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MECHANICAL VENTILATOR LEISTUNG LUFT2-g

1. 32 AUXILIARY FLOWS ccccsccescessesecsessesscsessesscscsesscsssesuesesscsarsussesacssescsacsacaesacsassesaceesesacsacacees 32 INSPIRATORY PAUSE csscsssececsessesecsessesessessesecsesscsseseseesuescsesuesesacsussesscsarsesecsatsesaceatsesaess 33 EXPIRATORY SENSIBILITY PSV cerent enteros ntt sinis 33 RESPIRATORY MECHANICS cccsssscessessececsessecsessesesscsessesscsassessesassessesuesesaesacsessesacsaseeeess 34 AUTOPEEP cccccccsscssesecsecsesecscsucescucsucsscsesussvesessssvesssussuesssassvesesusascsesassscsesassvssesstsveaesasaveeeeevee 34 COMPLIANCE AND RESISTANGCE ettet tet 35 P V LOW FLOW CURVE 35 SLOW VITAL CAPACITY tette tette ttt tette 36 36 aaa 36 TECHNICAL OPERATIVE PROFILE cc csssesessessesecsessessesecsessesessesscsussesacsussessesarsesscsacsaracees 37 REMOTE MONITOR ss sccscsecseccsessesecsessesussesscsecsessesseseceesuesacsesucsussessesesacsatseracsatseraceatsaceess 38 CHAPTER 7 VENTILATION MODES ADULT 39 VENTILATION MODE SELECTION sscssssssssssscssssesssssesssnsesssneesssneesssneessnesssnsesssneesssneeessses
2. 62 CHAPTER 11 CLEANING DESINFECTION AND STERILIZATION 65 CHAPTER 12 MOUNTING THE EQUIPMENT ON THE TROLLEY 66 ANNEX T SIMBOLOGY ene rene ee ree ere ee ee 67 MECHANICAL VENTILATOR R 04 04 50 LEISTUNG LUFT2 G en ANNEX 2 LUFT2 G 55 5 70 OPTIONAL AI 73 ANNEX 3 PREVENTIVE 74 ANNEX 4 BLOCK 76 ANNEX5 WARRANT Y u u u uuu RENS 77 ANNEX 6 GLOSSARY ai AA 78 7 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d GUIDELINES AND DECLARATIONS OF LEISTUNG EQUIPAMENTOS LTDA ABOUT ELECTROMAGNETIC COMPATIBILITY EMC Manufacturer guidelines and declarations Electromagnetic emission The LUFT2 G is designated for use in electromagnetic ambience as specified bellow It is recommended that the LUFT2 g user ensures it be utilized in such ambience Emissiontests Compliance Electromag
3. LAN Mow 1 The gas connection source is located the back of the case In its case are indicated corresponding inputs of air and O O oxygen AIR INPUT Male connector DISS 34 16 OXYGEN INPUT Male connector DISS 9 16 18 22 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d AT THE PRESSURE TIP TUBES ARE UTILIZED THE FEMALE CORRESPONDING CONNECTORS THE SCREWABLE CONNECTIONS USED IN THE AIR INPUTS ARE ACCORDING WITH NBR 11906 STANDARD WHICH DETERMINES THE MINIMAL CONDITIONS FOR THIS TYPE OF CONNECTION THE AIR AND OXYGEN INPUTS OF THE EQUIPMENT ARE MADE WITH VALVES THAT PREVENT REVERSE FLOW OF GASES THROUGH THE INPUT PORTS AND THE CROSSFLOW OF GASES INPUT PRESSURE DO NOT USE THE EQUIPMENT IN PRESENCE OF ANESTHESIC INFLAMMABLE GASES EXPLOSION AND OR FIRE DANGER TO AVOID CONTAMINATION THAT AFFECTS THE EQUIPMENT AND MAY IT MUST BE USED AIR AND OXYGEN COMPRESSED CLEAN AND DRY IN ORDER AN GENERATE A BAD OPERATION IN CASE OF MISSING OF ONE OF THE GAS SUPPLY AIR OR O2 THE EQUIPMENT CONTINUES OPERATING NORMALLY WITH THE OTHER GAS SUPPLY Paw LUFT2 G SUPPORTS INLET PRESSURE UP TO 1000 KPA 10 2 AVOIDING THE USE OF EXTERNAL PRESSURE REGULATORS UNTILL THIS VALUE BREATHING CIRCUIT Utilize respiratory circuit as the necessity pediatric or neonatal The difference is in the tubes diameter IN RESPIRATORY CIRCUITS WHICH HAVE W
4. 44 of 78 L MECHANICAL VENTILATOR R 04 04 50 LEISTUNG etes ret LEISTUNG LUFT2 G Rev 0 PEEP Sensibility Sens RISE TIME Rise Time is the time the ventilator requires reaching the selected pressure Increase or decrease this time may assist in the comfort of the patient In LUFT2 g the Rise Time is modulated by flow i e the higher the rise time the shorter the time to reach the adjusted pressure and the shorter the rise time the longer the time to reach the selected pressure For an appropriate ventilation the rise time must be adjusted in order to provide the smallest overshoot possible Pressure Rise ime Overshoot Y Time IF DURING A MANDATORY OR SPONTANEOUS CYCLE THE EQUIPMENT DETECTS ANY VARIATION OF FLOW GENERATING A PRESSURE VALUE HIGHER THAN THE DETERMINED THE ALARM OF INTERRUPTED CYCLE IS ACTIVATED AND LIMITS THE PEAK PRESSURE VALUE THE CAUSE OF THIS ALARM MAY BE CORRECTED THROUGH SENSIBILITY OR RISE TIME ADJUSTMENT CONTROLLED PRESSURE In PCV the airway pressure level is the main parameter to be adjusted because it will have a direct influence over the tidal volume available for the patient To adjust the controlled pressure you must remind that P Con adjustment refers to pressure value over established value for PEEP PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE PRESSURE Spontaneous ventilation mode triggered by flow or pressure through pa
5. Disconnect the power cable from plug It must trigger power outage alarm 10 Let the equipment without electric supply for approximately 75 of battery life It must trigger battery alarm EACH TEST IS INDEPENDENT SO IT IS POSSIBLE TO CHECK THE ALARMS IN ANY ORDER THE TIME BETWEEN THE PARAMETER ADJUSTMENT AND ALARM TRIGGERING MAY VARY IN EACH TEST IT 15 RECOMMENDED FOR THIS TEST TO BE DONE ALONG WITH PREVENTIVE MAINTENANCE DESCRIBED AT THE BEGINNING OF THIS CHAPTER 75 of 78 MECHANICAL VENTILATOR R 04 04 50 LEISTUNG LUFT2 G Rev 0 ANNEX 4 BLOCK DIAGRAM The following figure represents the pneumatic diagram ofLUFT2 g 17 LCD Display pir intel Ozinlet Pressure sensor sensor Regulator Prop va Prop va lve lve Anti suffocation Safetyvalv SOURCE Patient output Regulator nebulizer Expirat valve 76 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d ANNEX 5 WARRANTY LEISTUNG brand LUFT2 g model This equipment is guaranteed for 12 twelve months after purchase date where the factory is responsible for any defect or manufacturing failure This warranty must be stamped and signed by LEISTUNG EQUIPAMENTOS LTDA and accompanied of purchase chit The conditions for use installation and maintenance necessary for this equipment must be followed respecting technical specifications and installa
6. LEISTUNG MECHANICAL VENTILATOR LEISTUNG LUFT2 g R 04 04 50 REV 01 GMP CERTIFICATE NBR ISO 9001 2008 EN ISO 13485 2003 AC 2009 xnl MECHANICAL VENTILATOR tuor LEISTUNG LUFT2 G LEISTUNG EQUIPAMENTOS da 26 ase EMT 0 Press o 41 2 COn m 24 Freq 1 20 k 8 00 KR so FI02 1 25 25 0 50 as NII E xi E E 2 Onde Tins Freq V Tidal Sens 0 5 N 12 12 0 50 5 50 c min L omH20 L min 9 20178 04 04 50 01 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G Manufactured LEISTUNG EQUIPAMENTOS LTDA Street Joao Ropelatto 202 District Nereu Ramos City Jaragua do Sul SC ZIP 89265 300 Phone 55 47 3371 2741 Fax 55 47 3371 9267 VAT No 04 187 384 0001 54 I E 254 417 108 Auth GHL3983MX9H2 GMP Certificate EN ISO 13485 2003 AC 2009 NBR ISO 9001 2008 Website www leistungbrasil com E mail leistung leistungbrasil com Legal Responsible Marcelo Javier Fernandez TechnicalResponsible Eng Fernando Alves Negrao CREA SC 077160 5 ANVISA registration Technical Name Pressure Volume Lung Ventilator Commercial Name Mechanical Ventilator Leistung LUFT2 g ANVISA registration No 80203470006 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G
7. IN ALL MODES WHICH WORK WITH CONTROL PRESSURE AND SUPPORT PRESSURE THE CHANGES ARE DONE INDEPENDENTLY AND DIRECTLY BY THE OPERATOR IN ALL VENTILATION MODES OF LUFT2 g ADULT PEDIATRIC NEONATAL THERE IS A DEFAULT CONFIGURATION DEFAULT CONFIGURATION IS NONSPECIFIC AND IT MUST BE ADJUSTED BY THE OPERATOR ACCORDING THE PATIENT NEEDS LUFT2 G NEVER STOPS WORKING DURING CHANGING FROM A VENTILATION MODE TO ANOTHER ONE IN CASE TO CANCEL VENTILATION MODE CHANGE YOU MUST PRESS RESET KEY 51 of 78 MECHANICAL VENTILATOR R 04 04 50 Venns LEISTUNG LUFT2 G d CHAPTER 8 VENTILATION MODES NEONATALOGY VENTILATION MODE SELECTION Pressing MENU key main menu is accessed The first option is for ventilation modes Pressing ENTER key is shown a list of all the modes available for the select category The vertical and horizontal selection keys allow selecting the requested command When confirmed with ENTER key all the related parameters with the selected mode are shown If the ventilator is operating while the operator is configuring another ventilation mode changing will not be done until MANUAL INSPIRATION is pressed which allows finishing previous mode and initializing the new one Pressing RESET all changes are canceled and the previous mode is resumed Following is a brief description of the ventilation modes VENTILATION MODES PCV PRESSURE CONTROLLED VENTILATION In PCV the LUFT2 g delivers to
8. ventilator resumes to its previous mode 1500 s Back up ventilation output is automatic if the patient retakes spontaneous breathing or manual if the operator select any assisted controlled ventilation T Ins mode 1 20 s Freq 12 00 c min V Tidal VENTILATION MODE 0 400 L Refers to the selected mode for cycling during back up ventilation period VCV or PCV can be chosen APNEA TIME 50 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d Apnea is the period without spontaneous breathing the maximum period of time in which the ventilator waits before triggering audio and visual alarm and starting back up ventilation Apnea time may be adjusted from 5 to 60 seconds CYCLING VARIABLES To set back up ventilation the following variables must be adjusted Inspiratory time Respiratory frequency Tidal volume V Tidal andControlled pressure P con P CON WILL BE AVAILABLE WHEN SELECTING PCV MODE TIDAL VOLUME ADJUSTMENT WILL BE AVAILABLE SELECTING VCV MODE AND PEEP PEEP level during back up ventilation will be the same of the programmed in spontaneous mode WHEN ASSISTED MODE IS SELECTED THE CONFIGURATION OF BACK UP VENTILATION IS NEEDED BECAUSE IF THE PATIENT DOES NOT MAKE ANY INSPIRATORY EFFORT THE EQUIPMENT WILL RESPECT THE SELECTED APNEA TIME TO DELIVER BACK UP VENTILATION ACCORDING TO THE CONFIGURATION PERFORMED APNEA TIME IS NOT ACTIVE IN VCV AND PCV MODES
9. 39 VCV VENTILA O CONTROLADA POR VOLUMEE III I Ian 39 40 FLOW CURVES 41 6 0 41 SQUARE WAVE lt 41 SINUSOIDAL WAVE 41 DESCENDING RAMP 42 ASCENDING RAMP WAVE ettet tette ttt 42 INSPIRATORY TIME a 9 42 BREATHING 43 TIDAL VOLUME a amazi 9 43 Jj 43 SENSIBILITY 9 43 PCV PRESSURE CONTROLLED VENTILATION erret 44 RISE TIME NM 45 CONTROLLED PRESSURE 45 PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE PRESSURE RR 45 MAXIMUM INSPIRATORY TIME eter teet 46 SUPPORT PRESSURE I tette tette tret ttn ct 46 SIMV VCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT 02 044 4 47 SIMV PCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT s csssscsssessesecsessescsessesecsessesecsusse
10. G d 2 Once selected the time the ventilator will show the value of 10096 over selected value of and a horizontal bar will appear on the upper right corner of the screen indicating the selected time and elapsed time 3 The equipment can be disconnected from the patient as often as needed without havingits operation modified silencing for 30 seconds the alarms 4 The equipment permits changing in ventilation parameters and base pressure PEEP since the initial ventilation mode used to start the process is respected To change ventilation mode canceling 100 is required 5 After elapsed the selected time the equipment will resume FIO value that was selected before the procedure start 6 exit before the end of the procedure the operator must access manually the auxiliary flows menu and set the Os 100 time as 0 OBJECTIVE Simplify handling of the equipment during the process in airways and or lung recruitment after a depressurization Facilitate initial ventilation of the patient since his clinic and semiologic progress INSPIRATORY PAUSE Pressing MENU key select Inspiratory Pause option Inspiratory pause is a brief pause 0 10 2 00 seconds at the end of inspiration during which the pressure remains constant and the flow is zero To deactivate it access again Inspiratory Pause and set to O INSPIRATORY PAUSE IS AVAILABLE ONLY VOLUME CONTROLLED MODES WHEN INSPIRATORY TIME IS AC
11. GIVE A FLOW OF AT LEAST 100 l min SO THAT IT DOES NOT INTERFERES WITH ITS OPERATION IN CASE OF BAD CONNECTION WRONG ASSEMBLY OR INVERSION OF THE SENSORS THE EQUIPMENT WILL SHOW AT THE DISPLAY A MESSAGE INDICATING READING ERROR OF FLW AND THE OPERATOR MUST CONFIRM IF HE WILL WORK WITH OR WITHOUT THE EXPIRATORY FLOW READING 19 of 78 oe MECHANICAL VENTILATOR mai LEISTUNG LUFT2 G Rev 01 WHEN FINISHED THE COMPLIANCE TEST OF THE CIRCUIT THE EGUIPMENT SHOWS ON THE DISPLAY THE VALUES TO BE COMPENSATED AND THE OPERATOR CAN CHOOSE ABOUT COMPENSATE OR NOT THIS VALUE THE EQUIPMENT WILL COMPENSATE ONLY IF THE OPERATOR CHOOSE YES OTHERWISE IT WILL NOT DO IT ELECTRONIC BLENDER OPERATION AR O BLENDER fraction inspired of oxygen indicates the quantity of oxygen in the gas inspired by the patient In general it may vary from 21 79 of Nitrogen and 2196 of to 100 pure Oxygen for example a FiO of 6096 means that 60 of the inspired volume by patient is oxygen and 40 are composed by nitrogen and other gases FiO in LUFT2 g is generated by an electronic blender system which dispenses any external device The mixture is performed by two proportional actuators known as proportional valve which has this name due to its function to control proportionally the flow of air and oxygen that passes through each one of them Each flow is measured by its respective pneumotachograph device used for flow measurement wh
12. NEONATOLOGY THE DEFAULT SETTING OF ALARMS IS ADJUSTED DURING THE INITIALIZATION OF THE EQUIPMENT AND CORRESPONDS TO A MEAN VALUE OF ADJUSTMENT SCALES THE PARAMETERS ADJUSTMENT MUST BE DONE BY THE OPERATOR CONSIDERING INDIVIDUALLY EACH CLINIC CASE IT IS RECOMMENDABLE TO BE VERIFIED BY THE OPERATORALARMS VALUES VERIFICATION LIST ESPECIALLY IN EVENTUAL OPERATOR SWITCH 60 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G nn ALARMS VALUES VERIFICATION LIST _ F VY PATIENT gan RO DE LOST mK MODE CHECK P max P min VT max VT min Freq Max PEEP APNEA Vol Minute MMV PSV VCV PCV SIMV CPAP PSV ASSURED TIDAL VOLUME PSV BIPHASIC PRESSURE ADULT P min VT min Freq Max PEEP APNEA Vol Minute MMV PSV ex Min APNEA P max P min Freq Max VCV PCV SIMV CPAP PSV ASSURED TIDAL VOLUME PSV BIPHASIC PRESSURE PEDIATRIC P max P min VT max PCV SIMV CPAP PSV VT min Freq Max PEEP APNEA P max CONTINUOUS FLOW P min NEONATOLOGY Freq Max 61 of 78 MECHANICAL VENTILATOR R 04 04 50 Venns LEISTUNG LUFT2 G d CHAPTER 10 EXHALATION VALVE AND PATIENT CIRCUIT The figure below shows the exhalation valve assembly Exalatory valve cover Flow sensor Membrane Verify if the hoses are Verify if the f
13. cycle the patient requests In this mode upon starting inspiratory cycle the ventilator will control the pressure through flow assistance P Sup If upon ending of previewed inspiratory period the volume delivered to patient is smaller than the determined the ventilator extend the delivery time maintaining the flow constant to complete the missing volume If the volume is bigger than expected no volume is added in such cycle The objective of this mode is to ensure delivered time bigger or equal to established In this ventilation mode the following variables must be adjusted FiO Rise Time Time Tidal volume V Tidal Support pressure P Sup PEEP Sensibility Sens 48 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d BIPHASIC BIPHASIC PRESSURE VENTILATION In Biphasic mode the ventilator works in two pressure levels In pre determined times occurs transitory relief from the high pressure to low pressure and after that after a pre determined time the higher pressure is reestablished For patients who do not perform spontaneous efforts Biphasic mode is similar to controlled pressure mode with relation which may be or not be inverted with the only difference of allowing the patient to trigger the spontaneous cycles in two pressure levels opontaneous cycles performed by patient will be support pressure cycles with independent adjustment The tidal volume delivered in each c
14. d CONTENTS CONTENTS GUIDELINES AND DECLARATIONS OF LEISTUNG EQUIPAMENTOS LTDA ABOUT ELECTROMAGNETIC COMPATIBILITY 8 CHAPTER 1 PRESENTATION eer ere err 12 FHYSIGAECHARACTERISTIG S mi 12 WARNINGS CAUTIONS AND NOITES T 14 l islam P 14 PRECAUTION 15 NOTE 15 CHAPTER 2 INTRODUC ON a eee 16 gil zg 16 lbiygct 16 VENTICA TONS 16 ELECTRONIC BLENDER OPERATION AR O BLENDER 20 BIO MMEA SURE ME NT E x 20 CHAPTER 3 ASSEMBLY AND CONNECTION 22 POWER SOURCE CONNECITION UEM Ur 22 GAS SOURCE CONNECTION u u 22 ccs S u u
15. the respiratory system LUFT2 g changes automatically the flow to constant and the waveform to square with its occlusion at the end of inspiration The values of static compliance dynamic compliance and resistance found in the analysis will be available on the upper part of the screen P V LOW FLOW CURVE LUFT2 g performs measurement of inferior and superior inflection points of the pressure time curve through continuous insufflations of constant flows using low flow To request measurement of inflection points you must select low flow P V curve in respiratory mechanics menu This resource requests the operator to establish the maximum tidal volume value maximum pressure and flow that will insufflate the patient lung during the performing of the maneuver Upon confirming with ENTER key LUFT2 g performs an extended expiration leading the pressure from base to value zero to then insufflate air in the pre determined flow until it reaches the established value of pressure and or volume So the airway resistance component allowing LUFT2 g to establish automatically the superior and inferior inflection points which will be shown on the upper part of the screen 35 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d SLOW VITAL CAPACITY Vital Capacity is the maximum volume which may be expired after maximum inspiration The tool slow vital capacity furnishes the maximum lung capacity through slow inspirations of
16. this sector are the light indicators corresponding to the alarms which when activated are followed by an alert sound and by messages on screen The light indicators turns on intermittently to indicate which alarm is activated once solved the cause of the alarm the indicator will remain turned on permanently to indicate which alarm was triggered until the key RESET be pressed All the triggered alarms are registered with hour and date at the menu Alarms History See MENU key SILENCE This key is used to silence the alarm without affect the light indicators during a time of 1 minute If at the end of this time the cause of the alarm was not solved the sound will get started again RESET This key is used to nullify all the light and sound alarm indicators and it is maintained until any alarm is activated 28 of 78 L MECHANICAL VENTILATOR R 04 04 50 edna LEISTUNG LUFT2 G nee CHAPTER 5 LUFT2 G OPERATION E T orm LEISTUNG LU FT2 g 15 21 PATIENT ADULT Select and press lt ENTER gt When starting the equipment an initialization sequence is performed which includes memory test internal battery indicator LEDs etc Finished the initial sequence the categories to be ventilated are shown to be selected according to type of patient Adult Pediatric Neonatal This selection influences the options of the offered ventilation modes and the initial parameter values of operation IS CONSIDE
17. uuu Z 23 CHAPTER 4 INDICATORS CONTROLS AND 5 24 BRON PANE nn 24 INDICATOR SAREA IA 24 LOD SOREEN CM 25 NUMERIC DISPLAYS AND SUPPLYINGIINDICATORS 26 CONIROL AREA Sia 27 DIRECHO NA KEYS AAA 27 istum T E DIU QN EU 27 DIREC ACCESS FUNCTIONS AREA 27 clu O 27 STAND BY t 27 PREE ZEINA E nuan u na 28 MANU LIN LP E 28 ALARN GAREA ONIS DAR AN DUM I 28 f 28 cc 28 CHAPTER OPERATION u u uuu u S ee MEUS 29 MECHANICAL VENTILATOR 04 04 50 VENTILADORES PULMONARES LEISTUNG LUFT2 G SELECTION SEQUENCE ADJUSTMENT AND DATA 4 4 31 CHAPTER 6 MENU 32 VENTILATION 5 00 44 44 21
18. ATER DRAIN IN ITS BRANCHS INSPIRATORY EXPIRATORY VERIFY THE HEMERTICITY TO AVOID VOLUME LEAKAGE IN THE CIRCUIT WHEN THE CALIBRATION OF THE PATIENT CIRCUIT IS PERFORMED THE NEBULIZER MUST NOT BE CONNECTED IN IT VERIFY THE CORRECT POSITION OF THE DIAPHRAGM OF THE EXALATORY VALVE SEE CHAPTER 10 THE CONNECTORS OF THE PATIENT CIRCUIT ARE CONICAL TYPES 22mm IN PEDIATRIC AND 15mm IN NEONATAL AND THEY ARE ACCORDING WITH THE ISO 5356 1 NBR13475 STANDARD WHICH DETERMINES THE MINIMAL EXIGIBLE CONDITIONS FOR THESE CONNECTOR TYPES 23 of 78 1 MECHANICAL VENTILATOR R 04 04 50 es LEISTUNG LUFT2 G Rev 01 CHAPTER 4 INDICATORS CONTROLS AND ALARMS FRONT PANEL ELECTRIC ENERGY Battery 110 220 O Peak Pressure Tirc Yolume J LEISTUNG O lt ipd ya ES Bose Pressure Frequency DO ALARMS Max insp Pressure Inversion O Min Insp Pressue O Peep Apnea Max Frequency Air Oxygen O vr max min Power Outage Minute Vol max min Battery Microprocessor INDICATORS REA LEISTUNG LUFT2 g counts with a double monitoring system with graphic and numeric indications 24 of 78 MECHANICAL VENTILATOR R 04 04 50 ramones on LEISTUNG LUFT2 G LCD SCREEN Color LCD screen shows the selected values curves and resultant values The screen has an information distribution so that permits to
19. ATORY PRESSURE This alarm is activated if the airways pressure overpasses the fixed value at the maximum pressure limit control The sound is activated and the light corresponding to high inspiratory pressure Resolving the cause that activated the alarm the intermittent sound is turned off after 10 seconds but the light remains turned on continually until it is turned off manually through RESET key ALWAYS THERE IS A PARTIAL OR CONTINUOUS OBSTRUCTION OF THE PATIENT CIRCUIT THIS ALARM IS ACTIVATED 57 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d LOW INSPIRATORY PRESSURE This alarm is activated if upon ending respiratory cycle the pressure did not reach the fixed values at low inspiratory pressure The sound and light are activated light corresponding to low inspiratory pressure Resolving the cause that activated the alarm the intermittent sound is turned off after 10 seconds but the light remains turned on continually until it is turned off manually through RESET key This alarm also indicates if there was an accidental disconnection or if the circuit was taken off from the patient MAXIMUM EXPIRED TIDAL VOLUME It establishes a maximum expired tidal volume acceptable value If the resultant value remains high during three cycles or for a period of time longer than 10 seconds the alarm is activated with light and sound indicators and message on the screen MINIMUM EXPIRED TIDAL VOLUME It establishe
20. E EXPIRATION The part of the ventilation cycle that includes since the beginning of expiratory flow until the beginning of inspiratory flow INSPIRATORY PHASE INSPIRATION The part of the ventilation cycle that includes since the beginning of inspiratory flow until the beginning of expiratory flow At this phase any inspiratory pause is included FLOW Traffic gas rate that gets in and out of the lung ASSISTED INSPIRATION It is the inspiratory flow generated by positive switch at trans respiratory pressure due to an external agent like an increment in respiratory pressure generating a value higher than the reference value NEBULIZER An aerosol generator which requires a gas source to nebulizer liquid medicaments PEEP Positive End Expiratory Pressure TRANS RESPIRATORY PRESSURE The difference of pressure between airway and the surface of the body RATIO It is the relation between inspiration time and expiratory time SPONTANEOUS BREATHING The breathing started and finished by the patient SENSIBILITY It is the measurement of the patient effort to start a cycle SIGHS It is a number of additional respirations performed during a defined time intervals EXPIRATORY TIME Duration of expiratory phase in seconds INSPIRATORY TIME Duration of inspiratory phase in seconds As the inspiratory time increases the mean respiratory pressure increases and the ratio too TGI Tracheal Gas Insufflations during expiration A
21. EY The figures sequence shows how to fix the equipment on the trolley and how to fix the display in the support arm Fit the euipament on the trolley after that Fit the screen with the screws acording to the drawing fix them with the wing nut Fit the screen arm in the trolley and then fix them according to the drawing THE ASSEMBLED EQUIPMENT HAS A LIMITATION ABOUT RISK OF FALLING MAY BE INCLINED AT A MAXIMUM OF FIVE DEGREES DURING OPERATION WHEN MOVING THE EQUIPMENT ON THE TROLLEY IT IS NECESSARY TO BE CAREFULL IN ORDER TO AVOID IT TO FALL DOWN THE TRANSPORT OF THE EQUIPMENT MUST BE DONE IN ITS ORIGINAL PACKAGE WITH THE TROLLEY AND THE LCD DISPLAY DISASSEMBLED 66 of 78 L MECHANICAL VENTILATOR R 04 04 50 por ira LEISTUNG LUFT2 G ANNEX 1 SIMBOLOGY 1 Meaning of the standardized symbols printed the equipment internal and external Symbol Standard Description IEC 60601 1 1994 Alternating current udin Symbol No 417 5032 9 60601 1 1994 Direc MAANA Symbol 417 5031 BN Functional ground terminal IEC 60601 1 1994 Protection ground terminal Symbol No 417 5019 9 IEC 60601 1 1994 Symbol No 348 Attention Consult the documents IEC 60601 1 1994 Connected Connection to power Symbol No 417 5007 source internal or external IEC 60601 1 1994 Disconnected Disconnection from the Symbol No 417 5008 power source internal or external IEC 60601 1 1994 Eauipmen
22. KAGE VALUES LOWER THAN 10 L MIN IT IS COMPENSATED DURING ITS USE THE COMPLIANCE VALUE IS ALSO SHOWN AT TEST LINE SO COMPENSATING AUTOMATICALLY INDEPENDING ON THE PATIENT TYPE ADULT PEDIATRIC NEONATAL SELECTION SEQUENCE ADJUSTMENT AND DATA CONFIRMATION Using the selection keys the parameters to be selected can be accessed When selected the option pressing ENTER the parameter has its color changed permitting its configuration by the vertical and horizontal keys To finish press again ENTER to confirm change can be canceled by pressing RESET Change is also canceled if the parameter remains selected for more than 5 seconds or without any modification Is made in its value Adjustments made in parameters will not be activated until the mode configuration is finished and the ventilation is started through pressing Manual inspiration key ONCE CONFIRMED THE VALUES THE ACTION NOT BE UNDONE ALWAYS CHECK THE MODIFIED VALUES BEFORE CONFIRMING 81 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d CHAPTER 6 MENU Pressing MENU it will show in the right side of the LCD screen the following options VENTILATION MODES In Ventilation modes option is shown a list of the modes indicated for the selected patient Adult Pediatric or Neonatal With directional keys you must choose for a ventilation mode confirming pressing Immediately it will be shown on the display the val
23. L OUTPUT VOLTAGE CURRENT 110V 0 6 FREQUENCY POWER 40 VA FUSE 250V 0 5A T 20mm SB Slow PNEUMATIC INPUTS N USE ONLY MEDICAL GRADE GAS ENVIRONMENTAL SPECIFICATIONS VALUES 1096 up to 9526 Non condensable 096 up to 95 Non condensable THE MEASURE OF VOLUME AND PRESSURE IS STANDARDIZED BY BAROMETRIC PRESSURE AT SEA LEVEL BODY TEMPERATURE AND WATER VAPOR SATURATE BTPS AND THEY ARE ADJUSTED IN FUNCTION OF ALTITUDE Operation Relative Humidity Storage Transport 13 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d THE STORAGE OF THE LUNG VENTILATOR FOR LONG PERIODS TEMPERATURE GREATER THAN 27 OR WITHOUT ELECTRICAL CONNECTION FOR PERIODS GREATER THAN 2 MONTHS MAY AFFECT THE INTERNALLY BATTERY LIFE WARNINGS CAUTIONS AND NOTES WARNINGS IS CONNECTED WHENEVER THE EQUIPMENT IS IN USE AN ALTERNATIVE VENTILATION WAY MUST BE AVAILABLE OPERATION PROBLEMS REQUIRE IMMEDIATE CORRECTIVE ACTION THE ALARMS DO NOT MEAN A TOTAL SAFETY IN CASE OF THE EQUIPMENT BE DEFECTIVE THE PROFESSIONAL IN CHARGE OF ITS USE SHOULD USING YOUR OWN CRITERION AND KNOWLEDGE ADJUST THE EQUIPMENT ACCORDING TO THE PATIENT NEEDS DO NOT USE ANTI STATIC TUBES OR ELECTRICAL CONDUCTOR IN THE PATIENT CIRCUIT DO NOT STERILIZE THE EQUIPMENT WITH ETHYLENE OXIDE THERE IS A HIGH PROBABILITY TO OCCUR IRREVERSIBLE DAMAGE IN THE VENTILATOR COMPONENTS 4 THE EQUIPMEN
24. MEBRANE TRANSPARENT BECAUSE IT IS ENCHARGED OF ESTABLISH THE PRESSURE DIFFERENCE WHICH THE EQUIPMENT MEASURES TO FIX THE 63 of 78 WHEN STERILIZING THE VALVE DO NOT DISCONNECT THE PLASTIC TUBES MECHANICAL VENTILATOR 04 04 50 LEISTUNG LUFT2 G Hen VENTILADORES PULMONARES OUTPUT PARAMETERS OF THE PATIENT IF THE MEMBRANE IS FOLDED OR DAMAGED THE MEASURE WILL NOT BE CORRECT THE PATIENT CIRCUIT TYPE B IS MADE BY MATERIAL CERTIFIED BY FDA FOOD AND DRUGS ADMINISTRATION WHICH ENSURES THE BIOCOMPATIBILITY OF THIS MATERIAL THE COPY OF THIS CERTIFICATE CAN BE ACQUIRED FROM THE MANUFACTURERFABRICANTE IT MUST BE OBSERVED THAT DURING THE USE OF THE EQUIPMENT AFTERA DETERMINED TIME THE MEASURED PARAMETERS AT INITIAL TEST OF THE PATIENT CIRCUIT AND PERIPHERALS TEND TO VARY BY TEMPERATURE HUMIDITY LOCATION ETC THE VARIATIONS IN THE CIRCUIT MAY BE MORE SIGNIFICANT DURING THE FIRST HOURS OF OPERATION STABILIZING AFTER THAT 64 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d CHAPTER 11 CLEANING DESINFECTION AND STERILIZATION The parts in contact with the patient may be completely sterilized The protocols which define the methods and the frequency must be adapted to the procedure of decontamination and cleaning here indicated as a guide Upon removing the patient circuit of the package or always it is removed from the equipment in use it must have its parts exhalation valve tr
25. PEEP 0 cmH20 Auto PEEP is not evident may changes drastically the alveolar dynamic and generates a considerable risk in situation that affects the flow during expiration leading to unnecessary increasing of the respiratory system mechanical work To request Auto PEEP measurement just press MENU key select Respiratory Mechanics option and access Auto PEEP window Upon selecting Auto PEEP window LUFT NEO starts measuring it and shows on the screen the following message 34 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d Respiratory mechanics accepted When measurement procedure and calculus of Auto PEEP is concluded LUFT NEO shows on the upper part of the screen the value of the TOTAL PEEP Auto PEEP and PEEP COMPLIANCE AND RESISTANCE Respiratory system compliance is defined as the volume variation per unity of pressure changing For the static compliance the volume variation refers to the static plateau pressure and for dynamic compliance the volume variation refers to peak inspiratory pressure The mechanical dynamics of the respiratory system refers to situations in which the flow varies along the time while the static properties enhance the flow absence To measure compliance and resistance just select in respiratory mechanics menu the option compliance resistance and define the tidal volume that must be used during the measurement process To estimate the compliance and resistance of
26. PERATOR IN ALL VENTILATION MODES OF LUFT2 g ADULT PEDIATRIC NEONATAL THERE IS A DEFAULT CONFIGURATION DEFAULT CONFIGURATION IS NOT SPECIFIC AND IT MUST BE ADJUSTED BY THE OPERATOR ACCORDING TO THE PATIENT NEEDS LUFT2 gNEVER STOPS WORKING DURING CHANGING FROM A VENTILATION MODE TO ANOTHER ONE IN CASE TO CANCEL VENTILATION MODE CHANGE YOU MUST PRESS RESET KEY AFTER LINE TEST THE EQUIPMENT COMPENSATES LEAKAGES IN THE CIRCUIT UNTIL 10 L MIN THE EQUIPMENT COMPENSATES THE PATIENT CIRCUIT COMPLIANCE 56 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d CHAPTER 9 ALARMS COLORS AND MEANINGS OF GRAPHIC INDICATORS These signals were developed according to current standards in order to be immediately known by the operator An alarm indication like Caution or Danger to patient is a criterion used by LeistungEquipamentos Ltda and serves only as orientation the operator must adapt them to patient needs according to his own criterion COLOR MEANING RED Danger An immediate action of the operator is needed YELLOW Caution An action of the operator is necessary ALARMS PRIORITY SEQUENCE Alarms are triggered according to the following sequence from the highest to the lowest Am Ponty _ High Priority Minimum tidal exhaled volume Maximum frequency Maximum tidal exhaled volume Low Priority PEEP Maximum minute volume Power source ALARMS DESCRIPTION HIGH INSPIR
27. PONHRL Nano 54 CONTINUOUS FLOW S 54 NASAL CPAP CONTINUOUS POSITIVE PRESSURE VENTILATION 54 BACKUP VENTILATION u u u uu 55 ARANEA IRE 55 LING VARIABELE sasana 55 55 CHAPTER 9 ALARMS ee 57 COLORS AND MEANINGS OF GRAPHIC INDICATORS 57 ALARMS PRIORITY SEQUENCE LULU aaa 57 ALAFRMSDESORIPIDN u u eee M 57 FIGA INSPIRATOR Y PRESSURE uu u uuu 57 EOW WINS LOAN PRE SUP o D o o 0 58 MAXIMUM EXPIRED HDAL VOCUM E sprer EE 58 MINIMUM EXPIRED TIDAL 58 MAXIMUM MINUTE VOLUME ii 58 58 Wave E Esse 58 APNEA ACA EII 58 PEER ALARN EEEE 58 KAVA SI u ENT T 59 POWER UWA c 59 Soi IND C 59 RTS ROCE SOR S AS s 59 CHAPTER 10 EXHALATION VALVE AND PATIENT CIRCUIT
28. PSV airway pressure level is the main parameter to be adjusted because it will have direct influence about the tidal volume received by the patient To adjustsupport pressure you must remind that the adjust P Sup refers to support pressure value over the established for PEEP Tus CPAP MODE IS ACTIVATED WHEN THE SUPPORT PRESSURE OFFERED IS REDUCED AT ITS MAXIMUM 46 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d SIMV VCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT Permits the patient to synchronize spontaneous breathings PSV with mandatory breathings VCV ensuring to patient a minimum threshold of ventilation and oxygenation This is an alternative to start mechanical ventilation weaning process This mode has the function of decreasing the quantity of mandatory ventilations and permits the patient to perform spontaneous ventilations between each pre established VCV cycle Flow Pressure 7 In this ventilation mode the following variables must be adjusted FiO Rise Time R Time Inspiratory time T Ins Respiratory frequency Freq Tidal volume VTidal Support pressure P Sup PEEP Sensibility Sens SIMV PCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT Permits the patient to synchronize spontaneous breathings PSV with mandatory breathings PCV ensuring to patient a minim
29. R 04 04 50 Vena LEISTUNG LUFT2 G d TECHNICAL OPERATIVE PROFILE Within technical operative profile are found the options Maintenance Language Sighs Hour Date altitude compensation circuit test and PEEP alarm MAINTENANCE In this option are visualized the hours of use of the equipment as well as the hours of use and date corresponding to the maintenance done described in annex 3 LANGUAGE Enables the operator to choose among the languages ENGLISH PORTUGUESE and SPANISH IT IS IMPORTANT TO REMIND THAT TO CHANGE THE LANGUAGE THE EQUIPMENT MUST BE RESTARTED SIGHS This option permits to configure Quantity of sighs quantity of consecutive sighs 1 up to 3 performed in each cycle Cycles per hour quantity of times 5 10 15 20 the sigh cycles will be repeated per hour U Jy Volume amount of additional volume it will be added with the already set volume which will be given by the ventilator in each sigh Maximum pressure During sighs this value is taken as reference for activation of maximum alarm e HOUR DATE In this option you must adjust the local hour and date e ALTITUDE COMPENSATION To adjust in this option the altitude in relation with the sea level in which the equipment is being utilized e CIRCUIT TEST Must be performed when the patient circuit is replaced or changed in relation with the initial line test PERFORM CIRCUIT TEST THE VENTILATOR MUST IN STAND BY
30. RECT ACCESS FUNCTIONS AREA The area of direct access keys includes the keys more frequently used allowing a fast and easy access These keys gt e GRAPHIC e STAND BY e FREEZE IMAGE e MANUAL INSPIRATION gt GRAPHIC Permits to select Two curves PressureX TimeandFlowX Tempo Threecurves Pressure XTime FlowX Time Volume X Time Fourcurves PressureX Tempo FlowX Tempo Volume X Pressure and FlowX Volume Time Scale Permits to select the scale time to be used on the graphics STAND BY Permits to select Stand by mode which maintains the ventilator in state of repose without alarms until it gets connected to the patient again without losing the previous set operation parameters WHILE IN STAND BY ALL THE KEYS ARE LOCKED EXCEPT MANUAL INSPIRATION KEY 27 of 78 MECHANICAL VENTILATOR LEISTUNG LUFT2 G Rev 01 FREEZE IMAGE WA Freezes the graphs currently shown on screen maintaining active patient monitoring and updating output values and airway pressure bar MANUAL INSPIRATION 2 Each time this key is pressed a new inspiratory cycle is started It is only active at expiratory phase ALARMS AREA ALARMS Insp Pressure Inversion Min Insp Pressure Peep Apnea O Fio2 Max Frequency Air Oxygen C VT max min Power Outage Minute Vol max min Battery Microprocessor In
31. RED e ADULT PATIENTS WITH MORE THAN 30 KG OF WEIGHT e PEDIATRIC PATIENTS BETWEEN 10 AND 30 KG OF WEIGHT e NEONATAL PATIENTS WITH LESS THAN 10 KG OF WEIGHT 29 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d n LUFTZ g VENTILATION MODES Circuit Leakage Test Expiration Flow Test Compliance Test Line Compliance 60 cmH20 0 25 mL cmH20 Select and press lt ENTER gt Following is performed a test of the patient circuit It is necessary to install the circuit and maintain blocked the Y output during the entire test In this test is verified if there is leakage it measures and compensates the circuit compliance and is verified the PEEP control and exhalation valve flow THE INCORRECT OBSTRUCTION OF THE PATIENT OUTPUT MAY RESULT IN LEAKAGE ON THE SYSTEM IF THE EXHALATION VALVE IS ASSEMBLED INCORRECTLY OR WITHOUT ITS READING INTERNAL MEMBRANE INTERNAL MAILER THE EQUIPMENT WILL NOT BE ABLE TO READ THE EXHALATED VOLUME WHERE THE OPERATOR MAY OPT TO WORK WITHOUT THIS READING OR RESTART THE TEST Finally is accessed the operative modes menu The mode is chosen by the selection keys up and down Confirmation of the selection is done through pressing ENTER and will show on the screen the necessary parameters for its use 30 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d ONCE THE EQUIPMENT PASSES THE INITIAL TEST LINE SELF TEST WITH LEA
32. RESSURE SUPPORT PSV ADULT AND SPONTANEOUS k 7 PEDIATRIC SIMV VCV PCV PSV MINUTE MMV PSV VARIABLES PSV ASSURED TIDAL VOLUME BIPHASIC PRESSURE PRESSURE CONTROLLED PCV NEONATOLOGY ASSISTED CONTROLLED 16 of 78 L MECHANICAL VENTILATOR R 04 04 50 LEISTUNG LEISTUNG LUFT2 G Bein WE PRESSURE SUPPORT PSV SPONTANEOUS CPAP Nasal CPAP VARIABLES SIMV PCV PSV SPECIFICATIONS PCV VCV in adult and pediatric and PCV neonatology Backup ventilation Emergency ventilation FIO 21 to 100 electronically regulated on the panel with graphic display monitoring BY FLOW 0 5 up to 10 l min Sensibility BY PRESSURE 0 5 up to 15 compensated PEEP Pressure Control PCV EM 70 over PEEP with adjustable RISE Pressure Support PSV aby 70 over PEEP with adjustable RISE Expiration Sensibility Nebulization In VCV mode automatic adjustment In PCV and PSV modes up to 180 l min Inspiratory flow Continuous flow in neonatology 2 up to 15 I min Inspiratory flow in neonatology 2 up to 30 l min Off up to 50 Expiratory Flow Up to 120 l min Cycles per hour quantity maximum tidal volume and anual gael 3 i Inspiratory Pause VCV mode 0 up to 2 seconds with plateau value Oxygenation for aspiration with synchronized system 5 10 Manual trigger 100 15 or 20 min In VCV rect
33. SSISTED VENTILATION It is the process to provide a respiration with positive pressure as reaction of an inspiratory effort of the patient NON INVASIVE VENTILATION Ventilation performed through facial mask VOLUME Space occupied by material measured in cubic millimeters or liters 78 of 78
34. T ITS CONDITIONS IT IS RECOMMENDED TO CHANGE THE INTERNAL BATTERY EVERY FOUR YEARS THE MANUFACTURER IS NOT RESPONSIBLE FOR NORMAL OR SPECIAL DAMAGE ALARMS SYSTEM INTEGRITY TEST 1 With the test balloon connected to the equipment choose VCV at alarm board configure Pmax with a value lower than the peak value shown at the screen The Maximum Pressure alarm must be triggered 2 Adjust the Pmax value with a value higher than the peak value shown at the screen and disconnect the test balloon It must trigger Minimum pressure alarm Adjust the value Fmax with a value lower than the shown one at the screen after 10 cycles it must trigger the Maximum Frequency alarm 4 Adjust the minimum volume value with a value higher than shown in Tidal Volume It must trigger the minimum VT alarm 5 Adjust the maximum volume value with a value higher lower than shown in tidal volume It must trigger the maximum VT alarm 6 Disconnect the Pneumotachograph from exalatory valve It must triggers PEEP alarm Connect it again 7 Access one of spontaneous ventilation modes PSV after elapse apnea time it must trigger the apnea alarm 4 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d 8 Disconnect the air high pressure hose from the gas input It must trigger the air oxygen alarm Connect the air hose and repeat this procedure for the oxygen high pressure hose to check the same alarm 9
35. T MUST CONNECTED VOLTAGE WITH PROTECTIVE EARTH CONSTANT ATTENTION OF SPECIALIZED PERSONNEL IS REQUIRED WHEN PATIENT CONNECTION INTERFERENCE SUCH AS CELLULAR WIRELESS TELEPHONE DEFIBRILLATORS ELECTRO SURGICAL KNIFES MAGNETIC RESONANCE ETC USE TABLE OF PREVIOUS SECTION TO DETERMINE THE CORRECT SEPARATION DISTANCE THE USE OF ACCESSORIES AND CABLES OTHER THAN THE SPECIFIED ONES EXCEPT ACCESSORIES AND CABLES FURNISHED BY LEISTUNG EQUIPAMENTOS LTDA AS SPARE PARTS FOR INTERNAL COMPONENTS MAY RESULT IN EMISSION INCREASING OR IMUNITY REDUCTION OF LUFT2 G BEFORE FIRST UTILIZATION AND AFTER UTILIZATION IN EACH PATIENT IT IS NECESSARY TO CLEAN THE VENTILATOR TO STERILIZE THE ACCESSORIES FOLLOW THE INSTRUCTIONS ON CHAPTER 11 ELECTRICAL SHOCK DANGER NEVER DISASSEMBLE THE VENTILATOR CASE IN CASE OF PROBLEMS OR DIFFICULTIES CONTACT THE AUTHORIZED TECHNICAL SERVICE THE EQUIPMENT MUST BE SUPPLIED BY BATTERY WHEN THERE IS DOUBT ABOUT THE INTEGRITY OF GROUND CONNECTOR TAKING CARE NOT TO EXCEED THE BATTERY LIFE THE EQUIPMENT MAY AFFECTED BY HIGH FREQUENCY ELECTROMAGNETIC 14 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d PRECAUTIONS During the warranty period the stay or movement of equipment should be performed with the original packaging with its internal correspondent protection otherwise will result in loss of warranty Never sterilize the ventilator the internal
36. TIVATED THE EQUIPMENT SHOWS ON THE MAIN SCREEN THE PLATEAU PRESSURE VALUE EXPIRATORY SENSIBILITY PSV Modes that use PSV have flow in descending ramp waveform and allow adjusting the flow value that performs the changing between inspiration phase and exhalation phase cycle To change exhalation sensibility you must press option Exhalation Sensibility may be adjusted with values between 5 and 80 of inspiration flow peak and select Exhalation Sensibility 33 of 78 MECHANICAL VENTILATOR R 04 04 50 L EM LEISTUNG LUFT2 G ud SENSIBIL EXP 5 SENSIBIL EXP 50 Pressure 2 Pressure H20 IF THERE IS LEAKAGE IN THE PATIENT CIRCUIT LOW VALUE EXPIRATORY SENSIBILITY MAY HAMPER THE CYCLE DUE TO THE LEAKAGE BE GREATER THAN THE SELECTED INPUT VALUE RESPIRATORY MECHANICS AUTOPEEP Auto PEEP is conceptualized as the persistence of an alveolar positive pressure at the end of exhalation non intentional due to the presence of a final exhalation lung volume bigger than the previewed residual functional capacity It occurs in patients submitted to mechanical ventilation in consequence of starting an inspiratory phase with positive pressure before the expiratory time is enough to a complete exhalation of the inspired volume previously The result of this phenomenon is a progressive increasing of the lung volume and pleural pressure for each breathing Total PEEP 3 cmH20 PEEP 3 cmH20 Auto
37. XIMUM MINIMUM PEEP AND CONTINUOUS PRESSURE GAS SUPPLY SOURCE AIR O POWER OUTAGE LOW BATTERY CHARGE MICROPROCESSOR INTERRUPTED CYCLE IN PRESSURE MODES MAXIMUM MINIMUM FIO INVERTED RATIO ALARMS ARE TRIGGERED FOLLOWING PRIORITY ORDER WITH LIGHT OR SOUND WARNINGS AND OR SCREEN MESSAGE 18 of 78 MECHANICAL VENTILATOR R 04 0450 LEISTUNG LUFT2 G dni GRAPHICS PRESSURE FLOW TIME PRESSURE FLOW VOLUME TIME LOOP VOLUME PRESSURE LOOP FLOW VOLUME TENDENCY CURVES LAST 18HS ALARMS LOG LOG OF THE LAST 1000 EVENTS WITH DATE HOUR AND ALARM CAUSE OTHER MENUS MENU OF TIME INDICATION AND EXECUTED SERVICES ALTITUDE ADJUSTMENT FOR VOLUME COMPENSATION LANGUAGE SELECTION SELF TESTS PATIENT CIRCUIT LEAKAGE EXPIRATORY FLOW PEEP VALVE PATIENT CIRCUIT COMPLIANCE PATIENT CIRCUIT TEST AUTOTEST 15 PERFORMED BY THE OPERATOR WHENEVER THE EQUIPMENT IS TURNED ON ONCE REALIZED AUTOTEST THE EQUIPMENT MAKES THE CALIBRATION WITHOUT OPERATOR S INTERVENTION WHEN NECESSARY THE EQUIPMENT CLEANS THE FLOW SENSORS AUTOMATICALLY EXALATORY VALVE WITHOUT ITS OPERATION BE INTERRUPTED IN CASE OF LEAKAGE IN THE CIRCUIT DURING THE INITIAL TEST AUTOTEST THE EQUIPMENT SHOWS ON THE DISPLAY A MESSAGE INDICATING THE VALUES OF LEAKING FOR THE CORRECT OPERATION OF THE EQUIPMENT IT IS IMPORTANT THAT THERE IS NOT ANY LEAKING IN THE PATIENT CIRCUIT AT THE EXPIRATORY FLOW TEST THE GAS LINES AIR AND MUST
38. a maximum flow and decreases 0 2 19 towards the end of expiration The airway maximum pressure is decreased to minimum This wave may be used without generating a high pressure of the airway as happens if using square wave Transrespiratory 41 of 78 Transrespiratory MECHANICAL VENTILATOR R 04 04 50 Rev 01 L 2 LEISTUNG LUFT2 G VENTILADORES PULMONARES Inspiratory Expiratory Inspiratory Expiratory DESCENDING RAMP WAVE N Time s This waveform uses a fast flow acceleration followed by a slow downward This waveform may request very high flows to obtain an appropriate ratio This wave may be used to provide a better distribution of inspired air ASCENDING RAMP WAVE This waveform starts with a zero flow and increases linearly until a peak value followed by a fast downward of the flow Regarding to this pattern of ascending ramp flow wave the patterns corresponding to pressure and volume are seen with a concave upward INSPIRATORY TIME Flow L min The inspiratory time correspond to the orange color on the graph above 42 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d Integrated to current volume the inspiratory time works as a flow controller volume cycled therefore to perform changes in the velocity of the inspiratory flow the operator must change the variables inspiratory time and tidal volume BREATHING FREQUENCY Refers to ventilation cy
39. acheas drain and Y connector cleaned and sterilized Such methods are e Ethylene oxide 55 e Autoclave 121 C 15 p s c g 15 minutos e Glutaraldehyde Until two hours of disinfection Until eight hours of sterilization e acid e Enzymatic detergents cleaning THE STERILIZATION METHODS DESCRIBED ABOVE ARE RECOMMENDED FOR PATIENT CIRCUITS PROVIDED BY LEISTUNG EQUIPAMENTOS LTDA THE USE OF DESINFECTANT SOLUTIONS MUST BE DONE FOLLOWING MANUFACTURER RECOMMENDATIONS AND BY STERILIZATION PROTOCOLS ETHYLENE OXIDE IS TOXIC ALL THE COMPONENTS MUST BE DRY BEFORE BEING STERILIZED THE EXHALATION VALVE ACCEPTS ANY OF THE ABOVE METHODS FOR ANOTHER CIRCUIT CONSULT MANUFACTURER S RECOMENDATIONS AVOID THE USE OF PURE ALCOHOL CLEANSING SOLUTIONS WHICH CONTAIN SOLVENTS ACETONE CHLORINATED SUBSTANCES OR CHLOROFORM FOR CLEANING OF THE RESPIRATORY TUBES AND PLASTIC PARTS GLUTARALDEHYDE 15 TOXIC FOR THE AMBIENT AND USERS IT MUST BE MANIPULATED USING EQUIPMENTS OF INDIVIDUAL PROTECTION AND MUST BE ELIMINATED FOLLOWING THE STANDARD AND PROTOCOLS OF THE HOSPITAL ETHYLENE OXIDE USE MAY ACCELERATE THE APPEARANCE OF GUM AND 5 DERIVATIVES SUCH AS MODIFY THE PLASTIC PARTS THE VENTILATOR ITS CASE MUST NEITHER BE CLEANED WITH ETHYLENE OXIDE NOR IN AUTOCLAVE 65 of 78 MECHANICAL VENTILATOR R 04 04 50 maono muona LEISTUNG LUFT2 G CHAPTER 12 MOUNTING THE EQUIPMENT ON THE TROLL
40. angular descendent ramp sinusoidal and Flow waveform ascending ramp In PCV and PSV descendent ramp In case of break of one of them the equipment continues operating normally Inspiratory pressure inner safety valve Adjusted in 120 cm 17 of 78 Automatic By pass of the Air O net MECHANICAL VENTILATOR R 04 0450 LEISTUNG LUFT2 G d STAND BY To maintain the configuration without cycling Regulating pressure valve of air and input Internally incorporated into the equipment SCALES Automatic actualization for vertical and horizontal analysis FREEZE For graphics analysis Signal output To external communication and software update OUTPUT PARAMETERS AIRWAY PRESSURE PEAK PLATEAU MEAN BASE PEEP INSPIRATORY TIME EXHALATION TIME RATIO AND SPONTANEOUS BREATHINGS INSPIRED EXHALED TIDAL VOLUME INSPIRATORY PEAK FLOW DYNAMIC COMPLIANCE TOTAL FREQUENCY GRAPHIC INDICATOR OF SPONTANEOUS AND MECHANICAL CYCLES EXHALED MINUTE VOLUME CONCENTRATION BREATHING MECHANICS AUTOPEEP DYNAMIC COMPLIANCE STATIC COMPLIANCE STATIC INSPIRATORY RESISTANCE STATIC EXPIRATORY RESISTANCE SLOW VITAL CAPACITY P0 1 AIRWAY OBSTRUCTION PRESSURE P V CURVE WITH LOW FLOW TOBIN INDEX ALARMS INSPIRATORY MAXIMUM MINIMUM AIRWAY PRESSURE DISCONNECTION OF THE PATIENT CIRCUIT MAXIMUM MINIMUM EXHALED TIDAL VOLUME MAXIMUM MINIMUM EXHALED MINUTE VOLUME APNEA WITH ADJUSTABLE TIME MAXIMUM RESPIRATORY FREQUENCY MA
41. atory frequency Controlled pressure 30 00 c min To initiate the operation in spontaneous mode operator must accept all back up configuration by pressing ENTER key over the green arrow on configuration screen In case of not accepting or pressing RESET the ventilator resumes to its previous mode Back up ventilation output is automatic if the patient retakes spontaneous breathing or manual if the operator selects any assisted controlled ventilation mode APNEA TIME Apnea is the period without spontaneous breathing the maximum period of time in which the ventilator waits before triggering audio and visual alarm and starting back up ventilation Apnea time may be adjusted from 5 to 60 seconds CYCLING VARIABLES To set back up ventilation the following variables must be adjusted Inspiratory time Respiratory frequency and Controlled pressure P con PEEP PEEP level during back up ventilation will be the same of the programmed in spontaneous mode 55 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G WHEN PSV CPAP IS SELECTED THE CONFIGURATION OF BACK UP VENTILATION IS NEEDED BECAUSE IF THE PATIENT DO NOT MAKE ANY INSPIRATORY EFFORT THE EQUIPMENT WILL RESPECT THE SELECTED APNEA TIME TO DELIVER BACK UP VENTILATION ACCORDING TO THE CONFIGURATION PERFORMED IN ALL MODES WHICH WORK WITH CONTROL PRESSURE AND SUPPORT PRESSURE THE CHANGES ARE DONE INDEPENDENTLY AND DIRECTLY BY THE O
42. ch PERMITS TO CONTROL THE EQUIPMENT BY TOUCHING DIRECTLY THE SCREEN HUMIDIFIER HUMIDIFICATION AND HEATING OF GAS IT MUST BE USED THE MODEL AVAILABLE AT MARKET PATIENT EQUIPMENT INTERFACE PATIENT CIRCUIT WITH EXHALATION VALVE AND NEBULIZER PEDIATRIC NEONATAL NOTE IT MUST BE USED ONLY THE APPROPRIATE MODEL FORLUFT2 G TEST LUNG ADULT VERIFICATION OF OPERATION AND CYCLING OF THE EQUIPMENT TEST LUNG NEONATAL VERIFICATION OF OPERATION AND CYCLING OF THE EQUIPMENT LUFT2 G SOFTWARE SOFTWARE WHICH PERMITS THE CONNECTION OF THE EQUIPMENT WITH A COMPUTER Illustrative photos only THE UTILIZATION OF ACCESSORIES AND CABLES WHICH ARE NOT SPECIFIED BY LEISTUNG EQUIPMENTS LTDA MAY RESULT IN ELECTROMAGNETIC EMISSION INCREASING OR IMMUNITY REDUCTION OF THE EQUIPMENT 73 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d ANNEX PREVENTIVE MAINTENANCE is mandatory to be performed a preventive maintenance respecting the following chronogram Such preventive maintenance must be performed by a qualified professional and respecting the corresponding protocols At main menu the last item of the second level indicates the operation time and the registry of maintenance LUFT2 G PERFORMS AN SELFTEST OF THE BATTERY CONDITION EVERY FIVE MINUTES HOWEVER IT IS RECOMMENDED TO DISCONNECT FROM THE POWER AT LEAST ONCE A MONTH LETING THE EQUIPMENT UNDER BATTERY SUPPLY IN ORDER TO TES
43. cles quantity given by LUFT2 g to patient within the period of one minute TIDAL VOLUME Volume L Tidal volume V Tidal represents the volume in liters delivered to patient in each ventilation cycle PEEP PEEP Positive End Expiratory Pressure is a tool used to recruit and maintain the alveoli open besides optimizing gases exchanges and to combat lung shunts SOME PATHOLOGIES REQUIRE SPECIFIC PEEP VALUES TO RECRUIT THE ALVEOLI WITHOUT DAMAGING THEM THE USE OF PEEP GENERATES HEMODYNAMIC REPERCUSSIONS THAT MUST BE KNOWN BY THE OPERATOR SENSIBILITY During artificial ventilation a pre determined trigger variable must be reached to initiate the inspiration In VOV the ventilation may be controlled by time i e by respiratory frequency or controlled by the patient himself who triggers the cycles as his necessity In LUFT2 g the sensibility trigger is by pressure or flow The ventilator detects a drop in pressure or flow threshold which is produced by the patient effort in his airway The inspiration may be triggered if performed effort exceeds the pressure of flow threshold selected to sensibility 43 of 78 MECHANICAL VENTILATOR 04 04 50 VENTILADORES PULMONARES LEISTU NG LU FT2 G Rev 01 Pressure trigger Insufficient effort to start the cycle Pressure 0 Pressure 0 I Flow trigger Patient effort start Sensibility threshold Flow 0 T The pressure or flow threshold i
44. components is not compatible with sterilization techniques Follow the instructions at chapter 11 for equipment cleaning and accessories sterilization Never operate the equipment exposing it to direct heat or sunlight Never cover or place the equipment in order to block the air entry for cooling To ensure electrical protections and avoid risk of fire never change the fuses If the equipment does not work contact the Authorized Technical Support The improper replacement of the fuses nullifies warranty and represents a risk for the equipment operation operator and patient safety NOTES The ventilator is a medical device that has to be operated by qualified and trained personnel supervised by a doctor LUFT2 g is produced with recyclable materials and should not be thrown into common landfills because it contains toxic materials to nature for this contact an authorized dealer Electric Diagrams Circuit Diagrams component list repair instructions and training can be provided by Leistung Equipamentos Ltda by agreement between the parts Leistung Equipamentos Ltda is a company of continuous improvement in its products and technical specifications can change without previous notice 15 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d CHAPTER 2 INTRODUCTION Developed to be one of the most complete lung ventilators in the market LUFT2 g shows a friendly graphic interface with grea
45. d by the silence key If the cause of the alarm disappears it will be silenced automatically and the light will remain turned on in continuous form The light can be turned off pressing RESET key PEEP ALARM This alarm is activated when the PEEP value overpasses the limit established by the user To activate this alarm it is necessary to access MENU gt PEEP ALARM and select the limit value for PEEP in 58 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d LOW GAS PRESS This alarm is activated if the pressure of any one of gases inputs is less than 2 bar This alarm is turned off automatically when restoring the input pressures It cannot be restore manually but can be silenced during 60 seconds pressing SILENCE key POWER OUTAGE This alarm is activated if a power outage occurs while the ventilator is operating This alarm is turned off when the power is restored It cannot be silenced manually LOW BATTERY This alarm is activated when the equipment is operating without external power and the internal battery reaches a charge of 7596 of the nominal voltage see chapter 1 This alarm is turned off automatically when the power is restored It cannot be silenced manually If the power is not restored when the battery charge runs out the equipment is turned off all the gas supply valves get closed and the anti suffocation valve is enable which permits the air inlet of the ambient to the patient circ
46. e PEEP ALARM In this option is permitted the modification of PEEP alarm values The operator can choose to work among the limits of 2 4 6 8 10 cm THE ALARM WILL BE ACTIVATED ALLWAYS THE PRESSURE IS BELOW OR ABOVE THE FIXED VALUE OF PEEP BEING ITS ACTUATION IMMEDIATE OR THROUGH PRIORITIES WITH AS MAXIMUM THE TIME OF 5 SECONDS 37 of 78 L MECHANICAL VENTILATOR R 04 04 50 a LEISTUNG LUFT2 G REMOTE MONITOR Within the remote monitor option it is possible to select the following features ALARMS LOG Shows list containing the events of alarms since the last time the equipment was turned on i e the hour the date and the cause of the alarm TENDENCIES Shows a list of available graphs Select the graph and press ENTER To see other graphs press again MENU key and select another graph of the list To exit tendencies press RESET RESPIRATORY MECHANICS Shows the last measured value of total PEEP Auto PEEP dynamic compliance static compliance inspiratory resistance superior and inferior inflection point of the Pressure X Volume curve 38 of 78 MECHANICAL VENTILATOR R 04 04 50 Venns LEISTUNG LUFT2 G d CHAPTER 7 VENTILATION MODES ADULT PEDIATRIC VENTILATION MODE SELECTION Pressing Menu key main menu is accessed The first option is for ventilation modes Pressing ENTER a list containing all the usual modes for the selected category is shown The vertical and horizontal selec
47. e presence of continuous flow In this ventilation mode the following variables must be adjusted FiOs Inspiratory time T Ins Respiratory frequency Freq Continuous flow Flow Controlled pressure P Con PEEP Sensibility Sens NASAL CPAP CONTINUOUS POSITIVE PRESSURE VENTILATION Nasal CPAP is a spontaneous ventilation mode which permits the operator to establish pressure and continuous and constant flow in the breathing circuit 54 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d This mode is applied in Neonatology and may be offered to patient through cannulas or nasal prongs In this ventilation mode the following variables must be adjusted e FiO e Continuous flow Flow e PEEP BACK UP VENTILATION w g Back up ventilation is avallable in all ventilation modes which have a spontaneous BACK UP parameter VENTILATION In LUFT2 g NEONATAL the back up is obligatory in PSV CPAP When the selected mode Mode BM is PSV CPAP the ventilator provides directly the back up ventilation configuration screen EN PCV In SIMV PCV PSV back up ventilation is available and the operator can let it activated Apnea or deactivated At the moment that SIMV PCV PSV is selected the operator can select 10 00 s the option YES to activate back up ventilation or NO to deactivate it To set back up ventilation the following parameters must be adjusted 0 50 s Apnea Inspiratory time Respir
48. eak pressure mean pressure and base pressure as well as dynamic compliance inspiratory peak flow inspiratory time ratio and FlOs On the bottom of the display are the parameters adjustable by the operator such as FlO WAVEFORM RISE TIME INSPIRATORY TIME FREQUENCY TIDAL VOLUME CONTROL PRESSURE SUPPORT PRESSURE PEEP and SENSIBILITY To change the values the operator 25 of 78 MECHANICAL VENTILATOR R 04 04 50 Venns LEISTUNG LUFT2 G d must select the desired option press ENTER adjust the value and confirm it pressing ENTER again In sensibility option the operator may choose for work with SENSIBILITY BY FLOW l m or PRESSURE H2Ocm to change option go in sensibility and press ENTER then confirm the change with the side keys right left changing from l m to H2Ocm and the directional keys up down ranging work values Resultant values that remain in yellow and are located in monitoring area are not adjustable they are resultant parameters of the adjustable ones i e the values measured by the equipment Ex peak pressure base pressure and mean pressure in airways exhaled tidal volume frequency flow peak dynamic compliance inspiratory time ratio and FIO monitoring On the upper side of the screen is indicated 1 Upper left side Company s name and equipment model below there are the patient type and ventilation mode see chapters 7 and 8 2 Upper right side Date and hour the equip
49. elected pressure For an appropriate ventilation the rise time must be adjusted in order to provide the smallest overshoot possible IF DURING A MANDATORY OR SPONTANEOUS CYCLE THE EQUIPMENT DETECTS ANY VARIATION OF FLOW GENERATING A PRESSURE VALUE HIGHER THAN THE DETERMINED THE ALARM OF INTERRUPTED CYCLE IS ACTIVATED AND LIMITS THE PEAK PRESSURE VALUE THE CAUSE OF THIS ALARM MAY BE CORRECTED THROUGH SENSIBILITY OR RISE TIME ADJUSTMENT PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE PRESSURE Spontaneous ventilation mode triggered by flow or pressure through patient effort In this mode the ventilator supports the patient through maintaining a positive pressure adjusted in P Sup window This maintains free to patient to control the respiratory frequency inspiratory time and inspired air volume Therefore the tidal volume depends on inspiratory effort pre established support pressure and the mechanics of the respiratory system To perform this function the ventilator upon starting increases the pressure in the circuit to a defined pressure support level The control variable in this mode is P Sup support pressure The volume variation depends on physical conditions and it will be proportional to inspiratory effort of the patient and the adjusted support pressure To adjust controlled pressure you must have in mind that P Sup refers to the pressure value above the established value for PEEP As sa
50. ended that the client or user of Lung Ventilator LUFT2 g ensures that it is used in such environment Test Level Compliance E ABNT Level nvironment Guidances 60601 Electrostatic Floors should be wood concrete Discharges ESD or ceramic If the floors covered with synthetic material IEC 61000 4 2 8 kV by air Complies relative humidity should be at least 30 Fast Transient Burst 2 kV at power lines Quality of power supply should be Burst that of a typical commercial 1kV at I O lines IEC 61000 4 4 Complies hospital environment Surges 1 kV line s to line s Quality of power supply should be i that of a typical commercial or IEC 61000 4 5 2 kV line s to hospital ground Power outage short 5 Ui interruptions and voltage variations on 9596 voltage drop of the lines of power input Ut by 0 5 cycles 40 Ui IEC 61000 4 1 1 6096 voltage drop of Ut by 5 cycles Complies Quality of power supply should be that of a typical commercial or hospital environment 70 Ut 3096 voltage drop of Ut by 25 cycles 5 U gt 95 voltage drop of Ut by 5 seconds Magnetic fields at Magnetic fields at power supply power line frequency frequency should be that of a typical commercial or hospital Complies environment 9 of 78 L IIIS 08 MECHANICAL VENTILATOR R 04 04 50 Verri LEISTUNG LUFT2 G Rev 01 Manufacture
51. enses the use of galvanic one and also dispenses the periodic replacement avoiding this additional cost thus although it has a price higher than the galvanic one this difference is compensated in long term 21 of 78 MECHANICAL VENTILATOR R 04 04 50 Yasome nimwone LEISTUNG LUFT2 G CHAPTER ASSEMBLY AND CONNECTION POWER SOURCE CONNECTION ccectrica input The electrical connection is located in the back of the case In its case there are indicated the voltage values of operation along with the current ones and nominal power of the equipment There is also indicated the corresponding fuse values THE EQUIPMENT HAS INCLUDED FROM FACTORY FUSES OF 2A 20mm SB SLOW ABLE 90V UP 264V THE ELECTRICAL CHARACTERISTICS OF THE EQUIPMENT IS FOUND IN THE CHAPTER 1 OF THIS MANUAL THE SUPPLY INPUT IS UNIVERSAL THE EQUIPMENT WORKS IN WHOLE VOLTAGE RANGE 90V UP 264V WITHOUT OPERATOR S INTERVENTION EVEN WHEN THERE IS A VOLTAGE REDUCTION OF THE POWER DURING THE NORMAL OPERATION CERTIFY THAT THE CONNECTION OF THE EQUIPMENT IS REALIZED WITH A GROUNDED PLUG TO ASSURE ITS CORRECT OPERATION NEVER START THE EQUIPMENT WITHOUT GROUND CONNECTION THE ELECTRICAL INSTALLATION WHERE THE EQUIPMENT WILL BE PLACED MUST BE IN COMPLIANCE WITH THE NBR 13534 STANDARD WHICH DETERMINES THE MINIMAL CONDITIONS OF ELECTRICAL INSTALATION HEALTH CARE STABLISHMENTS GAS SOURCE CONNECTION
52. es objects and people A The field intensity established by fix transmitters like base transceiver stations telephone cellular and wireless land mobile radio amateur radio AM and FM transmitter and TV transmitter can t be predicted theoretically with accuracy To evaluate the electromagnetic environmental due to RF fix transmitters it is recommended to consider a local electromagnetic inspection If the local field intensity where the Lung Ventilator LUFT2 g is located exceeds the above applicable RF compliance level the Lung Ventilator LUFT2 g should be observed in order to verify the normal operation If an unusual performance is observed additional procedure may be necessary such as reorienting or replacement of Lung ventilator LUFT2 g B Above the frequency range of 150kHz up to 80 MHz the field intensity must be less than 3 V m 10 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d Recommended separation distances between portable and mobile RF communication equipment and the Lung Ventilator LUFT2 g The Lung Ventilator LUFT2 g is intended for use in an electromagnetic environment in which irradiated HF disturbances are controlled The customer or the user of the Lung Ventilator LUFT2 g can help to prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the Lung Ventilator LUFT2 g as recommended below according t
53. espiratory frequency Freq Tidal volume VTidal PEEP Sensibility Sens FIO is related to the fraction of oxygen inspired by the patient To modify just select its window with ENTER and adjust the fraction between 21 and 100 40 of 78 MECHANICAL VENTILATOR 04 0480 re LEISTUNG LUFT2 G hd FLOW CURVES LUFT2 g provides square and descending ramp flow waves Flow waves may be selected in volume controlled modes WAVEFORMS The initial work waveform in volume modes is always square and to change it you must access WAVEFORM in the bottom left corner of the screen press ENTER choose the requested waveform and confirm with ENTER The waveform is changed in the first cycle There are two common wave patterns SQUARE WAVE With this adjustment the flow accelerates very fast and reaches a flow 0 2 4 9 value which will be maintained during inspiration This wave pattern permits an appropriate ratio with a normal torrential If the airway peak pressure of the patient is higher than the normal the patient feels uncomfortable the wave pattern can be inverted in order to decrease this pressure or to accommodate a more normal breathing pattern When the flow pattern is square the volume has a ramp wave and the pressure is a scale followed by a ramp cmH20 Transrespiratory Pressure E SINUSOIDAL WAVE ROUND This type of flow accelerates slowly to
54. fety procedure LUFT2 g goes to expiratory phase if the maximum inspiratory time is reached 53 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d In this ventilation mode the following variables must be adjusted Rise Time R Time Maximum inspiratory time Tl max Support pressure P Sup PEEP Sensibility Sens CPAP MODE IS ACTIVATED WHEN THE SUPPORT PRESSURE Pan OFFERED IS REDUCED AT ITS MAXIMUM SIMV PCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUPPORT Permits the patient to synchronize spontaneous breathings PSV with mandatory breathings PCV ensuring to patient a minimum threshold of ventilation and oxygenation This is an alternative to start mechanical ventilation weaning process This mode has the function of decreasing the quantity of mandatory ventilations and permits to patient to perform spontaneous ventilations between each pre established PCV cycle In this ventilation mode the following variables must be adjusted FiO Rise Time R Time Inspiratory time T Ins Respiratory frequency Freq Controlled pressure P Con Support pressure P Sup PEEP Sensibility Sens CONTINUOUS FLOW is a ventilation mode with continuous flow time cycled and pressure limited In this mode the mandatory cycles are provided to patient however between each mandatory cycle the patient can breaths spontaneously due to th
55. ge the equipment its accessories or others 69 of 78 L MECHANICAL VENTILATOR R 04 04 50 LEISTUNG LEISTUNG LUFT2 G peu ANNEX 2 LUFT2 G ACCESSORIES DESCRIPTION FUNCTION PATIENT CIRCUIT WITH EXHALATION VALVE PATIENT EQUIPMENT INTERFACE NOTE 1 ONLY THE MODEL INCLUDED WITH THE EQUIPMENT MUST BE USED 2 THE PATIENT CIRCUIT IS MADE ACCORDING THE STANDARD ISO 5367 AND REGISTERED AT THE HEALTH MINISTRY BY THE MANUFACTURER HIGH PRESSURE HOSE AIR AND OXYGEN GAS SUPPLY TROLLEY SUPPORT DESK FOR THE EQUIPMENT WHITH ANTI CORROSION TREATMENT APPROVED IN SALT SPRAY TEST NBR8094 5770 70 of 78 MECHANICAL VENTILATOR 04 0480 re LEISTUNG LUFT2 G ae HUMIDIFIER SUPPORT SUPPORT FOR HUMIDIFIER FIXING ARTICULATED ARM ARTICULATED SUPPORT FOR PATIENT CIRCUIT ELECTRIC POWER SUPPLY NOTE IT MUST BE USED ONLY THE CABLE INCLUDED WITH THE EQUIPMENT TO FIX THE EQUIPMENT WITH THE TROLLEY INFORMATION ABOUT FUNCTIONS USER MANUAL REQUIREMENTS AND OPERATION OF THE EQUIPMENT TEST RESISTANCE SIMULATES RESISTANCE TO VERIFY THE CYCLES OF THE EQUIPMENT 71 of 78 L MECHANICAL VENTILATOR R 04 04 50 a LEISTUNG LUFT2 G nd FIO ANALYSIS CELL FOR CELL CONNECTION IN PATIENT CIRCUIT Illustrative photos only 72 of 78 rers Eung MECHANICAL VENTILATOR R 04 04 50 Yasome nimwone LEISTUNG LUFT2 G OPTIONAL TOUCHSCREEN MONITOR Monitor Tou
56. ich send to CPU board the current value of the generated flows by the proportional valves The value of FiO is given by the fraction of gas delivered by each proportional valve where each one of them gets responsible only for one part of the total inspired volume This system is very accurate because once the physical quantities are very well known like volume pressure and flow and the variation of concentration of oxygen in the air are very small as well as the percentage of oxygen 10096 provided is enough that the control calculates the flow value of each value will deliver to patient it is obtained with a negligible error the correct AIR INSPIRED FLOW FIO MEASUREMENT measurement is performed through measurement cells furnished along with the equipment As standard the cell that is included with the equipment is the galvanic oxygen cell which uses electrochemistry reactions for O percentage measurement in the inspired gas flow Due to this characteristic these cells has life time which starts counting from the moment it is exposed to oxygen in the air which must be replaced after its determined time The following figure illustrates the right place to put the cell 20 of 78 1 MECHANICAL VENTILATOR 04 62050 LEISTUNG LEISTUNG LUFT2 G As optional LeistungEquipments Ltd offers the paramagnetic oxygen cell which is installed internally in the equipment The use of paramagnetic cell disp
57. low sensor connected correctly membrane is not damaged UPON ASSEMBLING THE EXALATORY VALVE PUT THE DIAPHRAGM AS INDICATED IN THE FIGURE WITH THE SALIENCE DOWNWARD THE LONGER HOSE MUST BE AT EXTERNAL SIDE OF THE EXALATORY PAN VALVE IN THE TERMINALS MARKED WITH PROTRUDING POINT DO NOT DRY OR CLEAN THE EXALATORY VALVE WITH COMPRESSED AIR DO NOT INSERT IN THE BODY OF THE EXALATORY VALVE PIERCING OR XA CUTTING MATERIALS The figure below shows the patient circuit assembly 62 of 78 MECHANICAL VENTILATOR R 04 04 50 maono muona LEISTUNG LUFT2 G Exalatory Valve Optional Connector Y Connector WHEN ADDED COMPONENTS OF THE RESPIRATORY CIRCUIT OR OTHER COMPONENTS OR SUBSETS FOR THE RESPIRATORY SYSTEM THE PRESSURE GRADIENT MEASURED AT THE PORT OF CONNECTION OF THE PATIENT MAY INCREASE UPON REMAKING THE CIRCUIT TEST THIS GRADIENT IS AUTOMATICALLY CORRECTED BY THE EQUIPMENT A BAD CLOSURE OF THE DIAPHRAGM MAY AFFECT ON THE PARAMETERS READING GENERATING WRONG RESULTS THE DIAPHRAGM MUST LEAN ON THE COVER ACCOMODATION FOR WHICH IS AN CONVENIENT TO FIRST PUT IT IN THE COVER AND ASSURE THAT IT IS WELL LEANED TO THEN THREAD IT ON THE BODY i AT THE END OF THREADING DO NOT MAKE STRONG ADJUSTMENTS VERIFY IF THE TWO PLASTIC TUBES ARE COMPLETELY WITHOUT HUMIDITY SO IT IS POSSIBLE TO MEASURE CORRECTLY THE PRESSURE DIFFERENCE BECAUSE THEY HAVE DEFINED POSITIONS AND TO NOT DEFORM THE INTERNAL
58. ment was started below there are current date and hour of the equipment NUMERIC DISPLAYS AND SUPPLYING INDICATORS LEISTUNG LUFT2 g counts with a set of numeric displays Volume which show the values of pressures peak and base H20 expired volume and frequency e Pressure Frequency E m H20 THE MAXIMUM SAMPLING ERROR IS 10 LEISTUNG LUFT2 g counts with an indicator of the type ELECTRIC ENERGY of power source external 110 220V or internal Battery which the equipment is using Whenever the 110 220 indicator is turned on the internal battery is being recharged Battery 110 220 ALL MEASURES USED AND SHOWN BY THE EQUIPMENT ARE EXPRESSED FOR AMBIENT TEMPERATURE AND DRY PRESSURE ATDP 26 of 78 MECHANICAL VENTILATOR 04 04 50 VENTILADORES PULMONARES LEISTUNG LUFT2 G Rev 01 CONTROL AREAS SELECTION In this sector there are the keys that permit to select adjust and confirm of data and also the access to options selection by screen menu Qo Y I DIRECTIONAL KEYS Directional keys permit to gt gt gt the selection cursors of menus and parameters Also is utilized for adjustment of the selected parameters w b d ENTER When the parameters are selected activates adjustment mode and realize the values confirmation It is also utilized to activate menu options DI
59. must be adjusted e FiO 49 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d Rise Time Time Maximum inspiratory time max Pressure P Sup PEEP Sensibility Sens gt IN NIV THE SENSIBILITY IS MODULATED ONLY BY PRESSURE BACK UP VENTILATION Back up ventilation is available in all ventilation modes which have a spontaneous parameter In LUFT2 g the back up is obligatory in modes PSV CPAP MMV PSV PSV VT and NIV In modes SIMV VCV PSV SIMV PCV PSV andBiphasic back up ventilation is available and the operator can let it activated or deactivated No momento em que a modalidade SIMV VCV PSV SIMV PCV PSV ou Bif sico for _ selecionada o operador selecionar a SIM para ativar a de Respaldo ou para desativar a Ventilac o de Respaldo At the moment that PSV CPAP MMV PSV PSV VT or NIV is selectedthe ventilator provides directly the back up ventilation configuration screen To set back up ventilation the following parameters must be adjusted Ventilation mode Apnea Inspiratory time Respiratory frequency Tidal volume or Controlled pressure BACK UP To initiate the operation in spontaneous mode the operator must accept all back SU up configuration by pressing ENTER key over the green arrow on configuration screen Mode In case of not accepting or pressing RESET
60. netic ambience guidelines Lung ventilator LUFT2 g utilizes RF energy only for its internal functions However its RF emissions are very low and it is improbable it causes any interference with nearby equipments RF emissions ABNT NBR IEC CISPHR 1 1 emissions Lung ventilator LUFT2 g is appropriated for Class A establishments but domestic and may be used in ABNT NBR IEC CISPR11 residential establishments and those directly connected to the public low voltage power distribution that supplies Harmonic emissions IEC edifications for domestic use since the following 61000 3 2 Not applicable warning IS attended Emissions due to the Warning This equipment is designated for use only fluctuation of voltage flicker by health area professional It may causes radio IEC 61000 3 3 Not applicable interference or interrupts operation of nearby equipments It may be necessary to adopt mitigation procedure like reorientation or reallocation of the LUFT2 g or blindage of the local In order to avoid RF interference the Lung Ventilator LUFT2 g should not be used stacked on others equipment If this is required it is recommended to be observed the normal use of equipments 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G Manufacturer Guidance and Declaration Electromagnetic Immunity The Lung Ventilator LUFT2 g 15 intended for use in environment electromagnetic specified below It is recomm
61. o the maximum output power of the communication equipments Separation distance according to frequency of transmitter Rated maximum meters m tput f output power o 150 kHz up to 80 MHz up to 800 MHz up to transmitter watts W 80 MHz 800 MHz 2 5GHz a 1 17 P d 1 17 P d 2 33 P For transmitters with a maximum rated output power not listed above the recommended separation distance din metes m can be estimated using the equation applicable to the frequency of the transmitter 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 is applied NOTE 2 These guidelines may not be applied in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people 11 of 78 MECHANICAL VENTILATOR R 04 0450 LEISTUNG LUFT2 G dni CHAPTER 1 PRESENTATION In this User Manual are presented the necessary information for the correct use of the Lung Ventilator LUFT2 g The indications relating to enforcement and regulations mentioned in this manual is a guideline the physician should adapt as their criterion the needs of patients GENERAL Registry ANVISA No 80203470006 MEDICAL DEVICE CLASSIFICATION CLASS III OPERATION MODE CLASSI CLASSI I Internally Energized Internally Energized Device Device Clas
62. patient the adjusted pressure the inspiratory flow is automatically adjusted to maintain the pressure constant during the adjusted inspiratory time Therefore is pressure limited and time cycled IN PRESSURE MODES THE FLOW WAVEFORM CAN NOT BE CHANGED WHICH WILL BE ALWAYS DESCENDING RAMP The resultant volume is free and depends only on physical and mechanical conditions of the respiratory system 52 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d is an assisted controlled ventilation mode and the inspiratory cycles may be triggered by time flow or pressure In PCV airway pressure level is the main parameter to be adjust as it will have direct influence about the tidal volume available to patient To adjust controlled pressure you must have in mind that P Con refers to the pressure value above the established value for PEEP In this ventilation mode the following variables must be adjusted Rise Time R Time Inspiratory time T Ins Respiratory frequency Freq Controlled pressure P Con PEEP Sensibility Sens Rise Time 15 the time the ventilator requires reaching the selected pressure Increasing or decreasing this time may assist in the comfort of the patient In LUFT2 g the Rise Time is modulated by flow i e the higher the rise time the shorter the time to reach the adjusted pressure and the shorter the rise time the longer the time to reach the s
63. r Guidance and Declaration Electromagnetic Immunity The Lung Ventilator LUFT2 gis intended for use in environment electromagnetic specified below It is recommended that the client or user of Lung Ventilator LUFT2 g ensures that it is used in such environment Immunity tests Test level Compliance Electromagnetic Environment ABNT NBR IEC 60601 level Guidances Portable and mobile RF communication equipments must not be used close to any part of the lung ventilator LUFT2 g including cables Recommended separation distance equation with respect to the transmitter frequency d 1 17 P RF Conducted 3 Vrms IEC 61000 4 6 150 kHz up to 80 MHz d 1 17 P 80 MHz up to 800 MHz 12 Radiated 2 33 P 800 MHz up to 2 5 GHz IEC 61000 4 3 3 V m 80 MHz up to 2 5 GHz Where P is the maximum nominal power output of transmitter in watts W according to transmitter manufacturer and d is the recommended separation distance in meters m The field intensity established by RF transmitter as determined by electromagnetic inspection on the local should be less than compliance level in each frequency band Interference may occur around the equipment marked with this symbol 1 At 80 MHz and 800 MHz applies the highest range of frequency NOTE 2 This guidance may be not applicable in all situations The electromagnetic propagation is affected by absorption and reflection of structur
64. s a minimum expired tidal volume acceptable value If the resultant value remains high during three cycles or for a period of time longer than 10 seconds the alarm is activated with light and sound indicators and message on the screen MAXIMUM MINUTE VOLUME It establishes the maximum minute volume acceptable value If the resultant value of the maximum minute volume remains higher than expected during three cycles or more than ten seconds the alarm is activated with light and sound indicators and message on the screen MINIMUM MINUTE VOLUME It establishes the minimum minute volume acceptable value If the resultant value of the minimum minute volume remains lower than expected during three cycles or more than ten seconds the alarm is activated with light and sound indicators and message on the screen MAXIMUM FREQUENCY It is activated if the resultant frequency is higher than the fixed value in alarm When there are leakages or disconnection of the circuit it may cause a self cycle that will activate the alarm APNEA ALARM This alarm is activated if the time between two consecutive inspiratory efforts to start the ventilator is longer than the established period of apnea The ventilator switches automatically the ventilation modes from backup to controlled pressure until the patient demand is restored or another ventilation mode be selected A sound is activated and an intermittent light warning which indicates apnea It can be silence
65. s determined by the operator in the ventilator which always indicates the negative pressure under PEEP or the displaced flow in the circuit necessary to trigger the ventilator When the sensibility limit is reached the inspiratory valve is open and a new cycle starts To choose the numeric value of the sensibility just select its window and move the cursor on the vertical direction When the presented is with negative signal and unit of measure cmH2O it means the sensibility is adjusted by pressure and when it is with unit of measure L min it means it is adjusted by flow To change this configuration just access its window and move the cursor on horizontal direction PCV PRESSURE CONTROLLED VENTILATION In PCV the LUFT2 g delivers to patient the adjusted pressure the inspiratory flow is automatically adjusted to maintain the pressure constant during the adjusted inspiratory time Therefore PCV is pressure limited and time cycled IN PRESSURE MODES THE FLOW WAVEFORM NOT BE CHANGED WHICH WILL BE ALWAYS DESCENDING RAMP The resultant volume is free and depends only on physical and mechanical conditions of the respiratory system PCV is an assisted controlled ventilation mode and the inspiratory cycles may be triggered by time flow or pressure In this ventilation mode the following variables must be adjusted Rise Time R Time Inspiratory time T Ins Respiratory frequency Freq Controlled pressure P Con
66. secsacsesacsecseress 47 MMV PSV MINUTE MANDATORY VENTILATION WITH PRESSURE SUPPORT 48 MINUTE 9 9 99999 99 tette oct 48 PSV VT PRESSURE SUPPORT VENTILATION WITH ASSURED TIDAL VOLUME 48 BIPHASIC BIPHASIC PRESSURE VENTILATION retten 49 SUPERIOR TIME tette tte ttt ttc 49 SUPERIOR PRESSURE 49 INFERIOR 9 99 49 MECHANICAL VENTILATOR 04 04 50 VENTILADORES PULMONARES LEISTUNG LUFT2 G RI re II 49 NIV NON INVASIVE VENTILLATION 49 BACK UP VENTILATION uuu T 50 iP ATO MODE seats 50 a nu ns 50 YOUNG VAR ABEE 25 51 gs 51 CHAPTER 8 VENTILATION MODES 52 VENTILATION MODE SELECTION IR UE 52 PCV PRESSURE CONTROLLED VENTILATION 52 PSV CPAP PRESSURE SUPPORT VENTILATION OR CONTINUOUS POSITIVE PRESSURE aaran M 53 SIMV PCV PSV SYNCHRONIZED INTERMITENT MANDATORY VENTILATION BY PRESSURE WITH PRESSURE SUP
67. sification according to type of protection against electrical shock TYPE B applied part Level of protection against water penetration IPX1 Equipment not suitable for use in the presence of flammable anesthetic mixture with air oxygen or nitrous oxide PHYSICAL Ventilator without the screen VOLTAGE CURRENT 90 264 1 5 0 50 FREQUENCY 47 up to 63 Hz POWER 130 VA FUSE 250V 2A 20mm SB Slow INTERNAL POWER SOURCE Nominal capacity 5 0Ah VRLA Sealed does not emit gas csse comnts so 104 F 40 C 77 F 25 C 32 F 0 C 15 C Capacity after 3 months Auto discharge 68 F 20 C Capacity after 6 months Capacity after 12 months Maximum Discharge Current 77 F 25 C ones Capacity affected by temperature 12 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G nn Charge Floating 77 F Constant Voltage 25 C 13 6 13 8V 1 25A max Charging Time Maximum temperature 1319 55 Internal fuses 4A 20mm SB SPECIFICATIONS INFORMED BY BATTERY MANUFACTURER THE INTERNAL BATTERY AND FUSE ARE NOT REPLACEABLE BY OPERATOR RISK OF ELECTRICAL SHOCK THE CASE MUST BE REMOVED ONLY BY AN QUALIFIED PERSONNEL THE SWITCHING FOR INTERNALLY BATTERY OCCURS AUTOMATICALLY WITHOUT THE NECESSITY OF EXTERNAL INTERVENTION IT DOES NOT INTERFERES THE OPERATION OF THE EQUIPMENT BUT TRIGGERS AN ALARM AS EXPLAINED IN CHAPTER 9 ELECTRICA
68. t Tvpe Symbol No 878 02 02 HOP IEC 60601 1 1994 Symbol 878 03 01 Risk of electrical shock IEC 417 Fuse Symbol No 5016 200 Consult Instructions of Symbol No 3 3 i 67 of 78 MECHANICAL VENTILATOR R 04 04 50 ramones on LEISTUNG LUFT2 G 2 Meaning of the standardized symbols printed the equipment package Symbol Standard Description FRAGILE Handle carefully ISO 780 1997 E No 1 THIS SIDE UP ISO 780 1997 E No 3 Indicates of the up side of the package PROTECT AGAINST SUNLIGHT ISO 780 1997 E No 4 The package must be kept out of direct sunlight PROTECT AGAINST RAIN ISO 780 1997 E No 6 The package must be kept out of rain MAXIMUM STACKING UP Indicates the maximum number of packages can be stacked up for transport and storage ISO 780 1997 E No 14 TEMPERATURE LIMIT ISO 780 1997 E No 17 Indicates the limit temperature for storage and manipulation of the package 68 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d 3 Meaning of symbols printed in this user manual Symbol Standard Description WARNING Condition before which there is the possibility to cause damage to operator or others NOTE opecifies important observations which need to be considered for a correct use of the equipment ATTENTION IEC 60601 1 1994 Condition before which there is the Simbolo No 348 possibility to cause dama
69. t ease of operation allowing fast and safe adjustments of each parameter so offering to the professional a pleasing work and permitting to give more attention to patient LUFT2 g has all ventilation modes necessary to attend adult pediatric and neonatal patients plus an advanced respiratory mechanics menu for correct diagnosis able to be used in the most rigorous and complex therapies effectively and with reliability With a fast and safe interconnection system with the patient circuit avoiding any possibility of error it also includes default initial values which ensure a safe and accurate operation start giving to the operator the control of the equipment and assuring sensitivity values that avoid self cycling allowing a better progress of the patient without interferences Warning messages are very easy to understand which turns possible to take decisions respecting the alarms situation and critical parameters variation The final result is an ICU medical ventilator with a friendly interface where its handling is very easy and intuitive at the same time its configuration is simple and affective so LUFT2 g practicability and operator competence can walk together so that the maximum of LUFT2 g can be obtained perfect and natural mechanical ventilation delivering comfort and safety for adults and neonates VENTILATION MODES PATIENT TYPE VENTILATION VOLUME CONTROLLED ASSISTED CONTROLLED PRESSURE CONTROLLED PCV P
70. the operator a fast localization of the data to be read offering so a high operability 10 03 11 LEISTUNG LUFT2 g 2 10 03 11 VCV ADULT MENU PPeak PMean lt OPERATIVE 39 27 MODES ooo Pressure cm H20 Volume L x AUXILIARY L P Base m Flow ES 60 12 FLOWS 3 32 x INSPIRATORY VTidal t CDin 30 06 PAUSE 20 40 11 0 01 Rate amp T Ins 5 0 0 LUNG 12 1 20 i i MECHANICS V Minute E Flow Linin Flow L min x ECHN OPERAT ign PROFILE 10 0 4 80 4 34 150 150 0 10 100 100 02 50 ER MONITORING 4 5 0 il h 1 2 L Tins Rate v Tidal PEEP Sens 120 1 0 40 3 3 0 5 c min L cm H20 H20 Seeking a greater ease and speed in handling the 17 inches LCD display is organized in areas alarm area monitoring area configuration area and the graphs areas where all these information are evidenced with different colors All values in white color are possible to be adjusted through the operator s adjustments the resultant values cannot be adjusted and they are in yellow The alarm values are red colored giving to the operator a greater ease of configuration In alarms area there are the alarms of maximum pressure minimum pressure maximum volume minimum volume maximum frequency maximum minute volume and minimum minute volume as well as their resultant values In monitoring area it is possible to view the numeric values of p
71. the patient To use this tool you must select slow vital capacity in respiratory mechanics menu and the ventilator shows on the upper part of the screen the current CRV and the better CRV 1 0 1 parameter used during the mechanical ventilation weaning process and is defined as pressure of occlusion of the airway in the first 100 ms of the inspiration To use this tool you must select the option P 0 1 in respiratory mechanics menu and the ventilator will show it on the upper part of the screen the found value According to the III Brazilian Consensus of Mechanical Ventilation 2007 values of P 0 1 higher than 6 predict weaning failure TOBIN INDEX RSBI Tobin Index or RSBI Rapid Shallow Breathing Index is measured through the relation between respiratory frequency and tidal volume To use this tool the ventilator must be in assisted mode with maximum PEEP of 5 cmH O and support pressure between 8 and 10 After the adjustment of the parameters select Tobin index in respiratory mechanics menu and the ventilator shows in the upper part of the screen the measure value According to the III Brazilian Consensus of Mechanical Ventilation 2007 Tobin index values higher than 104 cpm l predict weaning failure SUPPORT PRESSURE VALUES HIGHER THAN THE DETERMINED BY THE MANUFACTURER Tus TOBIN INDEX VALUE MAY BE AFFECTED BY FACTORS LIKE PEEP AND 96 of 78 MECHANICAL VENTILATOR
72. tient effort In this mode the ventilator supports the patient through maintaining a positive pressure adjusted in P Sup window This maintains free to patient to control the respiratory frequency inspiratory time and inspired air 45 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d volume Therefore the tidal volume depends on inspiratory effort pre established support pressure and the mechanics of the respiratory system To perform this function the ventilator upon starting increases the pressure in the circuit to a defined pressure support level The end of the inspiration occurs when the inspiratory flow upon reduction reaches a pre determined value called expiratory sensibility Expiratory sensibility is adjusted in MENU Expiratory Sensibility and its variation may be adjusted with values between 5 and 80 of the inspiratory peak flow Flow Pressure 9 The control variable in this mode is P Sup support pressure The volume variation depends on physical conditions and it will be proportional to inspiratory effort of the patient and the adjusted support pressure In this ventilation mode the following variables must be adjusted Rise Time R Time Maximum inspiratory time TI max Support pressure P Sup PEEP Sensibility Sens MAXIMUM INSPIRATORY TIME As safety procedure LUFT2 g goes to expiratory phase if the maximum inspiratory time is reached SUPPORT PRESSURE In
73. tion according to user manual This warranty is annulled when a he equipment identification label was modified or removed b The installation of the equipment was not performed according to instruction manual C discovered that the damages were caused by bad electrical installation floating or voltage differences which the equipment works with d Damages due to hit or accidents of any type after purchase e is discovered intervention of any other person but technical service of LEISTUNG EQUIPAMENTO LTDA The installation of the equipment is responsibility of the buyer LEISTUNG EQUIPAMENTOS LTDA is not responsible for bad installation and use of the equipment 77 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d ANNEX 6 GLOSSARY ALARM It is a light or audio signal or both ones that occurs when an unexpected event happens in the equipment AUTOPEEP The lung pressure at the end of expiration CYCLE The period of a mechanical supported inspiration COMPLIANCE It is the relation between volume and pressure STATIC COMPLIANCE It is the relation between volume and pressure at locations without gas flow WEANING Gradual reduction of ventilation support ASSISTED EXPIRATION It is the expiratory flow generated by negative switch at trans respiratory pressure due to an external agent like a respiratory pressure drop generating a value lower than the reference value EXPIRATORY PHAS
74. tion keys allow selecting the desired mode When confirmed the mode by pressing ENTER are shown on the screen all the parameters related with the selected mode If the ventilator are at this moment ventilating a patient through another mode the changes are not concluded until manual inspiration key is pressed which permits to finish the previous mode and start a new one Pressing RESET all the changes are canceled and the previous mode is resumed Following there are brief descriptions of the ventilation modes VENTILATION MODES VCV VENTILACAO CONTROLADA POR VOLUME In VCV mode LUFT2 g integrates the air flow with inspiration time and delivers to patient the programmed current volume Therefore VOV is flow limited and volume cycled To perform flow changes the operator must change the current volume flow waveform or inspiratory time according to necessity i e the flow delivered by the equipment is the resultant of current volume inspiratory time and flow waveform requested by the operator 39 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d The resultant pressure is free and depends exclusively on physical and mechanical conditions of the respiratory system VCV is an assisted controlled ventilation mode and its inspiratory cycles may be triggered by time flow or pressure In this mode the following variables must be adjusted FiO Flow curve Wave Inspiratory time T Ins R
75. ues of the new mode to applied and confirm the change pressing j While the change is not confirmed the equipment will keep working under the adjustments done before To see the operative modes which this equipment counts with see chapter 7 LUFT2 G NEVER STOPS OPERATING DURING CHANGES OF OPERATIVE MODES IN CASE OF CANCELING CHANGES JUST PRESS RESET TO DENY ALL THE CHANGING PROCESS AUXILIARY FLOWS Pressing MENU select the AUXILIARY FLOWS option in this menu it is possible to activate the auxiliary flows outputs which are NEBULIZER Selecting this option the operator can adjust the time of exit of for nebulization synchronized with inspiration time this time may be 5 10 15 or 20 minutes according to the necessity This output is deactivated automatically at the end of the adjusted time or manually setting zero the time in menu gt TIDAL VOLUME ARE AUTOMATICALLY COMPENSATED DURING THE PERIOD IN WHICH THE NEBULIZER IS ACTIVATED TGl Selecting this option the operator may activate the output flow of tracheal gas insufflations synchronized with expiratory time To deactivate it is necessary to access the menu manually OXYGEN 100 Selecting this option is started an oxygenation as follows 1 The operator may choose among 5 10 15 or 20 minutes to ventilate the patient with pure oxygen 32 of 78 MECHANICAL VENTILATOR R 04 04 50 Venns LEISTUNG LUFT2
76. uit When the power reestablished the equipment is turned on again MICROPROCESSOR This alarm is activated if occurs a failure which prevent the microprocessor to maintain the control of the equipment A light warning and a continuous sound are activated Simultaneously all the gas supply valves get closed and the anti suffocation valve is enable which permits the air inlet of the ambient to the patient circuit DEFAULT ALARMS SETTING P max 40 cmH5O P min 05 PCV SIMV CPAP PSV 0 600 1 ASSURED TIDAL VOLUME Vol min 0 200 I PSV BIPHASIC PRESSURE Freq Max 30 com PEEP 04 APNEA 15 seconds Minute volume MMV PSV Max 9 0 Min 4 5 max 40 cmH5O NIV P min 05 cmH O Freq Max 30 P 30 cmH O P min 05 cmH O VCV PCV SIMV CPAP PSV Vol max 0 300 ASSURED TIDAL VOLUME PSV Vol min 0 100 1 PEDIATRIC BIPHASIC PRESSURE Freq Max 30 cpm PEEP 04 cmH20 15 seconds MMV PSV Minute volume 6 0 59 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d SOT P max 30 cmH2O P 05 cmH O 30 P max 25 cmH O P min 05 Vol 0 050 PCV SIMV CPAP PSV Vol min 0 005 Freq Max 30 cpm PEEP 04 APNEA 15 seconds P max 25 cmH2O MODO FLUXO CONTINUO P min 5 cmH2O Freq Max 30 cpm
77. um threshold of ventilation and oxygenation This is an alternative to start mechanical ventilation weaning process This mode has the function of decreasing the quantity of mandatory ventilations and permits to patient to perform spontaneous ventilations between each pre established PCV cycle 47 of 78 MECHANICAL VENTILATOR R 04 04 50 Vena LEISTUNG LUFT2 G d In this ventilation mode the following variables must be adjusted FiO Rise Time Time Inspiratory time T Ins Respiratory frequency Freq Controlled pressure P Con Support pressure P Sup PEEP Sensibility Sens PSV MINUTE MANDATORY VENTILATION WITH PRESSURE SUPPORT This mode works associating PSV mode with a minute volume value determined by the operator The ventilator evaluates periodically the minute volume delivered to patient In case of a minute volume smaller than determined LUFT NEO increase support pressure in order to increase the ventilation and reach the required value In this ventilation mode the following variables must be adjusted Rise Time R Time Minute volume V Min Support pressure P Sup PEEP Sensibility Sens MINUTE VOLUME Minute Volume refers to the volume delivered to patient within a period of one minute PSV VI PRESSURE SUPPORT VENTILATION WITH ASSURED TIDAL VOLUME Spontaneous mode which allows the operator to select a minimum tidal volume for each ventilation
78. ycle is free and depends on the respiratory mechanics pressure releasing time and patient effort In this ventilation mode the following variables must be adjusted FiO Rise Time R Time Superior time T Spr Superior pressure P Spr Inferior time T Inf Inferior pressure P Inf Support pressure P Sup Sensibility Sens SUPERIOR TIME Superior time refers to the interval of time in which the superior pressure remains constant SUPERIOR PRESSURE Superior pressure refers to high pressure reached in each cycle The superior pressure may be compared to the sum of PEEP with controlled pressure This pressure remains constant during the selected superior time INFERIOR TIME Inferior time refers to the interval of time in which the pressure remains in the level of base pressure INFERIOR PRESSURE Inferior pressure is the base pressure which remains in this level during inferior time Inferior pressure may be compared to PEEP NIV NON INVASIVE VENTILATION NIV mode is a way to ventilate the patient without invading his airway NIV is offered through use of adapted masks NIV is similar to PSV with the difference that eventual leakage by mask patient face adaptation can be compensated LUFT2 g in NIV allows the operator to establish the variable of inspiratory pressure limit and has the capacity to compensate leakages until 50 l min without generating auto trigger In this ventilation mode the following variables

MECHANICAL VENTILATOR LEISTUNG LUFT2-g

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