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User Manual

Inspiration 5i Ventilator
®

International Version
17” Screen
Pre face
Revision E of this user manual: Part Number EVM500044 (Inspiration® 5i – 17” Ventilator System, User
Manual international version) May-2020
© 2010 – 2020 eVent Medical. All rights reserved.
This manual is intended to provide the necessary information required to operate and maintain
eVent Medical’s Inspiration 5i Ventilator Systems. The ventilator should be operated, serviced, and
calibrated by trained professionals.
CAUTION: US Federal Law restricts this device to sale by or on the order of a physician.
The information contained in this manual is the sole property of eVent and may not be duplicated without
permission. This manual may be revised or replaced by eVent at any time and without notice. Ensure this
manual is the most current applicable version. If in doubt, contact eVent at http://www.event-
medical.com/contact.
This manual and its illustrations apply to the:

 Inspiration 5i Ventilator PN: F7300000 – 5i – L


PN: F7300000 – 5i – L - NC

 Each model, when shipped will be configured with the latest software for that model.
Adding the variant (NC) after the product model designates the product will be configured with NO
Internal Compressor. (e.g., F 7 30 00 00– 5i–L–N C)

Illustrations in this manual apply to the Inspiration 5i Ventilator and installed software / firmware versions
are displayed upon power up on the initial screen. Optional features for the Inspiration 5i ventilator are
defined in a separate section of this manual.
Inspiration, eVolution and CliniNet are registered trademarks of eVent Medical. Smart Sigh, Smart
Nebulizer, Virtual Report and MiniWeb are trademarks of eVent Medical. Other acronyms and products
referenced in this manual may be trademarked by separate companies.
Upon request, eVent Medical will provide certain technical, operation, sales and marketing information that
will assist clinicians and trained service professionals.

United States Europe

eVent Medical
60 Empire Drive
Lake Forest, CA 92630
Tel: +1 949 900 1917
Fax: +1 949 900 1905

www.event-medical.com

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Table of Contents
1. INTRODUCTION TO THE INSPIRATION 5I VENTILATOR ................................................... 13 
1.1.  INTENDED USE ............................................................................................................................ 13 
1.2.  CONTRAINDICATIONS: .................................................................................................................. 13 
1.3.  FREQUENT USED FUNCTIONS: ...................................................................................................... 13 
1.4.  SAFETY ....................................................................................................................................... 14 
1.5.  WARNINGS, CAUTIONS AND BASIC SAFETY INFORMATION .............................................................. 14 
1.6.  RESPONSIBILITIES AND GUARANTEES ........................................................................................... 19 
1.7.  NOTICES ..................................................................................................................................... 20 
1.7.1.  Copyright Notice .......................................................................................................20 
1.7.2.  Trademark Notice .....................................................................................................20 
1.7.3.  Notice of Conformity, Compliance and Approvals ....................................................20 
1.7.4.  Electromagnetic Compatibility ..................................................................................20 
1.7.5.  CE Notified Body.......................................................................................................20 
1.7.6.  Classification .............................................................................................................20 
1.7.7.  Regulatory Notice .....................................................................................................20 
1.8.  DEVICE LABELS AND SYMBOLS ..................................................................................................... 21 
1.9.  INSPIRATION 5I VENTILATOR OPTIONAL FEATURES ........................................................................ 25 
1.9.1.  Inspiration 5i Optional Features ................................................................................25 
2. PREPARING THE VENTILATOR FOR USE ........................................................................... 26 
2.1.  VENTILATOR SETUP ..................................................................................................................... 26 
2.2.  POWER SUPPLY .......................................................................................................................... 26 
2.3.  AC MAINS POWER SUPPLY .......................................................................................................... 26 
2.4.  DC (INTERNAL BATTERY) POWER SUPPLY .................................................................................... 27 
2.5.  DC INPUT CONNECTOR ................................................................................................................ 28 
2.6.  POWER ON / OFF / STANDBY KEY................................................................................................. 28 
2.7.  GAS SUPPLY ............................................................................................................................... 28 
2.8.  CONNECTING TO OXYGEN AND AIR SUPPLY .................................................................................. 29 
2.9.  HELIOX SETUP AND CALIBRATIONS ............................................................................................... 29 
2.9.1.  Heliox Setup ..............................................................................................................29 
2.10.  ATTACHING COMMUNICATION DEVICES (ETHERNET, RS232, AND NURSE CALL) ............................. 31 
2.10.1.  Ethernet Connection (RJ45 connector) ....................................................................31 
2.10.2.  RS232 Connection (RJ45 connector) .......................................................................32 
2.10.3.  Nurse Call Connection (RJ12 connector) .................................................................32 
2.11.  CAPNOGRAPHY (MAINSTREAM / SIDESTREAM) SENSORS ............................................................... 32 
2.11.1.  IRMA Mainstream CO2 Sensor .................................................................................33 
2.11.2.  ISA Sidestream CO2 Sensor.....................................................................................37 
2.12.  BREATHING CIRCUIT .................................................................................................................... 39 
2.12.1.  Nasal Prongs ............................................................................................................41 
2.12.2.  Flow Sensor ..............................................................................................................42 
2.12.3.  Exhalation Valve Cover and Diaphragm ..................................................................43 
2.12.4.  Humidification Devices .............................................................................................43 
2.12.5.  Nebulizer Use and Placement ..................................................................................43 
2.13.  TUBING SUPPORT ARM OPTIONS: ................................................................................................. 44 
3. EXTERNAL USER INTERFACE ............................................................................................. 45 
3.1.  VENTILATOR CONTROLS .............................................................................................................. 45 
3.2.  STARTUP (ON/OFF KEY) AND STANDBY ........................................................................................ 46 
3.3.  O2 ⬆ KEY (%O2 INCREASE KEY OR 100% O2 KEY) ....................................................................... 47 
3.4.  MANUAL BREATH KEY .................................................................................................................. 47 
3.5.  ALARM AUDIO PAUSE KEY ........................................................................................................... 48 

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3.6.  START UP PROCESS ....................................................................................................................48 
4. GRAPHICAL USER INTERFACE............................................................................................ 50 
4.1.  GENERAL DESCRIPTION ................................................................................................................50 
4.2.  GRAPHIC USER INTERFACE (GUI) .................................................................................................51 
4.2.1.  GUI Navigation ......................................................................................................... 51 
4.2.2.  Adjusting and Confirming Control Setting ................................................................ 54 
4.2.3.  Touch Screen Bypass Feature ................................................................................. 55 
4.2.4.  Gender Specific Color .............................................................................................. 55 
4.3.  USER INTERFACE KEYBOARD ........................................................................................................57 
4.3.1.  Keyboard Uses and Functions ................................................................................. 57 
4.3.2.  Keyboard Type Selection ......................................................................................... 57 
4.4.  SCREEN RULES AND TIME OUT .....................................................................................................58 
5. VENTILATOR SET UP AND OPERATION ............................................................................. 59 
5.1.  PATIENT SELECTION-SCREEN – NEW AND PREVIOUS PATIENT ........................................................59 
5.1.1.  Patient Option and Patient Startup ........................................................................... 60 
5.1.2.  Humidification Type .................................................................................................. 62 
5.1.3.  Calibrations ............................................................................................................... 62 
5.1.4.  Flow Sensor On/Off .................................................................................................. 63 
5.1.5.  Gas Type .................................................................................................................. 63 
5.1.6.  Patient ID .................................................................................................................. 63 
5.1.7.  Accept Button ........................................................................................................... 64 
5.2.  HOME TAB ...................................................................................................................................65 
5.2.1.  Inspiratory Hold ........................................................................................................ 66 
5.2.2.  Expiratory Hold ......................................................................................................... 66 
5.2.3.  Nebulizer Button ....................................................................................................... 66 
5.2.4.  PaCO2 Entry ............................................................................................................. 66 
5.3.  SETTINGS TAB .............................................................................................................................66 
5.3.1.  Current Settings Screen ........................................................................................... 66 
5.3.2.  Proposed Settings Screen ........................................................................................ 67 
5.3.3.  Choosing a Ventilation Mode Type .......................................................................... 68 
5.3.4.  Current & Proposed Settings .................................................................................... 69 
5.3.5.  Setting Bar: Current & Proposed Settings Selections .............................................. 71 
5.3.6.  I:E Ratio Window ...................................................................................................... 73 
5.3.7.  STARTING Ventilation.............................................................................................. 74 
5.3.8.  Auto Control .............................................................................................................. 74 
5.3.9.  SBT Mode ................................................................................................................. 75 
5.3.10.  Tube Compensation ................................................................................................. 79 
5.4.  MANEUVER TAB ...........................................................................................................................84 
5.4.1.  Suction Support ........................................................................................................ 84 
5.4.2.  Recruitment Maneuver Tools ................................................................................... 86 
5.4.3.  P0.1 Maneuver ....................................................................................................... 105 
5.4.4.  PiMax Maneuver ..................................................................................................... 106 
5.5.  ALARMS TAB ..............................................................................................................................107 
5.5.1.  Alarm Settings ........................................................................................................ 107 
5.5.2.  Alarm Default Settings ............................................................................................ 111 
5.5.3.  Alarm Auto Set Feature .......................................................................................... 112 
5.5.4.  Alarm Levels ........................................................................................................... 114 
5.5.5.  Alarm Audio Pause ................................................................................................. 114 
5.5.6.  Alarm Messages and Descriptions ......................................................................... 115 
5.5.7.  Technical Failure Alarms ........................................................................................ 125 
5.5.8.  Clearing Inactive (Latched) Alarms ........................................................................ 126 
5.5.9.  Event Log................................................................................................................ 126 
5.6.  CONFIGURATION TAB..................................................................................................................127 

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5.6.1.  Clinical Page: Configuration Settings and Options ............................................... 127 
5.6.2.  Audio / Visual Page: Configuration Setting Options ............................................. 131 
5.6.3.  Defaults Page: User Defined Custom Default Profiles .......................................... 132 
5.6.4.  Technical Page: Configuration Setting Options .................................................... 138 
5.6.5.  Technical Page: User Configuration-screen ......................................................... 138 
5.7.  MONITORING ............................................................................................................................. 140 
5.7.1.  Monitor Bar ............................................................................................................ 140 
5.7.2.  Numeric Monitored Data ........................................................................................ 140 
5.7.3.  Trended Data ......................................................................................................... 153 
5.8.  WAVEFORMS ............................................................................................................................. 162 
5.8.1.  Waveform Properties ............................................................................................. 162 
5.9.  LOOPS ...................................................................................................................................... 162 
5.9.1.  Loop Properties...................................................................................................... 162 
5.9.2.  Loop Study ............................................................................................................. 163 
5.10.  CAPNOGRAPHY.......................................................................................................................... 165 
5.10.1.  Warnings and Cautions ......................................................................................... 166 
5.10.2.  Capnography Waveforms and SBCO2 Curves ...................................................... 168 

6. CALIBRATIONS AND ALARM TEST PROCEDURES ......................................................... 171 


6.1.  FLOW SENSOR CALIBRATION...................................................................................................... 173 
6.2.  FLOW SENSOR CALIBRATION PROCEDURE AND INSTRUCTIONS .................................................... 174 
6.3.  CIRCUIT CHECK CALIBRATION .................................................................................................... 176 
6.3.1.  Circuit Check Performance and Technical Details ................................................ 177 
6.3.2.  Circuit Check Calibration-screens ......................................................................... 178 
6.3.3.  Default Circuit Check Failure Bypass Window ...................................................... 179 
6.3.4.  Oxygen Sensor Calibration .................................................................................... 180 
6.3.5.  Zero CO2 Sensor Calibration ................................................................................. 182 
6.4.  ALARM TEST PROCEDURES ........................................................................................................ 186 
6.4.1.  Alarm Functionality Setup Procedures .................................................................. 187 
6.4.2.  Alarm Functionality Tests....................................................................................... 187 
7. ACCESSORIES LIST ............................................................................................................ 190 
8. CLEANING............................................................................................................................. 191 
8.1.  EXTERIOR VENTILATOR CLEANING RECOMMENDATIONS .............................................................. 191 
8.2.  DECONTAMINATION METHODS FOR VENTILATOR PARTS AND ACCESSORIES ................................. 191 
9. PREVENTATIVE MAINTENANCE AND DISPOSAL ............................................................ 195 
9.1.  PREVENTIVE MAINTENANCE PROCEDURES.................................................................................. 196 
9.1.1.  Cooling Fan Filter: Cleaning or Replacement ........................................................ 196 
9.1.2.  Inlet Gas Supply Filters: Replacement .................................................................. 196 
9.1.3.  Oxygen Sensor: Replacement ............................................................................... 196 
9.1.4.  Internal Batteries: Replacement ............................................................................ 197 
9.1.5.  Fuses: Replacement ............................................................................................. 197 
9.1.6.  Performance Verification Testing........................................................................... 197 
9.2.  DISPOSAL.................................................................................................................................. 197 
10. TECHNICAL SPECIFICATIONS: .......................................................................................... 198 
10.1.  MEASUREMENT UNCERTAINTY.................................................................................................... 198 
10.2.  VENTILATOR BREATHING SYSTEM (VBS) COMPLIANCE AND RESISTANCE ..................................... 198 
10.3.  POWER AND GAS SUPPLY .......................................................................................................... 199 
10.4.  ENVIRONMENTAL ....................................................................................................................... 200 
10.5.  Physical Characterists: Ventilator, Sensors and Carts ..................................................... 201 
10.6.  TECHNICAL DATA: VENTILATOR .................................................................................................. 201 
10.7.  TECHNICAL DATA: CAPNOGRAPHY SENSORS .............................................................................. 202 

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11. VENTILATOR SPECIFICATIONS ......................................................................................... 205 


11.1.  ESSENTIAL PERFORMANCE REQUIREMENTS ................................................................................205 
11.2.  VENTILATION MODE TYPES AND MODE SELECTIONS ....................................................................206 
11.3.  BREATH TYPE BY CONTROL VARIABLES .......................................................................................206 
11.4.  OTHER VENTILATION MODE OPTIONS ..........................................................................................207 
11.5.  PATIENT STARTUP SETTINGS ......................................................................................................207 
11.6.  STANDARD MODE SETTINGS .......................................................................................................207 
11.7.  SPAP MODE SETTINGS ..............................................................................................................211 
11.8.  NCPAP+ MODE SETTINGS .........................................................................................................214 
11.9.  SBT MODE SETTINGS ................................................................................................................215 
11.10.  TUBE COMPENSATION SETTINGS ...................................................................................215 
11.11.  APNEA BACKUP SETTINGS ............................................................................................216 
11.12.  CONFIGURATION-SCREEN SETTING OPTIONS (CONFIG) ..................................................217 
11.13.  RECRUITMENT MANEUVER SETTINGS ............................................................................219 
11.14.  PACO2 ENTRY CONTROL SETTING ................................................................................223 
11.15.  MONITORED DATA / DISPLAYED PATIENT VALUES...........................................................223 
11.16.  GRAPHICS: REAL-TIME CURVES ....................................................................................231 
11.17.  ALARM LIMIT SETTINGS .................................................................................................232 
11.18.  ALARMS BY PRIORITY ...................................................................................................235 
12. THEORY OF OPERATION .................................................................................................... 237 
12.1.  VOLUME CONTROLLED CONTINUOUS MANDATORY VENTILATION (V–CMV) MODE.........................237 
12.2.  VOLUME CONTROLLED SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION (V–SIMV) MODE239 
12.3.  PRESSURE CONTROLLED CONTINUOUS MANDATORY VENTILATION (P–CMV) MODE .....................242 
12.4.  PRESSURE CONTROLLED SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION (P–SIMV) MODE
243 
12.5.  VOLUME TARGETED VENTILATION (VTV) MODES .........................................................................244 
12.6.  PRESSURE REGULATED VOLUME CONTROL CONTINUOUS MANDATORY VENTILATION (PRVC–CMV)
MODE 245 
12.7.  PRESS REGULATED VOLUME CONTROL SYNCHRONIZED INTERMITTENT MANDATORY VENTILATION
(PRVC–SIMV) MODE..........................................................................................................................246 
12.8.  VOLUME SUPPORT VENTILATION (VS) MODE ...............................................................................247 
12.9.  PRESSURE SUPPORT VENTILATION (PS) MODE ...........................................................................249 
12.10.  SPONTANEOUS POSITIVE AIRWAY PRESSURE VENTILATION (SPAP) MODE .....................251 
12.10.1. Spontaneous Breaths in SPAP Mode .................................................................... 251 
12.10.2. SPAP mode affects these three monitored values: ............................................... 252 
12.10.3. NCPAP+ Mode ....................................................................................................... 254 
12.11.  NON INVASIVE VENTILATION (NIV) SETTINGS .................................................................254 
12.11.1. NIV Patient Interface .............................................................................................. 254 
12.12.  BREATH TRIGGERING (ALL MODES) ...............................................................................255 
12.13.  LEAK COMPENSATION ...................................................................................................255 
13. TERMS, ABBREVIATIONS AND DEFINITIONS .................................................................. 256 
14. PNEUMATIC DIAGRAM ........................................................................................................ 262 
15. INDEX .................................................................................................................................... 263 
16. E-MAIL CONTACTS .............................................................................................................. 275 

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Index of Figures
FIGURE 1: POWER SUPPLY SOCKET................................................................................................................................... 27 
FIGURE 2: DC INPUT SOCKET ........................................................................................................................................... 28 
FIGURE 3: VENTILATOR OXYGEN AND AIR INLET CONNECTIONS ............................................................................................ 29 
FIGURE 4: HELIOX REGULATOR ......................................................................................................................................... 30 
FIGURE 5: COMMUNICATION PORTS: ETHERNET, RS232 AND NURSE CALL ........................................................................... 31 
FIGURE 6: ATTACHING THE IRMA MAINSTREAM CO2 SENSOR TO THE BREATHING CIRCUIT .................................................... 33 
FIGURE 7: ZERO CO2 SENSOR CALIBRATION SELECTION ..................................................................................................... 34 
FIGURE 8: PERFORMING A ZERO CO2 SENSOR CALIBRATION ............................................................................................... 35 
FIGURE 9: ATTACHING THE IRMA MAINSTREAM CO2 SENSOR TO THE VENTILATOR ................................................................ 35 
FIGURE 10: CO2 SENSOR POSITION AT CIRCUIT WYE.......................................................................................................... 36 
FIGURE 11: ATTACHING THE ISA SIDESTREAM CO2 SENSOR TO THE VENTILATOR.................................................................. 37 
FIGURE 12: ATTACHING THE SIDESTREAM CO2 SENSOR AND SAMPLE LINE ........................................................................... 39 
FIGURE 13: BREATHING CIRCUIT (FLOW SENSOR AT PROX. PORT) ....................................................................................... 40 
FIGURE 14: BREATHING CIRCUIT (FLOW SENSOR AT EXP. PORT) ......................................................................................... 40 
FIGURE 15: NCPAP PRONGS ........................................................................................................................................... 41 
FIGURE 16: NASAL PRONG PRESSURE LINE CONNECTION ................................................................................................... 41 
FIGURE 17: FLOW SENSOR ............................................................................................................................................... 42 
FIGURE 18: EXHALATION VALVE COVER AND DIAPHRAGM .................................................................................................... 43 
FIGURE 19: NEBULIZER CONNECTION ................................................................................................................................ 44 
FIGURE 20, FLEX ARM ASSEMBLY ..................................................................................................................................... 44 
FIGURE 21: INSPIRATION 5I FRONT PANEL .......................................................................................................................... 45 
FIGURE 22: POST SCREEN ................................................................................................................................................ 46 
FIGURE 23: STANDBY / ON /OFF KEY OPTIONS ................................................................................................................... 47 
FIGURE 24: INSPIRATION POWER UP & PATIENT SETUP SCREEN .......................................................................................... 49 
FIGURE 25: GRAPHIC USER INTERFACE.............................................................................................................................. 51 
FIGURE 26: GENDER SPECIFIC GUI COLORS ...................................................................................................................... 56 
FIGURE 27, PATIENT ID/ROOM BED ID KEYBOARD .............................................................................................................. 57 
FIGURE 28, USER COMMENTS KEYBOARD .......................................................................................................................... 57 
FIGURE 29, CONTROL SETTING LIMIT (SOFT BOUNDARY) FEATURE ...................................................................................... 58 
FIGURE 30: NEW PATIENT STARTUP SCREEN ..................................................................................................................... 60 
FIGURE 31: NEW PATIENT STARTUP SCREEN (ALERT MESSAGE – NO IBW) .......................................................................... 61 
FIGURE 32: PREVIOUS PATIENT STARTUP SCREEN.............................................................................................................. 62 
FIGURE 33: HUMIDIFICATION TYPE SELECTION OPTIONS ...................................................................................................... 62 
FIGURE 34: CALIBRATION OPTIONS.................................................................................................................................... 62 
FIGURE 35: HOME TAB ..................................................................................................................................................... 65 
FIGURE 36: CURRENT SETTINGS SCREEN .......................................................................................................................... 66 
FIGURE 37: PROPOSED SETTINGS SCREEN ........................................................................................................................ 67 
FIGURE 38: MODE TYPE / MODE SELECTIONS ..................................................................................................................... 68 
FIGURE 39, LEFT PANEL DISPLAY WITH TIME BASED SETTING CHANGES.................................................................................. 74 
FIGURE 40, AUTO CONTROL BOX IN P–CMV ...................................................................................................................... 75 
FIGURE 41, AUTO CONTROL IN V–CMV OR PRVC–CMV WITH VS SELECTED ...................................................................... 75 
FIGURE 42, AUTO CONTROL IN V–CMV OR PRVC–CMV WITH PS SELECTED ...................................................................... 75 
FIGURE 43, SBT SETTINGS SCREEN.................................................................................................................................. 76 
FIGURE 44: SBT AUTOMATIC EVENT MARKERS .................................................................................................................. 78 
FIGURE 45: TUBE COMPENSATION BUTTON DISPLAY ........................................................................................................... 81 
FIGURE 46: TUBE COMPENSATION SETTINGS SCREEN – TC ON ........................................................................................... 81 
FIGURE 47: TUBE COMP (PTRACH) WAVEFORM .................................................................................................................. 82 
FIGURE 48: APNEA BACKUP SETTINGS SCREENS ................................................................................................................ 83 
FIGURE 49: SUCTION SUPPORT MANEUVER SELECTION....................................................................................................... 84 
FIGURE 50: SUCTION SUPPORT PREPARATION PHASE ......................................................................................................... 84 
FIGURE 51: SUCTION SUPPORT PATIENT DISCONNECTED PHASE.......................................................................................... 85 
FIGURE 52: SUCTION SUPPORT POST OXYGENATION PHASE ............................................................................................... 85 

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Index of Figures
FIGURE 53: PVL TOOL (P) SETTINGS PAGE......................................................................................................................... 90 
FIGURE 54: STEP TOOL SETTINGS PAGE – (RM STEP) ........................................................................................................ 92 
FIGURE 55: RECRUITMENT MANEUVER CURVE ANALYSIS – PVL TOOL .................................................................................. 93 
FIGURE 56: RECRUITMENT MANEUVER CURVE ANALYSIS – TABULAR TEND DATA .................................................................. 94 
FIGURE 57: RECRUITMENT MANEUVER MONITORED BAR DISPLAY ........................................................................................ 96 
FIGURE 58: HOW THE PVL TOOL WORKS (SLOW INFLATION / DEFLATION) ........................................................................... 100 
FIGURE 59: INFLECTION POINT AND CURVE ANALYSIS PV LOOP DATA ................................................................................ 101 
FIGURE 60: P0.1 MANEUVER .......................................................................................................................................... 105 
FIGURE 61: PIMAX MANEUVER ........................................................................................................................................ 106 
FIGURE 62: ALARMS SETTINGS SCREEN – STANDARD ....................................................................................................... 107 
FIGURE 63: ALARMS SETTINGS SCREEN – CAPNOGRAPHY (MAINSTREAM) ........................................................................... 109 
FIGURE 64: ALARMS SETTINGS SCREEN – CAPNOGRAPHY (SIDESTREAM) ........................................................................... 109 
FIGURE 65: ALARMS SETTINGS SCREEN – SBT MODE ...................................................................................................... 110 
FIGURE 66: CLINICAL CONFIGURATION SETTINGS AND OPTIONS ......................................................................................... 127 
FIGURE 67: CLINICAL CONFIGURATION SETTINGS AND OPTIONS ......................................................................................... 127 
FIGURE 68: GRAPHIC CONFIGURATION OPTIONS ............................................................................................................... 131 
FIGURE 69: CUSTOM DEFAULT SETTINGS – USER DEFINED................................................................................................ 132 
FIGURE 70, CUSTOM DEFAULT PROFILE FOLDERS............................................................................................................. 132 
FIGURE 71: SELECTING CUSTOM DEFAULT SETTINGS ........................................................................................................ 133 
FIGURE 72: TECHNICAL CONFIGURATION SETTINGS AND OPTIONS ...................................................................................... 138 
FIGURE 73: SELECTING A MONITORING PARAMETER .......................................................................................................... 140 
FIGURE 74: MONITORED DATA – BASIC ............................................................................................................................ 141 
FIGURE 75: MONITORED DATA – WEANING ....................................................................................................................... 143 
FIGURE 76: MONITORED DATA – MECHANICS.................................................................................................................... 146 
FIGURE 77: MONITORED DATA – ETCO2.......................................................................................................................... 152 
FIGURE 78: TREND DATA WINDOW .................................................................................................................................. 153 
FIGURE 79: USER COMMENTS EVENT MARKER: VIEWING ................................................................................................... 155 
FIGURE 80: TREND DATA – EVENT MARKER CHANGE FEATURE .......................................................................................... 156 
FIGURE 81: TREND DATA UNFREEZE ICON AND CURSOR .................................................................................................... 157 
FIGURE 82: TREND DATA SELECTION WINDOW ................................................................................................................. 158 
FIGURE 83: LOOP SAVE FEATURE .................................................................................................................................... 164 
FIGURE 84: REAL-TIME GRAPHICS (CAPNOGRAMS) ........................................................................................................... 168 
FIGURE 85: REAL-TIME GRAPHICS (SBCO2 CURVES) ....................................................................................................... 169 
FIGURE 86: PACO2 USER ENTRY CONTROL ..................................................................................................................... 170 
FIGURE 87: CALIBRATIONS SCREEN ................................................................................................................................. 172 
FIGURE 88: FLOW SENSOR CALIBRATION-SCREEN............................................................................................................. 173 
FIGURE 89: CIRCUIT CHECK – START ............................................................................................................................... 178 
FIGURE 90: CIRCUIT CHECK – LEAK TEST ........................................................................................................................ 178 
FIGURE 91: CIRCUIT CHECK – PASSED............................................................................................................................. 179 
FIGURE 92: DEFAULT CIRCUIT CHECK FAILURE BYPASS WINDOW ....................................................................................... 179 
FIGURE 93: OXYGEN SENSOR CALIBRATION-SCREEN......................................................................................................... 181 
FIGURE 94: OXYGEN SENSOR CALIBRATION – RUNNING…100%........................................................................................ 182 
FIGURE 95: OXYGEN SENSOR CALIBRATION – PASSED ...................................................................................................... 182 
FIGURE 96: ZERO CO2 SENSOR CALIBRATION-SCREEN ..................................................................................................... 185 
FIGURE 97: ZERO CO2 SENSOR CALIBRATION – RUNNING….............................................................................................. 185 
FIGURE 98: ZERO CO2 SENSOR PASSED ......................................................................................................................... 186 
FIGURE 99: FAN FILTER:  CLEANING OR REPLACEMENT................................................................................................... 196 
FIGURE 100: INLET GAS SUPPLY FILTER REPLACEMENT .................................................................................................... 196 
FIGURE 101: V–CMV MODE ........................................................................................................................................... 238 
FIGURE 102: V–SIMV MODE .......................................................................................................................................... 240 
FIGURE 103: P–CMV MODE ........................................................................................................................................... 242 
FIGURE 104: P–SIMV MODE .......................................................................................................................................... 243 
FIGURE 105: SPONT MODE ........................................................................................................................................... 249 
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Index of Figures
FIGURE 106: SPAP MODE ............................................................................................................................................. 251 
FIGURE 107: INSPIRATION VENTILATOR PNEUMATIC SCHEMATIC......................................................................................... 262 

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In dex o f Tab les

Index of Tables
TABLE 1: REVISION HISTORY ............................................................................................................................................. 12
TABLE 1: DEVICE SAFETY INFORMATION: WARNINGS AND CAUTIONS .................................................................................... 14
TABLE 2: GUI ELEMENT DESCRIPTIONS ............................................................................................................................. 51
TABLE 3: PATIENT SELECTION – NEW SETTINGS ................................................................................................................. 59
TABLE 4: HOME TAB (SCREEN) DESCRIPTIONS ................................................................................................................... 65
TABLE 5: SETTINGS SCREEN DESCRIPTION ......................................................................................................................... 67
TABLE 6: CURRENT AND PROPOSED SETTINGS ................................................................................................................... 69
TABLE 7: SETTINGS BAR: CURRENT AND PROPOSED SETTINGS ............................................................................................ 71
TABLE 8: SBT SETTINGS .................................................................................................................................................. 77
TABLE 9: TUBE COMPENSATION SETTINGS ......................................................................................................................... 81
TABLE 10: RECRUITMENT MANEUVER MONITORED PARAMETERS.......................................................................................... 97
TABLE 11: P0.1 AUTOMATIC TERMINATION CRITERIA ......................................................................................................... 105
TABLE 12: ALARM SETTINGS – STANDARD ........................................................................................................................ 107
TABLE 13: ALARM SETTINGS – CAPNOGRAPHY ................................................................................................................. 109
TABLE 14: ALARM SETTINGS – SBT ................................................................................................................................. 110
TABLE 15: ALARM LIMIT DEFAULT SETTINGS – STANDARD ALARMS ..................................................................................... 111
TABLE 16: ALARM LIMIT DEFAULT SETTINGS – CAPNOGRAHY ALARMS ................................................................................ 112
TABLE 17: ALARM LIMIT DEFAULT SETTINGS – SBT ALARMS.............................................................................................. 112
TABLE 18: AUTO SET FEATURE – ALARM SETTING ADJUSTMENT RULES .............................................................................. 112
TABLE 19: HIGH PRIORITY ALARMS, DESCRIPTIONS AND CORRECTION ACTIONS .................................................................. 115
TABLE 20: MEDIUM PRIORITY ALARMS, DESCRIPTIONS AND CORRECTION ACTIONS .............................................................. 119
TABLE 21: INFORMATION MESSAGE PRIORITY ALARMS, DESCRIPTIONS AND CORRECTION ACTIONS ....................................... 123
TABLE 22: CLINICAL CONFIGURATION-SCREEN SETTINGS ................................................................................................... 127
TABLE 23: GRAPHIC CONFIGURATION-SCREEN SETTINGS................................................................................................... 131
TABLE 24: CUSTOM DEFAULT SETTINGS RULES (WHAT IS SAVED AND NOT SAVED) ............................................................. 136
TABLE 25: TECHNICAL CONFIGURATION-SCREEN SETTINGS AND OPTIONS ........................................................................... 138
TABLE 26: USER CONFIGURAITON-SCREEN ....................................................................................................................... 139
TABLE 27: MONITORED DATE – BASIC .............................................................................................................................. 142
TABLE 28: MONITORED DATA – WEANING ........................................................................................................................ 144
TABLE 29: MONITORED DATA – MECHANICS ..................................................................................................................... 146
TABLE 30: MONITORED DATA – CAPNOGRAPHY (ETCO2) .................................................................................................. 152 
TABLE 31: EVENT MARKERS – MANUAL ENTRY ................................................................................................................. 154
TABLE 32: EVENT MARKERS – AUTOMATIC ENTRY ............................................................................................................ 155
TABLE 33: TREND PARAMETERS – BASIC.......................................................................................................................... 158
TABLE 34: TREND PARAMETERS – ADVANCED .................................................................................................................. 159
TABLE 35: TREND PARAMETERS – MECHANICS ................................................................................................................. 160
TABLE 36: TREND PARAMETERS – ETCO2 ....................................................................................................................... 160 
TABLE 37: CAPNOGRAPHY: WARNINGS AND CAUTIONS ..................................................................................................... 166
TABLE 38: ALARM TEST SETTINGS ................................................................................................................................... 187
TABLE 39: ACCESSORIES INCLUDE WITH VENTILATOR ......................................................................................................... 190
TABLE 40: DECONTAMINATION METHODS FOR VENTILATOR PARTS AND ACCESSORIES ......................................................... 191
TABLE 41: PREVENTIVE MAINTENANCE SCHEDULE ............................................................................................................ 195
TABLE 42: VENTILATION MODES (THEORY OF OPERATION) ................................................................................................ 237
TABLE 43: V–CMV SETTINGS ......................................................................................................................................... 238
TABLE 44: V–SIMV SETTINGS ........................................................................................................................................ 240
TABLE 45: P–CMV SETTINGS ......................................................................................................................................... 242
TABLE 46: P–SIMV SETTINGS ........................................................................................................................................ 243
TABLE 47: PRVC–CMV SETTINGS ................................................................................................................................. 245
TABLE 48:PRVC–SIMV SETTINGS ................................................................................................................................. 246
TABLE 49: VS SETTINGS ................................................................................................................................................ 247
TABLE 50: PS MODE SETTINGS (CPAP + PS) ................................................................................................................. 250
TABLE 51: SPAP SETTINGS ............................................................................................................................................ 252
TABLE 52: ABBREVIATIONS.............................................................................................................................................. 261

EVM500044, Rev E Inspiration® 5i User Manual (International Version) 10


In dex o f Tab les

Index of Tables
TABLE 53: E-MAIL CONTACT DETAILS............................................................................................................................... 275

11 Inspiration® 5i User Manual (International Version) EVM500044, Rev E


Revision History

Revision History

Table 1: Revision History

Author Rev Description of Changes Date Created

Jeffrey Huang A Initial Release 23-Feb-2016

 Updated Notified Body Identification


Susan Gonzalez B 07-Jan-2020
 Updated Authorized Representative
Faye Dunn C Updated to meet SGS Technical File requirements. 10-Feb-2020

Faye Dunn D Added verbiage for reuse of parts and accessories to Table 41. 20-Feb-2020

Faye Dunn E Clarified sterialization details. 20-May-2020

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Section 1 Introduction to the Inspiration 5i Ventilator

1. Introduction to the Inspiration 5i Ventilator


This section briefly describes the Inspiration 5i ventilator mode, features, safety information, ventilator
controls and indicators.
Reference this manual and the Inspiration 5i Ventilator Service Manual when performing any
maintenance on the ventilator.

1.1. Intended Use


The Inspiration® 5i Ventilator System is designed for use on patient population sizes from
Neonatal through Adult who require respiratory support or mechanical ventilation and weigh a
minimum of 0.3kg (0.66lb). The Inspiration® 5i Ventilator System is to be used by healthcare
professionals in hospitals or healthcare facilities and intra-hospital transport to provide
continuous positive pressure ventilatory support using medical oxygen and compressed medical
air from either an internal air compressor or external air sources to deliver oxygen concentrations
of 21% to 100%. Ventilatory support can be delivered invasively or noninvasively to patients who
require Assisted/Control Ventilation, Synchronized Intermittent Mandatory Ventilation or
Spontaneous Ventilation.

1.2. Contraindications:
Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.

1.3. Frequent Used Functions:


 Ventilator setup (gas supply and accessories connections);
 Ventilator startup (power up, patient type setup, breathing circuit check and
calibration);
 Patient ventilation settings (Breath and Mode type, ventilatory parameters, patient
alarms settings and start ventilation);
 Monitoring the ventilation (numeric and graphic monitor analyses);
 User intervention and assessment on the patient ventilation:
o Insp and Exp Hold functions, O2 3 minutes function, manual breath delivery,
alarm adjustment and alarm silence function;
o Ventilatory parameters and mode changes: tidal volume, inspiratory pressure,
inspiratory time, breath rate, PEEP and oxygen concentration.
o Patient disconnection and reconnection for open suction and nebulization.

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Section 1 Introduction to the Inspiration 5i Ventilator

1.4. Safety
The symbols below draw your attention specifically to the remaining dangers associated with
proper use and to emphasize important technical requirements.

 Warning and Caution Symbol: Information or directions/warnings and


Cautions intended to prevent potential damage to the patient, caregiver or
device.

 Explanatory notes and comments relevant to the Inspiration 5i Ventilators.

1.5. Warnings, Cautions and Basic Safety Information


Table 2: Device Safety Information: Warnings and Cautions

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Section 1 Introduction to the Inspiration 5i Ventilator

 General Warning and Caution Information

To ensure proper ventilator operation and avoid the possibility of physical injury, only qualified
medical personnel should attempt to set up the ventilator and administer treatment with the
ventilator.
In case of ventilator failure, the lack of immediate access to appropriate alternative means of
ventilation can result in patient death. An alternative source of ventilation, such as a self-
inflating manual bag resuscitator (as specified in ISO 10651-4 with mask) should always be
available when using the ventilator.
If any damage to the ventilator is apparent, its life-supporting function can no longer be
guaranteed. Stop using the ventilator immediately and use an alternate form of ventilation.
The ventilator system is not intended to be a comprehensive monitoring device and does not
activate alarms for all types of conditions. For a detailed understanding of ventilator
operations, be sure to thoroughly read this manual before attempting to use the ventilator
system.
Do not add attachments or other components or sub-assemblies to the ventilator breathing
system can change the pressure gradient across the ventilator breathing system and that
such changes to the ventilator breathing system can adversely affect the ventilator
performance
Nebulization or humidification can increase the resistance of breathing system filters and that
the operator needs to monitor the breathing system filter frequently for increased resistance
and blockage.
Ventilator accuracy can be affected by the gas added by use of an external nebulizer.
To prevent patient injury, do not make unauthorized modifications to the ventilator.
The audio alarm volume level is adjustable. The operator should set the volume at a level that
allows the operator to distinguish the audio alarm above background noise levels.
Preventive maintenance and cleaning activities must be conducted in accordance with the
procedures and recommended intervals detailed in this manual to ensure prolonged operation
of the Inspiration 5i.
Before each use, check the water traps on the back (gas inputs) for any residual water or
particles.
Do not replace any accessories or other parts of the Inspiration while a patient is being
ventilated.

 Environment of Use

Do not position the ventilator next to anything that blocks or restricts the gas inlet or cooling
air circulation openings, gas exhaust port, fan intake, or alarm speaker, as this may:
Limit the air circulation around the ventilator, potentially causing over-heating;
Limit the ventilator's ability to exhaust patient exhaled gas leading to potential harm;
Limit the clinician’s ability to hear ventilator alarms.
To avoid injury, do not position the ventilator in a way that makes it difficult to disconnect the
patient.
To ensure proper operation, do not position the ventilator in a way that makes it difficult to
access the AC power plug.
Do not use the ventilator in a hyperbaric chamber. It has not been validated for use in this
environment.
Do not use the ventilator in the presence of strong magnetic fields. Doing so could cause a
ventilator malfunction.
Do not use the ventilator during radiotherapy (i.e. cancer treatment using ionizing radiation),
as doing so could cause a ventilator malfunction.

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To avoid the risk of ventilator malfunction, operate the ventilator in an environment that meets
specifications.
Nitric oxide shall not be attached to the ventilator inlet gas source.

 Before Using the Ventilator

Before activating any part of the ventilator, be sure to check the equipment for proper
operation and, if appropriate, run Circuit Check, oxygen sensor calibration and proximal flow
sensor calibration.
Lock the ventilator’s casters during use to avoid the possibility of extubation due to inadvertent
ventilator movement.

 Monitoring and Alarms

The Inspiration 5i Ventilator is not intended to be a comprehensive vital sign monitor for
patients on life-support equipment.
An alternative means of ventilation shall be available whenever the ventilator is in use. If a
fault is detected in the ventilator or its life-support functions are in doubt, disconnect the
ventilator from the patient and immediately start ventilation with such a device (for example,
a resuscitation bag). The ventilator must be removed from clinical use and serviced by eVent
Medical authorized service personnel.
It is recommended that additional independent monitoring devices be used during mechanical
ventilation. The operator of the ventilator must still maintain full responsibility for proper
ventilation and patient safety in all situations.
Check that the remote alarm system (nurse call) is activated before leaving the patient
unattended.
Do not put a vessel filled with a liquid on the ventilator. If a liquid enters the product, a fire
and/or electric shock may occur.
When using non-invasive ventilation (NIV), the patient’s actual exhaled volume may differ
from the exhaled volume reported by the ventilator due to leaks around the mask.

 Fire and Other Hazards

To reduce the risk of fire or explosion, do not place the Inspiration ventilator in a combustible
or explosive environment (for example, around flammable anesthetics or other ignition
sources). Do not use it with any equipment contaminated with oil or grease.

Only medically pure oxygen should be used for ventilation. Do not use anesthetics and
potentially explosive gases. Ensure that oxygen supplies are completely oil-free.
To avoid any potential fire hazard, keep all matches, lighted cigarettes, and other sources of
ignition away from the device.
To minimize the risk of fire, do not use high-pressure gas hoses that are worn or contaminated
with combustible materials like grease or oil.
To reduce the risk of fire, use only breathing circuits intended for use in oxygen-enriched
environments. Do not use antistatic or electrically conductive tubing.
In case of fire, immediately secure the patient’s ventilatory needs, switch off the Inspiration
ventilator, and disconnect it from its gas and electrical sources.
Replacement of ventilator batteries by inadequately trained personnel could result in an

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Section 1 Introduction to the Inspiration 5i Ventilator

unacceptable risk, such as excessive temperatures, fire, or explosion.


Class I ME Equipment: to avoid the risk of electric shock, this equipment must only be
connected to a supply mains with protective earth
If the “Battery not Available” alarm is displayed at startup, take the Inspiration ventilator to
your Biomedical service department to ensure that the internal battery is installed and or
recharged before use.
If the “Battery not Available” alarm message is displayed on the user interface during use,
you must check the battery status as soon as possible to prevent ventilator inoperable in case
of AC mains power is lost. If no action is taken and AC mains power is lost, the battery will
not work and the ventilator will shut down with high pitch continuous buzzer alarm (Ventilator
Inoperable).
The Inspiration ventilator is not intended for use during transports.
To ensure battery backup power is available, do not use the ventilator if the internal battery is
not installed or if the internal battery has a charge of less than 50%.
The Inspiration ventilator should always be plugged in to an AC power source during use and
storage to ensure the devices internal battery remains charged.
Before using the Inspiration ventilator, power on the device, disconnect it from the AC power
outlet, and ensure the battery charge indicator positioned in the upper right corner of the
screen displays a charge of at least 50%.
If the ventilator has been stored for an extended period without being plugged into an AC
power source, verify the devices internal battery has at least a 50% charge and connect to an
AC power source before use.
Use only a 24VDC for DC Input.

 Service and Testing

To ensure proper servicing and to prevent possible physical injury, only qualified personnel
should attempt to service the ventilator.
Do not service the ventilator or replace parts during patient ventilation or when the unit is
running.
To reduce the risk of electrical shock, disconnect electrical power from the ventilator before
servicing. Be aware that battery power remains even after the mains is disconnected. Be
aware that when the inspiration ventilator is off, some parts still carry high voltage.
Do not attempt service procedures other than those specified in the service manual.
Use replacement parts supplied by eVent Medical only.
Any attempt to modify the ventilator hardware or software without the express written approval
of eVent Medical automatically voids all warranties and liabilities.
To ensure the ventilator’s safe operation, always run the tests and calibrations prescribed in

this manual before using the ventilator on a patient. If the ventilator fails any tests, remove it
from clinical use immediately. Do not use the ventilator until necessary repairs are completed
and all tests have passed.
Maintenance should always be conducted in compliance with all relevant safety regulations.
Repairs, assembly and use must be conducted by trained personnel; and the ventilator must
be checked by trained personnel annually.

 Capnography Sensors: Mainstream (IRMA) and Sidestream (ISA)


The CO2 sensors are intended for use by authorized and trained medical personnel only.
Use only Nomoline sampling lines manufactured by PHASEIN (sidestream CO2 sensor).

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Section 1 Introduction to the Inspiration 5i Ventilator

Use only PHASEIN manufactured IRMA airway adapters (mainstream CO2 sensor).
Do not use the CO2 sensors in the presence of flammable anesthetic agents.
Carefully route CO2 sensor sampling lines to reduce the risk of patient entanglement or
strangulation.
Do not reuse disposable CO2 monitoring components.
Dispose of used CO2 monitoring components according to applicable regulations for medical
waste.
Do not attempt to lift the ventilator by a sampling line: doing so can disconnect the line or
cause the ventilator to fall onto the patient.
Orient the CO2 sensor and adapters so that they cannot fall on the patient.
Use appropriate sampling lines or airway adapters for the patient type. Components that are
too large for the patient can add dead space to the breathing circuit, and components that are
too small for the patient can cause excessive flow resistance.
To avoid occluding of the CO2 sensor, do not use the ISA (Sidestream) CO2 sensor with
metered-dose inhalers or nebulized medications.
Verify that the correct sensor is used for the patient type.
To ensure accurate CO2 sensor zeroing, place the sensor and adaptor in a well-ventilated
place in ambient air (21% O2 and 0% CO2) and avoid breathing near the sensor/adapter
before or during the zeroing procedure. Incorrect zeroing can cause false measurements.
Measurements can be affected by mobile and RF communications equipment. Ensure that
the CO2 sensor is used in the electromagnetic environment specified in this manual.
CO2 monitoring is intended only as an adjunct to patient assessment. It must be used in
conjunction with other assessments of clinical signs and symptoms.
Replace the sampling line if the input connector LED flashes red or the ventilator displays an
occlusion message.
No modification of the CO2 monitoring devices is allowed without authorization of the
manufacturer. Modified equipment must be inspected and tested appropriately to ensure
continued safe operation.
CO2 sensors are not designed for MRI environments. During MRI scanning, place the
ventilator outside the MRI suite

 Capnography Sensors:
The Nomoline sampling line, sampling line interface, and IRMA airway adapters are non-
sterile. To avoid damage, do not autoclave. See cleaning instruction on this manual.
Never sterilize or immerse the CO2 sensors in liquid.
Do not apply negative pressure to the Nomoline (i.e., by syringe) to remove condensed water.
Do not apply tension to the CO2 sensor cables.
The ISA “Plug-in and measure” sensors should be securely mounted in order to avoid the risk
of damage to the ISA.

 Electromagnetic Susceptibility
The Inspiration 5i ventilator complies with the IEC 60601-1-2 EMC (Electro Magnetic
Compatibility) Collateral Standard, which include E-field immunity and ESD requirements.
However, even though the device is compliant at the levels of immunity specified in the IEC
60601-1-2 standard, certain transmitting devices (e.g., cellular phones, walkie-talkies,
cordless phones, paging transmitters etc...) emit radio frequencies that could potentially
could influence or disturb device operation if located in close proximity to the ventilator.
Practitioners should be aware that radio frequency emissions are additive, and that the
ventilator must be located a sufficient distance from transmitting devices to avoid interruption.
Do not operate these transmitting devices within the vicinity of the Inspiration ventilator. Do

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Section 1 Introduction to the Inspiration 5i Ventilator

not use the Inspiration ventilator in an environment with magnetic resonance imaging (MRI)
equipment.

 Disposal

Dispose of all parts removed from the device according to your institution’s protocol. Follow
all local, state, and federal regulations with respect to environmental protection, especially
when disposing of the electronic device or parts of it (for example, oxygen cell, batteries).

 Notes

Federal law (USA) restricts the sale of this device except by or on the order of a physician.
When utilizing a closed-suction catheter system, in order to prevent a potential to reduction in patient
tidal volume and hypoxemia, it is recommended to use pressure-based breath rather than volume-
based breath in addition to increase oxygen concentration during the procedure.

1.6. Responsibilities and Guarantees


The manufacturer assumes no responsibility and exonerates itself accordingly from liability
claims where the operator or any third party has:
 Used the device improperly
 Failed to follow the operating instructions
 Disregarded any warnings, cautions or other technical data
 Modified the device in any way
 Operated the device using accessories that are not listed in the associated product
documentation or do not meet applicable international standards.

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Section 1 Introduction to the Inspiration 5i Ventilator

1.7. Notices
1.7.1. Copyright Notice
Copyright © 2010 to 2020 eVent Medical
This work is protected under Title 17 of the U.S. Code and is the sole property of the Company.
No part of this document may be copied or otherwise reproduced, or stored in any electronic
information retrieval system, except as specifically permitted under U.S. Copyright law,
without the prior written consent of the Company.

1.7.2. Trademark Notice


Inspiration, eVolution and CliniNet are registered trademarks of eVent Medical. Smart Sigh,
Smart Nebulizer, Virtual Report and MiniWeb are trademarks of eVent Medical. All other
brand names, acronyms and products referenced in this manual may be trademarked by
separate companies.

1.7.3. Notice of Conformity, Compliance and Approvals


The Inspiration 5i Ventilator was developed in accordance with pertinent international
standards and FDA guidelines.
o The Inspiration 5i Ventilator is manufactured within an EN ISO 13485 Council Directive
93/42/EEC, Annex II, Article 1 certified quality management system.
The Inspiration Ventilator Systems are class IIb medical devices,
which meet and comply with the Essential Requirements of Council
Directive 93/42/EEC and therefore bear the CE mark.

Standards to which conformity is declared


o EN/IEC 60601-1:2012 o IEC 60601-1-8:2006 o ISO 14971:2012
o IEC 60601-1-6:2010 o IEC/ISO 80601-2-12:2011 o IEC 62304:2006
o EN/IEC 60601-1-2:2014 o IEC/ISO 80601-2-55:2011 o IEC 62366:2007

1.7.4. Electromagnetic Compatibility


The ventilator system complies with the requirements of EN/IEC 60601-1-2:2014 (EMC
Collateral Standard) including the E-field susceptibility requirements at a level of 10 volts per
meter, at frequencies from 80 MHz to 2.5 GHz. However, even at this level of device immunity,
certain transmitting devices (cellular phones, walkie-talkies, cordless phones, paging
transmitters, RFID devices, etc.) emit radio frequencies that could interrupt ventilator
operation if operated in a range too close to the ventilator. Practitioners should be aware of
possible radio frequency interference if portable devices are operated in close proximity to
the ventilator. For more detail information, consult service manual.

1.7.5. CE Notified Body


SGS

1.7.6. Classification
CE classification: classified as protection class I, Type BF, internally powered drip-proof adult
/ pediatric / neonate ventilator for continuous operation.

1.7.7. Regulatory Notice


CAUTION: US Federal Law restricts the sale of this device except by or on the order of a
physician.

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Section 1 Introduction to the Inspiration 5i Ventilator

1.8. Device Labels and Symbols


These device labels and symbols appear on the Inspiration 5i Ventilator.
Device Labels and Symbols
External User Interface

% O2 Increase key

Manual Inspiration key / Mandatory breath

On / Off / Standby key

Alarm Silence / Mute key

Front Panel: Vent Inop indicator

Front Panel: Mains power connected indicator

The “Nebulizer” label is position next to the Nebulizer nipple connector.

The “Flow Sensor” label is positioned next to the Flow Sensor connection
port.

The “EtCO2” label is positioned below the Capnography sensor connection


port.

Ethernet Ethernet connection port


RS232 RS232 connection port

Nurse call connection port

Warning and Caution Symbol used in the device user manual: Refer to the
user manual for Information regarding warnings and Cautions intended to
prevent potential damage to the patient, caregiver or device.

Refer to instruction manual

Symbol used to in the device user manual to reference explanatory notes


and comments relevant to the Inspiration 5i Ventilator.

Earth Ground

Designates type BF Applied Part per IEC 60601-1

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Section 1 Introduction to the Inspiration 5i Ventilator

Device Labels and Symbols


External User Interface
Ingress protection by the enclosure:
#2 indicates protection against ingress of foreign objects ≥12.5mm
IP21
diameter.
#1 protection against vertically liquid dripping.

O2 2 – 6 bar (29 – 86 psi) The Oxygen inlet port label is positioned above the Oxygen inlet port.

Air 2 – 6 bar (29 – 86 psi) Air inlet port label is positioned above the Air inlet port.

DC–Input: DC input connection


24VDC
 The “DC Input” label is positioned to the left of the DC input
90W
connection port.
3.75A
AC–Input:
AC input connection
100 -240VAC
50/60 Hz  The “AC Input” label is positioned to the left of the AC input
160VA connection port.
Fuse: T3.15AH, 250 Volt
Type: Miniature ceramic non-
resettable
Size: 5 x 20mm
O2 Sensor Oxygen sensor location

Device serial number


Year of Manufacture
SN:
 The year of manufacture is shown on the serial number label on the
Inspiration ventilation unit.

Inspiratory gas flow to the patient from the ventilator


 The “To Patient” label is positioned just above the inspiratory port.

Expiratory gas flow from the patient to the ventilator


 The “From Patient” label is positioned just above the expiratory port.

Do not obstruct! Do not obstruct port or outlet

Internal battery compartment

Indicates WEEE (Waste Electrical and Electronic Equipment) Registration


per EU WEEE Reg. No. IE 00761, Directive, 2002/96/EC

Indicates the internal compressor is not installed

Device Labels and Symbols


Graphical User Interface

High Priority Alarm message

Medium Priority Alarm message

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Section 1 Introduction to the Inspiration 5i Ventilator

Device Labels and Symbols


Graphical User Interface

Information (low) Priority Alarm message

GUI Display: Indicates that the Vti limit alarm is set to alarm when
Vti limit is violated.

GUI Display: Indicates that the Vti limit alarm has been set to silent.

Graphics and Trending Unfreeze Icon indicates the graphics panel if


frozen

External DC input icon

Internal battery status (percent will vary depending on status)

Internal battery charging status

Internal battery not available


 Batteries are depleted or are not detected

Running on internal battery backup

At Startup and during use while attached to AC power, if the internal


batteries are depleted or are not detected, the “Battery not Available” alarm
message will be displayed in the alarm bar.
Indicates the settings and screen are locked
Lock / Unlock control is located at the bottom right of all user screens and
allows the user to lock or unlock the screen.

Device Labels and Symbols


These additional symbols may appear on PHASEIN CO2 sensors:

REF Catalog number

.SN. Serial number

LOT Batch code

Use-by date (do not use after specified date, YYYY-MM-DD

Temperature limits

Single use only, do not reuse

Complies with 93/42/EEC Medical Device Directive when connected to


medical devices approved by PHASEIN AB.

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Section 1 Introduction to the Inspiration 5i Ventilator

Device Labels and Symbols


These additional symbols may appear on PHASEIN CO2 sensors:
IPX4 IP classification of level of water protection (splash-proof)

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Section 1 Introduction to the Inspiration 5i Ventilator

1.9. Inspiration 5i Ventilator Optional Features


1.9.1. Inspiration 5i Optional Features
The Inspiration 5i ventilator’s software provides full functionality for all features and functions
defined in this manual.
o Capnography Mainstream and Sidestream Monitoring
 The Capnography feature provides plug-n-play functionality and requires the use
of an IRMA (mainstream) or ISA (sidestream) sensor.
 The Capnography IRMA (mainstream) or ISA (sidestream) sensor are sold
separately as optional hardware accessories.
 See section 2.11 for additional information.
o Recruitment Maneuvers
 See sections 11.13 and 5.4.2 for additional information on Recruitment
Maneuvers.
o SBT Mode
 See sections 11.9 and 5.3.9 for additional information on the SBT Mode.
o Suction Support
 See section 5.4.1 for additional information on the Suction Support feature.
o Tube Compensation
 See sections 11.10 and 5.3.10 for additional information on the Tube
Compensation feature.
o Internal Compressor
 The Inspiration 5i ventilator’s optional internal compressor if installed will
automatically turn on in the event the ventilators air supply is interrupted and will
maintain ventilation at the set FiO2, volume and flow required until the high-
pressure air supply is re-established.

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Section 2 Preparing the Ventilator for Use

2. Preparing the Ventilator for Use


2.1. Ventilator Setup

The Inspiration ventilator should only be assembled, operated and tested by


trained and qualified professionals.
Two people are required to assemble the Inspiration on its cart: one to support
the ventilator, and another to attach the ventilator to the cart. Ensure that the
flex arm is positioned toward the front of the ventilator.

The Inspiration ventilator includes the ventilator and cart assembly.


 Assemble the ventilator cart (packaged separately) according to the installation
instructions provided with the cart, and then attach the ventilator to the cart.
 The Inspiration ventilator (packaged separately) also includes installation instructions for
device use/startup and assembly.
 Once the ventilator is assembled, move the ventilator using the side rail (handle) and roll
the ventilator to the desired location.
 The usual ventilator position is on its casters next to the patient’s bedside.

2.2. Power Supply


The Inspiration can be powered from an AC mains supply or DC supply (24 VDC). If AC power
or DC supply are not available, the ventilator automatically switches to internal battery power for
continuous normal operation. The switching from AC power or DC supply to the internal battery
power or vice-versa does not affect the ventilator function.

Power cords must be secured using the retaining clip to prevent inadvertent
disconnection of the power cord from the ventilator.
Do not compromise the AC power cord grounding protection by using an
ungrounded extension lead.
Use only a 24VDC for DC Input.
Fuses must comply with IEC 60127-2/5, and power cords must comply with
IEC 245 Code 53 or IEC 227 Code 53.

2.3. AC Mains Power Supply


Before powering on the ventilator, check the operating voltage (100 to 240 VAC (50/60 Hz)
corresponds to local mains voltage).

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Section 2 Preparing the Ventilator for Use

Use a grounded three-pole cable for the mains power cord, and install the mains plug into a
grounded socket. Only use fuse 5x20mm size, with T3.15AH, 250 volt, type miniature ceramic
non-resettable.

AC mains Fuse Drawer for


power cord T3.15AH fuse
connection

DC Input
Retaining clip connection
for AC power
cord

Figure 1: Power Supply Socket

2.4. DC (Internal Battery) Power Supply


In the event of a loss of AC power, the internal battery provides temporary backup power. With
a full charge, the internal battery should power ventilator operation, with high-pressure gas
supplies and nominal settings in use, for minimum 4 hours. With the internal compressor in use,
battery life is minimum 60 minutes.

To ensure battery backup power is available, do not use the ventilator if the internal
battery is not installed or if the internal battery has a charge of less than 50%.
The Inspiration ventilator should always be plugged in to an AC power source during
use and storage to ensure the devices internal battery remains charged.
Before using the Inspiration ventilator, power on the device, disconnect it from the AC
power outlet, and ensure the battery charge indicator positioned in the upper right
corner of the screen displays a charge of at least 50%.
If the ventilator has been stored for an extended period without being plugged into an
AC power source, verify the devices internal battery has at least a 50% charge and
connect to an AC power source before use.
If the “Battery not Available” alarm message is displayed at Startup, take the Inspiration
ventilator to your Biomedical service department to ensure that the internal battery is
installed and or recharged before use.
If the “Battery not Available” alarm message is displayed on the user interface during
use, check the battery status as soon as possible. If no action is taken and AC mains
power is lost, the battery will not work and the ventilator will shut down with Device Alert
high pitch buzzer alarm.
Ventilator battery replacement shall be performed only by qualified and trained
personnel.

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Section 2 Preparing the Ventilator for Use

2.5. DC Input Connector


The ventilator can operate from a 24 VDC Input. The DC input connector on the back panel of
the ventilator is designed for use only with a 24 VDC.

 Use only a 24VDC for DC Input.

AC mains Fuse drawer


power
connector

Retaining
Clip DC-Input:
24VDC
90W DC Input
3.75A connector

Figure 2: DC Input Socket

2.6. Power On / Off / Standby Key


Connect the Inspiration 5i to the AC power outlet.
Press the On/Off/Standby key located on the front panel of the ventilator to Turn On the unit.
Press for at least 2 seconds. When pressed a single audible tone will sound.

2.7. Gas Supply


The Inspiration Ventilator is equipped with both oxygen and air high-pressure gas supply
connection fitting.

The gas supply hoses must be approved for at least 147 psi (10 bar)
pressure. The permissible gas supply operating pressure range is 29 to 86
psi (2 to 6 bar) for High-pressure O2.
Use medically pure oxygen only.
Oil impairs the individual ventilator components' ability to operate. Oxygen
and air supplies must be completely oil-free. Fault-free operation cannot
otherwise be guaranteed.
Warning: pure oxygen combined with oil is highly explosive!

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Section 2 Preparing the Ventilator for Use

2.8. Connecting to Oxygen and Air Supply

Oxygen Air
connection connection
Supply pressure Supply pressure
29 to 86 psi 29 to 86 psi
(2 to 6 bar) (2 to 6 bar)

Figure 3: Ventilator Oxygen and Air Inlet Connections

2.9. Heliox Setup and Calibrations


The Inspiration is designed to allow in use transition to Heliox delivery, but it is recommended
that a Circuit Check and proximal flow sensor calibration be performed prior to patient interface
or soon after setup to ensure precise delivery and measurement of tidal volumes. The Inspiration
Heliox feature is designed to work with an 80/20 Heliox tank.

2.9.1. Heliox Setup


The Inspiration Ventilator System can accommodate Heliox using an approved Heliox adapter
or regulator to connect to the ventilator’s high-pressure air inlet Figure 4. Once an adapter or
regulator is attached, connect an 80/20 Heliox tank.
After connecting the Heliox gas source to the INSPIRATION Ventilator:
o Select Heliox as Gas type from the Patient Startup Screen or from the Config. Screen
Clinical Page for in use activation.
 Once the Gas type is set to Heliox, a purple Heliox indicator icon will display on
the status bar indicating Heliox is in use. The Heliox icon will remain visible on the
Status bar until the Heliox Gas type is switched to Air and no longer in use.
 Additionally, when the Heliox Gas type is selected, the information message
priority alarm “Gas connected; Heliox?” will sound, display and latch on the
alarm bar to alert and prompt the user to acknowledge if Heliox is connected.
 Acknowledge by touching the message and the alarm will disappear.
 This message is displayed when first turning on Heliox and when the Heliox
gas supply is restored after changing cylinders.
 The Heliox Gas type is disabled (not selectable) if the patient type is Neonate and
the Gas Type selection button will not be displayed.

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Section 2 Preparing the Ventilator for Use

o Once Heliox is in use, let the ventilator run with Heliox for at least 5 minutes to allow
the Heliox gas to fully equilibrate within the ventilator, then perform a Circuit Check and
flow sensor calibration. The calibration will only take about 2 minutes to perform and
ensures the system compliance and flow sensor functionality are based on the lower
density Heliox gas source which is roughly 1/8 the density of air.
 In the event the connected Heliox tank becomes empty the Inspiration’s internal
compressor will automatically switch on to ensure breath delivery is not affected.
 If the oxygen is set below 100% the Inspiration’s internal compressor will
turn off.
 The Heliox feature is not available on units without an internal compressor.
 If the Inspiration’s internal compressor is disabled or removed, the
ventilator’s software will detect this and the Heliox option will be disabled
until the internal compressor is re-enabled or installed.
 If zero flow baseline on the flow-time waveform drifts during operation,
recalibrating the flow sensor will correct this.

It is recommended that a Circuit Check and flow sensor calibration be


performed prior to or soon after patient interface to ensure precise delivery
and measurement of tidal volumes.
Connection of a gas supply at the Helium-Oxygen mixture inlet that does not
contain 20% oxygen can cause hypoxia or death.
Although an 80/20 mixture of Helium and Oxygen is marketed as medical gas,
the Helium/Oxygen gas mixture is not labeled for any specific medical use.

 Heated humidifier performance should be carefully monitored during Heliox


therapy. Helium has significantly greater thermal conductivity compared to
nitrogen / oxygen gas mixtures and this could cause difficulty with some
heated humidification devices. A febrile patient may transfer heat via the
gas column to a proximal temperature sensor, which could affect the duty
cycle of the humidifier and decrease output. This could cause desiccation
of secretions in the airway.
 Alternately, in applications where a heated wire breathing circuit is used, this
heat transfer from the patient may affect the duty cycle of the heated wire
circuit, which may result in increased condensation in the breathing circuit.
The relative settings of some types of humidifiers may need to be reduced
to prevent overheating of the breathing gas.

Heliox regulator option:


 Using the Flotec Heliox regulator
along with the special Heliox to air
high-pressure gas hose allows the
user to attach the Heliox gas source
to the ventilators air inlet fitting.
Heliox kit, DISS, Flotec
 PN: F710568

Figure 4: Heliox Regulator

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Section 2 Preparing the Ventilator for Use

2.10. Attaching Communication Devices (Ethernet, RS232,


and Nurse Call)
As shown below in Figure 5, attach communication devices (Ethernet, RS232, and Nurse Call)
to the ventilator’s back panel.

Ethernet Port

RS232 Port

Nurse Call Port

Ethernet Activity
LED

Ethernet Link
LED

Figure 5: Communication Ports: Ethernet, RS232 and Nurse Call

2.10.1. Ethernet Connection (RJ45 connector)


The Ethernet communication port
o is used to upload software updates via a standard RJ45 Ethernet cable
 Inspiration system software, graphic software and CliniNet server software
o allows fast real-time communication with and data capture by hospital information and
charting systems via the inspiration’s SNMP protocols.
 SNMP stands for Simple Network Management Protocol
 The Inspiration’s SNMP protocol is public record available for download or review
at the OID Repository via the following link:
 http://oid-info.com/get/1.3.6.1.4.1.37251.
o allows the ventilator’s internal CliniNet Server and Virtual Report remote viewing
software to connect and transmit data to remote computers for real-time monitoring and
viewing of all ventilator data, setting, alarms, graphics and technical information.
o

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Section 2 Preparing the Ventilator for Use

2.10.2. RS232 Connection (RJ45 connector)


The RS232 serial port allows
o Communication with and data capture by hospital information and charting systems via
the inspiration’s RS232 communication protocols.
o An optional method of software downloads from a computer to the ventilator using the
software download cable (eVent Medical part number F910085).

2.10.3. Nurse Call Connection (RJ12 connector)


A remote alarm or nurse call interface is available on the ventilator system which can be used to
remotely annunciate the alarm status of the ventilator. Medium and high priority alarms are
remotely annunciated. The nurse call connector is located at the back of the ventilator.
Maximum Switching Voltage: 125 VDC/ 150 VAC
Maximum Switching Capacity: 30 W, 60 VA

2.11. Capnography (Mainstream / Sidestream) Sensors


The Inspiration 5i ventilator is designed to work with the PHASEIN IRMA (mainstream) and ISA
(Sidestream) Capnography sensors and adapters. The Inspiration’s Capnography software is
designed with plug-n-play functionality and will recognize which sensor (IRMA or ISA) is attached
and will automatically load all the Capnography related monitoring and trend data parameters,
graphics screens, event markers, settings and alarms specific to the type of PHASEIN CO2
adaptor attached to the ventilator. Both IRMA and ISA sensors adaptors have indirect contact
with patient.
 When the PHASEIN CO2 sensor is disconnected the ventilator will display an information
message alarm “No CO2 Sensor” to alert the user and all the Capnography related features
will be automatically disabled. All information is retained and will resume at previous
settings once the sensor connection is re-established.
The optional CO2 IRMA sensor is a mainstream, solid-state infrared sensor, which is attached to
an airway adapter that connects to an endotracheal (ET) tube or other airway, measures gases
flowing through these breathing circuit components.
 The sensor generates infrared light and beams it through the airway adapter or sample cell
to a detector on the opposite side. CO2 from the patient, flowing through the airway adapter
(IRMA) or aspirated into the sample cell (ISA), absorbs some of this infrared energy. The
CO2 concentration in the breathing gases is determined by measuring the amount of light
absorbed by gases flowing through the airway adapter or sample cell.
 The Inspiration 5i can display measurements derived from the CO2 sensor as numeric
values, waveforms, trends, and loops. The Capnography waveforms are a valuable clinical
tool that can be used to assess a variety of pulmonary, perfusion and metabolic conditions
as well as patient airway integrity and proper endotracheal (ET) tube placement.
 The CO2 sensor can be easily transferred from one Inspiration 5i ventilator to another, even
during ventilation.

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Section 2 Preparing the Ventilator for Use

2.11.1. IRMA Mainstream CO2 Sensor


2.11.1.1. IRMA Overview and Setup

Sensor head
Sensor clicks into place Position airway adapter so
Head LED faces up.

Sensor cable
Airway connects to vent
Adapter CO2 port

LED 15mm Male end


Face Up connects to Wye Do not place sensor
between ETT and elbow
as this may allow
15mm Female end connects to secretions to block the
patient interface adapter window.

Figure 6: Attaching the IRMA Mainstream CO2 Sensor to the Breathing Circuit

 To attach the IRMA sensor to the Adult or Infant airway adapter, snap the sensor
head onto the airway adapter as shown above in Figure 6. The sensor head clicks
into place when properly seated. The airway adapter will only connect to the sensor
in one orientation as shown above in Figure 6.
 Connect (interface) the airway adapter to the circuit:
o Connect the 15mm male connector to the Wye.
o Connect the 15mm female connector to the patient interface.
Do not place the airway adapter between the endotracheal tube and an
elbow: Doing so can allow secretions to block adapter windows, resulting in
incorrect CO2 sensor operation.

 Orient the airway adapter and sensor head/LED facing up as shown in Figure 6. Avoid
direct contact with the patient and use insulation material if needed.

To keep secretions and moisture from pooling in the airway adapter


windows, position the adapter and probe head so that the IRMA green LED
faces up.

 Verify that the sensor head and airway adapter are securely attached to the breathing
circuit.
 When the ventilator is on, a green LED on the CO2 sensor indicates that the CO2
monitor is being powered and properly connected.

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Section 2 Preparing the Ventilator for Use

 Zero CO2 Sensor Calibration:


o Snap in a new IRMA airway adapter into the IRMA probe, without connecting
the airway adapter to the patient circuit, enter Standby and then navigate to the
New or Previous Patient Start Up screen and press the Calibrations button.
o Select the Zero CO2 Sensor tab from the Calibrations screen as shown below in
Figure 7.

Figure 7: Zero CO2 Sensor Calibration Selection

Zeroing the CO2 sensor should be performed only when an offset in gas
value is observed, or when an unspecified accuracy message is displayed.

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Section 2 Preparing the Ventilator for Use

o The Zero CO2 Sensor Calibration-screen will load and display the last calibration
for the attached sensor, if no calibration history exists for the attached CO2
sensor, the date / time reference will be blank.
o Begin the Zero CO2 Sensor calibration process by pressing the START/Re-Test
button.
o During the calibration sequence, the screen will display and Running…. status
message and once calibration is complete the screen will display the calibration
status message as shown below in Figure 8.
o See section 6.3.5 for additional Zero CO2 Sensor Calibration information.

Figure 8: Performing a Zero CO2 Sensor Calibration

2.11.1.2. Attaching the IRMA Sensor to the Ventilator


As stated above, the ventilator automatically recognizes when the IRMA sensor is
attached, and enables all sensor related to the Capnography features when the sensor is
connected. Connect the IRMA Sensor to the ventilator as shown below in Figure 9.

Figure 9: Attaching the IRMA Mainstream CO2 Sensor to the Ventilator

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Section 2 Preparing the Ventilator for Use

2.11.1.3. Mainstream (IRMA) Sensor Position at Circuit Wye


 When using the IRMA or ISA sensors, if the ventilators flow sensor is positioned
proximally at the circuit Wye, the CO2 airway adaptor should be placed in line between
the breathing tube and the flow sensor to ensure CO2 measurement and curves are
not affected by the flow sensors continuous purge flow.
o If the CO2 airway adaptor is positioned by mistake between the flow sensor and
circuit Wye, the Capnography waveforms and curves may display frequent
downward dips during exhalation due to the flow sensor continuous FiO2
compensation purge flow.
 Reposition the CO2 airway adaptor between the breathing tube and the flow
sensor to resume normal Capnography performance.

Figure 10: CO2 Sensor Position at Circuit Wye

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Section 2 Preparing the Ventilator for Use

2.11.2. ISA Sidestream CO2 Sensor


2.11.2.1. ISA Overview, Setup and Attachment
As stated above, the ventilator automatically recognizes when the ISA sensor is attached
and enables all ISA sensor related Capnography features when the sensor is connected.
Connect the ISA Sensor to the ventilator as shown below in Figure 11.
The ISA sensor comes with a side rail-mounting bracket as shown below in Figure 11 and
allows for easy side rail mounting.

ISA
Mounting Sensor
Allen Bracket
Wrench

Slide ISA Sensor into


module rail mounting
bracket

Figure 11: Attaching the ISA Sidestream CO2 Sensor to the Ventilator

Connecting the CO2 Sensor: Warnings and Cautions


To ensure better waveforms and CO2 monitoring results, when using the IRMA or
ISA sensors, if the ventilators flow sensor is positioned proximally at the circuit
Wye, make sure the airway adaptor is connected between the patient’s breathing
tube and the proximal Flow Sensor.
Always ensure the integrity of the patient breathing circuit after insertion of the
airway adapter by verifying a proper CO2 waveform (capnogram) on the ventilator
display.
If the capnogram appears abnormal, inspect the CO2 airway adapter and replace
if needed.
Monitor the capnogram for higher-than expected CO2 levels during ventilation.
This can be caused by sensor or patient problems.
Do not use the CO2 sensor if it appears to have been damaged or if it fails to
operate properly. Refer servicing to eVent Medical authorized service personnel.
Do not operate the CO2 sensor when it is wet or has exterior condensation.

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Section 2 Preparing the Ventilator for Use

Connecting the CO2 Sensor: Warnings and Cautions


To reduce the risk of explosion, do not place the CO2 sensor in a combustible or
explosive environment (for example, around flammable anesthetics or other
ignition sources).
Position airway adapters with windows in a vertical, not a horizontal, position. This
helps keep patient secretions from pooling on the windows.
To prevent premature failure of the CO2 sensor, eVent Medical recommends that
you remove it from the circuit whenever an aerosolized medication is delivered.
This is due to the increased viscosity of the medication, which may contaminate
the airway adapter window.

 When the ventilator is on, a green LED on the ISA CO2 sensor indicates that the
sensor is being powered and properly connected.
 Perform an initial pre-use check on the ISA sidestream CO2 sensor:
o Block the sampling line for 10 seconds and verify that the CO2 monitor LED
flashes red indicating that the line is occluded.
o Attach the sample line to a sample port on bacteria filter and breathe into the
filter to verify that the ventilator displays valid CO2 waveforms and values.

 Attach the sample line to the sample port of an airway adapter or bacteria filter and
interface with the breathing circuit. Verify that the sampling line is securely attached.

2.11.2.2. Sidestream (ISA) Airway Adapter Position at Circuit Wye


 When using the IRMA or ISA sensors, if the ventilators flow sensor is positioned
proximally at the circuit Wye, the CO2 airway adaptor should be placed in line between
the breathing tube and the flow sensor to ensure CO2 measurement and curves are
not affected by the flow sensors continuous purge flow.
o If the CO2 airway adaptor is positioned by mistake between the flow sensor and
circuit Wye, the Capnography waveforms and curves may display frequent
downward dips during exhalation due to the flow sensor continuous FiO2
compensation purge flow.
 Reposition the CO2 airway adaptor between the breathing tube and the flow
sensor to resume normal Capnography performance.

 Replacement of the sampling line: The Nomoline sampling line is for single
patient use (non-reusable). The Nomoline sampling line should be replaced
every two weeks or whenever “Sampling Line Clogged” appears (whichever
comes first).

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Section 2 Preparing the Ventilator for Use

Insert the Nomaline connector


into the sample line connection
port

Connector for
Circuit WYE
sample port
ISA Sidestream
CO2 Analyzer

Nomaline
(CO2 Sample line)
Connection Port
Green LED when ON
Red LED when
occluded

Figure 12: Attaching the Sidestream CO2 Sensor and Sample Line

2.12. Breathing Circuit


This section describes attaching patient breathing circuits to the ventilator (Figure 13 and Figure
14). This section also includes information on specific components, including nasal prong
interfaces (Figure 15), the exhalation flow sensor (Figure 17), exhalation cover and diaphragm
(Figure 18), humidification devices, circuit support arm (Figure 20) and nebulizer use and
placement (Section 2.12.5).

Use the Inspiration ventilator only with standard breathing circuits (single
patient use or reusable) that comply with ISO 5367:2000.
Incompatible breathing circuit can result in degraded performance.
The organization is responsible for ensuring the compatibility of the
ventilator and all the parts used to connect to the patient before use.
To prevent possible cross-contamination, always use a bacteria filter that
complies with ISO 23328-1:2003, ISO 23328-2:2002 and ISO 5356- on the
inspiratory limb of the patient circuit.
Do not use antistatic or electrically conductive tubing.
Before connecting the ventilator to a patient, perform the Circuit Check to
ensure the circuit compliance is determined and minimal to no leaks are
present.

 eVent Medical recommends that breathing circuit parts that are in contact
with the patient (for example, tubes, HMEs) be biocompatible, as described
in ISO 10993.
 To ensure that all breathing circuit connections are leak-tight, perform the
Circuit Check every time you install a circuit or change a circuit part.
 Regularly check the water traps and the breathing circuit hoses for water
accumulation. Empty as required.
 The following commonly breathing circuits have been tested with Inspiration
5i ventilator: Galemed and Fisher & Paykel.

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Section 2 Preparing the Ventilator for Use

The breathing circuit may include these components:

Figure 13: Breathing Circuit (Flow Sensor at Prox. Port)

Figure 14: Breathing Circuit (Flow Sensor at Exp. Port)

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Section 2 Preparing the Ventilator for Use

2.12.1. Nasal Prongs


The breathing circuit can include a standard neonate / infant circuit with a Wye, or a standard
neonate / infant circuit with neonate / infant nasal prongs replacing the Wye (Figure 15). Use
of a proximal pressure line with the Inspiration ventilators is required. It is important to connect
the proximal pressure line correctly when using nasal prong interfaces.

 Connect the proximal pressure line from the nasal prongs to the right-side silver port:
connecting to a different port causes the ventilator to alarm.

o NCPAP+ mode is appropriate for use with most nasal prong systems as shown below
in Figure 15.

Argyle Infant Nasal Prongs


For nasal prong systems that attach to a patient Wye, F&P Infant Nasal Prongs
connect the Prox pressure line to the Wye.

INCA Infant Nasal Prongs Hudson Infant Nasal Prongs


For nasal prong systems whose pressure port is not centrally located. Connect pressure line
to the port and place the pressure port on exhalation side of the breathing circuit, between nasal
prongs and exhalation valve.
Figure 15: NCPAP Prongs

Attach one end of the proximal pressure line to right-side silver port on the ventilator front
panel as shown below in Figure 16. Attach the other end of the pressure line to the pressure
tap on the Wye (if using a Wye) or the pressure tap at the exhalation side of the breathing
circuit (when no Wye is used).

Figure 16: Nasal Prong Pressure Line Connection

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Section 2 Preparing the Ventilator for Use

2.12.2. Flow Sensor


o The Inspiration 5i ventilator’s flow sensor can be positioned
 Proximally at the circuit Wye between the Wye and ETT or
 Distally at the expiratory port between the expiratory limb of the circuit and the
exhalation cover.
o Attach color-coded multi-line tubing to flow sensor port on front panel of the ventilator.
o To allow continuous purge flow through the flow sensor lines and to prevent
accumulation of any fluid in the sensor tubing, orient the flow sensor as shown below
in Figure 17 with the sensors tubing oriented in an upward direction.
o Always position the Flow Sensor into the circuit with the wider side pointed toward the
patient connection.

To ventilator front panel


Prox. Position flow sensor connector Prox. Position
ETT connects here WYE connects here

Exp. Port Position Exp. Port Position


Distal expiratory limb of Connect this end to the
circuit connects here. exhalation cover

Figure 17: Flow Sensor

o By default, the Flow Sensor is enabled (On) for New Patient Start Up and the previous
selection (On or Off) is maintained with Previous Patient Start Up.
o For New Patient Start Up and when changing out the Flow sensor, perform a flow
sensor calibration.
 From the Patient Start Up screen press the Calibrations button and then select
Flow Sensor.
 Select Flow sensor position “Prox.” if the flow sensor is positioned at the circuit
Wye. Both the (Adult/Pedi) and (Infant/Pedi) flow sensor can be positioned at the
circuit Wye.
 Select Flow sensor position “Exp.” if the flow sensor is positioned at the expiratory
port. Only the (Adult/Pedi) flow sensor can be positioned at the expiratory port.
 When ready press the START button and then follow the on-screen instructions.
See section 6.1 for additional flow sensor calibration details.
2.12.2.1. Flow Sensor Specifications

 Adult / Pediatric Flow Sensor  Neonate / Pediatric Flow Sensor


o Dead space: 6.9 ml o Dead space: 0.75 ml
o Sensor length: 3.25” (6.35 cm) o Sensor length: 2.0” (5.1 cm)
o Sensor weight: 6.3 grams o Sensor weight: 4.0 grams
o Vt range: 100 ml and above o Vt range: 1 to 99 ml

 Because internal ventilator transducers are not separate from the flow sensor tubing,
it is important to orient the flow sensor with tubing pointing up. This allows the
sensors continuous purge flow to keep the tubing clear and help prevent internal
ventilator contamination.

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Section 2 Preparing the Ventilator for Use

2.12.3. Exhalation Valve Cover and Diaphragm

Operate the Inspiration ventilator only with an eVent Medical exhalation valve cover
(PN: F710214) and diaphragm (PN: EVM200325) as shown below in Figure 18.

Exhalation Exhalation
valve cover Diaphragm

Figure 18: Exhalation Valve Cover and Diaphragm

2.12.4. Humidification Devices


Any humidification device used with the ventilator must comply with international standards,
including EN 8185-1, ISO 9360, ASTM F1100-90, F1054-87, and ISO 5356-1.

2.12.5. Nebulizer Use and Placement


Use the Inspiration nebulizer feature only with standard small volume jet nebulizers (single
patient use or reusable) and disk filter that comply with international standards
ASTMF1100-90, F1054-87, ISO 5356-1, EN794-1, EN1281-1, and EN12342.
o Attach nebulizer driveline (tubing) to the Nebulizer nipple connector on the ventilator’s
front panel as shown below in Figure 19.
o Place the nebulizer in the proximal inspiratory limb of the patient circuit based on clinical
judgment and manufacturer recommendations and use the nebulizer according to
manufacturer instructions.
 See section 5.6.1.1 for complete details on the Smart Nebulizer’s functionality.
 See Table 23 for nebulizer and nebulizer interval settings.
o The Nebulizer generates flow between 6 to 8 l/min. When the nebulizer is active, gas
delivery to the patient is compensated to ensure that breath parameters (volume, flow
and FIO2) are not affected.
o Flow triggering is disabled when nebulizer is active. If flow triggering was active prior
to nebulizer activation, the ventilator uses pressure triggering while the nebulizer is
active but flow triggering will be restored when nebulization is complete
o Start nebulization:
 Select Smart Nebulizer from the ventilator’s Config Screen Clinical
page.
 Adjust nebulizer time if is desired for an automatic activation of the
nebulizer according to defined interval time.
 Once the nebulizer time is set, the nebulizer start/stop button will
be available on the Home Screen next to the Insp and Exp Hold.
 Press the nebulizer icon to start or stop the nebulization. Note the
color of nebulizer icon will become blue when it is running. If a time
interval is set, the nebulizer icon color will be yellow during the whole
interval time until next nebulizer automatic activation again.

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Section 2 Preparing the Ventilator for Use

Figure 19: Nebulizer Connection

The nebulizer feature is disabled during Neonate / Infant ventilation.


The Nebulizer will automatically turn off and will not be available when the flow
rate during breath delivery is less than 10 l/min.

2.13. Tubing Support Arm Options:


The Flex Arm Assembly (PN: F710616) includes the below items. Installation of the Flex Arm
Assembly is completed as follows:
 Fit the Mounting Bracket to a rail on either side of the ventilator and secure it in place
using hand-tight knob.
 Screw the Flex Arm down into the Mounting Bracket.
 Install the Tubing Hanger on the end of the flex pipe section and secure it in place using
the hand-tight knob.
 For ventilator storage or unit transport without patient, always retract and position the flex
arm close to the unit for a safe ventilator handling.

Tube Flex
Mounting Holder
Flex Arm Pipe
Bracket
Connection
Screw

Figure 20, Flex Arm Assembly

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Section 3 External User Interface

3. External User Interface

Only Clinicians are qualified to operate the Inspiration 5i Ventilator.

3.1. Ventilator Controls

Figure 21: Inspiration 5i Front Panel

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Section 3 External User Interface

3.2. Startup (On/Off Key) and Standby

Turn the ventilator ON by pressing the Standby / On / Off key on the


ventilator’s front panel (Figure 21). Press and hold for > one second.

o When powered ON, the ventilator performs power on self-test (POST), Figure 22. A
complete check of the ventilator for about 60 seconds duration time, and then the unit
is ready for patient setup and start ventilation.

Figure 22: Post Screen

During ventilation, pressing the Standby/Off Key (for > one second) will load the Standby
selection-screen (Figure 23). During ventilation when the Standby selection-screen loads,
ventilation continues until a selection other than Cancel is made. Select one of the following
options.
o Off
 Selecting Off will stop ventilation and turn the ventilator off.
o Patient Setup
 Selecting Patient Setup will stop ventilation and load the New Patient Startup
screen.
o Standby:
 Selecting Standby will stop ventilation, place the device in standby and load the
Current Settings screen. Standby displays in the upper left corner below Patient
Type.
o Cancel:
 Selecting Cancel will close the Standby screen, ventilation continues
uninterrupted and the previous screen will load.

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Section 3 External User Interface

Figure 23: Standby / On /Off Key Options

3.3. O2 ⬆ Key (%O2 Increase Key or 100% O2 Key)


The O2 ⬆ Key on the front panel when pressed, increases oxygen
concentration above the set level for 5 minutes and is available in all
ventilation modes.

Adult and Pediatric Patients


o Once pressed, 100% FiO2 will be delivered
o An indicator appears in the status bar when the 100% O2 function is active.
Neonate Patients
o Once pressed, 20% above the set FiO2 will be delivered
o An indicator appears in the status bar when the +20% O2 function is active. Indicator
displays the FiO2 delivered.
After five minutes, the delivered oxygen reverts to its original setting. Pressing the O2 ⬆ key
before the interval is complete turns O2 ⬆ delivery off and the delivered oxygen reverts to its
original setting. Oxygen related alarms are silenced during the O2 ⬆ delivery phase. If the
oxygen gas source is disconnected or interrupted, the “Oxygen Supply” and “O2 Increase Not
Avail.” alarm will be triggered. If corrected these alarms automatically silence and latch.
In addition to its normal functionality, when the O2 ⬆ Key is pressed a one point 100% oxygen
sensor calibration will be performed (Adult and Pedi patients only).
Suction Support Functionality
o If the O2 ⬆ Key is pressed during the Suction Support’s Post Oxygenation phase, the
Post Oxygenation phase will cancel, and ventilation will resume at the set O2 level. See
section 5.4.1 for additional information on the Suction Support feature.

3.4. Manual Breath Key


Pressing the Manual Breath Key delivers a mandatory breath during the
next expiratory phase. Only 1 breath is delivered even if the key remains
pressed. A Manual Breath indicator ICON “Manual Insp.” will be
displayed
in the Status Bar when a manual breath is delivered. During a manual breath, the patient
cannot trigger a breath and no other triggers will be permitted during this phase until to 200ms
into exhalation. If the Manual Breath key is pressed again after the manual Inspiration has
started, the function is “armed” (stored) and 1 further mechanical breath will be given no
sooner than 200ms after the previous breath cycles to exhalation. For Mandatory patient

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triggered breaths and Manual breaths the mandatory breath trigger indicator will display
RED indicating that the current breath being delivered is a Mandatory or Manual breath.
The manual breath function is active in all Modes except NCPAP+ when the rate is set to Off.
o In V–CMV, V–SIMV, P–CMV and P–SIMV, PRVC–CMV, PRVC–SIMV and VS, a
manual inspiration uses the current settings; except exhalation is limited to 20% of the
set or IBW based cycle time. The Tcycle of the manual is 4 s (adult and pediatric patient
types) or 2 s (neonate / infant patient type) unless the set Rate would result in a shorter
Tcycle.
 For example, if the set Rate is 10 b/min for an adult patient, Tcycle = 4s for the manual
inspiration, the volume is set Vt, and the target pressure = Pcontrol + PEEP.
o In PS mode, a manual inspiration is delivered at a target pressure of Psupport + PEEP
at IBW based default settings for Rate and I: E ratio. Exhalation is limited to 20% of the
IBW based cycle time.

3.5. Alarm Audio Pause Key

Alarm Audio Pause Key (two minutes audio pause)

Audio Pause for Active Alarms: To pause (silence) active alarms for two
minutes, press and release the Alarm Audio Pause Key. This will pause
the audible portion of the currently active alarms for two minutes. If the
alarm condition is resolved, the visual indicator disappears. If the alarm
condition has not been resolved, the alarm will remain active on the display
screen until the condition is resolved. If a new alarm event occurs, this will
cancel the alarm pause and the current active alarms will sound and
display. Pressing the alarm pause key again will deactivate the current
alarm audio pause session.
Audio Pause for Active and Inactive Alarms: Pressing and holding the
Alarm Audio Pause Key for two seconds will pause all active and inactive
alarms for two minutes. If a new alarm event occurs, no alarm will sound
but all alarms will display. Pressing the alarm pause key again will reset
the alarm pause.

3.6. Start Up Process


When the ventilator is powered on, the Boot Up (Post) screen appears briefly and you are

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automatically taken to the New Patient Startup Screen.


 Boot Up Screen displays current software and Hardware versions as well as ventilator
self-test status.

Figure 24: Inspiration Power Up & Patient Setup Screen

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Section 4 Graphical User Interface

4. Graphical User Interface


4.1. General Description

The Graphical User Interface (GUI) incorporates a 17” display that rotates 90o in a vertical axis
to the right (from user reference) and 180o to the left (from user reference) completing a total
rotation of 270 o. The GUI can also be tilted up to 90o backwards and 10o forwards.
 The term Touch Screen (TS) refers to the front LCD screen of the Inspiration, which
is configured with touch screen functionality.
o Devices Affected
 Inspiration 5i Part Number: F7300000–5i–L & F7300000–5i–F
 Inspiration 5i – NC Part Number: F7300000–5i–L–NC & F7300000–5i–F–NC

 The 5i when shipped will be configured with the latest software for that model.
 Adding the variant (NC), after the product model designates the product will be
configured with NO Internal Compressor.
 Users must be familiar with using the touch screen and knobs to select, start and confirm
parameters. (For additional technical information, please refer to the Inspiration 5i
Service manual)

o Touch Screen Handling Precautions


 The Touch Screen surface is sensitive against mechanical scratches. Do not use
pencils, ballpoint pens or your fingernails to point to the surface. Scratches on the
surface may affect the functionality of the Touch Screen. Use your finger or a special
pen with a rounded point.
o Touch Screen Calibration
 Prior to installation, the Inspiration ventilator should receive a full system and touch
screen calibration for higher precision. For additional information, please refer to the
Inspiration Service Manual. See index for keyword calibration to view specific
calibration criteria. See Section 6 for additional information on pre-use calibrations.

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Section 4 Graphical User Interface

4.2. Graphic User Interface (GUI)


4.2.1. GUI Navigation
The top portion of the Touch Screen allow the user to access additional parameter settings,
special feature settings, monitoring, alarm settings and configuration settings. Each of these
user screens is enabled with touch screen functionality.

Graphic User Interface

Figure 25: Graphic User Interface

Table 3: GUI Element Descriptions

Display & Setting Description


The Patient Type (Adult, Pediatric or Neonate) is visible from all user screens and is displayed
Patient Type in the top left section of the screen
The current active ventilation mode is visible from all user screens and is displayed three
different ways depending on the following.
BOLD BLUE: During normal ventilation, the Current Mode will be displayed in bold blue. When
Current Mode the ventilator is in Standby, the word Standby is displayed bold blue in the Current Mode field.
BOLD GREEN: When AUTO Control is On and the patient has transitions to the corresponding
spontaneous mode, the Current Mode (PS or VS) will be displayed in bold green.
BOLD RED: During Apnea Backup ventilation, the Current Mode will be displayed in bold red.
A round information icon is located to the right of the current mode display.
For Mandatory patient triggered breaths and Manual breaths, this round icon will display
Patient Effort /
RED indicating that the current breath being delivered is a Mandatory breath.
Trigger Indicator
For Spontaneous patient triggered breaths, this round icon will display YELLOW indicating
that the current breath being delivered is a Spontaneous breath.

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Table 3: GUI Element Descriptions

Display & Setting Description


The Status Bar is used to display criteria based indicator icons, which inform the user of specific
conditions or events as follows.
Indicates the Heliox feature is active and the Heliox gas type has
Heliox
been selected
Indicates the NIV control is set to ON. When NIV is active the
NIV ventilator will compensate for leaks up to 60.0 l/min STPD
Indicates that the Tube Compensation feature has been turned on
TC and is active.

O2 Sensor Off Indicates the Oxygen sensor has been disabled (turned Off)

100% O2 Indicates the O2 ⬆ Key has been pressed.

Indicates the Manual Inspiration Key has been pressed and a Manual
Manual Insp
breath has been delivered.
Status Bar
Nebu Indicates the Nebulizer has been turned on and is active.

Sigh Indicates that Sigh has been turned on and is active.

SBT Indicates that the SBT has been turned on and is active.

Indicates that Apnea Backup is enabled (not active). If Apnea or Auto


Apnea is not displayed, this means apnea backup is turned off and Auto
Control is also turned off.
Indicates that Auto Control has been turned On. When Auto is
Auto
displayed, Apnea Backup is background disabled. See section 5.3.8.

Cal Req. Indicates that calibration is required

Indicates that a Capnography sensor has been detected and the


ETCO2
ETCO2 monitoring features are now active.

A Battery icon status.

Internal Battery Meter Icon: When the ventilator loses AC power and
switches to internal DC power, the internal battery meter icon displays and the
current charge % level is shown on the Battery Icon.

Internal Battery Meter Icon: During use if the internal batteries are depleted
Battery Icon or are not detected, this icon will be displayed in the top right of the user
interface.
Internal Battery Charging Icon: When the AC is connected, and the battery is
charging.

DC input Icon: The ventilator switches to DC power.

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Table 3: GUI Element Descriptions

Display & Setting Description

The current date and time is visible from all user screens and is displayed in the top
Current Date and right section of the screen.
Time  Date and Time settings are provided in the password protected Technical
section on the Config Screen.
The following tabs are displayed for screen navigation.
(Home, Settings, Alarms, Maneuvers, and Config)
Navigation Tabs
Touch-selecting one of these navigation tabs loads the screen and user options for
that tab.
Up to three simultaneous active alarm indicators can be displayed in the Active Alarm
Field and will be visible on Main screen as well as all other user screens.
 Active alarms display on the alarm field according to priority from left to right.

Alarm Message Bar High Priority Medium Priority Information Priority

Once an alarm condition is corrected, the alarm message will latch (remain displayed
on the alarm bar) touch the alarm message to clear it. To clear all latched (inactive)
alarms, press and hold a latched alarm message for at least 2 seconds.
The monitoring bar is below the Alarm Display Field and is where the user defined
monitored parameters are displayed.
 User can choose a monitored parameter for each monitor field.
Numeric Monitoring
Bar  By default, 8 monitored parameters are displayed on the Numeric Monitoring
Bar. The user can choose to have five 8 or 12 monitored parameters.
 The number of monitored parameters displayed on the Monitoring Bar can be
adjusted on the Config. Screen Graphics page under Monitors.
Upper Left Panel The Left Panel displays Waveforms, Loops, and Trends.
Upper Right Panel The Upper Right Panel displays Waveforms, Loops, and Trends.
Lower Right Panel The Lower Right Panel displays Data, Trends, Trends Tabs and Event Markers.
Settings Bar The commonly adjusted settings specific to the current or selected proposed mode
START STARTS Button to start ventilation
Screen UNLOCK / LOCK:
UNLOCK / LOCK  To lock the screen, press and hold for 1 second.
 To unlock the screen, just press the button (no need hold).
 If user touches the screen while is locked, the lock icon will toggle between lock
and unlock, and the unit will emit a beep sound.

Alarm Audio Pause Press and hold for two seconds the alarm audible pause button to pause the active
and inactive alarms for two minutes. New active alarms will remain silenced for this
period.
Press the alarm audible pause button to pause the active alarms for two minutes. New
active alarms will deactivate the two minutes audible pause. See definition in sections
3.5 and 5.5.5 (Alarm Silence Key).

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Section 4 Graphical User Interface

4.2.2. Adjusting and Confirming Control Setting


To prevent accidental / unintentional changes, a dual fault philosophy is required. As shown
below, when a control is selected, the controls border will change from grey to green.
Touch-select the desired control (setting or parameter) then turn the knob to adjust / change
the controls setting value and then touch the control again or press the knob to accept and
activate the adjustment.
o Touch Screen Input Method 1

Touch (field boarder changes to green)

Change value (turn knob)

Accept value (touch field)

o Touch Screen Input Method 2

Touch (field boarder changes to green)

Change value (turn knob)

Accept value (push knob)

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Section 4 Graphical User Interface

4.2.3. Touch Screen Bypass Feature


To bypass the use of the touch screen and enable to scroll (rotary) knob for navigation and
selection, press the O2 ⬆ Key and the Standby Key at the same time. This will enable the
ventilator’s Touch Screen Bypass Feature.
o When Touch Screen Bypass Feature is enabled, a yellow cursor will display around the
currently selected tab. Once the yellow cursor is displayed, users can use the scroll
knob to navigate, select, change and activate all settings and functions.

Yellow Box Selection

Scroll to field (turn knob)

Push to Select (push knob)

Change value (turn knob)

Accept value (push knob)

4.2.4. Gender Specific Color


If you enter an IBW of 40 kg or less, the screen background panel color will be light blue (male
gender) or pink (female gender). Default Gender is male. If you manually enter the IBW then
Gender buttons are disabled, and the Panel Color will be based on the last updated Gender.
The screen background panels will be dark blue for patients whose IBW is greater than 40 kg

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Section 4 Graphical User Interface

(adult), regardless of gender.

Neonate & Pediatric Male GUI Color Neonate & Pediatric Female GUI Color
A Light Blue background panel color will be A Light Pink background panel color will be
displayed for male patients when the displayed for female patients when the
IBW is < 40 kg. IBW is < 40 kg.
Figure 26: Gender Specific GUI Colors

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Section 4 Graphical User Interface

4.3. User Interface Keyboard


As defined below an on-screen keyboard will automatically display when certain selections are
made to allow easy entry when specific types of data entry are required or desired.

4.3.1. Keyboard Uses and Functions


o Patient ID/Room Bed ID Keyboard
 As shown below in Figure 27, when the user selects (presses) the Patient ID button
on the New or Previous Patient Startup screens, the Patient Information Keyboard
will display to allow user to enter the Patient’s ID as well as the Patient’s Room/Bed
ID. This data is used by the CliniNet® Virtual Report™ remote monitoring software
and charting systems.
o User Comments Keyboard
 As shown below in Figure 28, when the user selects (presses) the User Comments
(CMTS) Event Marker on the Trends Screen left panel, User Comments Keyboard
will display to allow users to enter a comment. Once entered, this comment will
display on the Trend Screen for future reference.
o Custom Default Setting Profile Keyboard
 From the Config screens Defaults page, users can select a Custom Defaults profile
and rename the profile to an alpha numeric user defined name. This allows easy
selection and reference later. Up to four user defined profiles can be saved and
renamed as desired. See section 5.6.3 for additional details on User Defined
Configuration Setting Profiles.
o Password (Access) Code Keyboard
 From the Config screens Technical page, a password (access) code field is
provided, when selected the Keyboard screen will display to allow users to enter
the password to access the additional Technical, Service and Engineering
screens.

Figure 27, Patient ID/Room Bed ID Keyboard Figure 28, User Comments Keyboard

4.3.2. Keyboard Type Selection


o From the Config screens Technical page, a Keyboard selection button is provided to
allow users to define what type of keyboard will be displayed. The keyboard options
are as follows:
 Standard: The standard option displays the typical QWERTY type keyboard.
 Generic Alpha: The Generic Alpha option displays a keyboard with character
layout in the traditional US alphabet.

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4.4. Screen Rules and Time Out


o Screen Display Defaults to Home Screen (2 minute rule)
 The ventilator’s UI display will automatically change to the Home Screen two minutes
(120 seconds) post user interaction for the following Tabs: Settings, Alarms,
Maneuvers and Config. This rule applies for both, during ventilation and Standby
o Time Outs and Unaccepted Changes
 The Inspiration ventilator has an automatic timeout safety feature and return to
previous settings to prevent accidental or unaccepted changes.
o Time outs
 A mode selection (during ventilation or startup) will remain in the selected state for 60
seconds post user interaction. If this 60-second period elapses before the next user
interaction, the Settings screen will revert to the Current or default mode and settings.
 If the user touches any other changeable field and inputs a change with the knob but
fails to accept or activate the change, the field value will revert to its previous value
after 10 seconds.
o Unaccepted Changes
 If the user touches outside the selected field or touches another field before accepting
a change, the field value will revert to its previous value (Undo function).
o Control Setting Limit (Soft Boundary) Feature
 Soft Boundary setting limits exist on various ventilators on the market and provide an
additional layer of protection against adjusting certain settings above defined critical
high levels. Soft boundary setting limits simply provide a mandatory setting value stop-
point that prevents increasing the setting value above that point for 2 seconds prior to
allow the control to an adjusted to a higher value.
 Setting Control Soft / Max Boundary Visual Markers
o A WHITE arrow indicates the value changes.
o An ORANGE line indicates Lower Boundary.
o A RED line indicates Upper boundary.

Figure 29, Control Setting Limit (Soft Boundary) Feature

o To set the parameter above the Upper Boundary, wait 2 seconds at the
boundary-setting limit, then the values can be adjusted up again.

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Section 5 Ventilator Set Up and Operation

5. Ventilator Set Up and Operation


 Only trained users should change ventilator configuration: changing the
configuration can have serious consequences for subsequent ventilation.
 An alternate form of oxygen monitoring must be provided if the internal oxygen
sensor is turned off in the configuration-screen.

5.1. Patient Selection-screen – New and Previous Patient

Table 4: Patient Selection – New Settings


Setting Description
Left Panel Options
Patient Options Selection Options:
(Left Panel)  New
 Previous
Right Panel Option
Ideal Body Weight Calculator Selection Options:
 Patient Height:
 Gender:
 IBW:
 Patient Height and Gender are used to
automatically calculate the patients Ideal Body
Weight or IBW can be manually set directly.
Humidification Type Selection Options:
 Humidifier
 HME
 None
Calibrations User calibrations are performed here:
(See section 6 for additional  Circuit Check
calibration instructions.)  O2 Sensor
 Zero CO2 Sensor
Flow Sensor On/Off Selection Options:
 Flow Sensor On
 Flow Sensor Off
 When the Flow Sensor is turned Off, flow triggering is disabled and pressure
trigger will automatically be enabled.
 When the Flow Sensor is turned Off, exhaled volumes (Vte and Ve) and
exhaled flow (PFe) will be disabled.
Gas Type Selection Options:
 Air
 Heliox
Heliox is disabled with Neonate patient type

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Section 5 Ventilator Set Up and Operation

Table 4: Patient Selection – New Settings


Setting Description
Patient ID Entry Options:
 Patient ID
 Room/Bed ID
ACCEPT Accepts and saves the selected options and takes the user to
Settings screen

5.1.1. Patient Option and Patient Startup


o New patient:
For New patient startup, select New and enter the IBW. The ventilator can automatically
calculate the IBW based on entered values for patient height and gender (Figure 30 and
Figure 31) or you can enter the IBW directly. The initial default ventilator settings are based
on calculated or directly entered IBW.

Figure 30: New Patient Startup Screen

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Section 5 Ventilator Set Up and Operation

o New Patient: An Ideal Body Weight Must be Entered

For New Patient Startup, IBW is a required setting that must be entered before the Main
screen will load.

As shown below in Figure 31, pressing the ACCEPT button without establishing or
manually entering an IBW will result in the alert message “Ideal Body Weight must be
entered for new patient” being displayed in the right panel above the ACCEPT button.
The IBW is used to establish all initial ventilator settings, apnea backup settings and
alarm settings and therefore is required before the settings screen will load.

Figure 31: New Patient Startup Screen (Alert Message – No IBW)

o Previous Patient:
If Previous is selected, all settings, configurations, event logs, trends from the previous
patient will be retained. The Ideal Body Weight, Humidification Type and Gas Type
settings can be verified and changed here if necessary. User may also access and
perform calibrations at this time.

 Changing the IBW setting on the Previous Patient Startup screen will only
affect the monitored parameters, which are normalized to patient weight.

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Section 5 Ventilator Set Up and Operation

Figure 32: Previous Patient Startup Screen

5.1.2. Humidification Type


User can select the desired humidification type:
o The default humidification type is Humidifier.
o Humidification Compensation
 Humidification Compensation is enabled when Humidifier or HME is selected as
the humidification type and allows the ventilator to adjust for the assumed BTPS
conditions and apply the appropriate correction factor to correct:
 Inspiratory volume delivery during volume modes.
 Measured inspiratory tidal volume during pressure modes.
 Measured exhaled tidal volumes during all modes.
 When Humidifier is selected, the system assumes a dual limb heated wire circuit
is in use and no BTPS correction to Vte is applied.
 When HME is selected, the system assumes an HME or single (insp) limb heated
circuit is in use and applies a BTPS (HME) correction factor to Vte.

Figure 33: Humidification Type Selection Options

 The humidification type None assumes ATP conditions and is used for
device testing and should not be used during patient ventilation.

5.1.3. Calibrations
Press the Calibrations button to load the Calibration options screen where you can perform
the following: (See section 6 for additional calibration details and instructions.)
o Circuit Check: This test determines the breathing circuit system compliance for
compliance compensation and checks for leakage in the patient’s breathing circuit.
o O2 Sensor: Calibrates the O2 Sensor
o Zero CO2 Sensor: Calibrates (zeros) the attached CO2 sensor.

Figure 34: Calibration Options

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Section 5 Ventilator Set Up and Operation

 It is recommended to perform
a Circuit Check calibration between patients, when replacing the flow
sensor or if a drift in baseline flow is noticed.
a Circuit Check between patients, when replacing the breathing circuit or
a breathing circuit component.
an O2 Sensor Calibration between patients, when replacing the O2 Sensor
or if a drift is noticed with the O2 monitored value.
a zero CO2 sensor calibration when changing the Capnography airway
adapter.

5.1.4. Flow Sensor On/Off


Allows the user to disable (turn off) the flow sensor prior to starting ventilation. By default, the
flow sensor is always enabled (set to on) for New Patient Startup. For Previous Patient
Startup, the previous flow sensor On/Off setting is maintained.
o When the flow sensor is disabled (turned Off), the trigger type will switch to pressure
and flow triggering will be disabled. When the flow sensor is re-enabled (turned On)
the previous or IBW based trigger type and trigger level will be re-enabled.
o When the flow sensor is disabled (turned Off), exhaled volume and flow monitoring is
not possible and all exhaled volume monitors will switch to inspiratory volumes.

The Inspiration 5i ventilator utilize and external flow sensor that can be calibrated
for use proximally (at the circuit Wye) or distally (at the expiratory port).

o A flow sensor On/Of control is also provided on the Config screens Clinical page, which
allows the user to disable or re-enable the flow sensor during ventilation or Standby.
 If the flow sensor is disabled (set to Off) on the New or Previous patient startup
screen, the Flow Sensor On/Off control will not be displayed on the Config screens
Clinical page. See Table 23 for additional details on disabling or enabling the flow
sensor from the Clinical Configuration-screen.

5.1.5. Gas Type


The Gas Type selection option allows the user to define at Patient Startup (New or Previous)
the high-pressure gas source (Air or Heliox) that will be used in conjunction with oxygen during
ventilation.
o Selecting Heliox assumes a helium/oxygen mixture of 80/20 as the Heliox gas source.
o For Neonate patient type, Heliox delivery is disabled and the Gas Type selection option
will not be displayed.
o See section 2.9 for additional details on Heliox setup, calibration and use with the
Inspiration 5i ventilator.

5.1.6. Patient ID
The Patient ID button when pressed, will load the New Patient Information entry screen and
on-screen keyboard tool to allow users to enter the Patient’s ID as well as the Patient’s
Room/Bed ID.
This Patient’s ID and Room/Bed ID are used by the ventilators CliniNet® Virtual Report™
remote monitoring software as well as hospital information / charting systems.

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Section 5 Ventilator Set Up and Operation

o The ventilators remote monitoring platform (Virtual Report) is a separate software


application, which can be installed on any hospital network PC and allows access to
any Inspiration ventilator connected to the hospital network. Ventilators can be
connected to the hospital network wirelessly or via an Ethernet (RJ45) cable.
o Virtual Report when running on the hospital PC with network-authorized access will
scan the network using a standard SNMP manager looking specifically for Inspiration
ventilators with an assigned Patient’s ID and Room/Bed ID.
 The Inspiration ventilators with an assigned Patient’s ID and Room/Bed ID will be
automatically captured by Virtual Report and displayed as a selection option.
 Additionally, all Inspiration ventilators can be manually configured to display in
Virtual Report if the Patient’s ID and Room/Bed ID feature is not desired or is not
available.

For additional details on CliniNet® Virtual Report™, please visit our website at
www.event-medical.com/products/clininet.
To order our free (30-day) trial software, please contact customer service at
customer.service@event-medical.com or contact our office directly.

5.1.7. Accept Button


Press the ACCEPT button on the New or Previous Patient Startup screen to accept the Patient
Startup options. Once pressed, the Current Settings screen will load with the IBW based
initial default settings.
Review and adjust all settings (Current, Apnea Backup and Alarm settings) as required. The
ventilator remains in Standby mode until the START button is pressed. Pressing the START
button will start ventilation using the accepted settings.

As shown above in Figure 31, pressing the ACCEPT button without establishing or
manually entering an IBW will result in the alert message “An Ideal Body Weight
must be entered for new patient” being displayed in the right panel above the
ACCEPT button.

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Section 5 Ventilator Set Up and Operation

5.2. Home Tab

Figure 35: Home Tab

Setting Description
Settings Bar The commonly adjusted settings specific to the current or selected
proposed mode
Insp Hold and Exp Hold Insp Hold button
Exp Hold button
Nebulizer button: if enabled nebulizer time.
PaCO2 Entry: avaliable with capnography.
START STARTS Button to start ventilation
Table 5: Home Tab (Screen) Descriptions

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Section 5 Ventilator Set Up and Operation

5.2.1. Inspiratory Hold


In the Home Tab, touch and hold the Insp. It applies an inspiratory hold for Plateau Pressure
evaluation, static compliance calculation, and inspiratory and expiratory resistance calculation
if the mode is VCV with square wave flow. Max Insp Hold is 30s.
Inspiratory hold is not available during NCPAP+ mode.

5.2.2. Expiratory Hold


In the Home Tab, touch and hold the Exp. Hold button evaluate auto-PEEP. Max Exp Hold is
30s.
Expiratory hold is not available during NCPAP+ mode.

5.2.3. Nebulizer Button


The nebulizer button will be available on the Home Screen if the nebulizer time is set in the
Clinical settings under Config page.

5.2.4. PaCO2 Entry


The PaCO2 entry will be available on the Home Screen if the optional capnography module is
installed. Touch the PaCO2 button to enter the value for patient dead space calculation.

5.3. Settings Tab


5.3.1. Current Settings Screen
Current Settings screen will be displayed as shown below in Figure 36.

Figure 36: Current Settings Screen

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Section 5 Ventilator Set Up and Operation

5.3.2. Proposed Settings Screen


During ventilation if a new Mode Selection button or the Mode Type button is pressed, the
Proposed Settings screen will load as show below in Figure 37.

Figure 37: Proposed Settings Screen

Setting Description
Mode Selection Panel Allow users to select the desired mode for ventilation
(Left Panel)
Mode Type Mode Selection
CMV P–CMV, V–CMV or PRVC–CMV
SIMV P–SIMV, V–SIMV or PRVC–SIMV
SPONT PS, VS, SPAP or NCPAP+
Current Settings Panel Set advanced parameter settings
(Right Panel) (parameters displayed dependent on mode selected)
Basic Parameter Setting Bar Set basic parameter settings
(below right and left panels) (parameters displayed are dependent on mode selected)
Monitor Bar Display eight (8) or twelve (12) user-selectable monitoring
(above right and left panels) values.
START Button Initiates ventilation on user set parameters, switches to
Home Screen
Table 6: Settings Screen Description

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5.3.3. Choosing a Ventilation Mode Type


To choose a Mode, user will select the desired Mode Type; CMV, SIMV or SPONT from the
Mode selection Left panel.
Once the Mode Type is selected, user will select the desired breath type from the Mode
Selection options; Pressure (P), Volume (V), Pressure Regulated Volume (PRVC), Pressure
Support (PS), Volume Support (VS) or Spontaneous Positive Airway Pressure (SPAP).
As shown below in Figure 38, the mode NCPAP+ will only be displayed as a SPONT mode
selection option when the patient type is Neonate/Infant.

Neonate patient type


Figure 38: Mode Type / Mode Selections

Once the desired Mode is selected, review and adjust all settings (Current/Proposed, Apnea
Backup and Alarm settings) as required. Only those settings applicable to the selected mode
will be displayed.
The user must review and or adjust parameter settings from the Current/Proposed Settings
Right panel, and the parameter settings from the bottom settings bar. Only active settings
are displayed. When ready, press the START button to start ventilation.

 If the selected mode is not activated within two minutes (120 s) from the last
user interaction, the ventilator will revert to the previous settings.
 The <<BACK button is displayed on the Mode selection left panel when the
ventilator is in Standby or when a new mode is selected during ventilation.
 Pressing the <<BACK button while in Standby will exit Standby and load the
Previous Patient Startup screen.
 Pressing the <<BACK after selecting a new mode during ventilation will exit
the proposed mode settings screen and load the Current Settings screen.

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Section 5 Ventilator Set Up and Operation

5.3.4. Current & Proposed Settings


Table 7: Current and Proposed Settings
Parameter Definition Setting Range
Esens Exhalation sensitivity (also known as termination 10 to 80 % of
sensitivity) sets the percent of peak inspiratory flow at peak flow
which the ventilator cycles from inspiration to exhalation.
It applies to spontaneous (PS or VS) breaths only.
Increasing the Esens setting shortens inspiratory time.
PF x Esens% = flow rate to terminate inspiration.
NOTE:
 Adjusting Esens to match the patient’s desired
inspiratory time can improve patient / ventilator
synchrony.
 Leaks can cause an inability to terminate pressure
support breaths, causing profound asynchrony.
Increase the Esens setting as required when leaks
are present.
Rise time Rise time or ramp speed controls the time required for 1 to 20
inspiratory pressure to reach the set (target) pressure. 1 = Slow and
Applies to all pressure breaths; P–CMV, P–SIMV, PS, 20 = Fast
SPAP, PRVC–CMV, PRVC–SIMV, VS
Flow Pat Sets the Inspiratory Flow pattern for breath delivery. Square, Decel
Applies to Volume Control mandatory breaths only. 50%,
Decelerating
Trigger User can select Flow or Pressure Trigger. Flow or Pressure
H:L An SPAP setting that defines a ratio of time at high and 1:59 to 59:1
low PEEP levels.
Applies to SPAP mode only: Cycle + Ratio
NIV An advanced parameter setting in all modes that allows On or Off
user to ventilate with a NIV interface.
PS Tmax PS Tmax is the max time limit control setting for all Adult:
modes with a pressure support (PS) setting or PS based 0.50 to 5.0 s
breaths. PS Tmax functions as the inspiration
termination criteria for all PS based breaths. PS breaths Pediatric:
when delivered will terminate by flow, pressure and time. 0.50 to 5.0 s
Whichever termination criterion is met first will cause the
PS breath to cycle to exhalation. Neonate:
NOTE: When Psupport is set to 0 cmH2O, the PS Tmax 0.15 to 3.0 s
feature is background disabled. This will prevent time-
based termination of the patient’s breath and allow vital
capacity (VC) measurements to be obtained.
Pause Inspiratory pause or plateau applied during a volume 0.00 to 42.0 s
control breath. (US philosophy)
0 to 70 %
(European
philosophy)

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Table 7: Current and Proposed Settings


Parameter Definition Setting Range
Auto Control Auto Control is a feature in which the Inspiration On or Off
ventilator automatically transitions between CMV and
spontaneous modes in response to the presence or
absence of spontaneous breathing without any alarms or
need for staff intervention.
Section 5.3.8 describes Auto Control in more detail.
Auto Control Auto Control Time sets the length of time with no 3 to 60 seconds
Time spontaneous effort that is required to make the transition
from spontaneous mode back to CMV when Auto Control
feature is turned On.
Auto Control The Auto Control Spont mode selection toggle button PS or VS
Spont Mode allows users to select the Spont mode used when Auto
Selection Control is active. See section 5.3.8.
SPAP Type Sets configuration for SPAP ventilation settings Time Only,
Cycle + Time,
Cycle + Ratio
Leak Ventilator will automatically compensate for baseline On or Off
Compensation leaks during ventilation.
Section 12.13 describes leak compensation in more
detail.
If ON and NIV is set to Off the Inspiration will
compensate for leaks automatically from 0.0 to 25.0
l/min STPD.
If ON and NIV is set to ON the Inspiration will
compensate for leaks automatically from 0.0 to 60.0
l/min STPD.
Base Flow Available ONLY if Leak Compensation is set to Off. Sets 2.5 to 25.0 l/min
the base flow available in the system for flow triggering.
SBT Spontaneous Breathing Trial Mode START or STOP
SBT when activated allows the ventilator to deliver PS +
CPAP for a user defined time and provided SBT specific
alarms. Section 5.3.9 describes SBT in more detail.

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Table 7: Current and Proposed Settings


Parameter Definition Setting Range
Tube TC when enabled, allows the ventilator to automatically On or Off
Compensation compensate for the resistance associated with an
endotracheal or tracheostomy tube. TC unloads the
resistance of the endotracheal tube (ETT) during
inspiration by increasing the airway pressure, and in
expiration by decreasing the airway pressure according
to the non-linear pressure-flow relationship of the ETT.
Section 5.3.10 describes Tube Compensation in more
detail.
When TC is turned on:
 The ventilator automatically calculates the pressure drop
across the endotracheal tube during inspiration and
exhalation.
 The ventilator then adjusts the airway pressure to deliver
the set pressure to the distal (carina) end of the
endotracheal tube.
 This calculation takes into account flow, gas composition,
fraction of inspired oxygen (FIO2), tube diameter, length,
and pharyngeal curvature based on patient size (Neonatal,
Pediatric, Adult).
Apnea Backup Apnea backup provides backup ventilation if the Apnea On or Off
alarm limit elapses without breath triggering.
Backup ventilation is delivered according to the selected
Apnea Backup modes and settings. Backup ventilation
modes are the same as for normal ventilation except:
 The only SPONT mode available for Apnea Backup
ventilation is SPAP (PS and VS are not available)
 OFF is available in any mode type to disable backup
ventilation.

5.3.5. Setting Bar: Current & Proposed Settings Selections


Table 8: Settings Bar: Current and Proposed Settings
Parameter Definition Setting Range
O2 Oxygen concentration to be delivered. 21 to 100 %
Oxygen (%) Applies to all breaths in all modes.
Rate Respiratory rate sets the number of mandatory Adult:
breaths delivered by the ventilator. 1 to 60 b/min
Applies to all CMV and SIMV modes. Pediatric:
1 to 120 b/min
(Not available in PS, VS, SPAP) Neonate:
1 to 150 b/min

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Table 8: Settings Bar: Current and Proposed Settings


Parameter Definition Setting Range
Cycle This is an SPAP (dual PEEP mode) setting that Adult:
specifies how many times per minute the 1 to 60 c/min
ventilator will cycle from low PEEP to high PEEP. Pediatric:
Transitions between high and low PEEP levels 1 to 120 c/min
are synchronized with the patient’s spontaneous
respirations. Applies to SPAP mode only: Cycle Neonate:
+ Time and Cycle + Ratio 1 to 150 c/min

Vt Tidal volume set to be delivered during inspiration. Adult:


Applies to volume controlled or volume targeted 300 to 2000 ml
breaths only: V–CMV, V–SIMV, PRVC–CMV, Pediatric:
PRVC–SIMV, and VS. 40 to 500 ml
Neonate:
2 to 100 ml
Ti Set inspiratory time applied to a mandatory 0.1 to 10.0 sec
breath. Applies to P–CMV, P–SIMV, PRVC–CMV
and PRVC–SIMV breaths only.
I:E Ratio of inspiratory time to expiratory time for 1 : 9.0 to 4.0 : 1
mandatory breaths. Available if ventilator is
configured for European philosophy.
PEEP/CPAP PEEP (positive end expiratory pressure) and 0 to 50 cmH2O or
CPAP (continuous positive airway pressure), 0 to (90 cmH2O -
baseline pressures applied during the expiratory Pcontrol, Psupport),
phase. whichever is less
Applies to all breaths in all modes except SPAP
Pcontrol Pressure above PEEP to be applied during the Adult:
inspiratory phase. 5 to 90 cmH2O or
Applies to mandatory breaths in P–CMV and 0 to (90 cmH2O - PEEP),
P–SIMV whichever is less
Pediatric:
5 to 90 cmH2O or
0 to (90 cmH2O - PEEP),
whichever is less
Neonate:
2 to 90 cmH2O or
0 to (90 cmH2O - PEEP),
whichever is less
Psupport Pressure (above PEEP/CPAP) to be applied to a 0 to 90 cmH2O or
patient triggered breath during the inspiratory 0 to (90 cmH2O - PEEP),
phase. whichever is less
Applies to spontaneous breaths in SIMV and PS
modes.

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Table 8: Settings Bar: Current and Proposed Settings


Parameter Definition Setting Range
Flow Peak inspiratory flow setting. Adult:
1.0 to 120 l/min
Available if ventilator is configured for US
philosophy Pediatric:
1.0 to 90 l/min
Applies to volume-controlled mandatory breaths in
V–CMV and V–SIMV Neonate:
1.0 to 60 l/min
Ftrig Flow trigger sets the patient inspiratory flow that triggers Adult:
a breath. Applies to all modes except NCPAP+. 0.2 to 25.0 l/min
The ventilator generates a continuous base flow from
the inspiratory outlet to the expiratory outlet. The base
flow will vary when automatic leak compensation is On Pediatric:
NOTE: Adjusting Ftrig changes ventilator sensitivity to 0.1 to 15.0 l/min
patient effort. In case of auto-triggering, check the
ventilator and breathing circuit before increasing the
Neonate:
Ftrig setting.
0.1 to 10.0 l/min
Ptrig Pressure trigger sets the patient inspiratory pressure 0.5 to 20.0 cmH2O
that triggers a breath. Applies to all modes except
NCPAP+.
NOTE: Adjusting Ptrig changes ventilator sensitivity to
patient effort. In case of auto-triggering, check the
ventilator and breathing circuit before increasing the
Ptrig setting.
Phigh Sets the value of the baseline high PEEP 5 to 50 cmH2O or
pressure during Thigh. Applies to SPAP mode Plow to 50 cmH2O or
only. Phigh cannot be set < Plow 5 to (90 - Psup high)
Plow Sets the value of the baseline low PEEP pressure 0 to 50 cmH2O or
during Tlow. Applies to SPAP mode only. 0 to Phigh or
Plow cannot be set > Phigh 0 to (90 - Psup low)
Psup high A positive airway pressure setting in SPAP. 0 to 90 cmH2O or
Pressure (above Phigh) to be applied to a patient- 0 to (90 - Phigh)
triggered breath during the Thigh phase in SPAP. whichever is less
Applies to all Thigh cycles in SPAP mode.
Phigh + Psup High will not exceed 90 cmH2O
Psup low A positive airway pressure setting in SPAP. 0 to 90 cmH2O or
Pressure (above Plow) to be applied to a patient- 0 to (90 - Plow)
triggered breath during the Tlow phase in SPAP. whichever is less
Applies to all Tlow cycles in SPAP mode.
Plow + Psup Low will not exceed 90 cmH2O
Thigh Duration of Phigh airway pressure level. 0.1 to (60 - Tlow setting)
Applies to all Phigh phases in SPAP mode
Tlow Duration of Plow airway pressure level. 0.2 to 59.9 s (max 60 -
Applies to all Plow phases in SPAP mode Thigh setting)

5.3.6. I:E Ratio Display Window


When the user selects any setting that affects the I:E ratio or H:L ratio (SPAP), a small window
will pop up to show the I:E Ratio, Ti and Te or equivalent values for SPAP. See Figure 39,
Left Panel display with time based setting changes pop up I:E Ratio window.

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Figure 39, Left Panel display with time based setting changes

5.3.7. STARTING Ventilation


Once the parameter selections / adjustments have been made. The user must press the
START button to start ventilation.

5.3.8. Auto Control


Auto Control is a feature available in all CMV modes that when enabled, provides a seamless
automatic transition between the control (CMV) mode and a spontaneous mode in response
to the presence or absence of patient effort. It is a strategy for early detection and appropriate
ventilator support for patients ready to breathe independently.
These automatic transitions occur without user intervention or alarms. Auto Control is
designed to detect patient readiness to breathe independently and can provide a more
synchronous alternative to apnea ventilation for patients whose respiratory drive is variable
or depressed.

If Auto Control is ON the ventilator will switch from the CMV mode to the corresponding
spontaneous mode when the patient triggers two consecutive breaths. If the patient’s
breathing stops or slows, and the time between breaths exceeds the set Auto Control time
interval, the ventilator will automatically switch from the spontaneous mode back to the
original CMV mode without alarming.
Turning Auto Control On displays the Esens and Rise Time settings: select the appropriate
values for spontaneous breathing.
When Auto Control is ON, it replaces standard apnea ventilation and apnea backup ventilation
is automatically disabled. When Auto Control is deactivated (turned Off), apnea backup
ventilation is automatically re-enabled with the previous apnea backup settings.
Auto Control is only available for activation from a CMV mode. If you turn Auto Control On,
please note that the rise time (Rise) and the exhalation sensitivity (Esens) settings are now
visible, indicating that they should be set.
o The Auto Control (combo box) displays in all CMV modes as shown below
 As shown below in Figure 40, the Auto Control (combo box) displays the text (PS)
when the control mode P–CMV is selected or active.
 As shown below in Figure 41 and Figure 42, when the control mode V–CMV or
PRVC–CMV is selected or active, the Auto Control Spont mode selection toggle
button will be displayed. The Auto Control Spont mode selection toggle button
allows users to select the VS or PS mode as the spontaneous mode associated
with Auto Control. VS is the default mode for V–CMV and PRVC–CMV but can be
changed to PS.

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Figure 40, Auto Figure 41, Auto Control in V–CMV Figure 42, Auto Control in V–CMV or
Control Box in P–CMV or PRVC–CMV with VS Selected PRVC–CMV with PS Selected

o Mode Transitions when Auto Control is On


o Mandatory Breaths will transition to the Spont Breaths and vice-versa, when
Auto Control is set to On.
o To switch from Mandatory Breaths to Spont Breaths, patient needs to triggers
two consecutive breaths.
o After transitioning to Spont Mode, the ventilator will transition back to Mandatory
Mode if the patient does not trigger a breath before the user defined Auto Control
time elapses.
o After transitioning to the Spont Mode, if Auto Control is turned Off, the ventilation
will return to P-CMV.
o Auto Control Active Mode Display
 The current active ventilation mode label is shown in the Active Mode display area at
top left section of the GUI below Patient Type.
o When Auto Control is On, whichever mode is active (CMV or SPONT) is the
current mode.
 If the CMV mode (P–CMV, V–CMV or PRVC–CMV) is active then the CMV
mode is the current mode and will be displayed in the Active Mode display
area.
 If the spontaneous mode (PS or VS) is active then PS or VS is the current
mode and will be displayed in dark green font in the Active Mode display
area.
o Auto Control Dependent Monitored Data
 When Auto Control is set to On:
o Spont %1h and Spont %8h will display the percentage of time the patient is in
the spontaneous mode.
o Trend screen selection option (Auto) is available from the Trend Data Selection-
screens Advanced Tab

5.3.9. SBT Mode


The SBT mode and adjustable controls can be accessed from the Current Settings screen by
pressing the SBT button. SBT setting information listed below in Table 9.

The SBT mode is a weaning tool provided for the clinician to evaluate the patient’s ability to
tolerate spontaneous breathing with minimal support in an effort to determine if the patient is
ready for weaning and or extubation according to clinician’s judgment.

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Section 5 Ventilator Set Up and Operation

Clinicians should follow established scientific clinical guidelines for weaning criteria and
patient readiness for extubation.
SBT Mode is not available for Neonate / Infant patients.

o SBT Mode Activation


 The SBT function is available on Settings Tab.
 If the SBT mode is active and a New (Proposed Mode) is activated, the SBT mode
will be terminated and SBT will have to be started again by the user.
 When the SBT Button is pressed the Right Panel loads the SBT Settings screen as
shown below in Figure 43.
 Adjust the SBT mode settings as desired and when ready press the START button to
activate the SBT mode.
o When the SBT mode is activated, the SBT will be indicated at the top left of the
user interface, Status bar.
o While SBT is active, when the Settings Tab is pressed, the SBT Settings right
panel will load by default to allow users to see the Time Remaining, adjust
settings if desired or STOP (cancel) the SBT mode.
o When the SBT mode is activated, the time remaining counter will start at the
time equal to the SBT Time control setting and will decrease in value displaying
the actual elapsing time. When SBT reaches 0:00:00, the SBT mode has
completed and the Pre-SBT mode will resume.
o While the SBT mode is active, if the STOP button is pressed or the maneuver is
terminated or the maneuver completes, the Pre-SBT mode will resume and the
time remaining counters value will change to display 0:00:00.

Figure 43, SBT Settings Screen

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Section 5 Ventilator Set Up and Operation

o SBT Mode Settings


 The following settings are available on the SBT Settings screen.

Table 9: SBT Settings


Parameter Definition Setting Range
O2 O2 level when SBT mode is active. 21 to 100 %
Default = Set Non-SBT mode O2 unless changed by
User.
PEEP PEEP level when SBT mode is active. 0 to 30 cmH2O
Default = Set Non-SBT mode PEEP unless changed
by User.
Psupport Psupport level when SBT mode is active. 0 to 30 cmH2O
Default = IBW based default or Set Non-SBT mode
Psupport unless changed by User.
Esens Exhalation sensitivity when SBT mode is active. 10 to 80 %
Default = IBW based default or Set Non-SBT mode
Esens unless changed by User.
Rise Time Rise Time when SBT mode is active. 1 to 20
Default = IBW based default or Set Non-SBT mode 1 = Slow and
Rise Time unless changed by User. 20 = Fast

PS Tmax PS Tmax when SBT mode is active. Adult:


Default = IBW based default or Set Non-SBT mode 0.50 to 5.0 s
PS Tmax unless changed by User. Pediatric:
0.50 to 5.0 s
Neonate:
0.15 to 3.0 s
SBT Time The user defined duration the SBT mode will be 15 to 120 min
active once started.
Default = 30 min unless changed by User
NOTE: SBT Time cannot be adjusted while the SBT
mode is active
SBT Only Alarm Settings

RSBI High Medium priority alarm 5 or (5 > RSBI Low) to


900 b/min/l or OFF
RSBI Low Medium priority alarm 5 to 895 b/min/l or
(5 < RSBI High) or OFF
Rate High Medium priority alarm 2 or (1 > Rate Low) to
80 b/min or OFF
Rate Low Medium priority alarm 1 to 79 b/min or
(1 < Rate High) or OFF

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o SBT Trend Automatic Event Marker


 Each time the SBT mode is activated, canceled or completes successfully, a specific
SBT automatic Event Marker will be displayed on the Trend Data graph to indicate
the specific time of the SBT related event.
o SBT Event Markers allow visualization of SBT Start, Termination, and
Completion times as shown below and will appear on the Trend graphs
automatically based their specific criteria.
o Automatic Event Markers cannot be changed to another Event Marker.

Figure 44: SBT Automatic Event Markers

SBT Feature Started SBT Feature Canceled SBT Feature Completed Successfully

o SBT Mode Termination Criteria


 The SBT mode while active, will terminate (deactivate) and normal ventilation will
resume when:
o The SBT STOP Button is pressed
o The set SBT Time has elapsed
o The SBT High Rate alarm remains active for > 5 min
o The SBT Low Rate alarm remains active for > 5 min
o The SBT High RSBI alarm remains active for > 5 min
o The SBT Low RSBI alarm remains active for > 5 min
o An Apnea Backup mode is activated
o The Apnea alarm is triggered
o A Proposed Mode is Activated

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Section 5 Ventilator Set Up and Operation

5.3.10. Tube Compensation


Tube Compensation (TC) when enabled (turned ON) compensates for the resistance
associated with an endotracheal tube (ETT) or Tracheostomy Tube via closed-loop control of
continuously calculated tracheal pressure. TC unloads the resistance imposed by the
breathing tube in inspiration by increasing the airway pressure (if necessary), and in expiration
by decreasing the airway pressure (if necessary) according to the non-linear pressure-flow
relationship of the ETT or Trach tube. With an inspiratory pressure setting of zero, TC will still
provide an elevated airway pressure (if necessary), to compensate for the resistance imposed
by the breathing tube.
When TC is turned on, the ventilator automatically calculates the pressure drop across the
endotracheal tube during inspiration and exhalation. The ventilator then adjusts the airway
pressure to deliver the set pressure to the distal (carinal) end of the breathing tube. This
calculation takes into account flow, gas composition, Fraction of Inspired Oxygen (FIO2), tube
diameter, length, and pharyngeal curvature based on patient size (Adult or Pediatric).
o Inspiratory TC
 When inspiration occurs, flow is generated from the vent side of the breathing tube
to the inside of the lungs, and a pressure gradient occurs. Pressure at the proximal
end of the tube (Ppeak) is greater than that at the distal (carina) side of the tube
(Ptrach).
 The Ptrach value for pressure is now the pressure target when TC is active.
o Expiratory TC
 During expiration, pressure at the carinal side of the breathing tube (Pmin) is
greater than the pressure at the circuit side of the breathing tube because in this
phase, air is flowing from the lungs to the circuit. A carinal-side pressure greater
than the clinician selected positive end-expiratory pressure (PEEP) may inhibit a
patient’s exhalation. For example, even if PEEP is set at 5 cmH2O, the carinal
pressure is not necessarily 5 cmH2O at end expiration. Because of the resistance
of the breathing tube, carinal pressure may be greater than set PEEP. In order to
avoid this phenomenon, expiratory compensation is enabled, TC automatically
controls PEEP by using the calculated carinal pressure to maintain the set PEEP
at the carinal side of the breathing tube during end expiration.
 The calculated Pmin value serves as the target PEEP level during exhalation when
TC is active.

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Section 5 Ventilator Set Up and Operation

o Tube Compensation Warnings and Caution Notes


 TC Warnings

Setting an incorrect tube size setting can endanger the patient.


TC with Expiratory Compensation enabled, can temporarily decrease airway
pressure and may cause airway collapse, especially in patients with obstructive
pulmonary disease.

 TC Caution Notes

 TC is intended for use with spontaneously breathing patients to compensate the


patient extra work of breathing imposed by the endotracheal tube.
 Monitored airway pressures (inspiratory) may be higher than set values when TC is
active.
 Monitored airway pressures (expiratory) may be lower than set values when TC is
active.
 The tracheal pressure waveform displayed is an estimated pressure from flow and
pressure signals rather than measured.
 The physical endotracheal tube resistance is compensated for the tube length and
diameter. Other unknown factors such as patient’s secretions and tube kinking may
increase the tube resistance and are not compensated.

o Tube Compensation Feature Dependencies


 TC when enabled (set to On and activated) is:
o By default, active only during inspiration during all pressure-based modes when
the TC Type is set to Insp. Only.
o Active during both inspiration and exhalation during all pressure-based modes
when the TC Type is set to Insp. + Exp.
 The TC feature will be disabled and will not be available as a setting option for the
following applications:
o NIV
o NCPAP+

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Section 5 Ventilator Set Up and Operation

o Tube Compensation Activation and Settings


 To access the Tube Compensation Settings screen, press the Tube Comp button
located on the Current or Proposed Settings screen. See Figure 45: Tube
Compensation Button Display and Figure 46.
 “TC” will be displayed on the Status Bar when Tube Compensation is active.

Figure 45: Tube Compensation Button Display

Figure 46: Tube Compensation Settings Screen – TC On

o Tube Compensation Settings parameters.


Table 10: Tube Compensation Settings
Parameter Definition Setting Range
TC Tube Compensation On / Off control On or Off
(Default = Off for new patients)
Tube Sets the size of the patient’s breathing 2.0 to 10.0 mm
Diameter tube.
Default for New Patients
Adult: 7.5 mm
Pediatric: 5.0 mm
Neonate: 3.0 mm

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Section 5 Ventilator Set Up and Operation

Table 10: Tube Compensation Settings


Parameter Definition Setting Range
Tube Sets the length of the patient’s breathing 2.0 to 30.0 cm
Length tube.
Tube Length by Patient Type
Adult: 2.0 to 30.0 cm
Pediatric: 2.0 to 26.0 cm
Neonate: 2.0 to 15.0 cm
Default Tube Length
Adult: 30.0 cm
Pediatric: 26.0 cm
Neonate: 15.0 cm
TC Type Sets the Tube Compensation Type Insp. Only or Insp. + Exp.
Default TC Type New Patients
Insp. Only

o Tube Compensation Monitored and Trended Data


 Ptrach displays the calculated peak inspiratory pressure at the carina breath-to-
breath:
 Pmin displays the calculated end expiratory pressure at the carina breath-to-breath:
o Tube Compensation Waveform
 When TC is active (set to ON) the Ptrach pressure waveform will display as a dotted
orange line on top of the standard pressure waveform.

Figure 47: Tube Comp (Ptrach) Waveform

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Section 5 Ventilator Set Up and Operation

o Apnea Backup Ventilation


From the New or Proposed Settings screen, select Apnea backup to view the Apnea Backup
Settings (as shown below in Figure 48), and select the appropriate settings for apnea backup
ventilation. Apnea backup ventilation starts if the Apnea time limit (Tapnea) elapses before a
breath is delivered.

Apnea Backup Current Settings

Figure 48: Apnea Backup Settings Screens

o Apnea Alarm and Apnea Backup Ventilation


 Apnea Alarm: If Apnea Alarm is violated, the Apnea Backup Ventilation will take
place for backup ventilation.
 Cancel Apnea Alarm or Apnea Backup Ventilation: The following criteria will
cancel and reset the Apnea Alarm. The same criteria also are used to cancel the
Apnea Backup Ventilation and return to the previous ventilation mode.
o Patient triggers two consecutive breaths.
o Change ventilation mode.
o Turn Auto Control ON.
o Change the Respiratory Rate. Equivalent to change Tlow, Cycle or H:L ratio in
SPAP.
o Change the Apnea Time Alarm.
o Press the Manual Ventilation button.

o Apnea Backup and Auto Control


 When Auto Control is turned ON, Apnea Backup will be automatically background
disabled.
 When Auto Control is turned OFF, Apnea Backup will be automatically re-enabled
(turned ON) using the default or last user established apnea backup settings.

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5.4. Maneuver Tab


5.4.1. Suction Support
The Suction Support maneuver is intended for Open Suction only. It prevents some nuisance
alarms from happening during the disconnection and enhances patient oxygenation
automatically by pre-oxygenating before breathing circuit disconnection, recognize breathing
circuit disconnection and post-oxygenating after breathing circuit reconnection.

Suction Support works ONLY for Open Suction Procedure.

Figure 49: Suction Support Maneuver Selection

5.4.1.1. Suction Support Phases:


Press the Suction Support button to select the procedure and follow the instruction on the
ventilator screen.
o Preparation Phase
 Press the START button to initiate the procedure. See Figure 50.
 The ventilator will elevate the O2% in this phase (100% for Adult or Set O2+20%
for Neonate) and wait for 120s for the breathing circuit disconnection. If the
disconnection is not detected within 120s, the O2% will return to original set.

Figure 50: Suction Support Preparation Phase

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o Patient Disconnected Phase


 During the Disconnect phase, a time indicator counter will be displayed on the
Disconnect phase.
 When the circuit is reconnected to the patient, the ventilator will automatically
recognize the reconnection, ventilation will resume, and the Post Oxygenation
Phase will begin.

Figure 51: Suction Support Patient Disconnected Phase

o Post Oxygenation Phase

Figure 52: Suction Support Post Oxygenation Phase

 During the Post Oxygenation phase, the ventilator will recognize the breathing
circuit reconnection and will resume ventilation with Post Oxygenation period of 1
minute unless canceled by the user.
o Additional Information
 STOP button: the STOP button will cancel the Suction Support any time is
pressed and normal ventilation will be resumed with original set FiO2.
 Screen Navigation: during Preparation Phase and Patient Disconnected Phase,
you must STOP the procedure if you want to select different Tabs such as Home,
Settings, Alarms and Config. Only during the Post Oxygenation phase, the
navigation to another tab is allowed.
 Information message: the “Suction Active” information message priority alarm will
display on the alarm bar.
 Automatic Event Marker: each time the Suction Support maneuver is started, the
Event Log will update to display an Automatic Event Marker corresponding with
the exact time the maneuver was started. See and Table 33 for additional
details.

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5.4.2. Recruitment Maneuver Tools

5.4.2.1. PVL Tools: PVL Tool (p) and PVL Tool (v) Maneuvers –
Overview
PVL Tools: Allow either a pressure PVL Tool (p) or Volume PVL Tool (v) single breath Slow
Inflation / Deflation Maneuver to be performed.
o PVL Tool (p) Maneuver
 The PVL Tool (p) option allows clinicians to perform a single pressure breath
Slow Inflation and Slow Deflation Maneuver up to a max total maneuver time
(Tmaneuver) of 90 seconds.
o PVL Tool (v) Maneuver
 The PVL Tool (v) option allows clinicians to perform a single volume breath Slow
Inflation and Slow Deflation Maneuver up to a max Tmaneuver time of 90
seconds.
o The PVL Tools are automated respiratory mechanics maneuvers that capture, analyze,
record and display a quasi-static P/V (pressure/volume) curve as well as all monitored
data associated with the maneuver.
o The PVL Tool’s Curve Analysis feature measures and displays the inflation and deflation
pressure-volume curves of the lungs and automatically determines the lower and upper
inflection points as well as the deflation limb de-recruitment point, which can be manual
adjusted by the user.
o This curve, generated with very low flow, can provide the clinician with valuable and
objective information about the respiratory system mechanics. The information may be
useful for clinical diagnosis as well as for optimization of ventilator settings. A cursor
function permits graphical analysis of the curve, including automatic identification of
curve inflection points as well as manual inflection point adjustment for visual curve
fitting to determine the linear compliance.
o The PVL Tool maneuvers employ an adjustable pressure ramp or flow setting with which
airway pressure (p) or volume (v) is slowly increased to the target level and then
decreased to a lower pressure level.
o The P/V Tool maneuvers require no disconnection of the breathing circuit and no patient
setting changes. You can resume normal ventilation at any time.
o Additionally, upon successful completion of a PVL Tool maneuver, the maneuver related
static and dynamic compliance as well as inspired and expired volumes are displayed
above current ventilation monitored values.
o From the Curve Analysis screen, up to eight (8) of the most recent recorded PV Curves
will be available for selection and display and inflection point adjustment.
5.4.2.2. Step Tool Maneuver – Overview
o Step Tool
 Allows clinicians to perform either a single step (RM Step) or two step (RM Step
+ Rest Step) Recruitment Maneuver (RM) via continuous pressure control
ventilation at user defined RM Step and Rest Step settings.
o The Step tool allows a maximum recruitment strategy to be applied using the automated
RM Step and Rest Step maneuver process via pressure-control ventilation.
 Each step (i.e., RM Step and Rest Step) while active, ventilation is delivered at
the user defined, PEEP, Pcontrol, Rate, Ti and Rise Time specific to the RM
Step and Rest Step and for the user defined step time.

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o The Step Tool when active provides continuous breath-by-breath display of static and
dynamic compliance as well as inspired and expired volumes which are displayed
above pre-maneuver values and allows P/V curves to be captured. Once captured the
Step tool measures and displays the inflation and deflation pressure-volume curves of
the lungs and determines the lower and upper inflection points as well as the deflation
limb derecruitment point that can be manually adjusted by the user.
o From the Curve Analysis screen, up to eight (8) of the most recent recorded PV Curves
will be available for selection and display and inflection point adjustment.

5.4.2.3. Required Conditions for Use


The following conditions should be met before attempting a Recruitment Maneuver.
o It is important for PVL Tool maneuvers or Step Tool maneuvers, that the patient must
be invasively ventilated and does not make any spontaneous breathing throughout the
entire maneuver period. Clinicians should evaluate the need of sedation and/or
neuromuscular blockage before to perform the maneuver.
o The clinical Indications and Contraindications to perform the PV or Step Tool
recruitment maneuver must be evaluated and judged by the clinician.
o Recruitment maneuvers cannot be activated while the ventilator is in Standby.
Recruitment maneuvers can only be activated during ventilation.
 PVL Tool (p) and PVL Tool (v) are disabled when a Spont mode is active.
o There should be minimal to no gas leak throughout the entire system, which includes
the ventilator, the breathing circuit, filters, breathing tube and the ventilated patient.
 A Circuit Check should be performed to ensure the system compliance is
calculated and that the circuit is tight with minimal to no leaks.
o The Flow Sensor should be enabled, functional and calibrated.
 If Flow Sensor is disabled, the recruitment maneuver feature will be disabled and
the Recruitment button will not display on the Maneuvers Panel.
o Nebulization must be deactivated for at least 5 min prior to starting a recruitment
maneuver.

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5.4.2.4. Recruitment Maneuver Related Warnings, Cautions and


Notes

Recruitment Maneuver Warnings and Cautions


Normal ventilation is suspended for the duration of these maneuvers. The Clinician must
evaluate the indication and contraindication to apply the maneuvers. The patient must be
directly monitored by trained medical personnel during these maneuvers.
The PVL Tool (p) and PVL Tool (v) can apply high-pressures for extended periods of time.
Be careful when using the PVL Tool maneuvers on patients with obstructive diseases
(e.g., COPD), because each maneuver can generate excessive volumes.
To prevent possible patient discomfort and erroneous readings, do not attempt to perform
the PVL Tool maneuvers on an actively breathing patient.

PVL Tool: CAUTIONS


 For passive patients only
 Inactive in SPONT modes
 Inactive during NIV and Apnea Backup
 Inactive if Nebulizer is active and for 5 min after nebulization
 Inactive for 5 breaths after a previous Recruitment Maneuver
 Inactive if flow sensor is disabled or flow sensor calibration is required
 Reconfirmation is required if a setting exceeds critical limits
 Terminates if the STOP button is pressed or the maneuver Ppeak high alarm limit is
violated or a patient effort or pressure drop violates the Psens setting

Step Tool: CAUTIONS


 For passive patients only
 Inactive during NIV and Apnea Backup
 Inactive if Nebulizer is active and for 5 min after nebulization
 Inactive if flow sensor is disabled or flow sensor calibration is required
 Reconfirmation is required if a setting exceeds critical limits
 Terminates if the STOP button is pressed or the maneuver Ppeak high alarm limit is
violated

Recruitment Maneuver Notes


With the exception of End PEEP, all other recruitment maneuver settings have no effect on the
settings during normal ventilation and thus are set independent of the current ventilation modes
settings.
Performance of the PVL Tool Recruitment maneuvers requires a passive patient. In the event
that a patient effort is detected, the ventilator will abort the maneuver and deliver a PT Effort
Detected alarm message while simultaneously returning to normal ventilation at the current pre-
maneuver settings.
Curve Analysis related Cursor 1 and Cursor 2 monitored data: Once the cursor positions are
redefined by the operator, the original cursor related values cannot be restored.
Meaningful data from the PVL Tool maneuver requires that there be no gas leak on the patient
side of the Flow Sensor and that the Flow Sensor performs well at very low flows. It is
recommended that you perform a Circuit Check and Flow Sensor calibration before using the
PVL Tools.
During a PVL Tool (p) maneuver, if the maneuver Pcontrol + maneuver PEEP = > the high-
pressure alarm setting, the high-pressure alarm limit will automatically background adjust to
equal (maneuver Pcontrol + maneuver PEEP + 5 cmH2O). This means during the maneuver,
it overrides the operator set alarm threshold.
After completion of a PVL Tool maneuver, there may be transitional alarms for a breath or two
caused by the interruption of ventilation by the maneuver.

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Recruitment Maneuver Notes


If the compliance is normal to higher than normal, use a lower Ramp speed setting. If the
compliance is lower, you may select a higher Ramp speed setting.
Once you START a Recruitment Maneuver, you can terminate it any time by pressing the STOP
button.
The PVL and Step Tools are monitoring maneuvers that provide information, which may be
used to optimize PEEP and other ventilator settings. This is just one portion of the information
that must be considered along with hemodynamics and other clinical conditions. It is the
clinician's responsibility to appropriately interpret and apply this information in the care and
treatment the patient.
The Manual Breath button is disabled during a PVL Tool (p) and a PVL Tool (v) maneuver. Once
the PVL Tool (p) or PVL Tool (v) maneuver is no longer active and normal ventilation resumes,
the Manual Breath button will function normally.
During a Step Tool maneuver, the Manual Breath button functions normally.
During a PVL Tool (v) maneuver, the actual Tmaneuver time may be less than calculated if the
End PEEP level is > the Maneuver PEEP level or greater than calculated if the End PEEP level
is < the Maneuver PEEP level. PVL Tool (v) setting rules.
The Recruitment button displayed on the Main screen’s Maneuvers panel will change to a Blue
button while any Recruitment maneuver is active.

5.4.2.5. Recruitment Maneuver Setting Pages


As stated above, from the Tool Type Caution Message screen, press the OK button to
continue. Once the OK button is pressed, the settings page for the selected Tool Type will
then display as shown in Figure 53, and Figure 54.
5.4.2.6. PVL Tool (p) Settings Page
Adjust the PVL Tool (p) settings as desired. The calculated inflation limb time + deflation
limb time is displayed as Tmaneuver and is updated automatically based upon current
settings. When ready, press the START button to activate the PVL Tool (p) maneuver.
 While the PVL Tool (p) maneuver is active, the STOP button will be displayed. If pressed, the
maneuver will be terminated and normal ventilation will resume. Additionally, while active, the
“Maneuver Active” alarm message will be displayed.
 Each Recruitment Maneuver Tool Settings page displays a specific information message and
the information message for the PVL Tool (p) Maneuver is as follows.
Single PRESSURE Breath Slow Inflation Maneuver
End PEEP = new PEEP level after next PV maneuver
Reconfirm setting if:  Pcontrol + PEEP is > 50 cmH2O
 Pause is > 5 s

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 See section or 11.13 for detailed description of all recruitment maneuver settings and buttons.

Figure 53: PVL Tool (p) Settings Page

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5.4.2.7. PVL Tool (v) Settings Page


Adjust the PVL Tool (v) settings as desired. The calculated inflation limb time + deflation
limb time is displayed as Tmaneuver and is updated automatically based upon current
settings. When ready, press the START button to activate the PVL Tool (v) maneuver.
 While the PVL Tool (v) maneuver is active, the STOP button will be displayed. If pressed, the
maneuver will be terminated, and normal ventilation will resume. Additionally, while active, the
“Maneuver Active” alarm message will be displayed.
 Each Recruitment Maneuver Tool Settings page displays a specific information message and
the information message for the PVL Tool (v) Maneuver is as follows.

Single VOLUME Breath Slow Inflation Maneuver


End PEEP = new PEEP level after next PV maneuver
Reconfirm setting if:  Vt setting is > 10 ml/kg
 Pause is > 5 s
 See section or 11.13 for detailed description of all recruitment maneuver settings and buttons.

5.4.2.8. Step Tool Settings Page (RM Step)


Determine if the Step Tool recruitment maneuver will include a single step (RM Step) or
two steps (RM Step + Rest Step) and adjust all Step Tool settings as desired. When
ready, press the START button to activate the Step Tool maneuver.
 While the Step Tool maneuver is active, the STOP button will be displayed. If
pressed, the maneuver will be terminated, and normal ventilation will resume.
Additionally, while active, the “Maneuver Active” alarm message will be displayed.
 A time elapsed bar will display above the STOP button and the text label to the left of
the time elapsed bar will indicate what step (RM or Rest) is currently active as defined
below.
o During the RM Step:
 RM (s): will be the text label displayed to the left of the time elapsed bar.
o During the Rest Step:
 Rest (s): will be the text label displayed to the left of the time elapsed bar.
o Starting Number: 00:01 Resolution: 0.01
o As time elapses, a blue bar will fill in the time elapsed bar from left to right. The blue bar
will progress evenly based on the set (Step and Rest) Time and completely fill the time
elapsed bar by the end of the Step.
 Each Recruitment Maneuver Tool Settings page displays a specific information message and
the information message for the PVL Tool (v) Maneuver is as follows.
Continuous ventilation at defined Step & Rest settings
End PEEP = new PEEP level after next PV maneuver
Reconfirm setting if:  Pcontrol + PEEP is > 50 cmH2O

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Figure 54: Step Tool Settings Page – (RM Step)

5.4.2.9. Step Tool Settings Page (RM Step + Rest Step)


 When Rest Time is set > Off, the Rest Step is enabled and will proceed after RM Step
completes (Step Time elapses).
 Once the Rest Step begins, the static data from the last stable breath during the RM
Step will be captured and displayed in the dark blue fields on the monitor bar and the
light green fields always display the real-time breath-to-breath data for the current
step.
 See section 5.4.2.14 for a detailed description regarding the monitor bar’s dark blue
and light green fields and the monitored data available for display on the recruitment
maneuver’s monitor bar.
 See section 11.13 for detailed description of all recruitment maneuver settings and
buttons.

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5.4.2.10. Recruitment Maneuver Curve Analysis Page and Cursor


Feature
o As shown below in Figure 55, the Curve Analysis will load when
 A Recruitment Maneuver completes and the first non-maneuver breath is
delivered. or
 The user presses the Curve HX button on the Recruitment Maneuver settings
pager.
o When the Curve Analysis screen loads after completion of a Recruitment Maneuver,
the P/V curve for the Recruitment Maneuver that just completed will automatically be
displayed and the Curve History folder associated with the displayed P/V Curve will
display Blue as shown below in Figure 55.
o If the user presses Curve HX button, the Curve Analysis screen will load and the last
selected P/V Curve will be displayed. The Curve History folder associated with the
displayed P/V Curve will display Blue as shown below in Figure 55.

Figure 55: Recruitment Maneuver Curve Analysis – PVL Tool

o When a Step Tool maneuver completes successfully, the Curve Analysis page will load
and “Proceed to next step?” options will display below the Curve History folders.
 OK Button: When the OK button is pressed, the Step Tool setting screen will
load with the previous settings displayed.
 EXIT Button: When the Exit button is pressed, the Main screen will load with the
Maneuvers panel displayed.

5.4.2.11. Curve Analysis Tabular Trends (left Panel)


The Curve Analysis screen’s left panel displays a table of tabular trends.
 The Trend Data associated with each of the Curve History folders will be displayed in

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the Left panel of the Curve Analysis page.


 If no recruitment maneuvers have been performed or none have completed
successfully then no trend data will be displayed in the Left panel and no saved PV
Loops will exist and no Curve History folders will be displayed.
 Scroll Arrows will be displayed in Row 1 (Column 1).
o The Scroll Arrows allow the user to scroll through the last eight Saved P/V Curve
data and two saved loops will be displayed side by side.
o When a scroll arrow is pressed it will display blue indicating it has been pressed
and the trend data displayed in the Left panel will update to display the trend
data associated with the next saved PV Loop.
 Column 1 (Row 2 – 7) displays the trend parameters (e.g., Cstat, Vte) and unit of
measure for each trend parameter.
 Row 1 (Column 2 and Column 3) displays the Date and Time associated with each
of the Curve History folders and rows 2 – 7 display the trend data specific to each
saved PV Curve.
o By default, when Curve Analysis page loads, the Left Panel will automatically
display the trend data for the two most recent saved P/V Loops. If only one
exists, it will be displayed in column 2 and column 3 will be blank. If no
recruitment maneuvers have been performed or completed successfully then
column 2 and column 3 will be blank.

Figure 56: Recruitment Maneuver Curve Analysis – Tabular Tend Data

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5.4.2.12. PV Curve Graph (right panel)


 Figure 55 shows the Curve Analysis screen. When a Curve History folder is selected,
the P/V Curve associated with the selected folder will be displayed in the right panel.
o The Tool Type (i.e., PVL Tool (p), PVL Tool (v) or Step Tool) will be displayed in
the upper right corner of the P/V Graph to allow users to identify the recruitment
maneuver associated with the selected P/V Curve.
 The PV Curve’s lower and upper insp/exp limb inflection points will be automatically
identified by the software and the linear slope will be drawn between expiratory limb
inflection points and between the insp limb inflection points.
 The P/V Graph X and Y axes will auto scale by default but both the X and Y axes can
be manually scaled by touching a point along the axes.
 Cursor 1 and Cursor 2 Buttons
o On the Curve Analysis page, two cursor (Cursor 1 & Cursor 2) buttons are
displayed. To use the Cursor feature, a Curve History folder must first be
selected to ensure a P/V curve is displayed in the right panel. Once a P/V curve
is displayed in the right panel, select a cursor button to adjust that cursors
position along the P/V curve.
 Cursor 1 Button
 The black Cursor 1 button displays until selected. When the Cursor 1
button is selected it turns blue indicating Cursor 1 is selected for
manual scaling.
 When Cursor 1 is selected, users can rotate the rotary knob to adjust
the lower Insp/exp limb inflection points. The manual adjustment is
automatically saved when the button is pressed again, or the user
presses any other button or tab and the cursor 1 button’s color will
change back to black. Cursor 1 compliance and volume monitored
values for that breath will update based on the new manually assigned
inflection points.
 Users can adjust Cursor 1 as often a desired but once updated, the
original or previous cursor 1 inflection point values cannot be restored.
 Cursor 2 Button
 The black Cursor 2 button displays until selected. When the Cursor 2
button is selected it turns blue indicating Cursor 2 is selected for
manual scaling.
 When Cursor 2 is selected, users can rotate the rotary knob to adjust
the upper Insp/exp limb inflection points. The manual adjustment is
automatically saved when the button is pressed again, or the user
presses any other button or tab and the cursor 2 button’s color will
change back to black. Cursor 2 compliance and volume monitored
values for that breath will update based on the new manually assigned
inflection points.
 Users can adjust Cursor 2 as often a desired but once updated, the
original or previous cursor 2 inflection point values cannot be restored.
 For additional details on how each maneuver works see sections 5.4.2.18 and
5.4.2.19. For specific details on Inflection point determination criteria see section
5.4.2.20.

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5.4.2.13. Curve History (right panel)


 When a recruitment maneuver is completed successfully, the P/V Loop for that
maneuvers breath will be captured and saved.
 Figure 55 shows the Cursor History section displays a Curve History folder for each
successfully completed PVL Tool (p), PVL Tool (v) or Step Tool maneuver.
 Up to eight of the most recent recruitment maneuver P/V Loops can be stored. If a
ninth save is created the oldest Curve History folder will be removed (overwritten).
 The Curve History folder will be stored sequentially from left to right for each P/V
curve captured. The Curve History folders for the most P/V Curve will always be in
the top row with the newest Curve History folder in the top left most position.
 Each of the Curve History folders can be selected at any time by pressing the desired
folder Icon. The P/V curve for that folder will display in the Right Panel. Only one
P/V Curve can be displayed at a time.
5.4.2.14. Recruitment Maneuver Monitor Bar Display
o When the user presses the OK button on any of the Recruitment Maneuver Tool
Caution Message pages. The Recruitment Maneuver Tool Settings Screen for the
selected tool type will load.
o Unless a user defined Custom Default profile is selected, the eVent Default assigned
parameters will be displayed in the Monitor Bar as shown below in Figure 57. Additional
monitored parameters can be selected to replace a currently displayed parameter.
o 10 monitored parameters will be displayed on the Recruitment Maneuver Monitoring
Bar and the number displayed is not affected by user adjustments to the Monitors
Number of Display setting on the Config screen Graphic page.
o When the user touch-selects A parameter on the Recruitment Maneuver Monitoring
Bar,
 The Right Panel loads the recruitment maneuver parameter selection window
and displays a single page of selectable parameters. The single page of
selectable parameters.
Figure 57: Recruitment Maneuver Monitored Bar Display

Real-Time Monitored Data Static Monitored Data

5.4.2.15. Real-Time Monitored Data (light green fields)


 As on any other screen, the light green monitored data fields are always used to
display real-time monitored data. This includes the monitored data when the Step
Tool is active.
 When the PVL Tool (p) or PVL Tool (v) recruitment maneuvers are active, the current
monitored values for the pre-maneuver breath will remain displayed in the green
fields, as this is standard breath-to-breath philosophy for Monitoring data.

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5.4.2.16. Static Monitored Data (dark blue fields)


 The dark blue fields are used to display the static monitored data associated with
captured (saved) P/V Curve that has been automatically or manually selected for view
on the Curve Analysis screen.
 Once a recruitment maneuver completes successfully:
o normal ventilation will resume
o the static monitored data for that maneuver’s breath will be automatically saved
o the Tool Types Curve Analysis screen will load
o the Curve History folder for that saved P/V Curve will be automatically selected
o the static monitored data associated with the selected P/V Curve will be
displayed in the monitor bars dark blue fields
o Dark blue fields will display with - - - - until the recruitment maneuver completes
successfully or until a Curve History folder is selected from the Curve Analysis
screen.
 Once Curve History folder is selected, the static data for that P/V Curve will
continue to display in the monitor bars dark blue fields until the user selects
another Curve History folder or another recruitment maneuver completes
successfully.
 The real-time monitored data displayed in the light green fields will continue
updating based on current step or normal ventilation mode.
o The two fields together allow users to easily compare the (light green) real-time
breath-to-breath data from the active Step Tool or normal ventilation to the
selected P/V Curves static data.
5.4.2.17. Recruitment Maneuver Monitored Parameters
As stated above in section 5.4.2.14, unless a user defined Custom Default profile is selected,
the eVent Default assigned parameters will be displayed. Capnography related parameter
selection options will only be available for selection if a CO2 sensor is attached.
For a detailed description and definition of all monitored parameters, see Table 28, Table 29,
Table 30 and Table 31.

Table 11: Recruitment Maneuver Monitored Parameters


Monitored Data
Parameter Definition
Ranges
Default The parameters listed below are the default parameters that will be displayed on the
recruitment maneuvers Monitoring Bar for New Patients and for Previous patients
unless changed by the user.
Cstat Static compliance of the respiratory system. Cstat can help diagnose 0 to 300
changes in elastic characteristics of the patient’s lungs. ml/cmH2O
Cstat/kg Static Compliance normalized to the set ideal body weight 0.00 to 5.00
ml/cmH2O-kg
Cdyn Dynamic lung compliance is the compliance of the lung at any given 0 to 300
time during actual movement of air. It is change in volume over (PIP ml/cmH2O
– PEEP) so you are looking at the change in pressure it takes to
deliver a given volume.
Cdyn/kg Dynamic Compliance normalized to the set ideal body weight 0.00 to 5.00
ml/cmH2O-kg
Vti Measured Inspiratory tidal volume 0 to 5000 ml
Vti/kg Measured Inspiratory tidal volume normalized to the set ideal body 0.0 to 50.0 ml/kg
weight

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Table 11: Recruitment Maneuver Monitored Parameters


Monitored Data
Parameter Definition
Ranges
Vte Measured Exhaled tidal volume 0 to 5000 ml
Vte/kg Measured Expiratory tidal volume normalized to the set ideal body 0.0 to 50.0 ml/kg
weight
Cursor 1 i
i  Displays the measured Vti and pressure for the Insp limb Lower
Inflection Point specific to the cursor 1 position.
Cursor 1 e Vti / P1
Cursor 1
 Displays the measured Vte and pressure for the Exp limb Lower ml / cmH2O
e Inflection Point specific to the cursor 1 position.
Current assigned Range, Resolution and accuracy for Vti and
pressure are maintained. See Figure 59
Cursor 2 I
i  Displays the measured Vti and pressure for the Insp limb Upper
Inflection Point specific to the cursor 2 position.
Cursor 2 e Vti / P1
Cursor 2
 Displays the measured Vte and pressure for the Exp limb Upper ml / cmH2O
e Inflection Point specific to the cursor 2 position.
Current assigned Range, Resolution and accuracy for Vti and
pressure are maintained. See Figure 59
Additional The parameters listed below will be selectable by the user for display on the Monitoring Bar.
Capnography related parameters will only be available for selection if a CO2 sensor is
attached.
Ppeak Measured Peak inspiratory pressure during a breath 0 to 120 cmH2O
Peak inspiratory airway pressure. The highest pressure during the
previous breath cycle. It is influenced by airway resistance and
compliance. It may be higher than expected due to the Inspiration
ventilator’s breathing circuit compliance compensation or if enabled
Tube Compensation.
PEEP Measured peak end exhalation pressure 0 to 120 cmH2O
Plateau or end-inspiratory pressure. The pressure measured at the 0 to 120 cmH2O
Pplateau
end of inspiration when flow is or is close to zero.
Overdistention index is the ratio of the dynamic compliance during 0.00 to 5.00
C20/C
the last 20% of Inspiration (C20) to the total dynamic compliance (C)
VCO2/min CO2 elimination: Net exhaled volume of CO2 per minute 0 to 5000 ml/min
VteCO2 Expired CO2 volume updated breath-to-breath 0 to 2000 ml
Vd alv Alveolar Dead Space 0 to 1000 ml
 Vd alv will displays as ----- until a PaCO2 value is entered by the
user. Once a PaCO2 value is entered, Vd alv will be calculated
based on the PaCO2 value entered.
Valv Alveolar tidal volume permits assessment of actual alveolar tidal 0 to 3000 ml
volume as opposed to exhaled tidal volume.
 Valv will displays as ----- until a PaCO2 value is entered by the
user. Once a PaCO2 value is entered, Valv will be calculated
based on the PaCO2 value entered.

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5.4.2.18. How the Step Tool Maneuver Works


o Perform a Step Tool Recruitment Maneuver
 To perform a Step Tool Recruitment Maneuver, select Step Tool as the recruitment
maneuver Tool Type.
 Update Step Tool settings as desired/required and then press the START button
on the Step Tool settings screen. The ventilator will suspend normal ventilation
and begin delivering the Step Tool Maneuver pressure-controlled breaths at the
user-defined settings.
o While the Step Tool maneuver is active, the (real-time) P/V Curve will be displayed in
the left panel as each Step Tool breath is delivered. Once the Step time or Rest time
(if set) elapses, the maneuver is complete, and the ventilator will automatically resume
normal ventilation and the new PEEP level will equal the End PEEP setting.
o The last successful PV Loop delivered during the RM Step will be captured and
displayed on the Curve Analysis screen once the Step Tool Maneuver completes.
o While the Step Tool is active, the set Step and Rest Time cannot be adjusted.
However, all other Step Tool settings can be adjusted while the Step Tool is active.
 Once the RM Step completes and the Rest Step begins, the RM Step settings can
be adjusted as desired for the next Step Tool activation. This allows multi step
maximum recruitment strategies as well as PEEP titrations to be performed.
o The maneuver can be aborted and or restarted at anytime by pressing the STOP /
START button.
o If the Step Tool is canceled during the Rest Step, the Curve Analysis page will load and
the last successful PV Loop delivered during the RM Step will be displayed.

5.4.2.19. How the PVL Tool Slow Inflation and Slow Deflation
Maneuvers Work
o Perform a PVL Tool Recruitment Maneuver
 To perform a PVL Tool Recruitment Maneuver, select either PVL Tool (p) or PVL
Tool (v) as Tool Type.
 Update settings as desired/required and then press the START button on the
selected Tool Type’s setting screen. The ventilator will suspend normal ventilation
and begin delivering the PVL Tool Maneuver. The PVL Tool maneuvers employ an
adjustable pressure ramp or flow setting with which airway pressure or volume is
slowly increased to the target level and then decreased to a lower pressure level.
o While the selected PVL Tool maneuver is active, the (real-time) P/V Curve will be drawn
by the ventilator as the PVL Tool’s slow inflation / deflation breath is delivered. Once
PVL Tool maneuver completes successfully, the ventilator will automatically resume
normal ventilation and the new PEEP level will equal the End PEEP setting. The Curve
Analysis screen will load and the P/V Curve for that maneuver will be displayed. The
lower and upper insp/exp limb inflection points will be automatically identified by the
software and the linear slope will be drawn between expiratory limb inflection points
and between the insp limb inflection points.
o The maneuver can be aborted at anytime by pressing the Stop button. If at any time
during the maneuver the ventilator detects a patient effort or pressure drop that violates
the Psens setting, the ventilator will cycle into exhalation and normal ventilation will
resume.

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o The P/V Tool records the pressure-volume relation of the lungs at close to zero flow
(quasi-static) and it follows this sequence:
 Maneuver Activation: The operator activates/aborts the PVL Tool maneuver by
pressing the Start/Stop button.
 Maneuver PEEP: The ventilator will transition to the user defined PVL Tool
Maneuvers PEEP level and will hold at this PEEP level for the user defined PEEP
equilibration time (PEEP Teq).
 Linear Pressure Increase (inflation limb): Once the PEEP Teq time is reached,
the breathing circuit is pressurized linearly (Slow Inflation Phase) to the operator-
set pressure target (Pcontrol + PEEP) or volume target (set Vt) and the slope of
inflation is based on the user defined PVL Tool (p) Ramp or PVL Tool (v) Flow
setting. The resultant volume changes are recorded.
 Pause at Pressure or Volume Target: When the user defined pressure target
(Pcontrol + PEEP) or volume target (set Vt) is reached, the user defined Pause
time (if set) will be applied and the breath will be held at the pressure target or
volume target until the Pause time elapses. Both the inspiratory and expiratory
valves are closed for the duration of the Pause time (if set).
 Linear Pressure Decrease (deflation limb): Once the Pause time (if set) is
reached, Pressure is released linearly (Slow Deflation Phase) to the set End PEEP
level and the slope of deflation limb is based on the user defined PVL Tool (p)
Ramp or PVL Tool (v) Flow setting.
 Normal Ventilation Resumes at End PEEP Level: When the set End PEEP level
is reached at the end of the slow deflation phase, the PVL Tool maneuver
completes and normal ventilation resumes. The set End PEEP level becomes the
new PEEP level for normal ventilation. The Recruitment Maneuver Curve Analysis
window loads with the P/V curve frozen for analysis and cursor related inflection
point adjustment.
 During a PVL Tool (p) or PVL Tool (v) maneuver, the time from the end of
Deflation Limb (End PEEP) until the delivery of the next breath is the Te of
the normal breath based on the set breath rate.

Figure 58: How the PVL Tool Works (Slow Inflation / Deflation)

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5.4.2.20. Inflection Point Determination Criteria (Analyzing the PV


Curve)
o As defined below and illustrated in Figure 59, the ventilators software will capture,
analyze and display the inflation and deflation pressure-volume curves of the lungs and
determine the lower and upper inflection points as well as the deflation limb
derecruitment point.
 The lower inflection point of the inflation limb (LIPIN)
 The upper inflection point of the inflation limb (UIPIN)
 The linear compliance (slope) of the inflation limb (ClinIN)
 The lower inflection point of the deflation limb (LIPDE)
 The upper inflection point of the inflation limb (UIPDE)
 The difference in volume between the two limbs (∆VDE–IN)
 The linear compliance (slope) of the deflation limb (ClinDE)

Figure 59: Inflection Point and Curve Analysis PV Loop Data

o The Lower Inflection Point of the Inflation P/V curve (LIPIN)


 The LIPIN is the point of maximal curvature below the linear portion of the inflation
P/V curve. This is the point where the rate of increase in respiratory system
compliance is maximal and is referenced in Figure 59 as Point 1. This point is
where alveoli start to open as airway pressure increases. Or to put it another way,
in the lower section before (Point 1) the pressure per volume increase rises
particularly rapidly and only continues in a more vertical direction once the lung-
opening pressure (lower inflection point), (Point 1) has been reached/exceeded.
Point 1 is the intersection between the minimal and maximal compliance defined
as the lower inflection point.
 Obtaining Point 1 allows the system to identify (mark) the lower inflection
point of the deflation pressure/volume curve (LIPDE) referenced in
Figure 59 as Point 4.
 Point 4 is determined by drawing a vertical line from Point 1 on the
inspiratory limb upward to where it intersects with the deflation (expiratory)
limb. This intersection is Point 4.

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o The Upper Inflection Point of the Inflation P/V curve (UIPIN)


 The UIPIN is the point of maximal curvature at the end of the linear portion of the
inflation P/V curve, in other words the point where the rate of decrease in
respiratory system compliance is maximal. This point is where all recruitable
alveoli are open and start to overinflate. Or to put it another way, in the upper
section after (Point 2), the lung reaches the limits of its compliance and the rise in
pressure per volume increase rises particularly rapidly again (pressure increases
more rapidly than volume). This point is the next intersection between the maximal
and minimal compliance and is the (upper inflection point), (Point 2).
 Obtaining Point 2 allows the system to identify (mark) the upper inflection
point of the deflation pressure/volume curve (UIPDE) referenced in
Figure 59 as Point 3.
 Point 3 is determined by drawing a vertical line from Point 2 on the
inspiratory limb upward to where it intersects with the deflation (expiratory)
limb. This intersection is Point 3.

o The Linear Compliance of the Inflation P/V curve (ClinIN) and Deflation PV Curve
(ClinDE)

 This part of the curve is where the maximal compliance is obtained. In this zone,
changes in volume will require a minimal increase in pressure.
 The linear compliance of the inflation P/V curve (ClinIN) is referenced in Figure
59 as (Slope Insp Limb) and is plotted on the graph as a dotted straight line
between Point 1 and Point 2 and intersects with the X-Axes.
 The linear compliance of the deflation PV curve (ClinDE) is referenced in
Figure 59 as (Slope Exp Limb) and is plotted on the graph as a dotted straight
line between Point 3 and Point 4.
5.4.2.21. Recruitment Maneuver Alarms and Alarm Criteria
5.4.2.22. Recruitment Maneuver Alarms
 Information Priority Alarm
o Maneuver Active
 Displays and enunciates (two beeps) when a Recruitment Maneuver (PVL
Tool (p), PVL Tool (v) of Step Tool) is started and continues to display /
flashing in the alarm field until the Maneuver completes or is Terminated or
is Stopped.
 Once the Recruitment Maneuver is no longer active the “Maneuver Active”
alarm will cancel and no longer display in the alarm field.
 Medium Priority Alarm
o PT Effort Detected

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 Displays when the detected patient effort or pressure drop during the PVL
Tool Recruitment Maneuver violates the Psens setting.
 When the Psens setting is violated (exceeded), the PVL Tool Recruitment
Maneuver, terminates and normal ventilation resumes at the pre-maneuver
settings.
 When triggered, the PT Effort Detected alarm message will display and
sound and after normal ventilation resumes will latch (become inactive) in
the alarm field.
 The Psens setting is associated with the PVL Tool (p) and PVL Tool (v)
recruitment maneuvers and thus the “PT Effort Detected” alarm is only
triggerable while a PVL Tool (p) and PVL Tool (v) recruitment maneuver is
active.
5.4.2.23. Recruitment Maneuver Alarm Criteria
 Alarms Background Adjustments when a Recruitment Maneuver is active
o During the PVL Tool (p) and Step Tool recruitment maneuvers, if (Maneuver
PEEP + Maneuver Pcontrol) > Ppeak High alarm limit, then Ppeak High alarm
limit will be background adjusted to maneuver PEEP + maneuver Pcontrol + 5
cmH2O until the recruitment maneuver completes or is terminated or canceled.
o Vti Limit is disabled during an active recruitment maneuver
o Vte alarm is disabled during an active recruitment maneuver
o Apnea alarm will be disabled when the PVL Tool (p) and PVL Tool (v) maneuvers
are active.
o Apnea Backup will be disabled when the PVL Tool (p) and PVL Tool (v)
maneuvers are active.
5.4.2.24. Recruitment Maneuver Disable Criteria
 The Recruitment maneuver feature will be disabled, and the Recruitment button will
disappear if
o The Flow sensor is disabled.
 If the flow sensor is disabled during an active recruitment maneuver, then
the recruitment maneuver will terminate, and normal ventilation will
resume.
o Apnea Backup is triggered and while Apnea Backup active
o the Apnea alarm is triggered and while the Apnea alarm is active
o NIV is enabled (turned ON)
5.4.2.25. Recruitment Maneuver Termination Criteria
 An active Recruitment Maneuver will automatically terminate
o If the Flow Sensor is disabled during an active recruitment maneuver and then
normal ventilation will resume.
o If NIV is activated during an active recruitment maneuver and then normal
ventilation will resume.
o If Apnea Backup is triggered during an active recruitment maneuver and then
the system will switch to Apnea Backup ventilation.
 Once in Apnea Backup, if the patient triggers 2 consecutive breaths, the
ventilator will transition to normal ventilation and the recruitment maneuver
will have to be manually restarted by the user.
 If the recruitment maneuver (RM) screen is displayed at the time Apnea
Backup occurs, the Main screen will load, and the Recruitment button will
not be display on the Maneuvers Left Panel until apnea backup is resolved.
o If the Apnea alarm is triggered (Apnea Backup is set to OFF) during an active

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recruitment maneuver, then the system will transition to normal ventilation.


 If the recruitment maneuver (RM) screen is displayed at the time the Apnea
alarm occurs, the Main screen will load and the Recruitment button will not
be display on the Maneuvers Left Panel until the apnea alarm is resolved.
o If the PVL Tool (p) or PVL Tool (v) Recruitment Maneuver is active and the
Suction Support maneuver is started.

5.4.2.26. Suction Support functionality during Recruitment


Maneuvers
 While the Step Tool Recruitment maneuver is active, if the Suction Maneuver is
started, the Suction Support maneuver will function normally and the Step Tool
Recruitment maneuver WILL NOT be terminated and when the Suction Support
maneuver completes or is terminated, the Step Tool Recruitment maneuver will
resume.
 While the PVL Tool (p) or PVL Tool (v) Recruitment maneuver is active, if the Suction
Maneuver is started, the PVL Tool Recruitment maneuver will be terminated and
normal ventilation will resume and the Suction Support maneuver will function
normally.
5.4.2.27. Recruitment Maneuver Event Logs and Automatic Event
Markers
 Event Log entries related to recruitment maneuvers:
o See section 5.5.9 for Event Log details.
 Automatic Event Marker for Recruitment Maneuvers
o See Table 33.

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5.4.3. P0.1 Maneuver


P0.1 also known as P100 is the Airway Occlusion Pressure. P0.1 is the maximal slope of the
airway pressure drop (Max negative insp pressure) during the first 100 ms of inspiratory effort
when the airway is occluded. P0.1 indicates the patient’s respiratory drive and efforts. It
applies to patient-triggered breaths with pressure trigger only and with no base flow. A P0.1
value of -3 cmH2O indicates a strong inspiratory effort, and a value of -5 cmH2O, an excessive
effort, possibly because the patient is “air hungry" (peak inspiratory flow or total ventilatory
support is inadequate) or has an excessive drive.

Figure 60: P0.1 Maneuver

o From the Maneuver tab, select P0.1/PiMax shown in the Figure 60.
o Press the P0.1 START button to initiate the maneuver. The ventilator will wait for a
triggered breath to measure the pressure drop produced by the patient inspiratory effort
to during the initial 100 ms of the patient effort.
o The P0.1 maneuver is complete and the P0.1 monitored parameter will update to
display at Data/Mechanics tab and recorded in the Event Log for review.
o If the ventilator does not detect a triggered breath, the P0.1 maneuver will time out
based on Patient type.
Patient Type P0.1 Time Based Termination Criteria

Adult 10 seconds or Tapnea whichever is shorter

Pediatric 6 seconds or Tapnea whichever is shorter

Neonate 4 seconds or Tapnea whichever is shorter

Table 12: P0.1 Automatic Termination Criteria

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5.4.4. PiMax Maneuver


PiMax also known as MIP or NIF is the Maximum Negative Inspiratory Airway Pressure that
is achieved by the patient, during a maneuver based expiratory hold.

 The PiMax maneuver is disabled when the patient type is Neonate.

The PiMax maneuver measures the maximum negative inspiratory pressure generated during
inspiration against an occluded airway and is an indicator of inspiratory muscle strength if lung
volume is known at the time of measurement. To start the maneuver, touch START and hold
to close the inspiratory valve and open the exhalation valve. The patient can exhale and
during the maneuver and the most negative value achieved during any inspiratory effort will
be recorded and displayed as the PiMax value for that maneuver.

Figure 61: PiMax Maneuver

o From the Maneuver tab, select P0.1/PiMax shown in the Figure 61: PiMax Maneuver.
o Press the PiMax START button to initiate the maneuver. The ventilator will stop breath
delivery for the period the time is set by the user for patient to perform the maneuver.
o The ventilator will lower the PEEP to 1cmH2O for two reasons: First, to allow the patient
to exhale easily and second to close the valve quickly to prevent patient inhalation. This
way, the expiratory valve will perform as one-way valve that is common tool used for
PiMax manually measurement. In addition, at almost zero PEEP, the PiMax
measurement should be at or close to patient lung residual volume where the PiMax is
usually measured.
o When the PiMax maneuver is complete, it indicates the maximum inspiratory pressure
and normal ventilation resumes. The measured value will update to display on the
Data/Mechanics tab. In addition, it will be recorded in the Event Log for review.
o During the maneuver, the START button changes to STOP. Touching STOP terminates
the maneuver immediately and resumes normal ventilation.
o P0.1 / PiMax monitored value
 P0.1 / PiMax is a monitored parameter not a maneuver, P0.1/PiMax is a calculated
ratio from the P0.1 and PiMax maneuvers. When the user performs a P0.1 and a
PiMax maneuver, the monitored parameter P0.1/PiMax will display the calculated
ratio. See Table 30 for additional information on this monitored parameter.

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Section 5 Ventilator Set Up and Operation

5.5. Alarms Tab


This section provides information on all alarm settings; alarm auto set feature, alarm priorities,
alarm audible pause (silence), alarm messages, alarm/event log and some technical description.
 Operator’s Position: the user can access the alarm settings tab on the graphic user interface
of the ventilator. The user can rotate or tilt the graphic panel for easy access.
 Alarm Delay: The delay time is imperceptible from the moment the alarm condition first
occurs until the alarm is annunciated by the ventilator or transmitted to the nurse call RJ12
connector on the back of the ventilator.

5.5.1. Alarm Settings


5.5.1.1. Standard Alarm Settings
 By default when the Alarms tab is pressed, the Standard Alarm Settings are displayed
in the Alarm Settings right panel as shown below in Figure 62.

Figure 62: Alarms Settings Screen – Standard

Table 13: Alarm Settings – Standard


Standard
Alarm Value min Value max Unit Resolution Remarks
Settings
0.01 (0.10 to 1.00) Vi High displays if Prox.
Ve High or 0.10 or
50.0 l/min 0.10 (1.00 to 10.0) Sensor is disabled for any
Vi High 0.10 > Ve Low reason
0.1 (10.0 to 50.0)
0.01 (0.10 to 1.00) Vi Low displays if Prox.
Ve Low or 49.9 or
0.00 l/min 0.10 (1.00 to 10.0) Sensor is disabled for any
Vi Low 0.10 < Ve High reason
0.1 (10.0 to 50.0)
Vte High Vti High alarm limit displays if the proximal flow sensor is disabled for any reason
5 or 5 (0 to 300) One setting above
Adult 2500 or Off ml
1 Step > Vte Low 10 (300 to 2500) 2500 = Off

2 or 2 (0 to 300) One setting above


Pediatric 700 or Off ml
1 Step > Vte Low 5 (300 to 700) 700 = Off

1 or 1 (0 to 100) One setting above


Neonate 300 or Off ml
1 Step > Vte Low 2 (100 to 300) 300 = Off

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Table 13: Alarm Settings – Standard


Standard
Alarm Value min Value max Unit Resolution Remarks
Settings
Vte Low Vti Low alarm limit displays if the proximal flow sensor is disabled for any reason.
2490 or 5 (0 to 300)
Adult Off or 0 ml
1 Step < Vte High 10 (300 to 2500)
695 or 2 (0 to 300) Vte Low alarm is disabled
Pediatric Off or 0 ml when the SPAP mode is
1 Step < Vte High 5 (300 to 700) active
298 or 1 (0 to 100)
Neonate Off or 0 ml
1 Step < Vte High 2 (100 to 300)
2 or
Rate High 200 b/min 1
1 > Rate Low
199 or
Rate Low 1 b/min 1
1 < Rate High
1 or
Ppeak High 100 cmH2O 1
1 > Ppeak Low
99 or
Ppeak Low 0 cmH2O 1
1 < Ppeak High
1 or
Pmean High 100 cmH2O 1
1 > Pmean Low
99 or
Pmean Low 0 cmH2O 1
1 < Pmean High
Leak Rate 20 100 % 1
Apnea
3 60 s 1
(interval)
Vti Limit Terminates the breath if the volume delivered exceeds the Vti Limit alarm setting
One setting above
5 (0 to 300)
Adult 0 2500..Off ml 2500 = Off
10 (300 to 2500)
(default New Patients = Off)

One setting above


2 (0 to 300)
Pediatric 0 700..Off ml 700 = Off
5 (300 to 300)
(default New Patients = Off)

One setting above


1 (0 to 100)
Neonate 0 300..Off ml 300 = Off
2 (100 to 300)
(default New Patients = 300)

Automatically adjusts alarm settings based on current monitored values or settings depending on
AUTO SET
mode. (See section 5.5.3)

 Vti Limit: If the volume delivered during any breath exceeds the Vti Limit alarm setting
value, that breath will be immediately terminated, and the ventilator will cycle to
exhalation.
 If Smart Sigh is enabled, the Vti Limit is automatically background adjusted to higher
value when a Sigh breath is being delivered. When a Sigh breath is delivered Vti
Limit = Vti Limit Setting * Sigh Factor.
 The Vti Limit Reached alarm will sound in non-VTV modes after 4 consecutive
breaths have been terminated and after 8 consecutive terminated breaths in all VTV
modes (PRVC–CMV, PRVC–SIMV and VS).

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 The Vti Limit alarm pause bell displayed next to the Vti Limit alarm setting when
selected will pause the Vti Limit Reached audible alarm. The Vti Limit Reached alarm
message will be displayed in the alarm field but the audible alarm for this message
will be paused until the Vti Limit alarm pause bell is deselected.
5.5.1.2. Capnography Alarm Settings
 When the Mainstream (IRMA) Sensor is connected to the Inspiration 5i ventilator, the
Capnography Alarm Settings screen will be displayed as shown below in Figure 63.
If no Capnography sensor is connected, the Capnography alarms tab and related
alarm settings will not be displayed on the Alarm Settings screen.

Figure 63: Alarms Settings Screen – Capnography (Mainstream)

 When the Sidestream (ISA) Sensor is connected to the Inspiration 5i ventilator, the
Standard Alarm Settings screen will update to display the PetCO2 High and Low alarm
limit setting as shown below in Figure 64.

Figure 64: Alarms Settings Screen – Capnography (Sidestream)

Table 14: Alarm Settings – Capnography


Capnography
Alarm Value min Value max Unit Resolution Remarks
Settings

2 or
PetCO2 High 150 mmHg 1 HIGH Priority Alarm
1 > PetCO2 Low

149 or
PetCO2 Low Off or 1 mmHg 1 HIGH Priority Alarm
1 < PetCO2 High

1 for < 100 ml


VteCO2 Low Off or 1 1000 ml HIGH Priority Alarm
10 for ≥ 100 ml

2 or 1 for < 100 ml Medium Priority Alarm


Valv High 2000 or Off ml Off equals one setting
1 Step > Valv Low 10 for ≥ 100 ml above 2000 ml

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Table 14: Alarm Settings – Capnography


Capnography
Alarm Value min Value max Unit Resolution Remarks
Settings
1990 or 1 for < 100 ml
Valv Low Off or 1 ml HIGH Priority Alarm
1 Step < Valv High 10 for ≥ 100 ml
1.0 or
Valv/min High 50.0 l/min 0.1 for ≥ 1 l/min Medium Priority Alarm
0.1 > Valv/min Low
49.9 or 0.01 for < 1 l/min
Valv/min Low Off or 0.01 0.1 < Valv/min l/min HIGH Priority Alarm
High 0.1 for ≥ 1 l/min

Automatically adjusts alarm settings based on current monitored values or settings depending on
AUTO SET
mode. (See section 5.5.3)

5.5.1.3. SBT Mode Alarm Settings


 The SBT Alarm settings are applicable to the SBT mode only. The SBT mode alarm
settings can be adjust at any time but are only functional when the SBT mode is
active.

Figure 65: Alarms Settings Screen – SBT Mode

Table 15: Alarm Settings – SBT


SBT
Alarm Value min Value max Unit Resolution Remarks
Settings
5 or One setting above
High RSBI 900 or Off b/min/l 5
(5 > Low RSBI) 900 = Off
895 or One setting Below
Low RSBI Off or 5 b/min/l 5
(5 < High RSBI) 5 = Off
2 or One setting above
High Rate 80 or Off b/min 1
1 > Rate Low 80 = Off
79 or One setting Below
Low Rate Off or 1 b/min 1
1 < Rate High 1 = Off
AUTO SET Automatically adjusts alarm settings based on current monitored values or settings depending on
mode. (See section 5.5.3)

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Section 5 Ventilator Set Up and Operation

5.5.2. Alarm Default Settings


The initially established default alarm settings (alarm preset) are based on the patient’s Ideal
Body Weight (IBW).
o When the user selects New Patient, the patient’s IBW will be calculated or manual
entered during the New Patient Startup. Once the user pressed the ACCEPT button
and exits the New Patient Startup screen, the default (initial) alarm limit settings will be
established for all alarm limit settings as defined below in Table 16, Table 17 and Table
18.
 The default alarm limit settings are based on the patient’s IBW and are intended
as initial safe set point limits that should be reviewed and adjusted by the user
prior to activating ventilation.
 Changing the Previous patient’s IBW has no effect on the current setting,
proposed setting, apnea backup settings or alarm settings. Changing the patient’s
IBW during ventilation, has no effect on the current setting, proposed setting,
apnea backup settings or alarm settings.
o The alarm settings are adjustable at anytime by the user. With the exception of the Vti
Limit alarm setting, alarm settings do not auto adjust based on changes to the patient’s
ventilation settings.
 When a (VTV) ventilation mode PRVC–CMV, PRVC–SIMV or VS is activated, the
Vti Limit is automatically set to 1.5 X set Vt unless the Vti Limit is set to Off in which
case no adjustment will be made.
5.5.2.1. Standard Alarm Default Settings
Table 16: Alarm Limit Default Settings – Standard Alarms
Standard Alarms
High Alarm Limit Default Setting Low Alarm Limit Default Setting
Default Settings
Ve: IBW Rate x IBW Vt + 50% IBW Rate x IBW Vt - 50%
Vte: 50% above IBW Vt 50% below IBW Vt
Rate: 50% above IBW Rate 50% below IBW Rate
Ppeak: 10 cmH2O above IBW Pcontrol 10 cmH2O below IBW Pcontrol

Pmean:
Adult 13 cmH2O 9 cmH2O

Pediatric 12 cmH2O 8 cmH2O

Neonate 10 cmH2O 6 cmH2O

Leak: 100% –
Apnea: 20 s –

Vti Limit
Adult 2500 ml or 1.5 X set Vt (VTV Modes) –

Pediatric 700 ml or 1.5 X set Vt (VTV Modes) –

Neonate 300 ml or 1.5 X set Vt (VTV Modes) –

Vti Limit
Enabled –
(Alarm Bell)

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Section 5 Ventilator Set Up and Operation

5.5.2.2. Capnography Alarm Default Settings


Table 17: Alarm Limit Default Settings – Capnograhy Alarms
Capnography Alarms
High Alarm Limit Default Setting Low Alarm Limit Default Setting
Default Settings
PetCO2 55 mmHg 25 mmHg
VteCO2 – IBW Kg x 2.0 ml/kg
Valv Same as IBW Vt 60% below IBW Vt
Valv/min IBW Vt x IBW Rate 60% below (IBW Vt x IBW Rate)

5.5.2.3. SBT Alarm Default Settings


Table 18: Alarm Limit Default Settings – SBT Alarms
SBT Alarms
High Alarm Limit Default Setting Low Alarm Limit Default Setting
Default Settings
IBW Rate / IBW Vt in liters + 50% or IBW Rate / IBW Vt in liters - 50% or 40
SBT RSBI
110 whichever is greater whichever is greater

SBT Rate 50% above IBW Rate 50% below IBW Rate

5.5.3. Alarm Auto Set Feature


Table 19: Auto Set Feature – Alarm Setting Adjustment Rules
Auto Set Alarm Alarm Setting Adjustments When the Auto Set
During Standby
Feature Button is Pressed
Ve High Auto Set limits: V–CMV mode: (set rate x set tidal During Standby, Ve High and Vi High
volume) + 50%, alarm setting will only be updated if
Vi High
All other modes: monitored Ve + 50% Current Settings mode is V–CMV.
Uses inspiratory minute volume (Vi) if proximal flow All other modes no adjustment will be
sensor is disabled. made.

Ve Low Automatic limits: V–CMV mode: (set rate x set tidal During Standby, Ve Low and Vi Low
volume) - 50%, alarm setting will only be updated if
Vi Low
All other modes: monitored Ve - 50% Current Settings mode is V–CMV.
Uses inspiratory minute volume (Vi) if proximal flow All other modes no adjustment will be
sensor is disabled. made.

Vte High Automatic limits: (V–CMV, V–SIMV, PRVC–CMV, During Standby, Vte High alarm setting
PRVC–SIMV, VS: Set tidal volume + 50%), will only be updated if Current Settings
All other modes: monitored tidal volume + 50% mode is V–CMV, PRVC–CMV,
Uses inspiratory tidal volume (Vti) if proximal flow V–SIMV, PRVC–SIMV or VS.
sensor is disabled. All other modes no adjustment will be
If Vte / Vti High alarm limit is set to OFF, Auto Set made.
feature will not change Vte / Vti High alarm limit.
Vte Low Automatic limits: (V–CMV, V–SIMV, PRVC–CMV, During Standby, Vte Low alarm setting
PRVC–SIMV, VS: Set tidal volume - 50%), will only be updated if Current Settings
All other modes: monitored tidal volume - 50% mode is V–CMV, PRVC–CMV,
Uses inspiratory tidal volume (Vti) if proximal flow V–SIMV, PRVC–SIMV or VS.
sensor is disabled. All other modes no adjustment will be
If Vte / Vti High alarm limit is set to OFF, Auto Set made.
feature will not change Vte / Vti Low alarm limit.

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Section 5 Ventilator Set Up and Operation

Table 19: Auto Set Feature – Alarm Setting Adjustment Rules


Auto Set Alarm Alarm Setting Adjustments When the Auto Set
During Standby
Feature Button is Pressed
Rate High Automatic limits: (V–CMV, P–CMV, PRVC–CMV: During Standby, Rate High alarm
set rate + 50%), setting will only be updated if Current
All other modes: monitored total rate + 50% Settings mode is V–CMV, P–CMV or
PRVC–CMV.
All other modes no adjustment will be
made.
Rate Low Automatic limits: (V–CMV, P–CMV, PRVC–CMV: During Standby, Rate Low alarm setting
Set rate - 50%), will only be updated if Current Settings
All other modes: Monitored total rate - 50% mode is V–CMV, P–CMV or
PRVC–CMV.
All other modes no adjustment will be
made.
Ppeak High Automatic limits: (V–CMV, V–SIMV, PRVC–CMV, During Standby, Ppeak High alarm
PRVC–SIMV, VS: monitored Ppeak + 10 cmH2O), setting will only be updated if Current
(P–CMV, P–SIMV: set Pcontrol + set PEEP + 10 Settings mode is P–CMV, P–SIMV, PS
cmH2O), or SPAP.
(PS: set Psupport + set PEEP + 10 cmH2O), All other modes no adjustment will be
made.
(SPAP: set Phigh + Psup high + 10 cmH2O)

Ppeak Low Automatic limit (all modes): set PEEP +1 cmH2O, During Standby, Ppeak Low alarm will
(SPAP: set Plow +1cmH2O) be updated as defined.

Pmean High Automatic limit (all modes): monitored Pmean During Standby, Auto Set feature does
+10 cmH2O not change Pmean High alarm limit.

Pmean Low Automatic limit (all modes): monitored Pmean During Standby, Auto Set feature does
-10 cmH2O not change Pmean Low alarm limit.
(If monitored Pmean is below 10cmH2O,
Pmean Low = monitored Pmean -5 cmH2O

Leak Auto Set feature does not change Leak alarm limit. During Standby, Auto Set feature does
not change Leak alarm limit.
Apnea Auto Set feature does not change Apnea time limit. During Standby, Auto Set feature does
not change Leak alarm limit.
Vti Limit Auto Set feature does not change Vti limit. During Standby, Auto Set feature does
not change Leak alarm limit.
PetCO2 High Monitored PetCO2 +10 mmHg During Standby, Auto Set feature does
not change PetCO2 High alarm limit.

PetCO2 Low Monitored PetCO2 -10 mmHg During Standby, Auto Set feature does
not change PetCO2 Low alarm limit.
If PetCO2 Low alarm limit is set to OFF, Auto Set
feature will not change PetCO2 Low alarm limit.

VteCO2 Low Monitored VteCO2 - 40% During Standby, Auto Set feature does
not change VteCO2 Low alarm limit.
If VteCO2 Low alarm limit is set to OFF, Auto Set
feature will not change VteCO2 Low alarm limit.

Valv High Same as monitored tidal volume During Standby, Auto Set feature does
If Valv High alarm limit is set to OFF, Auto Set feature not change Valv High alarm limit.
will not change Valv High alarm limit.
Valv Low Monitored tidal volume - 60% During Standby, Auto Set feature does
If Valv Low alarm limit is set to OFF, Auto Set feature not change Valv Low alarm limit.
will not change Valv Low alarm limit.

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Section 5 Ventilator Set Up and Operation

Table 19: Auto Set Feature – Alarm Setting Adjustment Rules


Auto Set Alarm Alarm Setting Adjustments When the Auto Set
During Standby
Feature Button is Pressed
Valv/min High Same as monitored ExpMinVol During Standby, Auto Set feature does
not change Valv/min High alarm limit.
Valv/min Low Monitored ExpMinVol - 60% During Standby, Auto Set feature does
If Valv/min Low alarm limit is set to OFF, Auto Set not change Valv/min Low alarm limit.
feature will not change Valv/min Low alarm limit.
RSBI High Monitored RSBI + 50% Pressing the SBT Auto Set button
If RSBI High alarm limit is set to OFF, Auto Set feature during Standby does not affect any SBT
will not change RSBI High alarm limit. Alarm Settings.

RSBI Low Monitored RSBI - 50% Pressing the SBT Auto Set button
If RSBI Low alarm limit is set to OFF, Auto Set feature during Standby does not affect any SBT
will not change RSBI Low alarm limit. Alarm Settings.

Rate High Monitored RSBI + 50% Pressing the SBT Auto Set button
(SBT) If Rate High alarm limit is set to OFF, Auto Set feature during Standby does not affect any SBT
will not change Rate High alarm limit. Alarm Settings.

Rate Low Monitored RSBI - 50% Pressing the SBT Auto Set button
(SBT) If Rate Low alarm limit is set to OFF, Auto Set feature during Standby does not affect any SBT
will not change Rate Low alarm limit. Alarm Settings.

5.5.4. Alarm Levels


Each alarm priority has its own unique tone and pattern. Although each alarm priority has a
distinct tone and pattern, the audible volume or decibel (dB) level is based on a single volume
setting.
The factory default audio level for New Patient is set to 100% and can be adjusted by the
user. The audio level control can be adjusted on the Config screens Technical page.

5.5.5. Alarm Audio Pause

Alarm Audio Pause Key (two minutes audio pause)

Audio Pause for Active Alarms: To pause (silence) active alarms for two
minutes, press and release the Alarm Audio Pause Key. This will pause
the audible portion of the currently active alarms for two minutes. If the
alarm condition is resolved, the visual indicator disappears. If the alarm
condition has not been resolved, the alarm will remain active on the display
screen until the condition is resolved. If a new alarm event occurs, this will
cancel the alarm pause and the current active alarms will sound and
display. Pressing the alarm pause key again will deactivate the current
alarm audio pause session.
Audio Pause for Active and Inactive Alarms: Pressing and holding the
Alarm Audio Pause Key for two seconds will pause all active and inactive
alarms for two minutes. If a new alarm event occurs, no alarm will sound
but all alarms will display. Pressing the alarm pause key again will reset
the alarm pause.

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Section 5 Ventilator Set Up and Operation

5.5.6. Alarm Messages and Descriptions


This section provides a detailed list of all ventilator alarms, alarm descriptions, ventilator
response to alarm conditions and suggested corrective action. Follow the suggested
corrective action steps to resolve alarm conditions. If the alarm persists, contact a qualified
service technician.
5.5.6.1. About Diagnostic Alarm Messages
o There are two types of errors: Malfunctions and Alarms
 Malfunctions are related to technical failures
 Alarms are related to operational condition failures or mismatch.
o Alarms are categorized as High Priority, Medium Priority, and Information message
(Low) Priority.
o Both Alarms and Malfunctions (TF: Technical Faults) are logged in the ventilators
Events Log.

5.5.6.2. High Priority Alarms


Table 20: High Priority Alarms, Descriptions and Correction Actions

Description / Cause / Ventilator


High Priority Alarms Corrective Action
Response

Apnea The set apnea time has elapsed without a Check patient and ensure that
patient triggered or mandatory breath, displays settings are appropriate for
during Auto Control if set apnea time has patient condition.
elapsed and in all other mode except NCPAP+
when apnea backup is disabled.
Ventilator will look for patient’s next inspiratory
effort. After two consecutive spontaneous
breaths the Apnea alarm pauses and the
Apnea alarm message will latch.

Apnea Backup Active The set apnea time has elapsed without a Check patient and ensure that
patient triggered or mandatory breath. settings are appropriate for
patient condition.
The set Apnea Backup mode will become
active and the device will look for the patient’s
next inspiratory effort. After two consecutive
spontaneous breaths the ventilator switches
over to normal ventilation.
NOTE: If apnea backup is disabled, turned Off,
the ventilator will not provide apnea backup
ventilation when the apnea interval time has
elapsed.

Air Supply The air supply has been interrupted, Air supply 1. Check air supply
not available and compressor backup is not connections.
installed or is disabled. 2. Check air supply pressure.
Ventilation continues with 100% oxygen 3. Enable compressor backup.

Oxygen Supply The oxygen supply has been interrupted, 1. Check oxygen supply
oxygen supply not available. connections.
2. Check oxygen supply
Ventilation continues with air (21%). pressure.

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Section 5 Ventilator Set Up and Operation

Table 20: High Priority Alarms, Descriptions and Correction Actions

Description / Cause / Ventilator


High Priority Alarms Corrective Action
Response

High-pressure Circuit pressure has reached the Ppeak high- 1. Check patient and ensure
pressure alarm limit. Ventilator immediately that ventilator settings are
switches to exhalation. Ventilation continues appropriate for patient
but pressure is limited at the alarm setting. condition.
2. Check for circuit occlusions.

Low Pressure Circuit pressure has dropped below the Ppeak 1. Check patient and ensure
low pressure alarm limit, pressure cannot be that ventilator settings are
attained in the breathing circuit, possible leak or appropriate for patient
disconnect. condition.

Ventilation continues. 2. Check circuit connections.


3. Perform Circuit Check.
4. Replace circuit.
Disconnection A disconnection alarm criteria has been 1. Check patient and ensure
violated. Possible leak or disconnect in circuit. that ventilator settings are
appropriate for patient
Ventilation continues. condition.
2. Check circuit connections.
3. Perform Circuit Check.
4. Replace circuit.

Occlusion Pressure at the start of inspiration is too high, 1. Check patient and ensure
patient circuit occluded. that ventilator settings are
appropriate for patient
Ventilator opens to ambient air. condition.
2. Check for circuit occlusions.
3. Provide alternate ventilation
and contact service
technician.

High Tidal Volume Exhaled tidal volume is too high compared with Check patient and ensure that
the set alarm limit for Vte. ventilator settings are
appropriate for patient condition.
Note: If proximal sensor is turned off, inspired
breath volume (Vti) is shown instead.
Ventilation continues

Low Tidal Volume Exhaled tidal volume is too low compared with Check patient and ensure that
the set alarm limit for Vte. ventilator settings are
appropriate for patient condition.
Note: If flow sensor is turned off, inspired
breath volume (Vti) is shown instead.
Ventilation continues

High Minute Volume Exhaled minute volume is too high compared Check patient and ensure that
with the set alarm limit for Ve. ventilator settings are
appropriate for patient condition.
Note: If proximal sensor is turned off, inspired
minute volume (Vi) is shown instead.
Ventilation continues

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Section 5 Ventilator Set Up and Operation

Table 20: High Priority Alarms, Descriptions and Correction Actions

Description / Cause / Ventilator


High Priority Alarms Corrective Action
Response

Low Minute Volume Exhaled minute volume is too low compared Check patient and ensure that
with the set alarm limit for Ve. ventilator settings are
appropriate for patient condition.
Note: If proximal sensor is turned off, inspired
minute volume (Vi) is shown instead.
Ventilation continues

Battery too Low Internal / external rechargeable battery is too 1. Connect to AC power and
low or almost depleted. ensure that battery
recharges.
The high priority audible alarm sound cannot be 2. Check battery cable
silenced. connections.
3. Replace battery.

Imminent Shutdown This alarm announces that the ventilator will 1. Connect to AC power and
shutdown anytime and the AC must be ensure that battery
Connect AC Now connected. recharges.
2. Check battery cable
Besides the High Priority audible alarm, the connections.
high pitch continuous alarm (buzzer) will sound
as well and cannot be silenced. 3. Replace battery.

This alarm precedes the Device Alert state for


power failure or Vent Inop.

High Oxygen Inspiratory oxygen concentration (monitored 1. Perform oxygen sensor


O2) exceeds ventilator-set alarm limit, The calibration.
monitor O2 concentration is too high compared 2. Replace oxygen sensor.
with the set O2 value, Inspiratory O2 3. Contact service technician.
concentration is too high. Alarm occurs only if
oxygen sensor is not disabled.
Possible causes: gas mixing system error, O2
sensor faulty, O2 sensor drift out calibration.

Ventilation continues as set. See violation limits


criteria in section 11.17

Low Oxygen Inspiratory oxygen concentration (monitored 4. Perform oxygen sensor


O2) is below ventilator-set alarm limit, The calibration.
monitor O2 concentration is too low compared 5. Replace oxygen sensor.
with the set O2 value, Inspiratory O2 6. Contact service technician.
concentration is too low. Alarm occurs only if
oxygen sensor is not disabled.
Possible causes: gas mixing system error, O2
sensor faulty, O2 sensor drift out calibration

Ventilation continues

P. Line On Right Side? The single proximal airway pressure line is Reposition the proximal airway
connected to the wrong flow senor port. pressure line so that it is
connected to the right side
Note: This alarm is only active if the NCPAP + (silver) port of the flow sensor
mode is active. pressure ports.
NCPAP flow and ventilation continues.

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Section 5 Ventilator Set Up and Operation

Table 20: High Priority Alarms, Descriptions and Correction Actions

Description / Cause / Ventilator


High Priority Alarms Corrective Action
Response

Heliox Supply The Heliox high-pressure source is empty or 1. Check Heliox supply
disconnected, connection.
2. Check Heliox supply
Ventilation will continue with the other high- pressure.
pressure gas source
Note: This alarm only occurs if Heliox is
switched on.

Heliox Pres Low- Use Heliox high-pressure source is empty, air from 1. Check Heliox supply
Air the internal compressor is used instead connection.
2. Check Heliox supply
Note: This alarm only occurs if Heliox is pressure.
switched on. Ventilation continues and Device
switches over to pressure triggering mode. 3. Switch gas type to Air
(Config tab).

PetCO2 High The monitored exhaled PetCO2 value is too Check patient and ensure that
high compared with the set PetCO2 high alarm alarm limits and ventilator
limit. settings are appropriate for
patient condition.
Ventilation continues.
Note: This alarm can only occur when the
mainstream or sidestream CO2 sensor is in
use.

PetCO2 Low The monitored exhaled PetCO2 value is too low Check patient and ensure that
compared with the set PetCO2 low alarm limit. alarm limits and ventilator
settings are appropriate for
Ventilation continues. patient condition.
Note: This alarm can only occur when the
mainstream or sidestream CO2 sensor is in
use.

VteCO2 Low The monitored exhaled VetCO2 value is too low Check patient and ensure that
compared with the set VetCO2 low alarm limit. alarm limits and ventilator
settings are appropriate for
Ventilation continues. patient condition.
Note: This alarm can only occur when the
mainstream or sidestream CO2 sensor is in
use.

Valv Low The monitored Val value is too low compared Check patient and ensure that
with the set Val Low alarm limit. alarm limits and ventilator
settings are appropriate for
Ventilation continues. patient condition.
Note: This alarm can only occur when the
mainstream or sidestream CO2 sensor is in
use.

Valv/min Low The monitored Valv/min value is too low Check patient and ensure that
compared with the set Valv/min low alarm limit. alarm limits and ventilator
settings are appropriate for
Ventilation continues. patient condition.
Note: This alarm can only occur when the
mainstream or sidestream CO2 sensor is in
use.

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Section 5 Ventilator Set Up and Operation

Table 20: High Priority Alarms, Descriptions and Correction Actions

Description / Cause / Ventilator


High Priority Alarms Corrective Action
Response

Speaker Fault A fault has been detected with the main alarm Provide alternate ventilation and
speaker (Main alarm speaker failure). contact service technician.
Ventilation continues unaffected but with
continuous tone audible alarm.

Internal Pressure The pressure within the gas reservoir is too low. 1. Check oxygen supply
Low/Disconnect connections.
Ventilation continues, nebulizer is switched off 2. Check oxygen supply
pressure.

Technical Fault A technical fault has occurred. The technical Provide alternate ventilation and
(TF-1 to TF-29) fault alarm when triggered will display a specific contact service technician.
(see section 5.5.7) TF-## code which defines the TF condition.
Ventilator opens to ambient air

5.5.6.3. Medium Priority Alarms


Table 21: Medium Priority Alarms, Descriptions and Correction Actions

Medium Priority Description / Cause / Ventilator Response Corrective Action


Alarms

Battery low Internal battery voltage is too low. Make sure that 1. Connect to AC power
there is an alternative source of power available and ensure that
battery recharges.
Ventilation continues with DC power
2. Check battery cable
connections.
3. Replace battery.
Check Pcontrol / Pmax Pcontrol and/or high-pressure alarm settings are Adjust Pcontrol and/or
incorrect Ppeak High alarm limit
(i.e., Pcontrol + PEEP > Ppeak high alarm limit settings.
setting)
Ventilation continues. Pressure is limited at the high-
pressure alarm setting until the settings are corrected.

Check Psupport / Pmax Psupport and/or high-pressure alarm settings are Adjust Psupport and/or
incorrect Ppeak High alarm limit
(i.e., Psupport + PEEP > Ppeak high alarm limit settings.
setting)
Ventilation continues. Pressure is limited at the high-
pressure alarm setting until the settings are corrected.

Compressor The internal compressor has failed. Connect to functional air


supply and contact
Ventilation continues with 100% oxygen, where service technician.
possible.
Note: This alarm can only occur if the compressor
option on the engineering screen is enabled.

High external voltage The external DC supply voltage is too high. Contact service
technician
Ventilation continues

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Section 5 Ventilator Set Up and Operation

Table 21: Medium Priority Alarms, Descriptions and Correction Actions

Medium Priority Description / Cause / Ventilator Response Corrective Action


Alarms

High frequency The monitored Respiratory rate is too high as Check patient and ensure
compared with the high rate alarm limit. that ventilator settings are
appropriate for patient
Ventilation continues condition.

Low frequency The monitored Respiratory rate is too low as Check patient and ensure
compared with the low rate alarm limit. that ventilator settings are
appropriate for patient
Ventilation continues condition.

SBT High frequency The monitored Respiratory rate is too high as Check patient and ensure
compared with the SBT high rate alarm limit. that ventilator settings are
appropriate for patient
Ventilation continues, if the monitored Rate exceeds condition.
the SBT high frequency alarm limit for > 5 min, the
SBT mode will terminate and normal ventilation will
resume.
Note: This alarm can only occur when the SBT mode
is active.

SBT Low frequency The monitored Respiratory rate is too low as Check patient and ensure
compared with the SBT low rate alarm limit. that ventilator settings are
appropriate for patient
Ventilation continues, if the monitored Rate remains condition.
below the SBT low frequency alarm limit for > 5 min,
the SBT mode will terminate and normal ventilation
will resume.
Note: This alarm can only occur when the SBT mode
is active.

SBT High RSBI Monitored RSBI is too high as compared with the SBT Check patient and ensure
high RSBI alarm limit. that ventilator settings are
appropriate for patient
Ventilation continues, if the monitored RSBI value condition.
exceeds the High RSBI alarm limit for > 5 min, the
SBT mode will terminate and normal ventilation will
resume.
Note: This alarm can only occur when the SBT mode
is active.

SBT Low RSBI Monitored RSBI is too low as compared with the SBT Check patient and ensure
low RSBI alarm limit. that ventilator settings are
appropriate for patient
Ventilation continues, if the monitored RSBI value condition.
remains below the low RSBI alarm limit for > 5 min,
the SBT mode will terminate and normal ventilation
will resume.
Note: This alarm can only occur when the SBT mode
is active.

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Section 5 Ventilator Set Up and Operation

Table 21: Medium Priority Alarms, Descriptions and Correction Actions

Medium Priority Description / Cause / Ventilator Response Corrective Action


Alarms

High leak rate The monitored Leak % value is too high compared 1. Check patient and
with the set Leak% alarm limit. Possible circuit leak patient airway and
ensure ventilator
Ventilation continues settings are
appropriate for
patient condition.
2. Check circuit
connections.
3. Perform Circuit
Check.
4. Replace circuit.

High temperature The ventilators internal temperature is too high. Contact service
technician and provide
Ventilation continues alternative ventilation if
alarm continues.

Vti Limit Reached Delivered volume is being limited by Vti Limit alarm Check patient and ensure
settings. Inspiratory tidal volume exceeds Vti alarm that ventilator settings are
limit for 8 consecutive breaths VTV modes or 4 appropriate for patient
breaths all other modes except NCPAP+. condition.
Ventilation continues with delivered volume limited.

Target Volume Not Met Volume limited by Ppeak alarm limit (Ppeak High - 5 1. Check patient and
cmH2O) during VTV modes. ensure that ventilator
settings are
Ventilation continues, but volume limited appropriate for
patient condition.
Note: This alarm can only occur when a VTV mode
2. Check for circuit
(PRVC_CMV, PRBC–SIMV and VS) is active.
occlusions.

Pmean High The monitored mean airway pressure Pmean is too Check patient and ensure
high compared with the set Pmean high alarm limit. that ventilator settings are
appropriate for patient
Ventilation continues condition.

Pmean Low The monitored mean airway pressure Pmean is too 1. Check patient and
low compared with the set Pmean low alarm limit. ensure that ventilator
settings are
Possible leak or disconnect appropriate for
patient condition.
Ventilation continues
2. Check circuit
connections.
3. Perform Circuit
Check.
4. Replace circuit.

PT Effort Detected A patient effort or leak violated the Psens setting 1. Check circuit, airway
during a PVL Tool (p) or PVL Tool (v) slow inflation for leaks
maneuver. 2. Check patient and
ensure that ventilator
The maneuver will terminate and normal ventilation settings are
will resume. appropriate for
Note: This alarm can only occur when a PVL Tool (p) patient condition.
or PVL Tool (v) slow inflation maneuver is active. 3. Access patient LOC,
sedation etc…

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Section 5 Ventilator Set Up and Operation

Table 21: Medium Priority Alarms, Descriptions and Correction Actions

Medium Priority Description / Cause / Ventilator Response Corrective Action


Alarms

Ck. CO2 Sensor The CO2 sensor measurements are out of range 1. Verify correct airway
adapter installation.
Possible cause: Software Error, Hardware Error, 2. Perform CO2 sensor
Motor Error, Calibration lost, O2 sensor error calibration.
Ventilation continues 3. Replace CO2 sensor.

CO2 Sensor Accuracy? CO2 sensor hardware issue, out of calibration 1. Verify correct sensor
installation.
Possible cause: N20 outside range, O2 outside range, 2. Perform CO2 sensor
CO2 outside range, An agent is outside range, calibration.
Temperature outside range, Pressure outside range, 3. Replace CO2 sensor.
Agent unreliable
Ventilation continues

Ck.CO2 Adaptor The CO2 airway adapter is missing, occluded or 1. Verify correct airway
adapter installation.
installed incorrectly
2. Verify correct
Possible cause: Missing adapter, O2 port sampling line
failure/clogged installation.
Ventilation continues 3. Replace Adaptor

Ck. Sample Line The CO2 sample line is missing or not connected 1. Verify correct airway
adapter installation.
Ventilation continues 2. Verify correct
sampling line
installation.
3. Replace sample line

Replace CO2 Adaptor A problem has been detected with the CO2 airway Replace CO2 airway
adaptor. adaptor
Ventilation continues

Replace Sample Line A problem has been detected with the CO2 sample Replace Sample Line
line.
Ventilation continues

Zero CO2 Sensor CO2 sensor measurements are out of range or no Zero CO2 Sensor
reference
Ventilation continues

Valv High The monitored Val value is too high compared with Check patient and ensure
the set Val high alarm limit. that alarm limits and
ventilator settings are
Ventilation continues. appropriate for patient
Note: This alarm can only occur when the condition.
mainstream or sidestream CO2 sensor is in use.

Valv/min High The monitored Valv/min value is too high compared Check patient and ensure
with the set Valv/min high alarm limit. that alarm limits and
ventilator settings are
Ventilation continues. appropriate for patient
Note: This alarm can only occur when the condition.
mainstream or sidestream CO2 sensor is in use.

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Section 5 Ventilator Set Up and Operation

5.5.6.4. Information Message (Low) Priority Alarms


Table 22: Information Message Priority Alarms, Descriptions and Correction Actions

Information Message Description / Cause / Ventilator Response Corrective Action


Priority Alarms

Increase O2 not avail The 100% O2 function is not available. 1. Check oxygen supply
connections.
Possible causes: oxygen supply not available while 2. Check oxygen supply
100% O2 is being administered or, O2 calibration has pressure.
been started. 3. Retry oxygen sensor
Displays each time the user attempts to deliver 100% calibration.
O2 when 100% oxygen is not available. Oxygen
supply not available or oxygen sensor calibration in
progress.
Ventilation continues.

100%O2 cal. not avail Acquired calibration data is out of allowed range. 1. Check oxygen supply
connections.
Possible causes: oxygen supply empty, O2 cell faulty, 2. Check oxygen supply
Oxygen calibration not available, Oxygen calibration pressure.
interrupted.
3. Retry oxygen sensor
Ventilation continues and alarm displays each time calibration.
the user attempts O2

Battery not available The internal battery is not available. 1. Connect to AC power
and ensure that
Possible causes: Battery voltage completely depleted, battery recharges.
battery missing, battery not properly connected or 2. Check battery cable
faulty cable connections. connections.
Ventilation continues with AC Power if connected. 3. Replace battery.
W A R N I N G : If the “Battery not Available” alarm
message is displayed on the user interface during
use, check the battery status as soon as possible. If
no action is taken and AC mains power is lost, the
battery will not work and the vent will shutdown with
continuous high priority alarm (high pitch buzzer).

Battery in Use The ventilator is operating on battery. This message Ensure the AC power is
cannot be cleared. connected.
and
In addition, an audible alert tone will sound when AC
Audible Tone Alert power is disconnected, and the battery meter Icon will
be displayed in the upper right corner of all user
screens.
Once AC is reconnected, the audible tone will sound
again and the “AC connected” message is logged.

Flow cal. not available The flow sensor cannot be calibrated because it has Turn flow sensor On and
disabled (turned Off). Flow calibration interrupted. retry flow sensor
calibration.
Displays each time at flow sensor calibration if Flow
sensor is Off
Ventilation continues with pressure trigger

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Section 5 Ventilator Set Up and Operation

Table 22: Information Message Priority Alarms, Descriptions and Correction Actions

Information Message Description / Cause / Ventilator Response Corrective Action


Priority Alarms

Flow trigger not avail Flow trigger is not available. 1. Check flow sensor
connections.
Flow sensor attached incorrectly and requires 2. Retry flow sensor
calibration, or the ventilator is running on internal calibration.
compressor (pediatric or adult patient types).
3. Replace flow sensor.
Ventilation continues with pressure triggering and
Exhaled volume measurement switches to Inspired
volumes.

Gas connected; Heliox? Appears at startup and during ventilation when Heliox Verify that Heliox
gas type is selected. selection is appropriate
for patient.
Displays when the Gas Type Heliox has been
selected. Prompts user to make sure that Heliox has
been connected. Indicates the Flow correction for
Heliox is activated.
Ventilation continues

Inverse ratio set Ventilation settings have been set to an inverse ratio Verify that the setting
(Exhalation time < Inhalation time). change and inverse ratio
are appropriate for patient
Displays upon occurrence when the setting of condition.
parameters that determine rate and inspiratory time
has resulted in an inverse ratio condition.
Ventilation continues

Logbook cleared Displays each time at New patient startup, indicating Not applicable.
the log book has been cleared.

O2 sensor not avail The internal Oxygen sensor is disconnected or 1. Check to make sure
depleted. the O2 sensor cable
is connected and
Displays each time at patient startup, if the O2 sensor undamaged.
is depleted or disconnected. 2. Replace O2 sensor
Ventilation Continues.

Nebulizer not avail The Nebulizer is not available Utilize alternate nebulizer
source or change settings
Possible cause: Nebulizer is disabled or Neonate / and or patient type if
Infant patient type selected or inspiratory flow is less appropriate.
than 10 l/min.
Displays each time nebulizer activation is attempted
when Smart Nebulizer disabled or not available based
on settings or patient type selected.
Ventilation continues without nebulization.

SBT Active Displays when the SBT mode has been activated and Not applicable.
will display until maneuver completes or is terminated.

SBT Canceled Displays when the SBT mode has been manually Not applicable.
terminated or if an SBT mode termination criteria has
been violated.
Normal ventilation will resume

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Table 22: Information Message Priority Alarms, Descriptions and Correction Actions

Information Message Description / Cause / Ventilator Response Corrective Action


Priority Alarms

SBT Off Displays when the SBT mode has completed Not applicable.
successfully.
Normal ventilation will resume

Suction Displays when the Suction maneuver has been Not applicable.
activated and continues to display while the Suction
maneuver is active until the Suction Maneuvers Post
Oxygenation phase begins.
Ventilation continues

Maneuver Active Displays when a recruitment maneuver (Step Tool, Not applicable.
PVL Tool (p) or PVL Tool (v)) has been activated and
will display until maneuver terminates.

No CO2 Sensor There is no signal from the CO2 sensor. This message 1. Verify CO2 adaptor
is not shown if the CO2 monitoring feature is disabled. connection.
Depending on the specific reason for the loss of signal 2. Connect and or
between the ventilator and the CO2 sensor, other replace CO2 adaptor.
related alarms may also be triggered.
Displays anytime the ventilator loses
signal/communication with an IRMA or ISA sensor.

Mem CPU not protected EEPROM on the Motherboard is not write protected. Contact service.
Displays each time at patient startup if the jumper on
EEPROM on the controller board is set to remove
write protection.
Ventilation Continues

Mem power no protect EEPROM on the Power board is not write protected. Contact service.
Displays each time at patient startup if the jumper on
EEPROM on the power board is set to remove write
protection.
Ventilation Continues.

Mem sensor no protect EEPROM on the Sensor board is not write protected. Contact service.
Displays each time at patient startup if the jumper on
EEPROM on the sensor board is set to remove write
protection.
Ventilation Continues

5.5.7. Technical Failure Alarms


Technical fault error codes signify that a significant technical error has been detected.
Technical Fault error codes appear on the screen as TF xxx alarm. The ventilator is placed
in a standby condition with safety valve open and a continuous alarm sounding. Remove the
ventilator from service and contact a qualified service technician if a TF alarm occurs. Only
qualified personnel should attempt to service or make authorized modifications to Inspiration
ventilators.
o For additional information on Technical Faults and the specific TF-x codes, see the
Inspiration 5i Service Manual.

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5.5.8. Clearing Inactive (Latched) Alarms


o Clearing Latched Alarms
 Once an active alarm is resolved, it will stop flashing and will remain displayed
(latch) on the alarm bar.
 Each latched alarm can be cleared by touching the latched alarm on the alarm bar.
Once touched, the latched alarm will disappear from the alarm bar and the next
latched alarm (if any) will be displayed.
 Only inactive (latched) alarms can be cleared. Pressing an active alarm on the
alarm bar will not clear the active alarm.
o Batch Clearing of All Latched Alarms
 To clear all inactive (latched) alarms at one time, press and hold any latched
(inactive) alarm for 2 seconds and all latched alarms will be removed from the
alarm bar.
 Active alarms will not be affected and will continue to display on the alarm bar.

5.5.9. Event Log


Under the Alarms Tab, select Event Log. The Event log displays list of the last one thousand
(1,000) events. Events are logged in the order of occurrence by ID (ID = Number) and each
event is time and Date stamped and the following information is captured for each event.
o ID = Number assigned to event based on order of occurrence (e.g., 1,2,3)
o Time = The Time the event occurred
o Date = The Date event occurred
o Type = The Event type (e.g., Setting, Alarm, Event)
o Event = Event classification based on Type (e.g., Tube Comp, Suction, SBT Active)
o Set = A value specific to Event based on Type (e.g., On, Off, number value)
o Monitor = The monitored value for an alarm event or a Disconnection B criteria.

5.5.9.1. Filtering the Event Log


The Event Log can be filtered to present events by:

 ID To view all Events in the order of occurrence


 Type To view specific event types (i.e., Setting changes or Alarm events) all together
 Event to view specific events (i.e., High-pressure alarm or PEEP setting, P0.1 values) all
together

5.5.9.2. Scrolling the Logs


 Using Rotatory Knob Touch an event to scroll more precisely with the rotary Knob
and see more details about the settings
 Using Scroll Bar Touch the scroll bar on the right to jump quickly thought the
events. See Figure below.

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Figure 66: Clinical Configuration Settings and Options

5.6. Configuration Tab


As shown below in Figure 67, when the Config tab is selected, the Clinical page will be displayed
by default. Users can select the other the other Configuration Settings pages (Defaults, Audio /
Visual or Technical) from the Left panel. The setting and feature options for the selected
Configuration Settings page will display in Right panel as shown below in Figure 67, Figure 68,
Figure 69 and Figure 72.

5.6.1. Clinical Page: Configuration Settings and Options


See Table 23 below for all Clinical Configuration-screen Settings.

Figure 67: Clinical Configuration Settings and Options

Table 23: Clinical Configuration-screen Settings


Setting Value Description
Humidification HME, Humidifier, None Allows the user to change the selected humidification type during

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Table 23: Clinical Configuration-screen Settings


Setting Value Description
Type ventilation or Standby.
Select HME when using a heat-moisture exchanger
between the circuit Wye and patient.
Select Humidifier when using any type of heated humidifier
with or without a heated circuit.
Select None during device testing with a test lung and non-
humidified circuit.
Ventilator software uses the selected humidification type to
define the BTPS or HME humidification correction factor for
accurate volume delivery during volume ventilation and accurate
volume monitoring is all modes except NCPAP+.
Gas Type Air or Heliox Allows the user to define the high-pressure gas source (Air or
Heliox) that will be used in conjunction with oxygen during
ventilation or Standby.
Selecting Heliox assumes a helium/oxygen mixture of
80/20 as the Heliox gas source.
For Neonate patient type, Heliox delivery is disabled and
the Gas Type selection option will not be displayed.
See section 2.9 for Heliox setup and use with the Inspiration
5i ventilator.
Flow Sensor On or Off Allows the user to disable or re-enable the flow sensor during
ventilation or Standby. By default, the flow sensor is always
enabled (set to on) for New Patient Startup. For Previous Patient
Startup, the previous flow sensor On/Off setting is maintained.
When the flow sensor disabled (turned Off), the trigger type
will switch to pressure and flow triggering will be disabled.
When the flow sensor is re-enabled (turned On) the
previous selected trigger type and trigger level will also be
re-enabled.
When the flow sensor disabled (turned Off), exhaled
volume and flow monitoring is not possible and all exhaled
volume monitors will switch to inspiratory volumes.
If the flow sensor is disabled (set to Off) on the New or
Previous patient startup screen, the Flow Sensor
On/Off control will not be displayed on the Config
screens Clinical page.
The Flow Sensor will need to be enabled (set to On)
from the New or Previous patient startup screen for the
Flow Sensor On/Off control to be displayed on the
Config screens Clinical page.
O2 Sensor On or Off Allows the user to disable or re-enable the oxygen sensor during
ventilation or Standby.
When the oxygen sensor is disabled, the O2 monitor value
will display as ----- and the status bar at the top of the user
interface will display an “O2 Sensor Off” indicator.
The Inspiration 5i ventilator’s oxygen sensor can be safely
changed during patient ventilation and is located in the
back of the device to the right of the internal batteries.
IBW 0.3 to 200 kg The IBW setting can be changed during ventilation or Standby at
any time.
Adult: 41 to 200 kg
The IBW setting range on the Clinical page is limited by
Pedi: 9.7 to 40 kg patient type and cannot be set above or below the IBW
Neonate: 0.3 to 9.6 kg setting range specific to the current patient type.

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Table 23: Clinical Configuration-screen Settings


Setting Value Description
Nebulizer On or Off Additional Nebulizer Settings
Nebulizer: On or Off
Nebulizer Time: 1 to 480 min (increments of 1 min)
Interval: On or Off
Interval Time: 1 to 480 min (increments of 1 min)
For detailed information on Smart Nebulizer functionality, see
section 5.6.1.1 below.
Sigh On or Off Additional Sigh Settings
Sigh: On or Off
Sigh Factor: 0 to 50 % above PC, PS or Vt setting
Sigh Interval: 20 to 200 breaths
Sigh Number: 1 to 6 times
Sigh Factor sets the % increase above the current volume or
pressure setting to be delivered when sigh is active.
Sigh interval set the number of non-sigh breaths to be delivered
between sigh breaths.
Sigh number sets the number of sigh breaths that will be
delivered.
For detailed information on Smart Sigh functionality, see section
5.6.1.2 below.

5.6.1.1. Smart Nebulizer Functional Details


See section 2.12.5 Nebulizer Use and Placement
5.6.1.2. Smart Sigh Functional Details
The Inspiration ventilators include a sigh feature that allows sigh breaths to be delivered
at a user-defined frequency (every 20 to 200 breaths), number (1 to 6 sighs) and breath
amplitude (percentage 0 to 50% above volume or pressure setting).
 As defined above in Table 23, the sigh feature is activated from the Config. screen’s
Clinical page.
o To activate the sigh feature, set the Sigh On/Off control to On. When the If Sigh
On / Off control is set to On, all Smart Sigh setting options become visible,
selectable and settable.
 Adjust the Sigh Factor control to the desired %. The Sigh Factor defines
the pressure or volume percentage increase above (Pcontrol, Psupport and
Vt) to be applied to the sigh breath / breaths being delivered. (0 to 50%)
 Adjust the Sigh Interval control to the desired number. The Sigh Interval
control establishes the number of normal ventilation breaths that will be
delivered before the next Sigh becomes active. (20 to 200 breaths)
 Adjust the Sigh Number control to the desired setting. The Sigh Number
control defines the number of Sigh breaths that will be delivered each time
Sigh becomes active.

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 Smart Sigh is enabled in and may be activated during V–CMV, V–SIMV, P–CMV, P–
SIMV and PS modes only.
 Smart Sigh is disabled in SBT, SPAP, PRVC–CMV, PRVC–SIMV, VS and NCPAP+
modes.
o If Smart Sigh is set to On and the user activates SPAP, PRVC-CMV, PRVC-
SIMV, VS or NCPAP+ as the ventilator mode, Smart Sigh will be automatically
turn Off and disabled and the Smart Sigh settings will disappear from the Config
screen’s Clinical page.
 Smart Sigh is disabled when the SBT mode or Recruitment Maneuver Tools (PVL
Tool (p), PVL Tool (V) and Step Tool) are active.
o If Smart Sigh is set to On and the user activates the SBT mode or one of the
Recruitment Maneuver Tools, Smart Sigh will be automatically turn Off and
disabled and the Smart Sigh settings will disappear from the Config screen’s
Clinical page. Once the SBT mode or Recruitment Maneuver Tool is no longer
active, Smart Sigh will have to be restarted by the user.
 Alarm Adjustment During Sigh
o When the Sigh breaths are delivered, High-pressure alarms are background
increased by the Sigh Factor % in all pressure-based ventilation modes.
o When the Sigh breaths are delivered, High tidal volume alarms are increased by
the Sigh Factor % in all volume-based ventilation modes.

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5.6.2. Audio / Visual Page: Configuration Setting Options


See Table 24 below for all Graphic Configuration-screen Settings.

Figure 68: Graphic Configuration Options

Table 24: Graphic Configuration-screen Settings


Setting Value Description
Monitors Number of Display Allows the user to define the number of numeric monitor
Settings 8 or 12 numeric displays.
monitors

LCD 20 – 100% Allows the user to set the brightness of screen.


Brightness

Light On /Off If turned On, the graphic user interface will switch to light
Background colors.

Audio Level 35 – 100% Allows the user to set the audio level.

Screen Clicks On /Off Allows the user to set the click sound of the touch screen
panel On/Off.

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5.6.3. Defaults Page: User Defined Custom Default Profiles

Figure 69: Custom Default Settings – User Defined

At Startup, for New Patients, the Default settings used during the last ventilation will
automatically load as the Default settings for New and Previous Patients. If no user defined
default setting profile has been saved and selected, the ventilators factory default settings
(eVent Defaults) will be used.
User can define four (4) different global default setting configuration profiles and will be able
to save and or select / load a default setting profile at startup or during Standby.
While the eVent Defaults button is selected, the four Custom Defaults profile folders will
display as transparent “Data” or “No Data” folders to allow users to visualize the custom
default profile selection options. When the Custom Defaults button is selected, the Custom
Defaults profile folders will display as shown above in Figure 69.
o Custom Defaults allow users to configure the ventilators mode, apnea backup mode,
main graph display, monitors, trend graphs display and various other non-IBW related
setting / features and then save that specific configuration as a user defined custom
default profile.
o As shown above in Figure 69, a Custom Defaults profile folder will display
 Blue when selected
 As a tan “Data Folder” with the appearance of paper inside when a profile has
been assigned and saved to that folder. Data folders will also display the date and
time associated with the last time that Custom Default profile was updated and
saved.
 As a Tan “No Data Folder” (no paper inside) when no profile has been assigned
to that folder.
 Transparent when “eVent Defaults” is selected.

No Data Transparent Saved Data Transparent Saved Data Profile Selected Profile
No Data Profile Folder
Profile Folder Profile Folder Folder Folder

Figure 70, Custom Default Profile Folders

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5.6.3.1. Selecting / Activating a Custom Default Setting


As stated above, until changed by the user, eVent Defaults will load at New Patient
startup. To change the ventilator’s default settings to a custom default profile, press the
Custom Defaults button and follow the on-screen instructions.
As shown above in Figure 69, once the Custom Defaults button is pressed the right panel
updates to display the four custom default profile folders.
 Select the desired Custom Default Profile.
o Once selected, the Rename and Save Settings button as well as the green
ACCEPT button will appear.
 To change the selected profiles name press the Rename button. The
Keyboard screen will load to allow the profile name to be entered. Once
the new profile name has been entered, press the green ACCEPT button
to save the change and close the Keyboard screen.
 To save the current configuration as the selected custom default profile,
press the Save Settings button. See section 5.6.3.2 for additional
information regarding creating and saving a Custom Default setting profile.
 Press the green ACCEPT button
For safety, during ventilation, the currently loaded Defaults profile will
remain active and any Defaults profile selected and ACCEPTED during
ventilation will only be loaded at the next New patient startup.

o To load the selected Custom Default profile, press the green ACCEPT button.
 The selected Custom Default profile will automatically load if selected and
ACCEPTED while the ventilator is in Standby.
 The selected Custom Default profile will load at New Patient startup if
selected and ACCEPTED during ventilation.
 Once the green ACCEPT button is pressed, it will change to the blue
ACCEPTED button indicating the selected profile is currently loaded.

Figure 71: Selecting Custom Default Settings

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5.6.3.2. Creating and Saving a Custom Default Setting Profile


Each of the four Custom Default profiles can be updated and saved while the device is in
Standby or during ventilation.

The customization of certain features like, the display position of


waveforms, loops and trends and the default startup mode type and mode
selection, require ventilation to be active. Once ventilation is active, these
features can be adjusted as desired and saved to a custom default profile.

 Creating a User Defined Custom Default Profile


o To create a user defined custom default profile, it is recommended to perform
the following steps during ventilation on a test lung. However, many of these
steps can be completed during patient ventilation or during Standby.
 Select the desired default Mode Type and Mode Selection, adjust settings
and activate ventilation.
 Select the desired default Apnea Backup Mode Type and Apnea Backup
Mode, adjust settings and press the green ACCEPT button to accept the
Apnea Backup settings.
 Select the Config tab. From the Clinical Configuration Settings right panel,
 Select the desired Humidification Type
 Select and adjust to the desired Nebulizer Time to be used when the
Smart Nebulizer is turned On. The user can only turn On the Nebulizer
manually.
 Turn Nebulizer Interval to On and then select and adjust to the desired
Interval Time to be used when the Nebulizer Interval feature is turned
On. The user can only turn on the Nebulizer Interval feature manually.
 Turn Smart Sigh to On and select and adjust to the desired Sigh Factor,
Sigh Interval and Sigh Num. settings to be used when Smart Sigh is
turned on. The user can only turn On the Smart Sigh feature manually.
 From the Config tab press the Graphic button. From the Graphic
Configuration Settings right panel,
 Under Graph Settings, select either Waveforms or Loops and the
desired Number of Display to be displayed on the Main screen.
 Under Trend Data, select the desired number of Trend graphs to be
displayed on the Trend Data screen.
 Under Monitors, select the desired number of monitored parameters to
be displayed in the Monitoring Bar.
 From the Config tab press the Technical button. From the Technical
Configuration Settings right panel,
 Select and adjust LCD Brightness, Audio Level, Screen Clicks, Color
Panels, Patient Height (units) and Keyboard to the desired setting.

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 Select the Main tab.


 From the Main screen Right display panel, select the desired graphs to
be displayed in each graph window by pressing the blue button in the
upper right corner of each graph window.
 From the Main screen Left display panel, press the blue button in the
upper right corner until the maneuvers panel is displayed. Press the
P0.1/PiMax button and adjust the PiMax Time to the desired value.
 From the Main screen Left display panel, press the blue button to
define the default left panel to be displayed on the Main screen.
 Assign the desired Monitored parameters to be displayed on the Monitoring
Bar.
 For each Monitor displayed on the Monitoring Bar, press the Monitor
and then select the desired Monitored parameter to be displayed in that
position on the Monitoring Bar.
 Select the Monitoring tab, press the Trend Data button. From the Trend
Data screens Right panel
 Select the desired Trend graphs to be displayed in each trend graph
window by pressing the blue button in the upper right corner of each
graph window. Once configured as desired, press the <<BACK from
the Trend Data Left panel.
 From the Monitoring tab, press the Loop Study button to load the Loop Data
screen.
 From the Loop Data Left panel, enable or disable the Reference Loop
feature. Select “Ref. Loop On” to enable the Reference Loop feature
or “Ref. Loop Off” to disable the Reference Loop feature.
 From the Loop Data Right panel, select the desired Loop graphs to be
displayed in each Loop graph window by pressing the blue button in
the upper right corner of each graph window. Options include P/F, F/V
and P/F loops.
 Saving and Renaming the User Defined Custom Default Profile
o To save the current ventilator configuration as a Custom Default Profile, navigate
to the Config tab and press the Defaults button on the Configuration Settings
Left panel to load the Custom Default Settings Right panel.
 On the Custom Default Settings Right panel, press the Custom Defaults
button and select the desired Custom Default Profile to Update.
 Once a Custom Default Profile has been selected, press the Save Settings
button. This saves the current ventilator configuration as the user defined
profile associated with that Custom Default Profile.
o To rename a Custom Default Profile, select the desired Custom Default Profile
to rename.
 Once a Custom Default Profile has been selected, press the Rename
button. The Keyboard screen will load to allow a new profile name to be
entered. Once the new profile name has been entered, press the green
ACCEPT button to save the name change and close the Keyboard screen.

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5.6.3.3. Configurable Default Settings – (What is Saved and Not


Saved)
As defined below, there are specific features, settings, configuration and display options
that are saved with and can be assigned to a Custom Default profile. See Table 25 below
for a detailed list of the Custom Default Settings Rules regarding what is Saved and Not
Saved.

Most setting that are not associated with / based on IBW can be saved /
assigned to a user defined Custom Default Profile. Certain features like
Tube compensation, Smart Nebulizer, Smart Sigh etc… will not be saved
as these features must be enabled by the user.

Table 25: Custom Default Settings Rules (What is Saved and Not Saved)
Settings and Configuration Options Settings and Configuration Options
That WILL Be Saved That Will NOT Be Saved
to a Custom Default profile to a Custom Default profile

Monitoring Bar Parameters Patient Startup

Patient Type, Patient Height, Gender, IBW,


Selected parameters and their display order
Patient ID and Room/Bed ID

Main Screen Graphics Main Screen Graphics

Left Panel selection (F/V, P/V, P/F or Man.) Maximize/Minimize Graph Display
Right panel Graph types and display order Graphics Scale

Maneuvers Maneuvers

Recruitment Tool Type (PV Tool (p),


PiMax Time setting
PV Tool (v) and Step Tool) settings

Ventilation Mode Mode Settings

All mode settings


Mode Type and Mode Selection
(except Mode Type and Mode Selection)

Auto Control Auto Control

Spont Mode type selection (PS or VS) On or Off

Apnea Backup Apnea Backup

Apnea Backup Mode Type and Apnea Backup All Apnea Backup mode settings (except
Mode Apnea Mode Type and Apnea Backup Mode)

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Table 25: Custom Default Settings Rules (What is Saved and Not Saved)
Settings and Configuration Options Settings and Configuration Options
That WILL Be Saved That Will NOT Be Saved
to a Custom Default profile to a Custom Default profile

Trend Data Trend Data

Maximize/Minimize Graph Display and


Selected Trends and their display order
Graph scale

Loop Study Loop Study

Left Panel Reference Loop On/Off Maximize/Minimize Graph Display


Selected Loop types and their display order Graph scale

Humidification Type Alarm Settings

Humidification Type selection at Startup or from


the Config screens Clinical page.
Event Log: Display / filter configuration

Configuration Settings: Clinical Configuration Settings: Clinical


Humidification Type Gas Type and Flow Sensor On/Off
Nebulizer Time and Nebulizer Interval Time Nebulizer and Nebulizer Interval On/Off
Sigh Factor, Sigh Every and Sigh Number Sigh On/Off

Configuration Settings: Graphic Configuration Settings: Defaults


Monitors Number of Display Custom Default Settings
Graph Settings Each of the four user defined Custom
Default profiles are managed separately by
Graphic Selection Waveforms or Loops system software as defined throughout this
Graphs Number of Display section.

Trend Data Setting Number of Display

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Table 25: Custom Default Settings Rules (What is Saved and Not Saved)
Settings and Configuration Options Settings and Configuration Options
That WILL Be Saved That Will NOT Be Saved
to a Custom Default profile to a Custom Default profile

Configuration Settings: Technical Password Protected Technical Settings

LCD Brightness 100 to 20 % System Information (SW and HW Versions)


Audio Level 100 to 35 % Language Settings
Screen Clicks On or Off Date and Time Settings
Color Panels On or Off User Configuration Settings
Password Protected Engineering / Service
Patient Height (units) cm or in Screens
Standard or All engineering/service configuration settings
Keyboard
Generic Alpha and options

5.6.4. Technical Page: Configuration Setting Options

Figure 72: Technical Configuration Settings and Options

Table 26: Technical Configuration-screen Settings and Options


Setting Value Description
Keyboard Standard or Standard: The standard option displays the typical QWERTY type
Generic Alpha keyboard.
Generic Alpha: The Generic Alpha option displays a keyboard with
character layout in the traditional US alphabet.
Licensed The Licensed Options section for easy visualization of:
Options The Smart Board Serial Number
Which Licensed software options are installed
Password Alpha Numeric To view or adjust the additional Technical Settings enter the access code
is 2634 and press OK or CANCEL to return to previous screen. See the
Inspiration 5i Service Manual for additional information.

5.6.5. Technical Page: User Configuration-screen


To make modification in the User Configuration-screen, go to Config / Technical and use the
password 2634. This section is intended to explain the Philosophy concept and selection of the
Feature Configuration (existing installed features on the ventilator only). See table Table 27: User

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Configuraiton-screen. For other options available in the User Configuration-screen, please consult
the service manual.

Table 27: User Configuraiton-screen


Setting Value Description
Philosophy European Set European Philosophy to configure the ventilator for the user to set
I:E ratio instead Ti for PCV and Flow for VCV.
or
Set US Philosophy to configure the ventilator for the user to set Ti for
US PCV and Flow for VCV instead I:E ratio for both.
Compressor On/Off Enable or disable the internal backup compressor.
Backup
Altitude Meters or To set the altitude above sea level. That will be set in meters (European
settings Feet Philosophy) or in Feet (US Philosophy).

Feature Check Box The intended use for this page is for the end user or institution to
Configuration Selection enable or disable existing installed features that are not commonly used
or it is not of interest to be used by the institution.
CliniNet CliniNet Configuration 1: set network parameters.
CliniNet Configuration 2: assign identification name for device,
ventilator, patient and room/bed.

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5.7. Monitoring
5.7.1. Monitor Bar

The Monitor Bar shows breath-by-breath measured or estimated parameters. To customize the
parameters, select the any monitored parameter and the Data tab will locate the same parameter
to display the monitoring related panels, Basic, Advanced, Mechanics and EtCO2 (optional) if
connected.
 Customizing Monitor Bar: As example shown in Figure 73: Selecting a Monitoring
Parameter, when a parameter (PEEP) is selected from the Monitor Bar, the same parameter
is shown on the Data tab. Touch in a different parameter among the different Data tabs
(Basic, Advanced, Mechanics and EtCO2) to be replaced and displayed on the Monitor Bar.
Dashes next to a parameter indicate that either the monitored parameter is not applicable
or the measured criteria have not been met for a valid measurement.

Figure 73: Selecting a Monitoring Parameter

5.7.2. Numeric Monitored Data


Select the Data tab to display the monitoring related panels, Basic, Advanced, Mechanics and
EtCO2 (optional) if connected.
 Each tab displays breath-by-breath monitored data. Dashes next to a parameter indicate
that either the monitored parameter is not applicable, or the measured criteria have not
been met for a valid measurement.

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5.7.2.1. Monitored Data: Basic

Figure 74: Monitored Data – Basic

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Table 28: Monitored Date – Basic


Monitored Data
Parameter Definition
Ranges
Ppeak Measured Peak inspiratory pressure during a breath 0 to 120 cmH2O
Peak inspiratory airway pressure. The highest pressure during the
previous breath cycle. It is influenced by airway resistance and
compliance. It may be higher than expected due to the Inspiration
ventilator’s breathing circuit compliance compensation or if enabled
Tube Compensation.
Ptrach Calculated peak tracheal pressure during a breath -50 to 120 cmH2O
A Ptrach value is only displayed when tube compensation (TC) is
enabled (turned ON).
The Ptrach value displays as ----- when TC is disabled (turned
OFF)
Pmean Measured mean airway pressure averaged over the breath cycle. 0 to 120 cmH2O
The Pmean value is the moving average over the last 3 breaths.
PEEP Measured peak end exhalation pressure 0 to 120 cmH2O

Pmin Calculated peak end expiratory tracheal pressure during a breath -50 to 120 cmH2O
A Pmin value is only displayed when TC is enabled (turned ON).
The Pmin value displays as ----- when TC is disabled (turned OFF)
When Tube Compensation is active, Pmin may be lower than the
PEEP.
Vti Measured Inspiratory tidal volume 0 to 5000 ml
Vti is measured at the inspiratory valve and corrected for humidity
and compliance compensation and nebulizer delivery during all
modes and breath types except NCPAP+.
Vti/kg Measured Inspiratory tidal volume normalized to the set ideal body 0.0 to 50.0 ml/kg
weight
Vte Measured Exhaled tidal volume 0 to 5000 ml
Vte is measured at the expiratory flow sensor and corrected for
humidification compensation during all modes and breath types
except NCPAP+.
Vte/kg Measured Expiratory tidal volume normalized to the set ideal body 0.0 to 50.0 ml/kg
weight
Ve Exhaled minute volume 0.00 to 50.0 l/min
Ve is derived from Vte and is the moving average of the monitored
expiratory volume per minute, over the last 3 breaths.
Vi Inspired minute volume 0.00 to 50.0 l/min
Vi is derived from Vti and is only displayed if the proximal flow
sensor is disabled for any reason.
Vi is the moving average of the monitored inspiratory volume per
minute, over the last 3 breaths.
Ve/kg Measured Expiratory minute volume normalized to the set ideal 0.0 to 999 ml/kg
body weight
Ve Spont Spontaneous Expiratory minute volume 0.00 to 50.0 l/min
Ve Spont is the moving average of the monitored spontaneous
expiratory volume per minute, over the last 3 breaths.

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Table 28: Monitored Date – Basic


Monitored Data
Parameter Definition
Ranges
Vi Spont Spontaneous Inspiratory minute volume 0.00 to 50.0 l/min
Vi Spont is only displayed if the proximal flow sensor is disabled for
any reason.
Vi Spont is the moving average of the monitored spontaneous
inspiratory volume per minute, over the last 3 breaths.
Rate Total respiratory rate or breathing frequency 0 to 300 b/min
Rate is a moving average including both mandatory and
spontaneous breaths. When the patient triggers or the user
initiates a breath, Rate will update and thus may be higher than the
set Rate.
Rate Spont Spontaneous respiratory or breath frequency. 0 to 300 b/min
Rate Spont is a moving average of spontaneous breaths per
minute.

5.7.2.2. Monitored Data: Weaning

Figure 75: Monitored Data – Weaning

 Select the Weaning tab in the Right panel to view the following monitored
parameters.

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Table 29: Monitored Data – Weaning


Monitored Data
Parameter Definition
Ranges
Ti Inspiratory time 0.10 to 99.9 sec
In mandatory breaths, TI is measured from the start of breath
delivery until the set time has elapsed for the switch over to
exhalation. In spontaneous breaths, TI is measured from the start
of pressurization after a patient trigger until the flow falls to the
Esens setting, for the switch over (cycle) to exhalation. TI may
differ from the set inspiratory time if the patient is breathing
spontaneously.
Te Expiratory time 0.10 to 99.9 sec
In mandatory breaths, TE is measured from the start of exhalation
until the start of inspiration with the next breath. In spontaneous
breaths, TE is measured from the start of exhalation, as dictated by
the Esens setting, until the patient triggers the next inspiration. TE
may differ from the calculated expiratory time if the patient breathes
spontaneously.
PF Peak inspiratory flow 0.0 to 300 l/min
Peak flow is measured during spontaneous and mandatory breaths
PFe Peak expiratory flow 0.0 to 300 l/min
Peak expiratory flow is measured during spontaneous and
mandatory breaths
I:E Inspiratory : Expiratory ratio 1 : 99.0 to 99.0 : 1
Ratio of the patient’s inspiratory time to expiratory time. This
includes both mandatory and spontaneous breaths. I:E may differ
from the set I:E ratio if the patient breathes spontaneously.
H:L High : Low ratio 1 : 599 to 299 : 1
H:L Ratio is displayed during SPAP mode only and is the ratio of
the time at high PEEP (Phigh) to the time at low PEEP (Plow). H:L
may differ slightly from the set H:L ratio if a spontaneous breath is
delivered just prior to the start or end of a Phigh or Plow phase.
Ti/Ttot Calculated Inspiratory Time divided by total cycle time 1 to 99.9%
Respiratory Time Fraction indicates endurance. As the respiratory
muscles fatigue, the fraction of the breathing cycle spent in
inspiration tends to increase. When there is respiratory muscle
fatigue and impending respiratory failure the ratio between
inspiratory time and total time available for the breath may
incrementally increase to a point in which the respiratory pump can
no longer maintain itself and then may decrease dramatically.
Excessive work of breathing is the common cause of an elevated
Ti/Ttot.
Leak Leakage percent 20 to 100%
The percentage of the inspiratory tidal volume (Vti) measured at
the inspiratory port that is not returned during exhalation. It is
calculated using the delivered Vti and the measured Vte at the
expiratory Flow Sensor breath-to-breath. Leak values > 20% is
displayed and may indicates leak on the patient side of the Flow
Sensor (endotracheal tube, chest tube). Leaks in the circuit can
affect delivered tidal volume and may result in a lower Vte
compared to Vti and an elevated leak value.
Measured Leak is derived from (1 - Vte/Vti) displayed as a percent.

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Table 29: Monitored Data – Weaning


Monitored Data
Parameter Definition
Ranges
O2 Oxygen concentration of the delivered gas 15 to 103 %
It is measured by the oxygen cell (sensor) in the inspiratory
pneumatics. This parameter is not displayed if the oxygen supply
is disconnected, the oxygen cell is not installed or is defective, or if
the oxygen sensor is disabled.
HeO2 Heliox concentration (Helium oxygen) percentage delivered to the 0 to 79 %
circuit.
HeO2 only displays when Heliox is enabled and a Heliox gas source
is connected.
Spont %1h Percentage of spontaneous breaths for the last 1 hour 0 to 100 %
Spont %1h only displays a measured value when Auto Control is enabled

Spont %8h Percentage of spontaneous breaths for the last 8 hours 0 to 100 %
Spont %8h only displays a measured value when Auto Control is enabled

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5.7.2.3. Monitored Data: Mechanics

Figure 76: Monitored Data – Mechanics

 Select the Mechanics tab in the Right panel to view the following monitored
parameters.
Table 30: Monitored Data – Mechanics
Monitored Data
Parameter Definition
Ranges
Auto PEEP The difference between the measured and set PEEP. Auto PEEP 0 to 100 cmH2O
is the abnormal pressure generated by air "trapped" in the alveoli
due to inadequate lung emptying when insufficient expiratory time
is available between breaths to reestablish resting equilibrium.
This residual alveolar pressure remains at the end of exhalation
which is may undetected by the ventilator’s circuitry.
Ideally, Auto PEEP should be zero. When Auto PEEP is present,
volutrauma or barotrauma may develop. In active patients, Auto
PEEP may impose an extra workload to the patient. To obtain an
accurate Auto PEEP measurement, perform an expiratory hold by
pressing the Exp. Hold button located on the on the Main screens
Maneuvers left panel.
Auto PEEP or air trapping may result from an expiratory phase that
is too short, which may be observed under these conditions:
 The delivered tidal volume is too large
 The expiratory time is too short or the respiratory rate too high
 The circuit impedance is too high or
 There is an expiratory airway obstruction or dynamic airway
collapse
 The peak expiratory flow is too low

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Table 30: Monitored Data – Mechanics


Monitored Data
Parameter Definition
Ranges
Pplateau Plateau or end-inspiratory pressure. The pressure measured at the 0 to 120 cmH2O
end of inspiration when flow is or is close to zero.
Pplateau is displayed under these conditions:
 In volume modes when the set Pause is greater than zero.
 In non-volume modes when and inspiratory hold is performed.
RSBI Rapid shallow breathing index (RSBI) is the total breathing 0 to 3000 b/min/l
frequency (Rate) divided by the inspired tidal volume (Vti) and is
calculated with spontaneous breaths only. It has significance for
spontaneously breathing patients only. Because a patient with
dyspnea typically takes faster, shallower breaths than a non-
dyspneic patient, RSBI will be higher with dyspneic patients and
lower with non-dyspneic patients. RSBI is typically and frequently
used clinically as an indicator to judge whether a ventilated patient
is ready for weaning. RSBI is disabled for neonate patients.
C20/C Overdistention index is the ratio of the dynamic compliance during 0.00 to 5.00
the last 20% of Inspiration (C20) to the total dynamic compliance
(C)
C20/C Calculation
The slope of a line drawn between 2 points of zero flow (the start
and the end of inspiration in this case) is compared to the slope of
a line drawn during the last 20% of inspiration. If the C20 is less
than the Cdyn, the ratio between them is <1.0 indicating over-
distension. A ratio of greater than 1.0 indicates that the PV loop
can’t be used to assess over-distension. This happens during PC
ventilation when the ventilator maintains a constant inspiratory
pressure.
 C20/C = C20 divided by Cdyn
 C20 = (VT - V1) / (Pmax - P1)
 Cdyn = VT / Pmax
 VT = V1 + V2
 V1 = Vol del at P1
 V2 = VT - V1
 Pmax = Pend - PEEP
 P1 = P80 - PEEP

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Table 30: Monitored Data – Mechanics


Monitored Data
Parameter Definition
Ranges
RCe Expiratory Time Constant (RCe) is defined as the product of the 0.00 to 99.9 sec
total respiratory system compliance and the total expiratory
resistance. Where R is the respiratory resistance and C is
respiratory system compliance. The product of R and C has units
of time and is called the time constant. During mechanical
ventilation, RCe is the product of resistance and compliance of the
patient's respiratory system and the additional resistive elements,
such as the endotracheal tube (ETT), filters, ventilator tubing and
the ventilators expiratory valve. Since ETT resistance is markedly
flow-dependent, RCe is also flow-dependent.
Expiratory time constant. The rate at which the lungs empty, as
follows:
 Actual TE% emptying
1 x RCe 63%
2 x RCe 86.5%
3 x RCe 95%
4 x RCe 98%
RCe is calculated as the ratio between Vte and flow at 75% of the
Vte.
Calculated RCe: This method allows easy calculation of RCe
breath-to-breath in all modes and is proven to be an accurate
approximation of actual. By analysis of the slope of the expiratory
flow volume curve, this method determines the expiratory time
constant using the ratio of exhaled tidal volume to peak expiratory
flow at 75% of Expiration. Thus RCe is calculated breath-to-breath
as the relationship (ratio) between Vte and PFe at 75% of the
maximum expiratory volume.
Calculated RCe: Vte (L) / PFe (L/s) = 1 Time Constant (s)
In adults, an RCe value above 1.2 s indicates airway obstruction,
and a value below 0.5 s indicates a severe restrictive disease.
Use RCe to set optimal Te (Goal: Te > 3 x RCe): These actions
may reduce the incidence of Auto PEEP.
 In passive patients: Adjust rate and I:E.
 In active patients: Increase Psupport and/or ETS to achieve a
longer Te.
NOTE:
 Time Constant Value accuracy is affected by active
exhalation and is more accurate in passive conditions.
 Low Compliance states, such as ARDS, will have lower (or
shorter) expiratory time constants and therefore lower (or
shorter) Te requirements.
 High resistance diseases, such as asthma, will have longer
time constants and require longer Te release times.

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Table 30: Monitored Data – Mechanics


Monitored Data
Parameter Definition
Ranges
Cstat Static compliance of the respiratory system, including lung and 0 to 300
chest wall compliance. Cstat can help diagnose changes in elastic ml/cmH2O
characteristics of the patients’ lungs.
Cstat is automatically calculated and displayed for all mandatory
breaths when the flow is less than 5 LPM at end inspiration. During
spontaneous SIMV breaths, Cstat will only be displayed if an
Inspiratory Hold is performed for 0.2 s or more.
Pressure of the stable (PIP – PEEP) or (Pplat – PEEP) serves as
the denominator and delivered tidal volume less compliance
compensation is the numerator.
Cstat = Vt/ (Stable PIP - PEEP if any) or Vt/ (Pplat - PEEP if any).
Measures lung compliance without airflow. Altered by changes in
lung and thoracic compliance
Cstat/kg Static Compliance normalized to the set ideal body weight 0.00 to 5.00
ml/cmH2O-kg

Cdyn Dynamic lung compliance is the compliance of the lung at any given 0 to 300
time during actual movement of air. It is change in volume over PIP ml/cmH2O
- PEEP so you are looking at the change in pressure it takes to
deliver a given volume. Cdyn is altered by lung, thoracic and airway
resistance.
Cdyn/kg Dynamic Compliance normalized to the set ideal body weight 0.00 to 5.00
ml/cmH2O-kg

Rinsp Rinsp is the resistance to inspiratory flow caused by the 0 to 1000


endotracheal tube and the patient’s airways, during inspiration. cmH2O/l/s
It is calculated during Volume-controlled breaths only with a square
Flow Pattern and a set Pause > 0.20 s.
Rinsp is the inspiratory resistance of airways and tubes where R =
pressure difference/flow
Rinsp = (PendInsuff - Pplateau) / FendInsuff
Rexp Rexp is the resistance to expiratory flow caused by the 0 to 1000
endotracheal tube and major airways during exhalation. It is cmH2O/l/s
calculated during Volume-controlled breaths only with any Flow
Pattern and a set Pause > 0.20 s.
Rexp is the expiratory resistance of airways and tubes where R =
pressure difference/flow
Rexp = (Pplateau - P200) / F200
P200 = pressure at 200 ms from the start of exhalation
F200 = Flow at 200 ms from the start of exhalation

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Table 30: Monitored Data – Mechanics


Monitored Data
Parameter Definition
Ranges
P0.1 P0.1 is the airway occlusion pressure and is also known as P100. -30 to 0 cmH2O
The P0.1 maneuver measures the maximal slope of the airway
pressure drop during the first 100 ms of an inspiratory effort when
the airway is occluded. P0.1 is an indicator of the patient's
respiratory drive and effort. It applies to patient-triggered breaths
with pressure trigger only.
A P0.1 value of -3 cmH2O indicates a strong inspiratory effort, and
a value of -5 cmH2O, an excessive effort, possibly because the
patient is “air hungry" (peak inspiratory flow or total ventilatory
support is inadequate) or has an excessive drive.
If P0.1 is below -3 cmH2O (more negative)
 Increase pressure or volume settings (depending on mode)
 Increase the Rise time
NOTE: Due to changes in pneumatic impedance, P0.1 values may
vary with different settings of the Trigger function.
PiMax PiMax also known as MIP or NIF is the maximum negative airway -60 to 0 cmH2O
pressure that is achieved by the patient, during a PiMax expiratory
hold maneuver.
The PiMax maneuver measures the negative deflection in the
pressure tracing during the patient’s active effort to demand a
breath. During the maneuver, the inspiratory flow valve remains
closed and no inspiratory flow is delivered. The MIP is an indication
of the maximum negative pressure that the patient can draw.
P0.1/PiMax Airway Occlusion Pressure (P0.1) divided by maximal inspiratory 0 to 100 %
pressure (PiMax) displayed as a ratio.
The P0.1/PiMax ratio is an important parameter to monitor if the
P0.1 and PiMax parameters are being used as it has been shown
to increase the reliability of P0.1 measurement, which can
sometimes be falsely low due to the presence of respiratory muscle
fatigue.
After 15 to 30 min of spontaneous breathing, a p0.1/PiMax ratio <
0.14 has been shown to predict weaning success with a sensitivity
of 82% and specificity of 83%.
 Gandia F, Blanco J. (1992). Evaluation of indexes predicting the
outcome of ventilator weaning and value of adding supplemental
inspiratory load. Intensive Care Med. 1992;18(6):327-33.
When the user performs a P0.1 and a PiMax maneuver, the
monitored parameter P0.1/PiMax will display the calculated ratio.
WOBimp Work of Breathing Imposed 0.00 to 20.0 j/l
 See section 5.7.2.4 below for a detailed overview of this
monitored parameter.

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5.7.2.4. Work of Breathing Imposed (WOBimp)


WOBimp is a monitored and trended parameter defined as the work performed by the
patient to breathe through the ventilator’s valves, breathing circuit, and humidifier. The
WOBimp is only valid for and only measured during patient initiated breaths and it is the
change in airway pressure (Paw) or (Ptrach if TC is active) integrated over inspiratory
tidal volume (Vti) normalized to total inspiratory tidal volume until pressure exceeds the
PEEP/CPAP level. The pressure is measured up the endotracheal tube and is only
inclusive of the resistance of the endotracheal tube when the tubing compensation feature
is active. WOBimp quantifies the effort required for a patient to initiate a breathing cycle
and is dependent upon the intensity of the patient effort, type of mechanical trigger of the
ventilator and the sensitivity setting and the volume and resistance of the breathing circuit.
WOBimp does not indicate the total patient work, however, the significance of WOBimp
is indicator of the suitability of the ventilator settings to the patient breathing pattern.
 If based on Paw, WOBimp indicates the work required of the patient to be on the
ventilator and does not include work resulting from the ETT and the total respiratory
system.

o PEEPaw = airway baseline pressure


o PAW = pressure at the Y–piece
o Vti = Inspired tidal volume
o ∆v = change in volume
o ∆T = total volume = (trigger volume which is the total volume measured
from start of patient effort (PEEP > Paw) to the point pressurization returns to
baseline PEEP (PEEP=Paw)).
 If TC is active, it is based on endotracheal pressure using Ptrach and Pmin and will
include work resulting from the ETT.

o Pmin = calculated airway baseline tracheal pressure


o Ptrach = calculated airway tracheal pressure

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5.7.2.5. Monitored Data: Capnography (ETCO2)

Figure 77: Monitored Data – ETCO2

 Select the ETCO2 tab if available (optional feature) to view the following monitored
parameters. For more detailed information regarding capnography, see section
5.10.
Table 31: Monitored Data – Capnography (ETCO2)

Monitored Data
Parameter Definition
Ranges
PetCO2 Maximum partial pressure of CO2 exhaled during a tidal breath 0 to 150 or > 150
(end tidal CO2 pressure) mmHg

PeCO2 Partial pressure of mean expired CO2 0 to 150 or > 150


mmHg
FetCO2 Fractional end-tidal CO2 concentration 0 to 19.7 %

FeCO2 Fractional concentration of mean expired CO2 0 to 19.7 %

VCO2/min CO2 elimination: Net exhaled volume of CO2 per minute 0 to 5000 ml/min

VtiCO2 Inspired CO2 volume updated breath-to-breath 0 to 2000 ml

VteCO2 Expired CO2 volume updated breath-to-breath 0 to 2000 ml

Vd ana Anatomical Dead Space 0 to 1000 ml


 Vd ana will displays as ----- until a PaCO2 value is entered
by the user. Once a PaCO2 value is entered, Vd ana will be
calculated based on the PaCO2 value entered.

Vd alv Alveolar Dead Space 0 to 1000 ml


 Vd alv will displays as ----- until a PaCO2 value is entered by
the user. Once a PaCO2 value is entered, Vd alv will be
calculated based on the PaCO2 value entered.

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Table 31: Monitored Data – Capnography (ETCO2)

Monitored Data
Parameter Definition
Ranges
Vd/Vt phy Physiological Dead Space (Vd) / Tidal Volume (Vt) Ratio 0.0 to 100 %
 Vd/Vt phy will displays as ----- until a PaCO2 value is entered
by the user. Once a PaCO2 value is entered, Vd/Vt phy will
be calculated based on the PaCO2 value entered.

Valv Alveolar tidal volume permits assessment of actual alveolar tidal 0 to 3000 ml
volume as opposed to exhaled tidal volume.
 Valv will displays as ----- until a PaCO2 value is entered by
the user. Once a PaCO2 value is entered, Valv will be
calculated based on the PaCO2 value entered.

Valv/min Alveolar minute ventilation. Valv * f (normalized to 1 min). Permits 0.00 to 50.0 l/min
assessment of actual alveolar minute ventilation as opposed to
exhaled minute ventilation.
 Valv/min will displays as ----- until a PaCO2 value is entered
by the user. Once a PaCO2 value is entered, Valv/min will
be calculated based on the PaCO2 value entered.

5.7.3. Trended Data


When the Monitoring tab is selected, press the Trend Data button from the Left panel. The
Trend Data window will load as shown below in Figure 78.
o The number of trends displayed on the Trend Data right panel can be configured to
show 1, 2 or 3 trends by selecting the desired number for display from the Config
screens Graphic page.

Figure 78: Trend Data Window

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5.7.3.1. Trend Event Markers


Table 32: Event Markers – Manual Entry
Manual Event Markers: User Initiated

CMTS User Comment CXR X-Ray

INT Intubation SXN Suction

DX Diagnostic Procedure BG Blood Gas

RX Therapy Procedure NIV NIV Started

Changing a Selected Manual Event Markers


Trend Graph Event
Marker Behavior When an Event is logged on the Trend Graphs the Event Marker
Icon will appear on the Trend graph to indicate to the user an
Event was performed at that trend reference point. As illustrated
above the Event acronym will be displayed on the Event Marker
Icon. The ICON will horizontally and or vertically flip adjust above
and below trend line to ensure visibility in relationship to multiple
event markers, top and bottom trend borders as shown to the left.

Manual Event Marker will Manual Event Markers currently displayed on the trend graph can
display Blue when be changed (if desired) to another manual Event Marker. When an
selected for change. Event Marker is pressed it will briefly display Blue to indicate it is
selected. Once selected, simply touch the desired Event Marker
from the Left panel and the Trend graph will update to display the
selected Event Marker.
 All Manual Event Markers other than CMTS once logged on
the trend graph can be changed as referenced above and
defined below in section 5.7.3.4.

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Table 33: Event Markers – Automatic Entry


Automatic Event Markers: Feature or Maneuver Initiated

NEB Nebulizer Activated SBT SBT Mode Started

Tube Compensation
TC SBT SBT Mode Canceled
Activated

Recruitment Maneuver
RMT SBT SBT Mode Completed
Activated

Suction Maneuver
SXN
Activated

Each time an automatic Event Marker related feature is activated,


Automatic Event Markers its automatic event marker will be triggered for display on the trend
graph.

5.7.3.2. User Comments: (CMTS) Event Marker


 When the User Comment Manual Event Marker is pressed a keyboard screen will
load. Enter the desired user comments using the keyboard and press the OK button
when complete.

User Comments (CMTS) Manual Event Markers once logged on the Trend
graph cannot be changed or switched to a different manual event marker.

 Viewing User Comments Logged on the Trend Graph:


o To view a logged user comment on the trend graph, simply touch-select the
CMTS Event Marker on the trend graph. Once selected, the user comment text
box will display on the trend graph as shown below in Figure 79.
o To close the user comment text box, touch-select the CMTS Event Marker again.
The comment text box will automatically close after 10 seconds or when another
screen is displayed.

Figure 79: User Comments Event Marker: Viewing

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5.7.3.3. Viewing and Selecting Multiple Event Markers:


 No more than four Manual Event Markers can be selected within a five minute period
of time. If the user attempts to generate greater than four Manual Event Markers
during a five minute period, the ventilator will sound a single tone indicating the Event
Marker was not logged.
5.7.3.4. Changing a Logged Manual Event Marker:
 As stated above in 5.7.3.1, Manual Event Markers currently displayed on the trend
graph can be changed (if desired) to another manual Event Marker.
o On the Trend graph, select the Manual Event Marker Icon you want to change.
When selected, the Event Marker Icon will turn Blue for 10 seconds as shown
below in Figure 80.
o During this 10 second period, press the correct Event Marker button from the
Left Panel and the Trend graph will update to display the selected Event Marker.
Failing to press an Event Marker button before the 10 seconds has elapsed will
result in no change and the trend graph’s Event Marker will revert back to its
original color. (10 second Rule)
o With the exception of the CMTS Event Marker, all Manual Event Markers once
logged on the trend graph can be changed as defined above.

Figure 80: Trend Data – Event Marker Change Feature

5.7.3.5. Trend Graph Freeze/Unfreeze and Cursor Control


 Touching the trend graph within the axis will freeze the trend graph and displays a
user adjustable cursor. Users can touch and drag the cursor to any point along the
X axis, and the numeric values for the cursor’s position will display on the graph below
the blue trend buttons.
 You cannot adjust the trend graph’s scale when the cursor is displayed. To unfreeze
the trend graphs and remove the cursor display, simply touch the Unfreeze icon.

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Figure 81: Trend Data Unfreeze Icon and Cursor

5.7.3.6. Selecting Trend Parameters for Display on Trend Graph


 The specific trend parameters displayed on the Trend graphs can be individually
selected by the user.
o To change a displayed trend parameter, simply touch the blue Trend button for
the trend you want to change and the Trend Selection window will load in the
Right Panel as shown below in Figure 82. The blue Trend buttons are located
in the top right corner of each trend graph as shown above in Figure 78. The
trend parameter selected for change will display with a bright yellow background
color as shown below in Figure 82.
 Depending on the trend currently displayed, when the user touch-selects the blue
Trend Button the Trend Selection window will load as follows:
o When the user touch-selects a Basic parameter on the trend graph, the right
panel loads the Trend Selection Window with the Basic tab selected thus
displaying all the Basic category parameter selections.
o When the user touch-selects an Advanced parameter on the trend graph, the
right panel loads the Trend Selection Window with the Advanced tab selected.
o When the user touch-selects a Mechanics parameter on the trend graph, the
right panel loads the Trend Selection Window with the Mechanics tab selected.
o When the user touch-selects an ETCO2 parameter on the trend graph, the right
panel loads the Trend Selection Window with the ETCO2 tab selected.

 The user can select a parameter from any of the Basic, Advanced, Mechanics, or
ETCO2 right panel tabs by touching that categories tab and then selecting the desired
parameter. Once the user touch-selects a Trend parameter from the list, the selected
Trend parameter is assigned to the desired Trend graph and the Right panel updates
to display the new Trend graph.

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o If the user fails to make a selection within 10 seconds, the screen will revert back
to the previous panel view.
o If Trend graphs panel is maximized at the time the user selects a trend
parameter for change, the trend graph will automatically minimize. After trend
selection the the trend graph panel will remain minimized until the user chooses
to maximize it.
o The ETCO2 Trend tab in the right panel is only available on Inspiration 5i
ventilators and will only be displayed if the optional CO2 sensor is connected.

Figure 82: Trend Data Selection Window

5.7.3.7. Trended Parameters Basic


Table 34: Trend Parameters – Basic
Trended Y Axis
Description
Parameter Units
Ppeak Measured Peak inspiratory pressure during a breath cmH2O

Ptrach Calculated peak tracheal pressure at the end of the ETT cmH2O
breath-to-breath
Pmean Measured average mean airway pressure during inspiration cmH2O

PEEP Measured positive end expiratory pressure cmH2O

Pmin Calculated end expiratory pressure at the carina breath-to- cmH2O


breath
Vti Measured inspiratory tidal volume ml
Vti/kg Measured Inspiratory tidal volume normalized to the set IBW ml/kg
Vte Measured Exhaled tidal volume (ml). Available when proximal ml
flow sensor is on.
Vte/kg Measured Expiratory tidal volume normalized to the set IBW ml/kg

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Table 34: Trend Parameters – Basic


Trended Y Axis
Description
Parameter Units
Ve Measured exhaled minute volume, the total (spontaneous and l/min
mandatory) tidal volume of gas delivered in the previous
minute
Vi Inspired minute volume l/min
Measured inspired minute volume, the total (spontaneous and
mandatory) tidal volume of gas delivered in the previous
minute
Ve/kg Measured Expiratory minute volume normalized to the IBW ml/kg
Ve Spont Measured spontaneous exhaled minute volume, the total l/min
spontaneous tidal volume of gas delivered in the previous
minute
Vi Spont Measured spontaneous minute volume, the total spontaneous l/min
tidal volume of inspired gas in the previous minute. Displays
only when the proximal flow sensor is disabled.
Rate Measured number of spontaneous and mandatory breaths b/min
delivered in the previous minute.
Rate Spont Measured number of spontaneous breaths delivered in the b/min
previous minute.

5.7.3.8. Trended Parameters Advanced


Table 35: Trend Parameters – Advanced
Trended Y Axis
Description
Parameter Units
Ti Measured Inspiratory Time s
Te Measured Expiratory Time s
PF Peak Inspiratory Flow l/min
PFe Peak Expiratory Flow l/min
Ti/Tot Calculated Inspiratory Time divided by total cycle time %
Leak Measured leak %
O2 Oxygen concentration of the delivered gas %
HeO2 Heliox concentration (Helium oxygen) of the delivered gas %
Auto Auto Control Trend Graph displays the duration of time the CMV /
CMV and Spont modes are active. SPONT

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5.7.3.9. Trended Parameters Mechanics


Table 36: Trend Parameters – Mechanics
Trended Y Axis
Description
Parameter Units
Auto PEEP Calculated residual pressure at end exhalation cmH2O

Pplateau Plateau pressure cmH2O

RSBI Rapid Shallow Breathing Index, ratio of measured respiratory b/min/l


rate to inspiratory tidal volume
Cstat Static Compliance, lung stiffness ml/cmH2O

Cstat/kg Static Compliance, normalized to patient IBW ml/cmH2O-kg

Cdyn Dynamic Compliance, lung stiffness ml/cmH2O

Cdyn/kg Dynamic Compliance, normalized to patient IBW ml/cmH2O-kg

Rinsp Inspiratory Resistance of patient breathing circuit cmH2O/l/s

Rexp Expiratory Resistance of patient breathing circuit cmH2O/l/s


Available when proximal flow sensor is on.
WOBimp Wok of Breathing Imposed: Trend parameter defined as the j/l
work performed by the patient to breathe through the
ventilator’s valves, breathing circuit, and humidifier.
RCe Expiratory Time Constant s
Available when proximal flow sensor is on.

5.7.3.10. Trended Parameters Capnography (ETCO2)


 Capnography (ETCO2) data is only available on the Inspiration 5i ventilators and will
only be displayed if the optional CO2 sensor is connected.

Table 37: Trend Parameters – ETCO2

Trended Y Axis
Description
Parameter Units
PetCO2 Maximum partial pressure of CO2 exhaled during a tidal mmHg
breath( end tidal CO2 pressure)
PeCO2 Partial pressure of mean expired CO2 mmHg
FetCO2 Fractional end-tidal CO2 concentration %
FeCO2 Fractional concentration of mean expired CO2 %
VCO2/min CO2 elimination: Net exhaled volume of CO2 per minute ml/min
VtiCO2 Inspired CO2 volume updated breath-to-breath ml
VteCO2 Expired CO2 volume updated breath-to-breath ml
Vd ana Anatomical Dead Space ml
Vd alv Alveolar Dead Space ml
Vd/Vt phy Physiological Dead Space (Vd) / Tidal Volume (Vt) Ratio %

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Table 37: Trend Parameters – ETCO2

Trended Y Axis
Description
Parameter Units
Valv Alveolar tidal volume permits assessment of actual alveolar ml
tidal volume as opposed to exhaled tidal volume.
Valv/min Alveolar minute ventilation. Permits assessment of actual l/min
alveolar minute ventilation as opposed to exhaled minute
ventilation.

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5.8. Waveforms
5.8.1. Waveform Properties
o Upper Right and Left Panel:
 When the Upper Left or Right panel is configured to display waveforms, you can
assign different waveforms (pressure, flow and volume or EtCO2) by pressing the
blue toggle button.
 Waveform Display (Line Colors)
 Mandatory Breaths: (red = inspiration) and (light blue = exhalation)
 Spontaneous Breaths:(yellow = inspiration) and (light blue = exhalation)
 Scaling
 When the Blue eVent Logo is displayed above the Y axes, this means auto scaling
is active and the graphs will automatically adjust its scale to best fit the graphic.
 To manually scale the graph, touch the X or Y axes to manually scale that axes. The
manually assigned view will be maintained until changed by the user.
 Freeze / Unfreeze / Maximize
 Waveforms displayed in the Upper Right and Left panel can be maximized by
touching the maximize button in the upper left corner of the right panel. The right
panel will expand to cover the left panel and the minimize button will be displayed in
the upper left corner, touch it to minimize the right panel.
 Freeze the waveforms by touching in the middle of the graph and holding for very
short period. Touch the unfreeze icon to unfreeze the graph.
 While frozen, the X and Y axes cursor related data for each loop will be displayed
below each graphs blue toggle button.

5.9. Loops
5.9.1. Loop Properties
o Upper Right and Left Panel: Loops
 When the Upper Left or Right panel is configured to display loops, you can assign
different Loops (F/V Loop, P/V Loop, P/F Loop) by pressing the blue toggle button.
 Loop Display (Line Colors)
 Mandatory Breaths: (red = inspiration) and (light blue = exhalation)
 Spontaneous Breaths: (yellow = inspiration) and (light blue = exhalation)
 Scaling Right Panel Loops
 When the Blue eVent Logo is displayed above the Y axes, this means auto scaling
is active and the graphs Y axis (only) will automatically adjust its scale to best fit the
graphic.
 To manually scale the graph, touch the X or Y axes to manually scale that axes. The
manually assigned view will be maintained until changed by the user.
 Freeze / Unfreeze / Maximize
 Loops displayed in the Right panel can be maximized by touching the maximize
button in the upper left corner of the right panel. The right panel will expand to cover
the left panel and the minimize button will be displayed in the upper left corner of the
right panel, touch to minimize the right panel.
 Freeze the loops by touching in the middle of the graph and holding for very short
period. Touch the unfreeze icon to unfreeze the graph.
 While frozen, the X and Y axes cursor related data for each loop will be displayed
below each graph blue toggle button.

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5.9.2. Loop Study

Loop data is not available when the NCPAP+ mode is active.

5.9.2.1. Selecting Loop Data for Displaying


 Select on the Upper Right or Left graphic window the Loop Tab to display the Loops
options.
 Select specifically the F/V Loop to display the reference loop button (Ref) next to the
loop selection button. The “Ref” button is used to open the dialog in the Lower Right
graphic window for saving the reference Loop if it is desired. When the Ref button is
turned On the button becomes blue.

5.9.2.2. Saving a Reference Loop


 Press or turn On the “Ref” button to open the “Loop Study” screen in the Lower Right
graphic window. Figure 83.
 Press “Save Loop” folder to save a loop. The software will save the complete breath
loop automatically. If you press the “Save Loop”, the ventilator will wait until next
breath is delivered to be able to save the whole breath loop.
o When a saved loop is created by the user, all three loops (F/V, P/V and P/F) will
be saved to memory and the Saved Loops Icon with date time reference will be
display.
o Up to eight Saved Loops can be stored. If a ninth save is created the oldest
Saved LOOP will be overwritten. Once a saved loop is overwritten, it can be
restored.
o Saved Loops will be displayed sequentially from left to right for each save
created. This means the Buttons for the most recent Saved Loops will always
be in the top row with the newest Saved Loop Button in the top left most position.

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Figure 83: Loop Save Feature

 Deleting Saved Loops


o To delete a Saved Loop, press and hold a Saved Loop Button in the Left Panel
for a minimum of 2 seconds and release. When released, the Saved Loop
Button display with a red circled X as shown below.

o With the red circled X displayed on the Saved Loop button, press the Saved
Loop button a second and it will be deleted and disappear from the Left Panel
and all other remaining Saved Loop Buttons will automatically shift position in
the Left Panel.
o If the selected loop is not deleted after 10 seconds, the delete option will
automatically cancel.
 Displaying the Saved Loop Reference
o When the Reference Loop feature is set to “Ref, Loop On”, the selected Saved
Loops will display superimposed behind the active F/V and P/V and P/F loops.

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5.10. Capnography
Capnography is a clinical tool to evaluating the adequacy of ventilation, as the obvious goal of
ventilation is to remove the CO2 produced by the body’s metabolic processes. But conventional,
time-based Capnography allows only qualitative and semi-quantitative, and oftentimes
misleading, measurements, thus volumetric Capnography has emerged as the preferred method
to assess the quality and quantity of ventilation.
To this end, the Inspiration 5i ventilator’s volumetric Capnography feature provides the following
information.
 CO2 Elimination (VCO2/min, VteCO2) measurements provide continuous feedback regarding
ventilation and perfusion and permit assessment of metabolic rate and treatment progress.
 End-tidal CO2 (PetCO2, PeCO2, FetCO2 and FeCO2) measurement provides a proper assessment of
arterial CO2.

 Dead Space (Vdana, Vdalv) and Alveolar Volume (Valv and Valv/min) measurements permit a
proper assessment of actual alveolar ventilation.
 Physiological dead space (Vd/Vt phy) measurement permits the assessment of total dead space to
tidal volume ventilation in support of the weaning process.
 Capnograms (PCO2+Time, FCO2+Time and VteCO2+Time) provide additional CO2 elimination
visualization and the combination capnogram and spirogram SBCO2 curves (PCO2–Vte and
FCO2–Vte) shape (SlopeCO2) permits assessment of COPD, asthma, and inefficient ventilation.

The Inspiration 5i ventilator is designed to work with the PHASEIN IRMA (mainstream) and ISA
(Sidestream) Capnography sensors and adapters. The Inspiration’s Capnography software is
designed with plug-n-play functionality and will recognize which sensor (IRMA or ISA) is attached
and will automatically load all the Capnography related monitoring and trend data parameters,
graphics screens, event markers, settings and alarms specific to the type of PHASEIN CO2
adaptor attached to the ventilator.
 See section 2.11 for additional Capnography setup and calibration information and sections
11.15 (Monitored Data) and 11.17 (Alarms) for additional information.

The IRMA (Mainstream) and ISA (Sidestream) sensors and accessories are optional
components available for purchase and are required for Capnography CO2 and VCO2
monitoring.

The Inspiration 5i can display measurements derived from the CO2 sensor as numeric values,
waveforms, trends, and loops. The Capnography waveforms are a valuable clinical tool that can
be used to assess a variety of pulmonary, perfusion and metabolic conditions as well as patient
airway integrity and proper endotracheal (ET) tube placement.
The Inspiration’s Capnography features provides twelve (12) monitored parameters, a PaCO2
entry panel for calculation of alveolar volumes and Vd/Vt and a Capnograms screen which
displays PCO2, FCO2, VteCO2 waveforms as well as a SBCO2 panel to view PCO2/Vte and
FCO2/Vte curves.
The CO2 sensor can be easily transferred from one Inspiration 5i ventilator to another, even "on
the fly," during ventilation.
When the PHASEIN CO2 sensor is disconnected, the ventilator will display an information
message alarm “No CO2 Sensor” to alert the user and all the Capnography related features will
be automatically disabled. All information is retained, however, and will resume at previous
settings once the sensor connection is re-established.

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 Medical knowledge changes constantly as a result of new research and


clinical experience. eVent Medical has made every effort to ensure that the
information given is accurate and up to date, specifically as it pertains to
application and mode of operation. However, responsibility for all clinical
measures must remain with the reader.

5.10.1. Warnings and Cautions


Table 38: Capnography: Warnings and Cautions

 Capnography Warning Information


The CO2 sensors are intended for use by authorized and trained medical
personnel only.
Periodically check the CO2 sensor for excessive moisture or secretion build
up.
Volumetric Capnography measurements require accurate measurement of
delivered volumes. For this reason, an expiratory flow sensor and circuit
compliance compensation must be used. Furthermore, when circuit
compliance compensation is used, and if the circuit compliance changes,
volumetric accuracy will be affected.
A system leak, such as that caused by un-cuffed endotracheal tubes may
affect flow-related readings. These include flow, pressure, dead space, CO2
production, and other respiratory mechanics parameters.
Nitrous oxide, excessive levels of oxygen, Heliox mixtures, and halogenated
hydrocarbons can influence the CO2 measurements. The Inspiration
ventilators automatically compensate for oxygen and Heliox (80/20) gas
mixtures.
Do not use CO2 measurements as the sole basis for changing ventilation
parameters without reference to clinical condition and independent monitors
such as blood gas. CO2 measurements may be inaccurate in the presence of
a breathing circuit leak, secretions, or sensor malfunction.
Carefully route CO2 sensor sampling lines to reduce the risk of patient
entanglement or strangulation.
Do not reuse disposable CO2 monitoring components.
Dispose of used CO2 monitoring components according to applicable
regulations for medical waste.
Do not attempt to lift the ventilator by a sampling line: doing so can disconnect
the line or cause the ventilator to fall onto the patient.
Orient the CO2 sensor and adapters so that they cannot fall on the patient.
Use appropriate sampling lines or airway adapters for the patient type.
Components that are too large for the patient can add dead space to the
breathing circuit, and components that are too small for the patient can cause
excessive flow resistance.
To avoid occluding the bacteria filter, do not use the ISA (Sidestream) CO2
sensor with metered-dose inhalers or nebulized medications.
Verify that gas sample flow is not too high for the patient type.
Measurements can be affected by mobile and RF communications equipment.
Ensure that the CO2 sensor is used in the electromagnetic environment
specified in this manual.

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Table 38: Capnography: Warnings and Cautions


CO2 monitoring is intended only as an adjunct to patient assessment. It must
be used in conjunction with other assessments of clinical signs and symptoms.
Replace the sampling line if the input connector LED flashes red or the
ventilator displays an occlusion message.
No modification of the CO2 monitoring devices is allowed without authorization
of the manufacturer. Modified equipment must be inspected and tested
appropriately to ensure continued safe operation.
CO2 sensors are not designed for MRI environments. During MRI scanning,
place the ventilator outside the MRI suite.
Operating high-frequency electrosurgical equipment in the vicinity of the CO2
sensor can produce interference and cause incorrect measurements.
Excessively high or low pressure in the patient breathing circuit or in the
sampling line can cause incorrect readings and internal damage to the CO2
sensors.
Exhaust gases must be returned to the patient breathing circuit or scavenging
system.
The Nomoline sampling line, sampling line interface, and IRMA airway
adapters are non-sterile. To avoid damage, do not autoclave.

 Capnography Caution Information


The IRMA and ISA sensors contain no user serviceable parts.
Use only Nomoline sampling lines manufactured by PHASEIN (sidestream
CO2 sensor).
Use only PHASEIN manufactured IRMA airway adapters (mainstream CO2
sensor).
Do not position the CO2 sensor or cable in any manner that may cause
entanglement, strangulation, or accidental self-extubation. Use clips or
fasteners as appropriate to secure the sensor cable to the breathing circuit.
Do not use the CO2 sensors in the presence of flammable anesthetic agents.
Do not use damaged sensors or cables.
Do not sterilize or immerse sensors, except as directed in this manual.
Do not apply excessive tension to any sensor cable.
It is recommended that the CO2 sensor be removed from the circuit whenever
an aerosolized medication is delivered. This is due to the increased viscosity
of the medications, which may contaminate the ISA sensors and IRMA airway
adapter windows, causing the sensor to fail prematurely or to display incorrect
data.
To ensure accurate CO2 sensor zeroing, place the sensor and adaptor in a
well-ventilated place in ambient air (21% O2 and 0% CO2) and avoid breathing
near the monitor before or during the zeroing procedure. Incorrect zeroing can
cause false measurements.
Do not apply negative pressure to the Nomoline (i.e., by syringe) to remove
condensed water.
Do not operate the CO2 sensors outside the specified operating environment.
The ISA “Plug-in and measure” sensors should be securely mounted in order
to avoid the risk of damage to the ISA.

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5.10.2. Capnography Waveforms and SBCO2 Curves


As defined above in 2.11, The Inspiration 5i ventilator is designed to work with the PHASEIN
IRMA (mainstream) and ISA (Sidestream) Capnography sensors and adapters. The
Inspiration’s Capnography software is designed with plug-n-play functionality and will
recognize which sensor (IRMA or ISA) is attached and will automatically load all the
Capnography related monitoring and trend data parameters, graphics screens, event
markers, settings and alarms specific to the type of PHASEIN CO2 adaptor attached to the
ventilator.
o For specific details on how to connect the Capnography sensors and adapters to the
Inspiration 5i ventilator, see section 2.11.
o For specific details on how to perform a Zero CO2 Sensor calibration, see section 6.3.5.

5.10.2.1. Volumetric and EtCO2 Real-Time Waveforms


To view the Inspiration 5i ventilator’s Capnography related Volumetric and EtCO2 real-
time waveforms, an EtCO2 sensor must be connected. Once connected, select
Capnograms from the Monitoring screen.
o Capnograms (Waveforms)
 As shown below in Figure 84, when the Mainstream ETCO2 sensor is attached,
any of the three waveforms can be configured to display PeCO2, FeCO2 or VteCO2.

Figure 84: Real-Time Graphics (Capnograms)

5.10.2.2. SBCO2 Real-Time Curves


To view the Inspiration 5i ventilator’s Capnography related Volumetric SBCO2 real-time
curves, a Mainstream (IRMA) sensor must be connected. Once connected, select in the
Loops the SBCO2. Capnograms from the Monitoring screen. The SBCO2 parameter is not
available for Sidestream sensor.

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SBCO2
Curve
Selection

PCO2 / Vte
Curve

FCO2 / Vte
Curve

Figure 85: Real-Time Graphics (SBCO2 Curves)

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5.10.2.3. PaCO2 Entry Control Setting


A PaCO2 entry control is provided at the bottom of the Monitoring tabs Left Panel as shown
below in Figure 86. The PaCO2 entry control will only be displayed when a CO2 sensor is
attached to the Inspiration 5i ventilator.
o The PaCO2 entry field allows users to enter the PaCO2 value from a recent blood gas.
The PaCO2 value is required to calculate the Alveolar volumes as well as alveolar dead
space and Vd/Vt Physiologic values.
 Once a PaCO2 value has been entered by the user, the date and time
corresponding to that entry will display to the right of the PaCO2 control.
Once entered, the Alveolar volumes (Valv, Valv/min), alveolar dead space
(Vd alv), anatomical dead space (Vd ana) and Vd/Vt Physiologic values will be
continuously calculated based on the currently entered PaCO2 value. The PaCO2
value can be updated at anytime by the user and once updated, the PaCO2
dependent parameters will update breath-to-breath based on the new PaCO2 value
entered.

o PaCO2 Value Entry


 Each PaCO2 entry will be captured on the Event Log and maintained for historical
reference. To review all entered PaCO2 values simply filter the Event Log by
clicking on the Event column and all entered PaCO2 values will be displayed in the
order of entry.

Figure 86: PaCO2 User Entry Control

o Additionally, as shown in Figure 84 the PaCO2 value will be displayed as a yellow dotted
line intersecting with the Y axes on both the (PCO2 + Time) waveform and the (PCO2
+ Vte) SBCO2 curve. The PaCO2 tracing will only display if the user has entered a
PaCO2 value.

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6. Calibrations and Alarm Test Procedures


This section provides detailed information regarding user calibrations, and alarm testing procedures.

The Inspiration ventilator’s user calibration options can be accessed from both the New and Previous
Patient Startup screens by pressing the Calibrations button displayed in the Right panel.
The calibration options provided on the Calibrations screen allow user to:

 Perform a Circuit Check calibration


o The Circuit Check calibration calculates the breathing circuit compliance and includes
the compliance of the humidification chambers and filters if performed with these
accessories attached. The Circuit Check calibration should be performed between
patients and when the patient tubing system or tubing system components are replaced or
modified. See section 6.3 below.

 Perform an Oxygen Sensor calibration


o The oxygen sensor calibration performs a two (2) point calibration at 100% and 21%
FiO2. Oxygen sensor calibration should be performed between patients and when a
drift is noticed between the monitored O2 and set O2. In addition, if the ventilator has
been transported to another environment with different altitude than previous location,
the O2 calibration may be affected and should be performed before use. See section
6.3.4 below.

 Perform a Zero CO2 Sensor calibration


o The Zero CO2 Sensor calibration should be performed when changing the IRMA airway
adapter or when changing the CO2 Sensor or when the Zero CO2 Sensor alarm is
displayed. See section 6.3.5 below.

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The Calibrations screen (Figure 87) allows users to select which calibrations to perform, and the
current status for all calibrations is displayed below the calibrations screen.
 Calibration buttons will display with a grey circle if the previous calibration failed and the
status message “Calibration Required” will be displayed below the calibrations screen.

Figure 87: Calibrations Screen

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6.1. Flow Sensor Calibration

Figure 88: Flow Sensor Calibration-screen

The flow sensor calibration is used by the ventilator in order to define the position of and
characteristics of the flow sensor prior to use as well as to zero various internal transducers.
o The flow sensor can be positioned proximally at the circuit Wye or distally at the
expiratory port. During flow sensor calibration, the flow sensor position will be defined
by the user as (Prox.) if the flow sensor is positioned proximally at the circuit Wye or
(Exp.) if the flow sensor is positioned at the expiratory port. Only Adult/Pedi flow
sensors are allowed to be positioned at the ventilator’s expiratory port.
o During the flow sensor calibration procedure, the ventilator will automatically recognize
if a neonate or adult flow sensor is attached and perform the appropriate calibration.
The ventilator will also recognize the position of the flow sensor and assign the
appropriate compensation and correction algorithms based on the flow sensor’s
position, selected humidity type and calibration characteristics.
The flow sensor calibration data is stored in ventilator's NVRAM and is used during ventilation
to ensure accurate flow measurements, volume measurements and flow trigger performance.
Additionally, all exhaled flow and volume monitored data is obtained from the flow sensor.

Flow Sensor calibration requires at least one high-pressure gas source to be


available and connected to the device.
The manufacturer recommends that flow sensor calibration is performed routinely
prior to use; between patients and at all times following the manufacturers
instructions.
Flow sensor calibration should be performed with New Patient Startup and when
replacing the flow sensor.
For Neonate/Pedi flow sensor calibration a breathing circuit with a compliance of
> 0.35 ml/cmH2O is required.
Failure to perform a flow sensor calibration may cause inaccurate exhaled volume
and flow measurements and can also affect flow trigger performance resulting in
decreased sensitivity or auto-triggering.

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6.2. Flow Sensor Calibration Procedure and Instructions


From the Calibrations screen, press (select) the Flow Sensor button, to load the Flow
Sensor calibration-screen.
 Before performing a flow sensor calibration,
 Attach the complete patient tubing system, including flow sensor, to the ventilator.
 Select the correct flow sensor position by pressing the Flow Sensor Position toggle button.
o Select (Prox.) if the flow sensor is positioned proximally at the circuit Wye or (Exp.) if the
flow sensor is positioned at the expiratory port.

Flow Sensor Calibration at Exp Port not available. – Understand why.


If you want to calibrate the flow sensor (FS) at the Exp. port but Prox. is the only Flow
Sensor Position selection option, this means the previous patient type was Neonate and
the previous FS calibrated was Neo/Infant.
To resolve this and enable FS calibration at the Exp. port, the Adult or Pediatric patient
type must be identified by the ventilator. Go back to the New Patient Startup screen and
enter the adult or pediatric patient’s height or IBW. You will then see Adult or Pediatric
listed as the Patient Type above the left panel. Now go back to the FS calibration-screen
and Exp. will be available as a FS position selection option.

 Select the correct humidity type by pressing the Humidity Type toggle button.
o Select (Humidifier) when using a warmed-up heated humidifier during the flow sensor
calibration.
 Humidifier will display by default if the Humidification Type is set to Humidifier on
the New or Previous Patient Startup screen.
o Select (Other) when using unheated non-humidified gas during the flow sensor
calibration (whether or not a humidifier is attached).
 Other will display by default if the Humidification Type is set to HME or None on the
New or Previous Patient Startup screen.

 Performing a flow sensor calibration:


 When ready, Press the START button at the bottom of the Flow Sensor Calibration-
screen.
 The OK button will be displayed immediately after the START button is pressed and
the status/instruction message “Block Wye!” will be displayed above the OK button.
 Block the breathing circuit Wye and then press the OK button. Once the OK button
is pressed, the STOP button will be displayed, and the flow sensor calibration will
begin.
 The status message “Running…” will be displayed as the system identifies the actual
flow sensor position.
o During this step, if the Flow Sensor Position button was set to (Prox.) and the
flow sensor is positioned proximally at the circuit Wye, the system will display a
new status/instruction message prompting the user to “Unblock Wye” and the
OK button will again be displayed.
 Unblock the breathing circuit Wye and then press the OK button. Once the
OK button is pressed, the STOP button will again be displayed, and the
flow sensor calibration will continue. Pressing STOP cancels the current
flow sensor calibration.
 The system will now identify the flow sensor type and the status message
“Adult...Ped; Running...” or “Ped...Neonate; Running...” will be displayed
depending on the sensor type connected.

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o During this step, if the Flow Sensor Position button was set to (Exp.) and the
flow sensor is positioned distally at the expiratory port, the system will identify
the flow sensor type and the status message “Adult...Ped; Running…” will be
displayed and flow sensor calibration will continue.
 If a (Neonate) sensor is detected the error message (Error 44; Wrong
Sensor Type) will be displayed.
 If the identified flow sensor position does not match the user defined flow
sensor position, the error message (Error 45; Wrong Sensor Position) will
be displayed.
o When the flow sensor calibration is complete, the status message will update to
display either “Adult...Ped; OK” or “Ped...Neonate; OK” depending on the
sensor type connected.

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 If there is an error detected at any step, flow sensor calibration stops, and the
ventilator will display the related error number and message. Make sure you are
following the steps accordingly during the calibration, if the problem persists try the
following:
o Verify the Gas Supply is connected.
o Check the correct flow sensor type (Adult/Ped or Neonate).
o Check the correct flow sensor position (Prox or Exp). Neonate FS sensor is not
allowed to be positioned at the Exp. port.)
o Verify correct assembly and all the breathing circuit connections.
o Perform Circuit Check and verify that the Breathing Circuit is not leaking.
o For the flow sensor at “Prox” position, make sure you are initially blocking the
Wye and then unblocking the Wye according to the instruction.
o For the flow sensor at “Exp” position, the calibration instruction does not require
unblocking the Wye which will result in error.
o Avoid movement on the breathing circuit and the flow sensor during the
calibration process.
o Try a new flow sensor and repeat the calibration.
o If the problem persists, see the Inspiration 5i Service Manual for technical details
or contact a qualified service technician to help you.

6.3. Circuit Check Calibration


The Circuit Check may be run by the user in order to verify the integrity of the patient tubing system
components.
o Running the Circuit Check allows the operator to quantify any leakage from the patient tubing
system prior to clinical patient use.
Additionally, during the Circuit Check the device quantifies the compliance characteristics of the
patient tubing system to include the additional compliance of humidification chambers, water traps,
filters and other circuit accessories if performed with these components attached.
o The calculated system compliance (ml/cmH2O) will then be used by the ventilator on a
breath-by-breath basis to compensate for the circuit compliance effects and to ensure that
volume delivery and measurements are maintained to specification.
o Circuit compliance compensation cannot be disabled on the Inspiration ventilator and is
active during Adult, Pediatric and Neonate ventilation in all modes except NCPAP+ and the
calculated system compliance cannot be entered manually.
o During volume ventilation circuit compliance compensation ensures the set tidal volume (Vt)
is delivered to the patient by increasing the volume of gas delivered to the circuit (Vtd) to
include the amount of compressible volume lost due to the compliance effect of the circuit
(Vtcompl)
 Vti = Vtd - Vtcompl
Failure to perform Circuit Check may affect the following:
May lead to leaks that can affect patient ventilation.
Incorrect compliance factors will lead wrong circuit compliance compensation which
may over or under deliver in volume modes affecting accuracy.
Incorrect compliance factors will lead wrong circuit compliance compensation which
may over or underestimate monitored patient volume in pressure modes.
For patient safety, the Circuit Check (leak and breathing circuit compliance) should
be performed between patients and every time the patient breathing circuit or tubing
system components are replaced or modified.

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6.3.1. Circuit Check Performance and Technical Details

A Circuit Check may be performed using either of the external gas sources
or the ventilators internal compressor.

Prior to performing a Circuit Check, attach the complete patient tubing system, including
proximal sensor, filters and humidifier chamber to the ventilator.
From the Calibrations screen, press the Circuit Check button to load the Circuit Check
screen. Then when ready, press the START button to begin the test procedure. The initial
series of tests defined below, require the circuit Wye to be initially left open. See Figure
89, Figure 90, Figure 91, Figure 92, Figure 93, Figure 94 and Figure 95, for illustrations
of the steps defined below.
Step 1: Press START. During the short waiting period the system is zeroing the transducer.
Step 2: Block Wye and Press OK to start the breathing circuit pressurization.
PASS Result: The test passes if the leakage detected is less than or equal to 3cmH2O/sec
and the device will display a message in the test progress field “OK” indicating the Circuit Check
has passed. Once Circuit Check completes, the Tubing Compliance in ml/cmH2O and Leak
rate in cmH2O/s will be displayed on the screen.
FAIL Result: If the leakage is greater than 3 cmH2O/s the test fails, and the device will display
a message in the test progress field “Circuit Check Failed” and a fault specific error code will
be displayed. In case of Fail, the ventilator will not compensate the patient breathing circuit
compliance or in other words will use compliance value of 0.0mL/cmH2O. The Tubing
Compliance and Leak values will display “- - -“.

 System Leak Rate Acceptance Criteria:


o Leak rates between 0.0 to 3.0 cmH2O/sec are considered passing
 Leak rates above 1.5 cmH2O/sec (1.6 to 3.0 cmH2O) will be listed in red to
indicate a high Leak rate, but a passing value.
o A Circuit Check will fail if the leak rate is greater than 3 cmH2O/sec
 If the leak rate is greater than 3 cmH2O/sec, a system error message will
display (Error 6; Pressure drop; Leak rate X.X cmH2O/sec)
 Leak rate values less than 7.0 cmH2O/sec will be displayed.
 The leak rate is a measured value and will vary depending on the leak.

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6.3.2. Circuit Check Calibration-screens

Figure 89: Circuit Check – Start

Figure 90: Circuit Check – Leak Test

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Figure 91: Circuit Check – Passed

6.3.3. Default Circuit Check Failure Bypass Window


If the user attempts to enter ventilation after a failed Circuit Check, the user is presented
with a notification / decision-screen as shown below in Figure 92.
 Selecting Bypass allows the user to proceed to ventilation without performing a Circuit
Check. This response is then stored as log entry.
o If the Circuit Check Fails and is then Bypassed, the ventilator will continue to
use the last system calculated compliance.
 Selecting Cancel takes the user back to the Startup screen.

Figure 92: Default Circuit Check Failure Bypass Window

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Section 6 Calibrations and Alarms Test Procedures

6.3.4. Oxygen Sensor Calibration


Oxygen sensor calibration is run by the user in order to define the performance characteristics of
the internal oxygen sensor prior to use. The calibration data derived during this procedure is stored
in NVRAM and used during normal operation to ensure accurate FiO2 measurement during
ventilation.

The manufacturer recommends that oxygen sensor calibration is performed


routinely between each patient use and following replacement of the
oxygen sensor or Sensor board and when a drift is noticed between the set
and monitored O2 value.
Failure to perform oxygen sensor calibration as required may lead to
inaccuracies in the monitored oxygen percentage.

 The Oxygen Sensor Calibration requires the use of a high-pressure oxygen


supply as well as an air supply (either an external high-pressure air source
or the internal compressor).

o Once Oxygen Sensor calibration is started, the device performs an automated two point
calibration procedure using 100% oxygen and then 21% oxygen.
o Starting with 100% oxygen the device allows a period of time for the reservoir’s oxygen
concentration to stabilize and then a further period to allow the sensor reading to stabilize.
On completion the microprocessor compares the reading and associated gain against
specific limits.
 If the reading falls within the defined limits the process is repeated for 21% oxygen.
 If the reading falls outside the defined limits the calibration stops, and a specific error
code will be displayed.
o Upon completion the device reports an overall pass as Passed and failures with a specific
Error number and error message and displays this information in the test status/progress
field.
 If the reading falls within the defined limits the process is repeated for 21% oxygen.

6.3.4.1. Oxygen Sensor Calibration-screens

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Figure 93: Oxygen Sensor Calibration-screen

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Figure 94: Oxygen Sensor Calibration – Running…100%

Figure 95: Oxygen Sensor Calibration – Passed

6.3.5. Zero CO2 Sensor Calibration


Performing the Zero CO2 Sensor calibration defines internal CO2 sensor performance
characteristics. The calibration data is used during normal operation to ensure accurate CO2
measurements when a CO2 sensor is in use.

The IRMA Mainstream Sensor Zero test must be performed using room air.
The ISA Sidestream Analyzer does not require a zero test to be performed.

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 Zeroing the CO2 sensor should be performed only when an offset in gas value is
observed, or when an unspecified accuracy message is displayed.
 CO2 monitors are permanently factory calibrated and do not require routine
calibrations. However, the CO2 sensor calibration does require that you verify
accuracy for regular maintenance.

o Prior to performing the Zero CO2 Sensor calibration, ensure the CO2 sensor is securely
connected to the Inspiration 5i ventilator and that the ventilator is powered on. When
connected to the ventilator, a green LED on the top of the CO2 sensor will illuminate
indicating that the CO2 sensor is being powered and properly connected.
o Snap in a new IRMA airway adapter into the IRMA Sensor, without connecting the
airway adapter to the patient circuit, and then press the Zero CO2 Sensor button on the
Calibrations screen.
o The Zero CO2 Sensor Calibration-screen will load and display the last calibration for the
attached sensor, if no calibration history exists for the attached CO2 sensor, the date /
time reference will be blank.
o Begin the Zero CO2 Sensor calibration process by pressing the START/Re-Test button.
o During the Zero CO2 calibration sequence, the window will display the status message
Running…. as shown below in Figure 97.
o Once calibration is complete the window will display the calibration status message as
shown below in Figure 98.
o If there is an error at any step during the calibration, the calibration stops, and the
ventilator will display the appropriate error message.
 Verify that that the airway adapter windows are not blocked, and that the CO2
sensor is properly and securely connected and repeat the calibration.
 If the problem persists, refer to the Inspiration 5i Service Manual or contact a
qualified service technician.

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6.3.5.1. CO2 Sensor Calibration-screens

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Figure 96: Zero CO2 Sensor Calibration-screen

Figure 97: Zero CO2 Sensor Calibration – Running…

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Figure 98: Zero CO2 Sensor Passed

6.4. Alarm Test Procedures


 The alarm test procedures listed below comply with EN 794-1 recommendation.
 See section 1.6 for a list of product Compliance and Approval Notices.

Follow these instructions to test the Inspiration 5i ventilator’s operation and alarms before
attaching the device to a patient.
 The following alarms will be tested during the Alarm Test Procedure
o High-pressure alarm
o Low pressure alarm
o Disconnection alarm
o Low minute volume alarm and low tidal volume
o Oxygen supply/Low oxygen alarms
o Continuous High-pressure alarm
o Apnea backup active alarm
o Power source transition
o Battery low
o Battery too low
o Imminent Shutdown and Connect AC Now
o Device Alert
In addition to the alarm tests, perform the Circuit Check calibration as defined above in section
6.3 to verify breathing circuit integrity. Correct any test failures conditions and rerun tests before
attaching the device to a patient.

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Section 6 Calibrations and Alarms Test Procedures

6.4.1. Alarm Functionality Setup Procedures


o Prepare the ventilator for use as defined above in section 2 and perform the calibrations
defined above in section 6.1, 6.3 and 6.3.4.
o From the New Patient Startup screen, set Patient Height to 150 cm, and keep all other
startup options at their default setting. Then press the ACCEPT button to exit the
Startup screen and load the Current Settings screen.
o Adjust the Current Settings and Alarm Settings as defined below.

Table 39: Alarm Test Settings

Mode and Mode Settings Alarm Settings

Mode V–CMV Ve High 50 l/min


O2 21 % Ve Low 2 l/min

Rate 15 b/min Vte High 1000 ml


Vt 400 ml Vte Low 200 ml

PEEP 5 cmH2O Rate High 100 b/min

Flow 48 l/min Rate Low 1 b/min

Ftrig 3 l/min Ppeak High 40 cmH2O

Flow Pat. Decel Ppeak Low 3 cmH2O

Trigger Flow Pmean High 15 cmH2O

NIV Off Pmean Low 3 cmH2O

Pause 0.00 s Leak 100 %


Auto Control Off Apnea Time 20 s
Leak Comp On Vti Limit Off

6.4.2. Alarm Functionality Tests


o High-pressure alarm test:
 Allow the ventilator to cycle at the above settings with a standard test lung
attached. Change the Ppeak High alarm limit to 6 cmH2O.
 Verify that the High-pressure alarm sounds after two breaths, and that patient
pressure is limited to 6 cmH2O.
 Change the Ppeak High alarm setting back to 40 cmH2O.

o Low Pressure, Disconnection, Low Tidal Volume and Low Minute Volume alarm
tests:
 Change the Ve Low alarm limit to 12 l/min and disconnect the test lung from the
circuit.
 Verify that the Disconnection and Low Tidal Volume alarms sound after the next
breath.
 Verify that the Low Pressure alarm and Low Minute volume alarm sounds after
several breaths.
 Change the Ve Low alarm back to 2 l/min and reconnect the test lung.

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o Oxygen Supply and Low Oxygen alarm tests:


 Change the Oxygen% setting to 100% and disconnect the oxygen supply line.
 Verify that the Oxygen Supply alarm sounds immediately, and that the Low
Oxygen alarm sounds within a few breaths.
 Change the O2 setting back to 21%.

o Occlusion alarm test:


 Change the Ppeak High alarm setting to 20 cmH2O and block the expiratory limb
of the circuit.
 Verify that the Occlusion alarm sounds within two breaths, and that the alarm is
continuous until you unblock the circuit. The High-pressure alarm may also be
triggered.
 Unblock the circuit and change the Ppeak High alarm back to 40 cmH2O.

o Apnea Backup Active alarm test:


 Change the Rate to 5 b/min and change the Apnea time to 10 seconds.
 Verify that the Apnea Backup active alarm sounds and that Apnea Backup
ventilation begins within 10 seconds.
 Change the respiratory rate back to 10 b/min and change the Apnea time back to
20 seconds.
o Power Source transition test:
 Disconnect the AC power cord from the wall or the back of the ventilator and verify
that an audible tone sounds immediately.
 Verify that the ventilator begins battery operation without interrupting ventilation
and that the battery icon with estimated capacity displays in the upper right corner
of the screen.
 Reconnect the mains power cord and verify that an audible tone sounds
immediately and that the AC power indicator LED to the right of the scroll knob
turns green.
o Battery Alarm Tests:
 If testing of the internal battery is desired, assure that the battery is fully charged
to greater than 95%. Disconnect the high-pressure air source and AC mains and
operate the ventilator on 21% with the internal compressor if it is available. The
ventilator should operate for approximately 2 hours with the standard settings VCV
500mL, square Flow 30Lpm, RR 15bpm, PEEP 5cmH2O, FiO2 21% and monitor
Peak Pressure < than 30cmH2O. Assure stable delivery and no auto-triggered and
any alarm violation other than the battery during the test. If no internal compressor
is installed the ventilator should take approximately 4 hours to discharge.
 Assure that a medium priority low battery alarm sounds as the ventilator
discharges to a low value around 25 %. The ventilator should continue to run until
the ventilator detects a “Battery too low” Alarm around 10% or less. This is Non
Silenceable alarm and High Priority Alarm.
 From the start of Battery too low Alarm, the ventilator will transition to “Imminent
Shutdown Alarm and Connect AC Now Alarm” with high pitch buzzer continuous
sounding (Non Silenceable). At this point, the ventilator may shutdown any time
(Device Alert state). The ventilator was designed have enough battery to ventilate
at least 5 minutes from start of “Battery too low alarm until Device Alert state or
complete shutdown.
 On Device Alert State, the ventilator is complete off but buzzer should continuous
sounding for at least 2 minutes with the same sound intensity.

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o High FiO2 alarm test:


 If testing of the high FiO2 alarm is desired, remove the cover plate for the O2
sensor. Disconnect the electrical connector from the O2 cell. Operate the
ventilator with test settings. The O2 value will rise to a high value of around 103%.
Assure that the high O2 alarm sounds within a few breaths.

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Section 7 Accessories List

7. Accessories List
Item Description Part Number

01 Exhalation Membrane EVM200325 (detachable)

02 Exhalation Cover F710214 (detachable)

03 Galvanic Oxygen Sensor F910028

04 High-pressure Air Hose F910037 (detachable)

05 High-pressure Oxygen Hose F910038 (detachable)

06 Inspiration 5i Ventilator User Manual CD EVM500024-CD

07 E-Z Flow Sensor, Adult/Ped, Reusable F910321 (detachable)

08 E-Z Flow Sensor, Infant, Reusable F910322 (detachable)

09 E-Z Flow Sensor Tubing, Single Patient Use (SPU) F910361 (detachable)

10 E-Z Flow Sensor 9” Tubing, Single Patient Use (SPU) EVM200248 (detachable)

11 Inspiration 5i Ventilator Installation Instructions EVM500036

12 AC Power Cord, Japan/USA F910207 (detachable)

13 AC Power Cord International F910076-IN (detachable)

14 Inspiration 1 Year PM Kit F930136

15 Test Lung Kit, Adult EVM200012

16 Accessory Carton 12.1 F930507

17 P-Clip 6mm F910009

18 Cable Loop Clamp, 5/16” OD, Nylon EVL250014

19 Flex Circuit Support Arm F710616 (detachable)


20 Cart EVM200217
21 Power Cord Japan_USA F910207
Power Cord International F910076-IN

Table 40: Accessories include with ventilator

 Use only original eVent Medical accessories listed in the Table 40: Accessories
include with ventilator. Breathing Circuits, Humidifiers, and Nebulizers are not
included accessories and must be ordered speparately.
 Ventilator basic safety and essential performance can be compromised with non-
original eVent Medical accessories

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Section 8 Cleaning

8. Cleaning
Perform all cleaning and disinfection carefully, according to standard institutional procedures
to ensure the ventilator functions safely and effectively.

Only trained personnel should perform cleaning procedures.


To prevent transmission of disease, use protective equipment when handling
circuits, filters, HMEs or other potentially contaminated devices and accessories.
Follow manufacturer guidelines and maintenance instructions explicitly, using
only specified parts. Clean, disinfect ventilator components and
accessories as instructed in this section.
Do not reuse single-patient use bacteria filters, Flow Sensors, and
other accessories. They must be discarded after single use.
Do not attempt to sterilize the interior of the ventilator. Do not attempt to sterilize the
whole ventilator with ETO gas.
Exposure to sterilizing / cleaning agents may reduce the useful life of certain parts.
Using more than one technique on a single part may damage the part.

 The cleaning section of this manual complies ISO 14937 second edition 2009-10-15
and ISO 17664 first edition 2004-03-01.

8.1. Exterior Ventilator Cleaning Recommendations


Dampen a soft cloth with a nonabrasive glass cleaner and wipe down the screen of the Inspiration
Ventilator after every use or as needed.
Most glass cleaners or bleach-based cleaners are fine to use on touch screen surfaces.
 Do not use any vinegar-based solutions.
 Handle the touch screen with care and avoid using gritty cloths to prevent scratches.
The exterior surface of the Inspiration Ventilator should be cleaned after every use or as needed
with antibacterial or germicidal agent.

8.2. Decontamination Methods for Ventilator Parts and


Accessories
The following information provides general guidelines for cleaning and decontamination
applicable to Inspiration Ventilators, components and accessories. For parts not supplied by
eVent Medical, follow the manufacturer’s guidelines. After cleaning and decontaminating parts,
perform any required tests and calibrations.

Table 41: Decontamination Methods for Ventilator Parts and Accessories

PART PROCEDURE COMMENTS


How to decontaminate
Ventilator exterior, cart, Wipe with a soft cloth and mild It is important to remember that only the exterior of
high-pressure gas detergent or with isopropyl alcohol the ventilator should be cleaned in this manner.
supply hoses, after each patient use or as needed.
communication WARNING:
adaptors, power cords. Do not try to clean or sterilize the ventilator
Excluding the Touch interior as this can damage internal parts. The
Screen materials and design of the internal parts do not
require sterilization. Use appropriate patient
circuit bacteria filters to protect the patient and
device from potential cross contamination.

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Table 41: Decontamination Methods for Ventilator Parts and Accessories

PART PROCEDURE COMMENTS


How to decontaminate
Touch Screen LCD Dampen a soft cloth with isopropyl To clean the screen during use, press the Lock button
Display alcohol or a non-abrasive glass to lock the screen. It is important to unlock the screen
cleaner and wipe the screen surface when finished.
until clean.
WARNING:
Do not use any abrasive or gritty cloths on the
surface of the screen and avoid using cleaning
agents other than those recommended.

Disposable EZ-Flow This sensor is disposable and must WARNING:


Sensor marked as SPU be discarded after single patient
(single patient use) use. Do not attempt to reuse or sterilize.
The flow sensor can become contaminated with
body fluids or expiratory gases during ventilator
normal use.

Reusable EZ-Flow Only reusable EZ-Flow Sensors can WARNING:


Sensor (no tubing be cleaned:
attached) Do not attempt to reuse or sterilize the separate
Remove flow sensor tubing tubing (blue and clear) that are single patient
The separate tubing before cleaning the reusable use (SPU).
are SPU (single patient sensor. The tubing is single The flow sensor can become contaminated with
use) patient use and must be replaced. body fluids or expiratory gases during ventilator
Follow standard institutional normal use.
operating procedure to clean and /or The reusable EZ-Flow Sensor is provided in its
disinfect. original package, but not sterile. Follow standard
institutional operating procedure to clean or follow
the manufacturer’s guidelines.

Exhalation membrane / Follow standard institutional WARNING:


diaphragm operating procedure to clean or
disinfect the Exhalation membrane / The Exhalation membrane / diaphragm can
(blue silicone rubber) diaphragm between patients. become contaminated with body fluids or
expiratory gases during ventilator normal use.
The Exhalation membrane is provided clean in
its original package, but not sterile. Follow
standard institutional operating procedure to
clean or disinfect.
Visually inspect the diaphragm for any damage
and replace if necessary.

Exhalation Valve Cover Follow standard institutional Inspect the Cover before use and after each cleaning
operating procedure to clean or cycle for any damage. Look for staring or
(polysulfone) disinfect the Exhalation membrane / discoloration of the plastic. If any of these occur,
diaphragm between patients. dispose of and replace the cover.
Solutions such as Metricide have WARNING:
been tested according to the
manufacturers’ guidelines. Other Do not autoclave if medications containing
brand names with similar active chlorinated or aromatic hydrocarbons are used.
ingredients may also be suitable. The Exhalation Valve Cover can become
contaminated with body fluids or expiratory
gases during ventilator normal use.
The Exhalation Valve Cover is provided clean in
its original package, but not sterile. Follow
standard institutional operating procedure to
clean or disinfect the Exhalation Valve Cover.

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Section 8 Cleaning

Table 41: Decontamination Methods for Ventilator Parts and Accessories

PART PROCEDURE COMMENTS


How to decontaminate
Patient Breathing Circuit Follow the breathing circuit Follow manufacturers instructions for usage of Patient
manufacture instructions to clean Breathing Circuit.
(Reusable) and/or disinfect/sterilize prior to use.
Sterilize reusable breathing tubes Roll tubes into large coils. Do not twist, kink, or cross
between patients according to tubes when sterilizing them. The tubing lumen should
institution procedure and breathing not have vapor or moisture before wrapping for
circuit manufacture label. autoclaving.
Dispose of and replace single patient use items
between patients according to manufacturing
guidelines
WARNING:
Avoid exposing silicone rubber breathing tubes
to grease, oil, silicone-based lubricants, organic
solvents (benzene, ether, ketone, and
chlorinated hydrocarbons), acids, concentrated
alkaline cleaning products, and phenols and
derivatives.
The breathing circuits are provided clean in their
original package, but in general, they are not
provided in sterile condition. Follow the
breathing circuit manufacture instructions to
clean and/or disinfect.

CO2 Sensor The Sidestream (ISA) sensor should To prevent cleaning liquids and dust from entering the
be cleaned on a regular basis. ISA sensor through its LEGI (Nomoline) connector,
Sidestream (ISA) keep the Nomoline sampling line connected while
Follow Manuacturers instructions to cleaning the sensor
clean sensors.
WARNING:
.
The Nomoline sampling lines are non-sterile
The Nomoline sampling line is
devices and single patient use (SPU). To avoid
single patient use (SPU)
damage, do not autoclave any part of the
sampling line.
Never sterilize or immerse the ISA sidestream
sensor in liquid.

CO2 Sensor The Mainstream (IRMA) sensor IRMA airway adapters are single patient use only.
should be cleaned on a regular Remove the disposable IRMA airway adapter prior to
Mainstream (IRMA) basis. cleaning the IRMA sensor.
Follow Manuacturers instructions to WARNING:
clean sensors.
The IRMA oxygen sensor cell and IRMA airway
The airway adapters are single adapters are non-sterile devices. Do not
patient use (SPU) autoclave the devices as this will damage them

Reusable Ventilator Reusable Ventilator Parts and Accessories can be


Parts and Accessories reused no more than 50 times.

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Section 9 Preventative Maintenance and Disposal

9. Preventative Maintenance and Disposal


This section provides detailed information regarding preventive maintenance procedures, and disposal
recommendations.

Only trained personnel should perform preventive maintenance procedures.


Follow manufacturer guidelines and maintenance instructions explicitly, using only
specified parts.
To prevent damage to ESD-sensitive components, always follow ESD guidelines
when servicing and handling components inside the ventilator.

Preventive Maintenance Schedule

Table 42: Preventive Maintenance Schedule

Interval Maintenance Procedure Part Number


Every 250 hours Replace the Fan Filter (if necessary) F910214
or as needed

Every 1 year Replace the Fan Filter F910214


or as needed

Every 1 year Replace the Inlet Gas Filters (if necessary) F910205
or as needed

Every 1 year Replace Galvanic O2 Sensor (if necessary) F910028


or as needed

Every 1 year Replace Rubber Buffers (if necessary)  F810026


or as needed (refer to the Inspiration 5i Service Manual) 
Every 1 year Inspect Compressor Inlet Filter (if necessary)  F810044
or as needed (refer to the Inspiration 5i Service Manual) 
Every 1 year Perform Performance Verification Test 
or as needed (refer to the Inspiration 5i Service Manual) 
Every 2 years Replace Internal Batteries  F820003
or as needed
(refer to the Inspiration 5i Service Manual) 
Ventilator battery replacement shall be performed only 
by qualified and trained personnel.
As Required Replace Fuses F810135
Only as needed

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Section 9 Preventative Maintenance and Disposal

9.1. Preventive Maintenance Procedures


9.1.1. Cooling Fan Filter: Cleaning or Replacement
 Clean and or replace the fan filter every 250 Hours as needed.
 Replace the fan filter Every 1 year or as required.
 Check the fan filter regularly for blockages and contamination and clean as needed.

1. Use a small flat-blade screwdriver to loosen the filter


cover’s screw. Then pull the filter cover away from
the back panel.

2. Replace the fan filter or wash under running water.


If washed, do not reinstall the fan filter until it is
completely dry.

3. Push the filter cover back into the back panel and
retighten screw.
Figure 99: Fan Filter:
Cleaning or Replacement

9.1.2. Inlet Gas Supply Filters: Replacement


 Replace the inlet gas supply filter every year or as needed.
 Check the inlet gas supply filters regularly for blockages and contamination and clean or
replace as needed.

The two inlet gas supply filters protect the


ventilator from water and particulate
contamination. Inlet Gas
____________________________________________ Supply Filter
1. Remove the filter housing by turning
counterclockwise. Clean the filter
housing with a solution of water and Water Trap
mild detergent.
2. Replace the filter element. Do not
attempt to clean the filter element.
3. Reinstall the filter housing
Figure 100: Inlet Gas Supply Filter Replacement

9.1.3. Oxygen Sensor: Replacement


 Replace the galvanic oxygen sensor every 1 year or as needed.
 Use recommended replacement oxgen sensors only.
 Always perform an oxygen sensor calibration after replacement.

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Section 9 Preventative Maintenance and Disposal

9.1.4. Internal Batteries: Replacement


 Replace the internal batteries every two years or as required
 Always replace both batteries at the same time.
 Use recomended replacement (lead acid) batteries only.
 Calibrate internal batteries following replacement as described in the
Inspiration 5i Ventilator Service Manual.
 Only a qualified service technician should replace the battery as described in the
Inspiration 5i Ventilator Service Manual

9.1.5. Fuses: Replacement

 Replace the ventilator’s fuses as needed

9.1.6. Performance Verification Testing


 Performance Verification Testing should be conducted every 1 year.
 Only a qualified service technician should run performance verification as described
in the Inspiration 5i Ventilator Service Manual.

9.2. Disposal
 To dispose of the ventilator and its components and accessories:
o Deliver the device, free of charge and duty paid, to the manufacturer for disposal, or
o Surrender the device to a licensed private or public collection company, or
o Dispose of all parts removed from the device according to your institution’s protocol.
o Follow all local, state, and federal regulations with respect to environmental protection,
especially when disposing of the electronic device or its parts (e.g., oxygen cell,
batteries).

 All disposals must comply with applicable local regulations. Consult the responsible
authorities for guidance and requirements. Recycling and disposal procedure must
not:
o Pose risk to human health.
o Damage the environment.
o Cause a noise or odor nuisance.
o Damage the surroundings or landscape.

The internal batteries and galvanic oxygen sensor cell contain lead and acid. Dispose
of these materials according to hospital procedures and local governing ordinances.
Risk of electrocution! Some of the device’s electronic components carry AC mains
voltage.
Always disconnect the mains plug and remove the internal battery before opening the
ventilator.

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Section 10 Technical Specifications

10. Technical Specifications:


10.1. Measurement Uncertainty
Measured Parameter Offset Gain
Flow 0.075 SLPM 2% reading
Pressure 0.15 cmH2O 0.5% reading
Oxygen Concentration 2% reading
Temperature 1 0C

10.2. Ventilator Breathing System (VBS) Compliance and


Resistance
Description Result
< 4.0 cmH2O @ Flow 30Lpm including an
adult breathing circuit and adult/ped prox
flow sensor
< 2.0 cmH2O @ Flow 15Lpm including a
Inspiratory gas pathway resistance pediatric breathing circuit and adult/ped prox
flow sensor
< 1.0 cmH2O @ Flow 2.5Lpm including a
neonate breathing circuit and adult/ped prox
flow sensor

< 4.0 cmH2O @ Flow 30Lpm including an


adult breathing circuit and adult/ped prox
flow sensor
< 2.0 cmH2O @ Flow 15Lpm including a
Expiratory gas pathway resistance pediatric breathing circuit and adult/ped prox
flow sensor
< 1.0 cmH2O @ Flow 2.5Lpm including a
pediatric breathing circuit and adult/ped prox
flow sensor

< 3.0 mL/cmH2O including an adult breathing


circuit and adult/ped prox flow sensor
< 2.5 mL/cmH2O including a pediatric
breathing circuit and adult/ped prox flow
Ventilator Breathing System Compliance sensor
< 2.0 mL/cmH2O including an infant/neonate
breathing circuit and adult/ped prox flow
sensor

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Section 10 Technical Specifications

10.3. Power and Gas Supply


Power and Gas Supply
AC input 100 to 240 VAC (50/60 Hz)
Power consumption 160 VA (W)
DC input 24 VDC
Battery Type Lead Acid
Battery Backup time on Internal battery

Minimum 4 hours
Battery Backup time off compressor
(with fully charged battery) Settings: VCV500mL F30Lpm Rate 15bpm
PEEP 5cmH2O FiO2 21% Test Lung C20Rp20

Minimum 60 min
Battery Backup time on compressor
(with fully charged battery) Settings: VCV500mL F30Lpm Rate 15bpm
PEEP 5cmH2O FiO2 21% Test Lung C20Rp20

29 to 86 psi (2 to 6 bar) clean, dry,


Oxygen inlet supply pressure
and oil-free medical grade
Oxygen inlet supply flow 180 l/min (STPD, dry required)
29 to 86 psi (2 to 6 bar) clean, dry,
Air inlet supply pressure
and oil-free medical grade
Air inlet supply flow 180 l/min (STPD, dry required)
Heliox inlet supply pressure 29 to 86 psi (2 to 6 bar) clean, dry, and
(* Heliox gas source) oil-free 80% / 20% Only

15.8 l/min minute volume at 14.7 psi (1


bar).
Internal compressor
Compressor operation is enabled or
disabled in configuration-screen
Earth leakage current < 800 μA
Touch leakage current 50 μA Maximum

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Section 10 Technical Specifications

10.4. Environmental
Environmental Data Ventilator
10 to 40 °C at 10 to 80 % relative
Operating temperature
humidity
-10 to 60 °C at 5 to 95 % relative
Transport/Storage temperature
humidity
Atmospheric operating pressure 8 to 15.6 psi (550 to 1060 mbar)
< 10,000 ft (3048 m) above sea level
Operating altitude
< 50000 ft 86 psi15,240 m (storage)

 Following exposure to condensation, store the unit for over 24 hours in an environment
with a relative humidity below 95% non-condensing.

Environmental Data Capnography (CO2) Sensors


Sidestream (ISA) and Mainstream (IRMA) Sensors

Operating temperature 0 to 50 °C (32 to 122 °F) at < 4 kPa


(Sidestream CO2 sensor) H2O (90 % relative humidity at 30 °C)

Operating temperature 0 to 40 °C (32 to 104 °F) at


10 to 95% relative humidity,
(Mainstream CO2 sensor) non-condensing
Storage temperature -40 to 75 °C (-40 to 158 °F) at
(Sidestream CO2 sensor) 5 to 100% relative humidity *

Storage/transportation temperature
-20 to 50 °C (-4 to 122 °F) at
(Mainstream CO2 sensor) 5 to 100% relative humidity *

Operating: 52.5 to 120 kPa


Atmospheric pressure maximum altitude 15,000 ft (4572 m)
Storage: Sidestream: 20 to 120 kPa
maximum altitude 38,600 ft (11,760 m)
Storage: Mainstream: 500 to 1200hPa
maximum altitude 15,000 ft (4572 m)
Ambient CO2 < 800 ppm

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Section 10 Technical Specifications

10.5. Physical Characteristics: Ventilator, Sensors and Carts


Physical Data
17 x 20 x 34 in
Width x depth x height (ventilator)
(40 x 40 x 53 cm)
Weight of ventilator 60 lbs (27 kg)
Weight of Deluxe cart III: 35 lbs (16 kg)
Total unit weight including accessories ≈ 99 lbs (45 kg)
Physical Data Flow Sensor (External)
Dead space: 6.9 ml
Adult / Pedi flow sensor
Sensor length: 3.25” (6.35 cm)
For use at the Proximal Port or Expiratory
Port
Sensor weight: 6.3 grams
Vt range: 100 ml and above
Dead space: 0.75 ml Sensor
Neonate / Pedi flow sensor Sensor length: 2.0” (5.1 cm)
For use only at the Proximal Port Sensor weight: 4.0 grams
Vt range: 1 to 99 ml
Optional (ISA) Sidestream CO2 Sensor

1.3 x 3.1 x 1.9 in


Width x depth x height
(33 x 78 x 49 mm)
2.50 m + 0.02 m
Cable length
(98.4 in. + 8 in)
2.0 m + 0.01 m
Sample Line length
(78.7 in. + 0.39 in)
Weight 4.5 oz (130 g) excluding cable
Optional (IRMA) Mainstream CO2 Sensor and Airway Adapter

1.49 x 1.45 x 1.34 in


Width x depth x height
(38 x 37 x 34 mm)
Weight 0.88 oz (25 g) excluding cable

Dead Space Adult/Pedi: 6 ml


Airway Adapters Infant: 1 ml
Other Ventilator Data

Noise Level  55 dBa

10.6. Technical Data: Ventilator

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Section 10 Technical Specifications

Ventilator Technical Data


120 cmH2O via a dedicated
Maximum limited pressure
pressure relief valve
100 cmH2O controlled by high-
Maximum operating pressure
pressure alarm setting
Pressure measurements are made by
solid-state pressure transducers
Measuring and display devices positioned to monitor internal
operating, inspiratory, and expiratory
circuit pressures
Flow measurements are made by one
of two differential pressure fixed orifice
flow sensors, and are integrated with
Flow and volume measurement time to calculate inspiratory and
expiratory volumes. Flow and volume
measurement ranges are according to
monitored data specifications
A galvanic cell is positioned in parallel
to the inspiratory manifold to measure
Oxygen measurement
the delivered oxygen concentrations
from 15 to 103%.
All data appears on a touch screen
Display Touch Screen enabled color liquid crystal display
(LCD)

10.7. Technical Data: Capnography Sensors

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Section 10 Technical Specifications

Capnography Sensors Technical Data

0 to 15 % CO2 at 22 ± 5 °C and
1013 ± 40 hPa: ± (0.2 vol% + 2% of reading);
CO2 Sensor accuracy unspecified above 15 %.
For all specified environmental conditions:
± (0.3 kPa + 4% of reading)

Effects of Gas Interference on the Helium (He) (50 vol %): - 6% of reading at
CO2 Sensor indicated gas level.
CO (carbon monoxide)* (1 vol %): negligible.
(According to EN ISO 21647:2004
standard) Not for use with metered dose inhaler
propellants.
* In addition to EN ISO 21647:2004
standard.

Sidestream (ISA) CO2 sensor: < 3 s with 2m


Response time sampling line.
Mainstream (IRMA) CO2 sensor: < 1 s

Sample flow rate


Sidestream (ISA) Sensor: 50 + 10 ml/min

Sidestream (ISA) Sensor: < 10 s


Warm up time Mainstream (IRMA) Sensor: 10 s, full
specification within 60 s

Mainstream (IRMA) and Sidestream (ISA)


Identification threshold CO2 sensor: 0.15 vol%; reports lower
concentrations if apnea is not detected.

Capnography Sensors Technical Data

Below is the typical effect if using the default value (21 vol% O2) when measuring on gas mixtures
with different O2 concentration: Other Ventilator Data

O2 concentration in Effect on gas Displayed value if true


gas mix reading concentration is 5.0 vol% CO2

21 vol% 0% relative 5.0 vol%

50 vol% -2.76% relative 4.9 vol%

70 vol% -4.67% relative 4.8 vol%

95 vol% -7.05% relative 4.7 vol%


.x

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Section 11 Ventilator Specifications

11. Ventilator Specifications


This section provides specifications for the Inspiration 5i Ventilator.
 Pressures are shown on the Inspiration 5i ventilator in cmH2O, mbar and Hectopascals (hPa).
The unit mbar and hPa are used by some institutions instead of cmH2O. Since 1 mbar equals
1 hPa, which equals 1.016 cmH2O, the units may be used interchangeably.
 Certain CO2 measurements are shown in mmHg rather than Torr or kPa.
For reference, 1 Torr = 1 mmHg which equals 7.501 kPa.

11.1. Essential Performance Requirements


Per ISO/EN 80601-2-12: 2011, Medical electrical equipment Part 2-12: Particular requirements for
basic safety and essential performance of critical care ventilators, the ventilator’s essential performance
requirements are given by the following items which are specified in this section:
 Ventilator tidal volume and airway pressure accuracy delivery;
 High and Low oxygen alarms;
 High and Low pressure alarms;
 High and Low expiratory minute volume alarms;
 Occlusion alarm;
 Gas supply alarm (Air/Heliox and O2);
 Battery alarm management

 The ventilator accuracies listed in this chapter are applicable under the
operating the environmental conditions identified in the section 0

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Section 11 Ventilator Specifications

11.2. Ventilation Mode Types and Mode Selections


Ventilation Mode Types and Mode Selections
Mode Types Mode Selections Description

CMV P–CMV
Assist Control Continuous Mandatory Ventilation
V–CMV
(CMV)
PRVC–CMV

SIMV P–SIMV
Synchronized Intermittent Mandatory Ventilation
V–SIMV
(SIMV)
PRVC–SIMV

SPONT PS Spontaneous Ventilation


VS (SPONT)
SPAP
SPAP – Spontaneous Positive Airway
NCPAP+ NOTE:
Pressure. It is equivalent to APRV or BiLevel

11.3. Breath Type by Control Variables


Breath Types by Control Variable
Control Variable Breath Type Mode Selections

Volume Mandatory V–CMV


Volume Control
Mandatory + Spontaneous V–SIMV
Volume Control + Pressure Support

Pressure Mandatory P–CMV


Pressure Controlled

Mandatory + Spontaneous P–SIMV


Pressure Controlled + Pressure Support

Spontaneous PS
Pressure Support, SPAP & NCPAP SPAP
NCPAP+ (intermittent controlled mandatory PC breaths) NCPAP
NCPAP+

Dual Mandatory PRVC–CMV


Pressure Regulated Volume Targeted Pressure Control
Volume Control
and Mandatory + Spontaneous PRVC–SIMV
Volume Support Volume Targeted Pressure Control + Pressure Support
modes
Spontaneous VS
Volume Targeted Pressure Support

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Section 11 Ventilator Specifications

11.4. Other Ventilation Mode Options


Description Other Mode Options
Spontaneous Breathing Trial
(PEEP + PS at user defined settings and SBT
SBT Time)

Auto Control
(weaning mode feature for automatic transition Auto Control
from CMV to SPONT modes)

Non-Invasive Ventilation
(Mode feature for enhanced leak NIV
compensation)

Tube Compensation
(compensates for the patient’s artificial airway Tube Comp.
imposed resistance)

11.5. Patient Startup Settings


New Patient Startup Settings Setting Ranges
Patient Height 15 to 250 cm or 6 to 98 in
136 to 250 cm (default: 150 cm)
Adult
54 to 98 in (default: 59 in)
48 to 134 cm (default: 100 cm)
Pediatric
27 to 53 in (default: 39 in)
15 to 46 cm (default: 42 cm)
Neonate
6 to 26 in (default: 17 in)
IBW
Ideal Body Weight Limits per Patient Height
Adult > 41 kg
Pediatric > 9.7 ≤ 40 kg
Neonate > 0.3 ≤ 9.6 kg
Gender Male, Female
Humidifier, HME, None
Humidification Type
(default: Humidifier)

11.6. Standard Mode Settings


Standard Mode Settings Setting Ranges
Respiratory Rate
Adult 1 to 60 b/min
Pediatric 1 to 120 b/min
Neonate 1 to 150 b/min
Accuracy:
0 to 100 b/min ± 1 b/min
> 100 b/min ± 2%

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Section 11 Ventilator Specifications

Standard Mode Settings Setting Ranges

Tidal Volume and Target Tidal Volume


Adult 300 to 2000 ml
Pediatric 40 to 500 ml
Neonate 2 to 100 ml
Delivery Accuracy: (Compliance & BTPS Compensated)
2 to 4 ml ± 1 ml + 10%
5 to 49 ml ± 2 ml + 10%
50 to 2000 ml ± 5 ml + 10%
Heliox:(Adult and Ped only) ± 10 ml + 10%

Note: Ventilator tested with F&P adult and pediatric heated wire breathing circuit and
active humidifier at BTPS gas condition. The accuracy may be degraded if the
compressed volume from the breathing circuit or accessories changes from the previous
or original system calibration or ventilator breathing circuit check.

I-Time
(US philosophy setting)
All Patient Types 0.1 to 10 s
Accuracy:
< 10.0 seconds ±0.01 s
≥ 10.0 seconds ±0.1 s

I:E Ratio
(European philosophy setting)
All Patient Types 1 : 9.0 to 4.0 : 1
Accuracy:
Ti, Te and Tpause < 10.0 seconds ±0.01 s
≥ 10.0 seconds ±0.1 s

PEEP / CPAP
0 to 50 cmH2O or 0 to (90 cmH2O - Pcontrol, Psupport), whichever is less

Accuracy:
± (2 cmH2O + 4%)

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Section 11 Ventilator Specifications

Standard Mode Settings Setting Ranges

Pcontrol (above PEEP level)


5 to 90 cmH2O or
Adult (90 cmH2O - PEEP),
whichever is less
5 to 90 cmH2O or
Pediatric (90 cmH2O - PEEP),
whichever is less
2 to 90 cmH2O or
Neonate (90 cmH2O - PEEP),
whichever is less
Accuracy:
± (2 cmH2O + 4%)

Psupport (above PEEP level)


0 to 90 cmH2O or 0 to (90 cmH2O - PEEP), whichever is less

Accuracy:
± (2 cmH2O + 4%)

Flow Mandatory Spontaneous


(US philosophy configuration) (Flow Setting) (not settable)
Adult 1.0 to 120 l/min 1.0 to 180 l/min
Pediatric 1.0 to 90 l/min 1.0 to 90 l/min
Neonate 1.0 to 60 l/min 1.0 to 60 l/min
Accuracy:
1.0 to 10.0 l/min ± (1.0 l/min + 10%)
11.0 to 180 l/min: ± (5.0 l/min + 10%)

Trigger Type
Flow or Pressure

Flow Trigger (Ftrig)


Adult 0.2 to 25.0 l/min (default: 3 l/min)
Pediatric 0.1 to 15.0 l/min (default: 2 l/min)
Neonate 0.1 to 10.0 l/min (default: 1 l/min)

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Section 11 Ventilator Specifications

Standard Mode Settings Setting Ranges

Pressure Trigger (Ptrig)


0.5 to 20.0 cmH2O
All patient types
(default: 2 cmH2O)

Leak Comp
On or Off
Automatic Leak Compensation
If ON and NIV is set to Off the ventilator will
0.0 to 25.0 l/min
compensate for leaks automatically from:
If ON and NIV is set to ON the ventilator will
0.0 to 60.0 l/min
compensate for leaks automatically from:

Base Flow
The Base Flow is only available for
manual adjustment if Leak Comp is 2.5 to 25.0 l/min
set to Off.

NIV On or Off
Non-Invasive ventilation can be enabled in all modes.
If Leak Comp is On and when NIV is enabled the system will automatically
compensate for leaks up to 60.0 l/min STPD.
With NIV disabled, the system will compensate for leaks up to 25.0 l/min STPD.

PS Tmax Default initial setting based on


Time termination criteria for all PS breaths IBW
Adult 0.50 to 5.0 s
Pediatric 0.50 to 5.0 s
Neonate 0.15 to 3.0 s
Accuracy:
Same as Ti
When Psupport is set to 0 cmH2O, the PS Tmax feature is background disabled. This will
prevent time-based termination of the patient’s breath and allow vital capacity (VC)
measurements to be obtained.

Pause
Inspiratory Plateau
Pause
0.00 to 42.0 s (default: 0 s)
(US philosophy configuration)
Tplateau
0 to 70 % of breath cycle time
(European philosophy configuration)
Accuracy:
± (0.05 s + 1%)

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Section 11 Ventilator Specifications

Standard Mode Settings Setting Ranges

Oxygen
O2 21 to 100 %
Response Time to change in FiO2
settings from 21% to 90% O2.
Measured at patient connection port < 50 s for volume 500mL
(breathing circuit wye connector) with < 75 s for volume 150mL
adult and pediatric F&P breathing < 105 s for volume 30mL
circuit and active humidifier with
minimum water level.
Accuracy (Delivery):
± (3 %) full scale

Rise Time 1 to 20
1 = Slow and 20 = Fast

Flow Pattern
Flow Pat. Decel (Decelerating), De50% (Decelerating 50%),
or Square

Exhalation Sensitivity
Esens 10 to 80 % of peak insp flow

Auto Control
Auto Control On or Off
Auto Time 3 to 60 sec
Auto Spont Mode Selection PS or VS Mode

11.7. SPAP Mode Settings


SPAP is a dual PEEP mode, which is equivalent to APRV and BiLevel
o For additional details on the SPAP Mode see section 12.10.

SPAP Mode Settings Setting Ranges


High PEEP
Phigh 5 to 50 cmH2O or
Plow to 50 cmH2O or
5 to (90 - Psup high) cmH2O
Phigh cannot be set < Plow
Accuracy:
± (2 cmH2O + 4%)

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Section 11 Ventilator Specifications

SPAP Mode Settings Setting Ranges

Low PEEP
Plow 0 to 50 cmH2O or
0 to Phigh or
0 to (90 - Psup low) cmH2O
Plow cannot be set > Phigh
Accuracy:
± (2 cmH2O + 4%)

Pressure Support at High PEEP


Psup High 0 to 90 cmH2O or
0 to (90 - Phigh) cmH2O
whichever is less
Phigh + Psup High will not exceed 90 cmH2O

Accuracy:
± (2 cmH2O + 4%)

Pressure Support at Low PEEP


Psup Low 0 to 90 cmH2O or
0 to (90 - Plow) cmH2O
whichever is less
Plow + Psup Low will not exceed 90 cmH2O

Accuracy:
± (2 cmH2O + 4%)

Time at High PEEP


Thigh 0.1 to 59.8 s or
60 - Tlow setting
Accuracy:
< 10.0 seconds ±0.01 s
≥ 10.0 seconds ±0.1 s

Time at Low PEEP


Thigh 0.2 to 59.9 s or
60 - Thigh setting
Accuracy:
< 10.0 seconds ±0.01 s
≥ 10.0 seconds ±0.1 s

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Section 11 Ventilator Specifications

SPAP Mode Settings Setting Ranges

Cycle
(Low PEEP to High PEEP cycles per minute)
Adult 1 to 60 c/min
Pediatric 1 to 120 c/min
Neonate 1 to 150 c/min
Accuracy:
0 to 100 b/min ± 1 b/min
> 100 b/min ± 2%

H : L Ratio
H:L 1:59.0 to 59.0:1
Accuracy:
Thigh, Tlow < 10.0 seconds ±0.01 s
≥ 10.0 seconds ±0.1 s

SPAP Setting Philosophy


SPAP Type
Cycle + Thigh Setting Cycle + Time
Cycle + H:L Ratio Cycle + Ratio
Tlow + Thigh Time Only

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Section 11 Ventilator Specifications

11.8. NCPAP+ Mode Settings


o For additional details on the NCPAP+ Mode see section 12.10.3.

NCPAP+ Mode Settings Additional settings specific to NCPAP+

NCPAP+ Pcontrol and I-Time settings display


NCPAP+ is only available for Neonate patient type only if Rate is Set > 1 b/min

Rate Off or 1 to 40 b/min


PEEP/CPAP 2 to 10 cmH2O

Ti 0.25 to 1.50 s
Pcontrol 2 to 30 cmH2O

Flow 2.0 to 12.0 l/min


NCPAP+ setting relationship: Maximum Flow setting to PEEP setting
If NCPAP+ setting is: Maximum flow setting is:
2 cmH2O 7.0 l/min
3 cmH2O 8.0 l/min
4 cmH2O 10.0 l/min
5 cmH2O 10.0 l/min
6 cmH2O 10.0 l/min
7 cmH2O 12.0 l/min
8 cmH2O 12.0 l/min
9 cmH2O 12.0 l/min
10 cmH2O 12.0 l/min

NCPAP NCPAP+ = NCPAP if Rate is set to Off

Rate Off or 1 to 40 b/min


If Rate > 1 b/min use NCPAP+ table above
PEEP/CPAP 2 to 12 cmH2O

Flow 2.0 to 28.0 l/min


NCPAP setting relationship: Maximum Flow setting to PEEP setting
If NCPAP+ setting is: Maximum flow setting is:
2 cmH2O 8.0 l/min
3 cmH2O 13.0 l/min
4 cmH2O 15.0 l/min
5 cmH2O 17.0 l/min
6 cmH2O 19.0 l/min
7 cmH2O 21 l/min
8 cmH2O 23 l/min
9 cmH2O 24 l/min
10 cmH2O 25 l/min
11 cmH2O 26 l/min
12 cmH2O 28 l/min

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Section 11 Ventilator Specifications

11.9. SBT Mode Settings


o For complete details on the SBT Mode see section 5.3.9.

SBT Mode Settings Additional settings specific to SBT


(Spontaneous Breathing Trial)

SBT Time
15 to 120 min
(default = 30 min)
Accuracy:
±0.1 s

PEEP
0 to 30 cmH2O
(Default = Set Non-SBT mode PEEP unless changed by User.)
Accuracy:
± (2 cmH2O + 4%)

Psupport
0 to 30 cmH2O
(Default = IBW based default or Set Non-SBT mode Psupport unless changed by User.)
Accuracy:
± (2 cmH2O + 4%)

Esens Same as Esens referenced above.


Default = IBW based default or Set Non-SBT mode Psupport unless changed by User.

Rise Time Same as Rise Time referenced above.


Default = Same as Non-SBT mode Rise Time unless changed by User.

PS Tmax Same as PS Tmax referenced above.


Default = Same as Non-SBT mode PS Tmax unless changed by User.

O2 Same as O2 referenced above.

Default = Set Non-SBT mode O2 unless changed by User.

11.10. Tube Compensation Settings


o For complete details on tube compensation, see section 5.3.10.

Tube Compensation Settings Additional settings specific to Tube Comp.

TC
(Automatic Tube Compensation)
On or Off (default = Off)

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Section 11 Ventilator Specifications

Tube Compensation Settings Additional settings specific to Tube Comp.

Tube Diameter
2.0 to 10.0 mm
Default Tube Diameter for New Patients
Adult 7.5 mm
Pediatric 5.0 mm
Neonate 3.0 mm

Tube Length
2.0 to 30.0 cm
Adult 2.0 to 30.0 cm
Pediatric 2.0 to 26.0 cm
Neonate 2.0 to 15.0 cm
Default Tube Length for New Patients
Adult 30.0 cm
Pediatric 26.0 cm
Neonate 15.0 cm

Tube Compensation Type


Insp. Only or
Insp. + Exp.
Default Tube Compensation Type for New Patients
Insp. Only

11.11. Apnea Backup Settings


Apnea Backup Settings Additional settings specific to Apnea backup

Apnea Backup Modes V–CMV; V–SIMV; P–CMV; P–


Adult, Pedi or Neonate SIMV; PRVC–CMV, PRVC–SIMV;
User selected Breath type, mode and settings SPAP and OFF
The + O2 control sets the percentage increase above the
+ O2 % non-apnea modes O2 setting that will be delivered during
Apnea Backup Ventilation.
Apnea Backup Mode Settings
Adult, Pedi or Neonate Default Settings
(settings displayed depend on the selected apnea
backup mode)
Ventilation Mode P–CMV
Rate Based on IBW setting
Vt Based on IBW setting
Flow Based on IBW setting
Flow Pattern Decel
Pause 0.00 sec

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Section 11 Ventilator Specifications

Apnea Backup Settings Additional settings specific to Apnea backup


Same as the non-apnea mode
PEEP
PEEP until changed.
+O2 % (FiO2) 10 % above Main O2 setting
Ti (inspiratory time) Based on IBW setting
Pcontrol Based on IBW setting
Psupport Based on IBW setting
Tapnea (apnea time) 20 sec
Rise time 15
Esens 20
Apnea Backup On

11.12. Configuration-screen Setting Options (Config)


Config. Screen Options See section 5.6.3 for more details.
Clinical
Humidification Type Humidifier, HME, None
Air or Heliox
(Heliox: 0 to 79%)
Gas Type
Heliox is disabled with Neonate
patient type
Flow Sensor On or Off
Oxygen Sensor O2 Sensor; On or Off

IBW Adult: 41 to 200 kg


(Effects monitored data values that are Pedi: 9.7 to 40 kg
normalized to patient weight) Neonate: 0.3 to 9.6 kg
 Nebulizer On or Off
 User selected time (1 to 480
min, increments of 1 min)
Smart Nebulizer™
 Interval On or Off
 User selected interval (1 to 480
min, increments of 1 min)
 Sigh On or Off;
 Sigh Factor 0 to 50% of
Smart Sigh™ volume or pressure setting
 Sigh Interval: 20 to 200 breaths
 Number of sighs: 1 to 6

Config. Screen Options


Audio / Visual Graphics configuration Options

5, 8 or 10
Monitors Select Number of parameters
displayed in the Monitoring Bar
LCD Brightness 20 to 100 %
Light Background Off / On
Audio Level 35 to 100 %

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Config. Screen Options See section 5.6.3 for more details.


Screen Clicks Off / On
Config. Screen Options
Defaults

eVent Defaults Manufacturer default configuration

User defined (custom) default


Custom Defaults
configurations profiles
 Rename:
Default Settings 1 When the Rename button is
(User Defined Name) pressed, users can change the
name of a selected custom
default configuration profiles.
 Save Settings:
Default Settings 2 When the Save Settings button
(User Defined Name) is pressed, all current monitors,
graphic selections, mode type,
apnea backup mode type,
Config settings and all non-IBW
Default Settings 3 based settings are saved and
(User Defined Name) assigned to the selected
custom profile.
 ACCEPT:
Pressing the ACCEPT button,
will cause the selected Event or
Default Settings 4 Custom default settings profile
to load if selected during
(User Defined Name)
Standby or with the next patient
startup if selected during
ventilation.
Config. Screen Options

Technical Technical configuration Options

Patient Height (units) cm or in


Keyboard Standard or Generic Alpha
To view or adjust the additional
Technical and User Configuration
Password Access Settings enter the access code is
2634 and press OK or CANCEL to
return to previous screen.
Displays a list of all optional
features and provides an easy
visual indication via a check mark
for installed options or an X mark
Licensed Options for options not currently installed.
(Licensed software options are available Options Include:
as upgrades) * Recruitment Maneuvers
* SBT Mode
* Suction Support
* Tube Compensation

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11.13. Recruitment Maneuver Settings


o For a detailed review of all recruitment, maneuvers see section 5.4.2.

PVL Tool (p) Settings Single PRESSURE Breath Slow Inflation / Deflation Maneuver

PEEP 0 to 30 cmH2O
Level of PEEP applied during at the start of Default = Set Pre-maneuver PEEP
the PVL Tool maneuver and held for PEEP unless changed by User
Teq time

Pcontrol 5 to 60 cmH2O
Level of Pressure control applied during the Default = IBW default or set Pre-
inflation limb of the maneuver after PEEP maneuver Pcontrol until changed
equilibration time has been reached by User

Ramp 2 to 5 cmH2O/s
Rate of change in pressure per second Default = 2 cmH2O/s for New
during both inflation and deflation after Patients
PEEP equilibration time has been reached

PEEP Teq 0.0 to 30.0 s or


PEEP Equilibration Time 60 s - ((PC / Ramp) + Pause)
Time to stay at PVL Tool PEEP before the whichever is less
slow inflation breath is delivered. Default = 2.0 s for New Patients
For PVL Tool (p) and PVL Tool (v)
maneuvers only

Pause 0.0 to 30.0 s


Length of pause between inflation and Default = 0.0 s for New Patients
deflation limbs for PVL Tool (p) and
PVL Tool (v) maneuvers

End PEEP 0 to 30 cmH2O or


The new non-maneuver PEEP level that will (PVL Tool (P) PEEP + Pcontrol - 5
take effect after the recruitment maneuver cmH2O) whichever is less
completes successfully
Default = Set Pre-maneuver PEEP
unless changed by User

Psens 0.5 to 5.0 cmH2O


Termination sensitivity Default = 3.0 cmH2O for New
If there is a pressure drop > Psens setting, Patients
the maneuver will terminate, and normal
ventilation will resume at pre-maneuver
settings.

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PVL Tool (p) Settings Single PRESSURE Breath Slow Inflation / Deflation Maneuver

Tmaneuver Based on settings


Tmaneuver displays the total calculated
maneuver time in seconds based on the
maneuver’s settings.

 Tmaneuver calculation:
PVL Tool (p): Tmaneuver = PEEP Teq + (Pcontrol / Inflation Ramp) + Pause + ((Maneuver
PEEP - End PEEP + Pcontrol) / Deflation Ramp)
 Example: (PEEP Teq = 10 s), (Ramp = 2 cmH2O/s), (Pcontrol = 16 cmH2O), (Pause
= 4 s), (Maneuver PEEP = 10 cmH2O) and (End PEEP = 12 cmH2O)
 Tmaneuver = 10 + (16 / 2) + 4 + ((10 - 12 + 16) / 2) or
 Tmaneuver = 10 + 8 + 4 + 7 (Tmaneuver = 29 s)

Recruitment Maneuver Settings

PVL Tool (v) Settings Single VOLUME Breath Slow Inflation / Deflation Maneuver

PEEP 0 to 30 cmH2O
Level of PEEP applied at the start of Default = Set Pre-maneuver PEEP
the PVL Tool maneuver and held for unless changed by User
PEEP Teq time

Vt 40 to 2000 ml
Tidal volume delivered after PEEP Default = IBW default or Set Pre-
equilibration time has been reached maneuver Vt until changed by
User
Adult 300 to 2000 ml
Pediatric 40 to 500 ml

Flow 0.3 to 5.1 l/min


Rate of change in flow in l/min during both Default = 1.0 l/min for New
inflation and deflation after PEEP Patients
equilibration time has been reached PVL Tool (v) flow pattern = SQUARE
0.3 l/min = 5 ml/s & 5.1 l/min = 85 ml/s
Maximum Flow setting will be when Vt
/ Flow = no less than 0.40 sec
Minimum Flow setting will be when Vt
/ Flow = no more than 45.245 sec

PEEP Teq 0.0 to 30.0 s or


PEEP Equilibration Time 90.49 - ((Vt /(Flow*1000)/60)) X 2)
Time to stay at PVL Tool PEEP before the + Pause) whichever is less
slow inflation breath is delivered. Default = 2.0 s for New Patients
For PVL Tool (p) and PVL Tool (v)
maneuvers only

Pause 0.0 to 30.0 s


Length of pause between inflation and Default = 0.0 s for New Patients
deflation limbs for PVL Tool (p) and
PVL Tool (v) maneuvers

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Recruitment Maneuver Settings

PVL Tool (v) Settings Single VOLUME Breath Slow Inflation / Deflation Maneuver

End PEEP 0 to 30 cmH2O


The new non-maneuver PEEP level that will Default = Set Pre-maneuver PEEP
take effect after the recruitment maneuver unless changed by User
completes successfully

Psens 0.5 to 5.0 cmH2O


Termination sensitivity Default = 3.0 cmH2O for New
If there is a pressure drop > Psens setting, Patients
the maneuver will terminate, and normal
ventilation will resume at pre-maneuver
settings.

Tmaneuver Based on settings


Tmaneuver displays the total calculated
maneuver time in seconds based on the
maneuvers settings.

 Tmaneuver calculation:
PVL Tool (v): Tmaneuver = PEEP Teq + (Vt / Inflation Flow) + Pause
+ (Vt / Deflation Flow)
 Example: (PEEP Teq = 10 s), (Vt = 500 ml), (Flow = 50 ml/s) and
(Pause = 4 s)
 Tmaneuver = 10 + (500 / 50) + 4 + (500 / 50) or
 Tmaneuver = 10 + 10 + 4 + 10 (Tmaneuver = 34 s)
During a PVL Tool (v) maneuver, the actual Tmaneuver time may be less than calculated if
the End PEEP level is > the Maneuver PEEP level or greater than calculated if the End PEEP
level is < the Maneuver PEEP level.

Recruitment Maneuver Settings

Step Tool Settings Continuous ventilation at defined Step & Rest settings.

RM Step
Step PEEP 0 to 40 cmH2O or
Level of PEEP applied during the RM Step (90 cmH2O - Pcontrol) whichever
is less
Default = Set Pre-maneuver PEEP
unless changed by User

Pcontrol 5 to 60 cmH2O or
Level of Pressure control applied during the (90 cmH2O - Step PEEP)
RM Step whichever is less
Default = IBW default or set Pre-
maneuver Pcontrol until changed
by User

Rate 1 to 120 b/min


Breath Rate during both RM Step and Rest Default = IBW based default or
Step Pre-maneuver set Rate until
changed by User
Adult 1 to 60 b/min

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Recruitment Maneuver Settings

Step Tool Settings Continuous ventilation at defined Step & Rest settings.

Pediatric 1 to 120 b/min

I-Time (Ti) 0.10 to 10.0 s


Inspiratory time applied during breath Default = IBW based default or
delivery for both the RM Step and Rest Step Pre-maneuver set Ti until changed
phases of the Step maneuver by User

I:E Ratio 1 : 9.0 to 4.0 : 1


Displays in place of Ti when the European Default = IBW based default or
philosophy is enabled. Pre-maneuver set I:E until
changed by User

Rise Time 1 to 20
Rise time during both RM Step and Rest Default = 15 for New Patients
Step

Step Time 1 to 10 min


Default Step Time = 2 min for New
Patients.
Step Time sets the duration of time for the RM Step phase. Once RM Step time elapses, the
ventilator will transition to Rest Step if a Rest Time has been set. If Rest Time = 0 s, the
ventilator will transition back to the pre-maneuver mode and normal ventilation will resume and
PEEP will equal the set End PEEP value.

Rest Step
Rest PEEP 0 to 40 cmH2O or
(90 cmH2O - Pcontrol) whichever
is less
Default = Set Pre-maneuver PEEP
unless changed by User

Pcontrol 5 to 60 cmH2O or
Level of Pcontrol applied during the Rest (90 cmH2O - Rest PEEP)
Step whichever is less
Default = IBW default or set Pre-
maneuver Pcontrol until changed
by User

Rest Time 1 to 10 min


Default Rest Time = 0 min for New
Patients.
Rest Time sets the duration of time for the Rest Step phase. Once Rest Step time elapses,
ventilator will transition back to the pre-maneuver mode and normal ventilation will resume and
PEEP will equal the set End PEEP value. End PEEP takes affect even if Rest Time is set to
Off.

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Section 11 Ventilator Specifications

Recruitment Maneuver Settings

Step Tool Settings Continuous ventilation at defined Step & Rest settings.

End PEEP 0 to 30 cmH2O


The new non-maneuver PEEP level that will Default = pre-maneuver PEEP
take effect after the recruitment maneuver unless changed by the user.
completes successfully.

11.14. PaCO2 Entry Control Setting


o The PaCO2 entry field allows users to enter the PaCO2 value from a recent blood gas. The PaCO2
value is required to calculate the Alveolar volumes as well as alveolar dead space and Vd/Vt
Physiologic values.
 For additional information on this feature, see section 5.10.2.3.
PaCO2 Entry Control Setting

PaCO2 0.0 to 150.0 mmHg


Default = 0.0 unless changed by
User

11.15. Monitored Data / Displayed Patient Values


With the flow sensor is disabled, monitored values will be derived from measurements taken at
the internal sensors. In this condition, parameters such as Vte, Ve, PFe, Rexp and RCe which
require the external flow sensor will not be monitored and pressure triggering will be enabled.
o For a detailed description of all monitored parameters see
 Section 5.7.2.1 Monitored Data: Basic
 Section 5.7.2.2 Monitored Data: Weaning
 Section 5.7.2.3 Monitored Data: Mechanics
 Section 5.7.2.5 Monitored Data: Capnography (ETCO2)

Pressure Values Monitored Data Ranges


Ppeak 0 to 120 cmH2O
Peak pressure during a breath

Accuracy: ± (2 cmH2O + 4%)

Ptrach -50 to 120 cmH2O


Calculated peak tracheal pressure during a
breath. Available with the tube
compensation feature and only calculated
when tube comp is on

Accuracy: ± (2 cmH2O + 4%)

Pmean 0 to 120 cmH2O


Averaged mean pressure

Accuracy: ± (2 cmH2O + 4%)

PEEP 0 to 120 cmH2O


Pressure at end exhalation

Accuracy: ± (2 cmH2O + 4%)

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Pressure Values Monitored Data Ranges


Pmin -50 to 120 cmH2O
Calculated peak end expiratory tracheal
pressure during a breath. Available with the
tube compensation feature and only
calculated when tube comp is on.

Accuracy: ± (2 cmH2O + 4%)

Volume / Flow / Oxygen Values Monitored Data Ranges


Vte 0 to 5000 ml
Exhaled tidal volume Displayed as ---- if proximal flow
sensor is disabled.

Accuracy: 0 to 4 ml: ± (1 ml + 10%)


5 to 49 ml: ± (2 ml + 10%)
50 to 2000 ml: ± (5 ml + 10%)
Heliox: ± (10 ml + 10%)

Vte/kg 0.0 to 50.0 ml/kg


Exhaled tidal volume normalized to IBW Displayed as ---- if proximal flow
sensor is disabled.

Accuracy: Derived from Vte

Vti 0 to 5000 ml
Inspired tidal volume
Accuracy: 0 to 4 ml: ± (1 ml + 10%)
Vti = Vtd - Vcompl + Vneb 5 to 49 ml: ± (2 ml + 10%)
Vtd = Vti + Vcompl - Vneb 50 to 2000 ml: ± (5 ml + 10%)
Heliox: ± (10 ml + 10%)

Vti/kg 0.0 to 50.0 ml/kg


Inspired tidal volume normalized to IBW

Accuracy: Derived from Vti

Ve 0.00 to 50.0 l/min


Exhaled minute volume

Accuracy: + (0.01 l/min + 5%)

Ve/kg 0.0 to 999 ml/kg


Exhaled minute volume normalized to IBW

Accuracy: Derived from Ve

Ve Spont 0.00 to 50.0 l/min


Spontaneous exhaled minute volume

Accuracy: + (0.01 l/min + 5%)

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Volume / Flow / Oxygen Values Monitored Data Ranges


Vi 0.00 to 50.0 l/min
Inspired minute volume
Displays when the flow sensor is disabled
or unavailable

Accuracy: + (0.01 l/min + 5%)

Vi Spont 0.00 to 50.0 l/min


Spontaneous inspired minute volume
Displays when the flow sensor is disabled
or unavailable

Accuracy: + (0.01 l/min + 5%)

Leak 20 to 100%
Averaged calculated leak (1-Vte/Vti)
Accuracy: Derived: averaged calculated leak
(1-Vte/Vti)

PF 0.0 to 300 l/min


Peak inspiratory flow
Accuracy: <10 l/min ± (1 l/min + 10%);
>10 l/min: ± (5 l/min + 10%)

PFe 0.0 to 300 l/min


Peak expiratory flow
Accuracy: <10 l/min ± (1 l/min + 10%);
>10 l/min: ± (5 l/min + 10%)

O2 15 to 103 %
Monitored FiO2 Displayed as ---- if O2 sensor is
disabled.

Accuracy (monitored): ± 3% of full scale

HeO2 0 to 79 %
Delivered Heliox concentration Displayed as ---- if Heliox is not
selected as the Gas Type and
does not display if Heliox is
Disabled.

Accuracy: ± 5% of full scale

Time Values Monitored Data Ranges


Rate 0 to 300 b/min
Measured mandatory and spontaneous
breaths per minute

Accuracy: 0 to 100 b/min (± 1 b/min),


> 100 b/min + 2%

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Time Values Monitored Data Ranges


Rate Spont 0 to 300 b/min
Measured spontaneous breaths per minute

Accuracy: 0 to 100 b/min (± 1 b/min),


> 100 b/min + 2%

I–Time (Ti) 0.10 to 99.9 sec


Inspiration time

Accuracy: ±0.01 s

E–Time (Te) 0.10 to 99.9 sec


Expiratory time

Accuracy: ±0.01 s

I:E 1 : 99.0 to 99.0 : 1


Inspiratory to expiratory ratio

Accuracy: Derived from accuracies for monitored Ti and


Te or ± (0.1 s + 2%) whichever is greater.

Ti/Ttot 1 to 99.9%
Respiratory Time Fraction

Accuracy: Derived: I–Time divided by cycle time

H:L 1 : 599 to 299 : 1


Ratio of time at high and low PEEP levels
when SPAP is active

Accuracy: Derived from accuracies for monitored Tlow


and Thigh or ± (0.1 + 2%) whichever is
greater.

Spont% 1h 0 to 100 %
Percentage of spontaneous breaths for the Displayed as ---- if Auto Control is
last 1 hour set to Off and does not display if
Auto Control is Disabled.

Spont% 8h 0 to 100 %
Percentage of spontaneous breaths for the Displayed as ---- if Auto Control is
last 8 hours set to Off and does not display if
Auto Control is Disabled.

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Respiratory Mechanics Monitored Data Ranges


Cstat 0 to 300 ml/cmH2O
Static compliance, lung stiffness
Cstat is automatically calculated and displayed for all mandatory breaths when the flow is
less than 5 LPM at end inspiration. During spontaneous breaths, Cstat will only be
calculated and displayed if an Inspiratory Hold is performed for 0.2 s or more.
Pressure of the stable (PIP - PEEP) or (Pplat - PEEP) serves as the denominator and
delivered tidal volume less compliance compensation is the numerator.

Accuracy: Derived from Vt/(Stable PIP - PEEP if


any) or Vt/(Pplat - PEEP if any)

Cstat/kg 0.00 to 5.00 ml/cmH2O-kg


Static compliance normalized to IBW

Accuracy: Derived from Cstat

Cdyn 0 to 300 ml/cmH2O


Dynamic compliance
Cdyn is the compliance of the lung at any given time during actual movement of air. It is change
in volume over (PIP – PEEP). Altered by lung, thoracic and airway resistance
Example: Vt = 500 ml 500 / (30 - 10) or 500 / 20 = 25 ml/cmH2O
Pip = 30 cmH2O
PEEP = 10 cmH2O So Cdyn = 25 ml/cmH2O

Example: Vt = 800 ml
Pip = 40 cmH2O Cdyn = 22.9 or 23 ml/cmH2O
PEEP = 5 cmH2O

Accuracy: Derived

Cdyn/kg 0.00 to 5.00 ml/cmH2O-kg


Dynamic compliance normalized to IBW
Accuracy: Derived from Cdyn

Rinsp 0 to 1000 cmH2O/l/s


Inspiratory resistance of airways and tubes V–Mode only, Flow Pattern square
and Pause > 0.20 s

Rexp 0 to 1000 cmH2O/l/s


Expiratory resistance of airways and tubes V–Mode only, Flow Pattern any
and Pause > 0.20 s

Auto PEEP 0 to 100 cmH2O


Total PEEP - set PEEP = Auto PEEP
Accuracy: ± (2 cmH2O + 4%)

Pplateau 0 to 120 cmH2O


Plateau pressure
Accuracy: ± (2 cmH2O + 4%)

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Respiratory Mechanics Monitored Data Ranges


RSBI 0 to 3000 b/min/l
Rapid shallow breathing index, calculated
breathing rate divided by tidal volume
(RR/Vt = RSBI)
Accuracy: Derived from (measured breathing rate
divided by Inspiratory tidal volume

P0.1 -30 to 0 cmH2O


P0.1 also known as P100 is the Airway
Occlusion Pressure (Max Neg Insp
Pressure) during the first 100ms of
inspiration effort
Accuracy: ± (2 cmH2O + 4%)

PiMax -60 to 0 cmH2O


PiMax also known as MIP or NIF is the Max
Negative Inspiratory Airway Pressure
achieved by the patient during a maneuver
based expiratory hold.
Note: Disabled for Neonatal/Infant patient
type
Accuracy: ± (2 cmH2O + 4%)

P0.1 / PiMax 0 to 100 %


Airway Occlusion Pressure (P0.1) divided
by maximal inspiratory pressure (PiMax)
displayed as a ratio.
Accuracy: Derived from P0.1 and PiMax

C20/C 0.00 to 5.00


Overdistention index is the ratio of the
dynamic compliance during the last 20% of
Inspiration (C20) to the total dynamic
compliance (C)
Accuracy: ± 0.2

RCe 0.00 to 99.9 sec


Expiratory Time Constant
Expiratory Time Constant (RCe) is defined as the product of the total respiratory system
compliance and the total expiratory resistance. Where R is the respiratory resistance and C
is respiratory system compliance. The product of R and C has units of time and is called the
time constant. During mechanical ventilation, RCe is the product of resistance and compliance
of the patient's respiratory system and the additional resistive elements, such as the
endotracheal tube (ETT), filters, ventilator tubing and the ventilators expiratory valve. Since
ETT resistance is markedly flow-dependent, RCe is also flow-dependent.
Accuracy: Derived from measured Vte and PFe

WOBimp 0.00 to 20.0 j/l


Work of breathing imposed
Accuracy: ± 10%

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Capnography ETCO2 Data


Monitored Data Ranges
Available via optional CO2 sensors

PetCO2 0 to 150 or > 150 mmHg


Maximum partial pressure of CO2 exhaled Compensated for BTPS, HME, None
during a tidal breath( end tidal CO2
pressure)

Accuracy: ± (2.25 mmHg + 4%)

PeCO2 0 to 150 or > 150 mmHg


Partial pressure of mean expired CO2 Compensated for BTPS, HME, None

Accuracy: ± (2.25 mmHg + 4%)

FetCO2 0 to 19.7 %
Fractional end-tidal CO2 concentration

Accuracy: 0 to10 %: ± (0.2 vol% + 2% of reading);


10 to15 %: ± (0.3 vol% + 2% of reading);
15 to 25 %: (Unspecified)

FeCO2 0 to 19.7 %
Fractional concentration of mean expired
CO2

Accuracy: 0 to10 %: ± (0.2 vol% + 2% of reading);


10 to15 %: ± (0.3 vol% + 2% of reading);
15 to 25 %: (Unspecified)

VtiCO2 0 to 2000 ml
Inspired CO2 volume. Compensated for BTPS, HME, None
Updated breath-to-breath

Accuracy: 2 to 4 ml: ± (14%);


5 to 2000 ml: ± (9%)

VteCO2 0 to 2000 ml
Expired CO2 volume. Compensated for BTPS, HME, None
Updated breath-to-breath

Accuracy: 2 to 4 ml: ± (14%);


5 to 2000 ml: ± (9%)

VCO2/min 0 to 5000 ml/min


CO2 elimination: Net exhaled volume of CO2 Compensated for BTPS, HME, None
per minute

Accuracy: ± (9%)

Valv 0 to 3000 ml
Alveolar tidal volume Compensated for BTPS, HME, None

A PaCO2 entered value is required for


Valv monitoring

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Section 11 Ventilator Specifications

Capnography ETCO2 Data


Monitored Data Ranges
Available via optional CO2 sensors

Accuracy: 2 to 4 ml: ± (1 ml + 10%)


5 to 40 ml: ± (2 ml + 5%)
41 to 2000 ml: ± (10 ml + 5%)
Heliox: ± (10 ml + 10%)

Valv/min 0.00 to 50.0 l/min


Alveolar minute volume Compensated for BTPS, HME, None

A PaCO2 entered value is required for


Valv/min monitoring

Accuracy: ± (0.01 l/min + 5%)

Vd ana 0 to 1000 ml
Anatomical Dead Space Compensated for BTPS, HME, None

A PaCO2 entered value is required for


Vd ana monitoring

Accuracy: 2 to 4 ml: ± (14%);


5 to 2000 ml: ± (9%)

Vd alv 0 to 1000 ml
Alveolar Dead Space Compensated for BTPS, HME, None

A PaCO2 entered value is required for


Vd alv monitoring

Accuracy: 2 to 4 ml: ± (14%);


5 to 2000 ml: ± (9%)

Vd/Vt phy 0.0 to 100 %


Physiological Dead Space (Vd) / Tidal
Volume (Vt) Ratio
A PaCO2 entered value is required for
Vd /Vt phy monitoring

Accuracy: ± (9%)

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Section 11 Ventilator Specifications

11.16. Graphics: Real-Time Curves


Graphics: Real-Time Curves

Waveforms

The measurement and graphical representation of breath


delivery pressure breath-to-breath over time.
Pressure + Time Measured in cmH2O at the Prox. port or Exp. port if the
flow sensor is enabled and attached or internally if the
flow sensor is disabled.
The measurement and graphical representation of breath
delivery flow breath-to-breath over time.
Flow + Time Measured in L/min at the Prox. port or Exp. port if the flow
sensor is enabled and attached or internally if the flow
sensor is disabled.
The measurement and graphical representation of the
inspiratory tidal volume breath-to-breath over time.
Volume + Time Measured in mL at the Prox. port or Exp. port if the flow
sensor is enabled and attached or internally if the flow
sensor is disabled.

Loops

Pressure-Volume Loop
Measured cmH2O and ml at the Prox. port or Exp. port if
P / V Loop the flow sensor is enabled and attached or internally if the
flow sensor is disabled. Pressure displayed on x-axis and
volume on the y-axis
Flow-Volume Loop
Measured l/min and ml at the Prox. port or Exp. port if the
F / V Loop flow sensor is enabled and attached or internally if the
flow sensor is disabled. Flow is displayed on the y-axis
and volume on the x-axis
Pressure-Flow loop
Measured cmH2O and l/min at the Prox. port or Exp. port
P / F Loop if the flow sensor is enabled and attached or internally if
the flow sensor is disabled. Pressure is displayed on the
y-axis and Flow on the x-axis

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Section 11 Ventilator Specifications

Graphics: Real-Time Curves

Capnography Waveforms Waveforms Displayed on the Capnograms Screen

The measurement and graphical representation of the


carbon dioxide partial pressure breath-to-breath over
PCO2 + Time time.
Measured proximally in mmHg via Mainstream (IRMA) or
Sidestream (ISA) sensors
The measurement and graphical representation of the
carbon dioxide concentration breath-to-breath over time.
FCO2 + Time
Measured proximally in % via Mainstream (IRMA) or
Sidestream (ISA) sensors
The measurement and graphical representation of the
exhaled carbon dioxide volume breath-to-breath over
VteCO2 + Time time.
Measured proximally in ml via Mainstream (IRMA) sensor

SBCO2 Curves SBCO2 Curves Displayed on the Capnograms Screen

PCO2-Vte loop
The measurement and graphical representation of the
exhaled carbon dioxide partial pressure and exhaled tidal
PCO2 / Vte volume breath-to-breath.
PCO2 Measured proximally in mmHg via Mainstream
(IRMA) sensor and Vte in ml via flow sensor at the Prox.
port or Exp. port if the flow sensor is enabled and
attached.
FCO2-Vte loop
The measurement and graphical representation of the
exhaled carbon dioxide concentration and exhaled tidal
FCO2 / Vte volume breath-to-breath.
FCO2 Measured proximally in % via Mainstream (IRMA)
sensor and Vte in ml via flow sensor at the Prox. port or
Exp. port if the flow sensor is enabled and attached.

11.17. Alarm Limit Settings


Standard

Pressure Alarm Settings

Ppeak High 1 (or 1 > Ppeak Low) to 100 cmH2O

Ppeak Low 0 to 99 cmH2O (or 1 < Ppeak High)

Pmean High 1 (or 1 > Pmean Low) to 100 cmH2O

0 to 99 (or 1 < Pmean High) cmH2O,


Pmean Low
respectively

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Section 11 Ventilator Specifications

Standard

Volume Alarm Settings

Ve High 0.10 (or 0.10 > Ve Low) to 50.0 l/min


Ve Low 0.00 to 49.9 l/min (or 0.10 < Ve High)
Vte High
Adult 5 (or 1 step > Vte Low) to 2500 ml, or Off
Pediatric 2 (or 1 step > Vte Low) to 700 ml, or Off
Neonate 1 (or 1 step > Vte Low) to 300 ml, or Off
Vte Low
Adult 0 to 2490 ml or 1 step < Vte High, or Off
Pediatric 0 to 695 ml or 1 step < Vte High, or Off
Neonate 0 to 299 ml or 1 step < Vte High, or Off
Vti Limit
0 to 2500 ml or Off
Adult
(default New Patients = Off)
0 to 700 ml or Off
Pediatric
(default New Patients = Off)

0 to 300 ml or Off
Neonate
(default New Patients = 300)

Respiratory Rate Alarm Settings

Rate High 2 (or 1 > Rate Low) to 200 b/min


Rate Low 1 to 199 b/min or 1 < Rate High

Oxygen Delivery Alarm Settings Automatic Setting

Ventilator software automatically sets alarm


High Oxygen
limit to 7% above oxygen % setting.
Ventilator software automatically sets alarm
Low Oxygen
limit to 7% below oxygen % setting.

Other Alarm Settings Automatic Setting

Apnea (interval) 3 to 60 sec


Leak Rate
20 to 100 %
Sets the leak percent level for alarm

AUTO SET Automatically adjusts alarm settings based


on current monitored values or settings
Auto sets alarm values depending on mode. (See section 5.5.3)

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Capnography

Capnography Alarm Settings

PetCO2 High 2 (or 1 > PetCO2 Low) to 150 mmHg

PetCO2 Low 1 to 149 mmHg or 1 < PetCO2 High, or Off

2 (or 1 step > Valv Low) to 2000 ml, or Off


Valv High from 2 to 100 ml, 1 step = 1 ml
from 100 to 2000 ml, 1 step = 10 ml

1 to 1990 ml (or 1 step < Valv High), or Off


Valv Low from 2 to 100 ml, 1 step = 1 ml
from 100 to 2000 ml, 1 step = 10 ml

Valv/min High 1.0 (or 0.1 > Valv/min Low) to 50.0 l/min

0.01 to 49.9 l/min or 0.1 < Valv/min High,


Valv/min Low
or Off

VteCO2 Low 1 to 1000 ml, or Off

AUTO SET Automatically adjusts alarm settings based


on current monitored values or settings
Auto sets alarm values depending on mode. (See section 5.5.3)

SBT

SBT Alarm Settings

RSBI High 5 (or 5 > RSBI Low) to 900 b/min/l, or Off

RSBI Low 5 to 895 b/min/l (or 5 < RSBI High), or Off

Rate High 2 (or 1 > Rate Low) to 80 b/min, or Off

Rate Low 1 to 79 b/min (or 1 < Rate High), or Off

AUTO SET Automatically adjusts alarm settings based


on current monitored values or settings
Auto sets alarm values depending on mode. (See section 5.5.3)

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11.18. Alarms by Priority

See sections 5.5.6 and 5.5.6.1 for


additional information.

Apnea Internal Pressure Low/Disconnect

Apnea Backup Active High Oxygen

Air Supply Low Oxygen

Oxygen Supply P. Line On Right Side?

High-pressure Heliox Supply

Low Pressure Heliox Pres Low- Use Air

Disconnection PetCO2 High

Occlusion PetCO2 Low

High Tidal Volume VteCO2 Low

Low Tidal Volume Valv Low

High Minute Volume Valv/min Low

Low Minute Volume Speaker Fault

Battery too Low Technical Fault (TF-1 to TF-29) (see section 5.5.7)

Imminent Shutdown Connect AC Now

Device Alert

See sections 5.5.6 and 5.5.6.1 for


additional information.

Battery Low Target Volume Not Met

Check Pcontrol / Pmax Pmean High

Check Psupport / Pmax Pmean Low

Compressor PT Effort Detected

High External Voltage Ck. CO2 Sensor

High Frequency CO2 Sensor Accuracy?

Low Frequency Ck.CO2 Adaptor

SBT High Frequency Ck. Sample Line

SBT Low Frequency Replace CO2 Adaptor

SBT High RSBI Replace Sample Line

SBT Low RSBI Zero CO2 Sensor

High Leak Rate Valv High

High Temperature Valv/min High

Vti Limit Reached

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See sections 5.5.6 and 5.5.6.1 for


additional information.

Increase O2 not avail SBT Active

100%O2 Cal. not avail SBT Off

Battery not available SBT Canceled

Flow cal. not available Suction Active

Flow trigger not avail Maneuver Active

Gas connected; Heliox? No CO2 Sensor

Inverse ratio set Mem CPU not protected

Logbook cleared Mem power no protect

O2 sensor not avail Mem sensor no protect

Audible AC power disconnect / reconnect


Nebulizer not avail
tone

Battery in use

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12. Theory of Operation


This section provides details on the ventilators theory of operation specific to its ventilation modes,
breath triggering and leak compensation.

The Inspiration ventilator offers these Ventilation Modes:

Table 43: Ventilation Modes (Theory of Operation)


Mode Mode
Mode Description
Types Selections
Pressure-Controlled Continuous Mandatory Ventilation P–CMV

Volume-Controlled Continuous Mandatory Ventilation V–CMV


CMV
Pressure Regulated Volume Control Continuous Mandatory PRVC–CMV
Ventilation

Pressure-Controlled Synchronized Intermittent Mandatory P–SIMV


Ventilation

Volume-Controlled Synchronized Intermittent Mandatory V–SIMV


SIMV
Ventilation
Pressure Regulated Volume Control Synchronized Intermittent PRVC–SIMV
Mandatory Ventilation

Pressure Support Ventilation (CPAP + PS) PS

Volume Support Ventilation (CPAP + VS) VS


SPONT Spontaneous Positive Airway Pressure Ventilation SPAP
(dual PEEP mode)
Nasal Continuous Positive Airway Pressure (Nasal CPAP) NCPAP+

12.1. Volume Controlled Continuous Mandatory Ventilation


(V–CMV) Mode
During Volume-Controlled Continuous Mandatory Ventilation (V–CMV) mode, breathing phases
are flow or time-controlled. The user sets the tidal volume and peak flow rate and the ventilator
adjusts to ensure that the set tidal volume is achieved during inspiration. An increase in set
Peak Flow at a given tidal volume will result in a shorter inspiratory time. A decrease in set Tidal
Volume at a given Peak flow will also result in a shorter inspiratory time. Predicted I:E,
inspiratory time (Ti) and expiratory time (Te) will automatically be recalculated if adjustments to

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either set Tidal Volume, Peak Flow, Rate or Pause are made.
Increases in Tidal Volume or Peak Flow will result in a higher circuit pressure.

The set High-pressure Alarm is the pressure limit of the breathing circuit.
A High-pressure Alarm will terminate inspiration and the total set Tidal
Volume will not be delivered. An unattended High-pressure Alarm may
result in patient hypoventilation.

The patient can trigger a mandatory breath during the exhalation phase trigger window.

Figure 101: V–CMV Mode

Table 44: V–CMV Settings


Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

Rate Mandatory breaths per minute b/min


Vt Tidal volume delivered during inspiration (tubing ml
compliance compensated).
I:E Inspiratory to expiratory ratio (European philosophy)
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH2O
airway pressure, the pressure at the end of
exhalation.
Flow (Peak Flow) Maximum inspiratory flow l/min
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Flow Pat. Flow pattern: decelerating, decelerating 50%, or


square
Trigger Type Flow or Pressure l/min or cmH2O

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Table 44: V–CMV Settings


Setting Description Unit
NIV NIV can be turned On or Off in all modes
Pause Inspiratory pause s
0.00 to 42.0 seconds (US philosophy)
0 to 70 % of cycle time (European philosophy)
Auto Control Auto Control enables an automatic transition between
spontaneous supported breaths and mandatory
ventilated breaths based on patient effort. Auto
Control time is adjustable 3 to 60seconds.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On

The ventilator automatically limits the setting range for Rate, I:E, Peak Flow and Plateau to
ensure that:
Inspiration time is never less than 100 ms or 10 % of the breath.
Exhalation time is never less than 200 ms or 20 % of the breath.

12.2. Volume Controlled Synchronized Intermittent Mandatory


Ventilation (V–SIMV) Mode
Volume-Controlled Synchronized Intermittent Mandatory Ventilation (V–SIMV) mode, is a
mixture of mandatory and spontaneous ventilation. Mandatory breaths are volume-controlled,
and spontaneous breaths are pressure supported. Both mandatory and spontaneous breaths
can be pressure limited during V–SIMV if the current pressure exceeds the set high-pressure
alarm limit.
SIMV mode consists of a mandatory “expectation” phase, followed by a spontaneous phase

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during which spontaneous breathing is possible.


o At the start of SIMV mode the patient can trigger a mandatory breath within the
expectation window (tCMV). If the patient does not trigger a breath during this time, the
ventilator delivers a mandatory breath once the expectation window has elapsed.
o Spontaneous breathing is possible 200 ms after the start of exhalation and is possible
until the next expectation window begins. If the patient triggers a breath, the ventilator
delivers a pressure-supported breath that includes the set level of pressure support and
PEEP. The patient can trigger further spontaneous breaths until the next expectation
window begins.
o Once the SIMV cycle has elapsed, the next expectation window (and a new SIMV cycle)
begins and the patient can trigger a mandatory breath when at least 200 ms of the
previous exhalation has elapsed.

Figure 102: V–SIMV Mode

During the spontaneous phase, peak inspiratory flow is the criterion for switching from
inspiration to exhalation. When inspiratory flow drops to the set exhalation sensitivity (Esens),
which is a percentage of peak flow, exhalation begins. Esens controls the desired exhalation
sensitivity. Example: Esens is set to 40%, if the peak inspiratory flow is 60 l/min, the inspiratory
phase will end when the peak flow decelerates to 24 l/min. The patient’s inspiratory effort will
determine peak flow during spontaneous breathing.
In SIMV, the rate setting determines the number of mandatory breaths per minute. The I:E and
peak flow settings apply to the mandatory breaths.

Table 45: V–SIMV Settings


Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

Rate Mandatory breaths per minute b/min


Vt Tidal volume delivered during inspiration ml
(compliance compensated)
I:E Inspiratory to expiratory ratio (European
philosophy)

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Table 45: V–SIMV Settings


Setting Description Unit
PEEP/CPAP Positive end expiratory pressure/continuous cmH2O
positive airway pressure, the pressure at the end of
exhalation
Psupport For spontaneous breaths, pressure support (in cmH2O
addition to PEEP)
Flow (Peak Flow) Maximum inspiratory flow l/min
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Esens Exhalation Sensitivity for spontaneous breaths, %


the criterion for cycling from inspiration to
exhalation as a percentage of maximum peak
inspiratory flow breath-to-breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Flow Pat. Flow pattern: Decelerating, Decelerating 50%, or
Square.
Trigger Type Flow or Pressure l/min or cmH2O

NIV NIV can be turned On or Off in all modes


Pause Inspiratory pause s
0.00 to 42.0 seconds (US philosophy)
0 to 70 % of cycle time (European philosophy)
PS Tmax PS Tmax is the max time limit control setting for all s
modes with a pressure support (PS) setting or PS
based breaths. PS Tmax functions as the
inspiration termination criteria for all PS based
breaths. PS breaths when delivered will terminate
by flow, pressure and time. Whichever termination
criterion is met first will cause the PS breath to
cycle to exhalation.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On

The ventilator automatically limits the setting range for Rate, I:E, Peak Flow and Plateau to
ensure that:
Inspiration time is never less than 10 % of the breath.
Exhalation time is never less than 20 % of the breath.
Maximum peak flow is 180 l/min (3 l/second).

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12.3. Pressure Controlled Continuous Mandatory Ventilation


(P–CMV) Mode
In Pressure-Controlled Continuous Mandatory Ventilation (P–CMV) mode, the inspiratory and
expiratory breathing phases are time-controlled. The user sets the inspiration pressure
(Pcontrol) above the PEEP (baseline pressure), and the ventilator maintains Pcontrol during
inspiration. The patient can trigger a mandatory breath within the trigger window. Breath
triggering during all modes is described below in section 12.12.
Increasing Pcontrol or Ti should result in an increase in delivered tidal volume depending on the
compliance and resistance of the patient’s lungs and breathing circuit. If changes occur to the
compliance and/or resistance of the patient’s lungs or breathing circuit this may affect the
delivered tidal volume.

Figure 103: P–CMV Mode

Table 46: P–CMV Settings


Setting Description Unit

O2 Percentage of oxygen in delivered volume. %

Rate Mandatory breaths per minute. b/min


Ti Inspiration time. sec
I:E Inspiratory to expiratory ratio (European philosophy)
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH2O
airway pressure, the pressure at the end of exhalation.
Pcontrol Inspiration pressure above PEEP cmH2O

Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Rise time The rise to inspiratory pressure


Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH2O

NIV NIV can be turned On or Off in all modes

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Table 46: P–CMV Settings


Setting Description Unit

Auto Control Auto Control enables an automatic transition between


spontaneous supported breaths and mandatory
ventilated breaths based on patient effort. Apnea time
is adjustable from 3 to 60seconds.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On

The ventilator automatically limits the setting range for Rate, I:E, I time and Rise Time to
ensure that:
Inspiration time is never less than 10 % of the breath.
Exhalation time is never less than 20 % of the breath.
Pcontrol can be set greater than or equal to PEEP + 5 cmH2O. (Adult or Pediatric)
Pcontrol can be set greater than or equal to PEEP + 2 cmH2O. (Neonate)

12.4. Pressure Controlled Synchronized Intermittent


Mandatory Ventilation
(P–SIMV) Mode
Pressure-Controlled synchronized Intermittent Mandatory Ventilation (P–SIMV) mode, is a
mixture of mandatory and spontaneous ventilation. Mandatory breaths are pressure-controlled,
and spontaneous breaths are pressure supported. Breath triggering during SIMV ventilation is
described below in section 12.12.

Figure 104: P–SIMV Mode

Table 47: P–SIMV Settings


Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

Rate Mandatory breaths per minute. b/min


Ti Inspiration time. sec

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Table 47: P–SIMV Settings


Setting Description Unit
I:E Inspiratory to expiratory ratio (European philosophy)
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH2O
airway pressure, the pressure at the end of exhalation.
Pcontrol Inspiration pressure above PEEP cmH2O

Psupport For spontaneous breaths, pressure support (in addition cmH2O


to PEEP)
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Esens Exhalation Sensitivity for spontaneous breaths, the %


criterion for cycling from inspiration to exhalation as
a percentage of maximum peak inspiratory flow
breath-to-breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH2O

NIV NIV can be turned On or Off in all modes


PS Tmax PS Tmax is the max time limit control setting for all s
modes with a pressure support (PS) setting or PS
based breaths. PS Tmax functions as the inspiration
termination criteria for all PS based breaths. PS
breaths when delivered will terminate by flow, pressure
and time. Whichever termination criterion is met first will
cause the PS breath to cycle to exhalation.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On

12.5. Volume Targeted Ventilation (VTV) Modes


Volume targeted ventilation (VTV) modes include:
o PRVC–CMV: Pressure Regulated Volume Control Continuous Mandatory Ventilation
o PRVC–SIMV: Pressure Regulated Volume Control Synchronized Intermittent Mandatory
Ventilation.
o VS: Volume Support.

VTV provides pressure based breaths (with decelerating flow pattern and square pressure
pattern) that target a set tidal volume by adjusting delivered pressure on a breath-to-breath
basis. VTV modes deliver pressure controlled or pressure-supported breaths, the pressure
varies automatically and as needed to achieve the user defined target tidal volume.

Delivered pressure levels do not vary by more than 3 cmH2O from breath to breath or 1.5 cmH2O
when the Vt setting is below 5 ml. The ventilator starts by delivering a standard volume
ventilation test breath with a decelerating flow curve and short plateau. If the plateau pressure
is stable, the ventilator calculates compliance and establishes a pressure target for the first
PRVC breath. The ventilator then delivers a pressure control style breath with the Ti or I:E ratio
set at that starting pressure.

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During VTV if the Vti limit is not set to Off, an automatic over volume alarm
is set at 1.5 times the set target tidal volume. To prevent excessive tidal
volume delivery, the breath will terminate when the inspired tidal volume
alarm limit (Vti Lim) is reached or when a volume of 1.5 x the set tidal
volume (Vt) has been reached, whichever value is lower.

12.6. Pressure Regulated Volume Control Continuous


Mandatory Ventilation (PRVC–CMV) Mode
Pressure Regulated Volume Control Continuous Mandatory Ventilation (PRVC–CMV), is an
assist control mode in which all breaths are mandatory. The ventilator delivers breaths
according to the set respiratory rate and in response to patient triggered efforts. The ventilator
delivers pressure-controlled breaths with pressure levels that vary as needed to achieve the
target tidal volume.
The initial breath is a standard V–CMV at the set PEEP and set target tidal volume (Vt) with a
short inspiratory plateau. The subsequent breath will be a pressure limited breath delivered at
the initial plateau level for a duration equal to the set inspiratory time (Ti). All the following
breaths will be pressure limited and time cycled, and the inspiratory pressure will automatically
adjust by no more than 3cmH2O from breath to breath (1.5 cmH2O when Vt setting is below 5
ml) to achieve the set Vt.
If two consecutive test breaths fail to achieve a plateau due to an alarm condition, (i.e., a High-
pressure Alarm) the Inspiration ventilator delivers a standard P–CMV breath at 10 cmH2O above
the set PEEP (6 cmH2O when Vt setting is below 5 ml) for the set Ti. Compliance is measured
and for the next 5 breaths pressure changes up to 6 cmH2O can occur until the target Vt is
achieved.
Once uniform ventilation occurs in PRVC–CMV, in the event of a Disconnection Alarm, the
Inspiration will immediately re-establish ventilating pressures upon reconnect.
An active exhalation valve allows the patient to make respiratory efforts during inspiration while
maintaining inspiratory pressure.

Table 48: PRVC–CMV Settings


Setting Description Unit

O2 Percentage of oxygen in delivered volume. %

Rate Mandatory breaths per minute. b/min


Vt Tidal volume target. Inspiratory pressure will ml
automatically vary to attempt to achieve this tidal
volume.
Ti Inspiration time. sec
I:E Inspiratory to expiratory ratio (European philosophy)
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH2O
airway pressure, the pressure at the end of
exhalation.
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Rise time The rise to inspiratory pressure


Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH2O

NIV NIV can be turned On or Off in all modes

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Table 48: PRVC–CMV Settings


Setting Description Unit

Auto Control Auto Control enables an automatic transition


between spontaneous supported breaths and
mandatory ventilated breaths based on patient effort.
Apnea time is adjustable 3 to 60seconds.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On
The ventilator automatically limits the setting ranges to ensure that:
Inspiration time is never less than 100 ms
Exhalation time is never less than 200 ms

12.7. Press Regulated Volume Control Synchronized


Intermittent Mandatory Ventilation (PRVC–SIMV) Mode
Pressure Regulated Volume Control Synchronized Intermittent mandatory Ventilation
(PRVC–SIMV) mode, is a mixture of spontaneous and mandatory ventilation. Mandatory
breaths are volume targeted, pressure limited and time cycled. Mandatory PRVC breaths are
described above in section 12.6. PRVC–SIMV mode is similar to PRVC–CMV except that all
breaths in excess of the set respiratory rate are spontaneous breaths. The spontaneous breaths
in PRVC–SIMV can be pressure supported. Breath triggering during SIMV ventilation is
described below in section 12.12.

Table 49:PRVC–SIMV Settings


Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

Rate Mandatory breaths per minute. b/min


Vt Tidal volume target. Inspiratory pressure will ml
automatically vary to attempt to achieve this tidal
volume.
Ti Inspiration time. sec
I:E Inspiratory to expiratory ratio (European philosophy)
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH2O
airway pressure, the pressure at the end of
exhalation.
Psupport For spontaneous breaths, pressure support (in cmH2O
addition to PEEP)
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Esens Exhalation Sensitivity for spontaneous breaths, the %


criterion for cycling from inspiration to exhalation as a
percentage of maximum peak inspiratory flow breath-
to-breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH2O

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Table 49:PRVC–SIMV Settings


Setting Description Unit
NIV NIV can be turned On or Off in all modes
PS Tmax PS Tmax is the max time limit control setting for all s
modes with a pressure support (PS) setting or PS based
breaths. PS Tmax functions as the inspiration
termination criteria for all PS based breaths. PS breaths
when delivered will terminate by flow, pressure and time.
Whichever termination criterion is met first will cause the
PS breath to cycle to exhalation.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On

12.8. Volume Support Ventilation (VS) Mode


VS is a spontaneous breath mode in which all breaths are spontaneous. The ventilator delivers
breaths in response to patient effort, and patient effort determines the respiratory rate and
inspiratory time. The ventilator delivers pressure-supported breaths with pressure levels that
vary as needed to achieve the set target Vt. The starting test breath is pressure-support breath
at 10 cmH2O (6 cmH2O when Vt setting is below 5 ml) and subsequent pressure support breaths
are then delivered with increasing or decreasing pressure targets to restore the preset target
tidal volume. Pressures will not vary by more than 3 cmH2O per breath or 1.5 cmH2O when Vt
setting is below 5 ml. Volume Support is delivered in a spontaneous mode only and so is not
available in SIMV.

Table 50: VS Settings


Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

Vt Tidal volume target. Inspiratory pressure will ml


automatically vary to attempt to achieve this tidal
volume.
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH2O
airway pressure, the pressure at the end of exhalation.
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Esens Exhalation Sensitivity for spontaneous breaths, the %


criterion for cycling from inspiration to exhalation as a
percentage of maximum peak inspiratory flow breath-
to-breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH2O

NIV NIV can be turned On or Off in all modes

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Section 12 Theory of Operation

Table 50: VS Settings


Setting Description Unit
PS Tmax PS Tmax is the max time limit control setting for all modes s
with a pressure support (PS) setting or PS based breaths.
PS Tmax functions as the inspiration termination criteria
for all PS based breaths. PS breaths when delivered will
terminate by flow, pressure and time. Whichever
termination criterion is met first will cause the PS breath to
cycle to exhalation.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On

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12.9. Pressure Support Ventilation (PS) Mode


Pressure Support Ventilation (PS) Mode, is a pressure-based breathing mode that provides
ventilation once the patient reaches the inspiratory trigger threshold. The pressure support
setting determines the level of support pressure above PEEP during inspiration. The exhalation
sensitivity (Esens) will determine when inspiration ceases and exhalation begins as a
percentage of peak flow.
In PS mode when Psupport is set to 0 cmH2O, the mode is effectively Continuous Positive
Airway Pressure (CPAP). The continuous pressure is determined by the PEEP control.

Figure 105: SPONT Mode

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Table 51: PS Mode Settings (CPAP + PS)


Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

PEEP/CPAP Positive end expiratory pressure/continuous positive cmH2O


airway pressure, the pressure at the end of exhalation.
Psupport For spontaneous breaths, pressure support (in addition cmH2O
to PEEP)
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Esens Exhalation Sensitivity for spontaneous breaths, the %


criterion for cycling from inspiration to exhalation as a
percentage of maximum peak inspiratory flow breath-
to-breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH2O

NIV NIV can be turned On or Off in all modes


PS Tmax PS Tmax is the max time limit control setting for all modes s
with a pressure support (PS) setting or PS based breaths.
PS Tmax functions as the inspiration termination criteria
for all PS based breaths. PS breaths when delivered will
terminate by flow, pressure and time. Whichever
termination criterion is met first will cause the PS breath to
cycle to exhalation.
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On

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Section 12 Theory of Operation

12.10. Spontaneous Positive Airway Pressure Ventilation


(SPAP) Mode
Spontaneous Positive airway Pressure Ventilation (SPAP) is a pressure-based breathing mode
that allows patients to breathe spontaneously at two user-selected levels of PEEP. The user
sets the levels of high and low PEEP (Phigh and Plow) and level of pressure support at each
PEEP level (Psup high and Psup low).
The user also sets the time spent at each independent PEEP level. The method to determine
the time at each level of PEEP is set using the SPAP Type control found in the Current Settings
window.

 SPAP is equivalent to APRV and BiLevel.

If the settings principle is:


o Cycle + Time: The user adjusts cycles per minute and the time at high PEEP level (Ti
High); or
o Cycle + Ratio: The user adjusts cycles per minute and ratio of high to low PEEP level
periods (H:L), or
o Time only: The user selects the time settings for both the high and low PEEP levels (Ti
High and Ti Low).
The SPAP Type allows the user to configure the SPAP controls based on preference.
At each PEEP level, the patient can trigger a spontaneous breath. The level of support for
spontaneous breaths is set independently for each level of PEEP. The Psup high control adjusts
Psupport levels at High PEEP and Psup low control adjusts Psupport levels at Low PEEP). All
spontaneous breaths are triggered by the patient and the sensitivity of the Trigger is set by the
user. Esens and Rise Time settings will affect the nature of all spontaneous breaths. Transitions
between high and low PEEP levels are synchronized with the patient’s spontaneous breathing.

12.10.1. Spontaneous Breaths in SPAP Mode

Figure 106: SPAP Mode

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Section 12 Theory of Operation

12.10.2. SPAP mode affects these three monitored values:


 Exhaled tidal volume (Vte): reflects exhaled volumes from Phigh to Plow and
spontaneous exhaled volumes at either PEEP level.
 Exhaled minute volume (Ve): includes total minute volume, including spontaneous
exhaled volumes at both PEEP levels and during the low to high PEEP level transition.
 Ratio of time at high to low PEEP levels (H:L): is available for display on the Monitoring
screen.
As in all modes, the High-pressure Alarm is the pressure limit during SPAP. Inspiration will
terminate when current pressure reaches the High-pressure Alarm Limit.

Table 52: SPAP Settings


Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

Cycle * Cycle rate from high to low PEEP levels. c/min


Phigh High PEEP level cmH2O

Plow Low PEEP level cmH2O

Ti high Time at high PEEP level s


Ti low Time at low PEEP level s
Psup high Level of pressure support in addition to high PEEP cmH2O

Psup low Level of pressure support in addition to low PEEP cmH2O

Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH2O

Esens Exhalation Sensitivity for spontaneous breaths, the %


criterion for cycling from inspiration to exhalation as a
percentage of maximum peak inspiratory flow breath-
to-breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
H:L ++ Ratio of time at high to low PEEP levels. x:x
Trigger Type Flow or Pressure l/min or cmH2O

NIV NIV can be turned On or Off in all modes


PS Tmax PS Tmax is the max time limit control setting for all modes s
with a pressure support (PS) setting or PS based breaths.
PS Tmax functions as the inspiration termination criteria
for all PS based breaths. PS breaths when delivered will
terminate by flow, pressure and time. Whichever
termination criterion is met first will cause the PS breath to
cycle to exhalation.
SPAP Type Varies the type of controls in SPAP
(Cycle + Time), (Cycle + Ratio) or (Time Only)

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Section 12 Theory of Operation

Table 52: SPAP Settings


Setting Description Unit
Leak Comp. Leak compensation (default setting is On) l/min
Up to 25.0 l/min STPD with NIV set to Off
Up to 60.0 l/min STPD with NIV set to On
The ventilator automatically limits the setting ranges to ensure that:
Insufflation time is never less than 100 ms
Exhalation time is never less than 200 ms
* Cycle is only available when SPAP Type; Cycle + Time or Cycle + Ratio are selected.
++ H:L is only available when the SPAP Type Cycle + Ratio is selected.

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Section 12 Theory of Operation

12.10.3. NCPAP+ Mode


NCPAP+ mode is intended for use with neonate patients and is only available as a mode
selection with neonate patient types. Ventilator software automatically sets a default flow rate
and PEEP, which are adjustable for optimum low pressure and disconnect detection to
accommodate nasal prongs of different internal diameter size. One method of adjustment is to
set the highest flow that still results in alarms when both prongs are opened to air.
Ventilator software determines alarm limit values dynamically during NCPAP+, alleviating the
need to adjust alarm settings. The main display shows a pressure-time and the flow-time
waveform, (no other graphs are available in NCPAP+). O2 is the only monitoring value displayed
during NCPAP+.
o NCPAP+ settings if Rate is set to >1 b/min: O2, Rate, Ti, PEEP, Pcontrol, and Flow
o NCPAP+ settings if Rate is set to Off: O2, Rate, PEEP, and Flow

During NCPAP+, ensure that a qualified caregiver observes the patient at all times.
Due to the high resistance of neonate/infant nasal prongs and large leaks that are
typical of neonate/infant ventilation, it is possible for no alarm to occur if the nasal
prongs are attached to the circuit but are out of the patient’s nose.
Ensure that the proximal pressure line is properly connected to the circuit (central to
the nasal prongs or on the exhalation side) and the ventilator (right-most port of the
Flow sensor connector).
If using the proximal flow sensor, ensure that the flow sensor calibration is performed
on a Neonate flow sensor.
When transitioning to NCPAP+ from another mode, the initial settings displayed when
NCPAP+ is selected will be based off the patients ideal body weight established
during startup. The user can adjust these setting as desired prior to activation.

12.11. Non Invasive Ventilation (NIV) Settings


Non Invasive Ventilation (NIV) is an adjunct to ventilation available in all modes on the
Inspiration ventilator. Selecting NIV and verifying the Leak Compensation setting is set to On,
the Inspiration will automatically compensate for leaks in the patient circuit up to a maximum of
60l/min STPD. The increased leak tolerance when NIV is selected provides more effective
ventilation and better patient comfort when using a noninvasive interface between patient and
the ventilator circuit.
All ventilator alarms are enabled when NIV is enabled (ON).

A qualified caregiver must evaluate whether settings and alarms limits are
clinically appropriate.

12.11.1. NIV Patient Interface


NIV is appropriate for use with a non-vented mask and requires a standard heated or non-
heated wire dual-limb breathing circuit.

Under certain conditions, leaks from vented masks can cause auto-cycling and an
inability to maintain the set PEEP level.
A qualified caregiver must evaluate whether settings and alarms limits are clinically
appropriate.
During NIV, these adjustments may be appropriate:
Adjust the trigger level to avoid auto-cycling and adjust the leak alarm to avoid nuisance
alarms.
Adjust Esens to ensure that inspiration terminates appropriately.
Adjust Rise time for greatest patient comfort.

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Section 12 Theory of Operation

12.12. Breath Triggering (All Modes)


The Inspiration ventilator offers pressure and flow triggering in all invasive modes as well as NIV
Pressure triggering is based on pressure measured at the flow sensor (if in use) and an internal
pressure sensor at the inspiratory port. With the patient attached to the breathing circuit the
patient, circuit and ventilator all form a closed system. If the patient makes an effort to breathe
and decreases pressure in the breathing circuit, relative to PEEP, by a value equal to the
pressure sensitivity (Ptrig setting), a breath is initiated. Example: PEEP = 5 cmH2O and the
Trigger is set at -2 cmH2O when a patient makes a breathing effort and the circuit pressure
drops to 3 cmH2O a breath is initiated.
If Flow trigger is selected and the flow sensor is positioned proximally at the circuit Wye, a breath
will initiate when a patient effort causes flow movement across the flow sensor (toward the
patient) equal to the value set by the flow sensitivity (Ftrig setting).
If Flow trigger is selected and the flow sensor is positioned distally at the expiratory port, a breath
will initiate when a patient effort decreases the total flow in the circuit equal to the value set by
the flow sensitivity (Ftrig setting).

12.13. Leak Compensation


o Overview
 For an invasive ventilator to function properly there should be no significant leak
throughout the entire system. For optimal ventilator performance, leaks if present,
should be stopped or minimized rather than compensated.
 When the Leak Compensation (Leak Comp) control setting is set to ON, leak
compensation is active and the ventilator will automatically compensate for leaks
throughout the entire system, including ventilator, breathing circuit and patient
respiratory system up to 25.0 l/min or 60.0 l/min STPD when NIV is set to ON.
 As illustrated in the algorithms provided below, leak Compensation is achieved by
increasing or decreasing the Base Flow breath-by-breath to achieve and maintain
the set pressure profile based on the variation of measured PEEP versus Set PEEP.
o Maximum Leak Compensation is: o Leak Compensation is disable if:

 25.0 l/min STPD when NIV is set  Leak Comp is set to OFF
to OFF
 the Circuit is disconnected
 60.0 l/min STPD when NIV is set
 the mode is NCPAP+
to ON

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Section 13 Terms, Abbreviations and Definitions

13. Terms, Abbreviations and Definitions


Term Definition
A Ampere
AC Alternating current
Apnea Apnea Alarm Setting
ATM = Standard Atmosphere
ATM
(1 ATM = 760 Torr)

Auto Control CMV to PS,VS settings


Auto PEEP Total PEEP - Set PEEP
b/min Breaths per minute
The bar is a non-SI unit of pressure
Bar
(1 bar = 100 kPa or 750.06 mmHg or 750.06 Torr)

Base Flow Continuous Base Flow Rate (Bias Flow)


BMI Body Mass Index
BTPS Body Temperature Pressure Saturated
c/min Cycles per minute (SPAP mode setting)
The ratio of the dynamic compliance during the last 20% of Inspiration
C20/C (C20) to the total dynamic compliance. A C20/C ration of <0.80 is
indicative of over distention. >1.0 is usually normal
CIB Clinical Information Bulletin
Cdyn Dynamic Compliance
Cdyn/kg Dyn Compliance / Wt in kg
Centimeter of water pressure
cmH2O
(1 cmH2O = 10 –3 bar) and (1.016 cmH2O = 1 mbar or 1 hPa)

Cstat Static Compliance


Cstat/kg Static Compliance / Wt in kg
DC Direct current
Decel Decelerating Flow Pattern (Ramp)
Decel 50% Decelerating 50% Flow Pattern (Ramp)
Esens Exhalation Sensitivity
ETCO2 End Tidal Carbon Dioxide Measurement in mmHg
Ethernet Ethernet (RJ45) Port for software installation
Exp Min Vol Exhaled minute volume
F/V Loop Flow + Volume Curve Graph
Fractional concentration of carbon dioxide in exhaled gas
FeCO2
(The Fractional concentration of mean expired CO2)

FetCO2 Fractional concentration of end-tidal CO2 in exhaled gas

FiO2 Fraction of inspired oxygen (oxygen concentration)


FRC Functional Residual Capacity

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Section 13 Terms, Abbreviations and Definitions

Term Definition
Ftrig Flow Trigger level
GUI Graphical User Interface
GUI Graphical user interface
Hectopascal
hPa
(1 hPa equals 1 mbar, which equals 1.016 cmH2O)

Ratio of time at high to low PEEP levels


H:L
(SPAP mode setting and monitored value)

HME Heat Moisture Exchanger (filter)


Humidifier Humidification type selection
Hertz
Hz
(1 Hz = 1 cycle/sec)

I:E Inspiratory to Expiratory Ratio


I-time (Ti) Set inspiratory time
IBW Ideal Body Weight
ID Internal diameter
Kilopascal
kPa
(7.501 kPa = 1 Torr)

l Liter
l/min Liters per minute
LCD Liquid crystal display
Leak % Calculated leak Percentage
Leak compensation is a setting that allows the ventilator to compensate
Leak Comp
for leaks during ventilation automatically.
Milibar
mbar
(1 mbar equals 1 hPa, which equals 1.016 cmH2O)

Milliliter
ml
(1 ml = 10 –3 l)

Millimeter of mercury is a manometric non-SI unit of pressure


mmHg
(1 mmHg = 1 Torr) or (1 mmHg = 760 millimeters of mercury)

ms Millisecond
min Minute
NCPAP+ Nasal continuous positive airway pressure plus with rate and base flow
NIV  Non-Invasive Ventilation
O2 Oxygen and or Delivery Concentration
+O2% Apnea Backup Oxygen Setting
OI Oxygen Index
OID Object Identification Table
P/F Loop Pressure + Flow Curve Graph

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Section 13 Terms, Abbreviations and Definitions

Term Definition
PIB Product Information Bulletin
P/V Loop Pressure + Volume Curve Graph
P0.1 Airway Occlusion Pressure Measurement (manual or maneuver)
P0.1/PiMax Airway Occlusion Pressure to maximal inspiratory pressure ratio
Displays the Patient type established by the IBW: Neonate, Pediatric or
Patient Type
Adult
Pause Inspiratory Pause Time Setting
P–CMV Pressure Control Continuous Mandatory Ventilation
Control pressure, inspiratory pressure above PEEP delivered during a
Pcontrol
pressure-controlled breath (Pressure above PEEP)
Partial pressure of CO2 in exhaled gas
PeCO2
(The partial pressure of mean expired CO2)

PEEP Peak End Expiratory Pressure


PEEP Positive end expiratory pressure (Peak End Expiratory Pressure)
PetCO2 Partial pressure of CO2 at the end of expiration. Abstracted from ETCO2

PF Peak Inspiratory Flow


PFe Peak Expiratory Flow
Phigh High PEEP level (SPAP mode setting)
The maximum negative inspiratory pressure that is achieved by the
PiMax
patient, during a PiMax maneuver.
Plow Low PEEP level (SPAP mode setting)
Pmean Mean Airway Pressure
Calculated airway baseline tracheal pressure or Tracheal Peak End
Pmin
Expiratory Pressure
P0.1 Airway occlusion pressure (P100)
VTV breaths are delivered within a defined operation pressure (P op)
Pop
range PopLow to PopHigh.
Ppeak Peak Inspiratory Pressure
Pplateau Plateau Pressure
Pplateau Plateau (inspiratory hold or pause) pressure
Prox Proximal
PRVC Pressure Regulated Volume Control
Pressure Regulated Volume Control Continuous Mandatory Ventilation
PRVC–CMV
(a VTV mode)
Pressure regulated volume control synchronized intermittent mandatory
PRVC–SIMV
ventilation, a VTV mode
PS Pressure Support (SPONT Mode)
Pressure per square inch
psi
(1 bar = 14.50 psi)

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Section 13 Terms, Abbreviations and Definitions

Term Definition
P–SIMV Pressure Controlled Synchronized Intermittent Mandatory Ventilation
Level of pressure support in addition to high PEEP
Psup high
(SPAP mode setting)
Level of pressure support in addition to low PEEP
Psup low
(SPAP mode setting)
Pressure Support = inspiratory pressure delivered above PEEP during a
Psupport
spontaneous pressure support breath. (Pressure above PEEP)
Ptrach Calculated Tracheal Peak Inspiratory Pressure
Ptrig Pressure Trigger level
PVL Tool (p) Slow Inflation / Deflation pressure breath maneuver
PVL Tool (v) Slow Inflation / Deflation volume breath maneuver
PWM Pulse width modulation
Rate Measured total (mandatory and spontaneous) breaths per minute
Rate Sp Spontaneous Respiratory Rate
Rate/Vt Calculated respiratory rate divided by tidal volume (RSBI)
RCe Expiratory Time Constant
Rexp Expiratory Resistance
Rinsp Inspiratory Resistance
RS232 Serial interface
Rapid Shallow Breathing Index
RSBI
(Calculated respiratory rate divided by tidal volume)

s Second
SBT Spontaneous Breathing Trial Mode
SNMP Simple Network Management Protocol
SPAP Spontaneous Positive Airway Pressure
SPONT Spontaneous Ventilation (CPAP + PS)
Square Square Flow Pattern (Ramp)
Recruitment Maneuver (continuous ventilation at user defined RM Step
Step Tool
and Rest Step settings and times)
STPD Standard temperature and pressure, dry
Suction Support Automated suction assist feature
Tapnea Apnea Alarm Time Setting
Target Vt Target tidal volume (a VTV mode setting in PRVC and VS)
Tube compensation is a feature that allows the ventilator to automatically
TC (Tube Comp)
compensate for the resistance imposed by the patient’s artificial airway.
Te Expiratory Time
TF Technical fault
Thigh Time at high PEEP level (SPAP mode setting)
Ti Set or Monitored inspiration time

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Section 13 Terms, Abbreviations and Definitions

Term Definition
Ti/Ttot Calculated I–Time divided by cycle time
TIB Technical Information Bulletin
Tlow Time at low PEEP level (SPAP mode setting)
Torr is a unit of measurement for pressure
Torr
(1 Torr = 1 mmHg) and (760 Torr = 1 ATM)

TS Touch screen
UI User Interface
V Volt
VA Volt-ampere (watt)
VAC Volt, alternating current
Alveolar tidal ventilation. Vte - Vds.
Valv
(Displayed if optional CO2 sensor is connected)

Alveolar minute ventilation. Valv * f (normalized to 1 min)pg


Valv/min
(Displayed if optional CO2 sensor is connected)

V–CMV Volume Control Continuous Mandatory Ventilation


CO2 elimination. Net exhaled volume of CO2 per minute
VCO2/min
(Displayed if optional CO2 sensor is connected)

Alveolar Dead Space


Vd alv
(Displayed if optional CO2 sensor is connected)

Anatomical Dead Space


Vd ana
(Displayed if optional CO2 sensor is connected)

Physiologic Dead Space/Tidal Volume Ratio


Vd/Vt phy
(Displayed if optional CO2 sensor is connected)

VDC Volt, direct current


Ve Exhaled Minute Volume
Ve Spont Spontaneous Exhaled Minute Volume
Ve/Kg Exhaled Minute Volume normalized to ideal body weight
Ve Inspired Minute Volume (displays if the flow sensor is disabled)
Inspired Minute Volume normalized to ideal body weight
Ve/Kg
(displays if flow the sensor is disabled)

CliniNet Virtual Report is a remote monitoring external software


Virtual Report application that allow user to view all ventilator data, alarms and settings
in real-time.
VS Volume Support
V–SIMV Volume Controlled Synchronized Intermittent Mandatory Ventilation
Vt Tidal Volume
Vte Exhaled Tidal Volume
Vte/Kg Exhaled Tidal Volume normalized to ideal body weight

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Section 13 Terms, Abbreviations and Definitions

Term Definition
Exhaled CO2 volume. Updated breath-to-breath
VteCO2
(Displayed if optional CO2 sensor is connected)

Vti Inspiratory Tidal Volume


Vti/Kg Inspiratory Tidal Volume normalized to ideal body weight
Inspired CO2 volume. Updated breath-to-breath
VtiCO2
(Displayed if optional CO2 sensor is connected)

VTV Volume Targeted Ventilation includes PRVC and VS modes.


W Watt
WBM Web based monitoring
Work of Breathing Imposed: WOBimp is a monitored parameter defined
WOBimp as the work performed by the patient to breathe through the ventilator’s
valves, breathing circuit, and humidifier.
μA Microampere
Table 53: Abbreviations

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Section 14 Pneumatic Schematic

14. Pneumatic Diagram

Figure 107: Inspiration Ventilator Pneumatic Schematic

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Section 15 Index

15. Index
Apnea ......................................................................... 230 
Apnea Backup Active ................................................. 230 
1  Battery Flat ................................................................ 230 
Disconnection ............................................................ 230 
100% O2 Key ........................................................... 18, 44  Heliox Pres Low‐ Using Air ......................................... 230 
Heliox Supply ............................................................. 230 
High Minute Volume .................................................. 230 
High Oxygen ............................................................... 230 
A  High‐pressure ............................................................. 230 
High Tidal Volume ...................................................... 230 
Abbreviations and Definitions ....................................... 251  Internal Pressure Low/Disconnect ............................. 230 
Activating Ventilation ...................................................... 71  Low Minute Volume ................................................... 230 
Airway Occlusion Maneuver  Low Oxygen ................................................................ 230 
See Maneuvers P0.1 ................................................... 102  Low Pressure .............................................................. 230 
Alarm AUTO SET Feature ............................................... 110  Low Tidal Volume ....................................................... 230 
Alarm Descriptions and Corrective Actions  Occlusion ................................................................... 230 
High Priority Alarms.................................................... 113  Oxygen Supply ........................................................... 230 
Information Priority Alarms ........................................ 121  PetCO2  High ............................................................... 230 
Medium Priority Alarms ............................................. 117 
PetCO2  Low ............................................................... 230 
Alarm Settings 
Capnography ...................................................... 106, 229  Prox. Line on Right Side? ............................................ 230 
Default Alarm Settings ................................................ 109  Speaker Fault ............................................................. 230 
SBT ...................................................................... 108, 229  Technical Fault (TF‐1 to TF‐29 .................................... 230 
Standard ............................................................. 104, 227  Valv Low ..................................................................... 230 
Alarm Settings (AUTO SET)  Valv/min Low ............................................................. 230 
Alarm Setting Adjustment Rules ................................. 110  VteCO2  Low ............................................................... 230 
Apnea Time ................................................................ 111  Alarms Information Priority 
Leak High .................................................................... 111  100%O2 Cal. not avail ................................................. 231 
PetCO2 High ................................................................ 111  Battery not available .................................................. 231 
PetCO2 Low ................................................................. 111  Flow cal. not available ................................................ 231 
Pmean High ................................................................ 111  Flow trigger not avail ................................................. 231 
Pmean Low ................................................................. 111  Gas connected ........................................................... 231 
Ppeak High .................................................................. 111  Increase O2 not avail .................................................. 231 
Ppeak Low .................................................................. 111  Inverse ratio set ......................................................... 231 
Rate High .................................................................... 111  Logbook cleared ......................................................... 231 
Rate High (SBT) ........................................................... 112  Maneuver Active ........................................................ 231 
Rate Low (SBT) ............................................................ 112  Mem CPU not protected ............................................ 231 
RSBI High (SBT) ........................................................... 112  Mem power no protect .............................................. 231 
RSBI Low (SBT) ............................................................ 112  Mem sensor no protect ............................................. 231 
Valv High ..................................................................... 111  Nebulizer not avail ..................................................... 231 
Valv Low ..................................................................... 111  No CO2 Sensor ............................................................ 231 
Valv/min High ............................................................. 112  O2 sensor not avail ..................................................... 231 
Valv/min Low .............................................................. 112  SBT Active .................................................................. 231 
Ve High ....................................................................... 110  SBT Canceled .............................................................. 231 
Ve Low ........................................................................ 110  SBT Off ....................................................................... 231 
Vte High ...................................................................... 110  Suction Active ............................................................ 231 
Vte Low ............................................................... 110, 111  Alarms Medium Priority 
VteCO2 Low................................................................. 111  Battery Low ................................................................ 230 
Vti Limit ...................................................................... 111  Check Pcontrol / Pmax ............................................... 230 
Alarm Signals  Check Psupport / Pmax .............................................. 230 
Audible (dB) Level ....................................................... 112  Ck. CO2 Sensor ........................................................... 230 
Alarm Silence ................................................................18  Ck. Sample Line .......................................................... 230 
Alarm Silence Key Functions ....................................... 112  Ck.CO2 Adaptor .......................................................... 230 
Functions ...................................................................... 45 
CO2 Sensor Accuracy? ................................................ 230 
Alarm Tests and Procedures .......................................... 182 
Alarms  Compressor ................................................................ 230 
Reset Feature ............................................................. 124  High External Voltage ................................................ 230 
Technical Failure Alarms ............................................. 123  High Frequency .......................................................... 230 
Alarms High Priority  High Leak.................................................................... 230 
Air Supply ................................................................... 230  High Temperature ...................................................... 230 

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Section 15 Index

Low Frequency ........................................................... 230 
P Op High‐V not Deliver .............................................. 230 

Pmean High ................................................................ 230 
Pmean Low ................................................................. 230  Calibrations 
PT Effort Detected ...................................................... 230  Calibration Required Status Bar Icon ........................... 49 
Replace CO2 Adaptor .................................................. 230  Flow Sensor .......................................................... 39, 170 
Heliox ........................................................................... 26 
Replace Sample Line ................................................... 230 
New and Previous Patient ............................................ 59 
SBT High Rate ....................................................... 74, 230 
O2 Sensor ..................................................................... 44 
SBT High RSBI ....................................................... 74, 230 
Oxygen Sensor ........................................................... 178 
SBT Low Rate ........................................................ 74, 230 
Circuit Check .............................................................. 173 
SBT Low RSBI ........................................................ 74, 230 
Circuit Check (Acceptance Criteria) ............................ 174 
Valv  High .................................................................... 230 
Circuit Check (Bypass Screen) .................................... 177 
Valv/min High ............................................................. 230 
Touch Screen ............................................................... 47 
Vti Limit Reached ........................................................ 230 
Zero CO2 Sensor ......................................................... 180 
Zero CO2 Sensor .......................................................... 230 
Capnograms ................................................................... 226 
Apnea Alarm ............................................................... 230  Capnograms Screen Graph Selection 
Apnea Backup ...............................................................68  Left Panel SBCO2 Curves ............................................ 165 
Modes......................................................................... 211 
Right Panel Waveforms .............................................. 165 
Overview ...................................................................... 80 
Capnography 
Settings ....................................................................... 211 
Alarm Settings .................................................... 106, 229 
Status Bar Icon .............................................................. 49 
Alarm Settings Screen (Mainstream) ......................... 106 
Transition / Termination Rules ..................................... 80 
Alarm Settings Screen (Sidestream) ........................... 106 
Apnea Time Alarm Setting ................................... 105, 228 
FeCO2 ................................................................. 149, 224 
Apnea Ventilation Alarm ............................................... 230 
APRV  FetCO2 ................................................................ 149, 224 
See SPAP ..................................................................... 246  Introduction ............................................................... 162 
Auto Control ................................................... 67, 71, 206  Mainstream (IRMA) Sensor .......................................... 30 
Active Mode Display ..................................................... 72  Mainstream Sensor Connection ................................... 30 
CMV/Spont Trend ....................................................... 157  Mainstream Sensor Position (Circuit Wye) .................. 33 
Modes........................................................................... 72  Monitored Data ................................................. 149, 223 
Monitored Data ............................................................ 72  PaCO2 Entry Control Setting ............................... 167, 218 
Spont Mode Selection .................................................. 71  PeCO2 ................................................................. 149, 223 
Spont% 1h Monitored Date ........................................ 142  PetCO2 ................................................................ 149, 223 
Spont% 8h Monitored Date ........................................ 142  SBCO2 Curves ............................................................. 227 
Status Bar Icon .............................................................. 49 
Sensor Calibration ................................................ 31, 180 
Auto PEEP ........................................................... 143, 222 
Setup ............................................................................ 29 
Automatic Leak Compensation .............................. 67, 205 
Sidestream (ISA) Sensor ............................................... 34 
Sidestream Adapter Position (Circuit Wye) ................. 35 
Sidestream Sensor Connection .................................... 34 
B  Valv .................................................................... 150, 224 
Valv/min ............................................................. 150, 224 
Base Flow .............................................................. 67, 205  VCO2/min ........................................................... 149, 224 
Basic and Advanced Parameter Selections .....................66 
Vd alv ................................................................. 149, 225 
Battery 
Vd ana ................................................................ 149, 225 
External ........................................................................ 25 
Vd/Vt phy ........................................................... 150, 225 
Internal ......................................................................... 24 
VteCO2 ............................................................... 149, 224 
Replacement .............................................................. 193 
Status Bar Icon .............................................................. 49  VtiCO2 ................................................................ 149, 224 
Battery Life  Warnings and Cautions ........................................ 34, 163 
Internal Battery (Off Compressor) .............................. 195  Waveforms................................................................. 226 
Internal Battery (On Compressor) .............................. 195  Cautions 
BiLevel  Tube Comp ................................................................... 77 
See SPAP ..................................................................... 246  Changing Settings ............................................................ 51 
Breath Termination  Circuit Support Arm ......................................................... 41 
PS Tmax ...................................................................... 205  Cleaning ................................................................ 12, 187 
Breath Triggering .................................................... 204, 250  Methods ..................................................................... 187 
Breathing circuit ............................................................36  CliniNet .........................................................................28 
NCPAP+ patient interface ............................................. 38  CMV 
Pressure ..................................................................... 237 
Volume ....................................................................... 233 
CO2 Sensor 
Calibration ................................................................. 180 
Communication 
EVM500044, Rev E Inspiration® 5i User Manual (International Version) 264
Section 15 Index

Capnography Sensors ................................................... 29 
Ethernet........................................................................ 28 

Nurse Call ..................................................................... 29 
Patient ID Entry (at Startup) ................................... 57, 60  Environmental Data 
Room/Bed ID Entry (at Startup) ............................. 57, 60  CO2 Sensors ................................................................ 196 
RS232 ............................................................................ 29  Ventilator ................................................................... 196 
Compliance  Esens% .................................................................. 66, 206 
Cdyn.................................................................... 146, 222  ETCO2 
Cdyn/kg .............................................................. 146, 222  Status Bar Icon ............................................................. 49 
Cstat ................................................................... 146, 221  Event Log 
Cstat/kg .............................................................. 146, 221  Details ........................................................................ 124 
Compliance, tubing ..................................................... 173  Filtering Events .......................................................... 124 
Config. Screen ................................................................. 212  Event Markers 
Clinical ........................................................................ 125  Automatic Entry ......................................................... 152 
Defaults Options ......................................................... 130  Changing a Logged Event Marker .............................. 154 
Graphic Options .......................................................... 129  Manual Entry ............................................................. 151 
Technical Options ....................................................... 136  User Comments ......................................................... 153 
Configuration‐screen Settings 125, 129, 131, 133, 136, 187  Exhalation Cover ...........................................................40 
Connecting to Air Supply ...............................................26  Exhalation Diaphragm ...................................................40 
Connecting to Oxygen Supply ........................................26  Exhalation Sensitivity (Esens) ................................ 66, 206 
Contact Information  Exp. Hold Maneuver ......................................................63 
Clinical Support .......................................................... 269  Expiratory Time Constant (RCe) ........................... 145, 223 
Customer Service ........................................................ 269  External User Interface 
International Sales ...................................................... 269  Alarm LED Display ........................................................ 42 
Technical Service ........................................................ 269  Keys .............................................................................. 42 
US Office Address ........................................................... 2 
US Office Fax .................................................................. 2 
US Office Phone .............................................................. 2  F 
US Sales ...................................................................... 269 
Control Settings  Fan Filter replacement and cleaning ............................ 192 
Setting Limit Soft Boundary .......................................... 55  FiO2 ...............................................................................68 
Current and Proposed Settings ......................................66 
Flex Arm ........................................................................41 
Cycle (SPAP Mode Rate) ........................................ 69, 208 
Flow ..............................................................................70 
Flow Pattern .......................................................... 66, 206 
Flow Sensor 
D  Calibration ........................................................... 39, 170 
Connection ................................................................... 39 
Date and Time Display ...................................................50  Distal position at Exp port ............................................ 37 
Date/Time Settings ..................................................... 135  Flow cal. not available Alarm ..................................... 231 
Default Alarm Settings (Capnography)  Flow trigger not avail Alarm ....................................... 231 
PetCO2 High and Low .................................................. 110  On/Off (at Startup)................................................. 56, 60 
Valv High and Low ...................................................... 110  On/Off Selection ................................................ 126, 212 
Valv/min High and Low .............................................. 110  Proximal position at circuit Wye .................................. 37 
VteCO2 Low................................................................. 110  Specifications ............................................................... 39 
Default Alarm Settings (SBT)  Flow Trigger (Ftrig) ................................................ 70, 204 
Rate High and Low ...................................................... 110  FromPatient Port ...........................................................19 
RSBI High and Low ...................................................... 110  Fuse Replacement ....................................................... 193 
Default Alarm Settings (Standard) 
Apnea Time ................................................................ 109 
Leak High .................................................................... 109  G 
Pmean High and Low .................................................. 109 
Ppeak High and Low ................................................... 109  Gas Supply ....................................................................... 25 
Rate High and Low ...................................................... 109  Air Inlet ........................................................................ 26 
Ve High and Low ......................................................... 109  Gas Type 
Vte High and Low ....................................................... 109  Air .......................................................................... 56, 60 
Vti Limit ...................................................................... 109  Heliox ..................................................................... 56, 60 
Device Labels and Symbols ............................................18  Selection (at Startup) ............................................. 56, 60 
Disposal ...................................................................... 193  Gender Specific GUI Colors ............................................53 
Document Revision History ...........................................10  Graphical User Interface (GUI) ........................................ 47 
Graphics 
Capnograms Screen ................................................... 165 
Cursor Control ............................................................ 154 

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Section 15 Index

Freeze/Unfreeze ......................................................... 154  IBW (in use adjustment) .................................... 126, 212 
Loops .......................................................................... 226  IE Ratio .................................................................. 69, 203 
Real‐Time Curves ........................................................ 225  Index of Figures .......................................................... 7 
Waveforms ................................................................. 225  Index of Tables ........................................................... 9 
GUI  Information Priority Alarm Messages .......................... 230 
Gender Specific Colors.................................................. 53  Inlet Gas Supply 
Filter Replacement ..................................................... 192 
Insp Time ......................................................................69 
H  Insp. Hold Maneuver ....................................................... 63 
Inspiration i Series Ventilators 
Heliox  Optional Features 5i .................................................... 22 
Calibration .................................................................... 26  I n s p i r a t i o n   V e n t i l a t o r   p a r t   n u m b e r s  ................ 2 
Gas Connection ............................................................ 27  Intended Use .................................................................11 
Gas Supply Alarm ....................................................... 230  Internal Compressor .................................................... 195 
Gas Type Selection ............................................. 126, 212  Introduction ..................................................................11 
Gas connected ............................................................ 231  I‐Time (Ti) .............................................................. 69, 203 
HeO2 Trend Data ........................................................ 157 
Inlet Pressure.............................................................. 195 
Low Supply Pressure Alarm ........................................ 230  L 
Monitored Data .................................................. 141, 220 
Selection (at Startup) .............................................. 56, 60  Labels ............................................................................... 18 
Setup ............................................................................ 26  Language Selection ...................................................... 135 
Status Bar Icon .............................................................. 49  Leak Comp ....................................................................67 
Tank Regulator ............................................................. 27  Leak Compensation ............................................... 67, 205 
High (SBT) Rate Alarm Setting ............................. 108, 229  Overview .................................................................... 250 
High (SBT) RSBI Alarm Setting .............................. 108, 229  Leak Test, patient tubing ............................................. 173 
High External Voltage Alarm ........................................ 230  Lock / Unlock ................................................................20 
High Leak Alarm .......................................................... 230  Loop Study ............................................................. 159, 160 
High Leak Alarm Setting ...................................... 105, 228  Deleting Saved Loops ................................................. 161 
High Low Ratio ..............................................................66  Loop Data Display ...................................................... 160 
High Mean Airway Pressure Alarm .............................. 230  Loop Save Feature ..................................................... 160 
High Mean Airway Pressure Alarm Setting .......... 105, 227  Reference Loop Feature ............................................. 161 
High Minute Volume Alarm Setting ..................... 104, 227  Loops .............................................................................. 226 
High Minute Volume Volume Alarm ............................ 230  Low (SBT) Rate Alarm Setting .............................. 108, 229 
High Oxygen Alarm ...................................................... 230  Low (SBT) RSBI Alarm Setting .............................. 108, 229 
High PetCO2 Alarm ...................................................... 230  Low Battery Alarm ...................................................... 230 
High PetCO2 Alarm Setting................................... 107, 229  Low Heliox Supply Pressure Alarm............................... 230 
Low Mean Airway Pressure Alarm ............................... 230 
High‐pressure Alarm .................................................... 230 
Low Mean Airway Pressure Alarm Setting ........... 105, 227 
High‐pressure Alarm Setting ................................ 105, 227 
Low Minute Volume Alarm Setting ...................... 104, 227 
High Priority Alarm Messages ...................................... 230 
Low Minute Volume Volume Alarm ............................. 230 
High Rate Alarm .......................................................... 230 
Low Oxygen Alarm ...................................................... 230 
High Rate Alarm Setting ...................................... 105, 228 
Low PetCO2 Alarm ....................................................... 230 
High SBT Rate Alarm .............................................. 74, 230 
High SBT RSBI Alarm .............................................. 74, 230  Low PetCO2 Alarm Setting ................................... 107, 229 
High Temperature Alarm ............................................. 230  Low Pressure Alarm ..................................................... 230 
High Tidal Volume Alarm ............................................. 230  Low Pressure Alarm Setting ................................. 105, 227 
High Tidal Volume Alarm Setting ......................... 105, 227  Low Rate Alarm ........................................................... 230 
High Valv Alarm ........................................................... 230  Low Rate Alarm Setting ....................................... 105, 228 
High Valv Alarm Setting ....................................... 107, 229  Low SBT Rate Alarm .............................................. 74, 230 
High Valv/min Alarm ................................................... 230  Low SBT RSBI Alarm .............................................. 74, 230 
High Valv/min Alarm Setting ............................... 107, 229  Low Tidal Volume Alarm ............................................. 230 
High Vti Limit Alarm Setting ................................ 105, 228  Low Tidal Volume Alarm Setting .......................... 105, 227 
HL Ratio................................................................. 66, 208  Low Valv Alarm ........................................................... 230 
Humidification devices ..................................................40  Low Valv Alarm Setting ....................................... 107, 229 
Humidification Type ...................................... 59, 125, 212  Low Valv/min Alarm .................................................... 230 
Low Valv/min Alarm Setting ................................ 107, 229 
Low VetCO2 Alarm ....................................................... 230 
I  Low VteCO2 Alarm Setting ................................... 107, 229 

IBW ...............................................................................56 
Ideal Body Weight 
Calculator ..................................................................... 56 

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Section 15 Index

PEEP ................................................................... 139, 218 
M  PetCO2 ................................................................ 149, 223 
PF 141, 220 
Main Screen ..................................................................62 
PFe ..................................................................... 141, 220 
Main Screen Element Descriptions ................................48 
PiMax ................................................................. 147, 223 
Main Screen Graph Selection 
Pmean ................................................................ 139, 218 
Number of Graphs to Display ..................................... 129 
Pmin ........................................................... 139, 217, 218 
Right Panel Loops ....................................................... 159 
Ppeak ................................................................. 139, 218 
Waveforms or Loops .................................................. 129 
Pplateau ............................................................. 144, 222 
Maneuvers 
Pressure Values .......................................................... 218 
Expiratory Hold ............................................................. 63 
Ptrach ................................................................. 139, 218 
Inspiratory Hold ............................................................ 63 
Rate .................................................................... 140, 220 
P0.1 (Airway Occlusion Maneuver) .................... 147, 222 
Rate Spont ......................................................... 140, 220 
P0.1 Overview ............................................................ 102 
RCe (expiratory time constant) .......................... 145, 223 
PiMax (Max Insp Pressure) ................................. 147, 223 
Respiratory Mechanics .............................................. 221 
PiMax Maneuver Details ............................................ 103 
Rexp ................................................................... 146, 222 
PiMax Overview.......................................................... 103 
Rinsp .................................................................. 146, 222 
Recruitment .................................................................. 83 
RSBI .................................................................... 144, 222 
Suction Support ............................................................ 81 
Spont% 1h (% of spont breaths for the last 1 hr) 142, 221 
Manual Breath 
Spont% 8h (% of spont breaths for the last 8 hrs) ..... 142, 
Front Panel Key ...................................................... 18, 44 
221 
Front Panel Key Function ............................................. 45 
Ti/Ttot ................................................................ 141, 221 
Status Bar Icon .............................................................. 49 
Time Values ................................................................ 220 
Medium Priority Alarm Messages ................................ 230 
Valv .................................................................... 150, 224 
MIP Maneuver 
Valv/min ............................................................. 150, 224 
See Maneuvers PiMax ................................................ 103 
VCO2/min ........................................................... 149, 224 
Mode 
NCPAP+ ....................................................................... 249  Vd alv ................................................................. 149, 225 
NIV .............................................................................. 249  Vd ana ................................................................ 149, 225 
P‐CMV ......................................................................... 237  Vd/Vt phy ........................................................... 150, 225 
PRVC‐CMV .................................................................. 240  Ve 139, 219 
PRVC‐SIMV ................................................................. 241  Ve Spont ............................................................. 139, 219 
PS 244  Ve/kg .................................................................. 139, 219 
P‐SIMV ........................................................................ 238  Vi 139, 219 
SPAP ........................................................................... 246  Vi Spont .............................................................. 140, 219 
V‐CMV ........................................................................ 233  Volume / Flow Values ................................................ 219 
VS 242  Vte ..................................................................... 139, 219 
V‐SIMV ........................................................................ 235  Vte/kg ................................................................ 139, 219 
Mode Selection .............................................................64  VteCO2 ............................................................... 149, 224 
Modes of Ventilation ................................................... 232  Vti ....................................................................... 139, 219 
Monitored Data  Vti/kg ................................................................. 139, 219 
Auto PEEP ........................................................... 143, 222  VtiCO2 ................................................................ 149, 224 
Basic ........................................................................... 138  WOBimp (work of breathing imposed) .............. 147, 223 
C20/C .................................................................. 144, 223  Monitoring Screen Setting Descriptions .........................62 
Capnography ETCO2 ........................................... 149, 223  Monitors (Monitor Bar) 
Cdyn.................................................................... 146, 222  Number of Monitors to Display ......................... 129, 212 
Cdyn/kg .............................................................. 146, 222 
Cstat ................................................................... 146, 221 
Cstat/kg .............................................................. 146, 221  N 
E‐Time (Te) ......................................................... 141, 221 
FeCO2 .................................................................. 149, 224  Nasal CPAP Mode description (NCPAP+) ...................... 249 
FetCO2 ................................................................ 149, 224  Nasal prongs .................................................................... 38 
Heliox (HeO2) ...................................................... 141, 220  NCPAP+ Mode 
HL Ratio .............................................................. 141, 221  Flow setting................................................................ 209 
IE Ratio ............................................................... 141, 221  I‐Time setting ............................................................. 209 
I‐Time (Ti) ........................................................... 140, 220  Nasal Prong Selection .................................................. 38 
Leak .................................................................... 141, 220  Pcontrol setting .......................................................... 209 
O2 141, 220  PEEP/CPAP setting ..................................................... 209 
P0.1..................................................................... 147, 222  Prong pressure line connection ................................... 38 
P0.1/PiMax ......................................................... 147, 223  Rate setting ................................................................ 209 
PaCO2 Entry Control Setting ....................................... 167  NCPAP+ patient interface ................................................ 38 
Nebulizer 
PeCO2 ................................................................. 149, 223 
Functional Details ...................................................... 127 

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Section 15 Index

Gas delivery compensation when active ...................... 40  F7300000–5i‐L ............................................................. 47 
Port Label ..................................................................... 18  F 7 3 0 0 0 0 0 ‐ 5 i ‐ L ‐ N C  ................................................... 2 
Settings ............................................................... 126, 212  F7300000‐5i–L‐NC ........................................................ 47 
Setup ............................................................................ 40  F 7 3 0 0 0 0 0 ‐ 5 i ‐ S  .......................................................... 2 
Specifications................................................................ 40  F7300000–5i‐S ............................................................. 47 
Status Bar Icon .............................................................. 49  F 7 3 0 0 0 0 0 ‐ 5 i ‐ S ‐ N C  ................................................... 2 
New Patient Startup ......................................................... 56  F7300000‐5i–S‐NC ....................................................... 47 
NIF (See PiMax) ................................................... 147, 223  F810026 ..................................................................... 191 
NIF Maneuver  F810044 ..................................................................... 191 
See Maneuvers PiMax ................................................ 103  F810135 ..................................................................... 191 
NIV ........................................................................ 66, 205  F820003 ..................................................................... 191 
Status Bar Icon .............................................................. 49  F910028 ..................................................................... 191 
Non Invasive Ventilation (NIV) Settings ....................... 249  F910037 ..................................................................... 186 
Notices  F910038 ..................................................................... 186 
Copyright ...................................................................... 17  F910205 ..................................................................... 191 
Regulatory .................................................................... 17  F910214 ..................................................................... 191 
Trademark .................................................................... 17  RT137 ......................................................................... 186 
Nurse call  Part numbers .............................................................. 186 
warning ......................................................................... 12  Parts list ...................................................................... 186 
Nurse Call  Patient Selection‐screen ................................................56 
Interface pin assignments ............................................ 29  Pause .......................................................................... 205 
P‐CMV Mode description ............................................. 237 
Pcontrol ................................................................ 69, 204 
O  Peak Flow .............................................................. 70, 204 
PEEP / CPAP .......................................................... 69, 203 
O2 ⬆ Key  Performance Verification Testing ................................ 193 
Phigh ..................................................................... 70, 206 
Adult/Pedi Function ..................................................... 44 
Physical Data 
Front Panel Key ............................................................ 44 
Carts ........................................................................... 197 
Neonate Function ......................................................... 44 
CO2 Sensors ................................................................ 197 
Status Bar Icon .............................................................. 49 
Flow Sensors .............................................................. 197 
O2 Sensor Off 
Noise Level ......................................................... 197, 199 
Status Bar Icon .............................................................. 49 
Ventilator ................................................................... 197 
On/Off Key ....................................................................25 
PiMax .................................................................. 147, 223 
Ordering parts ............................................................. 186 
PiMax Maneuver ......................................................... 103 
Overdistention Index (C20/C) .............................. 144, 223 
Plateau ........................................................................ 205 
Oxygen (O2) ........................................................... 68, 206 
Plateau Pressure ................................................. 144, 222 
Oxygen Enrichment  Plow ...................................................................... 70, 207 
See O2 ⬆ Key ................................................................. 44  Pneumatic Diagram ..................................................... 257 
Oxygen Sensor  Power and Gas supply ................................................. 195 
Calibration .................................................................. 178  Power Supply 
O2 sensor not avail Alarm ........................................... 231  AC Power ..................................................................... 23 
On/Off Selection ................................................. 126, 212  DC (External) Power ..................................................... 25 
Replacement .............................................................. 192  DC (Internal) Power ..................................................... 24 
Pressure Trigger (Ptrig) .......................................... 70, 205 
Pressure units ............................................................. 200 
P  Preventative Maintenance .......................................... 191 
Preventive Maintenance 
P0.1 Maneuver ............................................................... 102  Fan Filter Replacement .............................................. 192 
P0.1 See Maneuvers ............................................ 147, 222  Fuse Replacement ...................................................... 193 
P100 Maneuver  Inlet Gas Filter Replacement ...................................... 192 
See Maneuvers P0.1 ................................................... 102  Internal Battery Replacement .................................... 193 
PaCO2 Entry Control Setting ................................. 167, 218  O2 Sensor Replacement ............................................. 192 
Part Number  Performance Verification Testing .............................. 193 
EVL220047 .................................................................. 186  Procedures ................................................................. 192 
EVL500501 .................................................................. 186  Schedule .................................................................... 191 
EVM500019 ........................................................ 123, 136  Product Specifications 
EVM500026 .................................................................... 2  Alarm Settings ............................................................ 227 
EVM200325 .................................................................. 40  Alarms High Priority ................................................... 230 
F710214 ........................................................................ 40  Alarms Information Priority ....................................... 230 
F710568 ........................................................................ 27  Alarms Medium Priority ............................................. 230 
F710616 ................................................................ 41, 186  Apnea Backup Settings .............................................. 211 
F 7 3 0 0 0 0 0 ‐ 5 i ‐ L  ........................................................... 2  Breath Triggering ....................................................... 204 

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Section 15 Index

Breath Types by Control Variable ............................... 201 
Cart Dimensions ......................................................... 197 

Cart Weights ............................................................... 197 
CO2 Sensor Technical Data ......................................... 198  Ramp (See Rise Time) ....................................................66 
Configuration‐screen Options .................................... 212  Rapid shallow breathing index (RSBI) .................. 144, 222 
Environmental Data (CO2 Sensors) ............................. 196  Rate ...................................................................... 68, 203 
Real‐Time Curves 
Environmental Data (Ventilator) ................................ 196 
Capnograms ............................................................... 226 
Flow Sensors ............................................................... 197 
Loops .......................................................................... 226 
Internal Compressor ................................................... 195 
SBCO2 Curves ............................................................. 227 
Monitored & Displayed Data ...................................... 218 
NCPAP+ Mode Settings .............................................. 209  Waveforms................................................................. 225 
Noise Levels ................................................................ 197  Recruitment Maneuver 
Operating Temperature and Altitude ......................... 196  PVL Tool (p) Settings ................................................... 214 
Patient Startup Options .............................................. 202  PVL Tool (v) Settings ................................................... 215 
Physical Data .............................................................. 197  Step Tool Settings ...................................................... 216 
Physical Data CO2 Sensors and Adapters .................... 197  Recruitment Maneuver Tools ........................................83 
Power & Gas Supply ................................................... 195  Alarm Criteria ............................................................. 100 
SBT Mode Settings ...................................................... 210  Alarms ........................................................................ 100 
SPAP Mode Settings ................................................... 206  Conditions for Use ....................................................... 84 
Tube Compensation Settings ...................................... 210  Curve Analysis Cursor Feature ..................................... 92 
Ventilation Modes ...................................................... 201  Curve Analysis Page ..................................................... 90 
Ventilator Dimensions ................................................ 197  Curve Analysis PV Curve ............................................... 92 
Ventilator Technical Data ........................................... 197  Curve History Trends ................................................... 90 
Ventilator Weight ....................................................... 197  Disable Criteria ........................................................... 100 
PRVC‐CMV Mode description ...................................... 240  Event Log Entries ....................................................... 101 
PRVC–CMV Settings ..................................................... 240  Event Markers ............................................................ 101 
PRVC‐SIMV Mode description ..................................... 241  Inflection Point Determination .................................... 98 
PRVC–SIMV Settings .................................................... 241  Monitor Bar Display ..................................................... 93 
PS Made Settings ......................................................... 244  Monitored Data ........................................................... 94 
PS Mode description ................................................... 244  PVL Tool (How it works) ............................................... 97 
PS Tmax ................................................................ 66, 205  PVL Tool (p) Overview .................................................. 83 
P–SIMV Mode ............................................................. 238  PVL Tool (p) Settings Page ............................................ 86 
P‐SIMV Mode description ............................................ 238  PVL Tool (v) Overview ................................................... 83 
P–SIMV Settings .......................................................... 238  PVL Tool (v) Settings Page ............................................ 88 
Psup High .............................................................. 70, 207  Step Tool (How it works) .............................................. 96 
Psup Low ............................................................... 70, 207  Step Tool Overview ...................................................... 83 
Psupport ............................................................... 69, 204  Step Tool Settings Page ................................................ 88 
PVL Tool (p)  Termination Criteria ................................................... 100 
End PEEP setting ......................................................... 214  Resistance 
Maneuver Active Alarm .............................................. 231  Expiratory (Rexp) ............................................... 146, 222 
Pause setting .............................................................. 214  Inspiratory (Rinsp) .............................................. 146, 222 
Pcontrol setting .......................................................... 214  Revision History ............................................................10 
PEEP setting ................................................................ 214  Rise Time ............................................................... 66, 206 
PEEP Teq setting ......................................................... 214 
Psens setting .............................................................. 214 
PT Effort Detected Alarm ........................................... 230  S 
Ramp setting .............................................................. 214 
Tmaneuver calculation ............................................... 215  Safety ......................................................................... 12, 55 
PVL Tool (p) Recruitment Maneuver Tool ...................... 214  Cycle Setting Related Left Panel Display ...................... 70 
PVL Tool (v)  HL Setting Related Left Panel Display .......................... 70 
End PEEP setting ......................................................... 216  Setting Related Left Panel Display IE ............................ 70 
Flow setting ................................................................ 215  Te Setting Related Left Panel Display ........................... 70 
Maneuver Active Alarm .............................................. 231  Ti Setting Related Left Panel Display ............................ 70 
Pause setting .............................................................. 215  SBT Mode 
PEEP setting ................................................................ 215  Activation ..................................................................... 73 
PEEP Teq setting ......................................................... 215  Alarm Settings .................................................... 108, 229 
Psens setting .............................................................. 216  Event Markers .............................................................. 75 
PT Effort Detected Alarm ........................................... 230  Overview ...................................................................... 72 
Tmaneuver calculation ............................................... 216  SBT Mode Active Alarm ............................................. 231 
Vt setting .................................................................... 215  SBT Mode Canceled Alarm ......................................... 231 
PVL Tool (v) Recruitment Maneuver Tool ...................... 215  SBT Mode Completed Successfully Alarm .................. 231 
Settings ................................................................ 74, 210 
Status Bar Icon ............................................................. 49 

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Termination Criteria ..................................................... 75  RSBI Low ............................................................ 108, 229 
SBT Mode Settings ........................................................67  Settings Alarm Settings Standard 
Screen Lock / Unlock .....................................................20  Apnea Time ........................................................ 105, 228 
Service Manual Part Number ....................................... 123  AUTO SET ........................................................... 105, 228 
Settings  Leak Rate ........................................................... 105, 228 
Apnea Backup On/Off ................................................... 68  Pmean High ........................................................ 105, 227 
Auto Control ......................................................... 67, 206  Pmean Low ........................................................ 105, 227 
Auto Control Spont Mode Selection ............................. 67  Ppeak High ......................................................... 105, 227 
Auto Control Time ........................................................ 67  Ppeak Low .......................................................... 105, 227 
Base Flow ............................................................. 67, 205  Rate High............................................................ 105, 228 
Current Settings Screen ................................................ 63  Rate Low ............................................................ 105, 228 
Exhalation Sensitivity (Esens) ............................... 66, 206  Ve High ............................................................... 104, 227 
Flow Pattern ......................................................... 66, 206  Ve Low ............................................................... 104, 227 
Flow Trigger .......................................................... 70, 204  Vte High ............................................................. 105, 227 
HL Ratio ........................................................................ 66  Vte Low .............................................................. 105, 227 
Humidification Type................................................ 56, 59  Vti Limit .............................................................. 105, 228 
IBW Calculator .............................................................. 56  Settings Apnea Backup 
IE Ratio ................................................................. 69, 203  Default Settings .......................................................... 211 
I‐Time (Ti) ............................................................. 69, 203  Modes ........................................................................ 211 
Leak Comp .................................................................. 205  Settings Config. Screen 
Leak Comp On/Off ........................................................ 67  Clinical Options .................................................. 125, 212 
Mode Selection ............................................................ 64  Configurable Defaults Options ........................... 130, 213 
NIV ........................................................................ 66, 205  Graphic Options ................................................. 129, 212 
O2 68  Technical Options .............................................. 136, 213 
Oxygen (O2) ................................................................ 206  Settings Config. Screen (Clinical) 
Patient ID and Room/Bed ID Entry ......................... 57, 60  Flow Sensor On/Off............................................ 126, 212 
Pause .................................................................... 66, 205  Gas Type (Air or Heliox) ..................................... 126, 212 
Pcontrol ................................................................ 69, 204  Humidification Type ........................................... 125, 212 
Peak Flow ............................................................. 70, 204  IBW Control........................................................ 126, 212 
PEEP / CPAP .......................................................... 69, 203  Nebulizer ............................................................ 126, 212 
Plateau ................................................................. 66, 205  Oxygen Sensor On/Off ....................................... 126, 212 
Pressure Trigger.................................................... 70, 205  Sigh .................................................................... 127, 212 
Proposed Settings Screen ............................................. 63  Settings Config. Screen (Defaults) 
PS Tmax ................................................................ 66, 205  Custom Default Settings 1 ......................................... 213 
Psupport ..................................................................... 204  Custom Default Settings 2 ......................................... 213 
Rate ...................................................................... 68, 203  Custom Default Settings 3 ......................................... 213 
Recruitment Maneuvers ............................................. 214  Custom Default Settings 4 ......................................... 213 
Rise Time .............................................................. 66, 206  Custom Defaults......................................................... 213 
SBT Mode ............................................................... 67, 74  Custom Defaults Creating .......................................... 131 
Soft Boundary Setting Limits ........................................ 55  Custom Defaults Renaming ........................................ 133 
SPAP Type ..................................................................... 67  Custom Defaults Rules ............................................... 133 
Tidal Volume ......................................................... 69, 203  Custom Defaults Saving ............................................. 133 
Time Outs and Unaccepted Changes ............................ 55  Custom Defaults Selecting ......................................... 130 
Triger Type ................................................................... 66  eVent Defaults ................................................... 130, 213 
Tube Compensation On/Off ......................................... 68  Settings Config. Screen (Graphic) 
Settings Alarm (Automatic) Settings  Graph Settings ........................................................... 129 
FiO2 High ..................................................................... 228  Monitors (Monitor Bar) ..................................... 129, 212 
Trend Data Settings ................................................... 129 
FiO2 Low ..................................................................... 228 
Settings Config. Screen (Technical) 
Settings Alarm Settings Capnography  Audio Level ................................................................ 212 
AUTO SET ............................................................ 107, 229  Keyboard Type ................................................... 136, 213 
PetCO2  High ....................................................... 107, 229  LCD Brightness ........................................................... 212 
PetCO2  Low ........................................................ 107, 229  Licensed Options Display ................................... 136, 213 
Valv High ............................................................. 107, 229  Password Access to User Config ........................ 136, 213 
Valv Low ............................................................. 107, 229  Patient Height (units) cm or in ................................... 213 
Valv/min High ..................................................... 107, 229  Screen Clicks On/Off .................................................. 213 
Valv/min Low ...................................................... 107, 229  Settings NCPAP+ Mode 
VteCO2  Low ........................................................ 107, 229  Flow ........................................................................... 209 
Settings Alarm Settings SBT Mode  I‐Time ......................................................................... 209 
AUTO SET ............................................................ 108, 229  Max Flow to PEEP setting........................................... 209 
Rate High ............................................................ 108, 229  Pcontrol ..................................................................... 209 
Rate Low ............................................................. 108, 229  PEEP/CPAP ................................................................. 209 
RSBI High ............................................................ 108, 229  Rate ............................................................................ 209 

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Settings PVL Tool (p)  Status Bar Icon ............................................................. 49 
End PEEP ..................................................................... 214  SIMV 
Pause .......................................................................... 214  Pressure ..................................................................... 238 
Pcontrol ...................................................................... 214  Volume ....................................................................... 235 
PEEP ............................................................................ 214  Slope (See Rise Time) ....................................................66 
PEEP Teq ..................................................................... 214  Smart Nebulizer ............................................................40 
Psens .......................................................................... 214  Smart Sigh Settings .............................................. 127, 212 
Ramp .......................................................................... 214  SPAP Mode ................................................................. 206 
Tmaneuver Display ..................................................... 215  Cycle (rate) setting ............................................... 69, 208 
Settings PVL Tool (v)  Description ................................................................. 246 
End PEEP ..................................................................... 216  HL Ratio setting .......................................................... 208 
Flow ............................................................................ 215  Phigh setting ........................................................ 70, 206 
Pause .......................................................................... 215  Plow setting ......................................................... 70, 207 
PEEP ............................................................................ 215  Psup High setting ................................................. 70, 207 
PEEP Teq ..................................................................... 215  Psup Low setting .................................................. 70, 207 
Psens .......................................................................... 216  SPAP Type (philosophy) setting ........................... 67, 208 
Tmaneuver Display ..................................................... 216  Thigh setting ........................................................ 70, 207 
Vt 215  Tlow setting ......................................................... 70, 207 
Settings Recruitment Maneuvers  SPAP Settings .............................................................. 247 
PVL Tool (p) ................................................................. 214  SPAP Type ............................................................. 67, 208 
PVL Tool (v) ................................................................. 215  Spare parts .................................................................. 186 
Step Tool .................................................................... 216  Specification 
Settings SBT Mode  Flow Sensor .................................................................. 39 
Esens .................................................................... 74, 210  SPONT 
O2 74, 210  PS 244 
PEEP ...................................................................... 74, 210  SPAP ........................................................................... 246 
PS Tmax ................................................................ 74, 210  VS 242 
Psupport ............................................................... 74, 210  Spontaneous Breaths in SPAP Mode ............................ 246 
Rise Time .............................................................. 74, 210  Standard ..................................................................... 203 
SBT Time ............................................................... 74, 210  Standby Key ..................................................................25 
Settings Screen ................................................................. 63  Standby Selection ..........................................................43 
Settings SPAP Mode  Startup 
Cycle ..................................................................... 69, 208  Patient Option (New or Previous) ................................ 57 
HL Ratio ...................................................................... 208  Startup Process .............................................................46 
Phigh ..................................................................... 70, 206  Startup screen ...............................................................46 
Plow ...................................................................... 70, 207  Status Bar Icon 
Psup High .............................................................. 70, 207  100% O2 (Adult/Pedi) .................................................. 49 
Psup Low .............................................................. 70, 207  20%+ Set O2 (Neo) ....................................................... 49 
Rate ...................................................................... 69, 208  Apnea Backup .............................................................. 49 
SPAP Type ................................................................... 208  Auto Control ................................................................ 49 
Thigh ..................................................................... 70, 207  Battery in use ............................................................... 49 
Tlow ...................................................................... 70, 207  Calibration Required .................................................... 49 
Settings Step Tool  ETCO2 ........................................................................... 49 
End PEEP ..................................................................... 217  Heliox ........................................................................... 49 
IE Ratio ....................................................................... 217  Manual Breath ............................................................. 49 
Pcontrol (Rest Step) .................................................... 217  Nebulizer ...................................................................... 49 
Pcontrol (RM Step) ..................................................... 216  NIV ............................................................................... 49 
Rate ............................................................................ 216  O2 Sensor Off ............................................................... 49 
Rest PEEP (Rest Step) ................................................. 217  SBT Mode ..................................................................... 49 
Rest Time (Rest Step) ................................................. 217  Sigh .............................................................................. 49 
Rise Time .................................................................... 217  Tube Comp ................................................................... 49 
Step PEEP (RM Step) ................................................... 216  Step Tool 
Step Time (RM Step) ................................................... 217  End PEEP setting ........................................................ 217 
Ti  217  IE Ratio setting ........................................................... 217 
Settings Tube Compensation  Maneuver Active Alarm ............................................. 231 
TC On/Off ............................................................. 78, 210  Pcontrol setting (Rest Step) ....................................... 217 
TC Type ................................................................. 79, 211  Pcontrol setting (RM Step) ......................................... 216 
Tube Diameter ...................................................... 78, 211  Rate setting ................................................................ 216 
Tube Length .......................................................... 79, 211  Rest PEEP setting (Rest Step) ..................................... 217 
Setup .............................................................................23  Rest Time setting (Rest Step) ..................................... 217 
Sigh  Rise Time setting ........................................................ 217 
Functional Details ....................................................... 127  Step PEEP setting (RM Step) ...................................... 216 
Sigh Settings ....................................................... 127, 212  Step Time setting (RM Step) ...................................... 217 

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Ti setting ..................................................................... 217  Event Markers (User Comments) ............................... 153 
Step Tool Recruitment Maneuver ................................. 216  FeCO2 ......................................................................... 158 
Suction Support  FetCO2 ........................................................................ 158 
Activation ..................................................................... 81  I‐Time (Ti) ................................................................... 157 
Disconnect Phase ......................................................... 82  Leak ............................................................................ 157 
Post Oxygenation Phase ............................................... 82  O2 157 
Preparation Phase ........................................................ 81 
PeCO2 ......................................................................... 158 
Suction Support Active Alarm ..................................... 231 
Symbols .................................................................. 12, 18  PEEP ........................................................................... 156 
Circuit Check ............................................................... 173  PetCO2 ........................................................................ 158 
PF 157 
PFe ............................................................................. 157 
T  Pmean ........................................................................ 156 
Ppeak ......................................................................... 156 
Table of Contents ....................................................... 3  Pplateau ..................................................................... 157 
Technical Data  Ptrach ......................................................................... 156 
Capnography Sensors ................................................. 198  Rate ............................................................................ 156 
Ventilator ................................................................... 197  Rate Spont ................................................................. 156 
Technical Settings  RCe ............................................................................. 157 
Altitude Setting ........................................................... 135  Rexp ........................................................................... 157 
CliniNet Configuration ................................................ 135  Rinsp .......................................................................... 157 
Compressor Backup (On/Off) ..................................... 135  RSBI ............................................................................ 157 
Philosophy (US/EU) .................................................... 135  Ti/Ttot ........................................................................ 157 
RS232 Protocol ........................................................... 135  Valv ............................................................................ 158 
Set Date / Time ........................................................... 135  Valv/min ..................................................................... 158 
Set Language .............................................................. 135  VCO2/min ................................................................... 158 
SW and HW Versions .................................................. 135  Vd alv ......................................................................... 158 
Terms and Definitions ................................................. 251  Vd ana ........................................................................ 158 
Theory of Operation .................................................... 232  Vd/Vt phy ................................................................... 158 
NCPAP+ ....................................................................... 249  Ve 156 
NIV .............................................................................. 249  Ve Spont ..................................................................... 156 
P‐CMV ......................................................................... 237  Ve/kg .......................................................................... 156 
PRVC‐CMV .................................................................. 240  Vi 156 
PRVC‐SIMV ................................................................. 241  Vi Spont ...................................................................... 156 
PS 244  Vte ............................................................................. 156 
P‐SIMV ........................................................................ 238  Vte/kg ........................................................................ 156 
SPAP ........................................................................... 246  VteCO2 ....................................................................... 158 
V‐CMV ........................................................................ 233  Vti ............................................................................... 156 
VS 242  Vti/kg ......................................................................... 156 
V‐SIMV ........................................................................ 235  VtiCO2 ........................................................................ 158 
VTV Modes ................................................................. 239  WOBimp ..................................................................... 157 
Thigh ..................................................................... 70, 207  Trend Data Graph Selection .......................................... 155 
Ti  69  Trend Data Parameter Selection ................................... 155 
Tidal Volume (Vt) .................................................. 69, 203  Trend Data Screen ....................................................... 150 
Tlow ...................................................................... 70, 207  Number of Trends to Display ..................................... 129 
To Patient Port ..............................................................19  Trigger Type .......................................................... 66, 204 
Touch Screen  Tube Compensation 
Calibration .................................................................... 47  Activation ..................................................................... 78 
Handling Precautions ................................................... 47  Expiratory TC ................................................................ 76 
Philosophy .................................................................... 48  Inspiratory TC ......................................................... 76, 80 
Touch Screen Bypass Feature .......................................... 52  Overview ...................................................................... 76 
Touch Screen User Interface ............................................ 47  Pmin Monitored Data ........................................ 139, 218 
Trend Data  Pmin Trend Data ........................................................ 156 
Auto PEEP ................................................................... 157  Ptrach Monitored Data ...................................... 139, 218 
Basic Parameters ........................................................ 156  Ptrach Trend Data ...................................................... 156 
Cdyn............................................................................ 157  Status Bar Icon ............................................................. 49 
Cdyn/kg ...................................................................... 157  TC On/Off ..................................................................... 78 
Cstat ........................................................................... 157  TC On/Off ................................................................... 210 
Cstat/kg ...................................................................... 157  TC Type setting .................................................... 79, 211 
E‐Time (Te) ................................................................. 157  Tube Diameter setting ......................................... 78, 211 
Event Markers ............................................................ 151  Tube Length setting ............................................. 79, 211 
Event Markers (Automatic) ........................................ 152  Tube Compensation Settings ................................. 68, 210 
Event Markers (Display Rules) .................................... 151 
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Section 15 Index

On/Off Key ................................................................... 25 
U  Patient ID and Room/Bed ID Entry......................... 57, 60 
Patient Option (New or Previous) ................................ 57 
User Interface  Patient Startup Options ............................................. 202 
Alarm Message Display ................................................ 50  Pneumatic Diagram.................................................... 257 
Alarm Silence Icon ........................................................ 45  Preparation for use ...................................................... 23 
Automatic Event Markers ........................................... 152  Previous Patient Startup .............................................. 56 
Battery Icon .................................................................. 49  Setting Limit Soft Boundary ......................................... 55 
Controls Dual Fault Philosophy .................................... 51  Settings Screen ............................................................ 63 
Current Mode Display .................................................. 48  Setup ............................................................................ 23 
Date and Time Display .................................................. 50  Setup and Operation .................................................... 56 
Event Markers ............................................................ 151  Standard Mode Settings ............................................ 203 
Freeze/Unfreeze ......................................................... 154  Standby Key ................................................................. 25 
Gender Specific Color Feature ...................................... 53  Startup Screens ............................................................ 46 
Keyboard ...................................................................... 54  Time Outs and Unaccepted Changes ........................... 55 
Left Display Panel ......................................................... 50  Touch Screen Bypass Feature ...................................... 52 
Lock Unlock Button ...................................................... 50  User Interface Freeze/Unfreeze ................................. 154 
Monitor Bar .................................................................. 50  User Interface Keyboard .............................................. 54 
Navigation Tabs ............................................................ 50  User Interface Philosophy ............................................ 48 
Patient Effort (Trigger) Indicator .................................. 48  Ventilator Modes 
Patient Type Display ..................................................... 48  Activating ..................................................................... 71 
Settings Bar .................................................................. 50  Ventilator Set Up ............................................................. 56 
Status Bar ..................................................................... 49  Ventilator Settings 
Time Outs and Unaccepted Changes ............................ 55  Apnea Backup .............................................................. 68 
Touch Screen Bypass Feature ....................................... 52  Auto Control .......................................................... 67, 71 
Auto Control Spont Mode Selection ............................ 67 
Auto Control Time ........................................................ 67 
V  Base Flow ..................................................................... 67 
Current & Proposed ..................................................... 66 
V‐CMV Mode description ............................................ 233  Cycle ............................................................................. 69 
V–CMV Settings ........................................................... 233  Esens% ......................................................................... 66 
Ventilation Modes ....................................................... 232  Flow Pattern................................................................. 66 
Types & Selection ......................................................... 65  Ftrig .............................................................................. 70 
Ventilator  HL Ratio ........................................................................ 66 
AC Power Supply .......................................................... 23  IE Ratio ......................................................................... 69 
Alarm Message Display ................................................ 50  Insp Time ..................................................................... 69 
Breath Types by Control Variable ............................... 201  Leak Comp ................................................................... 67 
Breathing Circuit Assembly........................................... 36  NIV ............................................................................... 66 
Calibrations Options ............................................... 56, 59  O2 68 
Circuit Support Arm ...................................................... 41  Pause............................................................................ 66 
Cleaning General Recommendations ......................... 187  Pcontrol ....................................................................... 69 
Controls Adjustment .................................................... 51  Peak Flow ..................................................................... 70 
Controls Dual Fault Philosophy .................................... 51  PEEP ............................................................................. 69 
DC Power Supply (External) .......................................... 25  Phigh ............................................................................ 70 
DC Power Supply (Internal) .......................................... 24  Plateau ......................................................................... 66 
Exhalation Cover and Diaphragm ................................. 40  Plow ............................................................................. 70 
External User Interface ................................................. 42  PS Tmax ........................................................................ 66 
Flow Sensor On/Off ................................................ 56, 60  Psup High ..................................................................... 70 
Flow Sensor positioned at Circuit Wye ......................... 37  Psup Low ...................................................................... 70 
Flow Sensor positioned at Exp port .............................. 37  Psupport ...................................................................... 69 
Front Panel Alarm LED Display ..................................... 42  Ptrig.............................................................................. 70 
Graphical User Interface (GUI) ..................................... 47  Rate .............................................................................. 68 
GUI Navigation ............................................................. 48  Rise Time ...................................................................... 66 
Humidification Type................................................ 56, 59  Setting Bar Setting Options .......................................... 68 
IBW Calculator .............................................................. 56  SPAP Type .................................................................... 67 
Intended Use ................................................................ 11  Thigh ............................................................................ 70 
Labels and Symbols ...................................................... 18  Tidal Volume ................................................................ 69 
Main Screen .................................................................. 62  Tlow ............................................................................. 70 
Mode Selection ............................................................ 64  Trigger Type ................................................................. 66 
Mode Types and Mode Selection ............................... 201  Virtual Report ...............................................................28 
Nasal Prong Pressure Line Connection ......................... 38  Volume Support Ventilation (VS) Mode ....................... 242 
New Patient Startup ..................................................... 56  Volume Targeted Ventilation (VTV) Modes ................. 239 
O2 and Air Supply (gas inlet) ......................................... 26  V‐SIMV Mode description............................................ 235 

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Section 15 Index

Tube Comp ................................................................... 77 
W  Waveforms .................................................................... 225 
Work of Breathing Imposed 
Warning  Calculation ................................................................. 148 
CO2 monitor placement ............................................... 30  Detailed Description .................................................. 148 
Warnings  Work of Breathing Imposed (WOBimp) ............... 147, 223 

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Section 16 E-mail Contacts

16. E-mail Contacts

Sales

International Sales: sales@event-medical.com

North American Sales: sales@event-medical.com

Service and Support

Customer Service: customer.service@event-medical.com

Technical Service: service@event-medical.com

Clinical Support: clinical@event-medical.com

Table 54: E-mail Contact Details

www.event-medical.com

275 Inspiration® 5i User Manual (International Version) EVM500044, Rev E

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