Home

Section 1 - DOCS Education

1. If the knob is rotated any window associated with the highlighted softkey is displayed when the knob is pressed The knob then controls scrolling through that new menu window The top item EXIT on each menu window is automatically highlighted when the window is activated The user may simply press the menu knob a second time to exit each window without making changes At the bottom of the window there may be selections allowing access to subordinate windows Some windows and settings discussed in this manual may not be present if the feature is not installed in the monitor If a parameter has been turned OFF in the PARAMS window settings in other windows such as alarm limits may be disabled Turn the rotary knob to highlight items on these menu windows Press the knob to select the item A single short beep is generated The key press beep is audible even when the alarms are silenced Some of the settings require an alpha numeric entry Rotate the knob to the desired character and press to select The cursor will automatically move to the next space If an error is made while entering a left arrow character can be selected in order to back over the existing text The down arrow character can be selected to jump to the next line The arrow characters are not available when entering passwords nGenuity 8100E Series Operator s Manual Page 3 5 Section 3 Setup Procedure Saved Setting Profiles Alarms and parame
2. 2 6 Commu nication Sockets reves rice ede ise ea cb e eg ge etes 2 7 Service Access Pahels coo ostiis D r urs Tre eve tust edv ee ALS 2 7 Chassis Ground 28 AC Power Cable Connection 2 8 Fuse Access Panel 2 8 Optional Printer nennen ennemi 2 8 Screen Display and Interface annie naie 2 9 Waveform Slots 2 11 Numerical Parameter Boxes 2 13 Main Menu esss we 2 15 Alarm and Message Areas sssssssseeeeeeeeeneee nennen rennen 2 15 Syst m Status BOX eraio ead a d es pete eerte a aa 2 15 Patient Information and CIOCK ssesesssssesseeeeee eene nnne nnn 2 16 Section 3 Setup Procedure Monitor Setup Battery Power Charging the MOnitor ecce tira cese e cente pa t Di e ianea aaia 3 1 Battery Indicators tronco RE eret ar 3 2 System Start and Auto calibration 9 8 Sensor and Probe Messages 3 3 CO Calibration 43 4 Softkey Functions Main M nu ccesseeecesseeeeeeeeeeececeeessesseeeaeseeeaesaeeeeesaeeeeeeaeeeees 3 5 CGharnging Settings ini ee reed e eter e A Eee 3 5 Saved Setting Profiles 9 6 ALARMS Softkey sess 3 7 Alarms Settings by Patient Size 9 8 AlarirLirnitS inrita eee coercet e cuca venue davek a dab aunt de De e Tea ena da ee dee e eU 3 8 ECG LEead Ea
3. NWARNING N e f the electrical integrity of the earth ground is in doubt the power cord should be disconnected and the machine should be operated from its internal electrical power source Explosion hazard Keep lighted cigarettes sparks and flames away from the battery The battery contains sulfuric acid electrolyte which can cause severe burns and eye damage as well as illness from sulfur oxide fumes Do not short circuit the battery terminals The resulting high current discharge can cause burns The monitor functions if plugged into AC mains power even while the battery is completely drained A defective battery should not be left inside the monitor The monitor can also function without the battery running on AC power only but this is not recommended in a clinical setting The battery should be allowed to charge to full strength before using If the battery is not fully charged before use the battery does not hold as much charge in the future Insufficient charging also degrades and shortens the life of the battery Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 3 1 Section 3 Setup Procedure Battery Indicators The battery icon is located on the lower portion of the main screen as Page 3 2 described in Screen Display and Interface in Section 2 The battery icon changes color to indicate the status of the battery The battery icon appears when using DC battery power or
4. E electrocardiogram S pulse oximetry N non invasive blood pressure nGenuity 8100E Series Operator s Manual Page 6 7 Section 6 Trends NIBP View Monitors with software version 1 2F and newer have a tabular trend view titled N BP When NIBP is selected the trend report will only show trend records that contain blood pressure measurement To activate 1 Press the TREND key to show the trend display 2 Press and hold the TREND key to access the trend settings 3 Select Trend Interval and choose NIBP to activate this display option Clearing the Memory To clear the trend memory 1 Press the TREND key to display the trend 2 Press and hold the TREND key again to display the Trend Setup window 3 Select the Clear Trends option and select YES to confirm the clearing of the trend data The trend memory is automatically cleared when The Time and or Date are changed in the menu e Defaults reset Page 6 8 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 7 Printing and Data Ports Description The monitor is optionally equipped with a thermal dot matrix printer which is located on the top of the rear of the unit The nGenuity 8100E Series monitor is capable of printing all vital signs parameters in tabular text The monitor can also produce graphical waveforms formats as specified by the user Snapshot Size The period of time in a graphical print that starts 4 5 seconds prio
5. nGenuity 8100E Series Operator s Manual Page 1 15 Section 1 Introduction Safety Definitions Definitions for Warning and Caution symbols Warnings Page 1 16 Designates a possible dangerous situation NWARNING A Non observance may lead to death or the most severe injuries Designates a possible dangerous situation NCAUTION A Non observance may lead to minor injuries or damage to the product NWARNING N Read this manual entirely before attempting clinical use of the monitor Inspect For Damage User should inspect the system for signs of damage Do not use the system if failure is evident or suspected Possible explosion hazard Do not use the monitor in the presence of gas mixtures which may be flammable Do not use this device in conjunction with flammable anesthetics such as cyclopropane and ether The monitor can sample from pure oxygen environments but the monitor itself should never be placed inside an oxygen rich environment such as an oxygen tent or gas containment apparatus When not in operation this device is not intended to be connected to any pressurized source containing an enriched oxygen environment All cords must have hospital grade plugs and be plugged into hospital grade outlets The electrical installation of the relevant room must comply with NFPA 70 National Electric Code or NFPA 99 Standard for Health Care Facilities Outside the United States the relevant room must com
6. 20 Br m TEMP 96 4 F NIBP 04 30 22 135 95 115 mmHg GAS EXP INS C02 5 0 3 0 kPa 12 14 06 04 38 22 HR ECG 60 BPM Sp02 98 RESP ECG 20 Br m TEMP 96 4 F NIBP 04 30 22 135 95 115 mmHg GAS EXP INS C02 5 0 3 0 kPa Figure 7 1 Tabular Printout NOTE Monitors without CO monitoring will not print out CO data nGenuity 8100E Series Operator s Manual Page 7 3 Section 7 Printing and Data Ports Graphical Printing JOHN M 5p02 98 NIBP 04 46 1 ID 12345678 is If both waveform 1 and 2 have been set to a physical parameter the print out is a split dual waveform If only one of the waveforms is turned on a single waveform is printed using the entire waveform area If both waveforms are turned off the waveform area of the print out is blank Selectable options for waveforms are ECG Il III V aVR aVL aVF PLETH ET CO2 and OFF Numerical values for heart rate SpOs NIBP temperature and respiration are printed below the waveform grid RM 109 94 25 96 04 48 51 DMD 5 95 115 mmHg RESP 20F Br m ST LL OFF ECG II x1 13 for top waveform Data in corner Data in corner for bottom waveform Data in corner for single waveform Indicates second waveform is off Figure 7 3 Single Waveform Printout Page 7 4 The printout can be configured with a variety of waveform pairs The example in Figure 7 2 Dual Waveform Printout above shows an EC
7. Sp02 96 i a ASAN Low Sp02 Alarm 90 ECG RESP CYCLE OFF 149 106 7 oF ALARMS PARAMS DISPLAY SP02 SENSOR x ADM DIS CONFIG PRINT lc NO ADHIT 96 4 imb Adult AUG 16 05 14 12 59 Figure 3 7 Combined Slots Displayed nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 3 Setup Procedure Cascaded Slots The monitor can cascade a waveform into the next lower slot and it is then displayed as twice or three times its original length The cascaded data is a continuous band of waveform using the sweep speed as set in the original waveform slot The GA N and RANGE settings are the same for the entire cascaded waveform The waveform label and scale are not shown for slots where data has been cascaded from a higher slot To cascade a waveform into the next lower slot set the lower slot TYPEto CASCADE The waveform above automatically cascades into the next lower slot A maximum of three 3 slots can be linked in cascade The display is set up in separate groups of three 3 slots so a waveform cannot be cascaded from slot 3 to slot 4 TYPE ECG II Cascade ECG aVR PLETH Cascade Cascade Display Figure 3 8 Cascade Slot Settings Cascade and the double height feature can be applied to the upper and lower groups of slots independently It is also not possible to cascade double height waveforms ewh 60x Sp02 96 M X L
8. Trend Messagges ncen cete nente trente einen da re Pru sr nne Data Formalt 3 vri een re nee ente one Hs NIBP View Clearing the Memory nGenuity 8100E Series Operator s Manual Criticare Systems Inc Contents Section 7 Printing and Data Ports DOSCrIDUION pe 7 1 Shapshob SIZ isc rea eerie Pe eei eda dete edt Uer e ATA Lee 7 1 History Size Print MOd S nciht vae e deci ev EA ca egere E eve TRE ds Demarid Prirt 2 rre reigeiet creta aa iaa aE ead oh eit v dva re TE EN 7 1 Continuous Print Alarm Print BP Print ss 7 2 Interval Print 4o sisal eee e eere E eve ee eve o Ee e EE YER ER 7 2 Freeze Print iicet eee rite deerit coa da dr deed Qe URP d aec or De eaa d Eee de uto 7 2 Trend Print ss 7 2 Print Formats we 7 3 Tabular Printing an 7 3 Graphical Printing 0 ccceecccseeeeceeeeeeeeeeeeeeeaeeeeeeeesaeeeeeseeeeesaeeeeesaeeneseaeeneeeaeeae 7 4 Mini Trend Printing rrt rre rnit tcn tnn nnn 7 5 Changing Printer Paper 27 6 Data Output Ports es TT COM Port ss 7 7 COM2 Port enne tnnt reni EE nnns eren nnns nens enne nns 7 9 Defibrillation Connector sesessssesseeseeeeee nennen enne nnne nnns nna 7 10 Nurse Call Vidd zo aep TE 7 10 CSV Data Format 5 eine t i e redes 7 11 Section 8 Maintenance Cleaning Disinfecting and Testing ssseeeeneennnn
9. respiration that is based off the capnogram There is also a selectable smart respiration function that can automatically switch sources if there is an interruption of waveform data The CO data is the primary source for the smart respiration function and it defaults to the CO source if it is available Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 1 5 Section 1 Introduction Non Invasive Blood The monitor uses ComfortCuff technology to determine non invasive Pressure NIBP blood pressure by means of oscillometry The oscillometric method detects volume displacements within the artery and senses pressure variations within the blood pressure cuff during inflation The monitor uses cuffs ranging in size from neonate cuffs to thigh cuffs Comfort Cuff ComfortCuff technology measures NIBP while the cuff inflates Technology Consequently a measurement is obtained more quickly and with less discomfort than with monitors which measure NIBP during cuff deflation Description of NIBP The NIBP cuff begins to inflate at the beginning of the NIBP Measurement measurement cycle As the cuff pressure approaches the diastolic pressure of the patient the cuff pressure waveform begins to indicate the pulse waveform The cuff pressure at this point is equal to the patient s diastolic pressure which is stored by the monitor As cuff pressure continues to increase the pulse waveform as measured from BP cuff pressu
10. 5 2 Waveforms Frozen 5 2 Alert ICONS coti tet b atta ence atu bebe arabe eesti 5 3 Special Alarm Condlitions etn ive cem aveva eee 5 3 Alarms at Start Up 5 3 Alarm Silence ee 5 3 Audible Alarms Disabled Warning Tone 5 4 Alami Volume iniecit bre rei tae RECUERDE cC eed ped Euch 5 4 Minimum Volume Auto Reset sssssssssseseeeeeeee nennen nennen nennen 5 4 Standby Mode 5 4 SpO Low Limit Auto Reset 5 5 SpO Low Limit Off Alarm e Alarms TOStiNG e ET Alarm Message List nene nrenneren eren nnnetnre enne nnn een Shared Source Alarms t EGG Alarms e nintritrieitetivemtenio ien nim iere me TEE ae Respiration Alarms recette recente re eee in rn en Deiner nd SpOz Alarms Temperature Alarms NIBP Alarms m CCES ET PR DS Syste Alerts to cer cer eris dpa EY Pl Ce adde dev deep Section 6 Trends BesctriptlOD Jm coorta et tbe et set gd te te E E Trend Ititervali nonne nett rettet n dear in denn Capacity cece Trend Screen Update Trend Setup E Graphical Trends nennen tenente trennen Scrolling the Graph oi ciet de tecti e i tdt deese de Interruption Due to Power Cycling Graphical Trend Screen 6 5 Tabular Trends ssse 6 6 Heart Rate Source Indication esssssseneenenenne 6 6 Respiration Source Indication 6 6 Tabular Trend Markers E
11. German Italian Spanish Russian and Portuguese To change the language 1 Press the ON OFF key to start the monitor The key is located on the top right side of the monitor the topmost key on the keypad 2 Turn the menu knob until the CONFIG softkey is highlighted The CONFIG softkey is located at the center bottom of the main menu 3 Press the knob in to select the CONFIG softkey The configuration window appears 4 Locate the language setting which is the sixth item from the top Turn the knob until the language setting is highlighted 5 Press the knob to select the language setting The current language shown to the right is highlighted 6 Turn the knob until the desired language appears 7 Press the knob again to select the new language 8 EXIT the configuration window Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 3 23 Section 3 Setup Procedure The language should be properly set when saving user default profiles The correct language can then be restored using only the DEFAULT key and the default profile dialog box when an unfamiliar language is set on the monitor In situations where the monitor has been left for over 24 hours without power or charged batteries the language setting as well as other defaults may be lost In this condition the monitor reverts to the language set in the last selected user default profile English is the default language when no other has been sele
12. Inc nGenuity 8100E Series Operator s Manual Page 4 5 Section 4 Patient Monitoring Multi Site Sensor Placement Page 4 6 In situations where finger sensors are not practical a Criticare Multi Site sensor can be used The sensor pads are small light weight and adjustable Figure 4 3 Multi Site Finger Placement The Multi Site sensor can be placed using adhesive tape Special care should be taken not to restrict blood flow in the finger tip Alternatively a Posey9 Wrap CAT 920 that has a velcro strap can be used to place and adjust the Multi Site sensor The sensor pads fit easily into precut slots in the Posey Wraps Figure 4 4 Multi Site Sensor with Posey Wrap An ear clip is provided with the CAT 940SD sensor kit Slide the sensor pads into the clip and place on the ear as shown below Double sided adhesive dots come with the 940SD sensor that can be used to adhere the clip to the ear Replacement ear clips and adhesive dots can be ordered separately see Accessories in Appendix A Figure 4 5 Multi Site Sensor with Ear Clip nGenuity 8100E Series Operator s Manual Criticare Systems Inc Using SpOs Sensors Criticare Systems Inc Section 4 Patient Monitoring The Multi Site sensor can also be placed on the forehead A forehead applicator and velcro head band are provided with the CAT 940 sensor kit Place the Multi Site sensor pads into the forehead applicator The forehead app
13. Pkg of 10 745 NIBP Cuff Child Pkg of 10 sssssssem 746 NIBP Cuff Small Adult Pkg of 10 sssssseee 747 NIBP Cuff Adult Pkg Of 10 cccccceceeeeeeeeeeeeeeeeeeeeneeeeeeeneeeeees 748 NIBP Cuff Large Arm Pkg of 10 749 NIBP Cuff Thigh Pkg Of 10 ccccceceeeseeceeeeeeeeeeeeeeseeeeseseeeeee 750 nGenuity 8100E Series Operator Manual Page A 3 Appendix A Accessories Temperature Probes Reusable Probes Disposable Probes Gas Monitoring Accessories Page A 4 Sampling Devices General Purpose Rectal Esophageal eeesss 420 Banjo Style Probe sssssssssseeseeeeeeeneeene enne 421 Skin Surface Probe sssssssssssesseeeeneeeeeenen nnn 422 Skin Surface Probe sssssssssssssessseeeeeneneeeeen nennen 437 General Purpose Rectal Esophageal sseesssss 438 Temperature Interconnect Cable ssssseeee 439 Temperature Starter Kit 1 ea 439 438 437 440 Sampling Lines Box of 25 sssssssssssee 625N Disposable Nasal Cannula Box of 10 eessen 624 Divided Nasal Cannula Box of 10 628 Oral Nasal Sampling Cannula essseeeenee 637 Endotracheal Adapter Straight Box of 10 sususss 616 Endotracheal Adapter Elbow Box 10 nn 617 WaterChek 2 water trap Box of 30 sussss 938F NC
14. ST elevations are reported on screen as current numerical values as short term graphs and long term trends The arrhythmia and ST analysis is fully integrated with the standard ECG package of the monitor The standard ECG alarms and ECG lead switching is available when using this feature This software package is intended for use by physicians to assist with the detection of ventricular arrhythmias and deviations in ST segment elevations that may indicate the presence of myocardial ischemia The monitor provides detection of only specific conditions within a defined range of physiological parameters as stated in these instructions The physician is responsible for the interpretation of the monitored data and alerts that are made available The arrhythmia and ST features are available through keycode activation on all nGenuity 8100E Series monitors The feature can be purchased and activated at any time Normally the keycode is entered as part of the original manufacturer s configuration when purchasing the arrhythmia and ST model version and should not need to be entered again nGenuity 8100E Series Operator Manual Page C 1 Appendix C Arrhythmia and ST Analysis Software Agreement Page C 2 Activation Each monitor using the arrhythmia and ST algorithm requires a specific software licenses separate from the express right to use the operating system software of the monitor Attempting to access the arrhythmia and ST feature
15. SUSPENDED ALARM ICONS A red bell icon with a X indicates that an alarm limit has been turned to OFF when the icon occurs in the Numerical Parameter Boxes When the red bell icon appears in the top waveform slot all the monitor s audible alarms have been silenced The duration of the silence condition appears to the right of the bell icon 2 min 2 minutes oO permanent Visual alarms continue to be displayed as described BATTERY ICONS A battery icon appears in the System Status Line indicating that a battery is present when AC power is not available The battery icon changes color depending on the charge status See Battery Indicators in Section 3 for more information about battery status and charging The monitor s alarms may be adjusted to suit the specific needs of the clinical environment Special functions are included for the benefit of the user so that nuisance alarms during patient setup do not become distracting to the caregiver Alarm Silence and Standby Mode are available for this purpose There are additional safeguards included to protect against the misuse of these functions Audible alarms do not occur until the first valid measurement has occurred for that parameter Visual messages and alarms are present immediately when a module is activated The alarms and start sequence can be altered by the presence of an external monitoring module See the instructions provided with the external module An alarm SI
16. Silent Medium Message ST AVR Low 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST AVL High 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST AVL Low 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST AVF High 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST AVF Low 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST V High 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST V Low 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message Page C 12 nGenuity 8100E Series Operator Manual Criticare Systems Inc ST Arrhythmia Monitoring Parameters Display Settings Criticare Systems Inc Appendix C Arrhythmia and ST Analysis Parameter Selectable Options Arrhythmia On Off ST On Off Lead ECG I ECG II ECG IIl ECG aVR ECG aVF ECG V Off Lead 2 ECG I ECG Il ECG IIl ECG aVR ECG aVF ECG V Off Lead 3 ECG I ECG Il ECG IIl ECG aVR ECG aVF ECG V Off Setting Selectable Options ST Graph 1 Duration 5 10 15 30 60 minutes Scale 1 2 3 4 5 6 mm ST Graph 2 Duration 5 10 15 30 60 minutes Scale 1 2 3 4 5 6 mm ST Graph 3 Duration 5 10 15 30 60 minutes Scale 1 2 3 4 5 6 mm Factor
17. nennen nennen Description of NIBP Measurement NIBP Clinical Testing and Accuracy E Cuff Inflation and Pressure Protection sesseenneem 1 7 Capnography 3 35 enti eoe nere ee REIR bere ERI er 1 8 Method of Measurement eese enne nente nennen nenne innen 1 8 Conditions of Uses n e Oe eoe Stability of Accuracy us NJO Comperisation tette e etri te tip teta D RES DE stad Temperature Measurement esses nere neenree teen een Specifications Warnings esce emeret iere Pere IRE Pen eset Cautions Leakage Current Voltage Fluctuations Equipotential Gro ndg ic eicere tae peser Software Error Related Hazard Mediation essen 1 18 Potential Interference Biocompatibility seeseesseesseeeeeeeneenneneeneenennnen nennen nennen latex Contenido ed ied eitis utei c cetera dove agde DEHP Gontent 3 i RincIang nme vetta aaa ai Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page iii Contents Page iv Section 2 Controls and Connections Front Panel UE 2 1 i o ie EEE PE E P PEPPER RAMIS 2 2 AC Power Indicator or Rotary Menu Knob cas nente eee rie hey attends 2 3 Color Display E 2 3 Left Side Panel sess 2 4 Water Trap and Sampling Connection 2 5 Rear Panel and Fixtures
18. range of the capnometer bar graph is 25 The numerical parameter box area is directly to the right of the waveform area The area is broken into four 4 numerical boxes These numerical parameter boxes align the numerics with the waveforms of a particular parameter There is an additional elongated numerical parameter box below the waveforms for NIBP data Another numerical parameter box to the right of the message and status lines displays temperature numerical data If a module is turned off in the PARAMS menu the numerical parameters are not shown Smart parameters such as respiration and heart rate switch to another available module if possible ECG BOX The top parameter box in the upper right hand corner is dedicated to display the heart rate The source of the heart rate i e ECG SpOs or NIBP is shown in the upper left The color of the heart rate numerics changes to match the color assigned to the source A bell icon appears in the lower right corner of the box if either heart rate alarm limit is set to off The bell icon is red with a white X indicating that an alarm is turned off RESPIRATION BOX The Respiration box displays the respiration rate and a bell icon if the respiration alarm is set to OFF SPO2 BOX The SpO box displays the oxygen saturation in percent A bell icon in the right center is shown if an oxygen saturation alarm limit is set to off Below the SpO value is a message stating what the set
19. 200 50 140 50 NIBP Diastolic 100 40 100 40 80 30 Temperature 100 0 F 94 0 F 100 0 F 94 0 F 100 0 F 94 0 F 37 8 C 34 4 C 37 8 C 34 4 C 37 8 C 34 4 C Respiration 44 4 36 4 60 14 CO2 Inspired OFF OFF OFF OFF 10 mmHg OFF 1 5 1 5 kPa 10 0Torr CO2 Expired 55 mmHg 15 mmHg 55 mmHg 15 mmHg 55 mmHg 5 mmHg 7 5 96 2 0 96 7 5 96 2 0 7 5 96 1 0 7 5 kPa 2 0 kPa 7 5 kPa 2 0 kPa 7 5 kPa 1 0 kPa 56 0 Torr 15 5 Torr 56 0 Torr 15 5 Torr 56 0 Torr 5 5 Torr Other Alarm Settings Both Adult and Ped Value Alarm Volume 3 Apnea 20 seconds ECG Lead Fail Medium Page B 4 nGenuity 8100E Series Operator Manual Criticare Systems Inc Appendix C Arrhythmia and ST Analysis Arrhythmia and ST Analysis Software Description Intended Use Compatibility Criticare Systems Inc This appendix describes the optional software extension for the nGenuity 8100E Series monitor The functions described here must be purchased as a separate upgrade if not originally available with your monitor The arrhythmia and ST analysis software extension has the capability to measure ST segment deviations and generate arrhythmia alerts for common ventricle arrhythmia conditions The arrhythmia and ST alerts can also have user specified alarm levels Automatic or user adjustable ST measurement points are provided The monitor measures ST segments continuously from the real time waveform collected by the internal ECG module
20. Cautions and Warnings enne C 5 Specifications v Interface Screens eret metta Fe vire cte e Ce e mue eo euo e tnc edebat C 7 Setup Windows 5 irr neta mittam uite tam eren C 8 ST Arrhythmia Defaults C 11 Alarms Settings Arrhythmia Setup sssssseneeeeeenene C 11 Alarms Settings ST Setup C 12 ST Arrhythmia Monitoring Parameters eseeeen C 13 Display SettihdS ete cene iere ee e e are eene in C 13 MID rM C 14 Graphical Trend Screen ener C 14 Tabular Trend Markers and Messages seee C 15 Data Format with ST e det SO EEG de ce aptid C 15 Clinical Preparation i eon eiie cereo nm ree tee eoe inea C 15 secre cm C 15 Clinical Use src eve dvd C 16 Pacemaker Detection cccsccsscssccssseesesesscesessesssesesescseesseeseaeseseeseneessaeeeeees C 16 Defibrillation tees coti ERE t EM RE el itte Dto det Arrhythmia Detection iss vccccisececesecatiuscrccssccnurarsncsancnsdetesanevonpcnatensecensuteannediaueavictaantersensd ST Segment Analysis De scriptionwca wires ara cin lara Ache e ra E En Starting S T 2 noe ase ee EC dee ede eed ST Filter Automatic ST Segment Detection ceeeeeeeceeseeneeeeeeeeeeeeaeeeeeeeeeneeeeeeneeeaeea C 18 ST J and ISO Point Manual Adjustment 0 ccccsceceeeeeeeeeteeeeeeeeteeeeeeenaes C 19 Tabular Printing 0 0 cece anei ST a
21. Lead Setup Electrode Application rettet reiner 4 12 EGG Auto Eead Switching itera Eres 4 13 Primary bead 6er emot eet eerie P ee guapos 4 18 Alternate Lead Priority certe rien per denen ta nai cen era 4 14 NIBP Monitoring Non invasive Blood Pressure seen 4 15 Selecting Cuffs and Hoses sese nennen Placing thie NIBP Gult eret eter e e Ferrea Procedure ees Taking NIBP Measurements Gas Monitoring esse Sampling Cicuit Connections seseeeeeeeeneeneeee nnns Water Trap eire n eio mie mie e ees Sampling Devices Intubated Patients Calibration and Startup Procedure for Gas Monitoring eseeeeeenn ne OGCGIUSIOLS Leer euro Mb cce iEn e ote Per NE tue ce Anesthetic Gas Exhaust Recovery COMonitoring 3 5 etcetera ro e e a nte nGenuity 8100E Series Operator s Manual Page v Contents Page vi Temperature Monitoring essere nnne rennen nnne Using Temperature Accessories y Directions for Use with Skin Surface Probe 4 28 Directions for Use with Esophageal Rectal Probe sese 4 28 L1 Ino ob RAD DH wastes ian codes CREE 4 28 Section 5 Alarms and Messages Alarm Description erret EE eH e EE Fr HE CE rad anon e PO ree 5 1 Audible Alarms 5 1 Visible Alarms
22. Patient Monitoring Lead Placement 3 Lead Setup Page 4 10 The monitor provides ECG options for 3 and 5 lead patient setups The following instructions describe both the 3 and 5 lead configurations For the correct electrical resistance and shielding it is important to use the recommended ECG cables for this monitor The three major planes that detect electrical activity are Lead Lead Il and Lead III known as the standard or conventional bipolar limb leads Lead II RA and LL commonly known as the standard lead configuration is often used for monitoring because its waveform characteristics are typically most prominent For general monitoring purposes Leads and ll are most commonly used Lead produces good P waves reflecting atrial activity e Lead Il produces good QRS complexes reflecting ventricular activity Place the electrodes on the patient in the standard lead configuration Leads I Il III may be selected in the monitors DISPLAY window Figure 4 9 Electrode Locations for 3 Lead Setup nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring 5 Lead Setup Place the electrodes on the patient in the 5 lead configuration Leads I Il IIl aVL aVF aVR or V may be selected in the monitor s DISPLAY window Figure 4 10 Electrode Locations for 5 Lead Setup The V lead chest lead in a 5 lead configuration can be placed in six standard positions V4 J
23. Power Switch Genuity ay CRITICARE Menu Knob Figure 2 1 nGenuity 8100E Series Front Controls nGenuity 8100E Series Operator s Manual Page 2 1 Section 2 Controls and Connections Keypad There are nine 9 keypad buttons including the ON OFF key and the eight 8 dedicated function keys Some of the keys have two 2 functions The primary function is activated with a momentary press of the key A secondary function if present is activated when the key is pressed and held for two seconds Key On Off 76 Stand By NIBP Trend Freeze Print Default Silence 5 000 0000 Function Power key Press to activate the patient monitor and press and hold to turn the monitor off Press this key momentarily to enter standby mode Press the key again to exit the standby mode NIBP measurement start key Press the key again to cancel a NIBP measurement NIBP Cycle Stat Press the key momentarily to display the NIBP cycle popup menu on the screen Press and hold this key to begin a Stat measurement Displays the trend table when pressed momentarily Press the key to exit the trend window While the trend table is displayed press and hold to access the trend settings menu Freezes all waveforms on the screen Numerical parameters continue to be updated Press the key again to resume continuous waveform display Press this key to begin printing or serial output Press the key again to st
24. Scavenging Kit Exhaust Line amp Adapter ssusss 655 Scavenging Kit Exhaust Line amp Adapter International 655 l nGenuity 8100E Series Operator Manual Criticare Systems Inc Calibration Accessories Calibration Kits Other Accessories Available Criticare Systems Inc Appendix A Accessories Cal Gas 5 CO Balance No sssennn 621 Cal Gas 10 CO Balance No see 622 Regulator EE 623 Regulator Tube need eie EH Ee eese He oed lat 613 Cal Gas Aerosol 5 CO Balance No seeeeese 641 Cal Gas Aerosol 10 CO Balance No eene 642 CO only 15er RP Ode i eh ER aa aii 612 5 CO cylinder 1096 CO cylinder regulator with tubing plastic storage case Printer Paper 5 Rolls P N 40065B002 sess 553 FUS08 eere enne nennen nns P N 82013B002 Battery sssssssss enn nnns P N 80519B001 Adaptor Plate GCX Mounting sssusss P N 42194B001 GCX Wall Mount Does not include wall channel amp adaptor plate CT 0024 01B Adapter Plate GCX Monitoring eseeeeeeeeee 1081 Roll Stand and Adapter Plate reenen 1091 Gr s Hor i r PEE 1092 Power Cord Domestic US ssssssseee 989 Power Cord United Kingdom seeseesseeeee 989 UK Power Cord International 989 INT Power Cord Unt
25. Unit Defaults Replace all configuration and alarm settings with unit default settings SELECT EDIT CUSTOM DEFAULTS ACCEPT STD DEFAULTS STD DEFAULTS STD DEFAULTS STD DEFAULTS CANCEL Figure B 1 Set Unit Defaults Screen From this display press and hold the DEFAULT key again The nstall Configuration Defaults screen displays See Figure B 2 Install Configuration Defaults Screen Install Configuration Defaults Replace the current set of configuration defaults with a different set of defaults SELECT ACCEPT HOSPITAL DEFAULTS ALT CARE DEFAULTS CANCEL Figure B 2 Install Configuration Defaults Screen The nstall Configuration Defaults screen permits choosing which set of 5 defaults are available to the user Criticare Systems Inc nGenuity 8100E Series Operator Manual Page B 1 Appendix B Alternate Care Defaults The selection procedure works the same as in the previous screens 1 With the SELECT feature highlighted press the menu knob to select from HOSPITAL DEFAULTS to ALT CARE DEFAULTS or vice versa 2 Turn the menu knob to select ACCEPT The message Action Completed appears Press the menu knob to effect the change When the alternate care facility defaults ALT CARE DEFAULTS are installed the Restore Unit Defaults screen list the possible configuration settings for alternate care facilities with their descriptions See Figure B 3 Restore Unit Defaults The descriptions
26. above 85 the monitor automatically returns to the higher value each time the monitor is turned on This function cannot be disabled There is an alarm message generated if the SpO Low Limit is set to OFF The message LOW SAT OFF appears in yellow text in the Alarm Message Lines The monitor also displays the alarm bell icon in the lower right corner of the SpO numerical display box The bell icon is normally displayed when any SpOsz limit is turned off To check and ensure that the audible and visual alarm limit settings are operating as expected the user may do so by performing the following suggested procedure at least once a year 1 Apply power to the monitor Observe that all displays and LEDs illuminate 2 Place the SpO probe on your finger Allow readings to stabilize 3 Observe the pulse rate that is being displayed and adjust the low pulse rate limit to a value greater than the observed pulse rate value 4 Verify that the low pulse rate violation message is displayed on the LCD message bar and that the alarm tone sounds 5 Once verified return the low pulse rate or SpOs waveform limit to the previously set value or to one that is required for the patient to be monitored nGenuity 8100E Series Operator s Manual Page 5 5 Section 5 Alarms and Messages Alarm Message List Shared Source Alarms LOW PULSE RATE HIGH PULSE RATE ECG Alarms ECG LOST ECG RA LEAD OFF ECG LA LEAD OFF ECG LL LEAD O
27. adaa aaaea eaa araia ai nasa sana A 2 NIBP ACC SSOF GS 7 9 E E T E E E ETA Cuffs and HOSES cnt retten tev inet e dvi e A bla Disposable Cuffs Temperature Probes Reusable Probes Disposable Probes Gas Monitoring Accessories esses nnne nennen nennen A 4 Sampling Devices Calibration Accessories Calibration Kits sit ire co eire terere ee cree rete Ere N es EE ue e Other Accessories Available Publications Appendix B Alternate Care Defaults Alternate Care Defaults essent Configuration Settings for Alternate Care Facilities PARAMS Menu Settings PRINT Men Settings tied dt ise dne e ne nentes DISPLAY Menu Settings ALARMS Menu Settings Other Alarm Settings nGenuity 8100E Series Operator s Manual Criticare Systems Inc Contents Appendix C Arrhythmia and ST Analysis Arrhythmia and ST Analysis Software essssssseeeneeeenenenennn C 1 Description Srani EN Intended Use itr te ttt cete cr D inen td Compatibility Software Agreement Activation T Compliance Ses enaA a aa A RI eh os tensive died VM PO EcL Transient POWer reet teer teneat rer D Pena n ina dn C 3 Lead Off Detection C 3 Respiration O 8 Sudden Changes In Heart Rate O 8 Method of Analysis 5rd o ctctoustaretebarnexscesaceyaredesipesncsaatucgacedsveradhsoucststceetestorenes C 4
28. dried with a soft dry cloth It is best to use a cotton cloth to clean the monitor Paper towels or tissues can scratch the surface of the display Do not use full strength alcohol on the display screen Repeated use of strong cleaners can damage the screen Clean the display window by wiping it with a clean soft lint free cloth sprayed with common glass cleaner Do not spray glass cleaner directly on the display NCAUTION A Do not immerse any Criticare pulse oximeter sensor connector in any liquid Doing so may damage the connector e Functional testers for SpOs monitors and sensors are not currently capable of assessing the absolute accuracy of SpOs devices A functional tester that was specifically developed to reproduce the calibration curve of a particular pulse oximeter monitor and or sensor may be used for testing the reading repeatability of that particular pulse oximeter monitor and sensor The SpO sensor may be wiped clean with alcohol The SpO sensor may be disinfected by placing the paddles and cable in a 2 glutaraldehyde solution Place only the sensor paddles and cable in the solution nGenuity 8100E Series Operator s Manual Page 8 1 Section 8 Maintenance Blood Pressure Cuffs Page 8 2 The reusable blood pressure cuff may be cleaned by wiping it with a damp cloth or sponge If necessary the cuff may be disinfected by wiping with 7096 alcohol mild bleach solution or other disinfectant Disposable
29. gt 2 na na na na Disabled High Medium Low Medium Advisory Silent Medium Message Bigeminy na na na na Disabled High Medium Low Message Advisory Silent Medium Message Trigeminy na na na na Disabled High Medium Low Message Advisory Silent Medium Message PVC na na na na Disabled High Medium Low Message Couplet Advisory Silent Medium Message Irregular na na na na Disabled High Medium Low Message HR Advisory Silent Medium Message Arrhythmia na na na na Disabled High Medium Low Message Relearn Advisory Silent Medium Message Criticare Systems Inc nGenuity 8100E Series Operator Manual Page C 11 Appendix C Arrhythmia and ST Analysis Alarms Settings ST Setup Alarm Settings Alarm Priority Alarm Type Range Default Options Default ST High 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message STI Low 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message STI High 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message STI Low 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST III High 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST III Low 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory Silent Medium Message ST AVR High 6 to 6 Off 2 0 Disabled High Medium Low Disabled Advisory
30. monitor provides real time analysis and generates alert messages for several defined conditions The analysis program incorporates functions that determine heart rate identify QRS beats measure ST segment levels perform rhythm analysis detect ventricular ectopy and detect ventricular fibrillation ST elevation levels for lead Ill and augmented leads aVR aVL and aVF are derived from leads and Il The ventricular fibrillation detection algorithm processes ECG waveform in sections of 1 5 seconds Waveform sections are evaluated using time domain methods of analysis If three consecutive sections fail to pass linear relationship testing the waveform is flagged as ventricular fibrillation nGenuity 8100E Series Operator Manual Criticare Systems Inc Cautions and Warnings Criticare Systems Inc Appendix C Arrhythmia and ST Analysis NWARNING N Physiological variations in the patient population generate a nearly infinite range of possible ECG waveform morphologies In some cases the 8100E Series may occasionally not alarm or alarm inappropriately for some arrhythmia waveforms High risk patients must be kept under close surveillance The monitor does not report the presence of atrial or supra ventricular arrhythmia events The accurate measurement range for arrhythmia beat detection is 20 to 250 beats per minute The monitor reports ECG heart rates from 250 to 300 beats per minute only when the arrhythmia feature i
31. more information INCORRECT LINE FREQUENCY SETTING The filter does not reject interference properly in Monitor mode if the interference does not match the selected frequency Even though the frequency may be incorrect the interference amplitude in Monitor mode is some what lower than in diagnostic mode This gives the appearance that the filter is acting poorly ECG SENSITIVITY This setting controls the ECG signal gain If it is set too high the signal may exceed the valid range for monitoring If this should occur lower the sensitivity setting For general monitoring the medium setting should be used Monitoring Module On Off Some monitoring modules Temperature and Respiration can be Selection turned OFF or ON in the PARAMS softkey window The waveforms numerical parameters and messages for that module are not displayed The audible alarms associated with that module are also disabled The ON OFF setting or absence of a monitoring module may also affect the Smart Heart Rate function SpO Settings There are three settings specific to the SpO module Average Search Time and Color e SpO Average sets the duration of the interval over which the SpO value is averaged The settings for each are listed in seconds e SpO Search sets the time interval from the time the pulse signal is lost until the SpOo SEARCH message appears Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 3 11 Section 3 Setup Pr
32. of Accuracy N5O Compensation Temperature Measurement Criticare Systems Inc Section 1 Introduction The 8100E Series monitor has been calibrated with dry NIST traceable calibration gases at room temperature and pressure 21C 740mmH g Given the small effect of water vapor upon the CO measurement see CO Monitoring Capnography in Section 4 and the unit s built in temperature and pressure measurements and compensations this monitor s method of gas analysis is best described as ATPS Ambient Temperature and Pressure Saturated 21C 750mmHg 100 Humidity Saturated The monitor is suitable for sustained pressure breathing circuit monitoring environments and has been tested per clause 51 101 Measurement Accuracy of EN 21647 2004 The monitor has an internal barometer and thermistor that allow compensation for changes over a range of temperature and atmospheric pressures The monitor complies with EN 21647 standards for cyclical pressure and testing found negligible drift of accuracy The module as installed in the 8100E Series monitor has been clinically tested for performance with a variety of patients The monitor has a manual N2O compensation feature for a fixed NoO value of 60 The user may select N70 compensation when 40 80 N5O is in use Body temperature is measured by the monitor using a thermistor temperature sensing elements in the temperature probe The thermistor can sense change in body tempera
33. off When the monitor is taking an NIBP reading the MAP designation becomes a CUFF designation to indicate that a reading is in progress When the reading is completed the CUFF designation returns to MAP CYCLE OFF 1 4 9 1 6 127 gt lt AGE 00 10 min SYS DIA TEMPERATURE BOX OF The temperature numerical box is dedicated to the temperature X channel The units F or C appear in the upper right corner of the 9 7 7 box A bell icon appears below the unit label if an alarm limit is set to e OFF Page 2 14 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Main Menu Alarm and Message Areas System Status Box Criticare Systems Inc Section 2 Controls and Connections The main menu area is directly under the help NIBP box on the left hand side of the screen There are up to six 6 selectable soft keys located on the screen as shown below ALAR PARAMS DISPLAY ADM DIS CONFIG PRINT Figure 2 10 Main Menu One of the six 6 softkeys is always highlighted If the user pushes the rotary knob any window associated with the highlighted softkey is displayed and the rotary knob control goes to that new window Different soft keys are selected by turning the rotary knob clockwise or counterclockwise until the desired key is highlighted When the softkeys are not being accessed they disappear from the screen after 45 seconds if inactivity Turn or push the rotary knob to display the s
34. patents and does not convey any license under the patent rights of Criticare Systems Inc nor the rights of others Criticare Systems Inc does not assume any liability arising out of any infringements of patents or other rights of third parties PROPERTY OF CRITICARE SYSTEMS INC ALL RIGHTS RESERVED nGenuity Vital Signs Monitor DOX Digital Oximetry ComfortCuff NIBP and Multi Site SpO Sensors are trademarks of Criticare Systems Inc Page ii nGenuity 8100E Series Operator s Manual Criticare Systems Inc Contents Soler EE ii Contents iii Warranty s Service Return Policy essen xii EC Declaration of Conformity esssssssseseeeeneeenenne nennen xiii Section 1 Introduction BIETET Srle E TC DRE 1 1 Irntended Use retire eterne ten re re tt ceteri t rho ener rent 1 1 nGenuity 8100E Series Options enne 1 1 Pulse Oximetry Measurement SpO eseeeeeeeneneneneen enn 1 2 Definition A DOX Digital Oximelty 1 eea ar orae aa aa Menge HORE 1 2 Methodi irimia aa aeaea E S EAEE A Ee Ee TAE a E 1 2 SpO Clinical Testing and Accuracy Heart Rate ECG Measurement S bin Mec T E a E E Stability Of ACCUraCy iiic riter pest eigen aE E E aeration Pacemaker Pulse Rejection Respiration eeeeeeene Non Invasive Blood Pressure NIBP x Comfort Cuff M Technology
35. the inflation bag in the cuff nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 8 Maintenance Temperature Cable Clean the cable according to hospital protocol for cleaning of reusable equipment cables Typically this protocol consists of the following 1 Disconnect the cable from the monitor and temperature sensor 2 Wipe the cable with a nonabrasive cloth moistened with a mild detergent and warm water or a disinfectant Dry thoroughly 3 Do not use alcohol or solvents to clean the cable 4 Do not allow the cable connectors and contact points to come in contact with liquids 5 Do not fully immerse the cable in liquids 6 Do not autoclave or EtO sterilize the cable Temperature Sensors Refer to the manufacturer s guidelines for cleaning disinfecting and sterilizing the temperature sensors Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 8 3 Section 8 Maintenance Accidental Wetting Page 8 4 NWARNING Shock Hazard The monitor is an AC powered device and an immersed monitor presents a danger to anyone who handles the device The action to be taken following accidental wetting of the equipment is as follows 1 Turn the power off Disconnect the AC power cord from the monitor If monitoring a patient transfer the patient to another monitor as quickly as possible Use a clean dry towel or cloth to remove the liquid from the monit
36. type is set to Tabular a demand tabular print is issued using the frozen numeric vital signs data on the screen After displaying a trend on the 8100E Series screen by pressing the TREND key pressing the PRINT key causes a trend print of the data displayed on the screen Pressing and holding the PRINT key while a trend is displayed on the monitor s screen causes all of the stored Trend data to print out The monitor must be set to internal printer for trend printing The trend data is not sent to the serial port nGenuity 8100E Series Operator s Manual Criticare Systems Inc Print Formats Tabular Printing Criticare Systems Inc Section 7 Printing and Data Ports The internal thermal dot matrix printer is capable of printing vital signs parameters in tabular text or graphical waveforms Select the printout format in the PRINT softkey menu A header is printed containing the monitor model the operating software revision the time and date and the patient information The title for each parameter follows Numerical values for all current parameters are printed The sample below shows a tabular print out CSI 8100E Series Rev 1 1 2 14 06 4 38 10 NAME SMITH JOHN D 12345678 Room number 100 2 14 06 04 38 10 HR ECG 60 BPM Sp02 98 RESP ECG 20 Br m TEMP 96 4 F NIBP 04 30 22 135 95 115 mmHg GAS EXP INS C02 5 0 3 0 kPa 12 14 06 04 38 16 HR ECG 60 BPM Sp02 98 RESP ECG
37. value is to initiate a Low SpO2 Alarm This value is set in the ALARMS menu CO2 BOX This box displays numerical values for the inspired and expired CO The label EXP stands for expired end tidal CO and INS stands for inspired COs The current units for CO display in the upper right corner nGenuity 8100E Series Operator s Manual Page 2 13 Section 2 Controls and Connections NIBP BOX The NIBP numerical box is located below the waveforms It displays the systolic diastolic and mean pressure after a NIBP reading has completed The systolic and diastolic values are shown in large text The mean value MAP is displayed to the right of the systolic and diastolic values in smaller characters MAP values are shown in parenthesis MAP mmHg CYCLE OFF 149 106 127 x AGE 01 00 When there is no valid reading dashes are displayed A valid reading is dashed after 30 minutes If a valid reading is being displayed the age of the reading is displayed After 30 minutes the age of the measurement goes to dashes if there is no valid reading the age also appears as dashes If a cycle time has been set the interval is displayed Otherwise the cycle time displays the word OFF in the NIBP box If a cycle time is active the amount of time remaining until the next NIBP reading is scheduled is displayed at the bottom right of the box Also a bell icon is displayed on the right side of the box to show if any NIBP alarm limit is set to
38. when using AC mains power Orange Battery is charging Green Battery is fully charged Yellow Battery is weak lt 30 min of charge remain Black Battery is nearly drained 15 min of charge remain When the battery icon is yellow or black the internal printer does not function Recharge the battery and or connect the monitor to AC before attempting to use the printer When the icon is black the monitor cannot perform NIBP readings Recharge the battery and or connect the monitor to AC before attempting to take NIBP readings While using battery power there is a short delay between a change in battery status and the updated display of the battery icon If the monitor is currently operating under AC power the monitor may take up to two minutes to display a change in battery status nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 3 Setup Procedure ress the power ey located at the top of the front contro System Start and P h ON OFF key datth f the f Auto calibration panel to start the monitor Immediately upon power up the monitor displays the title screen with the CSI logo The software revision appears in the lower left corner of the splash screen The monitor also activates a paper feed if the monitor has an internal printer e The informational message NO ADMIT displays indicating that no patient is currently identified for wireless or network communication purposes Communica
39. 0 to 40 BPM or from 80 to 120 BPM Heart Rate will be displayed on the 8100 heart rate display in ten seconds or less tested per AAMI EC 13 Clause 4 1 2 1 f 105 BPM ascending rate target 54 BPM descending rate target Time to alarm when the ECG input changes from an 80 BPM normal sinus rhythm to a 180 BPM ventricular tachycardia Hi Alarm 100 BPM is less than five seconds The waveform specified in AAMI EC 13 Figure 3a 80 BPM ventricular bigeminy when applied to the 8100 displays as 80 BPM Waveforms b c amp d from Figure 3 in EC 13 have not been applied to this product Criticare Systems Inc nGenuity 8100E Series Operator Manual Page C 3 Appendix C Arrhythmia and ST Analysis Method of Analysis Page C 4 The analysis feature is provided by means of a software plug in designed to work directly with the ECG module of the nGenuity 8100E Series monitor The ECG waveform is digitized in the ECG module and the signal is made available to the main processor where itis analyzed The analysis feature also provides additional digital filtering of the ECG waveform The displayed heart rate is based upon a 32 beat average of the R to R interval During periods of rapid changes in the heart rate a 4 beat average displays until the change subsides and the 32 beat average then resumes P R Segment S T Segment m Q T Interval P R Interval Figure C 1 Deflection Points on ECG Lead Il The
40. 10 15 30 60 minutes 2 4 8 12 24 hours Graphical Tabular Serial 6 12 18 24 seconds 6 12 seconds ECG I II IIl V aVR aVL aVF Resp PLETH ET CO2 Off X0 5 x1 0 x2 0 x4 0 ECG I Il Ill V aVR aVL aVF Resp PLETH ET CO2 Off x0 5 x1 0 x2 0 x4 0 12 5 25 0 50 0 mm sec Off Tabular TEXT CSV CUSP 2400 4800 9600 19200 38400 57600 HI SPEED Factory Default MM DD YYYY Not Applicable Not Applicable 2 min On English By Destination No No No Adult Factory Default Graphical Off Off Off Tabular 6 seconds 6 seconds ECG II x1 0 PLETH x1 0 25 0 mm sec Tabular CUSP 38400 1 20 seconds only available if Internal Print Type is set to Serial nGenuity 8100E Series Operator s Manual Page 3 29 Section 4 Patient Monitoring Introduction to Clinical Use Before you Begin Criticare Systems Inc This section provides instructions for patient connections and monitoring The caregiver is expected to be fully familiar with patient monitoring techniques and with the functions of this monitor before using it with a patient Protect yourself and your patient Read the precautions for each measured parameter that appears in this section These instructions describe use of the basic sampling devices and accessories that come with your monitor An extended list of approved accessories can be found in Accessories in Appendix A The monitor should alway
41. 10 foot long CAT 518DD reusable extension cable nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring SpO Sensor Placement Apply the sensor with the LED lights positioned on the nail side of the finger and the detector on the fleshy portion of the finger Do not tape over the pulse oximeter sensor housing Taping over the housing may cause injury and sensor failure due to excessive pressure If the sensor needs to be secured place tape over the cable immediately behind the sensor Figure 4 2 Finger Sensor Placement The sensor must be properly positioned for a plethysmographic waveform to appear Placing tape too tightly around an extremity reduces blood flow thus diminishing the amplitude of the plethysmographic waveform If possible do not place the pulse oximeter sensor on the same extremity as the blood pressure cuff or an arterial line Place the pulse oximeter sensor on the side of the patient opposite the blood pressure cuff or an arterial line The occlusion of the blood flow during blood pressure determinations could affect saturation readings The pulse oximeter sensor is light sensitive Too much ambient light makes it difficult for the system to provide accurate readings The system provides a high ambient light alarm message when it is necessary to shield the sensor from extraneous light sources such as phototherapy light or infrared heating lamps Criticare Systems
42. 2 Elbow Ventilation Adapter Setup The monitor automatically begins an auto calibration sequence when powered up During this time the monitor may display a flat capnogram When the calibration and warm up sequence is over the system message disappear and normal operation begins nGenuity 8100E Series Operator s Manual Page 4 23 Section 4 Patient Monitoring Page 4 24 Procedure for Gas Monitoring Occlusions Anesthetic Gas Exhaust Recovery 1 Check the settings of N5O Compensation in the PARAMS window 2 Slide the WaterChek trap into the monitor s gas receptacle The Attach a scavenging line to the rear exhaust port if anesthetic agents are being used A waste gas recovery system should be used Attach a sample line to the Luer fixture located on the front of the WaterChek trap Make sure there are no kinks or other obstructions in the line extending from the trap Attach a patient sampling device to the sampling line Use either a nasal cannula mask or ventilation tube adapter Replace sampling devices lines and water traps if they become blocked or filled monitor displays a visual message CO2 OCCLUSION if the gas sampling system is blocked If the sampling line or water trap becomes partially blocked the item should be replaced Always use an exhaust gas recovery system when using anesthetic gases Scavenging kit Cat No 655 can be used to connect the monitor to a g
43. 300 bpm ECG Pleth 30 240 bpm NIBP 20 300 bpm ECG Pleth 30 240 bpm NIBP 1 bpm or 1 unspecified gt 250 bpm Il Ill aVR aVL aVF V greater of 0 2 mm or 5 16 beat average 6 0 mm to 46 0 mm 0 1 mm Rates from 2 to 255 per minute Runs 2 to 6 Adjustable range 90 to 200 bpm Heart Rate Asystole Tachycardia Ventricular Fibrillation Bradycardia Ventricular Tachycardia Numerical PVC Rate ST elevation numerics for 3 leads Up to 6 ECG waveforms selectable 3 leads recorded in waveform slots Time Scales 5 10 25 30 60 minutes Vertical Scale 1 mm to 6 mm ST4 STI ST III ST AVR ST AVL ST AVF ST V PVC Rate Page C 6 nGenuity 8100E Series Operator Manual Criticare Systems Inc Appendix C Arrhythmia and ST Analysis Interface Screens The analysis extension uses the same interface and controls as the standard ECG feature of the monitor The heart rate numerical box is modified to provide main screen display of ST segment elevations and PVC rate An additional configuration is available for waveform slot 2 and 3 that allows display of historical ST segment elevations for three selectable lead views BPM 60 x ECG LEADS OFF 20 98 Low Sp02 Alarm 90 BP CHECK CUFF ST II 1 5 I 2 0 mm V 1 0 m PVC Rate 2 min MAP mmHg CYCLE OFF 149 106 127 x AGE 01 00 OF SPO2 SENSOR ALARMS PARAMS DISPLAY Q0 NO ADMIT 97 7x ADM DIS CONFIG PRINT rs Adult AU
44. 5 30 min 1 2 4 hrs NIBP user selectable 2 4 8 12 or 24 hours BPM HR SpO Temp Resp NIBP Systolic Diastolic Mean Internal thermal line printer Single or dual waveform Tabular 12 5 or 25mm sec continuous Snapshot at 50mm sec 10 4 active color TFT 640 x 480 pixels 6 maximum 0 5x 1x 2x 4x user selectable 6 25 12 5 25 or 50 mm sec selectable 9 membrane activated Push and rotate 24 steps turn English French German Portuguese Spanish Italian Russian RS 232 compatible digital DB9 COM 1 Mini DIN8 COM 2 Contact switch audio jack 1 8 inch 24V Q 100 ma maximum switching BNC connector Serial VGA Compatible Criticare Systems Inc Criticare Systems Inc Mechanical Electrical Weight Size Mechanical Shock Vibration Power Requirements Voltage Number of Batteries Battery Life Recharge time Environmental Operating Temperature Storage Temperature Operating and Storage Humidity Medical Device Electrical Protection Degree of Protection Protection against ingress Altitude Section 1 Introduction 13 2 Ib 6 kg no CO2 14 Ib 6 4kg with CO2 11 0 H x 13 0 W x 10 3 D 28 0cm H x 33 1 cm W x 26 2cm D No affect when tested to IEC 60068 2 27 standards No affect when tested to IEC 60068 2 64 standards 35W typical 100 240 VAC 50 60 Hz 1 sealed lead acid batteries 3 hr typical w o CO2 2 5hr typical w CO2 4
45. 5 hours 50 104 F 10 40 C 23 122 F 5 50 C 15 to 90 non condensing Class II Equipment Ilb EU Class Equipment Type CF Defibrillator Proof IPX1 1 000 10 000 feet All specifications are subject to change without notice Specification related to the ST and Arrhythmia option are found in Specifications in Appendix C nGenuity 8100E Series Operator s Manual Page 1 13 Section 1 Introduction Symbols Symbol Page 1 14 nGenuity 8100E Series Operator s Manual Definition Refer to Operator s Manual for Information Shock Hazard Equipotential Terminal European Community Mark Electrical Testing Laboratories ETL Mark Do not dispose of in municipal waste Wheeled bin symbol indicates separate collection for electrical and electronic equipment WEEE Directive 2002 96 EEC Type CF Equipment defib proof Identifies the degree of protection against fluid as drip proof Input Output port Output only port Alarm port Nurse call External display port Criticare Systems Inc Criticare Systems Inc Symbol gle l a jala A Section 1 Introduction Definition Fuse Gas Scavenging Port Air Intake Alternating Current AC Technical Support Phone Number Serial Number Part Reference Number Placement of cuff over the brachial artery Blood Pressure Cuff Single use device only Do not reuse Recyclable cardboard paper packaging
46. Arrhythmia and ST Analysis Compliance This analysis software has been developed using a real time ST and arrhythmia analysis data base Analysis features have been developed in accordance with its quality control practices and procedures in place to review potential hazards as they relate to software The combined capability of the integral ECG module and the analysis software comply with EC 60601 2 27 ECG Safety Standards Transient Power The nGenuity 8100E Series monitor has been tested with AC power line transients per the levels specified in EN 60601 1 2 AC power line transients in excess of EN 60601 1 2 limits may affect the proper operation of this device If interference from the power line or ground is suspected this can be confirmed by unplugging the monitor and running on the internal battery Power line transient interference is likely to disappear while running on battery Lead Off Detection Lead off detection in the 8100E Series monitor applies the following possible range of signals to the electrodes 20 V DC Max w No load across electrodes 0 05 uA Max LA RA LL V w Electrode shorted to RL 0 20 uA Max RL w Four electrodes shorted to RL Respiration The trans thoracic impedance respiration circuit generates a 65 kHz sinusoidal waveform across the respiration electrodes with an amplitude of 0 356 V peak peak 0 712 mA 500 ohm impedance between lead wire connections Sudden Changes In A step change in heart rate from 8
47. CG specifications The variable gain control is x200 x400 or x800 according to the ECG Sensitivity setting The propagation delay is 1000 milliseconds The accuracy of the synchronizing pulse amplitude is equal to 500 times that of leadview II The pulse shape and duration match those of leadview II The output impedance is 1000 ohms and propagation delay is less than 6 6 milliseconds Pacemaker Pulse Rejection With the pacemaker detector turned ON in the 8100E Series the system detects and rejects pacemaker pulses ranging from x2 to 700 mV amplitude and 0 1 to 2 0 ms duration Heart rates properly display over this range of pacemaker operation Pacer pulse markers are present if pace detect is on and appear in the ECG analog output as narrow positive spikes at the point of pace detection NCAUTION A Ambient noise sources may induce artifactual triggers of the pacemaker pulse detector and display Respiration Respiration is measured via the ECG electrodes The ECG uses the impedance measurement based off of lead Il When determining respiration from the ECG the monitor measures patient respiration by impedance pneumography As the patient s chest changes size and shape during inspiration and expiration the resistance between two chest or abdomen ECG electrodes changes Respiration rate is calculated from this change in resistance The user may select ECG which uses the impedance measurement based off of the lead or the CO
48. DOX technology to measure blood oxygen saturation SpO Hemoglobin exists in the blood in several forms e Oxygenated Oxyhemoglobin Reduced Deoxyhemoglobin Dyshemoglobins carboxyhemoglobin and methemoglobin In the monitor SpO pulse arterial oxygen saturation is the ratio of oxygenated hemoglobin to the sum of oxygenated hemoglobin plus hemoglobin which is available for binding to oxygen as expressed in the following formula ercent oxygen saturation 2 ee ees x 100 P yg oxyhemoglobin deoxyhemoglobin Dyshemoglobins such as carboxyhemoglobin and methemoglobin are not directly measured and therefore are not factored into the measurement The monitor does not use analog circuitry for signal processing Digital signal processing in the microprocessor results in lower noise from circuitry components resulting in a cleaner signal and better performance under low perfusion conditions There is also improved rejection of noise from the patient and environment due to the availability of the true unfiltered sensor signal for digital signal processing The digital pulse oximeter measures oxygen saturation and pulse rate using the principles of spectrophotometry and plethysmography The sensor is completely non invasive and there is no heat source that could burn the patient The pulse oximeter sensor contains two types of LEDs Each type emits a specific wavelength of light Since oxygenated hemoglobin and de
49. E Series Operator s Manual Page 4 15 Section 4 Patient Monitoring NWARNING A Check the patient frequently to ensure the NIBP cuff is not causing prolonged impairment of the patient s circulation NCAUTION A The accuracy of noninvasive blood pressure readings may be adversely affected by the presence of drugs or therapies which alter the patient s cardiovascular dynamics The sensitivity of blood pressure measurement may be affected when monitoring patients with intra aortic balloon pumps Selecting Cuffs and Hoses This monitor works with Criticare blood pressure cuffs and hoses only Using the monitor with other brands of cuffs may cause inaccurate measurements Proper cuff size and placement is essential to assure accurate blood pressure measurement The recommended cuff width to length ratio is about 2 1 so that if the cuff width is 4096 of arm circumference the cuff bladder length encircles 80926 of the arm A cuff that is too narrow results in falsely high pressure readings A cuff that is too wide results in falsely low pressure readings The cuff shown below on the left is too small for the arm therefore full cuff pressure is never applied to the artery This causes an erroneously high blood pressure reading The cuff shown on the right is of adequate width for the arm and full cuff pressure is applied to the brachial artery Figure 4 14 Blood Pressure Cuff Size Page 4 16 nGenuity 8100E Series O
50. FF ECG V LEAD OFF ECG LEADS OFF Respiration Alarms LOW RESP HIGH RESP RESP LOST ESU RESP OFF RESP IMPED HIGH RESP ERROR Page 5 6 Included here is a list of messages alerts and alarms that may appear in the waveform slots or in the system message lines of the display Alarms and messages for heart rate may be generated by the ECG SpOs or the NIBP module Priority Description High The heart rate value has dropped below the value set in the ALARMS menu High The heart rate value has exceeded the value set in the ALARMS menu Priority Description High The ECG signal is too low in amplitude Check electrodes lead wires and cables If necessary change to a different lead High Med Low The right arm lead is off Reconnect the lead High Med Low The left arm lead is off Reconnect the lead High Med Low The left leg lead is off Reconnect the lead High Med Low The chest lead is off Reconnect the lead High Med Low The ECG leads are off Either the right leg is off or there is more than one lead off Check the lead s Priority Description Medium The respiration value has dropped below the value set in the ALARMS menu This can be generated from the COs or the ECG module Medium The respiration value has exceeded the value set in the ALARMS menu This can be generated from the CO or ECG module Medium Unable to determine a respiration from the impedance ECG respiration data Medium The unit d
51. G 07 05 14 12 59 Figure C 2 Main Screen Display Criticare Systems Inc nGenuity 8100E Series Operator Manual Page C 7 Appendix C Arrhythmia and ST Analysis Setup Windows ALARMS Select Other Alarms Setups from the ALARMS menu to access the two additional settings windows for ST and Arrhythmia The arrhythmia alarms window will not be available if arrhythmia is turned OFF in the PARAMS menu Select Arrhythmia Setup to set the alarms for arrhythmia EXET Alarm Volume 5 ECG Lead Fail MEDIUM Patient size Adult HIGH Heart Rate 150 Sp02 OFF NIBP Systolic 200 NIBP Diastolic 100 NIBP Mean 150 Temperature F 100 0 Respiration 36 CO2 Inspired kPa 1 5 C02 Expired kPa 75 1 45 Apnea 60 seconds Other Alarm Setups Arrhythmia Setup Figure C 3 Select Arrhythmia Setup Alarm priorities that appear in yellow are fully adjustable Asystole VFIB and VTACH are permanently set to high priority EXIT UNITS HIGH LOW ALARM PRIORITY Heart Rate BPM 150 40 HIGH PVC Rate min 2 DISABLED PVC Run 2 DISABLED Asystole HIGH VFIB HIGH VTACH in HIGH VT gt 2 MEDIUM Bigeminy MESSAGE Trigeminy MESSAGE PVC Couplet MESSAGE Irregular HR MESSAGE Arrhythmia Relearn MESSAGE lt lt lt BACK Figure C 4 Extended ALARMS Window for Arrhythmia Page C 8 nGenuity 8100E Series Operator Manual Criticare Systems Inc Criticare Systems Inc Appendix C Arrhythmia and ST Analysis Select ST Setup to set the alarms for arrhy
52. G and an SpO waveform The top waveform information appear in the upper right corner of the printout The lower waveform information appears directly below the waveform in the right corner The examples above are the shortest printed waveform views available Longer printouts can be configured in the print menu nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 7 Printing and Data Ports Mini Trend Printing The monitor can print out the Mini Trend display To print a Mini Trend Criticare Systems Inc report 1 Press and hold the PRINT key with Mini Trends displayed 2 The Mini Trends print out in a strip from the serial printer The units of measurement display after the parameter values e Alarms are recorded with an asterisk Source for Heart Rate and Respiration is noted with a letter after the parameter value See Mini Trends in Section 3 Mini Trend prints will include up to 52 of the most recent records stored 14 30 HR 60E 60E 60E 60E 60E 60E 60E 60E 60E 60E 60E 60E 60E Sp02 98 98 98 98 98 98 98 98 98 89 98 98 98 130 125 120 125 130 135 130 125 120 125 130 135 130 NIBP 90 85 80 85 90 95 90 85 80 85 90 95 90 110 105 100 105 110 115 110 105 100 105 110 115 110 mmHg mmHg mmHg mmHg mmHg mmHg mmHg mmHg mmHg mmHg mmHg mmHg
53. Inc ST and Arrhythmia Alarm Description Alarm Conditions Criticare Systems Inc Appendix C Arrhythmia and ST Analysis Many of the alarms listed below have adjustable alarm priority levels The options are high medium silent medium low advisory and informational message The message level priority is the same as the informational level messages generated by the system software Message level alerts have no audible component Activation of arrhythmia and ST Analysis feature adds two new alarm categories that are not associated with the standard features of the 8100 monitor Medium level alarms without an audible component and advisory level alerts are selectable alarm level options for ST and arrhythmia alarms Advisory level alerts have the same visual component as informational messages but also include a tone Each advisory level audible burst consists of 2 pulses The frequency is 300 Hz and the repeat cycle is approximately 5 minutes The pitch of the advisory level tone is lower than the high medium and low level alarms discussed in Alarms and Messages in Section 5 The ST segment elevation must be beyond the alarm limits for at least 60 consecutive seconds before the alarm is activated Conversely the ST segment elevation must be within the alarm limits for another 60 seconds before the alarm is cleared NCAUTION A ST elevation conditions must exist consecutively for one minute before an ST elevatio
54. LENCE key is provided on the front panel of the monitor SILENCE 2 MINUTES Pressing the SILENCE key momentarily begins a 2 minute alarm silence The alarm icon appears in the System status Line followed by the phrase 2 min in white text New high and medium level alarms end the 2 minute silence when the alarm condition occurs Pressing the SILENCE key a second time ends the silence condition and normal alarms resume nGenuity 8100E Series Operator s Manual Page 5 3 Section 5 Alarms and Messages 200 Audible Alarms Disabled Warning Tone Alarm Volume Minimum Volume Auto Reset Standby Mode Page 5 4 PERMANENT SILENCE Press and hold the SILENCE key to permanently silence the alarms The alarm icon appears in the System Status Line followed by an infinity symbol Notice that the long key press tone occurs after holding the key in for two seconds confirming that permanent silence was selected NCAUTION A Note that future alarms are also silenced and do not end the silence condition This includes the silence of alarms at a higher level than the original condition Pressing the SILENCE key a second time ends the silence condition and normal alarms resume During a permanent alarm silence condition and when this safeguard is activated an Audible Alarms Disabled Warning Tone occurs when a new high or medium level alarm is generated The tone is a low pitched double beep the same as the long key press ton
55. M a ee aa Low Sp02 Alarm 90 CYCLE OFF MAP habe AGE 21 13 min 149 106 127 SP02 SENSOR Ri ALARMS PARAMS DISPLAY Xx ADM DIS CONFIG PRINT m Ast T 96 4 AUG 16 05 14 12 59 Figure 3 9 Cascaded Slots Displayed Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 3 15 Section 3 Setup Procedure Gain and Sweep Mini Trends Setting Mini Trend Page 3 16 The GAIN and SWEEP settings found in the DISPLAY menu can also be used to modify the way waveforms are displayed on the screen The upper three 25mm slots of the display allow for larger waveforms to be displayed Gain settings from the upper set of slots do not correspond to the gain settings of the lower three slots In order to obtain identical waveform sizes in the top and bottom slots set the gain of the lower three slots one step higher than the top three slots A minimum of four and a half seconds worth of data at a sweep speed of 25mm per second is displayed Waveforms can have sweep speeds of 50 25 12 5 or 6 25 mm per second Monitors with software version 1 2F and newer have the ability to display episodic trend data in a MINI TREND feature This display can be configured so that Waveform 3 or Waveform 4 can be set to MINI TREND This feature updates and displays trend records in waveform slots in either 3 through 6 or slots 4 through 6 Waveform display in waveform slots 4 through 6 is disabled when MINI TREND is set Wavefor
56. Medium On F 12 20 mmHg Off None ST selection present for all monitors but only functional if the monitor has the ST Arrhythmia option nGenuity 8100E Series Operator s Manual Page 3 27 Section 3 Setup Procedure Page 3 28 Display Settings Setting Waveform 1 Type Gain Sweep Size Waveform 2 Type Gain Sweep Size Waveform 3 Type Gain Sweep Size Waveform 4 Type Gain Sweep Size Waveform 5 Type Gain Sweep Size Waveform 6 Type Gain Sweep Size External Display nGenuity 8100E Series Operator s Manual Selectable Options Factory Default Lead I Lead II Lead Ill Lead V ECG Il Lead avL Lead avR Lead avF and Off 0 5x 1x 2x or 4x 1x 6 25 12 5 25 or 50 mm per second 25 mm per second 25 or 50 mm 25 mm Lead Lead II Lead III Lead V Cascade Lead avL Lead avR Lead avF Resp Pleth Cascade BxB ET CO2 and Off 0 5x 1x 2x or 4x 1x 6 25 12 5 25 or 50 mm per second 25 mm per second 25 or 50 mm 25mm Lead Lead II Lead III Lead V Cascade Lead avL Lead avR Lead avF Resp Pleth Cascade MINI TREND BxB ET CO2 and Off 0 5x 1x 2x or 4x 1x 6 25 12 5 25 or 50 mm per second 25 mm per second 25 mm 25 mm Lead Lead Il Lead III Lead V PLETH Lead avL Lead avR Lead avF Resp Pleth Cascade MINI TREND BxB ET CO2 and Off 0 5x 1x 2x or 4x 1x 6 25 12 5 25 or 50 mm pe
57. NT Password Protection Page 3 22 This softkey allows access to the configuration settings When activated a configuration settings window appears EXIT Date Format DD MM YYYY DA MONTH DEC YEAR 2006 17 47 Freeze timeout 2 minutes Alarm tone warning ON Language ENGLISH Line Frequency 60 Restore Factory Defaults NO Enter Service Mode NO Enter Simulation Mode NO Patient Size Adult Figure 3 13 System Configuration Window This window contains settings that are related to the general function of the overall monitor The window also has some settings that may affect physiological monitoring Several settings on the CONFIG screen are password protected These are functions that generally should not be changed during use and their settings should be adjusted by biomedical technicians or supervisory personnel These include Alarm Tone Warning Line Frequency Enter Service Mode and Enter Simulation Mode Contact your CSI dealer or the CSI Service Department for service passwords NCAUTION A The Alarm Tone Warning setting can permanently disable alarm functions See Alarms and Messages in Section 5 for more information on Alarms e The Line Frequency setting affects the ECG and SpO filter function See INCORRECT LINE FREQUENCY SETTING in this section The Heturn to Factory Defaults setting may make changes affecting all of the physiological monitoring modules Service mode and Simul
58. Page 3 4 During setup the monitor may attempt to calibrate the capnometer The internal capnometer has unique calibration warning messages as described below Monitoring modules such as the internal capnometer require an initial auto calibration at power up A short warm up period may also be necessary in very cold start up conditions CO monitoring and associated audible alarms are suspended during auto calibration The auto calibration cannot be canceled during initial power up Approximately five 5 seconds after power up the monitor performs an auto calibration lasting about 10 seconds NOTE This does not occur for monitors that do not have the CO module or when the module is turned off in the PARAMS menu The message CO2 ZEROCAL appears on the display during calibration The monitor then automatically begins monitoring CO values if the CO module is turned on in the setting and provided a breath is detected nGenuity 8100E Series Operator s Manual Criticare Systems Inc Softkey Functions Main Menu Changing Settings Criticare Systems Inc Section 3 Setup Procedure Softkeys are selected by turning the rotary knob clockwise or counterclockwise until the desired softkey is highlighted In the sample below the ALARMS softkey is highlighted indicating that the alarm settings window will be displayed if the menu knob is pressed ALAR PARAMS DISPLAY ADM DIS CONFIG PRINT Figure 3 1 Main Menu
59. SpO sensor is missing or defective Connect or replace the sensor The monitor has detected a fault with the SpOs function Contact the CSI Service Department The module cannot find a pulse in SpO signal The SpO low limit has been set to OFF in the ALARMS menu Description The temperature value has dropped below the value set in the ALARMS menu The temperature value has exceeded the value set in the ALARMS menu Temperature probe is not connected Temperature reading is not valid Temperature probe is defective Temperature reading is out of range Check probe position Temperature module is out of calibration Contact the CSI Service Department The monitor has detected a fault with the temperature module Contact the CSI Service Department Page 5 7 Section 5 Alarms and Messages NIBP Alarms BP LOW SYS BP HIGH SYS BP LOW DIA BP HIGH DIA BP LOW MAP BP HIGH MAP BP CHECK CUFF BP ERROR BP LO PULSE AMP BP MAX PRESSURE BP MAX TIME BP NO DEFLATE BP NOT TAKEN BP CALIB ERROR BP PLEASE WAIT Page 5 8 Priority Medium Medium Medium Medium Medium Medium Low Low Low Low Low Low Low Low Informational nGenuity 8100E Series Operator s Manual Description The systolic value has dropped below the value set in the ALARMS menu The systolic value has exceeded the value set in the ALARMS menu The diastolic value has drop
60. Systems Inc Section 4 Patient Monitoring NWARNING N e Skin abrasion and tissue burn hazard Separate the monitor and temperature cables from electrocautery systems keep both active and ground electrodes of the electrocautery system in close proximity so that the temperature sensor is outside the radio frequency current field The esophageal rectal sensors are not recommended for use with neonates and small infants undergoing tracheostomy or internal jugular artery catheterization and laser surgical procedures Possible airway obstruction hazard with esophageal sensors when accompanied by tracheal or bronchial intubation Using Temperature Skin surface temperature monitoring is intended for the detection of Accessories hypothermic and hyperthermic conditions The skin temperature Criticare Systems Inc sensor is designed for placement on the surface of the skin only This sensor consists of a thermistor affixed to an adhesive layer of material covered by a metallic film The sensor design provides accurate measurement of surface body temperature See Sensor Package insert for detailed information To insure the proper performance of the temperature accessories follow the precautions listed below Forced mating of the connectors without proper alignment may cause damage to the connectors and interruption in electrical continuity Pulling the cable cord may cause interruption in electrical continuity Grasp cab
61. The monitor s SpO connection accepts any DOX compatible SpO s sensor using the DB 9 connector Page 4 2 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Criticare Systems Inc Section 4 Patient Monitoring NWARNING The sensors and sensor extension cables are intended to be used only with the monitors specified for those sensors The user must verify the compatibility of the monitor sensor and cable prior to use otherwise patient injury may result If the SpO reading drops to 83 check the cable connections for proper connections and the SpO accessories for damage NCAUTION A The pulse oximeter sensor may cause skin irritation and pressure necrosis Inspect the pulse oximeter sensor site every two to four hours or per hospital protocol Move the sensor to a different location if skin irritation is present Excessive amounts of motion at the sensor sites may cause errors in reading Attempt a reading when motion has stopped or move the sensor to another site Ensure the sensors used are the sensors specified for the monitor See Sensor Selection in this section for approved sensors Initial SpOs readings on a patient in the range of 81 84 are related to an input signal which is equivalent in the Red and Infrared AC low level monitoring channels This type of signal may be indicative of a high ambien
62. Vo Figure 4 11 Electrode Locations for the V Lead Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 4 11 Section 4 Patient Monitoring Electrode Application Proper skin preparation is essential for ECG monitoring Before applying the electrodes remove natural skin oils by abrading the site with an alcohol pad Dry the area with gauze or a towel If the electrodes do not adhere well apply benzoin to the area before applying the electrodes Benzoin helps prevent skin breakdown and enhances electrode adhesion 1 Check the cables for fraying or other deterioration 2 Attach the ECG cable to the monitor 3 4 Start the monitor and confirm that it is functioning properly Set Attach the electrodes to the ECG cable the monitor to display an ECG waveform Check the settings for Pacer Detect and ECG Filter in the PARAMS menu Using the PARAMS menu select the desired lead configuration 3 or 5 leadwire Using the DISPLAY menu select the desired lead view LILI aVL aVF aVR or V Prepare and clean the patient application site as necessary Place the electrodes on the patient Lower the ECG sensitivity if the signal amplitude is too high Set the ECG display gain option so that the waveform is clearly displayed on the monitor s display screen 10 Remove the electrodes once every 24 hours and examine the skin for irritation and breakdown Apply clean electrodes
63. a range of 2 5 to 2 5 volts The ECG output resolution is 4 9 mV or better The monitor provides a contact switch for turning on and off a remote signaling device The nurse call switch is closed upon the activation of a high or medium priority alarm A standard 1 8 inch audio port is located below the BNC connector The switch is rated for signals of up to 24V 100mA The internal switch provides a minimum of 100V isolation The monitors provide a DB 15 VGA video port that is functional on monitors with TFT screens Contact CSI customer service for more information about remote video screens approved for use with this monitor nGenuity 8100E Series Operator s Manual Criticare Systems Inc CSV Data Format Criticare Systems Inc Section 7 Printing and Data Ports The Comma Separated Variable output presents the data in a form that is easily imported into a spreadsheet application where further analysis can be done on the data The data is output in ASCII format with each field time heart rate SoO temperature temperature type degrees F or C systolic diastolic and MAP separated with a comma Using the Microsoft Windows HYPERTRM EXE TERMINAL EXE for Windows 3 1 program and Microsoft Excel here is an example of how it may be used 1 Connect the COM1 port to the serial port on the computer 2 Start Terminal from the Accessories menu 3 Choose SettingslCommunications to set the computer s connector to t
64. able Sensors Box of 25 574SD 10 ea Adult 5 ea Pediatric 5 ea Infant 5 ea Neonatal Criticare Systems Inc nGenuity 8100E Series Operator Manual Page A 1 Appendix A Accessories ECG Accessories Universal ECG Cables Page A 2 3 Lead Snap ECG AHA Cable Assembly 1073 8 3 Lead Pinch ECG AHA Cable Assembly ssss 1073 P 5 Lead Snap ECG AHA Cable Assembly 1075 8 5 Lead Pinch ECG AHA Cable Assembly sssss 1075 P 3 Lead Snap ECG IEC Cable Assembly 1073 IS 3 Lead Pinch ECG IEC Cable Assembly 1073 IP 5 Lead Snap ECG IEC Cable Assembly 1075 IS 5 Lead Pinch ECG IEC Cable Assembly 1075 IP ECG Electrodes Set Of 3 ccccccccccccseeeeeeeeeeeeeeeneeeeeeeeeeeseesneeeeees 527 ECG Electrodes Set of 5 ceececcccseeeceeeeeeeeeeneeeeeeeeeetesennaeeeees 527 5 3 Lead Cable Neonatal Pediatric DIN Style 0 60 1094 3 5 Lead Cable Neonatal Pediatric DIN Style 0 60 1094 5 3 Neonate Pediatric Pre wired Electrodes DIN Style 0 60 1095 3 25 Disposable electrode for Cat No 1094 3 package of 25 5 Neonate Pediatric Pre wired Electrodes DIN Style 0 60 1094 5 25 Disposable electrode for Cat No 1094 5 package o
65. additional instructions The selected external printer must be configured so that it can communicate with the monitor Follow the configuration instructions provided with your printer The required settings are as follows Baud Rate 9600 or 19200 Parity No Parity Stop Bits 1 Data Bits 8 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Criticare Systems Inc Section 7 Printing and Data Ports COM Port The monitor uses the COM2 serial port 8 pin Mini DIN for loading system software updates and for reprogramming the monitor The communications ability of this port are for service use only Software is downloaded using the CSI Download Station Contact CSI Customer Service for more information about the software loader The connector pinouts are shown below PINOUT CHART 1 2 Pin Signal 4 1 Boot 2 4 ld N 2 Unused 3 ovo c 5 3 RX 2 o o cJ 4 Ground p V 5 TXL 6 TX3 l 7 7 RX3 Pinout 8 Boot 1 DIN8 connector Figure 7 8 COM2 Port Pinout Diagram nGenuity 8100E Series Operator s Manual Page 7 9 Section 7 Printing and Data Ports Defibrillation Connector Nurse Call Video Port Page 7 10 The monitor supports a standard BNC connector located just below the Mini DIN 8 port This port is for use in synchronization of cardioversion The output delay is no more than 30 milliseconds The ECG waveform output is a dedicated waveform represented as a 1VmV signal with
66. al Description Battery power is low Recharge batteries The patient has not been admitted in the ADM DIS menu The user has selected the waveforms to be frozen Press the FREEZE key again to resume normal display The printer has detected the end of the paper roll Paper is loaded and manual lever is up Move the lever to the down position Check for paper jam Internal printer communication problem Contact CSI Service The thermal printing element is not the correct temperature Contact CSI Technical Service The patient has not been admitted and wireless communication is not setup The numbers following the V indicate the unit s wireless network indentifier nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 6 Trends Description The trend memory stores patient data at regular intervals for review at a later time Trend data can be reviewed by printing it out on the monitor s built in printer or an external serial printer To view the tabular trend press the TREND key and the table appears in the lower channels of the waveform display Trend Interval The trend interval can be changed by pressing and holding the TREND key while viewing the tabular trend A second window appears Change the trend to the desired interval by rotating the knob Trend data for each parameter is stored as follows e SpO value is stored every 30 seconds at the zero and 30 seconds mark The precedent h
67. and its accessories may be returned to Criticare Systems Inc for safe disposal The shipping address is Criticare Systems Inc 20925 Crossroads Circle Waukesha WI 53186 nGenuity 8100E Series Operator s Manual Page 8 9 Appendix A Accessories SpO Accessories Reusable Sensors Adult Reusable Shell Finger Sensor 10 ft 934 10DN Adult Reusable Shell Finger Sensor 3ft DB 9 934SDN Reusable Multi Site Sensor 3 ft Kit a n 940SD Includes Forehead Applicator headband ear clip double sided adhesives microfoam tape Reusable Multi Site Sensor 3 ft Kit eeren 940HP Same as 940SD Kit and includes 518DD Extension Cable SpO Extension Cable 10ft sssssssseeeeeeee 518DD Multi site Sensor Ear Clip Attachment c cccccccccsccccssescsecscsecscesssecsesecsecassecsseecaees 514 Accessories Double Sided Adhesive Dots Pkg Of 50 ssssssss 525 Microfoam Tape 4 strips Pkg Of 14 526 Posey Wraps w Holes Pkg of 12 eeceeeeeeeeeeeeeeeeeeeeeeteeeees 920 Disposable Sensors Disposable sensors require a 10ft SpO Extension Cable Cat No 518DD Adult Disposable Sensors Box of 25 eessen 570SD Pediatric Disposable Sensors Box of 25 571SD Infant Disposable Sensors Box of 25 572SD Neonatal Disposable Sensors Box of 25 573SD Variety Pack Dispos
68. are Systems Inc Procedure for Admitting a Patient Procedure for Discharging a Patient Criticare Systems Inc Section 3 Setup Procedure To admit a patient proceed as follows 1 Set the menu to ADM DIS and press the knob the ADM DIS window appears If the patient data needs to be updated use the patient information procedure Rotate the knob to highlight Admit The admit selection is not available if a patient is already admitted Press the knob to select Admit Turn the knob to YES The message NEW PATIEN is also entered into the trend memory NOTE If there is no patient data this admits a blank patient Turn the knob back to EXIT to return to the main screen or proceed to update patient information To discharge a patient proceed as follows 1 o ao 2 C Set the menu to ADM DIS and press the knob the ADM DIS window appears Rotate the knob to highlight Discharge The discharge selection is not available if a patient has not been admitted Press the knob to select Discharge Turn the knob to YES The monitor responds with a confirmation screen Turn the knob to YES and press to confirm The monitor clears the patient data fields and returns the monitor to the last user default profile that was selected nGenuity 8100E Series Operator s Manual Page 3 21 Section 3 Setup Procedure CONFIG Softkey System Configuration ALARMS PARAMS DISPLAY ADM DIS PRI
69. are limited to 15 characters each and are in English only Restore Unit Defaults Replace all configuration and alarm settings with unit default settings SELECT ACCEPT ECG BP SPO2 TMP ECG BP SP02 BP AND SP02 SPO2 ONLY BP ONLY CANCEL Figure B 3 Restore Unit Defaults Page B 2 nGenuity 8100E Series Operator Manual Criticare Systems Inc Configuration Settings for Alternate Care Facilities Appendix B Alternate Care Defaults The configuration settings for the five alternate care setup defaults are the same as the basic hospital configuration settings except for the following grouped by menu PARAMS Menu Settings SPO2 Setting ECG BP SPO2 TMP ECG BP SPO2 BP AND SPO2 ONLY BP ONLY HeartRateTone 3 514 013 Volume ECG ON ON ON ON ON ECG Cable 3 lead 3 lead n a n a n a ECG Filter Monitor Monitor n a n a n a ECG Pace detect OFF OFF n a n a n a ECG Sensitivity MEDIUM MEDIUM n a n a n a NIBP ON ON ON OFF ON NIBP Tone NONE NONE NONE NONE NONE NIBP Cycle Time 5 minutes 5 minutes 5 minutes n a OFF SpO2 ON ON ON ON OFF Respiration ON ON OFF OFF OFF Temp ON OFF OFF OFF OFF CO2 ON OFF OFF OFF OFF PRINT Menu Settings Setting ECG BP SPO2 TMP ECG BP SPO2 BP AND SPO2 SPO2 ONLY BP ONLY Print Type Graphical X Graphical Tabular Tabular Tabular Alarm Pr
70. as collected enough QRS data to reposition the J and ISO points The ST point stays fixed at a location 60 milliseconds from the J point unless the user changes Select a point to adjust turn the knob to move the it manually ECG BPM 6 Q X vertical line Changes take effect immediately ISO pt Jpt STpt Br m EXIT II X lt Set J Point 0 ms ST and ISO are offset from the J point Sp02 Alarm 90 Set ISO Point ST 300 ms I I Set ST Point V 30 ms R Reset to Defaults NO Cancel Changes NO lt lt lt BACK V I 5 1G mm X 2 0 mm 1 0 mm ate 2 min MAP mmHg CYCLE OFF 149 106 127 X AGE 01 00 min oF SP02 SENSOR ee ay 7X ADM DIS CONFIG PRINT imi Adult AUG 07 05 14 12 59 Figure C 11 Main Display with ST Adjustment Window Page C 18 nGenuity 8100E Series Operator Manual Criticare Systems Inc Appendix C Arrhythmia and ST Analysis ST J and ISO Point Enter the ST point adjustment window by selecting Other Params Manual Adjustment Menus from the PARAMS window The ST point adjustment window provides an averaged QRS waveform for each lead view selected in the PARAMS menu The QRS waveform is updated if the current QRS deflections change Rotate the menu knob to highlight an adjustment point Press the menu knob and then turn to change the location of the selected point The window can be reset to defaults which allow the monitor to resume automatic determination of the ST segment The ad
71. as scavenging system T 2 Slide the tube over the nozzle of the exhaust port located on the side of the monitor Connect female Luer lock end to an exhaust recovery system A straight adapter 19mm O D 19mm I D with male Luer lock entrance is provided with the scavenging kit to provide a connection to scavenging tubing The monitor displays CO2 CHECK LINE if the scavenging line is blocked nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring CO Monitoring Allow the CO monitor to warm up and auto calibrate before use It is necessary to have the water trap sampling line attached so that the monitor draws the correct air flow When a patient is connected the monitor begins displaying the end tidal and inspired CO values in the parameter box The capnogram waveform if selected as a displayed waveform provides a graphic representation of the patient s respiration cycle The source of the numerical respiration rate may be determined from the capnogram or from the ECG data See Respiration Smart Source in Section 3 for a description of the smart respiration function USE OF NITROUS OXIDE Since nitrous oxide has a similar infrared signature to that of COs and it affects absorption of COs special care must be taken when measuring CO while anesthetics are being used The monitor provides a manually activated compensation for nitrous oxide between 40 and 80 when th
72. ation Mode are described in the nGenuity 8100E Series Service Manual CAT 1448 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 3 Setup Procedure Time Date Setting The time and date are set in the CONFIG softkey window Time format dictates whether the date is shown in day month year DD MM YYY Y or month day year MM DD YYYY format Changing the time and date while monitoring a patient does not affect the accurate display of patient data but it clears any trend data that has been recorded Freeze Waveforms The freeze function can be set to freeze the waveform frame from 30 seconds to five minutes Choosing OFF causes the FREEZE key to hold the screen permanently until the FREEZE key is pressed again The FREEZE key also captures waveforms that are obscured by dialog boxes and pop up windows When the FREEZE key is pressed the waveforms are redrawn on the screen The freeze function forces an exit from the current pop up window or dialog box Alarm Tone Warning The Alarm tone warning feature allows the user to permanently disable any and all audible alarms This feature turns off the double beep when a new alarm comes in and alarms are silenced This feature can only be accessed with a password NOTE Set this safeguard according to your facility protocols and according to local safety regulations for medical devices Language Settings The following languages are available in the monitor English French
73. ator discharge Tall T Wave Performance The nGenuity 8100E Series monitor properly counts normal rhythms with T Wave heights to 12096 of the QRS height at a heart rate of 80 BPM NWARNING N The presence of tall T waves greater than 120 80 when the Arrhythmia option is ON of the R wave may result in a double counting of beats Narrow Beat Rejection The nGenuity monitor does not reject narrow beats as defined in EC 13 either with or without the Arrhythmia option turned on Electrode Selection Proper ECG electrode size is determined by patient s body size Criticare recommends using adult 527 series patient ECG electrodes with snap style connections If adult electrodes overlap use smaller electrodes Pediatric neonate electrodes CAT 1094 will fit ECG cable Cat No 1095 Special attention should be taken to position electrodes so that the leads do not constrict around the infant s neck and limbs The caregiver may use third party electrodes with the monitor The substitute electrodes must comply with UL and IEC standards for such products The monitor is designed for use with silver silver chloride Ag AgCl electrodes Use of stainless steel electrodes is not recommended and will impair ECG performance ECG cables for either snap or pinch style electrode connections are available See Accessories in Appendix A for the complete list Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 4 9 Section 4
74. attached This cable CAT 1075 S is one of several ECG accessories available A list of approved ECG accessories is listed in Accessories in Appendix A Figure 4 8 ECG Cable Connection NWARNING N This device is not intended for intracardiac ECG applications Use the ECG monitor and accessories only as directed Do not place defibrillator paddles on or next to ECG patient electrodes Contact between defibrillator paddles and ECG electrodes could injure the patient The conductive parts of the lead electrodes including the neutral electrode should not come in contact with other conductive parts including an earth ground Such contact could result in patient injury or death or equipment damage NCAUTION A ECG electrodes can cause skin irritation Change the electrodes and reposition every 24 hours or sooner if there is sign of inflammation nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring Pacemakers and The monitor is designed to recognize pacer signals and reject them Electronic Devices as invalid portions of the ECG waveform The pacer signals are displayed to the user as white vertical bars spikes on the waveform The ECG monitor and accessories are protected against the effect of electrosurgery and high frequency equipment The ECG monitor has also been designed to be protected against the effects of cardiac defibrill
75. bles are found in the nGenuity 8100E Series Service Manual Check the cuffs and hoses for leakage as part of the NIBP verification found in the nGenuity 8100E Series Service Manual Service Checks If the monitor shows any signs of physical damage return it to the CSI Service Department for repair Have a qualified service technician perform the following performance and safety checks annually Perform complete functional testing of the monitor Test the monitor for electrical leakage and withstanding voltage Do not remove the cover Refer all servicing to a qualified technician Descriptions of these tests can be found in the nGenuity 8100E Series Service Manual Some test may require specialized equipment Printer Check The printer only prints if the battery icon is green or the AC mains cord is plugged in 1 Lift the paper feed lever up and insert paper Close the lever and the paper should automatically feed 2 Set print type for TABULAR in the PRINT window Press and hold the PRINT key on the front of the monitor 3 Verify that the correct date and time print Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 8 7 Section 8 Maintenance Alarms Verification To verify the alarm circuitry for SpO perform the following procedure 1 ce In the PARAMS window turn off all monitoring modules except for SpOs Set the display to show a plethysmograph waveform In the PARAMS window set t
76. blood pressure cuffs are for single patient use and are not intended to be disinfected The cloth cuff and neoprene bag may be sterilized with commercially available disinfectants such as ethylene oxide EtO Rinse thoroughly to remove any residual disinfectants Do not allow liquids to enter the neoprene bag The cloth cuff may also be sterilized in an autoclave If the cuffs become grossly soiled with blood or other body fluids the cloth cuffs should be laundered by hand or machine The dacron cloth cuff may be laundered or sterilized by first removing the neoprene inflation bag Feed the inflation tube back through the hole and then pull out the cloth flap Flap Figure 8 1 Remove Inflation Bag from Cuff Roll up the inflation bag and slide it out the open slot in the cloth cuff Be sure to observe the following laundering precautions disposable cuffs and neoprene inserts should not be laundered Remove the inflatable bag from the cuff before laundering or sterilizing the cuff Strong bleach solutions will damage the cuff Temperatures over 275 F 135 C will damage the cuff Close the Velcro fastener before laundering the cuff Soaking the cuff in dark colored solutions may stain or discolor the cuff Hand laundering as opposed to machine laundering will prolong the life of the cuff Wash the cuff in warm soapy water Rinse the cuff thoroughly After cleaning the cuff allow the cuff to air dry then insert
77. cted Page 3 24 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Printer Settings ALARMS PARAMS DISPLAY ADM DIS CONFIG Print Type Serial Type Criticare Systems Inc Section 3 Setup Procedure The PRINT softkey allows access to the printer settings window EXIT Print Type Alarm Print BP Print Interval Print Interval Print Type Snapshot Size History Size Waveform 1 Graphical OFF Tabular OFF Tabular 6 seconds 6 seconds ECG II x1 0 PLETH x1 0 25 0 MM SEC OFF CUSP Gain Waveform 2 Gain Printer Speed Serial Type Serial Format Baudrate 38400 Figure 3 14 Print Configuration Window If the internal thermal printer does not respond check Print Type to make sure that it is not set to OFF The settings A arm Print causes the monitor to print all parameters upon the activation of a new high or medium level alarm See Printing and Data Ports in Section 7 for more information on printing TABULAR PRINTING Numerical values for all current parameters are printed GRAPHICAL PRINTING If both waveform 1 and 2 have been set to a physical parameter the print out is a split dual waveform If only one of the waveforms is turned on a single waveform prints using the entire waveform area If both waveforms are turned off the waveform area of the print out is blank Trend and demand printing to a serial printer can be done by setting Serial Type
78. ctrode sites Electrode polarity positive negative or ground depends on the cable receptacle the lead wire is attached to and the lead selected on the monitor screen The ECG design uses the standard conventional bipolar limb leads leads Il III using 3 lead or 5 lead cable accessory With the 5 Lead cable accessory leads aVR aVL aVF and V lead may also be viewed The monitor has user selectable automatic lead switching capability when using the 5 lead settings If a lead becomes detached or is unmeasurable the monitor can automatically display an alternate lead view using the remaining leads nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 1 Introduction Stability of Accuracy The monitor is equipped with pacemaker detection and user selectable pacer rejection There are no known safety hazard due to the operation of a cardiac pacemaker or other electrical stimulators when used with this patient monitor The accuracy of the monitor is not affected by arrhythmia or other physiological conditions where the electrocardiogram amplitude and heart rate are within the detectable limits specified for the monitor The monitor has user selectable signal filtering in the 60 Hz and 50 Hz bands that reduce electrical interference from the AC mains power sources User selectable filters are also available The accuracy of the ECG analog output bandwidth is equal to the frequency response specified in the E
79. d Priority The ECG monitor automatically determines lead switching as shown Page 4 14 in the following table Primary Lead Switches to alternate on failure LL LA RA V Lead I II III Lead II I III Lead III I II Lead V I II III II Lead aVR aVL aVF I II III In cases indicated by a dash no switching occurs since the electrode is unused for that selected lead In cases where the RL fails no switching occurs because that electrode is required for each selectable lead configuration Since the augmented leads aVR aVL or aVF are calculated or derived from the actual limb leads failure of any lead except V causes failure of all the derived leads nGenuity 8100E Series Operator s Manual Criticare Systems Inc NIBP Monitoring Non invasive Blood Pressure Criticare Systems Inc Section 4 Patient Monitoring The following instructions describe procedures for preparing a patient for monitoring using the ComfortCuff NIBP module Shown below is the patient monitor with an adult size arm blood pressure cuff and a four 4 foot hose This adult arm cuff CAT 475 is one of many blood pressure cuffs available Use the NIBP accessories only as directed The monitors NIBP connection accepts any Criticare NIBP cuff using a quick connect style fitting ONY Figure 4 13 NIBP Cuff Connection nGenuity 8100
80. dow the monitor determines which window appears when the ALARMS softkey is selected By changing patient size the user effectively changes all the alarm limits for all the monitoring modules SpO ECG NIBP Temperature and Respiration The patient size setting also adjusts the maximum NIBP pressure limit For Adult and Pediatric the limit is 300 mmHg The limit for Neonate is 150 mmHg nGenuity 8100E Series Operator s Manual Page 3 19 Section 3 Setup Procedure Admitting and Discharging Patients NCAUTION A e Itis not necessary to admit a patient for the monitor to function properly There is no audible alarm for the No Admit condition A message appears in the informational message box to indicate that no patient is admitted e Itis possible to admit a blank patient If this is done there is no patient data label on printed reports Data from various patients could appear to merge together onto one trend table or graph tis recommended that the admit and discharge feature be used between each patient so that there is a clear break between patient histories in the memory This also ensures that label headers are properly printed out for each patient The discharge feature returns the monitor to the user default profile last selected If no user profiles have ever been selected on a new monitor the CUSTOM DEFAULTS found in the first position in the defaults window is used This feature has been included to help preve
81. e The Audible Alarms Disabled function Alarm tone warning can be set in the CONFIG menu A password is required to turn this function off The alarm volume can be set to levels 1 to 10 with 10 being the loudest This can be set in the ALARMS menu The alarm volume cannot be set to OFF To permanently silence the monitor press and hold the SILENCE key NOTE This function does not change the volume of the audible heart rate The pulse tone volume is adjusted separately in the PARAMS menu Heart Rate Tone Vol If the alarm volume is set to 1 the monitor automatically returns to the value 2 each time the monitor is turned on If the monitor was turned off with a value setting greater than one that value returns when the monitor is powered up again This function cannot be disabled The message ALARM CO2 appears in large red characters when the Standby Mode is active When in Standby Mode all alarms are silenced and the CO pump stops but remains on for zero calibration The function is turned on and off by pressing the STAND BY key nGenuity 8100E Series Operator s Manual Criticare Systems Inc SpO Low Limit Auto Reset SpO Low Limit Off Alarm Alarms Testing Criticare Systems Inc Section 5 Alarms and Messages If the SpO alarm limit level is set below 85 the monitor automatically returns to the value 8596 each time the monitor is turned on If the CUSTOM DEFAULTS are set with an SpOz low limit value
82. e 2 3 Section 2 Controls and Connections Left Side Panel The left side of the monitor has four connections for patient monitoring The electrocardiogram ECG pulse oximetry SpO temperature and the non invasive blood pressure NIBP measuring connections are standard on all nGenuity models The ECG uses an AAMI standard circular 6 contact connector located at the top One female 1 4 inch YSI temperature cable socket is located below the ECG connector e The DB 9 female serial connector is used for SpO sensor connection A male quick connect style NIBP fitting is located at the bottom on the left side More information about accessory connections can be found in Patient Monitoring in Section 4 of this manual Figure 2 3 Left Side Page 2 4 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 2 Controls and Connections Water Trap and Sampling The water trap connection is an optional model feature The water Line Connection trap is located on the left panel toward the rear of the unit The sampling connection is made at the connector on the front of the water trap and is used for CO monitoring The sampling line is a standard female Luer lock connector when using the WaterChek 2 water trap accessory NOTE Other water traps in the WaterChek series are compatible with this monitor Some older versions used a male Luer lock sampling line connection on the wa
83. e COMI Port RS232 Serial DB 9 COM Port MiniDIN 8 Service Analog Defibrillation BCN Connector Nurse Call Communication Socket e Video Port The monitor uses a serial port DB 9 female for the external data output port The monitor uses a standard RS232 communication protocol with a full hardware handshake PINOUT CHART Signal Unused RX1 TX1 DTR Ground DSR RTS CTS Unused 123 4 5 6 7 89 Pinout DB 9 connector Pin 1 2 3 4 5 6 7 8 9 Figure 7 7 COM1 Pinout Diagram SERIAL PRINTING The COM 1 port supports sending data to an external serial printer or computer terminal To send the data as described in the beginning of this section to the COM 1 port Serial Type must be set to Tabular in the PRINT softkey This will send trend and demand printing to a serial printer To print Alarm BP or Interval data to a serial printer Alarm Print BP Print and Interval Print Type must be set to Serial in the PRINT softkey Set the to Serial Formatto Text in the PRINT menu to simulate the tabular printout of the internal printer Set the Serial Formatto CSV in the PRINT menu to create a comma separated variable table The CSV format can be used by software programs A description of the CSV format is located at the end of this section nGenuity 8100E Series Operator s Manual Page 7 7 Section 7 Printing and Data Ports Page 7 8 SENDING DATA TO A COMPUTER A serial download cable is availabl
84. e CSA number must appear on the outside of the shipping container Return shipments will not be accepted if the CSA number is not clearly visible Please provide the model number serial number and a brief description of the reason for return Freight policy The customer is responsible for freight charges when equipment is shipped to CSI for service this includes customs charges Loaner service In the U S If it is necessary to provide a loaner system CSI will ship a loaner by overnight courier The loaner system must be returned to CSI at the customer s expense within one week after receipt of the repaired goods If the unit is not returned to CSI within that time the customer will be invoiced for the full purchase price of the equipment Outside the U S No loaners are available from CSI internationally Contact your local CSI representative Incoming Inspection The following incoming inspection is required whether it is a first time arrival or a return from service Prior to clinical use the instrument should be inspected for the following 1 The quality inspection seal on the instrument should be unbroken This seal indicates that the instrument has been tested according to manufacturers specifications 2 No physical damage is observed 3 The instrument s battery is to be charged by connecting the instrument to a power outlet for a minimum of 4 5 hours prior to clinical use 4 When connecting the instrument to a powe
85. e Systems Inc Priority High Section 5 Alarms and Messages Description No breath detected Check patient for apnea Check sampling device and adjust placement if necessary May indicate a leak in the breathing circuit Medium Sample line is not connected Connect sampling line Scavenging line blocked or defective scavenging system Remove occlusion or correct system Medium The sampling line or trap is completely blocked Replace sampling accessories as needed Low Trap not inserted Trap is partially blocked wrong type of trap or defective Replace trap Low The monitor is calibrating the gas module to current ambient conditions Monitoring is suspended Low The monitor has detected a fault with the gas calibration table Contact CSI Service Department Low The monitor has detected a fault with the user calibration Perform a user calibration Contact the CSI Service Department if the problem continues Low Invalid factory calibration Contact CSI Service Department Low The monitor has detected a fault with the gas bench Contact CSI Service Department nGenuity 8100E Series Operator s Manual Page 5 9 Section 5 Alarms and Messages System Alerts LOW BATTERY NO ADMIT WAVEFORM FROZEN PRINT PAPER OUT PRINT HEAD UP PRINT Vp ERROR PRINT TEMP ERR V000 NO ADMIT Page 5 10 Priority Advisory Informational Informational Informational Informational Informational Informational Information
86. e a female Luer locking sampling entrance Q Cat No 616 JI Cat No 617 C 0 3 Figure 4 20 Adapters with Luer lock Entrance The ventilation circuit adapters shown above are for single patient use only and are intended to be disposed after The adapters have a 15mm outside dimension to one connection end and a combination 15mm inside dimension with a 22mm outside dimension on the other end NCAUTION A e Additional adapters between the endotracheal tube and the sampling entrance should not exceed five 5 centimeters Standard breath circuit configurations are shown below beginning with a common endotracheal tube with a 15mm outside diameter The circuit then extends to meet a standard 22mm inside diameter ventilation flex tube Confirm the proper fit of all breath circuit components before attempting patient monitoring nGenuity 8100E Series Operator s Manual Criticare Systems Inc Calibration and Startup Criticare Systems Inc Section 4 Patient Monitoring Rampling Line Luer lock Endotracheal 22mm I D Ventilation Tube Tube 15mm O D with 15mm I D Adaptor os X 15mm I D 15mm O D Ventilation Adaptor with Luer lock Sampling Entrance Figure 4 21 Straight Ventilation Adapter Setup Sampling Line fw Luer lock eu GO TO N 15mm I D 15mm O D 22mm I D Ventilation Tube Elbow Adaptor with with 15mm I D Adaptor W Luer lock Sampling Entrance Bo Tube 15mm O D Figure 4 2
87. e adjusted in size and dimension by using the settings provided The gain listed on the DISPLAY window settings increases the display size of the waveforms It does not control the amplification gain of the source signal or the height of the slot where the waveform appears The waveforms displayed are user selectable with the exception of the first slot which is always an ECG waveform However the ECG lead for this waveform can be selected nGenuity 8100E Series Operator s Manual Page 3 13 Section 3 Setup Procedure Double Height Slots Page 3 14 The monitor can display waveforms in three 25mm slots and three smaller 12 5mm slots The 25mm slots can be combined to form 50mm slots The 12 5mm slots in the bottom group can be combine together to form 25mm slots No more than two slots can be combined to form a larger waveform display area To combine slots to form larger areas to display waveforms set the lower slot TYPE to OFF The slot above automatically increases in size to fill the space NOTE Slot 3 and 4 cannot be combined in this manner 1 2 3 4 5 6 External Display Figure 3 6 Combined Slot Settings Each waveform slot displays the parameter or source along the left edge of the screen The colors of the waveforms are user selectable in the PARAMS window The numerical parameter colors match the selected waveform color whenever possible ECG LEADS OFF BPH BP CHECK CUFF 1mV aVR
88. e compensation option is selected in the PARAMS window INTERFERING GASES FOR CO5 The monitor reports small changes in CO when anesthetic agents are used Expected CO changes are provided here for the purposes of comparison For Gas mixtures of 5 CO Agent Agent Volume Change of CO N50 60 0 1 with N O compensation ON 1 0 with N2O compensation OFF Halothane 496 40 396 Enflurane 596 10 396 Isoflurane 596 40 396 Sevoflurane 596 0 2 Desflurane 15 1 1 Xenon 80 Not intended for use with Xenon Helium 50 0 3 Ethanol 1 0 1 Isopropanol 1 0 1 Acetone 1 0 Methane 5 0 Propellant 1 0 Gas mixtures balanced with nitrogen Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 4 25 Section 4 Patient Monitoring Temperature Monitoring Page 4 26 The following instructions describe procedures for preparing a patient for temperature monitoring Shown below is the patient monitor with a skin surface temperature probe This reusable surface probe CAT 422 is one of many temperature probes available Use the temperature accessories only as directed The monitor s temperature connection accepts any Criticare YSI 400 style or YSI 700 style temperature accessory QAYWDIYAY Figure 4 23 Temperature Probe Connection nGenuity 8100E Series Operator s Manual Criticare
89. e from CSI use CAT 1088 to connect to standard male DB 9 computer serial ports A common computer terminal program and an unused RS232 serial port is needed for external communications Criticare recommends using the Windows HYPERTRM EXE program provided with all MicroSoft Windows operating systems HYPERTRM EXE can be found in the Windows accessory directory For older computers using MS Windows 3 1 the communications program TERMINAL EXE can be found in the Windows directory Set the monitor to serial printing with serial output selected With the computer terminal connected a data file may be collected The file may then be further evaluated by computer See the description for CSV format at the end of this section TERMINAL CONFIGURATION The cable connections should be completed and the terminal program should be configured before attempting to send data The recommended settings are as follows Baud Rate 9600 or 19200 Parity No Parity Stop Bits 1 Data Bits 8 Hardware Control None EXTERNAL SERIAL PRINTER ACCESORY The Seiko DPU 414 is pinned out as a modem would be DCE data communications equipment rather than as a typical printer computer DTE data terminal equipment Use CSI CAT 1089 to connect to the Seiko printer which provides the necessary null modem configuration A standard DB 9 serial connector is located on the back of the DPU 414 thermal printer Read the manual provided with the printer kit for
90. e monitor records the date change into the trend table This does not occur if the monitor was turned off at midnight nGenuity 8100E Series Operator s Manual Criticare Systems Inc Data Format Section 6 Trends The parameters are listed in the first column followed by the units Time stamps at the half minute mark are displayed with a plus sign Measured parameters that exceed or drop below alarm limits are highlighted When a sampling module is on and no value can be determined for the parameter three dashes are displayed in the trend table If a sampling module is turned off in the PARAMS window the word OFF displays in the trend If there is no NIBP data for a particular time stamp the NIBP trend area is left blank RATE p02 NI BP TEMP RESP C02 21 J AN 05 11 454 11 45 11 444 11 44 11 434 11 43 BPM 60E 60E 60E 60E 99 99 99 98 NEW POWER SYS mmHg 135 PATIEN DIA mmHg 95 MAP mmHg 115 F 98 6 98 6 98 6 OFF Br m 20 20 20 20 INS kPa 0 0 0 0 0 0 0 0 EXP 0 0 0 0 0 0 0 0 Figure 6 4 Trend Display Table NOTE Monitors without CO monitoring will not show CO data For the trend table shown the interval is set to 30 seconds The heart rate is being reported based on the electrocardiogram which is indicated by the E following the heart rate values The source of the heart rate data is indicated by a letter following each heart rate value Criticare Systems Inc
91. eart rate and precedent respiration are stored every 30 seconds at the zero and 30 seconds mark The secondary sources are recorded if the primary data is unavailable e NIBP storage is determined by cycle time interval demand and stat readings Every NIBP reading is stored in the trend memory Continuous temperature readings are stored every 30 seconds at the zero and 30 seconds mark Inspired and expired CO data is stored every 30 seconds at the zero and 30 seconds mark Capacity The trend memory can store up to 24 hours of trend data at 30 second intervals including NIBP at three minute intervals When the trend memory is filled to maximum capacity the new trend data begins to overwrite the oldest trend data in the memory Trend Screen Update The table is not updated while it is being viewed Scroll up to view data that is recorded after the trend screen is activated The trend screen automatically returns to the main screen after 45 seconds Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 6 1 Section 6 Trends Trend Setup Page 6 2 The trends may be viewed in graphical format in the trend window Up to two parameters may be viewed in graphical format The trend view may be changed in the Trend Setup window To view trends 1 2 3 4 5 Oo Press the TREND key to enter the trend window Either the Tabular or Graphics trend appears Press the and hold the TREND ke
92. ercent only 0 to 3 13 6 25 12 5 or 25 0 to 99 mmHg 0 to 12 5 0 to 12 5 kPa 0 to 99 Torr 1 mmHg 0 1 0 1 kPa 0 1 Torr 2 mmHg 0 3 vol 0 3 kPa 2 Torr 200ml min amp RR lt 120 Br min Manual On Off 200 ml min 200 ml min x 1096 20 ml 1 25 seconds 200 ml sec using an 8 ft sample line 170 milliseconds 200 ml min 10 90 1 08 seconds 200 ml min 15 sec including auto calibration to first reading 1 min to full accuracy 35 dBa maximum 1 meter 1 68 113 F 20 45 C 0 1 C over entire range 0 1 C YSI 400 or YSI 700 Page 1 11 Section 1 Introduction Page 1 12 Alarms Characteristics Indication Levels Settings Alarm Modes Volume Silence Trend Reports Types Trend memory Tabular Intervals Graphical Span Data Types Printer Optional Recorder Type Data Formats Paper Speed Controls Screen Resolution Waveforms Waveform Display Gain Waveform Sweep Speed Keys Rotary knob Languages System Outputs Com Ports Nurse Call Defibrillation Sync Video Port nGenuity 8100E Series Operator s Manual EN 475 Adjustable Audible Visual High Medium Low Informational User Defaults Hospital Defaults Factory Defaults Adult Pediatric Neonate High and low limit settings for each mode User Adjustable 1 10 Yes 2 minutes or permanent Tabular and Graphical 24 hours 30 sec 1 2 3 5 10 1
93. ere are two 2 AC power fuses located at the rear of the monitor directly below the AC power entry socket Replace with 1A 5x20 time lag fuses pn 82013B002 1 Press in the side clips at the same time with a tool and lift out the small black access cover The two 2 fuse sockets are visible Clips Figure 8 2 Remove the Fuse Cover Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 8 5 Section 8 Maintenance Figure 8 3 Fuses Exposed 2 Gently pull the fuses out of the fuse cover assembly Figure 8 4 Fuses Pulled 3 Reassemble in reverse order For more information about troubleshooting power problems refer to Troubleshooting in Section 8 of the service manual Page 8 6 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 8 Maintenance Annual Safety Tests The monitor should be electrically tested annually The safety tests should be performed only by experienced service technicians Refer to the nGenuity 8100E Series Service Manual CAT 1448 for additional information System Testing The monitor has built in system tests which should be performed regularly However the tests should be performed by qualified service personnel only Accessory Testing Check patient cables e g temperature cables SpO cables monthly for damage loose wires connections loose connectors cracked housing etc The procedures for electrical testing of power cords and ca
94. erminated sssseeeeeeeee 989 UT nGenuity 8100E Series Operator Manual Page A 5 Appendix A Accessories Publications Page A 6 nGenuity 8100E Series Operators Manual English 1447 nGenuity 8100E Series Operators Manual French 1447F nGenuity 8100E Series Operators Manual German 1447G nGenuity 8100E Series Operators Manual Italian 14471 nGenuity 8100E Series Operators Manual Portuguese 1447P nGenuity 8100E Series Operators Manual Spanish 1447S nGenuity 8100E Series Operator s Manual Russian 1447R nGenuity 8100E Series Service Manual English 1448 nGenuity 8100E Series Operator Manual Criticare Systems Inc Appendix B Alternate Care Defaults Alternate Care The nGenuity 8100E Series monitor has the capability to install either Defaults a set of five 5 hospital configuration defaults or a set of five 5 alternate care defaults The desired default set is programmed at the factory before a unit is first shipped It is be possible to switch between the sets at any time by using the correct password entry Press and hold the DEFAULT key then enter the password LIA608 to display the Set Unit Defaults screen See Figure B 1 Set Unit Defaults Screen When powering up a new monitor the EEPROM is loaded with the 5 hospital default configurations Set
95. etects electro surgical interference and suspends monitoring of the waveform and numerical values to avoid inaccurate physiological readings Low Generated by the ECG module Poor contact at the electrodes or defective ECG cables Low Cannot determine a respiration rate from the ECG sampling module data nGenuity 8100E Series Operator s Manual Criticare Systems Inc SpO Alarms LOW SpO2 HIGH SpO2 SpO2 LOST SpO2 SENSOR SpO2 HI AMBIENT SpO2 SIGNAL SpO2 NO SENSOR SpO2 ERROR SpO2 SEARCH LOW SAT OFF Temperature Alarms LOW TEMP HIGH TEMP TEMP NO PROBE TEMP BAD PROBE TEMP INVALID TEMP CALIB ERR TEMP ERROR Criticare Systems Inc Priority High Medium Medium Medium Low Low Low Low Low Informational Informational Priority Medium Medium Low Low Low Low Informational nGenuity 8100E Series Operator s Manual Section 5 Alarms and Messages Description The SpO value has dropped below the value set in the ALARMS menu The SpO value has exceeded the value set in the ALARMS menu The monitor is receiving no SpO signal Check sensor site for low perfusion and reposition sensor if necessary The SpO sensor is not properly positioned The SpO module is reading excessive light Shield the sensor or reduce the amount of ambient light The SpO signal is too weak to measure Check sensor site for low perfusion and reposition sensor if necessary The
96. f 25 ECG Truck Cable Universal esssseeeeeeennnne 1123 3 Wire ECG Leadset AAMI ssssssseeeneennnn 1124 A3 3 Wire ECG Leadset IEC ssssssseeeeeee 1124 13 5 Wire ECG Leadset AAMI ccceeeeeeeeeeceeeeeeeeeteeeenaaeees 1124 A5 5 Wire ECG Leadset IEC 0 0 2 cc ceeeecceeeeeeeeeeeeeeeeeeeeeeeeeeteeeeeaeees 1124 15 nGenuity 8100E Series Operator Manual Criticare Systems Inc NIBP Accessories Cuffs and Hoses Disposable Cuffs Criticare Systems Inc Appendix A Accessories Infant Blood Pressure Cuff 10 19 CM 473 Pediatric Small Adult Blood Pressure Cuff 18 26 cm 474 Adult Blood Pressure Cuff 25 35 cm sssssssssssss 475 Large Adult Blood Pressure Cuff 33 47 cm sesers 476 Thigh Blood Pressure Cuff 44 66 cm ssssssess 477 NIBP Hose 4 ft Straight Adult Quick Connect 705 NIBP Hose 10 ft Straight Adult Quick Connect 706 NIBP Hose 10 ft Coiled Adult Quick Connect 707 NIBP Hose 4 ft Coiled Adult Quick Connect 714 NIBP Hose 4 ft Straight Neonate Quick Connect Clippard 708 NIBP Cuff 3 6 cm Pkg of 10 740 NIBP Cuff 4 8 cm Pkg of 10 741 NIBP Cuff 6 11 cm Pkg of 10 742 NIBP Cuff 7 18 cm Pkg of 10 748 NIBP Cuff 8 15 cm Pkg of 10 744 NIBP Cuff Infant
97. ff 0 0 94 0 Torr Off Page 3 26 nGenuity 8100E Series Operator s Manual Factory Defaults Adult 5 medium 150 40 Off 90 200 50 100 30 150 50 100 0 F 37 8 C 94 0 F 34 4 C 35 Off 10 mmHg 1 5 96 1 5 kPa 10 0 Torr Off Off Off Off 55 mmHg 7 5 96 7 5 kPa 56 0 Torr 5 mmHg 1 0 96 1 0 kPa 5 5 Torr 5 medium 150 40 Off 90 200 50 100 30 150 50 100 0 F 37 8 C 94 0 F 34 4 36 Off 10 mmHg 15 1 5 kPa 10 0 Torr Off Off Off Off 55 mmHg 7 5 7 5 kPa 56 0 Torr 5 mmHg 1 0 1 0 kPa 5 5 Torr Pediatric Neonate 5 medium 180 90 Off 90 140 50 80 30 100 40 100 0 F 37 8 C 94 0 F 34 4 60 Off 10 mmHg 15 1 5 kPa 10 0 Torr Off Off Off Off 55 mmHg 7 5 7 5 kPa 56 0 Torr 5 mmHg 1 0 1 0 kPa 5 5 Torr Criticare Systems Inc Monitoring Parameters Criticare Systems Inc Parameter HR Source Respiration ECG Cable Detect Pacemaker ECG Filter Sensitivity Temperature Temperature Unit SpO Average SpO gt Search Time CO Units N5O Compensation NIBP Tone Heart Rate Tone Volume Selectable Options Smart ECG SpOs NIBP On Off 5 Lead 3 Lead On Off Diagnostic Monitor ST Low Medium High On Off F C 3 6 9 12 15 18 21 10 20 30 40 Percent mmHg kPa Torr On Off End None 1 10 Off Section 3 Setup Procedure Factory Default Smart On 5 Lead Off Monitor
98. g any external equipment to signal input signal output or other connectors forms a system and this new system must comply with the requirements of IEC 60601 1 1 If in doubt contact qualified technician or local representative Voltage Fluctuations When operated in the line voltage range specified in this manual any fluctuation will have a negligible effect Very low line voltage will cause the monitor to revert to battery power Very high line voltage may cause damage to the charger circuits The monitor is designed with circuitry that turns the unit off before spurious readings can be caused by a low battery condition Equipotential Ground Health care providers and patients are subject to dangerous uncontrollable compensating currents for electrical equipment These currents are due to the potential differences between connected equipment and touchable conducting parts as found in medical rooms The safety solution to the problem is accomplished with consistent equipotential bonding The monitor is fitted with a connecting lead made up with angled sockets to the equipotential bonding network in medical rooms Connection Lead Equipotential Socket A Terminal Equipotential Main Connector Body Earth Ground Software Error Related Criticare Systems Inc has quality control practices and procedures Hazard Mediation in place to review potential hazards as they relate to software The monitor is Year 2000 Co
99. ge C 23
100. he SpO2 Low Limit Alarm setting to HIGH This sets the alarm priority for only this alarm parameter Use an SpO simulator to set the monitor to display the plethysmograph waveform Confirm the heart rate and saturation reading In the ALARMS window adjust the SpO low alarm level above the saturation reading to cause an alarm condition Verify that the message LOW SPO2 appears at the top of the waveform channel in red letters Verify that you get an audible response The alarm should be a high priority alarm tone consisting of 3 beeps followed shortly by two beeps In the PARAMS softkey window change the SpO2 Low Limit Alarm setting to MEDIUM Verify that the message LOW SPO2 appears at the top of the waveform channel in yellow letters Verify that you get an audible response The alarm should be a medium priority alarm tone consisting of 3 beeps ALARM VOLUME TEST 1 Page 8 8 From the ALARMS window vary the ALARM VOLUME through the ranges from 1 to 10 Verify that the speaker volume changes according to the setting of the ALARM VOLUME Press the alarm SILENCE key once Verify that the low heart rate alarm stops for 2 minutes and that the 2 minute Alarm Silence icon appears in the system status area of the screen Press and hold the alarm SILENCE key for at least 2 seconds Verify that the low heart rate alarm stops and the Alarm Suspend icon appears in the system status area of
101. he proper port Check communications settings 4 Choose Transfers Receive Text File Assign a name to the data e g DATA TXT and press OK 5 At this point all data transmitted from the monitor appears on the screen and is saved in DATA TXT 6 When all the desired data has been accumulated choose Transfers Stop to close DATA TXT 7 Start EXCEL and choose FilelOpen 8 Enter Click on the file name and press the Text button 9 For Column Delimiter choose Comma For File Origin choose Windows ANSI Then choose OK 10 Choose OK again from the Open dialog to open and display DATA TXT The data is organized in a table by field Using the EXCEL presentation options this data could be graphed printed in tabular form or analyzed statistically in some other way nGenuity 8100E Series Operator s Manual Page 7 11 Section 8 Maintenance Cleaning Disinfecting and Testing Pulse Oximeter Sensors Criticare Systems Inc NWARNING N e Shock Hazard Turn the power off and disconnect the AC power cable before cleaning the monitor and sensor e Shock Hazard Never immerse the monitor The monitor has an internal power source that is active when the unit is unplugged Do not use abrasive cleaners on the monitor or on any sensors or probes Abrasive cleaners can damage the monitor sensors and probes The exterior surface of the monitor except for the display screen may be wiped clean with alcohol and
102. he top left corner of each slot set to for ECG waveforms The amplitude bar shown in white indicates the scale for 1mV positive and negative When the pacer detection feature is enabled the pacer spikes in the ECG waveform are shown in white IMPEDANCE RESPIRATION WAVFORM The impedance respiration waveform is based upon the ECG data The label ECG RESP appears at the beginning of the waveform The impedance respiration derives its color from the ECG color setting to indicate that it is sourced from ECG The waveform is auto ranging where the monitor attempts to keep the waveform centered in the slot at all times SPO2 WAVEFORM The waveform is auto ranging where the monitor attempts to keep the waveform centered in the slot at all times No amplitude bar is shown nGenuity 8100E Series Operator s Manual Criticare Systems Inc Numerical Parameter Boxes 60x 20x X Low Sp02 Alarm Co2 5 0 S Criticare Systems Inc 90 X mmHg Section 2 Controls and Connections CO2 WAVEFORM The CO waveform capnogram is always displayed in percent regardless of the units selected for displaying the numerical data The maximum range of the capnometer waveform is 25 BREATH BY BREATH BAR GRAPH BxB The label BxB appears at the beginning of the graph The user may select the CO data to be displayed as a breath by breath bar graph The breath by breath data always displays in percent The maximum
103. il i A ete tie Ii Pee Erden 3 8 Alarm Volume 3 9 Low SpO Alarm PARAMS Softkey Physiological Parameters 9 10 HR Source Smart Heart Rate 3 10 ECG Settings Filter Settings N Monitoring Module On Off Selection 3 11 SpOs SGttingS rire atin aren a rane cp Taa 3 11 Respiration Smart Source 3 12 NIBP Settings Temperature Settings 9 12 Heart Rate Tone Volume Pulse Tone senes 3 12 Color Settings naen ehhh tette es cep e aH Rp c p Tec dovere 3 12 CO Settings 3 12 DISPLAY Softkey 2 9 3 Waveform Description 9 138 Double Height Slots sess 3 14 Cascaded Slols cec ce ge geo ete te cl de ava 3 15 Gain and SWeep eie te ised eee tee Oi re iet pee rene R 3 16 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Criticare Systems Inc Contents DUIRDRR A a E e A A aa Setting Mini Trend Initiating Mini Trend rennen nre niente ntes 3 17 Mini Trend Display inerenti eret 3 17 ADM DIS Softkey Admit Discharge sese 3 19 Adult Pediatric Neonatal Patient Size sss 3 19 Admitting and Discharging Patients 3 20 Patient Inforrnation oio ritenere inten epe nra natales 3 20 Procedure for Admitting a Patient ssssssseseeeeenn 3 21 Procedure for Discharging a Patie
104. in a continuous waveform The monitor also detects end tidal and fraction Inspired CO levels displaying them numerically End tidal CO ETCO is defined as the maximum CO concentration at the end of expiration The monitor measures and displays this numerical value of CO concentration The ETCO value is updated continuously with each breath cycle The amount of CO in the gas mixture inhaled in by the patient is the fractional Inspired CO FICO The monitor measures CO using the principles of infrared absorption spectrometry An unknown concentration of gas CO is calculated by comparing its absorption of infrared light to that of a known standard The absorption of light is directly related to the concentration of gas As infrared light passes through the sample gas chamber the light transmitted is converted to a voltage signal The monitor converts the voltage to CO concentration and expresses it as mmHg percent 96 kPa user selectable or Torr Infrared analysis of the gas samples is done using Beer s Law The formula for Beer s Law I qe 504 I Infrared value of measured sample o Infrared value of light source e Exponential function amp A Extinction coefficient Concentration of the gas sample d Distance measured through the sample The Beer s Law calculation is performed by the monitor s software nGenuity 8100E Series Operator s Manual Criticare Systems Inc Conditions of Use Stability
105. ion Accessories Criticare Systems Inc ARRH BEGIN ST SETUP CHANGE When arrhythmia events begin and end the messages AHRH BEGIN and ARRH END appear in the table When the ST setup is changed the message ST SETUP CHANGE is recorded in the trend table ARRH END The table includes trend data for ST I ST II ST III ST aVR ST aVL ST aVF ST V and PVC Rate min 21 J AN 05 11 45 11 45 11 444 11 44 11 434 11 43 RATE BPM 60E 60E 60E 60E ARRH ST p02 99 99 99 98 BEGIN SETUP NIBP SYS mmHg 135 CHANGE DIA mmHg 95 MAP mmHg 115 TEMP wF 98 6 98 6 98 6 OFF RESP Br m 20 20 20 20 ST I mm 2 0 2 0 2 0 2 0 ST II mm 1 05 125 d05 1 5 ST III mm 1 0 1 0 1 0 1 0 ST AVR mm 0 5 0 5 0 5 0 5 ST AVL mm 0 0 0 0 0 0 0 0 ST AVF mm 0 5 0 5 0 5 0 5 ST V mm 1 0 1 0 1 0 1 0 PVC Rate min 2 2 2 2 Figure C 10 Trend Display Table with ST For complete information on trend data see Trends in Section 6 The ST Arrhythmia uses the same patient setup procedures as the normal ECG measurement techniques explained in Patient Monitoring in Section 4 The ST Arrhythmia software requires no special accessories or equipment Use the standard ECG accessory kit that came with your monitor for best results nGenuity 8100E Series Operator Manual Page C 15 Appendix C Arrhythmia and ST Analysis Clinical Use Refer to ECG Monitoring Electocardiogram in Section 4 for basic instructions for ECG monito
106. it OFF OF or or or BP Print Tabular Tabular Tabular OFF OFF Interval Print Off Off Off Off Off Interval Print Type Tabular Tabular Tabular Tabular Tabular Snapshot Size 6 seconds 6 seconds 6 seconds 6 seconds 6 seconds History Size 6 seconds 6 seconds 6 seconds 6 seconds 6 seconds Waveform 1 ECG II ECG II ECG II ECG II ECG II Gain x1 0 x1 0 x1 0 x1 0 x1 0 Waveform 2 PLETH PLETH PLETH PLETH PLETH Gain x1 0 x1 0 x1 0 x1 0 x1 0 Printer Speed 25 0 MM SEC 25 0 MM SEC 25 0 MM SEC 25 0 MM SEC 25 0 MM SEC Serial Type Tabular Tabular Tabular Tabular Tabular Serial Format CUSP CUSP CUSP CUSP CUSP Baudrate 38400 38400 38400 38400 38400 Criticare Systems Inc nGenuity 8100E Series Operator Manual Page B 3 Appendix B Alternate Care Defaults DISPLAY Menu Settings Setting ECG BP SPO2 TMP ECG BP SPO2 BP AND SPO2 SPO2 ONLY BP ONLY Waveform 1 ECG II x1 25 25 ECG II x1 25 25 OFF OFF OFF Waveform 2 Cascade Cascade OFF OFF OFF Waveform 3 Cascade Cascade PLETH x1 25 25 PLETH x1 25 25 OFF Waveform 4 PLETH x1 25 25 PLETH x1 25 25 OFF OFF OFF Waveform 5 OFF OFF OFF OFF OFF Waveform 6 OFF OFF OFF OFF OFF ALARMS Menu Settings Alarm Settings Adult High Adult Low Ped High Ped Low NeoHigh Neo Low Heart Rate 150 40 150 40 180 90 SpO2 OFF 90 OFF 90 OFF 90 NIBP Systolic 200 50
107. justable Adjustable Adjustable Adjustable Appendix C Arrhythmia and ST Analysis Description The ST segment elevation on lead view is below the limit selected in the ST alarms menu The ST segment elevation on lead view is above the limit selected in the ST alarms menu The ST segment elevation on lead view II is below the limit selected in the ST alarms menu The ST segment elevation on lead view II is above the limit selected in the ST alarms menu The ST segment elevation on lead view III is below the limit selected in the ST alarms menu The ST segment elevation on lead view III is above the limit selected in the ST alarms menu The ST segment elevation on lead view aVR is below the limit selected in the ST alarms menu The ST segment elevation on lead view aVR is above the limit selected in the ST alarms menu The ST segment elevation on lead view aVL is below the limit selected in the ST alarms menu The ST segment elevation on lead view aVL is above the limit selected in the ST alarms menu The ST segment elevation on lead view aVF is below the limit selected in the ST alarms menu The ST segment elevation on lead view aVF is above the limit selected in the ST alarms menu The ST segment elevation on lead view V is below the limit selected in the ST alarms menu The ST segment elevation on lead view V is above the limit selected in the ST alarms menu nGenuity 8100E Series Operator Manual Pa
108. justments can also be canceled allowing the previous settings to return Any manually set J ST or ISO point is discarded on the next power cycle Criticare Systems Inc nGenuity 8100E Series Operator Manual Page C 19 Appendix C Arrhythmia and ST Analysis Tabular Printing Page C 20 A header is printed containing the monitor model the operating software revision the time and date and the patient information The title for each parameter follows Numerical values for all current parameters are printed The sample below shows a tabular print out with ST and PVC Rate values CSI 8100E Series Rev 1 1 04 25 06 4 48 01 NAME SMITH JOHN ID 12345678 Room number 100 04 25 06 04 48 02 HR ECG 60 BPM Spo2 98 RESP ECG 20 Br m TEMP 96 4 F ST I OFF II OFF mm ST III OFF aVR OFF mm ST aVL OFF aVF OFF mm ST V OFF mm PVC Rate OFF min NIBP 04 46 16 135 95 115 mmHg 04 25 06 04 48 06 HR ECG 60 BPM Sp02 98 RESP ECG 20 Br m TEMP 96 4 F ST I OFF II OFF mm ST III OFF aVR OFF mm ST aVL OFF aVF CFF mm ST V OFF mm PVC Rate OFF min NIBP 04 46 16 135 95 115 mmHg 04 25 06 04 48 13 HR ECG 60 BPM Sp02 98 X RESP ECG 20 Br m TEMP 96 4 F ST I OFF II OFF mm ST III OFF aVR OFF mm ST aVL OFF aVF OFF mm ST V OFF mm PVC Rate OFF min NIBP 04 46 16 135 95 115 mmHg Figure C 12 Tabular ST Printout nGenuity 8100E Series Operator Manual Criticare Systems
109. l parameters of patients within clinical care settings It is intended that the user is a professional health care provider Physiological data system alarms and patient data analysis are available to the care provider from the monitor The user is responsible for the interpretation of the monitored data that is made available Physiological data should be reviewed by a qualified clinical personnel prior to any medical intervention The monitor is designed to be used with only one patient at a time The monitor including accessories is capable of monitoring a full range of patients from neonate to adult The nGenuity 8100E Series monitor comes standard with 5 Lead ECG ComfortCuff NIBP DOX SpO and one temperature channel for monitoring Options include internal printer and CO monitoring A color TFT screen with a six waveform display is standard on all nGenuity 8100E Series models The nGenuity 8100E Series monitor is also available with ST and Arrhythmia analysis as an option Catalog Number Printer Additional Features 8100E No Standard 8100E ST No ST Arrhythmia 8100E1 No CO 8100E1 ST No CO ST Arrhythmia 8100EP Yes Standard 8100EP ST Yes ST Arrhythmia 8100EP1 Yes CO 8100EP1 ST Yes CO ST Arrhythmia nGenuity 8100E Series Operator s Manual Page 1 1 Section 1 Introduction Pulse Oximetry Measurement SpO Definition DOX Digital Oximetry Method Page 1 2 The monitor uses Digital Oximetry
110. le at its connectors to disconnect the cable from instrument or disposable probe connectors During use do not entwine the cable with other electrical cables nGenuity 8100E Series Operator s Manual Page 4 27 Section 4 Patient Monitoring Directions for Use with 1 Directions for Use with Esophageal Rectal Probe Page 4 28 Skin Surface Probe 5 Check the monitor settings for correct setup Insert the cable s instrument side connector into the monitor s input jack Prepare skin site according to established protocol Suggest same skin preparation as for ECG electrodes Adhere sensor to skin site Unwind the cable from the protective card and peel the sensor from the card Align the cable s sensor side connector with the sensor s connector and push firmly to assure full contact Verify proper operation of monitor Disconnect sensor connector from cable connector when temperature monitoring is discontinued The disposable esophageal rectal temperature probe is a sensitive and accurate temperature transducer to be used clinically where continuous temperature monitoring is required See the esophageal rectal temperature probe insert for detailed probe description 1 If a patient has to be intubated with an endotracheal tube perform the intubation prior to placing the temperature probe into the esophagus Lubricate the temperature probe prior to insertion and place the p
111. lectrosurgery infrared energy and defibrillation Biocompatibility All patient contact or user contact materials in this monitor and it s accessories have passed ISO 10993 5 10 amp 11 biocompatibility tests or have been in use in clinical environments in large numbers over an extended period of time predating these standards Latex Content All Criticare Systems Inc products including patient monitors and accessories are free from latex in any location that may result in patient contact DEHP Content All Criticare Systems Inc products currently shipping are free of DBP and DEHP in any areas that would be intended for patient contact with blood mucous membranes or continuous skin tissue contact Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 1 19 Section 2 Controls and Connections Front Panel Criticare Systems Inc This section provides an overview of the nGenuity 8100E Series monitor s control panels switches accessory connections and communication sockets The front panel of the monitor features a color flat screen display Located to the right of the screen is the primary control panel equipped with the power button seven dedicated function keys and a menu knob Menu selections are displayed on the screen and can be selected via the menu knob The keypad is push button style composed of a touch sensitive membrane Below the display is an alarm SILENCE key Color Display Keypad
112. licator can be fastened with an adhesive strip or a head band can be used Figure 4 6 Sensor Forehead Application The Multi Site sensor can be used for measuring SpO on an infant foot Place the light emitting sensor pad on the top of the infant foot The detector should be placed on the bottom Adhesive tape may be used to hold the sensor pads in place Figure 4 7 Sensor Foot Placement Pulse oximeter sensors should be replaced if they fail or become excessively worn Replacement sensors may be ordered from Criticare Systems Inc See Accessories in Appendix A Disposable sensors are for single patient use only and should be used with highly infectious patients Reusable sensors should be disinfected between uses with each new patient Do not stretch sensor cables Store cables carefully after forming them into loose loops If cables are stretched electrical failures could result The sensors must not be tightly wound around fingers or other objects The cable used in DOX reusable sensors has a minimum acceptable bend radius of 0 75 inches 19mm For short term storage the sensor should be loosely looped or hung on a large diameter hook nGenuity 8100E Series Operator s Manual Page 4 7 Section 4 Patient Monitoring ECG Monitoring Electrocardiogram Page 4 8 The following instructions describe procedures for preparing a patient for ECG monitoring Shown below is the patient monitor with an ECG cable
113. lood pressure The source of the respiration data is indicated by a letter following each value E electrocardiogram and C COs Various messages appear in the tabular trend to indicate that system events have occurred A complete list is as follows FREEZE ON FREEZE OFF AUDIO ON AUDIO OFF SIM ON POWER NEW PATIEN NOTE Permanent silence and 2 minute silence are both recorded as an AUDIO ON OFF event in the tabular trend table The trend also records messages in the trend table that indicate the status of the monitor at that time The time and date stamp are also recorded when one of the following messages is recorded All messages appear in the trend table regardless of the interval selected for the table or the time that the message occurred When the monitor enters and exits Silence Mode the message AUDIO ON or AUDIO OFF is recorded in the trend table This includes 2 minute silence and permanent silence conditions When the monitor s waveforms are frozen and unfrozen the message FREEZE ON or FREEZE OFF is recorded in the trend table When the monitor is turned off and on the message POWER is recorded in the trend table When a new patient is admitted in the ADM DIS window the message NEW PATIEN is recorded into the trend table Note that Adult Ped or Neo is entered if when age changes When a patient is discharged in the ADM DIS window the message NEW PATIEN is recorded into the trend table At midnight th
114. lume is set to 1 it returns as 2 if the monitor is power cycled To turn off the alarms use the SILENCE key See Alarms and Messages in Section 5 for more information about alarms Low SpO Alarm The setting for the Low SpO2 Alarm displays in the SpO parameter box on the display Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 3 9 Section 3 Setup Procedure PARAMS Softkey When this key is activated a parameter settings window appears This Physiological Parameters softkey allows access to the physiological parameter settings Each of the sampling modules is listed here and can be turned on and off ALARMS MEZUGTNEE DISPLAY ADM DIS CONFIG PRINT NOTE CO2 parameters will only show on monitors with CO monitoring EXIT Heart Rate NIBP HR Source Smart NIBP tone Heart Rate Tone Vol 5 Temperature ECG H Unit of measure Cable 3 lead Pace detect OFF Filter Monitor Sensitivity MEDIUM p02 je Average 12 seconds Search time 20 seconds Respiration ON C02 Unit of measure N20 Compensation Figure 3 4 Parameter Window HR Source Turning off modules forces the monitor to generate the numerical Smart Heart Rate heart rate value from the remaining operating modules If the ECG signal is lost or turned off the monitor automatically switches to an SpO source for heart rate if SpO is available The monitor generates a heart rate from the ECG module the SpOs module or f
115. ly replaced if it becomes filled or occluded as shown below The front of the WaterChek 2 Cat No 938F N has a female Luer lock sampling line entrance Sampling Devices Shown below is the monitor with a patient gas sampling device nasal cannula and an 8 foot sampling line attached This nasal cannula CAT 624 is used for CO monitoring e T Figure 4 19 Nasal Cannula If using the nasal cannula position it directly under the patient s nose with the prongs inserted into the nostrils Slide the adjuster forward to close the loop around the head The nasal cannula is intended for single patient use only Alternate sampling devices such as masks may be used if they have a female Luer lock sampling entrance Intubation breathing circuits require a sampling entrance near the connection to the endotracheal tube Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 4 21 Section 4 Patient Monitoring Intubated Patients Page 4 22 The monitor can be used with intubated patients Recommended water traps and breath circuit adapters should be used The trap reservoirs should be checked regularly The breath circuit should be checked regularly for leaks or disconnections Follow the directions provided with your endotracheal tube for additional precautions The following ventilation circuit adapters are available from Criticare Alternate ventilation circuit adapters may be used if they hav
116. m display is disabled in slots 5 through 6 when MINI TREND is set in Waveform 4 To set MINI TREND 1 Scroll to Waveform 3 or 4 Press the rotary knob 2 The waveform TYPE is highlighted Rotate the knob until MINI TREND appears Press the rotary knob to select MINI TREND EXIT TYPE Waveform ECG II Waveform Cascade Waveform MINI TREND Waveform OFF Waveform OFF Waveform OFF External Display Figure 3 10 MINI TREND Selected for Slot 3 Waveforms affected should show OFF or TYPE 3 Exit from Display menu nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 3 Setup Procedure Initiating Mini Trend To initiate MINI TREND an NIBP reading needs to be taken 1 Set up the patient for NIBP See NIBP Monitoring in Section 4 2 Press the NIBP key to begin NIBP reading 3 The MINI TREND display displays the parameter values at the time of the NIBP reading NOTE If a parameter is set to OFF the column for that parameter will be blank The color of the parameter data will be the same as the color selected for the waveform and parameter box data Mini Trend Display If a slot is set to MINI TRENDS waveform slots 3 through 6 display up to 13 mini trend records The smaller display using waveform slots 4 through 6 shows up to 6 mini trend records A mini trend record consists of the following parameters Heart Rate HR e SpO NIBP Respiration Temperature e ETCO on monito
117. mmHg RESP Br m Br m Br m Br m Br m Br m Br m Br m Br m Br m Br m Br m Br m 96 4 Bs i nnnnnnnnn Figure 7 4 Mini Trend Printout NOTE When the monitor is in MINI TREND the monitor cannot print a continuous print of real time waveforms with vital signs data to the internal thermal printer To access alternative printing formats set the Waveform to OFF to turn off MINI TREND and then press and hold the PRINT key for a continuous waveform print with vital signs data A short press of the PRINT key still produces a tabular or graphical print as defined Print Type in the PRINT softkey nGenuity 8100E Series Operator s Manual Page 7 5 Section 7 Printing and Data Ports Changing Printer Paper The monitor uses CAT 553 thermal paper The paper must be loaded with the thermal reactive side down as shown in the pictures below 1 Open the printer door and remove the old spool 2 Insert the paper between the rollers The paper automatically feeds when the paper is inserted Figure 7 6 Feed Paper 3 Close the printer paper door Page 7 6 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Data Output Ports COMI Port Criticare Systems Inc Section 7 Printing and Data Ports The Model 8100E Series monitors support a variety of communication connections The communications ports are located along the left edge of the back of the monitor The ports are as follows
118. mpliant and utilizes a 4 digit year for all date time and leap year calculations Page 1 18 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 1 Introduction Potential Interference This device has been successfully tested to IEC 601 1 2 specified levels for emissions of and resistance to electromagnetic energy fields External disturbances which exceed these levels may cause operational issues with this device Other devices which are sensitive to a lower level of emissions than those allowed by IEC 601 1 2 may experience operational issues when used in proximity to this device MAGNETIC FIELDS Use of the monitor in an MRI environment may interfere with MRI image quality Use of MRI may interfere with the monitor The 8100E Series patient monitor is not intended for use in MRI environments RADIO FREQUENCY INTERFERENCE The monitor conforms with IEC 1000 4 3 for radio frequency interference and will operate with negligible adverse effects CONDUCTED TRANSIENTS The monitor conforms with IEC 61000 4 4 and IEC 61000 4 5 for conducted transients and will operate with negligible adverse effects X RAY The monitor will operate with negligible adverse effects in an X ray environment However the monitor should not be placed directly in the X ray beam which could damage the internal electronics of the monitor OTHER INTERFERENCE There is a negligible adverse effect to the monitor from electrocautery and e
119. n 8 1 Pulse Oximeter Sensors iiia a aaa rie ters 8 1 Blood Pressure Cuffs 8 2 Temperature Cable 8 3 Temperature Sensors we 8 3 Accidental Wetting tenerent nn retentu te so era erae dra naa dadas 8 4 Serviceable Components essent enne enne 8 5 Changing the Battery 8 5 Changing the Fuses 8 5 Annual Safety Tests wi 8 7 System Testing nice rou e eter ey Re hs elses 8 7 Accessory Testing nieto ene temen eite Lee E E 8 7 Service Checks e 8 7 Printer Check s 8 7 Alarms Verification 8 8 Maintenance Schedule eessssseeeseeeeeenenne nennen enne enne 8 9 Every Patienil ope resi dert rri RR RADAR Re Eten Fere herbae n dakari e RAN HR prd EE 8 9 Every Day PE Every Week eee edente a aA e ener Every 3 Months Every Year Battery Maintenance Long Term Storage 2 Disposal 2x eite cre eee ate etd a De iei iva nire ei e dives Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page vii Contents Page viii Appendix A Accessories SpOs ACCOSSOFrIGS itat o d ee LO edd oe alae eet A 1 Reusable Sernisors intei dre be ced Erbe c eei eiie A 1 Multi site Sensor Accessories esssssssssesseeeeeee enne enne eene nnn A 1 Disposable Sensors A 1 ECG Accessories A 2 Universal ECG Cabl Siin aieeaa nin
120. n alarm is generated There is an ST Arrhythmia alarm icon located in the upper corner of the main screen located near the PVC Rate numerical display The icon appears when one or more of the ST or PVC alarms are disabled in the alarm menus nGenuity 8100E Series Operator Manual Page C 21 Appendix C Arrhythmia and ST Analysis Arrhythmia Alerts ECG ASYSTOLE ECG VFIB ECG VFIB ASYS ECG VTACH TACHYCARDIA BRADYCARDIA ECG VT 2 RUN ECG BIGEMINY ECG TRIGEMINY ECG COUPLETS ECG IRREG HR ECG HIGH PVC MIN ECG PVC RUN ECG LEARNING Page C 22 Priority High High High High High High Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable nGenuity 8100E Series Operator Manual Description Asystole alarm appears when a heart beat has not been detected for 10 seconds This message replaces the ECG LOST message normally reported by the monitor Ventricular fibrillation alarm appears when the ECG signal has no detectable QRS or T components The waveform is irregular in shape interval and amplitude for a period of 4 seconds A period of 4 seconds composed of asystole and ventricular fibrillation conditions Eight or more PVC classified beats detected at a rate above the user defined limit for ventricular tachycardia This message replaces the HIGH PULSE RATE message normally reported by the monitor while the smart hea
121. nGenuity 8100E Series Vital Signs Monitor Operator s Manual nGenuity a ene f isat FEB 13 06 14 55 39 DAAL ie D L C C E oats Cat No 1447 Part No 39179B001 Date 01 10 Revision 3 Copyright COPYRIGHT O CRITICARE SYSTEMS INC 2006 2010 CRITICARE SYSTEMS INC Criticare owns all rights to this unpublished work and intends to maintain this work as confidential Criticare may also seek to maintain this work as an unpublished copyright This publication is to be used solely for the purposes of reference operation maintenance or repair of Criticare equipment No part of this publication may be reproduced in any manner or disseminated for other purposes In the event of inadvertent or deliberate publication Criticare intends to enforce its rights to this work under copyright laws as a published work Those having access to this work may not copy use or disclose the information in this work unless expressly authorized by Criticare to do so All product specifications as well as information contained in this publication are subject to change without notice All information contained in this publication is believed to be correct Criticare Systems Inc shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing performance or use of this material This publication may refer to information and products protected by copyrights or
122. nd Arrhythmia Alarm Description Alarm Conditions Arrhythmia Alerts esses enne nre nnenneeeneren rennen nren terit aM cA Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page ix Warranty Workmanship amp Materials Exemptions Safety Reliability amp Performance In Case of Emergency Contact cy Criticare Systems Inc Criticare Systems Inc CSI warranties new equipment to be free from defects in workmanship and materials for a period of one 1 year from date of shipment under normal use and service The 940 Series Multi Site Sensor carries a six month warranty CSI s obligation under this warranty is limited to repairing or replacing at CSI s option any part which upon CSI s examination proves defective EXCEPT AS DESCRIBED IN THE PARAGRAPH ABOVE CSI MAKES NO WARRANTIES EXPRESS OR IMPLIED INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE CSI s obligation or liability under this warranty does not include any transportation or other charges or liability for direct indirect or consequential damages or delay resulting from the improper use or application of the product or the substitution upon it of parts or accessories not approved by CSI or repair by anyone other than a CSI authorized representative This warranty shall not extend to any instrument which has been subjected to misuse negligence or accident any inst
123. nd slots can be combined to form double high waveforms See Cascaded Slots in Section 3 for details nGenuity 8100E Series Operator s Manual Page 2 11 Section 2 Controls and Connections Page 2 12 The color of each channel can be selected independently See PARAMS Softkey Physiological Parameters in Section 3 If the waveform pulses exceed the limit of the selected range for the waveform the waveform is clipped VISUAL ALARMS WITH WAVEFORMS The waveform slots are also used to display physiological alarms that appear at the top center of each slot For a high priority alarm the color of the message is red For a medium priority alarm the color of the message is yellow The bottom five 5 slots may be covered by menus and messages Since the top waveform slot is dedicated to ECG the ECG waveform and the ECG high and medium priority messages are always visible if ECG is currently being monitored and the top slot is active See Visible Alarms in Section 5 for a complete description of visual alarms SILENCE ALERT STATUS The silence alert visual icon appears in the upper right corner of the top waveform The silence icon shows a bell with an X and an infinity symbol when the Alarm SILENCE hard key is pressed and held for more than two seconds The Alarm Suspend icon shows a bell with an X and the words 2 min when the Alarm SILENCE hard key is momentarily pressed ECG WAVEFORM The lead type are displayed in t
124. ng to access the color sample box Turn the knob to scroll through the possible colors and press the knob to enter the selection Colors red yellow blue green orange violet light gold and white may be selected The unit of measure for CO measurement can be set to percent mmHg kPa or Torr N20 COMPENSATION A manual N5O compensation is set for the internal capnometer in the extended PARAMS window for CO monitoring This feature should be manually activated when N5O is being used nGenuity 8100E Series Operator s Manual Criticare Systems Inc DISPLAY Softkey ALARMS PARAMS ADM DIS CONFIG PRINT Section 3 Setup Procedure This softkey allows access to the display settings When activated the display settings window appears The monitor can display up to six waveforms and has user selectable waveform slot configurations See Waveform Slots in Section 2 for a list of displayed waveforms TYPE ECG II Cascade PLETH ECG I OFF OFF External Display Figure 3 5 Display Settings Window Waveform Description The waveform area is located in the upper left hand portion of the Criticare Systems Inc display The monitor has the capability to display six waveforms simultaneously The top waveform slots 1 2 and 3 are 25 mm in height Waveform slots 4 5 and 6 are 12 5 mm in height Slots can be configured in a variety of ways as described in the following text The waveforms may b
125. nitor Information about changing the batteries can be found in Changing the Battery in Section 8 Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 2 7 Section 2 Controls and Connections rf Chassis AC Power n Ground Cable l EN Connection Fuse Access Panel Figure 2 7 nGenuity 8100E Series Power Panel Chassis Ground This is used during testing and servicing of the unit See the nGenuity 8100E Series Service Manual CAT 1448 for more information about testing AC Power Cable An AC power cable connection is located at the center of the rear of Connection the patient monitor The cable plug is placed in the socket and the cord can be fit into the channel provided in the case Fuse Access Panel The fuses are located behind this panel Optional Printer This printer door provides quick access to the internal printer paper spool The printer lever releases the printer rollers for removing jammed paper The knob can be turned to feed paper See Printing and Data Ports in Section 7 for additional printer information Page 2 8 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Screen Display and Interface Criticare Systems Inc Section 2 Controls and Connections The display is divided into several areas that are dedicated to different types of data and interface functions The upper left corner contains six 6 slots for displaying continuous wa
126. nt CONFIG Softkey System Configuration sese Password Protection Time Date Setting coe ER ex Det e ieee Freeze Waveforms nini neri eiie nme eii ime iere iPod Alarm Tone Warning Language Settings Printer Settings Printer Type niter tr ehe Ie Y ERE MER RR Eee nha DR Re aede EE orale serial TVpe s csi oec eL ecl iL even des eA LA Default Settings Alarms Settings no ttem ves Monitoring P rameters 2 rnnt tnnt nee rri ent tnnc ine Display Settings Configuration Settings Printer Settihigs ii qc aet ep ERE Ede REC DX EAEN Section 4 Patient Monitoring Introduction to Clinical Use Before you Begin sau SpO Monitoring Pulse Oximetry sesssssseeseeeeeeenenee nennen 4 2 Sensor Selection xcci oett etre one e ye EN C edv eh aeg 4 4 SpO s Sensor Placement 4 5 Multi Site Sensor Placement 4 6 Using SpO Sensors ee 47 ECG Monitoring Electrocardiogram ssccecsseeseeereeeeneceeeeeeeeeeeaeeeeesaeeeeeeaeseeeeeeaeees 4 8 Pacemakers and Electronic DeViICES eee eee eeeee cere e cee eeeeseaeeeneeeeaeeeeeees 4 9 Tall T Wave Performance 24 9 Narrow Beat Rejection we 4 9 Electrode Selection on dede ELLO e eR e een eise 4 9 Lead Placement sivas etait eet Fette STD RP eee a 4 10 3 Lead Setup 5
127. nt unusual monitoring settings from being carried forward accidentally to new patients The patient must be admitted to properly use all the network communications features of the monitor Patient Information To enter change or update patient information 1 Set the menu to ADM DIS and press the knob 2 Turn the knob to Update and set to YES Press the knob The patient data field can now be selected 3 Go to Patient Size and check that it is correct Change to Adult Pediatric or Neonate as necessary 4 Go to the patient name and identity fields Turn the knob to select the desired field Press the knob to go to the blank line Turn the knob to select the correct letter NOTE Letters and digits may be entered using the rotary knob Two arrow characters also appear among the letters and digits Selecting the back arrow allows corrections to be made The down arrow skips directly to the next line when finished entering a line 5 Fill in the remaining patient information blanks as desired Enter a value for unit label only if using central station communication 6 Select EXIT to return to the main screen The patient data is updated on the main screen 7 Exit the ADM DIS window and re enter before attempting to admit a patient NOTE If menu text is entered and then the menu is not touched for 45 seconds the monitor accepts the inputs and removes the menu Page 3 20 nGenuity 8100E Series Operator s Manual Critic
128. ocedure Respiration Smart Source NIBP Settings Temperature Settings Heart Rate Tone Volume Pulse Tone Color Settings CO Settings for units that have CO monitoring Page 3 12 The respiration data can be generated from either ECG Lead or capnogram CO3 The monitor automatically switches if the primary source COs fails and the alternate source ECG is available The monitor switches back to the primary source when the CO data is available again The NIBP can be set to generate a tone upon completion of each measurement NOTE Press the NIBP CYCLE STAT key to access the cycle settings The temperature channel can be set to read in either Celsius or Fahrenheit This feature can be set in the PARAMS window The tone can be set to volumes 1 through 10 or OFF Also referred to as heart rate volume or pulse tone this only controls the tone volume associated with the heart rate rhythm It is not affected by adjustments to Alarm Volume or the SILENCE feature At the end of some monitoring module settings the setting Color appears with a color sample appearing to the right The color sample indicates the current color selected for the display of the numerical values and waveforms for that monitoring module The numerical values and the waveforms are always in matching colors with the exception of the breath by breath display which is always in white The colors can be changed as desired Select the color setti
129. oftkeys More information about the soft keys and their function is explained in Softkey Functions Main Menu in Section 3 The two 2 alarm lines are located under the NIBP numerical box All NIBP and temperature parameters have all of their alarm error messages displayed in this area ECG SPOs and respiration high and medium alarms are displayed here if there is not an active waveform associated with them All low level messages are displayed in the top alarm line The bottom line is for informational messages and advisory level alerts only The informational low and medium level alarm warnings are colored yellow and the high alarm warning messages are red For more information about alarms see Alarms and Messages in Section 5 The system status box is located directly below the two lines reserved for alarms and messages BATTERY WARNING ICON There is space reserved for one battery icon The battery icon represents the state of the internal rechargeable battery See Battery Indicators in Section 3 for a complete description of the icon and battery charging PATIENT SIZE MODE The next item in the status line is the patient mode This message lets the user know what the patient size or mode the system is in Adult Pediatric or Neonate The default physiological alarm limits may change depending on which mode is currently in use nGenuity 8100E Series Operator s Manual Page 2 15 Section 2 Controls and Connec
130. op printing Press this key momentarily to access custom default profiles Press and hold the key to alter custom default profiles password LIA6 8 required Press this key momentarily to begin a two minute alarm silence Press and hold the key to permanently silence the alarms Press the key again a second time to resume normal alarms An audible beep notifies the user that a primary function has been activated A double beep notifies the user that a secondary function has been selected by pressing and holding the key Page 2 2 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 2 Controls and Connections AC Power Indicator A green LED indicator is located to the right of the ON OFF power key The indicator is on if AC power is present Indicator Function Keys Rotary Menu Knob Figure 2 2 Detail of Right Side of Front Panel Rotary Menu Knob The knob can be turned left or right to make selections from any of the menus that appear on the front display The selected menu option can then be activated by pressing in on the knob Color Display The display provides real time waveform data and numerical data of the measured parameters The display screen provides main screen menu options that are selected and activated by the menu knob Additional menus that appear on the display screen are also selectable with the menu knob Criticare Systems Inc nGenuity 8100E Series Operator s Manual Pag
131. or housing The monitor should be inspected by a service technician as Soon as possible If the internal mechanism is saturated allow the liquid to drain out for 24 hours before shipping If liquid has entered the monitor it needs to be dried and cleaned internally Full testing is required before the monitor can be used Contact the CSI Service Department as soon as possible Time is critical The longer any liquid remains in the monitor the more damage it can do It is important to service the monitor immediately after any liquid is spilled into it nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 8 Maintenance Serviceable Components Changing the Battery Changing the rechargeable battery requires opening the case of the monitor The case should only be opened by experienced electrical technicians Consult the service manual for more information about battery replacement NCAUTION A Do not open the case Sensitive electronic components may be damaged by electrostatic discharge Opening the case requires an electrostatic ESD protected work bench Shock hazard The interior of the case contains exposed circuitry Do not short circuit the battery terminals The resulting high current discharge can cause burns The battery contains sulfuric acid electrolyte which can cause severe burns and eye damage as well as illness from sulfur oxide fumes Changing the Fuses Th
132. ot calculate a blood pressure on the first inflation If a patient experiences a sudden dramatic drop in blood pressure the system may not measure the blood pressure on the first attempt The system automatically attempts another pressure measurement and detects the change on the second attempt Do not compress the cuff or the cuff hose externally Compression of the cuff or the cuff hose causes measurement error For optimum accuracy the patient should remain still during blood pressure measurement Excessive patient motion may adversely affect any oscillometric NIBP device nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring Gas Monitoring The following instructions describe procedures for preparing a patient for CO monitoring Sampling Circuit The monitor uses a sidestream gas sampling circuit composed of a Connections water trap a sampling line and a sampling device The water trap is a combination filter and moister condenser Shown below is the patient monitor with water trap CAT 938F N and sample line CAT 625N The monitors gas sampling receptacle fits WaterChek series water traps y QOQRADYVOY VT Figure 4 17 Gas Sampling Connection Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 4 19 Section 4 Patient Monitoring Page 4 20 The monitor s gas sampling connection from
133. oxygenated hemoglobin absorb light selectively and predictably the amounts of these two compounds can be determined by measuring the intensity of each wavelength that passes through the measuring site nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 1 Introduction The light from the LEDs shines into a pulsating vascular bed A photodetector located opposite or alongside the LEDs measures the intensity of each wavelength transmitted through the monitoring site The light intensity is converted to an electrical signal which is input to the monitor The effects of skin pigmentation venous blood and other tissue constituents are eliminated by separating out the pulsating absorption data SpO is calculated with every pulse and averaged with the results from previous pulses to arrive at the current numeric display value The display is updated at least once per second with the numeric values that were calculated during the intervening period The plethysmographic pulse wave is not auto gained The amplitude display of the plethysmographic pulse wave is proportional to the pulse volume changes occurring in the tissue illuminated by the SpO sensor SpO Clinical Testing All Criticare oximeters DOX compatible have SpO calibration and Accuracy tables which were originally generated by monitoring desaturated human patients or volunteers and matching their displayed SpOs value to the value determined by sam
134. peat every eight seconds For each burst there is a short delay between the 3rd and 4th pulse The frequency of each pulse is 1000 Hz MEDIUM PRIORITY ALARMS Each burst consists of 3 pulses The frequency is 800 Hz and the repeat cycle is approximately 25 seconds LOW PRIORITY ALARMS Each burst consists of two pulses The frequency is 350 Hz and the repeat cycle is 15 seconds ADVISORY ALERTS Each burst consists of two pulses The frequency is 300 Hz and the repeat cycle is approximately five minutes nGenuity 8100E Series Operator s Manual Page 5 1 Section 5 Alarms and Messages 1mv II x1 Visible Alarms SPO2 SENSOR VQ0 NO ADMIT imi Adult HIGH PULSE RATE Waveforms Frozen Page 5 2 The monitor provides visible text alarms on the interface display screen FLASHING NUMERICAL PARAMETERS If a physiological parameters exceeds a high limit or falls below a low limit value the numerical value displayed flashes This function cannot be suspended and is visible when pop up menus are activated ALARM MESSAGE LINES There is space for two text lines provided directly below the NIBP parameter box If multiple alarms are active they alternate in the alarm area The bottom line is used for the informational messages and advisory alerts Low level alarms and informational level messages are displayed in this area for the vital signs that have a waveform displayed For parameters that do not have a waveforms dis
135. ped below the value set in the ALARMS menu The diastolic value has exceeded the value set in the ALARMS menu The mean arterial pressure value has dropped below the value set in the ALARMS menu The mean arterial pressure value has exceeded the value set in the ALARMS menu Displayed when a neonatal cuff is used while the monitor is in the adult or pediatric mode Switch to neonatal mode when using a neonatal cuff Can also indicate a leak in the cuff or the cuff is wrapped too loosely The monitor has detected a fault with the NIBP function Contact CSI Service Department Pulse amplitude is too low Reposition cuff Maximum allowed cuff pressure 300 mmHg adult or 150 mmHg neonatal has been attained Maximum time 2 minutes allowed for measuring the blood pressure has been exceeded Repeat measurement The monitor was unable to deflate the NIBP cuff Disconnect the cuff and contact the CSI Service Department The monitor was unable to take a blood pressure reading Check cuff position The monitor had detected a fault with the calibration Cycle the power to the monitor If the problem persists contact the CSI Service Department The cuff has not completely deflated Wait for deflation and then press the NIBP key again Criticare Systems Inc Gas Alarms APNEA CO2 CHECK LINE CO2 OCCLUSION CO2 INSERT TRAP CO2 ZEROCAL CO2 FCAL ERROR CO2 UCAL ERROR CO2 ERROR CO2 BENCH FAIL Criticar
136. perator s Manual Criticare Systems Inc Placing the NIBP Cuff Criticare Systems Inc Procedure Section 4 Patient Monitoring Cuffs for thighs are available for large patients or those where neither arm is available for cuff placement Blood pressure measured at the thigh is typically 20 30 mmHg higher when the patient is standing not prone than blood pressure measured at the upper arm Wrap the cuff snugly around the extremity leaving enough room between the cuff and the extremity for two fingers If the cuff is too loose it cannot be inflated properly and may cause errors in measured BP values t is best to wrap a bare extremity putting the cuff over clothing may cause errors in measured values Care should be taken to center the dot on the cuff directly over the brachial artery Shown below as a circle with a vertical line The hose should not be twisted or kinked The end of the cuff marked by an index line should fall inside the range marked clearly on the inside of the cuff If not use a different size cuff Place this side against the skin Este lado hacia la piel Ce c te en contact avec la peau Figure 4 15 Blood Pressure Cuff Size Range 1 Check the System Status Line for the correct mode The status line indicates Adult Pediatric or Neonate Select a cuff as described previously in this section Connect the BP cuff to the monitor Secure the cuff around the patient s extremit
137. pired C02 Expired Apnea 5 MEDIUM Adult HIGH 150 OFF 200 100 150 100 0 7 5 60 seconds Figure 3 2 Alarm Settings Window Adult The pediatric and adult settings are initially identical as factory defaults but can be adjusted independently and saved as desired EXTT Alarm Volume ECG Lead Fail Patient size Heart Rate Sp02 NIBP Systolic NIBP Diastolic NIBP Mean Temperature Respiration C02 Inspired C02 Expired Apnea 5 MEDIUM Neonate HIGH 180 OFF 140 80 100 100 0 7 5 60 seconds Figure 3 3 Alarm Settings Window Neonate NOTE CO2 Inspired CO2 Expired and APNEA Time Out only show on monitors with CO monitoring nGenuity 8100E Series Operator s Manual Page 3 7 Section 3 Setup Procedure Alarms Settings The monitor retains separate alarm setting for three different patient by Patient Size sizes When the patient size mode is changed to adult pediatric or neonate the monitor recalls alarm limit setting specific to each patient size The extended alarm limit window which is present for monitors with ST Arrhythmia also has size specific versions As in the main the screen the pediatric alarm settings are the same as adult in the Factory Default profile See Arrhythmia and ST Analysis in Appendix C To set all the alarm limits adjust the settings as necessary including the extended windows that appear under Other Alarm Setups Then change to the next patient size and adj
138. played all level of alarms are reported in the Alarm Message Lines The informational low and medium level alarm text messages are colored yellow and the high alarm warning messages are red WAVEFORM SLOT VISUAL ALARMS When a high or medium alarm occurs for a vital sign that has an active waveform the message is displayed in the top center of the waveform in large text If there are multiple alerts to be displayed in a waveform slot the messages alternate If the waveform exists in multiple slots either through cascade or duplicate waveforms from alternate leads the waveform messages only occur in the top most slot Waveform Slot Alarms are not visible during the following conditions The waveform is not selected to be displayed A pop up window or menu covers the waveform slot If a high or medium level alarm message cannot be displayed in the waveform slot due to a pop up window the alarm message is displayed in the Alarm Message Lines near the bottom of the screen Alarm text messages that appear in the waveform slot are not frozen The high and medium alarm messages appear based on the current waveform data not the frozen waveform shown nGenuity 8100E Series Operator s Manual Criticare Systems Inc Alert Icons D Special Alarm Conditions Alarms at Start Up Alarm Silence X2 Min Criticare Systems Inc Section 5 Alarms and Messages There are two alert icons that may appear on the main screen
139. pling arterial blood and measuring functional SaO with a clinical laboratory grade multi wavelength optical oximeter i e CO oximeter The final SpOs calibration curve was then generated based upon numerous patients data over the range of 40 to 99 SaO All accepted data were taken from patients with dyshemoglobin i e carboxyhemoglobin methemoglobin concentrations near zero This oximeter is a two wavelength device which is calibrated to measure functional SpO only when dyshemoglobin concentrations are near zero The accuracy specifications of this device will not be met with high concentrations of dyshemoglobins Significant concentrations of carboxyhemoglobin results in a higher displayed SpO value than is actually present in the patient SpO clinical accuracy validation to CO oximeter SaO readings was performed for this sensor using a DOX compatible monitor The personal demographics of the study participants for the SpO clinical accuracy validation include a mix of adult males and females from 18 45 years of age All were healthy during the course of the study Physical characteristics and skin tone were by chance with a mix from slight to stout and light to dark Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 1 3 Section 1 Introduction Heart Rate ECG Measurement Method Page 1 4 The heart rate is determined primarily from the ECG waveform data A beat detection algorithm is u
140. ply with all electrical installation regulations mandated by the local and regional bodies of government Cables cords and leadwires may present a risk of entanglement or strangulation Verify safe and proper positioning of these items after patient application Leakage currents may increase if other equipment is interconnected to the patient The increased leakage currents may present a hazard to the patient nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 1 Introduction NWARNING N High Frequency HF surgical equipment may affect ECG operation The ECG waveform will return to normal momentarily after the HF source is removed Ensure that electrodes and sensors are not placed near the HF source Unapproved modifications to the monitor may cause unexpected results and present a hazard to the patient Unapproved use of the accessories can also present a hazard to the patient or affect monitor performance Do not re use accessories labeled as single use Risk of patient contamination may occur Improper disposal of batteries may result in explosion leakage or personal injury Do not open batteries Do not dispose of batteries in a fire Follow all local regulations concerning the disposal of spent Lead acid and Lithium lon batteries or contact Criticare for assistance Risk of electrical shock Do not remove cover Refer servicing to qualified personnel U S Federal law restrict
141. ported Description A graphical method of setting the ISO J and ST points for ST analysis is available through the PARAMS screen This allows the user to adjust the reference and measurement points with the menu knob An averaged QRS is displayed for each lead view Page C 16 nGenuity 8100E Series Operator Manual Criticare Systems Inc Appendix C Arrhythmia and ST Analysis A ST historical graph display is available for waveform slots 2 and 3 that is divided into 3 boxes Each box contains a graphical plot of the ST elevation numbers for each lead view The time scale is adjustable from 5 10 15 30 or 60 minutes and the vertical scale is adjustable from 1 mm to 6 mm in 1 mm steps The graphs are updated once per minute with the most recent data displayed at the right hand end e fthe ST value is dashed then the graph will be railed low fthe ST value is greater than the vertical scale allows the graph will rail high Starting ST 1 Confirm that the ST Arrhythmia extension has been activated on your monitor 2 Select the PARAMS softkey on the main menu and enter the first window If the ST Arrhythmia extension is present additional settings now appear on the right side of the window 3 Rotate the menu knob past the end of the ECG settings The highlight cursor then jumps to the beginning of the S7 Arrhythmia parameter settings 4 Highlight S7 and press the menu knob to select 5 Rotate the menu knob and t
142. r to pressing the print key and lasting the duration of the Snapshot setting in the print menu i e if the print type is set to graphical and snapshot is set to 6 seconds then the 8100E Series monitor prints out the waveform data selected 4 5 seconds prior to a print keypress and 1 5 seconds after the print keypress History Size History size is a period of time defined by the user that is prior to the snapshot time period History size can be selected as 6 or 12 seconds Print Modes Demand Print If the print type is set to Tabular pressing the PRINT key causes an immediate print out of the vital signs numbers date time and patient data in a tabular text format If the print type is set to Graphical pressing the PRINT key causes an immediate print out of the selected waveforms for a duration as selected by snapshot size Continuous Print If print type is set to Graphical pressing and holding the PRINT key for two seconds causes the selected waveforms to print out continuously until the PRINT key is pressed again at 12 5mm sec or 25mm sec If set to 50mm sec it defaults to 25mm sec Alarm Print The monitor issues a printout if a high or medium alarm occurs as selected by the user in the PRINT softkey window If the print type is set to Tabular a tabular demand print format is issued if an alarm setting is violated If the print type is set to Graphical and snapshot size is set to 6 seconds a 6 second graphical prin
143. r outlet and then turning the instrument on all displays appear to function correctly and no system errors occur If a discrepancy to these inspection items is observed do not use the instrument and immediately report the discrepancy to the CSI Service Department Page xii nGenuity 8100E Series Operator s Manual Criticare Systems Inc EC Declaration of Conformity Model 8100E Series To view the Declaration of Conformity visit the Criticare website at www csiusa com A copy of the Declaration can also be faxed Patient Monitor Contact Criticare s customer service department at 262 798 8282 to obtain a faxed copy of the Declaration Representative in the MDSS GmbH European Union Schiffgraben 41 30175 Hannover Germany Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page xiii Section 1 Introduction Description Intended Use nGenuity 8100E Series Options Criticare Systems Inc The nGenuity 8100E Series monitor interprets and displays real time physiological data including waveforms and numerical data The monitor is designed for multi parameter measurements including ECG NIBP SpOs temperature and respiration Optional CO monitoring is also available For all these vital parameters the 8100E Series monitor has limit alarms and alerts The monitor also prints strip chart recordings and stores tabular trends for review The 8100E Series monitor is intended to monitor physiologica
144. r second 25 mm per second 12 or 25 mm 25mm Lead I Lead II Lead Ill Lead V Off Lead avL Lead avR Lead avF Resp Pleth Cascade BxB ET CO2 and Off 0 5x 1x 2x or 4x 1x 6 25 12 5 25 or 50 mm per second 25 mm per second 12 or 25 mm 12mm Lead I Lead II Lead Ill Lead V Off Lead avL Lead avR Lead avF Resp Pleth Cascade BxB ET CO2 and Off 0 5x 1x 2x or 4x 1x 6 25 12 5 25 or 50 mm per second 25 mm per second 12mm 12mm On Off Off Criticare Systems Inc Configuration Settings Printer Settings Criticare Systems Inc Configuration Date format Date Time Freeze Timeout Alarm Tone Warning Language Line Frequency Restore Factory Defaults Enter Service Mode Enter Simulation Mode Patient Size Setting Print Type Demand Alarm Print BP Print Interval Print Interval Print Type Snapshot Size History Size Waveform 1 Gain waveform 1 Waveform 2 Gain waveform 1 Printer Speed Serial Type Serial Format Baud Rate Section 3 Setup Procedure Selectable Options MM DD YYYY DD MM YYYY Day Month Year Hour Minute 30 seconds 1 2 3 4 5 minutes Off On Off English French German Italian Spanish Russian Portuguese 50 60 Hz Yes No Yes No Yes No Adult Pediatric Neonate Selectable Options Graphical Tabular Off Off Graphical Tabular Serial Off Graphical Tabular Serial Off 1s 2s 5s 10s 15s 20s 30s 1 2 5
145. raph that can be set to appear in waveform slot 2 or 3 NOTE An additional ST window is accessed by selecting Other Params Menus This additional window allows manual setting of the ST measurement points and is discussed later in this appendix DISPLAY EXIT TYPE GAIN Waveform ECG II x1 0 Waveform ST HIST x1 Waveform ECG III x1 Waveform PLETH Xi Waveform RESP x1 Waveform OFF x1 External Display OFF Duration Scale ST Graph 10 minutes 2 mm ST Graph 10 minutes 2 mm ST Graph 10 minutes 2 mm Figure C 8 Display Settings Window with ST Page C 10 nGenuity 8100E Series Operator Manual Criticare Systems Inc Appendix C Arrhythmia and ST Analysis Select ST HIST for the TYPE in the waveform slot A historical graph can be displayed for three lead views The lead views and colors are adjusted in the PARAMS menu while duration and scale of the graph is adjusted in the DISPLAY menu ST Arrhythmia Defaults Alarms Settings Arrhythmia Setup Alarm Settings Alarm Priority Default Alarm Type Range Adult Pediatric Neonate Options Default Heart Rate High 80 250 150 150 180 High High Heart Rate Low 20 160 40 40 90 High High PVC Rate 2 59 2 2 2 Disabled High Medium Low Disabled Advisory Silent Medium Message PVC Run 2 6 2 2 2 Disabled High Medium Low Disabled Advisory Silent Medium Message Asystole na na na na High High VFIB na na na na High High VTACH 90 200 160 160 180 High High VT
146. re fluctuation becomes stronger reaching its maximum at the patient s mean arterial pressure i e when cuff pressure mean BP The monitor stores this value as mean pressure As cuff pressure increases further it approaches the patient s systolic pressure and the cuffs pulse waveform decreases in amplitude The cuff pulse waveform disappears at the point where cuff pressure is equal to the patient s systolic pressure When the monitor determines that the cuff waveform has decreased to zero amplitude it stores the cuff pressure value as the systolic pressure and releases the pressure from the cuff This typically occurs at about 10 mmHg over the patient s systolic pressure The cuff then rapidly deflates Dynamic Measurement Ranges Systolic mmHg Diastolic mmHg MAP mmHg Adult 50 280 30 225 35 245 Pediatric 50 280 30 225 35 245 Neonate 50 135 20 100 30 120 Page 1 6 nGenuity 8100E Series Operator s Manual Criticare Systems Inc NIBP Clinical Testing and Accuracy Cuff Inflation and Pressure Protection Pressure in mmHg Section 1 Introduction This device was clinically tested per the requirements of EN 1060 and AAMI SP 10 The NIBP module as installed in the 8100E series monitor has been tested to meet the performance specifications listed in this manual The maximum cuff inflation rate is 15 mmHg sec The software limits inflation to 300 mmHg adult 300 mmHg pediatric or 150 neonate A secondary circ
147. ring Pacemaker Detection With the pacemaker detector turned ON in the 8100E Series monitor the system detects and rejects pacemaker pulses ranging from x 2 to 700 mV amplitude and 0 1 to 2 0 ms duration Heart rates are properly displayed over this range of pacemaker operation Defibrillation When used with CSl approved AAMI Compliant ECG electrodes the 8100E Series monitor recovers display of the ECG waveform within five seconds following defibrillation Arrhythmia Detection Whenever a potential Asystole VFIB and or VTACH is detected a marker similar to an admit discharge marker is placed in the tabular trends showing the approximate period of the event The text is ARRH START and ARRH END regardless of which arrhythmia type is identified When ST Arrhythmia is enabled using the keycode the alarm messages are altered as follows e ECGLOST is replaced with ASYSTOLE HIGH PULSE RATE is replaced with TACHYCARDIA when ECG is the heart rate source e LOW PULSE RATE is replaced with BRADYCARDIA when ECG is the heart rate source ST Segment Analysis The ST segment analysis can be activated independently from the arrhythmia feature The feature provides both automatic and manual adjustment of the ST segment points When the ST feature is activated additional settings appears in the menus and the ST elevation unit markers appears in the upper right corner of the main display The ST values remain dashed until ST deviations are re
148. robe in accordance with currently acceptable medical procedures Verify the position of the probe by acceptable medical procedures Align the sensor s connector with the monitor cable s connector and push firmly to assure full contact Forced mating of the connectors without proper alignment may cause damage to the connectors and interruption in electrical continuity Cleaning To clean the temperature cables and sensors see Temperature Cable in Section 8 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 5 Alarms and Messages Alarm Description Audible Alarms Criticare Systems Inc The monitor provides both audible and visible alarm indicators to alert the operator of system status changes and physiological parameter alarms Alarms are provided for all monitored parameters Each parameter limit alarm condition triggers both audible and visible alarms until one of the following events occurs The parameter value returns to within the alarm limit The alarm limit is set beyond the present parameter value The SILENCE key is pressed Audible alarms only The monitor is placed in Standby Mode Audible alarms only All alarms conform to EN 475 requirements Informational messages and a system alerts do not have an audible alarm component HIGH PRIORITY ALARMS The high priority alarm consists of a pair of bursts Each burst consists of five tone pulses The pair of bursts re
149. rom the NIBP in that order of preference The NIBP heart rate is updated with each NIBP measurement rather than being continuously updated with the ECG or SpO waveform data When the heart rate is based on NIBP data the numerical heart rate value is removed two minutes after the last NIBP measurement is completed ECG Settings Cable can be set to 3 lead or 5 lead The default is 5 lead Pace Detect can be set to ON or OFF The default is OFF Sensitivity can be set to LOW MEDIUM or HIGH The default is MEDIUM See Filter Settings in this section for details on Filter settings Page 3 10 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 3 Setup Procedure Filter Settings The ECG should be set to Monitor mode for optimal filtering The monitor may also be set to Diagnostic mode if a relatively less filtered ECG waveform is desired ELECTROSURGICAL UNIT ESU FILTER The filter may be set to Monitor mode for ESU filtering This provides filtering of the noise produced by electrosurgical and electrocautery equipment LINE FREQUENCY In the PARAMS window the filter setting may be set to diagnostic or monitor mode The frequency which is rejected in Monitor mode is either 50 Hz or 60 Hz depending on the selected frequency in the CONFIG window The frequency should be set to that frequency of the local AC mains power That value is 60 Hz in the U S and 50 Hz in most of Europe Contact your local distributor for
150. rs with the CO function The first header line denotes time and parameter measured The second header line denotes the unit of measurement for each parameter Mini Trends are updated upon the completion of an NIBP reading The current displayed vital signs are stored and displayed on the screen The display shows the newest values on the bottom When the 13 slots are full a new reading displays at the bottom and the oldest reading leaves the screen Mini Trends are cleared with a power cycle and by entering Standby Mode Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 3 17 Section 3 Setup Procedure 1nV ECG BPM II 60 x Sp02 NIBP RESP TEMP1 20x mmHg Br m F 26 30 110 l 9 8 85 105 x 80 100 85 105 90 110 95 115 CYCLE OFF 149 106 127 x AGE 01 00 min oF SPO2 SENSOR ALARMS PARAMS DISPLAY igen MT 97 7x ADM DIS CONFIG PRINT imi Adult AUG 07 05 14 12 59 Figure 3 11 Interface with Mini Trend Display For the trend tables shown the readings coincide with an NIBP cycle of five 5 minutes The heart rate is being reported based on the electrocardiogram which is indicated by an E following the heart rate values The source of the heart rate HR data is indicated by a letter following each heart rate value e E electrocardiogram e S pulse oximetry SpO gt e N non invasive blood pressure NIBP The source of the respiration data is indicated b
151. rt rate is sourced from ECG data This message replaces the LOW PULSE RATE message normally reported by the monitor while the smart heart rate is sourced from ECG data At minimum 2 seconds of PVC classified beats detected at a rate above the selected ventricular tachycardia limit has been detected Indicates that two or more cycles of a ventricular beat followed by a non ventricular beat have occurred Indicates that two or more cycles of a ventricular beat followed by two non ventricular beats have occurred Indicates two consecutive ventricular beats detected with non ventricular beats occurring before and after the pair Consistently irregular heart rate with 6 consecutive HR intervals that vary by 100 milliseconds or more The number of detected premature ventricular complexes per minute has exceeded the preselected threshold The number of consecutively detected premature ventricular complexes has exceeded the preselected threshold The monitor is acquiring sixteen QRS beats in order to identify the patient s normal rhythm Criticare Systems Inc ST Alerts LOW ST on HIGH ST on LOW ST on Il HIGH ST on Il LOW ST on III HIGH ST on Ill LOW ST on AVR HIGH ST on AVR LOW ST on AVL HIGH ST on AVL LOW ST on AVF HIGH ST on AVF LOW ST on V HIGH ST on V Criticare Systems Inc Priority Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Adjustable Ad
152. rument from which CSI s original serial number tag or product identification markings have been altered or removed or any product of any other manufacturer Criticare Systems Inc is not responsible for the effects on safety reliability and performance of the 8100E Series Patient Monitor if assembly operations extensions readjustments modifications or repairs are carried out by persons other than those authorized by Criticare Systems Inc or the 8100E Series Patient Monitor is not used in accordance with the instructions for use or the electrical installation of the relevant room does not comply with NFPA 70 National Electric Code or NFPA 99 Standard for Health Care Facilities Outside the United States the relevant room must comply with all electrical installation regulations mandated by the local and regional bodies of government CRITICARE SYSTEMS INC Telephone 262 798 8282 20925 Crossroads Circle Tech Support 800 458 2697 Waukesha WI 53186 Orders 800 458 4615 USA Fax 262 798 8290 Internet www csiusa com nGenuity 8100E Series Operator s Manual Page xi Service Return Policy Return Procedure In the event that it becomes necessary to return a unit to Criticare Systems Inc the following procedure should be followed Obtain return authorization Contact the CSI Service Department at 800 458 2697 to obtain a Customer Service Authorization CSA a number Outside the US call 001 262 798 8282 Th
153. s be checked by the caregiver before use for actual patient monitoring Perform the following procedure before using the monitor with each patient 1 Make sure that monitor has been fully charged before use Check that the AC power cord is plugged in for long term monitoring situations 2 Check the menus and default settings to confirm that the monitor is setup correctly 3 Examine the accessories for wear damage or contamination Replace or disinfect the accessories as required 4 Turn the desired monitoring modules to ON in the PARAMS softkey window 5 Select the correct mode of operation Adult Pediatric Neonate by entering the patient size in the ALARMS ADM DIS or CONFIG softkey windows NCAUTION A All accessories connected to the patient monitor must comply with all applicable UL Underwriters Laboratories standards and IEC standards for such products e Substitution of recommended sensor and sampling accessories may cause inaccurate measurements and degrade patient safety or may damage the monitor nGenuity 8100E Series Operator s Manual Page 4 1 Section 4 Patient Monitoring SpO Monitoring The following instructions describe procedures for preparing a patient Pulse Oximetry for SpOs monitoring Shown below is the patient monitor with a pulse oximetry finger sensor attached This adult finger sensor CAT 934SDN is one of many sensor styles available Use the SpO sensors only as directed
154. s the primary lead Lead switching only occurs in the primary lead view Lead failure during monitoring causes one of the following results 1 If failure occurs in the primary lead while currently being displayed the system attempts to switch from the current lead view to an alternate lead view The system switches to a valid non failed lead view if a valid lead exists The failed electrode is indicated by an alarm message The slot label of the primary lead visibly changes to the new lead view The alternate waveform is drawn in the slot 2 If the failure occurs for Lead II while no ECG leads are displayed the primary lead is changed to an alternate lead The smart heart rate is determined from the new lead view No lead switching is apparent from the main screen 3 If no alternate is available for a primary lead an ECG LEADS OFF alarm is generated The smart heart rate defaults to the next available source indicated by a change of the heart rate numerical display No lead switching occurs 4 If required electrodes for a displayed non primary lead are not available an error message displays The waveform becomes a straight line No lead switching occurs When the lead fail condition is corrected the system reverts back to the original lead that was displayed before the fail condition occurred Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 4 13 Section 4 Patient Monitoring Alternate Lea
155. s this device to sale by or on the order of a physician Cautions NCAUTION N Use the monitor only with recommended accessories Use of unapproved accessories may cause inaccurate readings Equipment accuracy may be affected at extreme temperatures Do not store equipment at extreme temperature Temperatures exceeding specified storage temperatures could damage the system e A possible explosion hazard exists Do not use the monitor in the presence of flammable anesthetics Do not press on the keys with surgical instruments or other tools Sharp or hard objects could damage the keys Use only your fingertips to press on the keys Do not allow the conductive parts of the patient electrodes to contact other conductive parts including ground earth Changes or modifications not expressly approved by Criticare Systems Inc may void the user s authority to operate the equipment and may also void the warranty Always monitor patients with a pacemaker very closely since the 8100E may count at the pacemaker rate during cardiac arrest or some arrhythmias Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 1 17 Section 1 Introduction Leakage Current The monitor complies with leakage current limits required by medical safety standards for patient connected devices A hazard caused by the summation of leakage currents is possible when several pieces of equipment are interconnected Connectin
156. s turned off The arrhythmia feature is not intended for use with neonates with high heart rates The presence of tall T waves greater than 80 of the R wave may be counted as double beats resulting in a heart rate twice the actual rate NCAUTION A The nGenuity arrhythmia analysis algorithms are only intended to detect ventricular arrhythmias Always monitor patients with a pacemaker very closely since the nGenuity monitor may count at the pacemaker rate during cardiac arrest or some arrhythmias nGenuity 8100E Series Operator Manual Page C 5 Appendix C Arrhythmia and ST Analysis Specifications ECG Connectors Lead Selection ECG Sensitivity ECG Beat Detection Range Frequency Response Protection Pacemaker Heart Rate Source Range with arrhythmia detection Range arrhythmia off Accuracy ST Analysis Lead Views Elevation Accuracy Method Range Resolution Arrhythmia Detection PVC Detection Ventricle Tachycardia Alarm High Priority Alarms Display Main Display Waveforms Elevation Graphs Trends Graphical and Tabular 3 or 5 Lead Standard AAMI 3 Lead Il Ill 5 Lead Il Ill aVR aVL aVF V Low 0 5 Medium 1 0 High 2 0 0 25mV to 5mV Diagnostic 0 05 100 Hz 3db Monitor 0 50 40 Hz 3db ST Filter 0 05 to 40 Hz 3db Electrosurgery HF Equipment and use of Defibrillator Detection Rejection Smart Switching ECG primary Pleth NIBP 20
157. sed to identify QRS beats The monitor has a user selectable smart heart rate function It automatically uses alternate sources to determine heart rate if the primary source becomes unmeasurable The plethysmograph SpO waveform is used if the ECG heart rate is unavailable In the absence of SpO and ECG data the NIBP oscillometric data is the final default source for a heart rate measurement Response times for the ECG heart rate meter change from 80 BPM to 40 BPM and from 80 BPM to 120 BPM is less than or equal to 10 seconds The alarm for tachycardia is less than or equal to 10 seconds per EC 13 The pulse rate accuracy for SpO is the root mean square rms difference between paired pulse rate data recorded with the pulse oximeter and a reference method NOTE The accuracy of the heart rate depends upon the source The range of the measurable NIBP based heart rate does not extend as far as the range available in other modules used by the smart heart rate feature NOTE The NIBP based heart rate is not a continuous measurement and is only current during an NIBP measurement The electrocardiogram ECG or EKG records the changing potential generated by electrical activity of the heart To obtain an overall view of the heart s electrical activity three or five electrodes attached to lead wires detect electrical impulses from the patient s heart to the skin The monitor calculates the difference in electrical force between two ele
158. t noise environment or a short circuit fault in the sensor wiring Verify monitoring system on a healthy individual user and or verify the patient s plethysmographic waveform quality prior to clinical evaluation nGenuity 8100E Series Operator s Manual Page 4 3 Section 4 Patient Monitoring Page 4 4 Sensor Selection Select an approved DOX compatible sensor based on patient size and monitoring conditions For optimum results refer to the following table of EN ISO 9919 approved sensors for various patient monitoring applications Patient Size Duration Activity Suggested Sensor gt 40kg Short Long Term High DOX 934 10DN reusable Short Term Low DOX 934SDN reusable gt 30kg Short Long Term High 940SD Multi Site reusable 570SD adult disposable 10 50kg Short Long Term High 940SD Multi Site reusable 571SD pediatric disposable 1 20kg Short Long Term High 940SD Multi Site reusable 572SD infant disposable 573SD neonate disposable The DOX 934SDN finger sensor has a 3 foot cable The DOX 934 10DN sensor provides a 10 foot cable for greater patient mobility during long term monitoring The 934 series sensors are reusable sensors The Multi Site sensor is reusable and uses the 10 foot long Cat No 518DD extension cable Multi Site sensors are fully adjustable and are usable through a full range of patient sizes The 570 571 572 and 573 sensors are disposable All disposable sensors use the
159. t strip is issued displaying the waveforms selected in the PHINT menu if an alarm setting is violated This strip represents the history size added to the snapshot data Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 7 1 Section 7 Printing and Data Ports BP Print Interval Print Freeze Print Trend Print Page 7 2 The monitor issues a printout at the completion of a successful non invasive blood pressure reading as selected by the user in the PRINT menu If print type is set to Tabular a tabular demand print format is issued at the end of a successful non invasive blood pressure reading If print type is set to Graphical and snapshot size is set to 6 seconds a 6 second graphical print strip is issued displaying the waveforms selected in the PRINT menu at the completion of a successful non invasive blood pressure reading Interval prints are periodic automatic printouts as selected by the user in the PRINT menu They are graphical tabular or serial as selected in the PRINT window A freeze print is initiated by depressing the PRINT key after setting the monitor in Freeze mode pressing the FREEZE key The printout is determined by the settings in the PRINT menu This strip represents the history size added to the snapshot data If print type is set to Graphical the waveforms selected are printed out The data printed is for a history time period followed by a snapshot time period If print
160. te Parameter Slot 5 NIBP if not in use ALARMS PARAMS DISPLAY priory Alarms Parameter Slot 6 ADM DIS CONFIG PRINT System Status Temperature if on Patient Data Figure 2 8 Screen Diagram Page 2 10 nGenuity 8100E Series Operator s Manual Criticare Systems Inc ECG ALARM MESSAGE Section 2 Controls and Connections NOTE Your screen may appear different from below based on waveforms selected and their chosen slots BPM NIBP ALARM MESSAGE ADM DIS 149 106 SYS DIA ALARMS PARAMS DISPLAY VODO NO ADMIT CONFIG 20 98 Low SpO2 Alarm 90 c02 EXP INS 5 0 X 1 1 CYCLE OFF AGE 01 00 97 7 AUG 07 05 14 12 59 MAP mmHg 127 x SP02 SENSOR PRINT im Adult Figure 2 9 Sample Interface Screen Waveform Slots The waveform area is located in the upper left hand corner of the Criticare Systems Inc display The monitor has the capability to display six 6 waveforms simultaneously The waveforms that can be displayed are user selectable with the exception of the first waveform which is locked into being an ECG waveform the lead type is user selectable Each waveform slot displays the parameter or source vertically along the left edge of the screen Amplitude bar and range are shown at the beginning of the slot if applicable to that type of waveform Each parameter s waveform is shown in a selectable color The waveforms can be cascaded to fill multiple slots a
161. ter default settings may be independently modified as part of a customized default profile Setting changes generally remain after the monitor is power cycled Changes made to the settings remain in current memory until a patient is discharged or the monitor is left without power If the monitor loses its current setting it returns to the last profile selected from the memory If no profile has ever been selected initially itis CUSTOM DEFAULTS and it begins with the same settings as the Factory Default Settings listed at the end of this section The permanent Factory Default profile can be accessed and restored in the CONFIG window The user defined profiles can be accessed and restored by pressing the DEFAULT key See Alternative Care Defaults in Appendix B for instructions for loading ALTERNATE CARE defaults Page 3 6 nGenuity 8100E Series Operator s Manual Criticare Systems Inc ALARMS Softkey ALAR PARAMS DISPLAY ADM DIS CONFIG PRINT Criticare Systems Inc Section 3 Setup Procedure This softkey allows access to all the parameter alarm settings When the menu is activated by pressing the knob an alarm limit settings window appears The alarm window appears as the adult pediatric or neonate window as set in the third item Patient size EXIM Alarm Volume ECG Lead Fail Patient size Heart Rate Sp02 NIBP Systolic NIBP Diastolic NIBP Mean Temperature Respiration C02 Ins
162. ter trap on NC Figure 2 4 Left Side with Water Trap Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 2 5 Section 2 Controls and Connections Rear Panel and Printer AC Power Fixtures Optional Connection Communication oe Fuse Chassis Connections ccess Access Ground Panel Panel Figure 2 5 Rear View NOTE Service access panels fuse panels and the chassis ground are discussed in the service literature for the monitor There are no user procedures necessary for these items during normal operation of the monitor NOTE Some communications connections may have protective covers that need to be removed before use Page 2 6 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 2 Controls and Connections Communication Sockets There are five 5 communications sockets available along the back edge of the monitor These connections provide links to external printers computers and other medical devices See Printing and Data Ports in Section 7 for more information about serial printing and communications NOTE Some communication ports may have covers that need to be removed before use COM Port 1 Serial DB 9 COM Port 2 Mini DIN BNC Port ECG OUT Nurse Call Connection Video Out DB 15 Figure 2 6 nGenuity 8100E Series Data Connections Service Access Panel The battery door is located on the lower back side of the mo
163. the screen nGenuity 8100E Series Operator s Manual Criticare Systems Inc Maintenance Schedule Every Patient Every Day Every Week Every 3 Months Every Year Battery Maintenance Long Term Storage Disposal Criticare Systems Inc Section 8 Maintenance Clean and disinfect the sensor cables and sensor nspect the accessories and cables for damage Change the gas sampling device and sampling line Charge the battery s as necessary Change the water trap or as needed Clean the exterior of the unit or clean as needed Perform the annual safety tests described above e Verify the CO auto calibration Calibrate if necessary e Check the CO absorber Change if necessary Check the gas flow rate Contact CSI Service if calibration is needed Although the battery requires no maintenance the battery should be allowed to fully charge at least once every three months To preserve battery shelf life always charge the battery before removing it from the monitor NOTE Older batteries do not have the same operating times and battery charge times as newer batteries Replace batteries in a timely manner No special preparation is necessary for long term storage of the monitor At the end of its useful life the monitor and its accessories may be disposed of according to your institution s policies and procedures for disposal of patient contact medical waste Alternately the monitor
164. the unit of measurement is listed vertically on the left side for the first displayed line graph The second line graph is labeled vertically on the right side The graphical trend window displays for about 45 seconds before timing out The trend window does not update automatically The trend window updates each time it is accessed The most current data is always displayed on the right side Time stamps for the selected Trend Interval are indicated below the line graphs Scrolling the Graph The trend window can be set to display up to 24 hours of data Rotating the knob clockwise scrolls the graph to show older data Rotating the knob counter clockwise scrolls back towards the most current data The rate of advance varies with the selected Trend Interval Trend Interval Minutes per each click 2 hours 1 4 hours 2 8 hours 4 12 hours 6 24 hours 12 The time stamps are updated each time the knob is rotated It is not possible to scroll past the current time The trend graph resets to the current time stamp upon exiting to the main screen and returning to the trend window The trend graph remains at the selected time location while entering and returning from the trend settings window Interruption Due to The graphical trend has gaps due to power cycling of the monitor If Power Cycling the period of missing data is within the last 24 hour period the gaps appear where the power was turned off These gaps are defined with gray backgro
165. the water trap accepts gas sampling lines using the Luer style connections It is important to use the recommended water trap and sample line combinations in order to provide the correct flow rates for monitoring purposes NWARNING A Never attach intravenous tubes to gas sampling connections Gas sampling lines may be inadvertently connected to intravascular fluid systems allowing air into a blood vessel Change sample lines and sampling devices between each patient Infectious agents may be transmitted through reuse of sampling lines NCAUTION A Do not connect the monitors exhaust for return flow to the breathing circuit Infectious agents may be transmitted through reverse flow from sampling devices Use of longer sampling lines or extensions decreases the monitor s response time and can affect accuracy Leakage or internal venting of sampled gases may cause inaccurate gas readings Please contact technical services to resolve these issues NOTE The water trap is for single use only Do not attempt to drain and reuse the water trap nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring Water Trap The water trap has a connection located at the top that fits up and into the gas receptacle of the monitor Luer lock entrance Slide up and AM into receptacle Figure 4 18 WaterChek 2 Water Trap The trap slides out of the front receptacle and can be quick
166. thmia EXIT Alarm Volume 5 ECG Lead Fail MEDIUM Patient size Adult HIGH Heart Rate 150 Sp02 OFF NIBP Systolic 200 NIBP Diastolic NIBP Mean Temperature F Respiration C02 Inspired kPa C02 Expired kPa 745 Apnea 60 seconds Other Alarm Setups ST Setup Figure C 5 Select ST Setup The ST elevation alarms are fully adjustable for each lead view NOTE The ST alarms window shown below do not appear if ST is turned off in the PARAMS menu EXIT UNITS ST I mm ST Il mm HI 2 2 ST III mm 25 2 2 2 2 x LOW ALARM PRIORITY mud DISABLED 2 DISABLED 2 DISABLED 2 DISABLED sa DISABLED z2 DISABLED s23 DISABLED ST AVR mm ST AVL mm ST AVF mm ST V mm COO ooooccoco Use ST I settings for all Leads YES BACK Figure C 6 Extended ALARMS Window with ST nGenuity 8100E Series Operator Manual Page C 9 Appendix C Arrhythmia and ST Analysis PARAMS EXIT Heart Rate HR Source Smart NIBP Heart Rate Tone Vol 5 NIBP tone ECG H Temperature Cable 5 lead Unit of measure Pace detect OFF Filter Monitor ST Arrhythmia Sensitivity MEDIUM Arrhythmia Relearn Sp02 n ST Average 12 seconds Lead 1 Search time 20 seconds Lead 2 Lead 3 Respiration ON Other Params Menus C02 ON H No Action Unit of measure mmHg N20 compensation OFF Figure C 7 PARAMS Window with ST Arrhythmia The lead view and color selections in the PARAMS menu allow adjustment of the ST elevation g
167. tion setup is not necessary for general use Contact Criticare customer service for information about using wireless communication or networks e Audible alarms are suspended for each parameter until the first valid measurement has been taken for each parameter Visual alerts are always active e f a patient had been previously admitted by the monitor a notice message HESUME MONITORING appears in a yellow box Press the knob to continue monitoring with the current patient Select NO to change patient The monitor is composed of several technology modules that measure different physiologic parameters Some modules such as the oximeter are ready for use within seconds of powering up Sensor and Probe Depending on the accessories attached to the monitor upon start up Messages various messages concerning detached sensors and probes appear These are only visual alarms until valid measurements are taken by the accessories after which a low level alarm sounds when the sensors and probes are disconnected If sensor and probe messages from unused modules become a distraction the messages disappear if the module is turned off The OFF settings are located in the PARAMS windows described in PARAMS Softkey Physiological Parameters in this Section Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 3 3 Section 3 Setup Procedure CO Calibration 8100E Series monitors may have an optional internal capnometer
168. tions Patient Information A Patient Information Bar runs along the bottom of the display This and Clock area displays the last name 12 characters the first name 10 characters and middle initial one character of the patient the hospital identification number for the patient 16 characters and the patient s room number five characters The current date and time appear to the extreme right of the patient information Page 2 16 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 3 Setup Procedure Monitor Setup This section provides an overview of the setup procedures for nGenuity 8100E Series monitor The monitor should be set up by the health care provider before using it on patients If the monitor is new preparations such as loading paper and batteries should be performed See Changing the Battery in Section 8 for battery changing instructions For monitors with the optional internal printer see the paper loading instructions in Changing Printer Paper in Section 7 Battery Power The monitor has one 1 rechargable lead acid battery Charging the Monitor The monitor has an internal battery charger and charges the battery whenever the AC cord is plugged in including while the monitor is in use The green AC mains power indicator light should illuminate when the power cord is plugged in correctly If the green light is not on check the connections and the power socket for malfunctions
169. to Tabular To print Alarm BP or Interval data to a serial printer Alarm Print BP Print or Interval Print Type must be set to serial NOTE Monitors with older software revisions may have a selection called Print Device in place of Serial Type Print Device sets all printing to the internal printer or serial printer or turns off the printing function nGenuity 8100E Series Operator s Manual Page 3 25 Section 3 Setup Procedure Default Settings Alarms Settings The monitor defaults to the Adult Factory Defaults Alarm Alarm Volume ECG lead fail Heart Rate Heart Rate SpO SpO NIBP Systolic NIBP Systolic NIBP Diastolic NIBP Diastolic NIBP Mean NIBP Mean Temperature Temperature Respiration Respiration CO Inspired CO Inspired CO Expired CO Expired Type High Low High Low High Low High Low High Low High Low High Low High Low High Low Range 1 10 high medium low 80 250 Off 20 160 Off 70 98 Off 1 98 Off 75 240 Off 35 150 Off 50 180 Off 15 50 Off 70 200 Off 25 125 Off 68 0 111 0 F Off 20 0 44 0 C Off 68 0 111 0 F Off 20 0 44 0 C Off 6 150 Off 0 150 Off 0 100 mmHg Off 0 0 12 5 Off 0 0 12 5 kPa Off 0 0 94 0 Torr Off 0 100 mmHg Off 0 0 12 5 Off 0 0 12 5 kPa Off 0 0 94 0 Torr Off 0 100 mmHg Off 0 0 12 5 Off 0 0 12 5 kPa Off 0 0 94 0 Torr Off 0 100 mmHg Off 0 0 12 5 Off 0 0 12 5 kPa O
170. to a different spot Check the lead wires and cables periodically for frays and cracks If there is excessive patient motion the leads may be taped to the patient Do not tape directly over the electrodes Secure the leads with adhesive tape about two centimeters from the application site as shown below Page 4 12 Figure 4 12 Securing an ECG Electrode nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 4 Patient Monitoring ECG Auto Lead If a 5 lead cable is being used the monitor has the ability to display Switching alternate leads in cases of fault in the selected lead If a 3 lead cable is used failure of any lead results in no other usable leads so no lead switching is possible However the monitor does display which lead or electrode has failed Since the 5 lead switching system uses a right leg drive failure of the RL lead results in no leads being available The monitor identifies the RL as having failed with the message ECG LEADS OFF Lead failure assumes that signal has been lost from an electrode that is required for the desired lead view Loss of signal from unnecessary electrodes does not cause lead switching Primary Lead The monitor identifies a primary lead that is used to report heart rate numerical data If no leads are being displayed the primary lead defaults to lead Il If ECG waveforms are being displayed the monitor selects the waveform closest to the top of the screen a
171. ture by changing electrical resistance Unusual fast artificial variations in temperature readings may occur with accompanying applications of an electrocautery system Electrical leakage current of the cable when used with the monitor and sensor comply with IEC 601 1 EN 60601 1 The monitor is compatible with any YSI 400 or YSI 700 series temperature probe nGenuity 8100E Series Operator s Manual Page 1 9 Section 1 Introduction Specifications Page 1 10 ECG Connectors Lead Selection Gain Selection ECG Sensitivity Frequency Response Electrosurgery Protection HF Equipment Protection Defibrillator Protection Pacer Detection Rejection Heart Rate Source Range Accuracy Pulse Tone Respiration Source Rate Range Resolution Accuracy SpO Range Resolution Accuracy Indications Method Modes Operation Sensor Wavelength Sensor Power nGenuity 8100E Series Operator s Manual 3 or 5 Lead Standard AAMI 3 Lead Il Ill 5 Lead Il Ill aVR aVL aVF V 0 5 1 0 2 0 4 0 Low 0 5 Medium 1 0 High 2 0 Diagnostic 0 05 100 Hz 3db Monitor 0 50 40 Hz 3db Yes Yes Yes Yes Smart Switching ECG primary Pleth NIBP 20 300 bpm ECG Pleth 30 240 bpm NIBP 1 bpm or 1 ECG whichever is greater 3 bpm maximum Selectable On Off ECG CO primary 6 to 150 breaths minute ECG 0 to 120 breaths minute CO 1 breath min
172. uit limits maximum possible cuff pressure to 330 mmHg in adult pediatric mode and 165 mmHg in neonatal mode Cuff pressure is allowed to remain above 30 mmHg for a maximum of two minutes The monitor automatically deflates the cuff if the time limit is violated The monitor contains hardware protection for overpressure conditions pressure transducer failures or microprocessor and pump control circuit failures B P Cuff Inflation Pressure Shown during inflation E Systolic Pressure VAM Actual Blood Pressure Waveform A Diastolic Pressure ip i i lt Cuff deflates rapidly 50 a5 i after monitor determines p i i systolic pressure 20 i 10 i i 0 m Time gt Pulse Waveform Measured from B P Cuff h Pressure Fluctuation Diastolic Mean Systolic Pressure Pressure Pressure Figure 1 1 NIBP Cuff Pressure and Pulse over Time Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 1 7 Section 1 Introduction Capnography Measurement of CO Method of Measurement Page 1 8 The 8100E Series monitor uses the sidestream method of measuring CO Gas is aspirated through a nasal cannula or a ventilation circuit adapter The gas sample enters from a sampling tube into a water trap which removes water vapor and particulate matter from the gas sample The gas then enters the CO detector where it is analyzed The monitor measures CO concentrations and displays them
173. unds If the power was turned off for a period of more than a day a blank period is inserted between the new and old data The new data begins on a new window with new time stamps The gap between the monitoring sessions is equal to the Trend Interval in length Page 6 4 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 6 Trends Graphical Trend Screen Two physiological parameters may be displayed at the same time in the graphical trend window For NIBP the pressure values for diastolic systolic and mean are represented The line graphs are color corresponding to the numerical display as selected in the Graphical Trend menu For parameters such as heart rate and respiration the color of the line graph changes to the color of the source data ECG LEADS OFF 60 20x 97 Lt 0 I 10 12 JUN 18 05 22 12 JUN 18 05 10 12 CYCLE OFF 147789107 4 o ALARMS PARAMS DISPLAY BP PLEASE WAIT 3 J e 1 ADM DIS CONFIG PRINT i Adult John Smith 14 12 59 Figure 6 3 Graphical Trend Screen Criticare Systems Inc nGenuity 8100E Series Operator s Manual Page 6 5 Section 6 Trends Tabular Trends Heart Rate Source Indication Respiration Source Indication Tabular Trend Markers Trend Messages Page 6 6 The source of the heart rate data is indicated by a letter following each heart rate value E electrocardiogram S pulse oximetry and N Non invasive b
174. urn to ON NOTE Arrhythmia must be on in order to turn ST on ST Filter Activation of ST analysis automatically switches filtering to the ST Filter setting Learn There is a setting in the PARAMS menu to command a rhythm re learn During the re learn period 16 beats the ST values are dashed ST J and ISO Points In the PARAMS menu access the Other Params Menu and open the Set ST J and ISO points window The user can adjust the ISO J and ST points These are used by the algorithm when making ST deviation calculations The ISO point identifies the isoelectric baseline elevation from which the ST calculation is made It is usually located just before the Q wave Criticare Systems Inc nGenuity 8100E Series Operator Manual Page C 17 Appendix C Arrhythmia and ST Analysis The ST point identifies the position where the ST segment ends usually just before the rising edge of the T wave It is at this point that the measurement is taken to determine the vertical height or depression relative to the ISO point selected along the isoelectric baseline The J point is a reference point from which the ISO and ST points are located It is usually located at the point where the S wave returns to baseline Automatic ST Segment The default ST point is located 60 milliseconds after the J point The Detection default ISO point is located about 100 milliseconds before the J point The algorithm uses the default positions until it h
175. ust the settings again including the extended windows Repeat again with the last patient size to complete the setting of all alarm limits Alarm Limits Alarms activate when a high alarm limit is exceeded or the measured value drops below a low alarm limit High and Low limit values can be set to the same values In such a case the monitor alarms when any value but the selected value is measured NCAUTION A e Turning an alarm limit off disables both the audible and visual portion of the alarm Some alarms automatically reset when the monitor is power cycled See Alarms at Start Up in Section 5 for details The low limit alarm can never be set higher than the high limit alarm The high limit adjustment is similarly restricted When adjusting limit values some of the range may not be available because the monitor does not display ranges beyond the point that the other limit is set Alarm limits cannot be changed for monitoring modules that have been turned off If an alarm limit cannot be selected check the PARAMS menu to confirm the module is turned on ECG Lead Fail This is an adjustable alarm level setting for a condition where the monitor cannot detect connected ECG leads Set this according to the protocols of the facility or to the specific patient need Page 3 8 nGenuity 8100E Series Operator s Manual Criticare Systems Inc Section 3 Setup Procedure Alarm Volume The alarm volume can be set from 1 to 10 If the vo
176. ute 2 breaths minute 1 99 1 70 99 range 2 50 69 range 3 lt 50 unspecified Statistical represents one st dev 66 of clinical samples Plethysmograph Numerical Audible pulse tone pitch varies with SpO Dual wavelength LED Adult Pediatric Neonate Continuous Use 660nm 905nm 80mW Criticare Systems Inc NIBP Technique Measurement Time Automatic Measurement Cycles Inflation Pressure Range Resolution Transducer Accuracy STAT mode Capnometry CO Units Display Method Calibration Waveform Scale Range Resolution Accuracy N50 Compensation Flow rate Flow Tolerance System Response Time Rise Time Delay Time Time from cold start Pneumatic Sound Pressure Temperature Channels Range Accuracy Display Resolution Probe Type Criticare Systems Inc nGenuity 8100E Series Operator s Manual Section 1 Introduction Oscillometric measure upon inflation 40 seconds average standard adult cuff 2 3 5 10 15 30 min 1 2 4 hrs Adult 0 to 300 mmHg Pediatric 0 to 300 mmHg Neonatal 0 to 150 mmHg 1 mmHg x 2 mmHg or 2 of reading whichever is greater 5 min of consecutive readings mmHg Percent kPa Torr Inspired COs Expired CO End Tidal Numerical values capnogram and breath by breath ETCO bar graph Non dispersive Infrared Auto calibrating Auto calibrating Manual Calibration Selectable p
177. veform data or graphs The waveforms are user selectable and can be user configured The silence icon for the silence mode 2 minute or permanent is shown in the upper right corner of the top waveform slot The right column provides space for the reporting of physiological parameter data in numerical form Each parameter has a selectable color for the parameter numerical data that matches the color of the waveform displayed in the slots Numerical parameters for NIBP are reported below the waveform slots and for temperature are reported above the date and time on the screen Heart rate is fixed to Parameter Slot 1 and Temperature is fixed to Slot 6 when turned on Slot 5 is used for NIBP parameters when assigned a function Slots 2 4 will display Respiration SpO2 and CO2 in that order from top to bottom if functions are active unless waveform slots have been assigned a different order in which case the parameter slots will match the corresponding waveforms nGenuity 8100E Series Operator s Manual Page 2 9 Section 2 Controls and Connections The bottom portion of the display has space dedicated to the following message types and functions The main screen menu of selectable softkeys Two 2 message lines for alarms and alerts A system status line for battery status and patient size mode Data from temperature monitoring The patient information bar and date time clock Parameter Slot 1 Waveform Slot 1 Heart Ra
178. without pass codes obtained through the manufacturer is illegal and may void your authorization to use the monitor The arrhythmia and ST license cannot be transferred between monitors but it can be transferred with the monitor as part of a legal sale of the equipment The user is prohibited from tampering with the keycode lock out bypassing the keycode protection duplicating or otherwise making copies of the arrhythmia and ST software extension If the arrhythmia and ST software becomes damaged or nonfunctional it can be restored by the manufacturer If a damaged monitor has a valid arrhythmia and ST license and requires software replacement the customer is charged only for the service order and not for a new software license The analysis keycode setting appears in the service window of the nGenuity 8100E Series monitors Contact your dealer or CSI customer service for more information In case of accidentally selecting the keycode simply turn off the monitor without completing the key code entry The keycode will not be overwritten unless you enter the complete keycode For 8100E Series models that do not include the arrhythmia and ST analysis feature the message nvalid Keycode appears next to the setting NOTE The same service password is used on all nGenuity 8100E Series monitors Each monitor has a unique keycode to activate the analysis feature nGenuity 8100E Series Operator Manual Criticare Systems Inc Appendix C
179. y a A Oo I Make sure there are no kinks or other obstructions in the hose extending from the cuff 6 Press the NIBP key on the front keypad of the monitor nGenuity 8100E Series Operator s Manual Page 4 17 Section 4 Patient Monitoring Page 4 18 Taking NIBP Measurements Pressing the NIBP key causes the monitor to take one measurement The monitor may make a second attempt if there is excessive motion during the first attempt to take a measurement Press and hold the NIBP CYCLE STAT key to begin taking Stat NIBP measurements NIBP measurements are then taken repetitively for 5 minutes The numerical parameters on the display are updated with each measurement If an NIBP cycle time has been selected the monitor automatically takes NIBP measurements at scheduled intervals Press the NIBP key to begin measuring at automatic intervals For optimum accuracy the patient should keep the cuffed part of the arm at the same level as the heart NIBP measurement points above the level of the heart gives reduced pressure values Measurement points below the heart level gives increased values These errors are due to the weight of the blood Figure 4 16 Arm Position for NIBP Measurement An average measurement on a non moving patient takes less than 40 seconds At the end of each measurement the cuff automatically deflates The monitor automatically attempts a second measurement with no displayed error message if it cann
180. y Default Off Off ECG aVL ECG Il ECG aVL ECG ECG aVL ECG V Factory Default 10 minutes 2mm 20 minutes 2mm 30 minutes 2mm nGenuity 8100E Series Operator Manual Page C 13 Appendix C Arrhythmia and ST Analysis ST Trends Graphical Trend Screen ST parameters may be displayed in the graphical trend window ST ST Il ST III ST AVR ST AVL ST AVF ST V and PVC RATE can be selected for display The line graphs are shown in the color corresponding to the numerical display For parameters such as heart rate and respiration the color of the line graph changes to the color of the source data BPM ECG LEADS OFF 2 0x Br m 97 Low SpO2 Alarm 90 ST 1 5 m I 2 0 mm X PVC Rate 2 min II 0 10 12 JUN 18 05 22 12 JUN 18 05 10 12 CYCLE OFF 147 8900 5 o ALARMS PARAMS DISPLAY Bp PLEASE WAIT 37 1 ADM DIS CONFIG PRINT iE Adult John Smith 14 12 59 Figure C 9 Graphical Trend Screen The sample trend screen shows ST aVR and PVC Rate data This data would normally appear in a line the same color as the ECG waveform and numerics but is represented here as a set of thinner black lines Page C 14 nGenuity 8100E Series Operator Manual Criticare Systems Inc Tabular Trend Markers Appendix C Arrhythmia and ST Analysis Various messages appear in the tabular trend when ST and and Messages Arrhythmia are activated Data Format with ST Clinical Preparat
181. y a letter following the value e C CO e E electrocardiogram Page 3 18 nGenuity 8100E Series Operator s Manual Criticare Systems Inc ADM DIS Softkey Admit Discharge DISPLAY ALARMS PARAMS CONFIG PRINT Adult Pediatric Neonatal Patient Size Criticare Systems Inc Section 3 Setup Procedure A patient is admitted or discharged in ADM DIS window It is necessary to correctly specify the Patient Size since this adjusts the monitoring defaults EXIT Admit NO Discharge NO Patient Size Adult Update NO Last name First Name Middle initial Room number ID number Unit Label 000 Figure 3 12 Admit Discharge Window NOTE Patient Size can be also set in the ALARMS window This is the same setting and can be changed in either location NOTE The Unit Label is for identification purposes when using wireless or hardwire networks Do not change the number unless otherwise instructed to by the manufacturer The monitor is designed to look at the patient size information selected in the ADM DIS window and determine whether the monitor should use the adult pediatric or neonatal alarm settings while monitoring The patient mode is determined by patient size and is displayed in the System Status Line not with other patient data at the bottom of the display screen The patient size mode is shown as Adult Pediatric or Neonate When the patient size is changed in the ADM DIS win
182. y to enter the trend settings Set the trend type to Graphical or Tabular If Graphical is selected set the Trend Interval and Trend Parameters as desired EXIT the trend setting window The trend displays 7 Rotate the knob clockwise to see older data 8 Press the TREND key to exit trends Selecting EXIT returns to the main screen Press the TREND key again to return the trend display after changing the settings NOTE The trend setting window defaults to Tabular Trend The Settings for Trend Interval First Trend Parameter and Second Trend Parameter are not visible until the Trend Type is set to Graphical nGenuity 8100E Series Operator s Manual Criticare Systems Inc Criticare Systems Inc Section 6 Trends If Graphical is selected set the Trend Interval and Trend Parameters as desired EXIT Trend Type Graphical Trend Interval 4 Hours First Trend Parameter HR Second Trend Parameter SP02 Clear Trends NO Figure 6 1 Graphical Trend Setup Window If Tabular is selected the Trend Screen is set to Basic Trend Display Select YES or NO for Use parameter colors EXIT Trend Type Tabular Trend Interval 30 seconds Use Parameter Colors NO Clear Trends NO Figure 6 2 Tabular Trend Setup Window nGenuity 8100E Series Operator s Manual Page 6 3 Section 6 Trends Graphical Trends The graphical trend window covers the lower five waveform slots The physiological parameter and

Section 1 - DOCS Education

Contents

Download Pdf Manuals

Related Search

Related Contents