chemicals stated are the generic equiva WARNING To avoid microbial contamination and potential performance problems do not clean disinfect or reuse single patient use SPU or disposable components Discard per local or institutional regulations ents of Mr Muscle Window amp Glass 7s Component Cleaning and Disinfection Risks associated with reuse of single patient use items include but are not limited to microbial cross contamination leaks loss of part integrity and increased pressure drop When cleaning reusable components do not use hard brushe
358. nappropriate for the patient s predicted body weight PBW Each setting has either soft bounds can be overridden or hard bounds no override allowed that alert the operator to the fact that the settings may be inappropriate for the patient In the event that the patient is connected without any parameters being specified the ventilator enters Safety PCV a safe mode of ventilation regardless of the circuit type in use neonatal pediat ric or adult or patient s PBW Safety PCV is entered after POST if a patient connection is made prior to settings confirmation Safety PCV uses New Patient default settings with exceptions shown in the following table Table 10 9 Safety PCV Settings Parameter Safety PCV value PBW Neonatal 3 kg Pediatric 15 kg Adult 50 kg mode A C mandatory type PC ftor total respiratory rate Neonatal 25 1 min Pediatric 16 1 min Adult 16 1 min T Neonatal 0 3 s Pediatric 0 7 s Adult 1 s Pj 15 cmH 70 07 Neonatal 40 Pediatric 100 Adult 100 Operator s Manual Table 10 9 Safety PCV Settings Continued Short Self Test SST Circuit type Parameter Safety PCV value PEEP 3 cmH 0 Trigger type Neonatal V_tpig Pediatric P_tpic Adult P_trig PsEns 2 cmH70 VSENS 1 0 L min TPpeaK 20 cmH70 TVE Tor alarm OFF We tor alarm 0 05 L min TVg alarm OFF VTE MAND alarm OFF WV TE spont alarm OFF Last set value or adult if none availab
359. nce 7 2 Table 7 1 Operator Preventive Maintenance Frequency Part Patient circuit inspiratory and expiratory limbs Water traps and drain bag Oxygen sensor calibration Inlet air filter bowl Frequency Several times a day or as required by the institution s policy Maintenance e Check both limbs for water accumulation e Empty and clean Check and empty as needed From the ventilator setup screen touch the More Settings tab To calibrate the oxygen sensor touch Calibrate in the oxygen sensor area of the screen Reference Oxygen sensor cali bration testing p 4 34 for information on testing the oxygen sensor calibration e Replace bowl if it is cracked e If any sign of moisture is visible remove ventilator from use and contact service personnel Reusable inspiratory filter e Before every use e After 15 days of continu ous use in the inspiratory limb replace e Yearly or after 50 auto clave cycles replace e Whenever excess resis tance is suspected e Inspect and replace if cracked crazed or dam aged Sterilize between patients and circuit chang es or according to the institution s policy Steril ize before non destructive disposal or dispose of filter according to the insti tution s policy e Run SST to check resis tance of the inspiratory imb e Use care when changing inspiratory filter to avoid filter damage and
360. nd Puritan Bennett 980 Universal Ventilators In order for a Puritan Bennett 980 Pediatric Adult Ventilator to be used with Neonatal patients the NeoMode 2 0 software option must be installed t2 Intended Use NeoMode 2 0 is intended to provide respiratory support to neonatal patients with predicted body weights as low as 0 3 kg 0 66 Ib It is intended to cover a wide variety of clinical patient conditions in hospitals and hospital type facil ities and may be used during intra hospital and intra hospital type facility transport It supports delivered tidal volumes as low as two 2 mL e3 Safety Symbol Definitions This section contains safety information for users who should always exercise appropriate caution while using the ventilator E 1 NeoMode 2 0 Appendix Table E 1 Safety Symbol Definitions Symbol A Definition WARNING Warnings alert users to potential serious outcomes death injury or adverse events to the patient user or environment o Caution Cautions alert users to exercise appropriate care for safe and effective use of the product Q Note Notes provide additional guidelines or information ea Safety Information A WARNING The Puritan Bennett 980 Series Ventilator contains phthalates When used as indicated very limited exposure to trace amounts of phthalates may occur There is no clear clinical evidence that this degree of exposure increases clinical ri
361. nd can ensure the patient is adequately oxygenated The ventilator declares a 402 alarm after 30 seconds to eliminate nuisance alarms from transient 07 delivery variations The O2 measured by the 6 40 Operator s Manual Ventilator Settings oxygen sensor is shown in the patient data area Reference Vital Patient Data p 3 42 to include 05 if it is not displayed 6 5 23 Low Exhaled Mandatory Tidal Volume VVE manp Alarm The alarm indicates the measured exhaled mandatory tidal volume is less than or equal to the 4V manp alarm setting The 4Vte manp alarm updates when a new measured value of exhaled mandatory tidal volume is available The W7 manp alarm can detect an obstruction a leak during volume ventila tion or a change in compliance or resistance during pressure based ventilation that is when the same pressure is achieved but tidal volume decreases There are separate alarms for mandatory and spontaneous exhaled tidal volumes for use during SIMV SPONT and BiLevel The ventilator phases in a change to the We MAND alarm immediately to ensure prompt notification of a low exhaled tidal volume condition 6 5 24 Low Exhaled Spontaneous Tidal Volume 4V E spont Alarm The JV7g spont alarm indicates the measured exhaled spontaneous tidal volume is less than or equal to the Vr7 cpon alarm setting The alarm updates when a new measured value of exhaled spontaneous tidal volume is available The Ve spont alarm can det
362. nect PCBA 10083941 Purge Control Cable 10083940 Purge Supply Line 10083966 PCBA Mounting Screws 10083963 Proximal Flow Option Label 10005748 Operator s Manual analysis message assist breath assist control A C mode augmented alarm autotriggering background checks backup ventilation BUV base flow base message batch changes battery back up system BD BDU Table Glossary 1 Glossary of Ventilation Terms A message displayed on the GUI screen during an alarm condition iden tifying the root cause of the alarm A mandatory breath triggered by patient inspiratory effort in A C and SIMV modes A ventilation mode where only mandatory VC PC or VC breaths are delivered to the patient The initial cause of an alarm has precipitated one or more related alarms When an alarm occurs any subsequent alarm related to the cause of this initial alarm augments the initial alarm The ventilator delivers repeated unintended breaths triggered by fluctu ating flows or pressures as opposed to patient demand Patient circuit leaks and low flow or pressure sensitivity settings are common causes of autotriggering Continuously running tests during ventilation that assess the ventilator s electronics and pneumatics hardware A safety net feature which is invoked if a system fault in the mix subsys tem inspiratory subsystem or expiratory subsystem occurs compromis ing the ventilator s ability to v
363. neous minute volume in liters 6 characters Operator s Manual Product Data Output Component Table 5 1 MISCA Response Continued Maximum circuit pressure in cmH 0O 6 characters Mean airway pressure in cmH50O 6 characters End inspiratory pressure in cmH 0 6 characters Expiratory component of monitored value of E ratio assuming inspiratory com ponent of 1 6 characters High circuit pressure limit in cmH 0 6 characters Not used 6 characters Low exhaled tidal volume limit in liters 6 characters Low exhaled minute volume limit in liters 6 characters High respiratory rate limit in breaths per minute 6 characters High circuit pressure alarm status NORMAL ALARM or RESET 6 characters Not used 6 characters Low exhaled tidal volume mandatory or spontaneous alarm status NORMAL ALARM or RESET 6 characters Low exhaled minute volume alarm status NORMAL ALARM or RESET 6 characters High respiratory rate alarm status NORMAL ALARM or RESET 6 characters No O supply alarm status NORMAL ALARM or RESET 6 characters No air supply alarm status NORMAL ALARM or RESET 6 characters Not used 6 characters Apnea alarm status NORMAL ALARM or RESET 6 characters Field 58 59 Not used 6 characters Field 60 Ventilator time HH MM 6 characters Field 61 N
364. nity 0 cece cece eee eee eee 11 31 Recommended Separation Distances for RF 11 34 pn oie budendsa E a ID nG PALABAN AA EREA 11 35 Safety Symbol Definitions 0 cece cece eee eens A 3 Safety Symbol Definitions aaa B 2 Leak Compensation Volumes Based on Patient Type B 3 Decne SCUUINOS tia ota ceeds aetna PANATA a nba ates B 6 Safety Symbol Definitions 0 aaa C 2 Safety Symbol Definitions ccc cece cece eee eens D 2 Absolute limits for PAV Monitored Data D 9 PAV Work of Breathing terms c cece eee eens D 13 Default PBW based Resistance Values D 23 Safety Symbol Definitions aaa E 2 Recommended Breathing Circuits cc cee eee eee eee E 8 Delivered Volume Accuracy maaawa E 12 Table E 4 Monitored Inspired Volume Vn Accuracy E 12 Table E 5 Monitored Exhaled Tidal Volume Vre Accuracy E 13 Table F 1 Safety Symbol Definitions 0 cece ee cee eee ene eee F 2 Table F 2 Proximal Flow Option Patient Data Symbols F 8 Table F 3 Proximal Flow Option SST test Sequence F 10 Table F 4 Proximal Flow Sensor Volume Accuracy 0 eeeeeeee F 17 Table F 5 Proximal Flow Sensor Specifications F 18 Table F 6 Proximal Flow Option Component Part Numbers F 18
365. not been reviewed 2 If the settings are acceptable touch Accept ALL The Previous Setup button disappears when the previous settings are con firmed and re appears when ventilating with new settings 4 5 Constant Timing Variable During Respiratory Rate Changes A breath timing graph appears at the bottom of the setup screen which illus trates the relationship between inspiratory time expiratory time I E ratio Operator s Manual Ventilator Shutdown respiratory rate and the effects on breath timing due to flow pattern tidal volume and Vmax during mandatory PC VC BiLevel or VC breaths With BiLevel PC and VC breaths three padlock icons are located underneath the breath timing graph allowing the operator to select from left to right T LE ratio or Te as the constant variable during rate changes or Ty Ty T ratio or T in BiLevel If the ventilation mode is SPONT the padlock icons do not appear and the breath timing graph only displays T for a manual inspiration If the mandatory type is VC the icons do not appear but the breath timing graph displays T 1 E ratio and Te To choose a constant timing variable for rate changes 1 Touch a padlock icon corresponding to the parameter to make constant during rate changes this changes the padlock s appearance from unlocked to locked The locked parameter glows in the settings area 2 Turn the knob to adjust the parameter s value 3 Touch Acc
366. ns information regarding ventilator logs on the Puritan Ben nett 980 Series Ventilator WARNING To avoid a potential electrical shock do not attempt to correct any electrical problem with the ventilator while it is connected to AC power s2 Problem Categories For the Puritan Bennett 980 Series Ventilator Operator s Manual trouble shooting is limited to responding to ventilator alarms and reviewing various ventilator logs For detailed alarm information including how to respond to alarms Reference Chapter 6 to address individual alarms that may occur during ventilator use Qualified service personnel who have attended the Covi dien training class for Puritan Bennett 980 Series Ventilators should consult the Puritan Bennett 980 Series Ventilator Service Manual for detailed repair information and ventilator diagnostic codes ss How to Obtain Ventilator Service To obtain service for the ventilator call Covidien Customer Service at 1 800 635 5267 and follow the prompts sa Used Part Disposal Follow local governing ordinances and recycling plans regarding disposal or recycling of device components Discard all damaged parts removed from the ventilator during the maintenance procedures according to your institution s protocol Sterilize contaminated parts before non destructive disposal 8 1 Troubleshooting 8 2 s5 Ventilator Logs The ventilator uses various logs to store event information for later retrieval
367. nsition time 2 5 x duration of the spontaneous inspiration or the start time of the spontaneous breath the length of the apnea interval Ta If the current mode is BiLevel in the P state and the current breath is mandatory the time t until the first VIM of the new A C mode is the lesser of PEEP transition time 2 5 x duration of the active gas delivery phase or the length of the apnea interval Ta or the length of the current breath cycle If the current mode is BiLevel in the P state and the current breath is spontaneous and the spontaneous start time has occurred during P the time t until the first VIM of the new A C mode is the lesser of 3 5 x duration of the spontaneous inspiration or the length of the apnea interval Ta or the length of the current breath cycle Operator s Manual Short Self Test SST e f the current mode is BiLevel in the P state and the current breath is spontaneous and the spontaneous start time has occurred during Py the time t until the first VIM of the new A C mode is the lesser of PEEP transition time 2 5 x duration of the spontaneous inspiration or the start time of the spontaneous breath the length of the apnea interval Ta If the command to change to SIMV occurs after the restricted phase of exha lation has ended and before a next breath or the apnea interval has elapsed the ventilator delivers the first SIMV VIM at the moment the command is
368. nsition to the Pi level takes place at the end of the Ty period a 9 2 Patient Monitoring in BiLevel If the patient breathes spontaneously at either pressure level BiLevel monitors and displays the total respiratory rate including mandatory and spontaneous breaths BiLevel also displays the exhaled tidal volume and total exhaled minute A 8 Operator s Manual Technical Description volume for both mandatory and spontaneous breaths a 9 3 APRV Strategy in BiLevel Lengthening the T4 period and shortening the Tj period to only allow incom plete exhalation of the mandatory breath volume results in an inverse Ty T ratio In this breath timing configuration with T T ratios of greater than 4 1 BiLevel becomes Airway Pressure Release Ventilation APRV APRV is characterized as longer Ty periods short T periods usually less than one second and inverse Ty T ratios Since at these breath timing settings all of the patient triggered spontaneous breaths occur during the Ty period APRV resembles CPAP ventilation with occasional short periods of incomplete exhalation referred to as releases which are controlled by the f setting Figure A 6 APRV With Spontaneous Breathing at Py 2 3 1 i VEN 11341 A 1 Peirce cmH20 3 Shortened release time T 2 Lengthened inspiratory time Ty In APRV the Py level is set to optimize pulmonary compliance for spontaneous breathing while mainta
369. nspiration when Pcync reaches the set lens threshold and detects the end of inspiration when the Psync signal reaches the set Ecens threshold Alarms during IE Sync C wo If an alarm occurs during IE Sync which causes the ventilator to enter inspiratory or expiratory Back Up Ventilation BUV the trigger type automatically changes to the factory default trigger type which can be institutionally configured If and when the alarm that caused BUV is corrected IE Sync will not automatically be re enabled if IE Sync is still desired then the user must re enable it An apnea condition during IE Sync causes the trigger type to change to P tpic with Pseys of two 2 cmH50 IE Sync breaths go through a startup period when normal ventilation resumes after the following resets e Circuit occlusion e Circuit disconnect e Loss of both gas supplies SVO e Calculated lung compliance value is invalid e Calculated patient resistance value is invalid If there are five 5 internal resets in a 20 minute period IE Sync will automat ically become disabled and will be set to V_tpig with new patient default sen sitivities Reference the table Ventilator Settings Range and Resolution in Chapter 11 of this manual A message displays on the GUI if IE Sync becomes disabled due to internal resets and the unread items icon appears on the ven tilator setup dialog Operator s Manual C 7 IE Sync Appendix C 4 Page Left Intentionally B
370. nterior surface of the from patient port with the solution to clean it Operator s Manual 7 11 Preventive Maintenance Figure 7 3 From Patient Port VEN_11624_A 3 Allow to dry by orienting the filter in the upright position for the contact time period recommended by the solution s manufacturer Figure 7 4 Expiratory Filter Drying Orientation VEN 11625 A 7 12 Operator s Manual Service Personnel Preventive Maintenance a Rinse all filter surfaces that were exposed to the cleaning solution with water using care to prevent liquid from entering the filter 5 Allow the filter housing to dry until all liquid has evaporated 7 5 3 Exhalation Valve Flow Sensor Assembly Disinfection Note Exhalation valve flow sensor assembly disinfection is not required on a routine basis but it may be disinfected Reference Component Cleaning Agents and Disinfection Procedures p 7 6 for a list of appropriate disinfectants P Note Follow the institution s infection control protocol for handling storage and disposal of potentially bio contaminated waste Caution To avoid damaging the hot film wire do not insert fingers or objects into the center port when disinfecting the exhalation valve flow sensor assembly The exhalation valve flow sensor assembly contains the exhalation valve body exhalation valve flow sensor exhalation valve diaphragm expiratory filter seal and pressure sensor filter The expiratory flow sensor el
371. nti lator annunciates a CIRCUIT DISCONNECT alarm after the inspiratory filter is dis connected 2 Connect the inspiratory filter to the To Patient port to autoreset the alarm LOW EXHALED MANDATORY TIDAL VOLUME LV 7 manp alarm test Set V7 to 225 mL The ventilator annunciates a LOW EXHALED MANDATORY TIDAL VOLUME LV t mann alarm on the third consecutive breath after Accept is touched LOW EXHALED TOTAL MINUTE VOLUME lV tor alarm test Set LVe tor alarm limit to 3 45 L min The ventilator annunciates a LOW EXHALED TOTAL MINUTE VOLUME Wg tor alarm on the next breath after Accept is touched HIGH CIRCUIT PRESSURE TPprax alarm test 1 Make the following patient and alarm settings changes Vz 500 mL VMAX 30 L min TPPEAK 20 cmH20 2 After one breath the ventilator annunciates a HIGH CIRCUIT PRESSURE TPpr ap alarm If the alarm does not sound check the patient circuit for leaks SEVERE OCCLUSION alarm test 1 Make the following alarm settings changes TPPEAK 50 cmH20 Operator s Manual 6 11 Performance 6 Press the alarm reset key to reset all alarms Adjust Dsens to the VMAX setting Disconnect the ventilator breathing circuit from the FROM PATIENT port and block the gas flow While maintaining the occlusion ensure the safety valve open indicator appears on the status display the GUI shows the elapsed time without normal ventilation support and the test lung inflates and deflates rapidly wit
372. ntilation o t o 3 6 VEN_11507_A 1 Pressure cmH 0 5 PEEP 2 Flow L min 6 Inspiration phase 3 Volume mL 7 Expiration phase 4 Target pressure 10 7 3 VC VC breaths require initialization and must go through a startup routine VC Startup During VC startup the ventilator delivers at least one breath test breath to determine the pressure target needed to deliver the desired set volume During the time the ventilator is delivering the test breaths the message VC startup is displayed in the GUI s prompt area Note To allow for optimal function of startup and operation of VC in the ventilator it is important not to block the tubing while the patient is undergoing suctioning or other treatment that requires disconnection from the ventilator The ventilator has a disconnect detection algorithm that suspends ventilation while the patient is disconnected Operator s Manual Short Self Test SST After VC Startup the ventilator will make adjustments to the target pressure in order to deliver the set volume V7 In order to reach the desired volume promptly the maximum allowed pressure adjustments for an Adult or Pediatric patient will be greatest during the first five breaths following Startup or a change in Vz or V7 supp The values of the maximum pressure adjustments for each patient type are summarized below Table 10 2 Maximum Pressure Adjustments Conditions Maximum c
373. ntilator functions Ref erence GUI Control Keys p 2 16 211 Breath Delivery Unit The breath delivery unit contains the hardware and software to enable the ven tilator to provide patient support 2 11 1 BDU Controls and Indicators BDU Controls e ON OFF switch Lift the switch cover and turn the ventilator ON or OFF Operator s Manual 2 25 Product Overview Figure 2 8 Ventilator Power Switch and AC Indicator VEN 10285 C 1 AC power indicator 2 ON OFF switch e Service mode button Press and release this button when the Covidien splash screen appears on the status display after powering on the ventilator to enter Service mode Reference Service Mode Button TEST p 2 27 Reference Status Display Indicators and Descriptions p 2 30 for an image of the splash screen 2 26 Operator s Manual GUI Controls and Indicators Figure 2 9 Service Mode Button TEST VEN 11246 D 1 Service mode button Note The Covidien splash screen shows the Covidien logo and appears momentarily as a banner on the status display BDU AC Indicator The status display and the AC power indicator are the only visual indicators on the BDU The AC indicator illuminates green whenever the ventilator is con nected to AC power All other visual indicators on the ventilator are on the GUI Reference Typical Status Display Indicators and Messages p 2 30 for a description of the status display indicators and symbols Reference the sec
374. ntilator has recovered from unintended power loss lasting more than five minutes detects circuit dis connect The GUI screen displays elapsed time without ventilator support Resets when patient is reconnected High No ventilation Check patient Reconnect circuit Ventilator detects circuit disconnect the GUI screen dis plays elapsed time without ventilator support Resets when patient is reconnected COMPLIANCE Low LIMITED Vy alarm is not adjustable patient data alarm Compliance compensation limit reached Check patient and circuit type Inspired volume may be lt set Compliance volume required to com pensate delivery of a VC VC or VS breath exceeds the maximum allowed for 3 of the last 4 breaths Operator s Manual 6 19 Performance Table 6 5 Non technical Alarm Summary Continued TPpEAK patient data alarm Medium Analysis message Last breath gt set imit Last 3 breaths gt set limit Last 4 or more breaths gt set imit Remedy message Check patient circuit amp ET tube Comments Measured airway pressure gt set limit Ventilator trun cates current breath unless already in exhalation Possible dependent alarms WITE MAND 4 Ve TOT Trot Cor rective action Check patient Check tube type ID setting Consider reducing Supp setting or increas ing TPpeak TPcomp patient data alarm Last s
375. ntilator is equipped with two alarms the primary alarm and secondary alarm The primary alarm annunciates high medium and low priority alarms when they occur The secondary alarm also named immediate priority in the table below is a continuous tone alarm and annunciates during Vent Inop con ditions or complete loss of power This alarm is powered by a capacitor and lasts for at least 120 seconds Operator s Manual 6 15 Performance The table below lists alarm priority levels and their visual audible and autore set characteristics An alarm autoresets when the condition causing the alarm no longer exists Table 6 2 Alarm Prioritization Priority Level Immediate Visual indicator Specific to alarm con dition or component failure Audible indicator Continuous tone alarm sounding for at least 120 s Autoreset characteristics N A High Immediate atten tion required to ensure patient safety Flashing red omni directional LED located on the top of the GUI red alarm banner on GUI screen red bar next to alarm setting icon on Alarms screen High priority audible alarm a sequence of five tones that repeats twice pauses then repeats again Visual alarm does not auto reset Visual alarm indicators remain steadily illumi nated following an autoreset The alarm reset key must be pressed to extinguish visual indicator Medium Prompt attention necessary Flashing yel
376. ntrolled PC or volume control plus VC breath types also called Mandatory Type e VC Volume Control The ventilator delivers an operator set tidal volume e PC Pressure Control The ventilator delivers an operator set pressure e VC Volume Control Plus Volume control plus a mandatory pressure controlled breath type that does not restrict flow during the inspiratory phase and Operator s Manual Ventilator Settings automatically adjusts the inspiratory pressure target from breath to breath to achieve the desired tidal volume despite changing lung conditions Reference Mandatory Breath Delivery p 10 17 for more information on VC Mandatory inspirations are triggered in the following ways e Pressure Trigger P_trig Changes in circuit pressure cause the ventilator to deliver a breath These pressure changes relate to the pressure sensitivity Pseys set by the operator If the patient makes an effort to inspire the airway pressure drops If the pressure drops by at least the value of Peeps the ventilator delivers a breath e Flow Trigger V_tpig Changes in flow in the circuit cause the ventilator to deliver a breath The breath delivery and exhalation valve flow sensors measure gas flow in the ventilator breathing system As the patient inspires the delivered low remains constant and the exhalation valve flow sensor measures decreased flow When the difference between the two flow measurements is at l
377. o exhalation during sponta neous pressure based breaths Range if Leak Sync not enabled 20 to 95 or OFF Range if Leak Sync enabled NEONATAL 1 L min to 15 L min PEDIATRIC 1 L min to 40 L min ADULT 1L min to 65 L min Resolution Leak Sync not enabled 1 Resolution Leak Sync enabled 0 5 L min for values lt 10 L min 1 L min for values 5 10 L min Range 1 to 80 1 L min to 10 L min when Sponta neous Type is PAV NOTE Default value is not expected to need adjustment Only adjust after becoming experienced with PAV and only if it is suspected that the ventilator is not cycling at the patient s end of inspiration Expiratory time TE For PC or VC breaths the time interval between the end of inspiration and the beginning of the next inspiration The end of the exhalation phase is consid ered to be when the flow rate at the patient wye remains less than 0 5 L min above the base flow Range 0 20 s Resolution 0 01 s Flow pattern The flow shape of the delivered mandatory or VC breath Range SQUARE descending ramp Operator s Manual Operator s Manual Performance Specifications Table 11 9 Ventilator Settings Range and Resolution Continued Setting Flow sensitivity Vsens Description For flow triggered breaths determines the volume of flow below the base flow required to begin a man datory or spontaneous patient initiated breath Range and Res
378. o configured When setting the alarm volume a sample tone is generated allowing the practitioner to decide the appropriate alarm volume for the sur rounding ambient conditions If a high priority alarm occurs the alarm volume increases one 1 increment from its current volume level if it is not acknowl edged within 30 s If a high priority alarm is not acknowledged within 60 s the audible alarm volume escalates to its maximum volume Reference To adjust alarm volume p 3 41 for instructions on adjusting the alarm volume Operator s Manual Ventilator Settings WARNING The audio alarm volume level is adjustable The operator should set the volume at a level that allows the operator to distinguish the audio alarm above background noise levels Reference To adjust alarm volume p 3 41 6 5 5 Alarm Testing Testing the alarms requires oxygen and air sources and stable AC power Test the alarms at least every six months using the procedures described Required Equipment e Test lung P N 4 000612 00 e Adult patient circuit If the alarm does not annunciate as indicated verify the ventilator settings and repeat the test The alarm tests check the operation of the following alarms e CIRCUIT DISCONNECT e LOW EXHALED MANDATORY TIDAL VOLUME XVE MAND e LOW EXHALED TOTAL MINUTE VOLUME Wg tor e HIGH CIRCUIT PRESSURE Ppeax e SEVERE OCCLUSION e AC POWER LOSS e APNEA e LOW EXHALED SPONTANEOUS TIDAL VOLUME lV re spont
379. o contains an oxygen sensor which monitors the air oxygen mixture according to the operator set 05 setting After the gas mixes it flows to the inspiratory pneumatic system where the breath delivery flow sensor measures the gas flow and controls a PSOL valve for proper breath delivery tidal volumes and pressures The inspiratory pneu matic system contains a safety valve to avoid over pressure conditions before flowing through bacteria filters to the patient through the inspiratory limb of the patient circuit Upon exhalation gas flows out the patient circuit expiratory limb through the expiratory bacteria filter through the exhalation valve 4 1 Operation which includes the exhalation valve flow sensor and through the exhalation port a3 Ventilator Setup WARNING To avoid interrupted ventilator operation or possible damage to the ventilator always use the ventilator on a level surface in its proper orientation To set up the ventilator 1 Connect the ventilator to the electrical and gas supplies Reference Power Cord Retainer on BDU p 3 7 and Reference Connecting the Ventilator to the Gas Sup plies p 3 9 2 Connect the patient circuit to the ventilator Reference the figures on p 3 76 and p 3 17 to connect the adult pediatric or neonatal patient circuits respectively 3 Turn the ventilator ON using the power switch Reference Ventilator Power Switch and AC Indicator p 2 26 a Before ventilating a patient
380. o recognize is that patient s continuous breathing effort drives the PAV support no effort no support The Supp setting specifies the amount of resistance and elastic based pres sure to be applied at each ith interval at the patient wye By taking all of the above information into consideration EQUATION 2 can be rewritten to include the Supp setting recognizing that V and V are driven by the patient not by the ventilator It is important to note that the ventilator is not amplifying its own flow only the flow generated by Pyys EQUATION 4 i airway Phe SVL Ruirway SVL K 1 SVI x Ky Pressure generated by the ventilator in S Supp setting 100 ranges from 0 05 response to the instantaneous values of to 0 95 lung flow and lung volume at the wye This value is the sum of the three indi vidual pressure elements in parenthe ses in Equation 4 i P wye D 18 Operator s Manual Ventilator Settings Guidance Resulting Pressure Gradient The pressure gradient driving breathing gas into the patient s lungs is given by the sum of P wye and the patient s inspiratory effort therefore EQUATION 5 i i i AP Grapient 7 P wye t Puus APlcaapient _ Instantaneous pressure gradient Phos Instantaneous pressure generating capability of patient s inspiratory muscles pi Pressure generated by the ventilator in wye response to the instantaneous values of lung flow and lung volume at the wye
381. o running EST to ensure accurate testing To perform EST 1 Review and perform all self test prerequisites Reference EST Self Test Prerequi sites p 3 52 2 Collect the appropriate equipment Reference Equipment for EST p 3 54 3 Access Service Mode Reference Service Mode p 3 33 Operator s Manual Product Connectivity 4 Verify all three CALIBRATION tests under the CALIBRATION tab have passed 5 Touch the SELF TEST tab from the horizontal banner at the top of the monitoring screen 6 Touch the EST tab from the left hand menu options 7 Touch Run All to run all tests in sequence or select the desired individual test s Choose one of the available options touch Accept to continue touch Cancel to go back to the previous screen or touch Stop to cancel EST 9 Follow the prompt to remove the inspiratory filter and connect the gold standard circuit 10 Touch Accept 11 Follow prompts to complete EST The EST tests require operator intervention and will pause indefinitely for a response Reference EST Test Sequence p 3 54 12 At the DISCONNECT O prompt disconnect the high pressure oxygen source 13 At the CONNECT AIR AND O prompt connect both high pressure air and oxygen sources 14 Touch Run All or select the desired individual test After each test the ventilator displays the results 15 If a particular test fails either repeat the test or perform the next test 16 When all of the EST t
382. ocess for all parameters needing adjust ment 4 Touch Accept or Accept ALL to confirm the change s 5 Connect the circuit to the patient s airway to start ventilation 45 1 Ventilator Settings WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs The following ventilator settings appear at the new patient setup screen e Predicted Body Weight PBW Adjust the patient s PBW or select the patient s gender and height Reference Predicted Body Weight PBW Calculation p 4 21 e Ventilation type Determines the type of ventilation to be delivered Invasive or Non invasive NIV Invasive Conventional ventilation using endotracheal ET or tracheostomy trach tubes Non invasive NIV Ventilation using non vented full face masks nasal masks infant nasal prongs or uncuffed ET tubes Reference Non invasive Ventilation NIV p 4 22 e Mode Specify the breathing mode A C assist control SIMV synchronous intermittent mandatory ventilation S
383. of operation or more below the O parameter for at least 30 seconds The percentage window increases by 5 for four minutes after increasing the set O2 value Response e Check the patient the air and oxygen supplies the oxygen analyzer and the ventilator e Calibrate oxygen sensor Reference Oxygen Sensor Calibration p 4 34 for details regarding calibrat ing the oxygen sensor e Use an external O monitor and disable the O sensor TV patient data alarm Exhaled tidal volume gt alarm setting for the last two breaths e Check patient settings e Check for changes in patient s resistance and compliance TVE tor patient data alarm Minute volume gt alarm setting Check patient settings Trot patient data alarm The breath rate from all breaths is gt alarm setting Check the patient and the ven tilator settings TPyenr patient data alarm The inspiratory pressure trans ducer has measured a pressure gt 110 cmH50 in VC TC or PAV The ventilator transitions to exhalation A reduced tidal volume is likely e Check the patient the patient circuit including filters and the endotra cheal tube Ensure the ET tube ID is the correct size Check the ventilator flow and or volume settings Re run SST e Obtain an alternate venti lation source e Remove the ventilator from clinical use and obtain service INOPERATIVE BATTERY The battery c
384. of monitored value of I E ratio assuming inspiratory com ponent of 1 6 characters Field 76 LE ratio 6 characters Field 77 Delivered O2 6 characters Field 78 Inspired tidal volume V5 in L 6 characters Field 79 Intrinsic PEEP PEEP in cmH530 6 characters Field 80 Estimated total resistance Ryor in cmH O L s 6 characters Field 81 Estimated patient resistance Rpay in cmH O L s 6 characters Field 82 Estimated patient elastance Epay in cmH30 L 6 characters Field 83 Estimated patient compliance Cpay in mL cmH50 6 characters Field 84 Not used Field 85 Rapid shallow breathing index 7 6 characters Field 86 Spontaneous percent inspiratory time T Tror 6 characters Field 87 Monitored PEEP in cmH20 6 characters Field 88 Spontaneous inspiratory time Tj spont in seconds 6 characters Field 89 Exhaled spontaneous minute volume Vp sponr in L min 6 characters Field 90 Intrinsic PEEP PEEP from expiratory pause maneuver in cmH30O 6 characters Field 91 Total PEEP PEEPror from expiratory pause maneuver in cmH30O 6 characters Field 92 Static compliance Csrar from inspiratory pause maneuver in mL cmH 70 6 characters Field 93 Static resistance Rsrar from inspiratory pause maneuver in cmH O L s 6 characters Operator s Manual Data Transfer Table 5 2 MISCF Response Continued Plateau pressure Pp from inspiratory pause maneuver in cmH O 6 characters High spontaneous ins
385. of that parameter during normal ventilation 3 42 Operator s Manual Product Connectivity 4 When done configuring the selected preset touch Accept and select another preset to configure if desired 5 Touch Defaults to return configuration to factory settings 6 If done configuring parameters exit Service Mode by touching Exit To configure the patient data displayed on the GUI 1 Double tap a patient data parameter at the top of the GUI screen A menu of buttons appears identified with patient data parameters The parameter at the location touched will be replaced with the new parameter of choice To view more parameters touch the left or right pointing arrows to reveal more parameters 2 Touch the button corresponding to the replacement parameter The existing parameter is replaced with the new parameter 3 Repeat steps 1 and 2 for as many parameters as desired Displaying Patient Data With a Larger Font To improve visibility of patient data a screen is available that appears with a larger font Up to 14 data values may be displayed which include e Institutional default patient data values if configured e Remaining user selected patient data values up to 14 including waveforms and loops To institutionally configure the large font patient data defaults 1 Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode
386. ol Definitions Symbol Definition WARNING Warnings alert users to potential serious outcomes death injury or adverse events to the patient user or environment Caution Cautions alert users to exercise appropriate care for safe and effective use of the product Note Notes provide additional guidelines or information Oo gt WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs a4 Setting Up BiLevel Bi Level is a ventilatory mode along with A C SIMV and SPONT To set up BiLevel 1 Operator s Manual At the ventilator setup screen enter PBW or gender and height Touch BiLevel After selecting BiLevel mode the ventilator uses the PC mandatory breath type which cannot be changed Choose the spontaneous type PS or TO Choose trigger type P reg Or Varig Select desired ventilator settings The default settings for BiLevel mode appear To change a setting touch its button and turn the knob to set its value P mus
387. olume sup ported breaths Range NEONATAL 2 mL to 310 mL PEDIATRIC 25 mL to 1590 mL ADULT 25 mL to 2500 mL Resolution 0 1 mL for lt 5 mL 1 mL for 5 mL to lt 100 mL 5 mL for 100 mL to lt 400 mL 10 mL 400 mL Trigger type Determines whether flow Range changes V_trig pressure NEONATAL V_tpic changes P_tpig Or PEDIATRIC ADULT V tpi P tric O intrapleural pressure IE Sync in SPONT if IE Sync option changes IE Sync trigger installed patient breaths Tube ID The internal diameter of Range 4 5 mm to 10 mm when the artificial airway usedto spontaneous type is TC ventilate the patient Range 6 mm to 10 mm when spon taneous type is PAV Resolution 0 5 mm Tube type The type of artificial airway Range Endotracheal ET tracheal used to ventilate the patient Trach Ventilation type Invasive or non invasive NIV ventilation type based upon the type of breathing interface used Invasive ET or Trach tubes NIV masks infant nasal prongs or uncuffed ET tubes Range INVASIVE NIV Operator s Manual Operator s Manual Performance Specifications Table 11 10 Alarm Settings Range and Resolution Setting Alarm volume Description Controls the volume of alarm annunciations Range and Resolution Range 1 minimum to 10 maximum Resolution 1 Apnea Interval Ta The Apnea alarm condition indicates that neither the ventilator nor the patient
388. olution Range NEONATAL 0 1 L min to 10 L min PEDIATRIC ADULT 0 2 L min to 20 0 L min Resolution 0 1 L min Gender The patient s gender Range Male or Female Height The patient s height Range 19 5 cm to 280 cm 7 5 in to 110 in Resolution 0 5 cm for heights lt 35 cm 1 cm for heights lt 254 cm 2 cm for heights gt 254 cm 0 25 in for heights lt 14 in 0 5 in for heights lt 100 in 1 in for heights gt 100 in Reference Predicted Body Weight PBW Calculation p 4 21 High spontaneous inspira tory time limit FT SPONT Active in NIV only allows the operator to select the maximum spontaneous inspiratory time Range NEONATAL 0 2 s to 1 7 s PEDIATRIC ADULT 0 4 s to 5s Humidification type Humidifier volume The type of humidification system used on the venti lator The empty fluid volume of the currently installed humidifier Range HME non heated expiratory tube heated expiratory tube Range 100 mL to 1000 mL Resolution 10 mL Elevate 02 The percentage of O to be added to the current air O mixture for two minutes Range 1 to 100 Resolution 1 between 1 and 10 5 between 5 and 7596 jumps to 10096 when increased above 7596 LE ratio In PC and VC breath types specifies the ratio of inspiratory time to expira tory time Range 1 299 to 149 1 Resolution 0 01 for values gt 1 10 0 1 for values lt 1 10 0 and gt 1 100 0 1
389. onates and the young male and female adolescent adults at the foot of the ARDS tables their PBW values were taken as the 50th percentile numbers in the Fenton tables and the CDC and NCHS charts and tables respectively Note that the Fenton tables provided the exclusive information for premature and infant data between 20 weeks and 50 weeks of fetal and gestational growth 123 Note Any repeated values noted in the tables are the result of decimal rounding s7 Non invasive Ventilation NIV Non invasive ventilation NIV is used when the clinician determines a mask or other non invasive patient interface rather than an endotracheal tube would result in the desired patient outcome 4 71 NIV Intended Use NIV is intended for use by neonatal pediatric and adult patients possessing adequate neural ventilatory coupling and stable sustainable respiratory drive 4 7 2 NIV Breathing Interfaces Covidien has successfully tested the following non vented interfaces with NIV e Full face Mask Puritan Bennett Benefit Full Face Mask large part number 4 005253 00 ResMed Mirage Non Vented Full Face Mask medium e Nasal Mask ResMed Ultra Mirage Non vented Mask medium e Infant Nasal Prongs Sherwood Davis amp Geck Argyle CPAP Nasal Cannula small Hudson RCI Infant Nasal CPAP System No 3 m neonatal ET tube Mallinckrodt Uncuffed Tracheal Tube Murphy 3 0 mm 1 Fenton TR BMC Pediatrics 2003 3 13 http Avww
390. ons Table 1 1 Shipping Carton Symbols and Descriptions Description Serial number Part number 158 F 70 C 68 F 20 C Temperature limitations z Manufacturer This side up This side up 9 Fragile Fragile 95 fee Humidity limitations 10 to 95 relative humidity non condens PD ing operation and storage s umriy imitations Temperature limitations 10 C to 40 C 50 F to 104 F operation 20 C to 70 C 68 F to 158 F storage 106 kPa Q 70 kPa Atmospheric pressure limitations Atmospheric pressure limitations 70 kPa to 106 kPa 10 2 psi to 15 4 psi a Keep dry Keep dry CSA certification mark that signifies the product has been evaluated GR to the applicable ANSI Underwriters Laboratories Inc UL and CSA us standards for use in the US and Canada The following table describes the symbols shown on the ventilator shipping cartons Other symbols appearing on various labels are shown in Chapter 2 Operator s Manual Safety Information Table 1 1 Shipping Carton Symbols and Descriptions Continued Symbol Description R US federal law restricts this device to sale by or on the order of a X physician ONLY Refer to instruction manual 13 Safety Information 1 3 1 Safety Symbol Definitions This section contains safety information for users who should always exercise appropriate caution while using the ventilator
391. ons on p 11 3 in this manual If adding accessories to the patient circuit always run SST to establish circuit compliance and resistance prior to ventilating the patient Note If the ventilator has not reached operating temperature from recent usage allow it to warm up for at least 15 minutes before running SST to ensure accurate testing Note Check the inspiratory and expiratory limbs of the breathing circuit and in line water traps regularly for water buildup Under certain conditions they can fill quickly Empty and clean the in line water traps as necessary Reference the manufacturer s instructions for additional information How to Empty the Condensate Vial E N The condensate vial may accumulate liquid especially if a non heated wire patient circuit is in use Operator s Manual E 5 NeoMode 2 0 Appendix WARNING To avoid liquid entering the ventilator empty the condensate vial before the liquid level reaches the maximum fill line The condensate vial assembly is integrated with the neonatal expiratory filter and does not contain a drain port Empty the condensate vial when fluid reaches the maximum fill line To empty the condensate vial fs While holding the expiratory filter twist the condensate vial clockwise approxi mately one quarter turn to remove it Remove by carefully lowering the vial all the way down to the base of the exhala tion compartment and then slide the vial out Quickly empty t
392. oper Battery Orientation VEN_10327_B 1 White battery in use LED 3 Green charge status LEDs 2 Red battery fault indicator 4 Charge level button 3 20 Operator s Manual Product Connectivity 5 Tighten the thumbscrew to secure the battery and prevent the primary battery from being removed Note Remove the primary battery by reversing the steps After loosening the thumbscrew slide the battery ejector to the left to eject the battery Figure 3 11 Battery Compartment Locations 4 VEN 10278 C 1 BDU extended battery receptacle and 3 BDU primary battery thumbscrew battery ejector 2 BDU primary battery receptacle and 4 BDU primary battery positioned for battery ejector installation Operator s Manual 3 21 Installation Extended batteries The extended battery receptacle is located forward of the primary battery Like the primary battery the extended battery may be hot swapped To install or remove an extended battery in the BDU 1 Properly orient the battery as shown above 2 Push the battery into the forward receptacle in the BDU all the way until it clicks indicating the battery is latched Reference Battery Compartment Locations p 3 2i Note Remove the battery by sliding the battery ejector to the left The battery ejects itself from its receptacle There is no thumbscrew for extended batteries A WARNING Even though the Puritan Bennett 980 Ventilator meets the standards listed in
393. or Tfror Corrective action Check patient and settings NO AIR SUPPLY High Ventilation con Check patient and Switch to 100 O3 tinues as set air source except O7 100 NO O gt SUPPLY Low Ventilation con Check O source Operator set O2 tinues as set equals 21 Resets Only air avail if O supply con able nected High Ventilation con Check patient amp O z Ventilator delivers tinues as set source 21 Oz instead of except 02 set 07 Resets if 21 oxygen supply con nected PROCEDURE High Patient connect Provide alternate Ventilator begins ERROR ed before setup ventilation Com safety ventilation complete plete setup pro cess Resets when venti lator startup proce dure is complete 6 28 Operator s Manual Table 6 5 Non technical Alarm Summary Continued Analysis message Little no ventila tion Remedy message Check patient Provide alternate ventilation Clear occlusions drain circuit Ventilator Settings Comments Ventilator enters occlusion status cycling OSC Patient data dis plays are blanked and GUI screen dis plays elapsed time without ventilator support SEVERE High OCCLUSION PROX INOPERA Low TIVE if Proximal Flow Sensor is in use Data from Proxi mal Flow Sensor are not being used Check proximal flow sensor con nections and tubes for occlusions or leaks Data obtained from the proximal flow sensor are inv
394. or Waveforms Note Waveforms can be selected on any port but only on one port at a time Operator s Manual 5 3 Product Data Output Figure 5 1 Comm Setup Screen Waiting for patient connect Communications Setup Dci 9600 arity Mode None 10 300 44 Ramp 0 0 N VEN 11358 D 5 4 3 Comm Port Configuration Configuring the Comm port allows the ventilator to communicate with devices listed in the Comm Setup screen or to capture waveform data in ASCII format from the ventilator To configure Comm ports 1 5 Touch COM1 COM2 or COM3 Turn the knob indicating the desired device configuration Select the desired baud rate If waveforms was selected the baud rate automati cally becomes configured to 38400 Select 7 or 8 data bits Select parity of even odd or none if data bits 8 Connect the device to the previously configured port Reference Port Loca tions p 5 18 for a description and the locations of the Comm ports 5 4 Operator s Manual Data Transfer Note When a USB port is configured as a Comm port it is necessary to use a USB to serial adapter cable This adapter must be based on the chipset manufactured by Prolific For further information contact your Covidien representative Selecting waveforms when configuring a Comm port allows the ventilator to continuously transmit pressure flow and sequence numbers in ASCII format from the selected serial port at a baud rate of
395. or in altitudes higher or barometric pressures lower than those specified could compromise ventilator operation Reference Environmental Specifications p 11 7 for a complete list of environmental specifications Operator s Manual 1 11 Introduction WARNING The ventilator should be connected to a gas pipeline system compliant to ISO 7396 1 2007 because e Installation of the ventilator on a non ISO 7396 1 2007 compliant gas pipe line system may exceed the pipeline design flow capacity e The ventilator is a high flow device and can interfere with the operation of other equipment using the same gas source if the gas pipeline system is not compliant to ISO 7396 1 2007 1 3 10 Warnings Regarding Infection Control A A WARNING Patients receiving mechanical ventilation may experience increased vulnerability to the risk of infection Dirty or contaminated equipment is a potential source of infection It is recognized that cleaning sterilization sanitation and disinfection practices vary widely among health care institutions Always follow your hospital infection control guidelines for handling infectious material Follow the instructions in this manual and your institution s protocol for cleaning and sterilizing the ventilator and its components Use all cleaning solutions and products with caution Follow manufacturer s instructions for individual cleaning solutions Reference Chapter 7 of this manual WARNING To prevent infect
396. or monitors both expiratory flow and circuit pressures to detect reconnection The ventilator declares a reconnect if any of the following crite ria are met for the applicable time interval e Exhaled idle flow within the reconnect threshold is detected e Inspiratory and expiratory pressures are both above or both below reconnect threshold levels or 10 48 Operator s Manual Short Self Test SST e Inspiratory pressure rises to a reconnect level If the disconnect condition is corrected the ventilator detects the corrected condition within one second Ventilator triggering apnea detection expiratory and inspiratory pause manual inspirations and programmed maneuvers or one time events are sus pended during a patient circuit disconnect condition Spirometry is not moni tored during a disconnect and all alarms based on spirometry values are disabled During a disconnect condition ventilator settings changes are possi ble If the disconnect alarm is autoreset or manually reset the ventilator re estab lishes PEEP Once PEEP is reestablished the ventilator reinstates breath delivery according to settings in effect before the disconnect was detected Circuit disconnect detection is not active during OSC SVO or prior to patient connection 10 13 3 Annunciating Occlusion and Disconnect Alarms Occlusion and disconnection cannot be declared at the same time Therefore the ventilator annunciates only the first event to be d
397. ormal mode after it has been turned on and POST completes the ven tilator is set up and breath delivery parameters have been entered If the clini cian chooses s he can select Quick Start which uses default values or institutionally configured breath delivery settings after PBW has been entered Entry into Normal mode is not allowed if a primary battery is not detected in the ventilator BDU a major POST fault occurs or there is an uncorrected major system fault or uncorrected Short Self Test SST or Extended Self Test EST failures or non overridden alerts During Normal mode the omni directional LED on the top of the GUI appears green in color in a steadily lit state If an alarm occurs the LED flashes in a color corresponding to the priority of the alarm Reference Alarm Prioritization p 6 16 for details regarding alarm priority If another alarm occurs concurrently with an existing alarm the LED displays the color corresponding to the highest priority level If the alarm de escalates the latched area located on either side of the alarm LED indicator of the alarm LED displays the color of the highest priority alarm while the center of the LED displays the color of the current alarm s priority For more information on specific alarms touch the logs icon in the constant access icons area of the GUI Quick Start Quick Start is an extension of Normal mode where institutionally configured default settings are applied after the pati
398. ort in which the ventilator monitors the difference between inspiratory and expiratory flow measurements The ventilator triggers a breath when the difference between inspiratory and expiratory flows increases to a value that is at least the value selected for flow sensitivity Vceys Table Glossary 2 Units of Measure Centimeter A unit of length Feet A unit of length Hertz A unit of frequency indicating cycles per second Kilogram A unit of weight Glossary 9 Glossary 10 mL ms VA AC also ac ASCII CE CSA CRC DC also dc EMC EN ETO IEC ISO LCD LED MRI Table Glossary 2 Units of Measure Continued Liter A unit of volume Pound A unit of weight Meter A unit of length Milliliter A unit of volume Millisecond A unit of time Second A unit of time Volts A unit of voltage Volt amperes A unit of power Table Glossary 3 Technical Abbreviations Alternating current The movement of electrical charge that periodically reverses direction American Standard Code for Information Interchange A standard char acter encoding scheme A certification mark issued under the authority of the European Common Market that indicates compliance with the Medical Device Directive 93 42 EEC Canadian Standards Association Cyclic Redundancy Check or Code An algorithm or a computational result based on the remainder of a division defined over the ring of polynomials in the Galois fie
399. ory and expiratory sides minimize rebreathing of exhaled gas during SVO During SVO the venti lator e Displays the elapsed time without ventilatory support e Does not display patient data including waveforms e Does not detect patient circuit occlusion or disconnect conditions Visible indicators on the ventilator s GUI and status display illuminate when the ventilator is in the SVO state Other safeguards built into the ventilator include a one way valve check valve in the inspiratory pneumatic circuit allowing the patient to inhale through the safety valve with limited resistance This check valve also limits exhaled flow from entering the inspiratory limb to reduce the possibility of re breathing exhaled CO gas Power On Self Test POST Every time the ventilator is powered on or resets and at the beginning of Short Self Test SST and Extended Self Test EST it performs Power On Self Test POST POST checks the integrity of the GUI and Breath Delivery subsystems and communication channels without operator intervention and takes approx imately twelve 12 s to complete Operator s Manual Short Self Test SST If POST detects a major fault qualified service personnel must correct the problem and successfully pass EST Reference the Puritan Bennett 980 Series Ventilator Service Manual for more details on POST 10 18 Short Self Test SST e SST is a short about 5 minutes and simple sequence of tests that verifies proper
400. ory pause maneuvers as Specifications A wo Reference the table Ventilator Settings Range and Resolution in Chapter 11 of this manual for the following specifications e Low pressure P e High pressure Py e Low pressure time T e High pressure time Ty e Ty T ratio e Respiratory rate f e Rise time Yo Technical Description BiLevel is a mode of ventilation that alternately cycles between two operator set pressure levels P and Py The pressure durations are defined by operator set timing variables T and Ty Transitions between the two pressure levels PL and Py are analogous to breath phase transitions in PC At the extreme ranges of T and Ty BiLevel can resemble the single breath type mode A C PC or the more complex breath type mode an inverted like IMV If Ty and T assume normal values with respect to PBW for example Operator s Manual A 9 1 Technical Description Ty TL 1 2 or 1 3 then BiLevel assumes a breathing pattern similar to if not qualitatively identical to A C PC However as T begins to shorten with the Ty T ratio extending beyond 4 1 the breathing pattern assumes a distinctly different shape In the extreme the exaggerated time at P and abrupt release to P would match the pattern patented by John Downs and defined as APRV In between the A C PC like pattern and the APRV like pattern there would be patterns with moderately long Ty and T intervals allo
401. ot used 6 characters Field 62 Date MMM DD YYYY 12 characters Field 63 Static compliance Cstaq from inspiratory pause maneuver in mL cmH530O 6 char acters Field 64 Static resistance Rstar from inspiratory pause maneuver in cmH30 L s 6 characters Operator s Manual Data Transfer Table 5 1 MISCA Response Continued Dynamic compliance Cpyn in mL cmH530 6 characters Dynamic resistance Rpyn in cmMH gt O L s 6 characters Negative inspiratory force NIF in cmH 30 6 characters Vital capacity VC in L 6 characters Peak spontaneous flow PSF in L min 6 characters Ventilator set base flow in liters per minute 6 characters Flow sensitivity setting in L min 6 characters Not used 6 characters End inspiratory pressure in cmH O 6 characters CO Inspiratory pressure or Py setting in cmH20 6 characters Inspiratory time or Ty setting in seconds 6 characters Apnea interval setting in seconds 6 characters Apnea inspiratory pressure setting in cmH 0 6 characters Apnea respiratory rate setting in breaths per minute 6 characters Apnea inspiratory time setting in seconds 6 characters Apnea 07 setting 6 characters Apnea high circuit pressure limit in cmH 0 6 characters Alarm silence state ON or OFF__ 6 characters Apnea alarm status NORMAL ALARM_ or RESET_ 6 characters Severe Occlusion Disconnect alarm status NOR
402. p 7 5 Caution To avoid moisture entering the ventilator and possibly causing a malfunction Covidien recommends using a wall air water trap when using piped medical air from a facility based air compressor Caution Use only the cleaning agents specified Reference Surface Cleaning Agents p 7 5 for approved cleaning agents o 9 99 9 Operator s Manual 1 13 Introduction Caution Do not block cooling vents Caution Ensure proper connection and engagement of expiratory and inspiratory filters Caution Follow instructions for proper GUI and BDU breath delivery unit mounting as described in the Puritan Bennett 980 Series Ventilator Installation Instructions Caution Follow proper battery installation instructions as described in this manual Caution When transferring the ventilator from storage conditions allow its temperature to stabilize at ambient conditions prior to use o 99 99 Caution Remove extended and primary batteries from ventilator prior to transporting in a vehicle Failure to do so could result in damage to the ventilator 1 3 13 Notes Note Federal law USA restricts the sale of this device except by or on the order of a physician Ni Note When using non invasive ventilation NIV the patient s actual exhaled volume may differ from the exhaled volume reported by the ventilator due to leaks around the mask 1 14 Operator s Manual 1 1 4 A Safety Information
403. panded alarm banner O gt SENSOR O sensor is out of calibration Re calibrate or replace Oz or has failed sensor DEVICE ALERT Various Technical alarm cate Follow remedy message dis played on GUI A non technical alarm is an alarm caused due to a fault in the patient venti lator interaction or a fault in the electrical or gas supplies that the practitioner may be able to alleviate Table 6 5 Non technical Alarm Summary Base message Priority AC POWER LOSS Low Analysis message Operating on N A vent main bat tery Remedy message Comments Ventilator s power switch is ON Venti lator automatically switches to battery power AC power not available Battery operating indicator on status display turns on Resets when AC power is restored Operator s Manual Table 6 5 Non technical Alarm Summary Continued APNEA patient Medium data alarm Analysis message Apnea ventila tion Breath interval gt apnea interval High Extended apnea duration or mul tiple apnea events Remedy message Check patient amp settings Ventilator Settings Comments The set apnea inter val has elapsed without the ventila tor patient or operator triggering a breath Resets after patient initi ates a third consec utive breath Possible dependent alarm We TOT CIRCUIT High DISCONNECT No ventilation Check patient Reconnect circuit Ve
404. panels of the GUI and BDU and in various locations on product options 1 7 Manufacturer sail Covidien Ilc 15 Hampshire Street Mansfield MA 02048 USA 1s Electromagnetic Compatibility The ventilator system complies with the requirements of IEC 60601 1 2 2007 EMC Collateral Standard including the E field susceptibility requirements at a level of 10 volts per meter at frequencies from 80 MHz to 2 5 GHz However even at this level of device immunity certain transmitting devices cellular phones walkie talkies cordless phones paging transmitters RFID devices etc emit radio frequencies that could interrupt ventilator operation if operat ed in a range too close to the ventilator Practitioners should be aware of pos sible radio frequency interference if portable devices are operated in close proximity to the ventilator The Puritan Bennett 980 ventilator requires special precautions to be taken regarding electromagnetic compatibility EMC and must be installed and put into service according to the EMC information provided in Chapter 77 in this manual Operator s Manual 2 Product Overview 21 Overview This chapter contains introductory information for the Puritan Bennett 980 Series Ventilator Note Items shown in bold italic font are contained as entries in the glossary Communication between the ventilator s graphical user interface GUI and the breath delivery unit BDU occurs continuously via indepen
405. patient circuit for patient ventilation e Accessories water traps etc e Expiratory filter and condensate vial Operator s Manual 3 47 Installation e Humidifier if applicable Other necessary items include e Ano 1 stopper to block the patient airway at the patient wye e Two gas sources air and oxygen connected to the ventilator at a pressure between 35 psi and 87 psi 241 3 kPa and 599 8 kPa SST Test Sequence To run SST 1 Ensure a patient is NOT connected to the ventilator 2 So that the ventilator does not detect a patient connection ensure that the breathing circuit wye is not attached to a test lung or covered in any way that would cause an increase in pressure at the wye 3 Turn the ventilator on using the power switch located at the front of the BDU below the status display The ventilator runs POST when the power switch is turned on Ensure the ventilator is operating on full AC power Otherwise SST test failures may result 4 Wait at least 15 minutes to allow the ventilator to warm up and stabilize to ensure accurate results 5 At the ventilator startup screen touch SST or the Configure icon wrench dis played in the lower right area of the GUI The SST history log appears along with Patient Setup Run Leak Test and Run All SST buttons 6 Connect the patient circuit filters condensate vial and all accessories to be used in patient ventilation Ensure the patient wye is not blocked 7 Touch R
406. ped tubing etc e The ventilator EXHAUST port is blocked or resistance through the port is too high e The exhalation valve fails in the closed position occlusion detection at the From patient port begins after 195 ms of exhalation has passed The ventilator does not detect a severe occlusion if e The pressure difference between the inspiratory and the expiratory transducers is less than or equal to 5 cmH50 e The exhalation valve fails in the closed position and the pressure in the exhalation limb is less than 2 cmH gt 0 e Silicone tubing is attached to the EXHAUST port of the ventilator i e for metabol ic monitoring purposes The ventilator checks the patient circuit for occlusions during all modes of breathing except Stand by state and Safety Valve Open at delivery of every breath Once the circuit check begins the ventilator detects a severe occlusion of the patient circuit within 200 ms The ventilator checks the EXHAUST port for occlusions during the expiratory phase of every breath except during dis connect and safety valve open Once the EXHAUST port check begins the ventilator detects a severe occlusion within 100 ms following the first 200 ms of exhalation All occlusion checking is disabled during pressure sensor autoz eroing When an occlusion is detected an alarm sounds the ventilator enters the OSC Occlusion Status Cycling state and displays a message indicating the length of time the patient has gone
407. perates from its extended batteries if present first and then switches to the primary batteries The ventilator primary and extended batteries are charged whenever the ventilator is plugged into AC power the ventilator does not have to be powered up If the ventilator is oper ating on battery power the status display shows which battery is in use and its charge level and the remaining time the battery will operate before charging is required again Operator s Manual 3 3 Installation Battery Charging Batteries requiring charging are charged whenever the ventilator is connected to AC power whether operating or not The ventilator charges its primary battery first then its extended battery The time required to charge a single battery either primary or extended is approx imately six hours at room temperature whether the ventilator is turned off but connected to AC power or operating but charging time can vary based on temperature or depletion state of the battery The status display provides the battery s capacity Green LED bars located on the ends of both primary and extended batteries if installed scroll upwards indicating battery charging A white LED bar rep resents the battery is in use and a round LED indicator illuminates red if there is a battery fault When running on battery power battery capacity is deter mined by the number of green LED bars illuminated Reference Proper Battery Orientation p 3 20 to view the
408. performed during SST Table 3 3 SST Test Sequence Test step Function SST Flow Sensor Cross Check Test Tests O and Air Flow Sensors SST Exhalation Valve Performance Calibrates the exhalation valve and creates a table for use during calculations SST Circuit Pressure Test Exercises delivery PSOL Checks inspiratory and expiratory autozero solenoids Cross checks inspiratory and expiratory pressure transducers at various pressures SST Leak Test Tests ventilator breathing system for leaks SST Exhalation Filter Test Checks for exhalation filter occlusion and exhalation compart ment occlusion SST circuit Resistance Test Checks for inspiratory and expiratory limb occlusions and cal culates and stores the inspiratory and expiratory limb resistance parameters SST circuit Compliance Test Calculates the attached patient circuit compliance SST Prox if Proximal Flow Option Verifies functionality of Proximal Flow Subsystem is installed e Note The humidifier volume setting entered during SST should always be equal to the chamber s or column s empty compressible volume Please do not enter either the container s compressible volume when full or the container s water volume when full Operator s Manual 3 49 Installation For humidifier containers not listed please enter the manufacturer s published compressible volume empty column A value during SST Table 3 4 Humidifier Volumes
409. perim posed on the circuit pressure waveform e PAV based patient data estimates including patient resistance Rpay lung com pliance Cray and intrinsic PEEP PEEP PAV Note Graphic displays of lung pressure and patient work of breathing are not actual measurements and are derived from equations using filtered estimates of pressure and flow The WOB graphic is only available when SPONT mode and the PAV breath type are selected The shadow trace can be enabled or disabled when selecting the graphic display or after a display is paused The act of pausing does not affect the WOB graphic but does store the shadow trace Once paused the operator can enable or disable the shadow trace then view the paused waveform again with or without the shadow trace 3 5 3 WOB Terms and Definitions The following table provides a definition and description of each of the Work of Breathing WOB terms D 12 Operator s Manual Ventilator Settings Guidance Table D 3 PAV Work of Breathing terms WOByor WOB term Definition Total Work of Inspiration Description With the PAV breath type active the patient and the ven tilator always share the in the work of breathing The percent WOB7 7 performed by the ven tilator always equals the Yo Supp setting and the percent WO B77 performed by the patient always equals 100 minus the Supp setting WOB7 7 is the sum of the work to move the breathing gas through the
410. piratory time ALERT_ or blank 6 characters Dynamic compliance Cpyn in mL cmH530 6 characters Dynamic resistance Rpyn in cmH50O L s 6 characters Peak spontaneous flow PSF in L min 6 characters Peak expiratory flow PEF in L min 6 characters End expiratory flow EEF in L min 6 characters Proximal Flow Sensor state ON or OFF eld 102 Negative inspiratory force NIF in cmH 3O 6 characters eld 103 Po 1 pressure change in cmH20 6 characters Vital capacity VC in L 6 characters Alarm Silence ON or OFF 6 characters Apnea ventilation alarm 6 characters High exhaled minute volume alarm 1V tot 6 characters High exhaled tidal volume alarm TVy 6 characters High O2 alarm 6 characters High inspiratory pressure alarm TPprak 6 characters High ventilator pressure alarm TPyenr 6 characters High respiratory rate alarm Mor 6 characters Field 113 AC power loss alarm 6 characters Field 114 Inoperative battery alarm 6 characters Field 115 Low battery alarm 6 characters Field 116 Loss of power alarm 6 characters Field 117 Low exhaled mandatory tidal volume alarm 4V7e manp 6 characters Field 118 Low exhaled minute volume alarm WW tor 6 characters Possible responses are NORMAL LOW MEDIUM HIGH or RESET Operator s Manual 5 15 Product Data Output Table 5 2
411. play lock LED turns off and an unlocked image briefly appears on the screen Using Gestures When Operating the GUI The GUI incorporates a gesture based interface where features can be actuat ed with the fingers using different motions The following table explains ges tures used with the GUI Table 4 1 Gestures and Their Meanings Gesture Description Used for How to Use Swipe Quickly brush the Opening or closing dialogs Swipe toward the center of the screen to screen surface or panels that slide in and open dialogs or panels Swipe toward the with the fingertip out from the screen sides or side of the screen or upward if viewing the top moving waveform data additional patient data or large font patient expanding or collapsing data panels to close tooltips scrolling lists or To move a paused waveform swipe in the alarm banners maximizing desired direction or minimizing waveforms Swipe upward anywhere on a waveform to maximize it and swipe downward on the maximized waveform to minimize it Swipe a tooltip upward to expand to a long description and downward to collapse to a short description A downward swipe any where in the patient data area opens the additional patient data panel and another swipe on the additional patient data tab dis plays the large font patient data panel 4 6 Operator s Manual Ventilator Shutdown Table 4 1 Gestures and Their Meanings Continued
412. pletely delivers a breath with a target pressure of 15 cmH50 for 2000 ms then cycles to exhalation This breath is followed by amandatory breath according to the current settings but with PEEP 0 and 05 equal to 100 for adult pediatric circuit types or 40 for neonatal cir cuits During OSC and only during OSC the TPpgak high circuit pressure alarm limit is disabled to ensure it does not interfere with the ability of the ven tilator to detect a corrected occlusion When the ventilator does not detect a severe occlusion it resets the occlusion alarm re establishes PEEP and rein States breath delivery according to current settings Inspiratory and expiratory pause and manual inspirations are suspended during a severe occlusion Pause maneuvers are canceled by a severe occlusion During a severe occlusion ventilator settings changes are possible Severe occlusions are not detected when the ventilator is in the Safety Valve Open SVO state A corrected occlusion is detected within 15 s 10 13 2 Disconnect A circuit disconnect condition is detected when the ventilator cannot ensure that a patient is receiving sufficient tidal volume due to a large leak or discon nected patient circuit This discussion applies when Leak Sync is disabled When a disconnect is detected an alarm sounds the ventilator indicates that a disconnect has been detected and displays a message indicating the length of time the patient has gone without
413. pont breath gt set Pprak limit 5 cmH20 Medium Last 3 spont breaths gt set cmH20 Last 4 or more spont breaths gt set Pprak limit 5 cmH320 In TC Check for leaks tube type ID set ting Pressure of sponta neous breaths gt set limit Possible dependent alarms 4 VTE SPONT VE tor Tror 4VTE SPONT Corrective action Check for leaks Check for the correct tube type Check that the tube inside diameter cor responds to the patient PBW Check the TPpEAK setting 6 20 Operator s Manual Table 6 5 Non technical Alarm Summary Continued Analysis message Remedy message Ventilator Settings Comments Last 2 breaths pressure lt set imit Last 4 breaths pressure lt set imit Pprag patient Low data alarm Medium High Last10 or more breaths pres sure lt set limit Check for leaks Peak inspiratory pressure lt alarm setting Available only when Manda tory Type is VC or when Vent Type is NIV Target pres sure the low limit PEEP 3 cmH50 Ventilator cannot deliver target volume Possible dependent alarms ror Corrective action Check patient and settings check for leaks Because the VC pressure control algorithm does not allow the target inspiratory pressure to fall below PEEP 3 cmH 0 attempting alarm off o set the 4Pprag alarm limit at or below this level will turn the TO2
414. power loss of at least five minutes and the ventilator detects a patient attached before Ventilator Startup is complete Until confirmation of the ventilator settings the ventilator annunciates a high priority alarm and enters Safety PCV Reference Safety PCV Settings p 10 72 The PROCEDURE ERROR alarm requires confirmation of ventilator settings after restoration of ventilator power in case a new patient is attached to the ventilator Safety PCV is an emergency mode of ventilation providing ventila tion according to displayed settings until settings confirmation and is not intended for long term patient ventilation Severe Occlusion Alarm A severe occlusion alarm occurs when gas flow in the ventilator breathing system is severely restricted The ventilator enters Occlusion Status Cycling OSC where the ventilator periodically attempts to deliver a pressure based breath while monitoring inspiration and exhalation breath phases for a severe occlusion If an occlusion is not detected the ventilator considers the occlusion condition reset clears the occlusion alarm and continues ventilation with the settings in use before the occlusion occurred The ventilator indicates an occlu sion was detected Monitored Patient Data Monitored patient data appear in the Patient Data Banner at the top of the GUI screen above the waveforms display Reference Areas of the GUI p 4 3 Operator s Manual Ventilator Settings Reference Vital Pati
415. ppears containing the Installed Options and Prox tabs 3 Touch the Prox tab The Prox Setup screen appears 4 Touch Start that appears next to the text Prox Manual Purge To begin touch the Start button During the purge a message appears in the GUI prompt area stating the purge process is being performed Reference Message During Autozero and Purge Processes p F 9 Operator s Manual F 15 Proximal Flow Option Appendix Ve Configure SST Opbons Comm Setup Neonate SIMV PC PS r12 Alarms Figure F 7 Manual Purge Ve tora Vre MAND Vren iror kE PEEP Press IB 206533 5 1 0 52 Prox Setup Prox Manual Purge To begin touch the Start button 150 40 0 G5 40 25 3 0 VEN 11430 E If the Proximal Flow Option becomes inoperable during ventilation the venti lator annunciates an alarm and flow sensing reverts to the ventilator s internal delivery and exhalation valve flow sensors This switch over may be triggered by any of the following events e The Proximal Flow Sensor is not detected e Pressure and flow readings are out of range e Hardware problems are reported by the Proximal Flow Option PCBA e There is a communication failure between the ventilator and the Proximal Flow option If any of these conditions occur the GUI displays an alarm message similar the one shown below Follow the information contained in the remedy message to troubleshoot the alarm Operator s Manual Part numb
416. priate time interval The duration of the breath in seconds Tb is 60 f Figure 10 3 Breath Activity During Time triggered Inspiration VEN 10759 B 1 Breath activity VIM 3 Time period Tb 60 f 2 Breath activity PIM 10 4 4 Operator initiated Triggers If the operator presses the Manual inspiration key an OIM operator initiated mandatory breath is delivered The ventilator will not deliver an OIM under the following conditions e During an active inspiration whether mandatory or spontaneous e During the restricted phase of exhalation e During circuit disconnect and Occlusion Status Cycling OSC conditions Reference Manual Inspiration p 10 22 later in this chapter for information on the restricted phase of exhalation 10 4 5 IE Sync Trigger IE Sync is a software option that allows the ventilator to trigger a breath based on a model of the movement of the patient s respiratory system Reference Appendix C in this manual for a detailed description of the IE Sync option 10 8 Operator s Manual Short Self Test SST 10 5 EXhalation Detection and Initiation When exhalation occurs it is called cycling Mandatory breaths can be volume cycled or time cycled by the ventilator or pressure cycled by the patient Spon taneous breaths can be flow cycled or pressure cycled by the patient or time cycled by the ventilator A patient cycled exhalation relies on measurements such as inspiratory flow rate or airway p
417. ption Symbol High compensation pressure TPcome High delivered oxygen percentage T07 Operator s Manual Ventilator Settings Table 6 1 Alarm Descriptions and Symbols Continued Alarm description Symbol High exhaled minute volume Ng TOT High exhaled minute volume setting TVE toT High exhaled tidal volume Wr High exhaled tidal volume setting Vie High inspired tidal volume limit TVi High internal ventilator pressure TP vent High respiratory rate Trot High respiratory rate setting T ror High spontaneous inspiratory time TTI spont High spontaneous inspiratory time limit TTI spont High circuit pressure TPprak High circuit pressure limit TPprAK Low circuit pressure VP pEAK Low circuit pressure setting LPprak Low exhaled mandatory tidal volume VTE MAND Low exhaled mandatory tidal volume LV MAND setting Low exhaled minute volume We tot Low exhaled minute volume setting LVE ToT Low exhaled spontaneous tidal volume IV 7p SPONT Low exhaled spontaneous tidal volume VIE SPONT setting Low delivered oxygen percentage 107 Operator s Manual 6 7 Performance 6 5 2 Alarm Reset Key The alarm reset function can be used for any non technical alarm Reference Alarm Handling p 6 15 for an explanation of technical vs non technical alarms Alarm reset reinitializes the algorithm the ventilator uses to initially detect the alarm except for A C POWER LOSS
418. r of the GUI on the vent setup screen Reference Pushpin Icon p 4 5 Low priority alarm icon appears on alarm ban ner Medium priority alarm icon appears on alarm banner High priority alarm icon appears on alarm ban I ner 2 10 3 On screen Symbols and Abbreviations Touch an on screen symbol briefly 0 5 s to display a tooltip on the GUI screen The tooltip contains a definition of the symbol and other descriptive text avail able with either short or long descriptions The short description expands to show more information by touching more on the tooltip dialog or collapses by touching less The tooltip closes by touching close or fades in five 5 seconds if left alone Expanding the tooltip dialog prevents the tooltip from timing out Touching outside the tooltip causes the dialog to close The table below summarizes the ventilator s symbols and abbreviations Operator s Manual Operator s Manual Table 2 7 Symbols and Abbreviations GUI Controls and Indicators Symbol or Abbreviation Definition Ta Apnea interval Dsens Disconnect sensitivity Cpyn Dynamic compliance Rpyn Dynamic resistance EEF End expiratory flow Pi END End inspiratory pressure LEAK Exhalation leak VTE MAND Exhaled mandatory tidal volume VE TOT Exhaled minute volume VE SPONT Exhaled spontaneous minute volume VTE SPONT Exhaled spontaneous tidal volume VIE
419. r a T greater than eight 8 s or less than 0 2 s or a T less than 0 2 s the ventilator disallows the change 10 15 7 Peak Inspiratory Flow Vmax The Vmax setting determines the maximum rate of delivery of tidal volume to the patient during mandatory VC breaths only Changes to Vmax are phased in at the start of inspiration Mandatory breaths are compliance compensated even at the maximum Vmax setting Circuit compliance compensation does not cause the ventilator to exceed the ventilator s maximum flow capability When proposing a change to the Vmax setting the ventilator compares the new value with the settings for Vr f flow pattern and Tp It is impossible to set a new Vmax that would result in an I E ratio that exceeds 4 00 1 or a T greater than 8 0 s or less than 0 2 s or a T less than 0 2 s 10 62 Operator s Manual Short Self Test SST 10 15 8 Plateau Time Tp The Tp setting determines the amount of time inspiration is held in the patient s airway after inspiratory flow has ceased Tp is available only during VC mandatory breaths for A C and SIMV mode and operator initiated man datory breaths Tp is not available for PC mandatory breaths Changes to the Tp setting are phased in at the start of inspiration When proposing a change to the Tp setting the ventilator computes the new lE ratio and Tj given the current settings for Vr f Vmax and flow pattern It is impossible to set a new Tp th
420. r delivers the currently specified apnea breath setting for spontaneous breaths or the currently specified mandatory breath setting for mandatory breaths either volume or pressure based A volume based manual inspiration is compliance compensated Pressing the Manual inspiration key while in BiLevel mode will transition from Ty to T or T to Ty depending on when in the breath cycle the key was pressed 49 Respiratory Mechanics Maneuvers To access respiratory mechanics maneuvers 1 Touch or swipe Menu tab on the left side if the GUI 2 Touch RM 4 28 Operator s Manual Figure 4 12 RM in Menu Tab 10 29 10 1 79 PEEP P 37 UK a 3 Touch the particular tab for the desired maneuver Figure 4 13 Respiratory Maneuver Tabs C16 286 10 17 1 Inspiratory Pause Maneuver PEEP Pusa Display Previous Pause Date Time Vital Capacity pao Press START to begin maneuver and NIF display results a i START Adult Vuax 44 Uren 10 300 timan mi Tol Ramp Operator s Manual MEAN N Ve Tor Pio 2 00 cmH 0 Ventilator Shutdown Vre mano 29 gt Ve ror 0 29 il AMA 2 KI 08 4 1 01pm VEN 11348 D Vie mano 256 gt Por Cstat Rsrat pil nHO Ca 06 54 24pm VEN 11356 D 4 29 Operation 4 Follow the prompts on the GUI screen 5 Accept or reject the maneuver results If the result is accepted its value is saved 4 9 1 Inspiratory Pause Maneuver
421. r eliminate the leak Check patient and circuit type Inspired volume may be less than set TPprak patient data alarm The measured airway pressure is gt set limit Reduced tidal volume likely e Check the patient e Check the patient circuit e Check the endotracheal tube JPpeak patient data alarm Because the VC pressure con below PEEP 3 cmH50 attempti alarm off The peak inspiratory pressure in the patient circuit lt alarm set ting This alarm is only available when NIV is the selected Vent Type or when VC is the select ed Mandatory type during INVASIVE ventilation Check for leaks in the patient circuit and VBS rol algorithm does not allow the target inspiratory pressure to fall ng to set the LPpeax alarm setting at or below this level will turn the TO7 patient data alarm The O2 measured during any phase of a breath cycle is 796 12 during the first hour of operation or more above the O2 parameter for at least 30 seconds The percentage window increases by 596 for four minutes after increasing the set O2 value Check the patient the air and oxygen supplies the oxygen analyzer and the ventilator Operator s Manual Ventilator Settings Table 6 6 Non Technical Alarms and Suggested Responses Continued Alarm message 105 patient data alarm Meaning The O measured during any phase of a breath cycle is 7 12 during the first hour
422. r of bytes between lt STX gt and 6 End of transmission 03 hex lt CR gt 3 Number of data fields between lt STX gt 7 Terminating carriage return and lt ETX gt 4 Start of transmission 02 hex 1229 if Philips is selected for serial port in communication setup The table below lists MISCF responses to SNDF commands 5 10 Operator s Manual Q Note Non applicable fields will either contain zero or be blank Data Transfer Table 5 2 MISCF Response Component Description Response to SNDF command 5 characters Number of bytes between lt STX gt and lt CR gt 4 characters 1229 if Phillips is selected for the Comm port in Communication Setup Number of fields between lt STX gt and lt ETX gt 3 characters Start of transmission character 02 hex Ventilator time HH MM 6 characters Ventilator ID to allow external hosts to uniquely identify each Puritan Bennett 980 Ventilator 18 characters Date MMM_DD_YYYY_ 12 characters Vent Type NIV or INVASIVE_ 9 characters Mode A C___ SIMV__ SPONT_ or CPAP 6 characters Mandatory Type PC NC VC __ 6 characters Spontaneous Type PS ALE VS PA 6 characters Trigger Type setting V rec P rric 6 characters Respiratory rate setting in breaths min 6 characters Tidal volume V7 setting in L 6 characters Peak flow Vmax setting in L min 6 characters O2 setting 6 chara
423. r spontaneous and manda tory breaths The TVy alarm indicates the delivered volume of any breath the set alarm limit Range and Resolution Range OFF and NEONATAL 5 mL to 500 mL PEDIATRIC 25 mL to 1500 mL ADULT 25 mL to 3000 mL Resolution 1 mL for values lt 100 mL 5 mL for values gt 100 mL and lt 400 mL 10 mL for values gt 400 mL Range 6 mL to 6000 mL Resolution 1 mL for values lt 100 mL 5 mL for values gt 100 mL to lt 400 mL 10 mL for values gt 400 mL High respiratory rate alarm setting Tfror The Tfroz alarm indicates the measured breath rate gt the set alarm limit Range OFF or NEONATAL 10 1 min to 170 1 min PEDIATRIC ADULT 10 1 min to 110 1 min Resolution 1 1 min High spontaneous inspiratory time limit FT SPONT The TT sponr indicator allows the operator to select the maximum spontaneous inspi ratory time of an NIV breath No alarm is annunciated only the symbol TT spont appears on the screen near the NIV indicator when inspiration time exceeds the setting If FT spont is exceeded the ventilator transitions from inspiration to exhalation Range NEONATAL 0 2 s to lt the value of the NIV inspiratory time limit trigger for the patient s PBW and circuit type s PEDIATRIC ADULT 0 4 s to lt the value of the NIV inspiratory time limit trigger for the patient s PBW and circuit type s Resolution 0 1 s Low exhaled mandatory tida
424. rate pressure and flow measurements the ventilator performs an autozero function to calibrate the Proximal Flow Sensor It does this by peri odically opening the pressure sensor on the Proximal Flow Option PCBA to atmosphere during exhalation and uses the resulting measurements as offset corrections Operator s Manual Part numbers The purge function is designed to clear the pneumatic lines of fluids that may collect and is performed periodically by sending a brief flow of air through the sensor lines Autozero and purge functions are only active during exhalation which limits the effect of the purge gas on delivered oxygen concentration During the autozero or automatic purge processes the measurement and display of proximal flow data is not shown in real time and a brief message appears on the GUI indicating the purge process is occurring During autozero or automatic purge processes the pressure waveforms when shown display the current PEEP value and the flow waveform when shown displays a value of O Figure F 3 Message During Autozero and Purge Processes PEEP Pue 18 26 20 1 65 32 50 052 26 gt VEN 11429 D ro SST Requirements SST must be run prior to ventilation and all circuit components and accessories must be installed in the configuration to be used on the patient in order for the ventilator to calculate the correct compliance and resistance This includes a neonatal patient circuit Proximal Flow Sensor and
425. rec ognized The point at which the new rate is phased in depends on the current phase of the SIMV interval and when the rate change command is accepted If the rate change occurs during the mandatory interval the maximum mandatory inter val is that for the new or old rate whichever is less If the patient generates a successful inspiratory effort during the spontaneous interval the ventilator responds by delivering a spontaneous breath Respiratory rate changes are phased in during exhalation only The new SIMV interval is determined by the new respiratory rate and is referenced to the start of the current SIMV period interval following these rules e Inspiratory time Tj of current breath is neither truncated nor extended e The new inspiration is not delivered until 200 ms of exhalation have elapsed The time until the new SIMV interval begins is e whichever is greater the new SIMV period interval or 3 5 x the last or current T4 e but not greater than the current SIMV period interval 10 11 Spontaneous SPONT Mode In SPONT mode the patient initiates inspiration according to the trigger type in effect but OIM breaths are allowed which are delivered with the currently specified mandatory breath parameters The following spontaneous breath types are available in SPONT mode e PS e VS e TC Operator s Manual 10 39 Theory of Operations 10 40 t amp 10 11 1 e PAV if the PAV option is installed The insp
426. red O2 6 37 High exhaled minute volume 6 38 High exhaled tidal volume 6 38 High inspired tidal volume 6 38 High respiratory rate 6 39 how to test 6 9 INSPIRATION TOO LONG 6 39 latched 6 5 lockable 6 6 Loss of power 6 36 Low circuit pressure 6 39 Low delivered O2 6 40 Low exhaled mandatory tidal volume 6 41 Low exhaled spontaneous tidal volume 6 41 Low exhaled total minute volume 6 41 non technical 6 18 primary 6 4 prioritization 6 16 PROCEDURE ERROR 6 42 reset 6 8 silence 6 8 symbols 6 6 technical 6 17 volume 6 8 Alarm Functions 6 4 alarm settings range resolution accuracy 11 19 alarm settings range resolution accuracy 11 17 Apnea Ventilation 10 41 10 45 apnea ventilation 10 57 Apnea Ventilation in SIMV 10 44 B Background Diagnostic System 10 74 battery life 3 25 battery installation 3 18 3 22 BDU indicators audible 2 35 visual 2 27 BiLevel 2 0 option A 1 Breath Delivery Unit 2 25 Breath triggers flow 10 6 IE Sync 10 8 operator initiated 10 8 pressure 10 5 time cycled 10 8 BUV settings 10 75 C CircuitType and PBW 10 58 compliance compensation 10 13 10 17 Compliance Compensation in Volume based Breaths 10 13 Component Cleaning and Disinfection 7 6 Component Sterilization 7 23 configurable features alarm volume 3 41 date and time 3 38 larg
427. ressure The ventilator uses the three 3 methods described below to detect exhalation e Airway pressure method spontaneous breaths e Percent peak flow method spontaneous breaths e Time cycling method mandatory breaths e TE Sync cycled in SPONT mode only if the IE Sync option is installed 10 5 1 Airway Pressure Method If expiratory sensitivity Esens is set to a value too low for the patient ventilator combination a forceful expiratory effort could cause circuit pressure Ppr ag to rise to its limit The ventilator monitors circuit pressure throughout the inspira tory phase and initiates an exhalation when the pressure equals the inspiratory pressure P target value an incremental value This transition to exhalation occurs during spontaneous pressure based ventilation and in volume support VS Note The allowable incremental value above the target pressure is 1 5 cmH 0 once a portion of inspiration time Tn has elapsed Before Tn the incremental value is higher to allow for transient pressure overshoots For the first 200 ms of inspiration the incremental pressure is 10 of the target pressure up or 8 cmH gt 0 whichever is greater From 200 ms to Tn the incremental pressure decreases in a linear fashion from the initial value to 1 5 cmH 0 Operator s Manual 10 9 Theory of Operations Figure 10 4 Exhalation via the Airway Pressure Method 3 1 1 1 i 1 i cmH 0 VEN_10761_C 1 Pressur
428. ressure over an entire respiratory cycle Maximum circuit pressure the maximum pressure during the inspiratory and expiratory phases of a breath An initial alarm Pressure support a spontaneous breath type in which the ventilator delivers an operator set pressure in addition to PEEP during the inspira tory phase Available in SPONT SIMV and BiLevel modes Pressure sensitivity The operator set pressure drop below PEEP derived from the patient s inspiratory flow required to begin a patient initiated breath when pressure triggering is selected Proportional solenoid valve Pressure support A setting of the level of inspiratory assist pressure above PEEP at the patient wye during a spontaneous breath when spontaneous breath type is PS Pressure triggering a method of recognizing patient inspiratory effort in which the ventilator monitors pressure in the patient circuit The ventila tor triggers a breath when the airway pressure drops by at least the value selected for pressure sensitivity Psens A message displayed on the GUI during an alarm condition suggesting ways to resolve the alarm The flow dependent pressure drop across a conduit Measured in cmH O L s or hPa L s Operator s Manual Operator s Manual Table Glossary 1 Glossary of Ventilation Terms Continued restricted phase of exhalation rise time safety net safety valve SV safety ventilation service mode SIMV SIS so
429. riate alarm settings Table 3 2 Ventilator Configuration Feature Factory Con Institution Operator Configured User Lock figured ally Configu Configu by Circuit able rable rable Type Vital patient X X X X data banner Large font X X X X patient data panel Waveform X X X X layout Display X X X brightness Light set tings Alarm volume X X X X Elevate O X X X X control Date time X X X X format Default mL kg X X Can t be ratio changed in Normal mode Operator s Manual 3 35 Installation 3 36 Feature New patient startup defaults including PBW vent type mode mandatory type trigger type 07 elevate O Factory Con figured Table 3 2 Ventilator Configuration Institution ally Configu rable X Operator Configu rable Configured by Circuit Type X User Lock able Opacity Operator s Manual Product Connectivity 3 8 1 Preparing the Ventilator for Use Caution Do not lean on the GUI or use it to move the ventilator Doing so could break the GUI its locking mechanism or tip the ventilator over Prior to ventilating a patient configure the GUI so it is capable of displaying all the desired parameters information and patient data This eliminates the necessity for taking the patient off the ventilator as configuration of many of the items requires the unit to be in Service Mode To perform insti
430. riate care for safe and effective use of the product Note Notes provide additional guidelines or information WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs s4 Leak Sync Breathing circuit leaks can cause the ventilator to erroneously detect patient inspiratory efforts called autotriggering or delay exhalation in pressure sup port Patient interfaces such as masks are particularly prone to significant leaks Inaccurately declaring inspiration or exhalation can result in patient ventilator dysynchrony and increased work of breathing Changing inspiratory or expiratory sensitivity settings can temporarily correct the problem but requires continued frequent clinical intervention to ensure that sensitivity is adjusted appropriately as conditions change for example if the patient moves or the circuit leak changes Operator s Manual Technical Discussion Leak Sync adds flow to the breathing circuit to compensate for leaks The maximum Leak Sync flow
431. rm settings Ppeax LV ToT LV re MAND VIE MAND LV re SPONT INSPIRATION TOO LONG LV re SPONT default to NIV new patient values not user settable Reference Alarm Settings Range and Resolution p 11 17 INSPIRATION TOO LONG alarm not available Dsens Dcens setting defaults to OFF if Leak Sync is enabled Note In any delivered spontaneous breath either INVASIVE or NIV if Pressure Support is set to O cmH50 there is always a target inspiratory pressure of 1 5 cmH 30 applied When in NIV the Vent Setup button s appearance changes letting the opera tor know the vent type is NIV Operator s Manual Ventilator Shutdown Figure 4 9 Vent Setup Button NIV Indicating NIV vent type V Adult Tex Ramp o0 PEEP Puran Ve ror Vre mano 55 257 10 1 74 32 54 286 257 VEN 11353 D 4 7 5 Conversion from NIV to INVASIVE Vent Type The table below shows automatic settings changes made when changing vent type from NIV to INVASIVE Table 4 4 NIV to INVASIVE on Same Patient Current NIV setting Ventilator settings TT spont New INVASIVE setting N A Alarm settings LPpeak VE tor Vte mann Vte spont Alarm settings Default to new patient values dependent upon selected INVASIVE ventilator settings Reference Alarm Settings Range and Resolution p 11 17 INSPIRATION TOO LONG alarm becomes available Dsens Dsens setting defaults to INVASIVE new patient
432. roximal flow sensor outlet during Leak test When prompted to reconnect the patient to the expiratory filter during the Exhalation Filter test resume blocking the proximal flow sensor outlet N A SST Circuit Compliance Calculates the attached patient circuit compliance N A SST Prox Verifies functionality of Proxi mal Flow System Includes tests of barometric pressure autozero purge and pressure cross check functions Operator s Manual Part numbers r 9 1 Attaching the Proximal Flow Sensor for SST During SST the ventilator prompts to attach the Proximal Flow Sensor To attach the Proximal Flow Sensor to the patient circuit 1 Verify the Proximal Flow Sensor pneumatic lines and connector are not dam aged 2 Open the connector panel door and firmly attach the sensor connector to the receptacle in the BDU s front connector port labeled Prox Figure F 4 Attaching Proximal Flow Sensor to Ventilator VEN_11292_A 1 Proximal Flow Sensor connector 2 Proximal Flow Sensor connector insertion port 3 When prompted block the breathing circuit wye 4 When prompted to attach the Proximal Flow Sensor unblock the circuit wye and insert the smaller end of the sensor into the wye 5 When prompted cap or seal the larger end of the sensor marked with UP and an arrow 6 Follow the prompts to complete SST Operator s Manual F 11 Proximal Flow Option Appendix
433. rtificial airway and respira tory system displayed at the start of the next inspiration after the Inspiratory Pause maneuver It is an estimate of how restrictive the patient s airway is based on the pressure drop at a given flow expressed in cmH30O L s Rstar Is computed during a VC mandatory breath with a square flow waveform Csrar is calculated using this equation V Cig tN STAT P PEEP ckt C Static compliance P The pressure in the patient circuit mea STAL ckt sured at the end of the 100 ms interval defining the pause mechanics plateau V Total expiratory volume patient and PEEP The pressure in the patient circuit mea Pt breathing circuit sured at the end of expiration C Compliance of the breathing circuit ckt during the pause maneuver derived from SST Rsrar is calculated using this equation after Cstar is computed and assuming a VC breath type with a SQUARE waveform Static resistance Static compliance RSTAT Csrar 6 48 Operator s Manual Ventilator Settings Fi Coki C Pena Pew STAT Rsrar 7 V pt C Compliance of the breathing circuit Mean pressure in the patient circuit ckt during the pause maneuver derived over the 100 ms interval defining the from SST pause mechanics plateau Flow into the patient during the last V 100 ms of the waveform pl Pye Peak circuit pressure During the pause the most recently selected graphics are displayed and frozen to determine when inspiratory pres
434. ry time for mandatory PC breaths The ventilator accepts the specified range of direct I E ratio settings as long as the resulting Tj and T settings are within the ranges established for mandatory breaths Changes to the I E ratio phase in at the start of inspiration Directly setting the I E ratio in VC mandatory breaths is not allowed Reference nspiratory Time T p 10 65 for an explanation of the interdependencies of f Ty Te and I E Setting f and I E automatically determine the values for Tj and Tg The maximum I E ratio setting of 4 00 1 is the maximum that allows adequate time for exhalation and is intended for inverse ratio pressure control ventilation 10 15 16 High Pressure Py in BiLevel The pressure level entered by the operator for the inspiratory phase of the mandatory breath in BiLevel ventilation 10 15 17 Low Pressure P in BiLevel The pressure level entered by the operator for the expiratory phase of the man datory breath in BiLevel ventilation 10 15 18High Time Tp in BiLevel The duration of time in seconds the ventilator maintains the set high pressure level in BiLevel ventilation 10 66 Operator s Manual Short Self Test SST 10 15 19Low Time T1 in BiLevel The duration of time in seconds the ventilator maintains the set low pressure level in BiLevel ventilation 10 15 201y T Ratio in BiLevel The ratio of Ty to T in BiLevel ventilation similar to I E ratio when ventilating a p
435. s Operator s Manual Ventilator Settings 6 5 7 Alarm Delay Determination of an Alarm Condition The delay time from the moment the alarm condition first occurs until the alarm is annunciated is imperceptible Delay to from a Distributed Alarm System For alarm conditions relayed via the serial port the overall delay is dependent upon the polling rate of the external device The delay from the time the serial port is polled by the external device until the alarm message leaves the serial port does not exceed 3 seconds An example of an external device is a patient monitor 6 5 8 Alarm Handling Current alarm settings are saved in the ventilator s non volatile memory NVRAM If the alarm settings are changed by another clinician those set tings become applicable For example there are no operator selectable default alarm settings The ventilator system s alarm handling strategy is intended to e Detect and call attention to legitimate causes for caregiver concern as quickly as possible while minimizing nuisance alarms e Identify the potential cause and suggest corrective action for certain types of alarms However the clinician must make the final decision regarding any clinical action e Make it easy to discern an alarm s priority level e Allow quick and easy alarm setup Ventilator alarms are categorized as high priority medium priority or low pri ority and are classified as technical or non technical The ve
436. s resulting in malfunction of the ventilator s spirometry system WARNING Follow disinfectant manufacturer s recommendations for personal protection such as gloves fume hood etc to avoid potential injury 1 Pre soak exhalation valve flow sensor assembly in the enzymatic solution Refer ence Operator Preventive Maintenance Frequency p 7 2 The purpose for this pre soak is to break down any bio film that may be present Follow manufactur er s instructions regarding duration of soak process Caution Do not use any type of brush to scrub the exhalation valve flow sensor assembly as damage to the flow sensing element could occur 2 Rinse in clean de ionized water 3 Prepare the chemical disinfectant according to the manufacturer s instructions or as noted in the institution s protocol Reference Component Cleaning Agents and Disinfection Procedures p 7 6 for the proper disinfecting agents 4 Immerse the in the disinfectant solution oriented as shown and rotate to remove trapped air bubbles in the its cavities Keep immersed for the minimum time period by the manufacturer or as noted in the institution s protocol Operator s Manual Service Personnel Preventive Maintenance Figure 7 11 Immersion Method VEN_10292_A 5 Atthe end of the disinfecting immersion period remove and drain all disinfectant Ensure all cavities are completely drained Rinsing 1 Rinse the exhalation valve flow sensor assembly using
437. s greater support from the ventilator The patient performs the remaining work If the total WOB changes resulting from a change to resistance or compliance the percent support remains constant 10 68 Operator s Manual Short Self Test SST 10 15 26Rise Time The rise time setting allows adjustment of the speed at which the inspiratory pressure reaches 95 of the target pressure Rise time settings apply to PS including a setting of O cmH 0 VS PC or VC breaths The higher the value of rise time the more aggressive and hence the more rapid the rise of inspiratory pressure to the target which equals PEEP P or Psypp The rise time setting only appears when pressure based breaths are available The range of rise time is 1 to 100 A setting of 50 takes approximately half the time to reach 95 of the target pressure as a setting of 1 e For mandatory PC VC or BiLevel breaths a rise time setting of 1 produces a pressure trajectory reaching 95 of the inspiratory target pressure PEEP P in two 2 s or 2 3 of the Tj whichever is shortest e For spontaneous breaths VS or PS a rise time setting of 1 produces a pressure trajectory reaching 95 of the inspiratory target PEEP Pcypp in 0 4 x PBW based T TOO LONG x 2 3 s e When both PC and PS breaths are active the slopes and thus the pressure trajec tories can appear to be different Changes to T and P cause PC pressure trajecto ries to ch
438. s Manual Product Connectivity 3 6 7 Humidifier Use the humidifier to add heat and moisture to the inhaled gas Connect the humidifier to a hospital grade electrical outlet Choose the humidifier type and volume appropriate for the patient The humidifier may be mounted with the humidifier bracket as shown Reference Covidien Accessories and Options p 9 4 for the part number of the humidifier bracket WARNING Selection of the incorrect humidifier type and or volume during SST or during patient ventilation can affect the accuracy of delivered volume to the patient by allowing the ventilator to incorrectly calculate the compliance correction factor used during breath delivery This can be a problem as the additional volume required for circuit compressibility compensation could be incorrectly calculated resulting in over or under delivery of desired volume WARNING To ensure proper compliance and resistance calculations perform SST with the humidifier and all accessories used for patient ventilation installed in the ventilator breathing system WARNING Follow the humidifier manufacturer s Instructions for Use IFU when using a humidifier with patient ventilation O Caution Follow humidifier manufacturer s instructions for use IFU for proper humidifier operation To install the humidifier bracket 1 Attach humidifier bracket to the ventilator s accessory rail by placing the bracket behind the railing and fastening t
439. s chawciacwecadclaucee sane 2 5 BDU Front Label Symbols and Descriptions 2 9 BDU Rear Label or Panel Symbols and Descriptions 2 11 Common Symbols Found on GUl or BDU Labels 2 13 GUI Control Key Asa asaan GAGA AGANG 2 16 GUI Visual Indicators aaa 2 18 Symbols and Abbreviations e cece cence cence ees 2 21 GUI Audible Indicator Functions a 2 24 Status Display Indicators and Descriptions 2 30 BDU Audible Indicator Functions cece eee eee 2 35 Color LEGEND rssirosireeni miniran Peer ECAN EO E ENTE AA 2 36 Patient Types and PBW Values sasawa saaan 3 15 Ventilator Configuration aaa 3 35 SST Test Sequence Lpa kanan KAKA ANG NG KG NNAEK ENNA seus 3 49 Humidifier VOlUMES paa a mak NN bdoed epvenddesdsxeede ones 3 50 Individual SST Results ccc ccc eee cece cece teen eens 3 51 Overall SST OUtCOMES cece eee asus aasawa aaa 3 51 EST Test Sequence 2243 22 nssuaveds i ceiwsopexkesbcsaueendeed 3 55 Individual EST Results 0 cece cece eee eee n eee eenee 3 57 Overall EST Outcomes 21 2525 ak NAA h Naka ER 3 58 Gestures and Their MeaningS ccccecc ence nee eees 4 6 Setting Up a Patient for NIV 0 cece cece ence eee ees 4 23 INVASIVE to NIV on Same Patient cece eee eae 4 24 NIV to INVASIVE on Same Patient ccc eee eee ee eee 4 25 MISCA
440. s into the lungs as they would in the absence of the pressure assistance provided by the TC feature This is particularly important for patients whose respiratory systems are already functioning poorly and would have to exert even greater muscular effort to overcome the increased resistance to flow through the artificial airway Tube Compensation provides programmable inspiratory pressure assistance during otherwise unsupported spontaneous breaths This assists the patient in overcoming the flow resistance of the artificial airway Pressure is programmed to vary in accordance with the resistance to flow of the artificial airway The ventilator continuously calculates the pressure differential and adjusts the compensation pressure accordingly Tube Compensation also includes safety protection safety checks and logic checks which prevent the operator from entering certain incompatible set tings such as a large airway size paired with a small predicted body weight If the type of humidifier has been changed after running SST with TC the volume can be adjusted at the same time to avoid a reduction in compensation compliance accuracy Technical Description Tube Compensation is a spontaneous mode enhancement which assists patients spontaneous breaths not already supported by specific pressure based breath types such as PS VS and PAV by delivering positive pressure proportional to the flow based resistive pressure developed across th
441. s log records changes to ventilator settings for retro spective analysis of ventilator patient management The time and date old and new settings and alarm resets are recorded A maximum of 500 settings changes can be stored in the log The settings log is cleared when the ventilator is set up for a new patient The settings log is accessible in normal ventilation mode and Service mode e Patient Data Log This log records every minute up to 4320 patient data entries consisting of date and time of the entry patient data name and the patient data value during ventilator operation It is cleared when the ventilator is set up for a new patient Three tabs are contained in the patient data log e Vital Patient data The log contains the same information that the clinician has configured in the patient data banner at the top of the GUI If the patient data parameters in the banner are changed these changes are reflected the next time the patient data log is viewed e Additional Patient Data 1 This log corresponds to the patient data param eters set on page 1 of the additional patient data banner A total of 15 param eters are stored here consisting of date and time of the entry recorded every minute patient data name and the patient data value during ventilator oper ation Operator s Manual Ventilator Logs e Additional Patient Data 2 This log corresponds to the patient data param eters set on page 2of the addit
442. s or implements that could damage surfaces Table 7 3 Component Cleaning Agents and Disinfection Procedures Part Exhalation valve flow sensor assembly Cleaning Agent Procedure Reference Exhalation Valve Flow Sensor Assembly Disinfec tion p 7 13 for specific instruc tions Cidex 2 5 ASP e Sporox Il Sultan Cidex OPA ASP Comments Cautions Do not drop the exhalation valve flow sensor assembly or handle roughly during disinfection or storage Reusable patient circuit tubing Disinfect per manufacturer s instructions for use e Inspect for nicks and cuts and replace if damaged e Run SST to check for leaks when reinstalling the circuit or when installing a new circuit Operator s Manual Service Personnel Preventive Maintenance Table 7 3 Component Cleaning Agents and Disinfection Procedures Continued Part Disposable patient circuit tubing Cleaning Agent Procedure Discard Comments Cautions Discard per the institution s protocol Breathing circuit in line water traps Disinfect per manufacturer s instructions for use e Inspect water traps for cracks and replace if dam aged e Run SST to check for leaks when reinstalling the circuit or when installing new components Breathing circuit components Disinfect per manufacturer s instructions for use e Inspect components for nicks and cuts and replace if dam
443. s suspended during a disconnect occlusion or safety valve open SVO state Apnea is not declared when the apnea interval setting equals or exceeds the breath period For example if the respiratory rate setting is 4 min an apnea interval of 15 s or more means apnea cannot be detected The ventilator bases apnea detection on inspiratory not expiratory flow and allows detection of a disconnect or occlusion during apnea ventilation Apnea detection is designed to accommodate interruptions to the typical breathing pattern due to other ventilator features that temporarily extend the inspiratory or expiratory inter vals rate changes for example but still detect a true apnea event The following figure shows an apnea breath where Ta equals the breath period Operator s Manual 10 41 Theory of Operations Figure 10 19 Apnea Interval Equals Breath Period 1 2 i VEN 10769 B 1 TbO 3 PIM 2 Tb1 4 Ta apnea interval The figure below shows an apnea breath with Ta greater than the breath period Figure 10 20 Apnea Interval Greater Than Breath Period VEN 10770 B 1 TbO 4 VIM 2 Tb1 5 Ta apnea interval 3 PIM The following figure shows an apnea breath with Ta less than the breath period 10 42 Operator s Manual Short Self Test SST Figure 10 21 Apnea Interval Less Than Breath Period VEN_10771_B 1 TbO 6 Apnea interval 2 Tb1 7 Apnea TbO 3 PIM 8 Apnea ventilation 4 Dashed l
444. sable carton of 12 DAR 351U5856 Condensate vial reusable 10063031 Condensate vial drain cap Assy Patient Circuit Heated Wire Adult reusable 4 074613 00 G 061235 00 Assy Patient Circuit Heated Wire Pediatric Patient circuit Pediatric reusable G 061237 00 Assy Patient Circuit Pediatric Reusable G 061223 00 Patient circuit Adult single use 6 003030 00 Ventilator breathing circui available in USA Neonatal disposable DAR not 3078447 Ventilator breathing circuit Neonatal disposable Hudson RC Teleflex 780 06 Ventilator breathing circuit Neonatal disposable Fisher amp Paykel RT235 19 O ring seal condensate vial reusable 10085527 20 Neonatal expiratory filtration system disposable with con densate vial 4 076900 00 21 Proximal Flow monitoring sensor disposable 10 box 10047078 Not shown Exhalation valve module reprocessing kit 6 carton Hardware options 10086048 Not shown Gold standard test circuit 21 inch for performing EST 4 018506 00 Proximal Flow Monitoring Option 0084331 Software options Not shown Leak Sync Software 0086418 Not shown Leak Sync Software Upgrade 0096528 Not shown IE Sync Software 0086354 Not shown IE Sync Software Upgrade 0096529 Operator s Manual Accessories 9 8 Item number Not shown Table 9 1 Covidien Accessor
445. serve the following warning A single circuit leak test can be run but the full suite of SST test must success fully pass before releasing the ventilator for clinical use If a complete SST is interrupted and ventilation was allowed before starting SST normal ventilation is allowed if e SST did not detect any failures or alerts before the interruption and e no other errors that would prevent ventilation occurred and e there were no changes to the circuit type at the start of the interrupted SST During SST the ventilator displays the current SST status including the test currently in progress results of completed tests Test data are available in Service Mode where applicable or are displayed on the screen The ventilator logs SST results and that information is available following a power failure The alarm silence and alarm reset keys are disabled during SST as well as the Manual Inspiration Inspiratory Pause and Expiratory Pause keys 3 9 2 EST Extended Self Test The ventilator s Extended Self Test EST function is designed to verify the ven tilator s operational subsystem integrity All required software support to perform EST is resident on the ventilator EST requires approximately ten 10 minutes to complete Note SST is not part of the EST test suite To determine patient circuit resistance and compliance run SST EST Self Test Prerequisites Follow all identified guidelines when performing the EST self te
446. sk However in order to minimize risk of phthalate exposure in children and nursing or pregnant women this product should only be used as directed A WARNING The ventilator offers a variety of breath delivery options Throughout the patient s treatment the clinician should carefully select the ventilation mode and settings to use for that patient based on clinical judgment the condition and needs of the patient and the benefits limitations and characteristics of the breath delivery options As the patient s condition changes over time periodically assess the chosen modes and settings to determine whether or not those are best for the patient s current needs A WARNING Neonatal patients are at risk for hypercarbia or hypoxemia during We Tot alarm conditions E 2 Operator s Manual Ventilation Features WARNING Disabling the low exhaled minute volume JV tor alarm increases the patient s risk of Hypercarbia or Hypoxemia WARNING When Using NIV the patient s exhaled tidal volume Vg could differ from the ventilator s monitored patient data value for Vg due to leaks around the interface To avoid this ensure Leak Sync is installed When NIV is selected Leak Sync is automatically enabled es Description The ventilator determines values for operational variables and allowable set tings based on breathing circuit type and predicted body weight PBW The PBW range for neonates is 0 3 kg to 7 0 kg 0 66 Ib to
447. sosseessossssssesse 6 5 Condensate Vial aaa Amana 7 9 Filter Top and Bottom VIEWS ssssssssseeessssssssssseeeseessssssssseoseeosossssssesse 7 10 From Patient Port na ABAKA NAA ea n eae 7 11 Expiratory Filter Drying Orientation s seseserserserserserseesessessessesses 7 12 Exhalation Valve Flow Sensor Assembly s ssessesserserserseesesssssessssses 7 14 Exhalation Valve Flow Sensor Components ssssssssssessesssssssssesee 7 14 Exhalation Valve Flow Sensor Assembly Removal 7 15 Exhalation Valve Diaphragm Removal sssssssesssssesseessesneeseeees 7 15 Expiratory Filter Seal Removal sesssessssscssecssecseesseccseesseessceneeesecses 7 16 Pressure Sensor Filter Removal sessssscssecssecssccseesseccssesseessceseeeseecses 7 16 Immersion Method a scunadaissncihatanausealaeaics 7 18 Exhalation Valve Flow Sensor Assembly Reprocessing Kit 7 20 Installing the Pressure Sensor Filter sssssssseeesesssssssssseeseesssssssssesse 7 20 Installing the Expiratory Filter Seal oo sseesssscssesseecssecseesscesseeseeses 7 21 Installing the Diaphragm essessscsssssesssssccsscssesssssessessscesseseesnseseees 7 22 Installing the Exhalation Valve Flow Sensor Assembly 7 23 BOGS CROW ces sae te aaa erat Gti NN 8 4 Ventilator with Accessories sescssesssccssecsscsssccsecseecsscensecseecscecsecssceeneess 9 3 Additional Access iessen nnana 9 4 Inspiration Using Pressure Sensitivity
448. ssary to deliver more or less volume As the patient s condition improves allowing more patient control over spontaneous ventilation the VS algorithm decreases the amount of inspiratory pressure necessary to deliver the target volume Conversely VS increases inspiratory pressure if the patient s respiratory drive becomes com promised In the absence of leaks or changes in patient resistance or compliance Volume Support achieves and maintains a steady breath to breath tidal volume within five 5 breaths of VS initiation or startup During VS the inspiratory pressure target cannot be lower than PEEP 1 5 cmH 0 and cannot exceed Pprag 3 CMH20 Operator s Manual 10 25 Theory of Operations VS Startup During startup the ventilator delivers a breath test breath to determine the pressure target needed to deliver the desired set volume During the time the ventilator is delivering the test breath the message VS startup is displayed in the GUI s prompt area Test breaths are defined as A PS spontaneous breath with Psypp the lesser of 15 cmH 0 and Ppgax PEEP 3 cmH 70 Note To allow for optimal function of startup and operation of VS in the ventilator it is important not to block the tubing while the patient is undergoing suctioning or other treatment that requires disconnection from the ventilator The ventilator has a disconnect detection algorithm that suspends ventilation while the patient is disconnected
449. ssis tance Consid er reducing Yo Supp setting Provide alter nate ventila tion Remove ventilator from use and contact Ser vice Battery installed but not functioning or charging for gt 6 hours Resets when battery is function al Operator s Manual 6 23 Performance 6 24 Table 6 5 Non technical Alarm Summary Continued INSPIRATION TOO LONG patient data alarm Analysis message Last 2 spont breaths PBW based T limit Medium Last 4 spont breaths PBW based T limit PAV STARTUP TOO LONG patient data Last 10 or more spont breaths PBW based T limit PAV startup not complete for gt 45s alarm occurs only if PAV is in use PAV startup not complete for gt 90 s PAV startup not complete for gt 120s Remedy message Check patient Check for leaks Check for leaks shallow breathing amp settings for Comments Inspiratory time for spontaneous breath gt PBW based limit Ventilator transi tions to exhalation Resets when T falls below PBW based limit Active only when Vent Type is INVASIVE Unable to assess patient s resistance and compliance during PAV startup Possible dependent alarms VE spont We TOT Mror Cor rective action Check pati Patient s inspirato ry times may be too short to evaluate resistance and com pliance Check that selected humidifica tion type and empty humi
450. sssseresssssssssssseeesessssssss 10 42 Figure 10 20 Apnea Interval Greater Than Breath Period cccessssseesceseenee 10 42 Figure 10 21 Apnea Interval Less Than Breath Period csssssescsecsscessecseecees 10 43 Figure 10 22 Apnea Ventilation in SIMV s sseesssssssseecseesssssssssoseeesssssnsssesscecsessssssss 10 45 Figure A 1 Spontaneous Breathing at Py uu ccsssssssssecssessscseessscsessncessesseseesneesees A 1 Figure A 2 BiLevel MOTEL A 2 Figure A 3 BiLevel Setup Screen ou nananana ana nanannananaasawsaasanasansanasassassasssassassanssnasa A 4 Figure A 4 BiLevel with Pressure Support ssssssssesesssssssssssscessessnsssssseccseesnsssssseoosee A 5 Figure A 5 Spontaneous and Synchronous Intervals ssessseecssecseccseesseecseerees A 8 Figure A 6 APRV With Spontaneous Breathing at Py sssssessseecssseesssseesssees A 9 Figure B 1 Enabling Leak SVAc kaaa atic sates acinus B 4 Figure B 2 GUI Screen when Leak Sync is Enabled sessessescsecssceseecseccneersees B 5 Figure B 3 Leak Sync Monitored Patient Data eessssssssssceesecsseessecseecneersees B 7 Figure B 4 Circuit Disconnect During VC ou ssessssssscsscecsccccscsecnscecsesssseeseeseneencaee B 9 Figure Col Setup Screen NN U ANGIN INN GANA NANDUN cee C 3 Figure C 2 Monitoring Setup aaa anan kun aasansadands C 4 Figure C 3 Monitoring Dialog a cciciantutiesyaeunsndinienamecesntuewinasannainieiees C 5 Figure C 4 Monitoring Waveform eesesssssesss
451. ssure Accu racy Verif ies current versus pressure values in flash memory correspond with actual installed exhalation valve Exhalation Va EV Performa Verif ies the exhalation valve operates within specifi cations of the last exhalation valve calibration Exhalation Va EV Velocity Trans ducer Verifies the velocity transducer is sending a signal and the control circuit recognizes it It does not verify the quality of the signal Safety System Tests safety valve operation Backup Ventilation Verifies backup ventilation systems mix inspiratory and exhalation Communication Verifies GUI communication ports function both seria and ethernet Internal Storage Verifies internal storage device function LCD Backlight Veri ies GUI LCD backlight intensity function Operator s Manual Product Connectivity Table 3 7 EST Test Sequence Continued EST Test Step Function Required User Interaction Status Display Verifies status display function e Verifies LCD function e Communicates with BD CPU GUI Audio Tests GUI alarm indicators cycling through each low prompts alarm status indication BD Audio Verifies BD audible alarm is functional Also verifies low prompts power fail capacitor can operate loss of power alarm Rotary Knob Test Verifies knob rotation function low prompts Offscreen Key Test Verifies GUI
452. ssures during exhalation 10 12 Operator s Manual Short Self Test SST 1 6 Compliance and BTPS Compensation 10 6 1 Compliance Compensation in Volume based Breaths Compliance compensation accounts for the gas volume not actually delivered to the patient during inspiration This gas is known as the compliance volume Vc Vc is the gas lost to pressurizing the breathing circuit and includes the volumes of the patient circuit any accessories such as a humidifier and water traps and internal ventilator gas passages Figure 10 6 Square Flow Pattern paaa VEN 10247 A 1 Flow y axis 4 Compliance volume Vc 2 Actual VMAX 5 Set Vr 3 Set VMAX 6 T Operator s Manual 10 13 Theory of Operations 10 14 4 Figure 10 7 Descending Ramp Flow Pattern _ a VEN_10248_A Flow y axis 5 Set Vy Actual VMAX 6 T Set VMAX 7 Minimum VMAX Compliance volume Vc In the ventilator an iterative algorithm automatically computes the compliance volume There is a maximum tubing to patient compliance ratio to reduce the potential for over inflation due to an erroneous patient compliance estimation The maximum ratio is determined by the selected patient circuit type and pre dicted body weight PBW Operator s Manual Short Self Test SST C Factor 2ict pt Factor Compliance volume factor Compliance of the patient circuit Cor ckt j P C Compliance of the patient pt The compliance volume is calculated as Vo
453. st Inspect all equipment required for any self test to ensure it is not damaged in any way 1 Collect all required equipment prior to performing any self test of the ventilator Successful self test is not possible without the use of the listed equipment 2 Disconnect the ventilator from the patient 3 Fully charge the primary ventilator battery Operator s Manual Product Connectivity 4 Connect the ventilator to AC power using the hospital grade power cord until completion of any self test 5 Ensure the ventilator is powered down 6 Ensure both air and oxygen sources register pressure between 35 and 87 psi 241 to 599 kPa To perform Extended Self Test EST or to access additional service functions the ventilator must be in Service Mode Reference Service Mode p 3 33 Note 15 While in the Service Mode normal ventilation is not allowed WARNING Always disconnect the ventilator from the patient before running EST Running EST while the ventilator is connected to the patient can injure the patient WARNING A fault identified during this test indicates the ventilator or an associated component is defective Rectify the fault and perform any required repairs prior to releasing the ventilator for patient use unless it can be determined with certainty that the defect cannot create a hazard for the patient or add to the risks which may arise from other hazards Perform EST during any of the listed conditions
454. st status passed or failed e General Event log The general event log contains ventilator related informa tion not found in any other logs It includes changes in alarm volume when the ventilator entered and exited Stand By GUI key presses respiratory mechanics maneuvers O calibration patient connection elevate O and warning notifica tions The General event log can display up to 256 entries and is not cleared upon new patient setup e Service Log The service log is accessible during normal ventilation and Service modes and contains the nature and type of the service reference numbers specific to the service event for example sensor and actuator ID numbers manual and automatic serial number input and the time and date when the service event occurred It is not cleared upon new patient setup To view ventilator logs 1 Touch the clipboard icon in the constant access icon area of the GUI The log screen appears with tabs for the various logs 2 Touch the tab of the log desired Operator s Manual 8 3 Troubleshooting 3 View the information for each parameter desired Figure 8 1 Log Screen PEEP 20 282 10 1 7 1 29 43 162 282 Logs Alarms Adult U f Vr Vmax NG 10 300 44 To Ramp 0 0 N VEN 11360 D 1 Individual logs tabs 2 Pages contained in the log being viewed Ventilator logs can be saved by entering Service mode and downloading them via the ethernet port Reference the Puritan
455. state the ventilator measures pressure and flow in the patient circuit to determine if a patient is attached If a patient is detected the ventilator continues ventilation as set prior to the request alerts the oper ator that Stand by state is pending and requests the patient be disconnected A countdown timer appears alerting the operator of the time remaining to dis connect the patient After the patient is disconnected the ventilator requests confirmation of the disconnection When the ventilator enters Stand by state a message appears on the GUI any active alarms are silenced and reset and the associated alarm reset entries are logged in the Alarm Event Log Alarm detection is suspended and breath delivery is suspended while a bias flow is maintained for patient detection During Stand by state the ventilator displays the elapsed time the patient has been without ventilation Since the ventilator maintains a bias flow for patient detection it resumes ventilation at the previ ous settings when the patient is reconnected There is no need to touch Exit Stand By Reconnecting the patient returns the ventilator to normal operation During Stand by state patient data values are not displayed and the LED located at the top of the GUI cycles between yellow and green Entry into and exit from Stand by state is recorded in the General Event log Operator s Manual Product Connectivity 3 7 4 Service Mode WARNING Before entering Service
456. static resistance Rstaq Glossary 3 Table Glossary 1 Glossary of Ventilation Terms Continued invasive ventilation kPa latched alarm L min low priority alarm lockable alarm maintenance mandatory breath mandatory type manual inspiration medium priority alarm mode NIST non invasive ventila tion NIV non technical alarm normal ventilation Patient ventilation while intubated with an endotracheal or tracheosto my tube Kilopascal A unit of pressure approximately equal to 10 cmH 0 An alarm whose visual alarm indicator remains illuminated after the alarm has autoreset Liters per minute A unit of flow As defined by international standards organizations an alarm that indi cates a change in the patient ventilator system During a low priority alarm the yellow low priority LED indicator lights the low priority audible alarm one tone sounds and the GUI screen shows an alarm banner with the symbol An alarm that does not terminate an active alarm silence function All actions necessary to keep equipment in or restore it to serviceable condition Includes cleaning servicing repair modification overhaul inspection and performance verification A breath whose settings and timing are preset can be triggered by the ventilator patient or operator The type of mandatory breath volume control VC VC or pressure control PC An operator initiated mandatory OIM
457. sults If Accept is touched the results are displayed Cancel an automatic inspiratory pause maneuver by touching Cancel on the GUI screen To perform a manual inspiratory pause 1 Press and hold the inspiratory pause key on the GUI bezel or touch and hold Start on the GUI screen if performing an inspiratory pause from the GUI screen as shown above The ventilator prompts that the maneuver has started and to release to end the maneuver The ventilator performs the inspiratory pause maneuver and displays Pp Cstat and Rstat along with the date and time 4 30 Operator s Manual Ventilator Shutdown 2 Touch Accept or Reject to save or dismiss results If Accept is touched the results are displayed Cancel a manual inspiratory pause maneuver by releasing the Inspiratory Pause key 4 9 2 Expiratory Pause Maneuver An expiratory pause extends the expiratory phase of the current breath for the purpose of measuring end expiratory lung pressure PEEPyo7 or total PEEP It has no effect on the inspiratory phase of a breath and only one expiratory pause per breath is allowed For E ratio calculation purposes the expiratory pause maneuver is considered part of the exhalation phase During an expiratory pause both inspiratory and exhalation valves are closed allowing the pressures on both sides of the artificial airway to equilibrate This allows intrinsic PEEP PEEP to be calculated PEEP is PEEP 7 minus the set PEEP level An e
458. sure stabilizes Cstar and Rsrar are displayed at the start of the next inspiration following the inspiratory pause and take this format Cot at XXX or Rstat YYY Special formatting is applied if the software determines variables in the equa tions or the resulting Cstaz or Rstat values are out of bounds e Parentheses signify questionable Cstar or Rstaz values derived from question able variables e Flashing Cstaz or Rstat values are out of bounds Retat means resistance could not be computed because the breath was not of a mandatory VC type with square flow waveform 6 6 30 Dynamic Compliance Cpyn Cpyn is a dynamic estimate of static compliance for each mandatory breath delivered Operator s Manual 6 49 Performance 6 6 31 Dynamic Resistance Rpyn Rpyn is a dynamic estimate of static resistance for each mandatory breath delivered 6 6 32 Co9 C C5 C is the ratio of compliance of the last 20 of inspiration to the compli ance of the entire inspiration 6 6 33 End Expiratory Flow EEF A measurement of the end expiratory flow for an applicable breath 6 6 34 Peak Spontaneous Flow PSF A measurement of the maximum inspiratory spontaneous flow for an applica ble spontaneous breath 6 6 35 Displayed 07 The percentage of oxygen in the gas delivered to the patient measured at the ventilator s outlet upstream of the inspiratory filter It is intended to provide a check against the se
459. sypp Pj is greater than Py 1 5 cmH50 all spontaneous breaths at P are assisted by the Psypp setting and all spontaneous breaths at Py are assisted by Psupp Py PD All spontaneous breaths not supported by PS or TC for example a classic CPAP breath are assisted with an inspiratory pressure of 1 5 cmH 30 For example if PL 5 cmH 0 Py 15 cmH50 and Psupp 20 cmH 20 2 3 All spontaneous breaths at P are assisted by 20 cmH50 of pressure support P Psupp for a total pressure of 25 cmH5 0Q and All spontaneous breaths in Py are assisted by 10 cmH5O of pressure support Psypp Py PD for the same total pressure of 25 cmH 0 Figure A 4 BiLevel with Pressure Support 2 3 VEN 10252 C Pressure y axis 4 Py Py Pressure support 10 cmH 0 5 PL P Pressure support 20 cmH 0 During spontaneous breaths the pressure target is calculated with respect to P as Manual Inspirations in BiLevel Mode KIN Pressing the MANUAL INSP key during BiLevel mode causes the ventilator to Operator s Manual A 5 BiLevel 2 0 Appendix A 6 e Cycle to Py if the current pressure level is P e Cycle to Py If the current pressure level is Py To avoid breath stacking the ventilator does not cycle from one pressure level to another during the earliest stage of exhalation a7 Respiratory Mechanics Maneuvers in BiLevel In BiLevel respiratory mechanics maneuvers are limited to inspiratory pause and expirat
460. t always be at least 5 cmH50 greater than P A 3 BiLevel 2 0 Appendix J Note The rise time setting determines the rise time to reach target pressure for transitions from Pj to Py and for spontaneous breaths even when pressure support Psypp O Expiratory sensitivity Esens applies to all spontaneous breaths 6 Set T Ty or the ratio of Ty to T To select settings that would result in a Ty T ratio greater than 1 1 or 4 1 you must touch Continue to confirm after reaching the 1 1 and 4 1 limits Figure A 3 BiLevel Setup Screen Preng aS Se E T E Setup Setup Vent Ventilation Type invasiv 110 b OR 10 480 74 O 26 160 50 3 0 25 VEN 11361 D 7 Touch Start 8 Set apnea and alarm settings by touching their respective tabs at the side of the ventilator settings screen and changing settings appropriately as Using Pressure Support with BiLevel Spontaneous breaths in BiLevel mode can be assisted with pressure support according to these rules Reference BiLevel with Pressure Support p A 5 e Pressure support Psypp can be used to assist spontaneous breaths at P and Py Psupp is always set relative to P Target pressure Pj Psupp A 4 Operator s Manual Technical Description Spontaneous patient efforts at P are not pressure supported unless Pcypp gt Py P All spontaneous breaths whether or not they are pressure supported are assisted by a pressure of 1 5 cmH gt 0 If P
461. t O2 for alarm determination and not as a measurement of oxygen delivered to the patient O2 data can be displayed as long as the O monitor is enabled If the monitor is disabled dashes are displayed If a device alert occurs related to the O monitor a blinking O is displayed 6 50 Operator s Manual 7 Preventive Maintenance 71 Overview This chapter contains information on maintenance of the Puritan Bennett 980 Series Ventilator It includes e How to perform routine preventive maintenance procedures including frequency e How to clean disinfect or sterilize the ventilator and its main components e How to store the ventilator for extended periods e How to dispose of used parts 72 Ventilator Operational Time The ventilator contains an hour meter that records the number of operational hours since the ventilator was manufactured An additional timer tracks the number of hours since the last preventive maintenance activity was performed Both the GUI and the status display show the number of hours before the next preventive maintenance is due 73 Preventive Maintenance Intervals WARNING To ensure proper ventilator operation perform Preventive Maintenance intervals as specified in the following tables Reference Operator Preventive Maintenance Frequency p 7 2 and Reference Service Preventive Maintenance Frequency p 1 2 in the Operator s Manual Addendum on Preventive Maintenance 7 1 Preventive Maintena
462. t down until it snaps out To avoid Operator s Manual 7 15 Preventive Maintenance damaging the flow sensor element do not insert fingers into the center port Figure 7 7 Exhalation Valve Flow Sensor Assembly Removal VEN_10288_A To remove disposable components of the exhalation valve flow sensor assembly 1 Remove and discard the exhalation valve diaphragm the exhalation valve filter seal and the pressure sensor filter Pinch the expiratory filter seal between two fingers to remove it Figure 7 8 Exhalation Valve Diaphragm Removal VEN_10289_A 7 16 Operator s Manual Service Personnel Preventive Maintenance Figure 7 9 Expiratory Filter Seal Removal VEN_10290_A Figure 7 10 Pressure Sensor Filter Removal VEN_10291_A 2 Dispose of removed items according to the institution s protocol Follow local gov erning ordinances regarding disposal of potentially bio contaminated waste Disinfection WARNING Do not steam autoclave the exhalation valve flow sensor assembly or sterilize with ethylene oxide gas Either process could cause the ventilator s spirometry system to malfunction when reinstalled in the ventilator Operator s Manual 7 17 Preventive Maintenance o WARNING Use only the disinfectants described Reference Component Cleaning Agents and Disinfection Procedures p 7 6 Using disinfectants not recommended by Covidien may damage the plastic enclosure or electronic sensor component
463. t notification of a high circuit pressure condition The minimum TPpgag limit 7 cmH O corresponds to the lowest peak pres sures not due to autotriggering anticipated during a mandatory breath The maximum 7TPpgak limit 100 cmH50 was selected because it is the maximum pressure required to inflate very low compliance lungs The ventilator allows circuit pressure to rise according to a computed triggering profile for the initial phase of PC and PS breaths without activating the TPprag alarm This triggering profile helps avoid nuisance alarms due to possible tran sient pressure overshoot in the airway when aggressive values of rise time are selected A brief pressure overshoot measured in the patient circuit is unlikely to be present at the carina 6 5 15 High Delivered 05 10 96 Alarm The 10 96 alarm indicates the measured O2 is at or above the error percent age above the 0 setting for at least 30 seconds to eliminate transient O2 delivery variation nuisance alarms The TO gt alarm detects malfunctions in ventilator gas delivery or oxygen monitor The ventilator declares a T02 alarm after 30 seconds Although the ventilator automatically sets the 102 alarm limits the oxygen sensor can be disabled The error percentage Is 12 above setting for the first hour of ventilator operation 7 above the setting after the first hour of operation and an additional 5 above the setting for the first four minutes following a decrease in t
464. ta displayed by the ventilator The PCBA also contains valves and an accumulator for purging the sensor lines from blockages Proximal Flow Sensor The Puritan Bennett Proximal Flow Sensor is required for use with the Proximal Flow Option The sensor is installed near the patient circuit wye The other end of the sensor connects to the ventilator s front panel behind a clear door designed to protect the connection point from exposure to spills or from sprayed liquids during cleaning and disinfection Operator s Manual F 5 Proximal Flow Option Appendix F 6 Figure F 1 Proximal Flow Sensor VEN_10297_A r7 On screen symbols When using the Proximal Flow Option flow pressure and volume waveform data along with delivered and exhaled volumes are derived from Proximal Flow Sensor measurements at the patient circuit wye Proximal flow data are displayed on the waveform plot with a Y appearing in inverse video next to the measurement symbol Operator s Manual Figure F 2 Sample GUI screen Showing Proximal Flow Data 1 PEEP Ve rora Vre manoni 18 26 19 1 6 5 32 50 0 49 26 VEN 11428 D Data measured using Proximal Flow Sensor Vy Flow throughout the breath cycle at patient circuit wye Pcircy Pressure throughout the breath cycle at patient circuit wye Inspired and exhaled flows and volumes at the patient wye are measured and identified by the symbols shown below and correspond to their non proximal flow
465. taneous breaths The first SIMV VIM breath is phased in according to the following rules e The VIM breath is not delivered during an inspiration or during the restricted phase of exhalation e Ifthe current mode is A C the first SIMV VIM is delivered after the restricted phase of exhalation plus the shortest of the following intervals referenced to the begin ning of the last or current inspiration 3 5 Tj current Ta or the length of the current breath period Operator s Manual 10 37 Theory of Operations 10 38 If the current mode is SPONT and the current or last breath type was spontaneous or OIM the first SIMV VIM is delivered after the restricted phase of exhalation plus the shortest of the following intervals referenced to the beginning of the last or current inspiration 3 5 x Tj or current Ta If the current mode is BiLevel in the Py state and the current breath is mandatory the PEEP level will be reduced to P once the exhalation phase is detected The time t until the first VIM of the new A C mode is the lesser of PEEP transition time 2 5 x duration of the active gas delivery phase or the length of the apnea interval Ta or the length of the current breath cycle If the current mode is BiLevel in the Py state and the current breath is sponta neous the PEEP level will be reduced once the exhalation phase is detected The time t until the first VIM of the new A C mode is the lesser of PEEP tra
466. tatus Display Indicators and Descriptions Continued Status Display Indicator or Message Meaning Safety Valve Open SVO indicator During SVO the patient can breathe room air through the safety valve to the extent the patient is able to breathe unaided Reference Safety Valve Open SVO p 4 36 for more information on the SVO state On AC power indicator When this image appears on any status display indicator indicates the ventilator is operating on AC power Status display appearance when the ventilator is breathing in Normal mode Note the appearance jon Air of the AC power icon TE PEEP cmH Ventilator Hours 1000 Air available indicator When this image appears on any status display indicator indicates the ven tilator is connected to a pressurized air source O available indicator When this image appears on any status display indicator indicates the ven tilator is connected to a pressurized O source 2 34 Operator s Manual GUI Controls and Indicators BDU Audible Indicators The continuous tone alarm is the only audible indicator in the BDU and is described in the table below Table 2 10 BDU Audible Indicator Functions Indicator Description Continuous tone alarm A continuous tone annunciated when there is a Ventilator Inoperative Vent Inop Immediate priority condition This alarm lasts for a minimum of two 2 minutes 2 11 2 Connectors The vent
467. ted all inspirations are VIMs Figure 10 13 No Patient Inspiratory Effort Detected VEN_10762_B 1 VIM 2 Tb 10 32 Operator s Manual Short Self Test SST The figure below shows A C breath delivery when patient inspiratory effort is detected The ventilator allows PIM breaths to be delivered at a rate greater than or equal to the set respiratory rate Figure 10 14 Patient Inspiratory Effort Detected VEN_10763_B 1 PIM 2 Tb set The figure shown below illustrates A C breath delivery when there are both PIM and VIM breaths delivered Figure 10 15 Combined VIM and PIM Breaths VEN_10764_B 1 VIM 3 Tb set 2 PIM If changes to the respiratory rate are made they are phased in during exhala tion only The new breath period depends on the new respiratory rate is based on the start of the current breath and follows these rules e The current breath s inspiratory time is not changed e A new inspiration is not delivered until at least 200 ms of exhalation have elapsed e The maximum time t until the first VIM for the new respiratory rate is delivered is 3 5 times the current inspiratory time or the length of the new breath period whichever is longer but t is no longer than the old breath period e If the patient generates a PIM after the ventilator recognizes the rate change and before time t the new rate begins with the PIM Operator s Manual 10 33 Theory of Operations 10 9 1 Changing to A C Mode
468. tem of continuous testing processes If an error is detected in the background diagnostic system the ventilator notifies the operator by posting an entry in the diagnostic log If the ventilator experi ences an anomaly which causes an unintended reset the ventilator will recover from that reset and deliver a breath within three 3 s without any operator intervention After recovering from a reset the ventilator uses the same set tings that were in effect before the reset occurred The background test process compares monitored values of ventilator func tions with expected values of ventilator sensors under normal conditions regardless of whether the ventilator is in Stand by or is ventilating a patient The ventilator will continue to ventilate the patient with the highest level of support possible and may revert to one of the states described Reference Ventilator Protection Strategies p 4 35 Background tests include e Periodically initiated tests performed at intervals of a specific number of machine cycles These tests check hardware components directly affecting breath delivery safety mechanisms and the GUI and detect and correct corruption of control vari able data e Boundary checks performed at every analog measurement These checks verify measurement circuitry including sensors Ventilation Assurance is a safety net feature invoked if the Background Diag nostics detect a problem with certain components in either the gas m
469. terference may occur in the vicinity of equipment marked with the following symbol gt NOTE 1 At 80 MHz and 800 MHz the higher frequency range applies NOTE 2 these guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 1 The ISM industrial scientific and medical bands between 150 kHz and 80 MHz are 6 765 to 6 795 MHz 13 553 MHz to 13 567 MHz 26 957 MHz and 40 66 MHz to 40 70 MHz The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood mobile portable communica tions equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the separation distance for transmitters in these frequency ranges Operator s Manual 33 Specifications 34 2 The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2 5 GHz are intended to decrease the likelihood mobile portable communications equipment could cause interference if it is inadvertently brought into patient areas For this reason an additional factor of 10 3 is used in calculating the separation distance for transmitters in these frequency ranges 3 Field strengths from fixed transmitters such as base stations for radio cellular cordl
470. that is attached to the patient to any of the non clinical ports listed below when the ventilator is ventilating a patient Figure 5 2 Port Locations VEN 11244 D 1 RS 232 Port COM 1 2 Ethernet Port non clinical use 3 Nurse call Port remote alarm port 4 USB Port USB 1 COM 2 non clinical use 5 USB Port USB 2 COM 3 non clinical use 6 HDMI Port non clinical use 7 Service Port non clinical use 5 18 Operator s Manual Data Transfer 5 5 1 Port Use Reference Data Transfer p 5 1 for data transfer details RS 232 Port To use the RS 232 port 1 Obtain a cable with a male DB 9 connector to connect to the RS 232 port on the ventilator 2 Make the appropriate connection to a monitoring device A gender changer null modem cable or socket saver may be required Consult with the institution s Infor mation Technology professional as required 3 Ensure to specify the baud rate parity and data bits in the ventilator communica tion setup to correctly match the parameters of the monitoring device 4 A monitor designed to use this port is required for obtaining data from the venti lator Set up the monitoring device to receive ventilator data These data can include waveform data 5 Program the remote device to send the appropriate RS 232 commands as described in the next section Reference Reference MISCA Response p 5 6 and Reference MISCF Response p 5 11 for MISCA and MISCF responses to SNDA and SNDF
471. the GUI screen indicates Leak Sync is active e Dogns is displayed in units of L min rather than 96 e f the ventilator detects a leak during a respiratory mechanics maneuver the message Leak Detected is displayed e Anew leak or change in leak rate is typically quantified and compensated within three breaths Monitored patient data stabilizes within a few breaths B 4 Operator s Manual Technical Discussion e Select inspiratory and expiratory sensitivity settings as usual If the ventilator auto triggers try increasing flow sensitivity Vsens Note The absence of the Leak Detected message does not mean there is no leak Q LAP Note Leak Sync is automatically enabled when ventilating a new patient and the circuit type is neonatal regardless of the Vent Type If Leak Sync is disabled it remains disabled when switching between INVASIVE and NIV Vent Types Figure B 2 GUI Screen when Leak Sync is Enabled 10 15 0 74 Paid 50 1 VEN_11366_D 1 LS appears on Vent Setup button notifying the operator that Leak Sync is enabled 8 6 1 Adjusting Disconnect Sensitivity Dsens When Leak Sync is enabled the Circuit Disconnect alarm becomes active based on the Dsgns setting which is the maximum allowable leak rate at set PEEP When Leak Sync is disabled Dsgns is automatically set to 75 Operator s Manual B 5 Leak Sync Appendix WARNING When Vent Type NIV and Leak Sync is disabled Depns is automatically set to OFF
472. the patient 2 If the settings are acceptable touch Accept to confirm To change any settings touch the setting turn the knob clockwise to increase the value of the setting or counter clockwise to decrease the value of the setting and touch Accept to con firm To make several settings changes at once make the desired changes then touch Accept ALL to confirm The appearance of the settings changes from white non italic font showing the current setting to yellow italics noting the pending setting After the settings are accepted the appearance changes back to white non italic font 3 Connect the circuit to the patient s airway to initiate ventilation To ventilate a new patient 1 Touch New Patient on the GUI screen The New Patient settings screen appears to enter the ventilation control parameters Reference Ventilator Settings Range and Resolution p 11 8 for default ventilator parameter settings Figure 4 3 New Patient Settings Waiting for patient connect Setup Vent Ventlaton Type Ais 110 b OR 10 300 44 36 100 49 0 0 T PEEP cmH O 00 N VEN_11350_D 2 Enter the patient s PBW or gender and height if gender is selected the height selection becomes available Operator s Manual 4 9 Operation 3 If the default ventilator settings are appropriate for the patient touch START to confirm the settings otherwise touch a ventilator setting and turn the knob to adjust the parameter Continue this pr
473. thout valid estimates of Rpay and Cpay and because those values are unknown when PAV starts a startup routine obtains these values during four maneuver breaths that include an end inspiratory pause that provides raw data for Rpay and Cpay and both estimated values must be valid If either value is invalid during any of the four startup breaths the software schedules a substitute maneuver breath at the next breath Reference PAV p D 3 A low priority alarm becomes active if a 45 second interval elapses without valid estimates for Rpay and Cpay If the condition persists for 90 seconds the alarm escalates to medium priority If the condition persists for 120 seconds the alarm escalates to high priority The JVE r9r and fror alarms are also associated with this condition Similarly if Repay and Cpay cannot be updated with valid values after a successful PAV startup a low priority alarm is activated if the condition persists for 15 min utes If the values still cannot be updated with valid values after 30 minutes the alarm escalates to medium priority D 22 Operator s Manual Ventilator Settings Guidance s If PAV estimates a high lung resistance following a sharp spike in the expiratory flow waveform then a PBW based resistance value is used Reference the wave form and table below Figure D 3 Use of Default Lung Resistance VEN_11344_A 1 Flow V 5 High peak expiratory flow 2 Expiration 6 E
474. ths for the previous one minute interval also applies in BiLevel Range and Resolution Range 0 00 L min to 99 9 L min Resolution 0 01 L min for 0 00 to 9 99 L min 0 1 L min for 10 0 to 99 9 L min Exhaled spontaneous minute volume VE SPONT The sum of exhaled sponta neous volumes per minute also applies in BiLevel Range O L min to 99 9 L min Resolution 0 01 L min for 0 00 to 9 99 L min 0 1 L min for 10 0 to 99 9 L min Exhaled spontaneous tidal volume V7E spont The exhaled volume of the last spontaneous breath Range 0 mL to 6000 mL Resolution 0 1mL for 0 mL to 9 9 mL 1 mL for 10 mL to 6000 mL Exhaled tidal volume V7 The volume exhaled by the patient for the previous man datory or spontaneous breath also applies in BiLevel Range 0 mL to 6000 mL Resolution 0 1mL for 0 mL to 9 9 mL 1 mL for 10 mL to 6000 mL Leak Sync exhaled tidal volume Vg LE ratio The volume exhaled by the patient for the previous man datory or spontaneous breath during Leak Sync also applies in BiLevel The ratio of the inspiratory time to expiratory time for the previous breath Range 0 mL to 6000 mL Resolution 0 1mL for 0 mL to 9 9 mL 1 mL for 10 mL to 6000 mL Range 1 599 to 149 1 Resolution 0 1 for 9 9 1 to 1 9 9 1 for 149 1 to 10 1 and 1 10 to 1 599 Inspiratory compliance C20 C The ratio of compliance of the last 20 of inspiration to the complianc
475. tient circuit to filter To use the drain bag 1 Remove the drain port cap from the expiratory filter condensate vial drain port 2 Attach the drain bag tube to the condensate vial s drain port Operator s Manual 3 13 Installation 3 Hang the drain bag on the holder located on the ventilator s accessory rail as shown below Reference Covidien Accessories and Options p 9 4 for part number of drain bag holder Figure 3 6 Drain Bag VEN_11209_A 3 5 4 Connecting the Patient Circuit Reference Connecting the Adult or Pediatric Patient Circuit p 3 16 or Refer ence Connecting the Neonatal Patient Circuit p 3 17 to connect the adult pediatric or neonatal patient circuits 3 14 Operator s Manual Product Connectivity WARNING Use patient circuits of the lowest compliance possible with the ventilator system to ensure optimal compliance compensation and to avoid reaching the safety limit of five times set tidal volume or the compliance compensation limit Reference the table below for circuit types corresponding with predicted body weight PBW Table 3 1 Patient Types and PBW Values Circuit Type PBW in kg Ib Allowed but not recommended Neonatal 0 3 kg to 7 0 kg 0 66 to 15 Ib Not applicable Pediatric 7 0 kg to 24 kg 16 Ib to 53 Ib 3 5 kg to 6 9 kg and 25 kg to 35 kg 7 7 Ib to 15 Ib and 55 Ib to 77 Ib Adult 25kg to 150 kg 55 Ib to 331 Ib 7 0 kg to 24 kg 16 Ib to 53 Ib
476. tilator declares a disconnect if the exhaled volume is lower than the Dsgns setting for three consecutive breaths The Dsgys setting helps avoid false detections due to leaks in the circuit or the patient s lungs and the three consecutive breaths requirement helps avoid false detections due to a patient out drawing the venti lator during volume control VC breaths e Flow less than a value determined using the Dsgyns setting and pressure less than 0 5 cmH70 detected for ten 10 consecutive seconds during exhalation A WARNING When vent type is NIV and Degns setting is turned OFF the system may not detect large leaks and some disconnect conditions it would declare as alarms during INVASIVE ventilation Once the ventilator detects a patient circuit disconnect the ventilator declares a high priority alarm and discontinues breath delivery regardless of what mode including apnea was active when the disconnect was detected If there is an active alarm silence when the disconnect occurs the alarm silence is NOT cancelled The ventilator displays the length of time the patient has been without ventilatory support During the disconnect the exhalation valve closes idle flow 10 L min flow at 100 O or 40 O in NeoMode if available with Leak Sync disabled and 20 L min with Leak Sync enabled begins and breath triggering is disabled A message appears identifying how long the patient has gone without ventilatory support The ventilat
477. tilator on 1 Touch or swipe the menu tab on the left side of the GUI 2 Select New Patient 2 Touch Vent Setup 3 Enter patient s PBW or gender and height 3 Perform steps 4 through 7 as if setting the ven tilator up for a new patient 4 Touch NIV vent type 4 Review the settings including apnea and alarm 5 Select mode settings and change if necessary 6 Select mandatory type 7 Complete ventilator settings including apnea and alarm settings Operator s Manual 4 23 Operation 4 7 4 Conversion from INVASIVE to NIV Vent Type WARNING For proper ventilation when changing the Vent Type on the same patient review the automatic settings changes described Adjust appropriately based on the relevant tables Some ventilator settings available during INVASIVE ventilation are not available during NIV Reference the following table for automatic settings changes when changing vent type from INVASIVE to NIV Table 4 3 INVASIVE to NIV on Same Patient Current INVASIVE setting New NIV setting Breath Mode BiLevel Breath mode A C Breath Mode SIMV or SPONT High Tj spont TT sponr limit setting available Mandatory Type VC Mandatory type Neonatal PC Adult Pediatric VC Spontaneous Type Any type except PS Spontaneous type PS Trigger type Pressure Trigger type Flow Flow triggering is the only allowable trigger type during NIV Alarm settings LPprak if applicable IV TOT Ala
478. ting For setting of gt 20 mL 4 10 of setting mL 3 0 2 5 of setting cmH 20 0 cmH70 to 70 cmH70 For adult and pediatric circuit type settings 25 mL to 2500 mL For neonatal circuit type settings 2 mL to 310 mL O2 delivered 3 21 to 100 Py 2 0 4 of setting cmH 0 5 cmH 0 to 90 cmH70 Operator s Manual Performance Specifications Table 11 12 Delivery Accuracy Continued 2 0 4 of setting cmH 0 0 cmH 0 to 45cmH30 Table 11 13 Monitoring Patient Data Accuracy Parameter Accuracy Range Peak circuit pressure Pprax 2 4 of reading cmH O 5 cmH 0 to 90 cmH 0 Mean circuit pressure Pyyean 2 4 of reading cmH70 3 cmH 0O to 70 cmH 0 End expiratory pressure PEEP 2 4 of reading cmH O 0 cmH 30 to 45cmH 0 End inspiratory pressure Pj exp 2 4 of reading cmH 0 5 cmH 0 to 90 cmH 0 Inspired tidal volume V7 4 mL 15 of actual mL 2 mL to 2500 mL Exhaled tidal volume V7 4 mL 10 of actual mL 2 mL to 2500 mL Inspired tidal volume during Leak Sync V7 For adult and pediatric circuit type settings For T lt 600ms 10 20 x 600 ms T ms of reading mL For T gt 600 ms 10 20 of reading mL For neonatal circuit type set ting 10 20 of reading mL For readings lt 100 mL the accuracy shall apply when the percentage of inspiratory leak vol
479. tion below for a summary of the information appearing on the status display Operator s Manual 2 27 Product Overview Status Display The status display is a separate display located on the BDU Reference BDU Front View p 2 8 item 6 The status display provides the following informa tion according to the state of the ventilator During normal ventilation the status display shows Current power source AC or DC Safe State status Safety Valve Open SVO or Vent Inop Presence of primary and extended batteries and their charging status Relative available battery charge level Circuit pressure graph displaying pressure units TPpgag alarm setting and current PEAK and PEEP values Connection of air and oxygen Ventilator operational hours Visual indication of current alarm volume setting Note The status display provides a redundant check of ventilator operation If the GUI stops operating for any reason ventilation continues as set The figure below shows a sample of the status display during normal ventila tion Operator s Manual GUI Controls and Indicators Figure 2 10 Sample Status Display During Normal Ventilation Ventilator Hours 100 Primary and extended battery status 6 presence or absence Alarm volume setting 7 Gas connection status 8 Power status 9 Measured peak circuit pressure updat ed at the end of the current breath VEN 11254 B Pprax alarm setting Measured inspiratory pressure
480. tion pressure accordingly For more information regarding TC Reference Tube Com pensation p 10 27 Inspiratory flow profile The inspiratory flow profile is determined by patient demand and the rise time setting As the rise time setting is increased from minimum to maximum the time to achieve the pressure target decreases The maximum avail able flow is up to 30 L min for neonatal circuit types 80 L min for pediatric circuit types and up to 200 L min for adult circuit types without Leak Sync Exhalation valve during inspiration Adjusts to minimize pressure overshoot and maintain the target pressure Inspiratory valve during inspiration Adjust to maintain target pressure Because the exhalation valve acts as a relief valve venting any excess flow inspiratory flow can be delivered aggressively and allows reduced work of breathing Expiratory detection The end inspiratory flow or airway pressure method or IE Sync cycling if IE Sync is installed whichever detects exhalation first Time backup and the TPpeax alarm are also available as backup strategies Pressure or flow during exhalation Pressure is controlled to PEEP For pressure triggering set to deliver a bias flow of 1 L min near the end of expiratory flow For flow triggering set to deliver base flow Inspiratory valves during exhalation For pressure triggering set to deliver a bias flow of 1 L min near the end of expirator
481. tor settings to the patient Pressure control A mandatory breath type in which the ventilator delivers an operator set inspiratory pressure for an operator set inspiratory time Available in A C and SIMV modes and for operator initiated mandatory OIM breaths in SPONT mode Expiratory pressure transducer Positive end expiratory pressure The measured circuit pressure refer enced to the patient wye at the end of the expiratory phase of a breath If expiratory pause is active the displayed value reflects the level of any active lung PEEP Glossary 5 PEEP PI Pi END PIM PMEAN PPEAK primary alarm PS PSENS PSOL Psupp PTRIG remedy message resistance Table Glossary 1 Glossary of Ventilation Terms Continued Intrinsic PEEP Indicates a calculated estimate of the pressure above the PEEP level at the end of exhalation Determined during an expiratory pause maneuver Inspiratory pressure The operator set inspiratory pressure at the patient wye above PEEP during a pressure control PC mandatory breath Inspiratory pressure transducer End inspiratory pressure The pressure at the end of the inspiration phase of the current breath If plateau is active the displayed value reflects the level of end plateau pressure Patient initiated mandatory breath A mandatory breath triggered by patient inspiratory effort Mean circuit pressure a calculation of the measured average patient circuit p
482. tting highlighted 2 Touch and turn the knob for any other settings that need to be changed 3 Touch Accept or Accept ALL To change a setting using the Vent Setup button 1 Touch Vent Setup 2 Change the settings as described previously 3 Touch Accept or Accept ALL to confirm the changes The ventilator settings and the alarm settings chosen remain in memory after the a power cycle as long as the same patient is chosen when the ventilator is set up again If a new patient is being ventilated the ventilator and alarm set tings revert to their default values If all power is lost both AC and battery the ventilator and alarm settings in effect prior to the power loss are automat ically restored if the power loss duration is five 5 minutes or less If the power loss lasts longer than five minutes ventilation resumes in Safety PCV Ventila tor and alarm settings must be reset for the patient being ventilated Reference Safety PCV Settings p 10 72 for a list of these settings To use the Previous Setup button 1 To return to the previous settings touch Previous Setup on the GUI screen The ventilator restores the main control and breath settings previously used as well as the alarm and apnea settings and prompts a review by highlighting the previous values in yellow The ventilator alarm and apnea settings tab text is also shown in yellow and the tabs show a yellow triangle indicating there are previous set tings that have
483. ture and pressure saturated 37 C at ambient barometric pressure at 100 relative humidity Centimeters of water A unit of pressure approximately equal to 1 hPa The volume of gas that remains in the patient circuit and does not enter the patient s respiratory system One of three breath timing variables inspiratory time I E ratio or expira tory time the operator can hold constant when the respiratory rate setting changes Applies only to the pressure control PC mandatory breath type including VC and BiLevel A ventilator initiated mandatory breath delivered in A C mode Central processing unit The electronic components of the ventilator BD and GUI responsible for interpreting and executing instructions entered by the operator An alarm that arises as a result of another primary alarm also referred to as an augmentation Disconnect sensitivity A setting that specifies the allowable loss percent age of delivered tidal volume which if equaled or exceeded causes the ventilator to declare a DISCONNECT alarm The greater the setting the more returned volume must be lost before DISCONNECT is detected If the Leak Sync option is in use Ds_ens is the maximum allowable leak rate and is expressed in terms of L min Diameter index safety standard A standard for high pressure gas inlet fit tings Expiratory sensitivity A setting that determines the percent of peak inspi ratory flow or flow rate expressed in L min
484. tutional configuration 1 Enter Service Mode and confirm no patient is attached by touching Configura tion Reference Service Mode p 3 33 for instructions on entering Service Mode 2 Touch Configuration at the top of the screen in Service Mode A list of buttons appears allowing configuration of the corresponding parameters 3 Reference the sections below for specific instructions on institutional configura tion of each parameter To return to factory default configuration 1 Enter Service mode and confirm no patient is attached by touching Confirm Ref erence Service Mode p 3 33 for instructions on entering Service Mode 2 Touch Configuration at the top of the screen in Service Mode A list of buttons appears allowing configuration of the corresponding parameters 3 Select the desired modified setting from the left hand menu options 4 Touch Default 3 8 2 Configuring the GUI The display can be configured in various ways Reference Ventilator Configura tion p 3 35 for the parameters which are factory configured institutionally configurable and operator configurable Once the factory or institutionally configurable items have been configured they remain the default values Factory configured values cannot be changed however if the parameters listed in the referenced table are institutionally configured then those values remain in memory as default settings If changes are made to operator config Operator s M
485. ual E 13 NeoMode 2 0 Appendix Page Left Intentionally Blank E 14 Operator s Manual F Proximal Flow Option Appendix r Overview This appendix describes the operation of the Proximal Flow Option for the Puritan Bennett 980 Series Ventilator The Proximal Flow Option is solely used for monitoring flows pressures and tidal volumes and does not control these parameters in any way The Proximal Flow Sensor is designed to measure the lower flows pressures and tidal volumes at the patient wye typically associated with invasively venti lated neonatal patients For general parameter and general ventilator setup information reference Chapter 4 in this manual r2 Intended Use The Proximal Flow Option is used for measuring flows pressures and tidal volumes of invasively ventilated neonatal patients with predicted body weights PBW of 0 3 kg 0 66 Ib to 7 0 kg 15 4 Ib using ET tube sizes from 2 5 mm to 4 0 mm The NeoMode 2 0 software option must also be installed on the ventilator r3 Safety Symbol Definitions This section contains safety information for users who should always exercise appropriate caution while using the ventilator F 1 Proximal Flow Option Appendix Table F 1 Safety Symbol Definitions Symbol Definition WARNING A Warnings alert users to potential serious outcomes death injury or adverse events to the patient user or environment Caution Cautions alert users to exer
486. uct Data Output Page Left Intentionally Blank 5 22 Operator s Manual 6 Performance s 1 Overview This chapter contains detailed information about Puritan Bennett 980 Series Ventilator performance including e Ventilator settings e Alarm interpretation and alarm testing e A detailed description of selected alarms e Monitored patient data 62 System Options Various software options are available for the ventilator Details for each of these options are described in the appendices included in this manual s3 Environmental Considerations WARNING Use of the ventilator in altitudes higher or barometric pressures lower than those specified could compromise ventilator operation Reference Environmental Specifications p 11 7 for a complete list of environmental specifications sa Ventilator Settings Default ventilator settings are based on the circuit type selected during SST A neonatal pediatric or adult patient circuit can be used and all accessories needed to ventilate the patient should be attached when SST is performed 6 1 Performance 6 2 6 4 1 Ventilation Type 6 4 6 4 2 w The clinician enters the vent type specifying how the patient will be ventilated invasively or non invasively NIV The vent type optimizes the alarm limits for NIV patients and disables some settings for NIV ventilation Mode Available ventilation modes are mandatory A C or spontaneous SPONT modes as wel
487. uidance EQUATION 1 Vx R Vpr x ELUNG THORAX R Resistance elements artificial plus patient air ways ELUNG THORAX Elastance of the lung and thorax 1 CL unG THORAX PAV Appendix Estimates of Patient Resistance and Elastance If the PAV software estimates of patient resistance and elastance Rpay and Epay remain stable this equation could be rewritten as EQUATION 2 i i i i i Puus Vz X Rairway Vix K VLxKy Instantaneous value of pressure flow K4 Rpay or airway resistance R ainway being a function of flow K2 Epav P aus could then be estimated at every control period if V R inday and Vi were also known Valid Individual Pressure Measurements Throughout any inspiration the individual pressure elements that make up Pmus can be expressed as EQUATION 3 _ prey are Or inp OLUME Pmus TI ARTIFICIAL AIRWAY PATIENT PATIENT Pmus Pressure generating capability of PFLOW ae Flow based pressure drop across the patient s inspiratory muscles patient FLOW VOLUME P REE Flow based pressure dropacross p PAGE Volume based pressure to overcome the artificial airway the lung thorax elastance CIAL AIRWAY Operator s Manual Ventilator Settings Guidance Equations 2 and 3 provide the structure to explain how PAV operates The clinician enters the type and size of artificial airway in use and the software uses this information to estimate the resistance of the artificial airway at any lung flow Apply
488. umbers Operator s Manual Introduction Covidien Argentina Aguero 351 Capital Federal 1171 ABC Argentina Tel 5411 4863 5300 Fax 5411 4863 4142 Covidien Asia Singapore Regional Service Centre 15 Pioneer Hub 06 04 Singapore 627753 Tel 65 6578 5288 Fax 65 6515 5260 Covidien Australia 52A Huntingwood Drive Huntingwood NSW 2148 Australia Tel 61 1800 350702 Fax 61 2967 18118 Covidien Austria GmbH Campus 21 Europaring FO9402 A 2345 Brunn am Gebirge Tel 43 0 2236 37 88 39 Fax 43 0 2236 37 883940 Covidien Belgium BVBA SPRL Generaal De Wit telaan 9 5 2800 Mechelen Belgium Tel 32 1529 44 50 Fax 32 15 29 44 55 Covidien Brazil Av Das Na es Undias 12995 Andar 23 Brook lin Sao Paulo SP Brasil 04578 000 Tel 5511 2187 6200 Fax 5511 2187 6380 Covidien Canada 19600 Clark Graham Baie d Urfe QC HIX 3R8 Canada Tel 1 514 332 1220 Select Option 2 Fax 1 514 695 4965 Covidien Chile Camino lo Boza Ex 8395 Pudehuel Santiago Chile Tel 562 739 3000 Fax 562 783 3149 Covidien China 2F Tyco Plaza 99 Tian Zhou Rd Shang Hai 200233 P R China Tel 86 4008 1886 86 Fax 86 2154 4511 18 Covidien Colombia Edificio Prados de la Morea Carretera Central Del Norte Cra 7a Kilometro 18 Chia Cundinamarca Bogota Colombia Tel 571 619 5469 Fax 571 619 5425 Covidien Costa Rica Global Park Parkw
489. ume is less than 80 For adult and pediatric circuit type settings 25 mL to 2500 mL For neonatal circuit type set tings 2 mL to 310 mL Exhaled tidal volume V7 during Leak Sync For adult and pediatric circuit type settings For Te lt 600ms 10 20 x 600 ms Tp ms of reading mL For Te gt 600 ms 10 20 of reading mL For neonatal circuit type set ting 10 20 of reading mL For readings lt 100 mL the accuracy shall apply when the percentage of inspiratory leak volume is less than 80 For adult and pediatric circuit type settings 25 mL to 2500 mL For neonatal circuit type set tings 2 mL to 310 mL Operator s Manual 27 Specifications Table 11 13 Monitoring Patient Data Accuracy Continued Parameter Accuracy Range Proximal exhaled tidal volume 1 10 of reading mL 2 mL to 310 mL Vtey Proximal inspired tidal volume 1 10 of reading mL 2 mL to 310 mL Vry O2 monitored 3 15 to 100 Respiratory rate f 0 8 1 min 1 1 min to 150 1 min Table 11 14 Computed Value Accuracy Parameter Accuracy Range PAV based lung compli 1 20 of measured value 10 mL to 100 mL cmH 0 ance Cpay mL cmH 30 PAV based total airway 3 20 of measured value 5 0 cmH O L s to 50 cmH gt O L s resistance Rto7 cmH O L s PAV based work of 0 5 10 of measured 0 7 J L to 4 J L breathing WOB7 7 work J L with a percent
490. un All SST to perform all SST tests or touch Run Leak Test to perform the SST Leak test of the ventilator breathing circuit s Touch Accept to continue or Cancel to go back to the previous screen 9 After accepting touch the Circuit Type button corresponding to the patient circuit type used to perform SST and to ventilate the patient adult pediatric or neona tal 10 Touch the Humidification Type button corresponding to the humidification type used for patient ventilation If no humidifier is used touch HME If a humidifier is used touch Humidification Volume and turn the knob to enter the volume Ref erence Humidifier Volumes p 3 50 to determine the correct volume to enter 3 48 Operator s Manual Product Connectivity 11 Touch Accept to start SST 12 Follow the prompts Certain SST tests require operator intervention and will pause indefinitely for a response Reference Individual SST Results p 3 51 for a summary of the SST test sequence and results 13 After each test the ventilator displays the results If a particular test fails the test result appears on the screen and a choice to repeat the test or perform the next test is given When all of the SST tests are complete the SST status screen displays the individual test results 14 TO proceed to patient set up if SST did not detect an ALERT or FAILURE touch EXIT SST then touch Accept or cycle the ventilator s power The following table lists the tests
491. uracy During Leak Sync B 8 B 7 2 Exhaled Tidal Volume Vrg Accuracy During Leak Sync B 8 B 7 3 LEAK Calculation EG cad Oe ceeds eR OSES B 9 B 7 4 Circuit Disconnect Alarm During Leak Sync 7 B 9 C 1 C 2 C 3 C 4 C 5 C 6 C 7 C 8 C 9 D 1 D 2 D 3 D 4 D 4 1 D 4 2 D 4 3 D 4 4 D 4 5 D 4 6 D 4 7 D 4 8 D 5 D 5 1 D 5 2 D 5 3 D 5 4 D 5 5 E 1 E 2 E 3 E 4 E 5 E 6 IE Sync Appendix OvervieW PARA C 1 Intended Use vide cows diac ae ey RRR eeR ee RMR OE C 1 Safety Symbol Definitions aaa C 1 IE Sync Description XX seers eseb eee otetewes ses C 2 Setting Up IE Sync we eee C 2 Setting Up IE Sync for Monitoring Only C 4 IE Sync Monitoring Display aa C 5 Technical Description a C 7 Alarms during IE Sync ee ee ee C 7 PAV Appendix Overview ma NW LAKE AM see ceed GUMAAN KEEP AW cess D 1 Intended USE paan EK AGAADER KAKANAN KABA AKA D 1 Safety Symbol Definitions 20 2000s D 2 PAVE mana EG SAGADA NOD eles ud sexe D 3 Setting Up PAV PEPE OPO sha oe ox tatu od wee Cee ee D 5 PBW and Tube lD anag nanana ariaya ihe ha ad D 6 Apnea Parameters Adjustment 2002 00005 D 7 Alarm Settings Adjustment 2 ee D 8 PAV Ventilator Settings 00002 eee eee D 8 PAVE Alarm Settings 00 eh onus Hada dan ee daoueed RANA D 8 Monitored Data hse teed oS cua taverns rod desde ot ews D 9 PAV Alarms sss w nnientod AA ae D 10
492. uration reaches three seconds or pressure stability conditions have been detected for not less than 0 5 s An automatic inspiratory pause maneuver request if the maneuver is not yet active will be canceled if any of events1 9 11 12 14 or 15 occur Reference Inspiratory and Expiratory Pause Events p 10 51 Other characteristics of inspiratory pause include Operator s Manual Short Self Test SST e During an inspiratory pause the apnea interval Ta is extended by the duration of the inspiratory pause e Ifthe ventilator is in SIMV the breath period during which the next scheduled VIM occurs will also be extended by the amount of time the inspiratory pause is active e All activations of the inspiratory pause control are logged in the Patient Data Log e Severe occlusion detection is suspended e When calculating I E ratio inspiratory pause is considered part of the inspiration phase e The expiratory time remains unchanged and will result in a change in the I E ratio for the breath that includes the inspiratory phase Once the inspiratory Pause maneuver is completed the operator can review the quality of the maneuver waveform and accept or reject the maneuver data 10 14 2 Expiratory Pause An expiratory pause extends the exhalation phase of a single breath in order to measure end expiratory lung pressure PEEPyo7 and allows intrinsic PEEP PEEP to be calculated as PEEPt 7 minus set PEEP The pressures on either si
493. ure or flow during inspiration Pressure rises according to the selected rise time Spontaneous type PS and Pcypp lt 5 CcmH3O and PBW setting with target pressure equal to the effective pressure PEEP Psupp Effective pressure CmH 0 0 1 2 2 9 3 4 4 3 Pressure or flow during inspiration Pressure rises according to the selected rise time Spontaneous type PS and Pcypp 5 cmH 0 and PBW setting and target pressure equals Psupp PEEP Pressure or flow during inspiration Pressure rises according to the selected rise time Spontaneous type VS and PBW setting and target pressure equals the pressure determined during the test breath or pressure target determined from assessment of delivered volume from the previous breath For more information on VS Reference Volume Support VS p 10 25 Operator s Manual 10 23 Theory of Operations 10 24 Table 10 3 Spontaneous Breath Delivery Characteristics Continued Characteristic Tube Compensation TC Implementation Tube Compensation provides programmable inspiratory pressure assistance during otherwise unsupported spontaneous breaths This assists the patient in overcoming the flow resistance of the artificial airway Pressure is programmed to help the patient overcome part or all of the resis tance of the artificial airway The ventilator con tinuously calculates the pressure differential based on tube type and tube ID and adjusts the compensa
494. usable expiratory and inspira Steam autoclave per manufac e Donotchemically disinfect tory filters turer s instructions for use or expose to ETO gas Check filter resistance using ventilator SST or other means before reuse e Follow manufacturer s rec ommendations for reuse Expiratory filter condensate vial Steam autoclave per manufac e Inspect the condensate vial turer s instructions for use for cracks after processing e Replace condensate vial if damaged Operator s Manual 7 25 Preventive Maintenance Table 7 5 Component Sterilization Procedures Continued Part Procedure Comments Cautions Reusable drain bag tubing Clean and autoclave the reus N A short piece of tubing attached able tubing clean the clamp to drain bag and clamp Reference Surface Cleaning Agents p 7 5 for approved cleaning agents Whenever replacing or reinstalling a component run SST before ventilating a patient 77 Service Personnel Preventive Maintenance Covidien recommends only qualified service personnel perform preventive maintenance activities Complete details are described in the Puritan Ben nett 980 Series Ventilator Service Manual At ventilator startup and in Service mode the GUI and status display indicate when there are 500 hours or less before preventive maintenance is due 7s Safety Checks Covidien factory trained service personnel should perform Extended Self Test EST
495. ution LEAK Percent leak the percentage Range 0 to 100 of total delivered volume Resolution 1 during inspiration attributed to the leak calculated as leak volume during inspiration total delivered inspiratory volume x 100 LEAK Exhalation leak The leak rate Range OL min to 200 L min at PEEP during exhalation Resolution 0 1 L min LEAKy Exhalation Leak at PEEP Range 0 L min to 200 L min during Leak Sync measured Resolution 0 1 L min by the proximal flow sensor 1 If the estimated value of Cpay EPay Rpay Or Ryor violates expected PBW based imits parentheses around the value indicate the value is questionable If the estimated value exceeds its absolute limit the limit value flashes in parentheses Table 11 12 Delivery Accuracy Parameter Inspiratory pressure P Accuracy H 3 0 2 5 of setting cmH 0 Range 5 cmH 20 to 90 cmH20 End expiratory pressure PEEP 2 0 4 of setting cmH 0 0 cmH30 to 45 cmH70 Pressure support Psypp Tidal volume V For adult and pediatric circuit type settings For Tj lt 600ms 10 10 of setting x 600 ms Tj ms mL For T 2 600 ms 10 10 of setting mL For neonatal circuit type settings For setting of 2 mL VC only 1 10 of setting mL For setting of 3 mL to 4 mL 2 10 of setting mL deliv ered volume shall be gt 1 mL For setting of 5 mL to 20 mL 3 15 of set
496. utton Operator s Manual 4 11 Operation Figure 4 5 New Patient setup Screen Waiting for patient connect Setup Vent Ventilation Type Invasiv 110 b aaya Trigger Ty and hari 10 300 44 Li o0 00 N To enter settings into the ventilator 1 Adjust the setting value 3 0 190 46 EN Touch the ventilator setting button needing changes VEN 11350 D Select Vent type Mode Mandatory type Spontaneous type and Trigger type by touching the corresponding button Continue in this manner until all changes are made then touch Accept or Accept Touch START Ventilation does not begin until the breathing circuit is connected to the patient s airway After ventilation begins waveforms begin plotting on the displayed waveforms axes Reference Waveforms p 3 44 for information on setting up the graphics display If changes to any settings are required return to the Vent Setup screen as described above or touch a setting icon in the current settings area Reference Areas of the GUI p 4 3 item 9 Operator s Manual Ventilator Shutdown Note A yellow triangle icon appears on tabs and buttons displayed on the GUI containing unread or un viewed items When the item containing the icon is touched the icon disappears Note To make any settings changes after completing patient setup touch the Vent tab on the left side of the Setup dialog and make settings changes as described above The current sett
497. vals as necessary to synchronize the transitions between Pj and Py to match the patient s breathing pattern The actual durations of Ty and T vary according to whether or not the patient makes any spontaneous inspiratory efforts during those periods x Downs JB Stock MC Airway pressure release ventilation A new concept in ventilatory support Crit Care Med 1987 15 459 461 Operator s Manual A 7 BiLevel 2 0 Appendix To manage synchrony with the patient s breathing pattern the BiLevel algo rithm partitions the T4 and T periods into spontaneous and synchronous inter vals as shown in the figure below Figure A 5 Spontaneous and Synchronous Intervals 2 t 5 VEN_10253_B 1 Pressure y axis 5 T 2 TH 6 Synchronous interval 3 Py 7 Spontaneous interval 4 PL By partitioning Ty and T into spontaneous and synchronous phases BiLevel responds to patient efforts or lack of them in a predictable pattern e During the spontaneous interval of each pressure level successful inspiratory efforts cause the ventilator to deliver soontaneous breaths e During T synchronous intervals successful inspiratory efforts cause the ventilator to cycle from P to Py If there is no spontaneous patient effort this transition takes place at the end of the T period e During Ty synchronous intervals successful expiratory efforts cause the ventilator to cycle from Py to P If there is no spontaneous exhalation the tra
498. ventilation Patient data are not displayed during a circuit disconnect condition The ventilator monitors the expiratory pressure and flow delivered volume and exhaled volume to declare a disconnect using any of these methods e The ventilator detects a disconnect when the expiratory pressure transducer mea sures no circuit pressure and no exhaled flow during the first 200 ms of exhala tion The ventilator postpones declaring a disconnect for another 100 ms to allow an occlusion if detected to be declared first because it is possible for an occlu sion to match the disconnect detection criteria Operator s Manual 10 47 Theory of Operations e Despite many possible variations of circuit disconnections and or large leaks it is possible for a patient to generate some exhaled flow and pressure The ventilator then uses the disconnect sensitivity Dseys the percentage of delivered volume lost during the exhalation phase of the same breath to declare a disconnect setting to detect a disconnect e f the disconnect occurs during a spontaneous breath a disconnect is declared when the inspiration is terminated by maximum inspiratory time or the TT spont limit setting when Vent Type is non invasive NIV and the ventilator detects inspi ratory flow rising to the maximum allowable e f the disconnect occurs at the endotracheal tube the exhaled volume will be much less than the delivered volume for the previous inspiration The ven
499. vity Dsens setting in Yo or OFF 6 characters Rise time setting 6 characters PAV percent support setting 6 characters Expiratory sensitivity Esens setting in or L min for PAV breath type 6 characters PBW setting in kg 6 characters Target support volume V7 supp setting in L 6 characters High pressure Py setting in BiLevel in cmH O 6 characters Low pressure P setting in BiLevel in cmH 0 6 characters High pressure time Ty setting in BiLevel in seconds 6 characters ield 66 High spontaneous inspiratory time limit TT spon setting in seconds 6 characters Circuit type setting ADULT PEDIATRIC or NEONATAL 9 characters ield 67 Low pressure time T setting in BiLevel in seconds 6 characters ield 68 Expiratory time Tg setting in seconds 6 characters ield 69 End inspiratory pressure P gnp in cmH50O 6 characters Operator s Manual 5 13 Product Data Output Table 5 2 MISCF Response Continued Field 70 Respiratory rate fror in breaths min 6 characters Field 71 Exhaled tidal volume Vg in L 6 characters Field 72 Patient exhaled minute volume Ve tor in L min 6 characters Field 73 Peak airway pressure Pprax in cmH20 6 characters Field 74 Mean airway pressure Pugan in cmH 0 6 characters Field 75 Expiratory component
500. wing the patient suffi cient time to breathe spontaneously at both P4 and P In these types of breathing patterns but less so with APRV BiLevel like SIMV can be thought of as providing both mandatory and spontaneous breath types In this sense BiLevel and SIMV are classified as mixed modes Direct access to any of the three breath timing parameters in BiLevel is accom plished by touching the Padlock icon associated with the Ty period T period or the Ty T ratio displayed on the breath timing bar in the setup screen While in BiLevel mode spontaneously triggered breaths at either pressure level can be augmented with higher inspiratory pressures using Pressure Support PS or Tube Compensation TC breath types Synchrony in BiLevel Just as BiLevel attempts to synchronize spontaneous breath delivery with the patient s inspiratory and expiratory efforts it also attempts to synchronize the transitions between pressure levels with the patient s breathing efforts This allows Ty to be extended to prevent transitions to P during the patient s spon taneous inspiration Likewise the T interval may be extended to prevent a transition to Py during the patient s spontaneous exhalation The trigger sensitivity setting Pseys Or Vsens is used to synchronize the transi tion from P to Py The transition from Py down to P is synchronized with the patient s spontaneous expiratory effort The BiLevel algorithm will vary the T and Ty inter
501. without ventilation how long the ventilator has been in OSC This alarm has the capability to autoreset since occlusions such as those due to patient activity for example crimped or kinked tubing can correct themselves Once a severe occlusion is detected the ventilator acts to minimize airway pressure Because any severe occlusion places the patient at risk the ventilator minimizes the risk while displaying the length of time the patient has been without ventilatory support Severe occlusion is detected regardless of what mode or triggering strategy is in effect When a severe occlusion is detected the ventilator terminates normal ventilation terminates any active alarm silence annunciates an occlusion alarm and enters the safe state exhalation and inspiratory valve de energized and safety valve open for 15 s or until inspi ratory pressure drops to 5 cmH5 0O or less whichever comes first 10 46 Operator s Manual Short Self Test SST During a severe occlusion the ventilator enters OSC in which it periodically attempts to deliver a pressure based breath while monitoring the inspiration and expiration phases for the existence of a severe occlusion If the severe occlusion is corrected the ventilator detects the corrected condition after two complete OSC breath periods during which no occlusion is detected When the ventilator delivers an OSC breath it closes the safety valve and waits 500 ms for the safety valve to close com
502. x must take the estimated tube compensation into con sideration The target pressure compensation at the patient wye is derived from the knowledge of the approximate airway resistance of the ET or trache ostomy tube being used The compensation pressure in cmH5O for available tube sizes and gas flows is shown Reference ET Tube Target Pressure vs Flow p 10 30 and Reference Tracheostomy Tube Target Pressure vs Flow p 10 31 The estimated compensation must be added to the value of PEEP for calcula tion and setting of TPprag Specified Performance Performance using TC is specified to be 0 5 10 of actual joules liter residual work during inspiration at the 10096 support Yo Supp level Work is computed over the entire inspiratory interval kx Pe enp Prp kal Vdt W Work J L PIR Tracheal pressure Peenp End expiratory pressure k Conversion constant 0 098 J cmH 0 x L Operator s Manual 10 29 Theory of Operations The following figures indicate pressures at steady state flows for ET tubes and tracheostomy tubes respectively at 100 support at the wye for sizes between 4 5 mm and 10 mm Figure 10 11 ET Tube Target Pressure vs Flow 45mm 5mm 55mm 6mm ZA 0 20 40 60 80 100 120 140 160 180 200 VEN_10249_A 1 Pressure CmH 0 2 Flow L min 10 30 Operator s Manual Short Self Test SST Figure 10 12 Tracheostomy Tube Target Pressure vs Flow 4 5 mm 5mm 5 5mm 6mm VEN 10250
503. xhalation with normal return to zero flow 3 Inspiration 7 Normal peak expiratory flow 4 Exhalation with slow restricted return to zero flow Table D 4 Default PBW based Resistance Values PBW Resistance PBW Resistance PBW Resistance PBW kg Resistance kg cmH0 L s kg cmH 0 L s kg cmH 0 L s cmH 0 L s 25 18 1 43 13 5 61 11 3 79 10 1 26 17 7 44 13 3 62 11 2 80 10 1 27 17 4 45 13 2 63 11 1 81 to 150 10 28 17 1 46 13 0 64 11 0 29 16 8 47 12 9 65 10 9 30 16 5 48 12 7 66 10 9 31 16 2 49 12 6 67 10 8 32 15 9 50 12 4 68 10 7 33 15 7 51 12 3 69 10 7 34 15 4 52 12 2 70 10 6 Operator s Manual D 23 PAV Appendix D 24 Table D 4 Default PBW based Resistance Values Continued PBW Resistance PBW Resistance PBW Resistance PBW kg Resistance kg cmH 0 L s kg cmH 0 L s kg cmH 0 L s cmH30O L s 35 15 2 53 12 1 71 10 5 36 14 9 54 12 0 72 10 5 37 14 7 55 11 8 73 10 4 38 14 5 56 11 7 74 10 4 39 14 3 57 11 6 75 10 3 40 14 1 58 11 5 76 10 3 41 13 9 59 11 4 77 10 2 42 13 7 60 11 3 78 10 2 Operator s Manual E NeoMode 2 0 Appendix e1 Overview This appendix describes how to use NeoMode 2 0 software on the Puritan Ben nett 980 Neonatal Ventilator NeoMode 2 0 enables the use of the ventila tor with neonatal patients and is included with all Puritan Bennett 980 Neonatal Ventilators a
504. xpiratory pause can be either automatically or manually admin istered and is executed at the next mandatory breath in A C SIMV or BiLevel modes In SIMV the breath cycle in which the pause becomes active when the next scheduled ventilator initiated mandatory VIM breath occurs will be extended by the amount of time the pause is active For A C and SIMV the expiratory pause maneuver is scheduled for the next end of exhalation prior to a mandatory breath In BiLevel the expiratory pause maneuver is scheduled for the next end of exhalation prior to a transition from P to Py During the expi ratory pause maneuver PEEP and PEEPyo7 equilibration time values are dis played and regularly updated because stabilization of one of these values can indicate the pause can be ended During the expiratory pause the Apnea Inter val Ta is extended by the amount of time the pause is active Expiratory pause requests are ignored if the ventilator is in apnea ventilation safety PCV OSC BUV and Stand by state Additionally SEVERE OCCLUSION alarms are sus pended during expiratory pause maneuvers If flow triggering Is active backup pressure sensitivity Pseys detects patient breathing effort Maximum duration for a manual expiratory pause is 15 seconds and three 3 seconds for an automatic expiratory pause During a manual or automatic expiratory pause PEEP and PEEPr 7 appear on the GUI with the next VIM to allow the clinician to view when these va
505. y During Normal Ventilation 2 29 Pneumatic Daghan aa As 2 37 Pneumatic Diagram Optional Proximal Flow System 2 38 Example of Freestanding Ventilator Placement sesseccecsseeees 3 5 Power Cord Retainer on BDU sssssssssssseesssssssssseseesssssssssesseeesersnsssesseeesree 3 7 Connecting the Ventilator to the Gas Supplies sssssssssseessssssess 3 9 Adult Pediatric Filter Installation 0 cssssssscscsccssecssecseccseesneesseess 3 12 Installing the Neonatal Filter ssssssesseecsecssesssccssesssesssenseeserses 3 13 Drai Bag a aa Papag a a AA 3 14 Connecting the Adult or Pediatric Patient Circuit 3 16 Connecting the Neonatal Patient Circuit ou nannansnnasaasanaaa 3 17 Ventilator Battery aa AA 3 19 Proper Battery Orientation sssssssssssessessesesseeseesssssesssssssssaseaseees 3 20 Battery Compartment LOCATIONS oo nana nna nnawnawaawsawa awa assasnnsawsawaa 3 21 Flex Arm Installation aaa AGANG 3 26 Bracket Installation on Rail sssssessssseeesessssssssssceseesssssnsssesseersessnsssesse 3 28 Humidifier Installation to Ventilator sessssssssseseesssssssssesseeessssssssesee 3 29 Service Mode Button TEST sssssssssssssesssssssssssssssssesssesosssenoessssseeeseeereee 3 34 PA Kage RG AA AA 4 3 PLIST INCOM aga AA AA RR 4 5 New Patient SettihNgs aNG aan 4 9 Open Menu Tapus GNG ANAKAN 4 11 New Patient setup Screen num ml alamna nan nanaawanaawansawansawsasansan
506. y flow For flow triggering set to deliver base flow near the end of expiratory flow Exhalation valve during exhalation Adjusts to maintain the operator selected value for PEEP Operator s Manual Short Self Test SST 10 8 1 Pressure Support PS Pressure Support is a type of spontaneous breath similar to PC by which the pressure is controlled to reach a constant value preset by the practitioner once an inspiratory effort is detected This target value is held until the detec tion of end of inspiration Subsequently the exhalation valve control initiates the exhalation driving the pressure to the PEEP level 10 8 2 Volume Support VS Volume support is a pressure supported spontaneous breath type available when SPONT is selected as the mode The target support volume V7 sypp Is the target volume for pressure supported breaths Reference Ventilator Settings Range and Resolution p 11 8 for details regard ing the following VS settings e Expiratory sensitivity Esens e Rise time e Target support volume V7 supp Technical Description Volume Support VS breaths are patient triggered pressure supported spon taneous breaths The VS algorithm varies the inspiratory pressure of each breath to deliver the operator set target tidal volume V7 supp If the delivered volume for a breath is above or below the set target volume VS adjusts the target pressure for the next breath up or down as nece
507. y is released and at least three 3 s of expiratory pause have elapsed pressure sta bility conditions have been detected for 5 0 5 s or pause duration lasts 15 s An active automatic expiratory pause is terminated if any of events1 3 or 11 13 occur Reference nspiratory and Expiratory Pause Events p 10 51 An active automatic expiratory pause is complete if pause duration reaches three 3 s or pressure stability conditions have been detected for gt 0 5 s or pause duration lasts 15 s The automatic expiratory pause maneuver request the maneuver is not yet active is canceled if events1 9 11 12 or 15 occur Reference nspiratory and Expiratory Pause Events p 10 51 The automatic expiratory pause maneuver is terminated and inspiration begun if any of events1 3 or 11 13 occur Reference nspiratory and Expiratory Pause Events p 10 51 Other characteristics of expiratory pause include e During an active manual expiratory pause severe occlusion detection is suspend ed e When calculating I E ratio the expiratory pause is considered part of the exhala tion phase e During the expiratory pause the inspiratory time remains unchanged so the I E ratio is changed for the breath that includes the expiratory pause e All activations of the expiratory pause control are logged in the Patient Data log Once the expiratory pause maneuver is completed the operator can review the quality of the maneuver waveform and accept or
508. y processing images and is unavailable When processing is finished the camera icon is no longer dim and the screen capture function is available To transfer the captured images to a USB storage device 1 Swipe the Menu on the left side of the GUI Reference Open Menu Tab p 4 11 2 Touch Screen Capture A list of screen captures appears identified by time and date A slider also appears if more images than shown are present 3 Insert a passive USB storage device flash drive into one of the USB ports at the rear of the ventilator Reference Port Locations p 5 18 If more than one USB storage device is installed in the ventilator touch the button of the destination USB device where the image will be copied Operator s Manual Data Transfer 4 In the list of images touch the image name 5 Touch Copy The image is stored on the destination USB storage device 6 Alternatively touch Select All and all images in the list are stored on the USB device and which can then be viewed and printed from a personal computer Note The file format of screen captures is PNG 5 4 2 Communication Setup To specify the communication configuration for the ventilator 1 Touch the Configure icon in the constant access icons area of the GUI A menu appears with several tabs 2 Touch Comm Setup tab The Comm Setup screen appears allowing three 3 ports that can be configured These ports can be designated as DCI Philips Spacelabs
509. ystem 2 38 VEN 11443 C Operator s Manual Note GUI Controls and Indicators Items enclosed by dotted line represent components internal to the ventilator Operator s Manual Restrictor Prox Flow R4 Solenoid Valve Prox Flow SOL 6 Module Proximal Flow System Pressure Sensor Prox Flow Accumula tor Pprox Humidifier 9 Wye patient circuit Sensor Proximal Flow Filter neonatal expiratory Condensate vial neonatal expiratory 2 39 Running H F 1 Page Left Intentionally Blank 2 40 Running H F 3 3 Installation 3 1 gt A A Overview This chapter contains information for the installation and set up of the Puritan Bennett 980 Series Ventilator Before operating the ventilator system thor oughly read this Operator s Manual Topics include e Safety reminders e Ventilator setup e Battery information e Ventilator operating modes e Preparing the ventilator for use e Tests to perform prior to ventilating a patient Safety Reminders WARNING Explosion hazard Do not use in the presence of flammable gases An oxygen rich environment accelerates combustibility WARNING To ensure proper operation and avoid the possibility of physical injury only qualified medical personnel should attempt to set up the ventilator and administer treatment with the ventilator WARNING To prevent electrostatic discharge ESD and potential fire hazard do not use antistati
510. ystem leaks associated with these interfaces by providing pressure based disconnect alarms minimizing false dis connect alarms and replacing the INSPIRATION TOO LONG alarm with a High Spontaneous Inspiratory Time limit TT spon setting and visual indicator The following list shows the subset of INVASIVE settings active during NIV e Mode A C SIMV SPONT BiLevel is not available during NIV e Mandatory Type PC or VC VC is not available during NIV e Spontaneous Type PS TC and VS are not available during NIV During NIV alarm setup the clinician may set alarms to OFF and must deter mine if doing so is appropriate for the patient s condition Operator s Manual 10 59 Theory of Operations 10 60 10 15 4 Mode and Breath Type Specifying the mode defines the types and sequences of breaths allowed for both INVASIVE and NIV Vent Types Table 10 8 Modes and Breath Types Mode Mandatory Breath Spontaneous Breath Sequence Type Type AIC INVASIVE VC VC or Not allowed All mandatory patient ventilator PC or operator initiated NIV VC or PC SIMV INVASIVE PC VC or Pressure supported PS or Each new breath begins with a man VC TC datory interval during which a NIV VC or PC patient effort yields a synchronized mandatory breath If no patient effort is detected during the mandatory interval the ventilator delivers a man datory breath Subsequent patient efforts before the en
511. zO L 10 cmH70 L PAV based patient resistance Reavy The difference between esti mated total resistance Rtg and the simultaneously esti mated resistance of the artifi cial airway When PAV is selected the ventilator dis plays the current filtered value for patient resistance and updates the display at the successful completion of each estimation Rpay can be dis played in the vital patient data banner Reference Vital Patient Data p 3 42 Range 0 0 cmH 0O L s to 60 cmH O L s Resolution 0 1 cmH O L s for values lt 10 cmH20 L s 1cmH 0 Us for values 3 10 cmH O L s PAV based total airway resistance Ro Ror is an estimated value captured just past peak expi ratory flow and is equal to the pressure loss across the patient airway plus respirato ry system patient airway ET tube expiratory limb of the VBS expiratory flow This pressure loss is divided by the expiratory flow estimated at the same moment yielding the estimate for Rro7 The complete operation is orches trated and monitored by a software algorithm When PAV is selected the ventila tor displays the current fil tered value for total resistance and updates the display at the successful com pletion of each calculation Rror can be displayed in the vital patient data banner Reference Vital Patient Data p 3 42 Range 1 0 cmH70 L s to 80 cmH30 L s Resolution 0 1 cmH50 L s for values lt 10 cmH50 L s 1

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