Evolution E3 Service Manual

Preface
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Revision F of this user manual: Part Number EVM500041 (eVolution 3e Series Ventilator, User Manual,
International Version) Aug-2018
© 2010 – 2018 eVent Medical All rights reserved.

This manual is intended to provide the necessary information required to operate and maintain the
eVent Medical eVolution 3e Ventilator System. 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.
No part of this User Manual may be reproduced or stored in a database or retrieval system nor
transmitted, in any form or by any means—electronic, photocopying, recording, or otherwise, without
prior written permission of eVent Medical.
Intended for use with the eVolution ventilator, this manual is subject to technical modification and may be
revised or replaced by eVent Medical at any time without prior notice. We recommend you have the
most current version of this manual.
Nothing in this manual shall limit or restrict in any way eVent Medical’s right to revise or otherwise
change or modify, without notice, the equipment (including its software) described herein. In the absence
of an express, written agreement to the contrary, eVent Medical has no obligation to furnish any such
revisions, changes, or modifications to the owner or user of the equipment (including its software)
described herein.
This manual and its illustrations apply to the:
• eVolution 3e Ventilator, HP System PN: EVL100500 – HP
• eVolution 3e Ventilator System PN: EVL100500 – T

Ø Each model, when shipped will be configured with the latest software for that model.
Ø Adding the variant (HP) after the part number designates the product model. HP models will be
configured with high pressure air and oxygen gas connections an NO internal Turbine.
(e.g., E V L 1 0 0 5 0 0 – H P )
Ø Adding the variant (T) after the part number designates the product model. T models will be
configured with an internal Turbine and a single high pressure oxygen gas connection.
(e.g., E V L 1 0 0 5 0 0 – T )
Ø Adding the variant (NF) after the products model indicates the products exhalation system will be
configured for use with an external expiratory filter.
Illustrations in this manual apply to the eVolution 3e Series Ventilator and installed software / firmware
versions are displayed upon power up on the initial screen.
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 eVent Medical, Ltd
60 Empire Drive Caulfield House Kiltrogue,
Lake Forest, CA 92630 Claregalway Co
Tel: +1 949 900 1917 Galway, Ireland
Fax: +1 949 900 1905 Tel: +353 89 8536035
tomgcaulfield@gmail.com
www.event-medical.com
®
EVM500041, Rev F eVolution 3e Series User Manual (International Version) 2
Table of Contents
Table of Contents
1. INTRODUCTION TO THE EVOLUTION 3E VENTILATOR ....................................................................................... 13

1.1. INTENDED USE ........................................................................................................................................................ 13

1.2. CONTRAINDICATIONS: ............................................................................................................................................. 13
1.3. FREQUENT USE FUNCTIONS: ..................................................................................................................................... 13
1.4. SAFETY ................................................................................................................................................................. 13
1.5. WARNINGS, CAUTIONS AND BASIC SAFETY INFORMATION .............................................................................................. 14
1.5.1. Copyright Notice ......................................................................................................................................... 19
1.5.2. Trademark Notice ....................................................................................................................................... 19
1.5.3. Notice of Conformity, Compliance and Approvals ....................................................................................... 19
1.5.4. Electromagnetic Compatibility .................................................................................................................... 19
1.5.5. CE Notified Body .......................................................................................................................................... 20
1.5.6. Classification ............................................................................................................................................... 20
1.5.7. Regulatory Notice ........................................................................................................................................ 20
1.6. DEVICE LABELS AND SYMBOLS ................................................................................................................................... 20
1.7. RESPONSIBILITIES AND GUARANTEES .......................................................................................................................... 23
1.8. CLINICAL SPECIFICATIONS ......................................................................................................................................... 23
1.8.1. Essential Performance Requirements .......................................................................................................... 23
1.8.2. Ventilation Mode Types and Mode Selections ............................................................................................ 24
1.8.3. Breath Type by Control Variables ................................................................................................................ 24
1.8.4. Other Ventilation Mode Options ................................................................................................................. 25
1.8.5. Patient Types by Ideal Body Weight ............................................................................................................ 25
1.8.6. Patient Startup Settings .............................................................................................................................. 25
1.8.7. Standard Mode Settings .............................................................................................................................. 25
1.8.8. SPAP Mode Settings .................................................................................................................................... 29
1.8.9. Tube Compensation (optional software) ..................................................................................................... 30
1.8.10. NCPAP+ Mode Settings* ........................................................................................................................... 31
1.8.11. Hi FlowO2 (Optional Software) ................................................................................................................. 32
1.8.12. Apnea Backup Settings .............................................................................................................................. 32
1.8.13. Configuration Screen Setting Options (Config) .......................................................................................... 33
1.8.14. Monitored Data / Displayed Patient Values .............................................................................................. 34
1.8.15. Graphics: Real-Time Curves ....................................................................................................................... 38
1.8.16. Alarm Limit Settings .................................................................................................................................. 38
1.8.17. Alarms by Priority ...................................................................................................................................... 40
1.9. TECHNICAL SPECIFICATIONS: ..................................................................................................................................... 41
1.9.1. Power and Gas Supply ................................................................................................................................. 41
1.9.2. Environmental Data .................................................................................................................................... 41
1.9.3. Physical Data ............................................................................................................................................... 41
1.9.4. Technical Data ............................................................................................................................................. 42
1.9.5. Technical Data: Capnography Sensors ........................................................................................................ 42
1.9.6. Compliance and Approvals .......................................................................................................................... 42
1.9.7. Electromagnetic Compatibility Declaration ................................................................................................ 42
2. PREPARING THE VENTILATOR FOR USE ............................................................................................................ 47
2.1. VENTILATOR SETUP ................................................................................................................................................. 47
2.2. POWER SUPPLY ...................................................................................................................................................... 47
2.3. AC MAINS SUPPLY .................................................................................................................................................. 47
2.4. DC (EXTERNAL BATTERY) SUPPLY .............................................................................................................................. 48
2.5. DC (INTERNAL BATTERY) POWER SUPPLY .................................................................................................................... 48
2.6. ON AND OFF POWER SWITCH ................................................................................................................................... 49
2.7. GAS SUPPLY .......................................................................................................................................................... 49
2.8. HIGH PRESSURE BASED SYSTEM: CONNECTING TO OXYGEN AND AIR SUPPLY ..................................................................... 50
2.9. OPTIONAL, TURBINE BASED SYSTEM: CONNECTING TO OXYGEN SUPPLY ............................................................................ 50
2.10. ETHERNET AND NURSE CALL ................................................................................................................................... 51
2.10.1. Ethernet Connection (RJ45 connector) ...................................................................................................... 51
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3 eVolution 3e Series User Manual (International Version) EVM500041, Rev F
Table of Contents
2.10.2. CliniNet Server and Virtual Report™ ........................................................................................................ 51
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2.10.3. Nurse Call Connection (RJ12 connector) .................................................................................................... 51

2.11. BREATHING CIRCUIT .............................................................................................................................................. 52
2.11.1. Nasal Prongs ............................................................................................................................................. 52
2.11.2. Exhalation System ..................................................................................................................................... 53
2.11.3. Humidification Devices .............................................................................................................................. 54
2.11.4. Nebulizer Use and Placement .................................................................................................................... 54
2.12. TUBING SUPPORT ARM OPTIONS: ............................................................................................................................ 54
2.13. CAPNOGRAPHY (MAINSTREAM / SIDESTREAM) SENSORS .............................................................................................. 55
2.13.1. Classifications ............................................................................................................................................ 55
2.13.2. IRMA Mainstream CO2 Sensor ................................................................................................................... 56
2.13.3. ISA Sidestream CO2 Sensor ........................................................................................................................ 59
3. OPERATION ...................................................................................................................................................... 61
3.1. VENTILATOR CONTROLS ........................................................................................................................................... 61
3.1.1. Standby Key ................................................................................................................................................. 62
3.1.2. O2 ⬆ Key (%O2 Increase Key or 100% O2 Key) ............................................................................................ 63
3.1.3. Manual Breath Key ...................................................................................................................................... 63
3.1.4. Alarm Silence Key ........................................................................................................................................ 63
3.2. CLEANING RECOMMENDATIONS ................................................................................................................................ 64
3.3. CALIBRATION ......................................................................................................................................................... 64
3.4. START UP PROCESS ................................................................................................................................................. 64
4. GRAPHICAL USER INTERFACE ........................................................................................................................... 65
4.1. GENERAL DESCRIPTION ............................................................................................................................................ 65
4.2. DEFINITIONS AND REFERENCES .................................................................................................................................. 65
4.3. DEVICES AFFECTED .................................................................................................................................................. 65
4.4. PHILOSOPHY (USER INTERFACE) ................................................................................................................................. 65
4.4.1. Graphic User Interface Navigation .............................................................................................................. 65
4.4.2. Adjusting and Confirming Control Setting ................................................................................................... 69
4.4.3. Touch Screen Bypass Feature ...................................................................................................................... 70
4.4.4. Linked / Dependent Control Settings ........................................................................................................... 71
4.5. SAFETY ................................................................................................................................................................. 71
4.5.1. Screen Display Defaults to Main Screen (2 minute rule) ............................................................................. 71
4.5.2. Time Outs and Unaccepted Changes ........................................................................................................... 72
4.5.3. Control Setting Limit (Soft Boundary) Feature ............................................................................................ 72
4.5.4. Handling Precautions .................................................................................................................................. 74
5. VENTILATOR SET UP ......................................................................................................................................... 75
5.1. POWER UP SCREEN ................................................................................................................................................. 75
5.2. PATIENT SELECTION SCREEN - NEW PATIENT AND PREVIOUS PATIENT ............................................................................... 75
5.2.1. Patient Option and Patient Setup ................................................................................................................ 76
5.2.2. Ideal Body Weight Calculator ...................................................................................................................... 77
5.2.3. Humidification Type .................................................................................................................................... 78
5.2.4. Pre-Patient Tests ......................................................................................................................................... 78
5.2.5. Calibrations ................................................................................................................................................. 79
5.2.6. Accept Button .............................................................................................................................................. 79
5.3. SETTINGS TAB ........................................................................................................................................................ 79
5.3.1. Current Settings Screen ............................................................................................................................... 79
5.3.2. Proposed Settings Screen ............................................................................................................................ 80
5.3.3. Choosing a Mode and Breath Type ............................................................................................................. 81
5.3.4. Right Panel: Current & Proposed Settings Selections .................................................................................. 82
5.3.5. Setting Bar: Current & Proposed Settings Selections ................................................................................... 83
5.3.6. Smart Nebulizer™ ........................................................................................................................................ 85
5.3.7. Smart Sigh™ ................................................................................................................................................ 86
5.3.8. Trend Data Settings ..................................................................................................................................... 86
5.3.9. Tube Compensation (optional software) ..................................................................................................... 87
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Table of Contents
5.3.10. Activating Ventilation ............................................................................................................................... 88
5.3.11. Auto Control Settings ................................................................................................................................ 88
5.4. HOME TAB ........................................................................................................................................................... 90
5.5. DATA TAB ............................................................................................................................................................ 90
5.5.1. Monitored Data: Parameters and Definitions ............................................................................................. 91
5.5.2. Trended Data .............................................................................................................................................. 93
5.6. ALARMS TAB ........................................................................................................................................................ 94
5.6.1. Alarm Auto Set Feature ............................................................................................................................... 94
5.6.2. Alarm Setting Parameters ........................................................................................................................... 96
5.6.3. Event Log ..................................................................................................................................................... 96
5.6.4. Alarm Signals .............................................................................................................................................. 97
5.6.5. Alarm Levels ................................................................................................................................................ 98
5.6.6. Alarm Silence Key ........................................................................................................................................ 98
5.6.7. Alarm Definitions ........................................................................................................................................ 98
5.6.8. About Diagnostic Alarm Messages ........................................................................................................... 104
5.6.9. Disconnection Alarms ................................................................................................................................ 104
5.6.10. Technical Failures Alarms ........................................................................................................................ 107
5.6.11. Alarm Reset and Clearing Inactive (Latched) Alarms .............................................................................. 108
5.6.12. Hazards Based on User / Device Errors ................................................................................................... 109
5.7. CAPNOGRAPHY .................................................................................................................................................... 110
5.7.1. Warnings and Cautions ............................................................................................................................. 112
5.7.2. Capnography Waveforms and SBCO2 Curves ............................................................................................ 114
5.8. CONFIG TAB ....................................................................................................................................................... 115
5.8.1. Monitors .................................................................................................................................................... 117
5.8.2. Compliance Comp ..................................................................................................................................... 118
5.8.3. O2 Sensor: ................................................................................................................................................. 118
5.8.4. Low Flow O2 (Blower Based System) ........................................................................................................ 119
5.8.5. Audio / Visual ............................................................................................................................................ 119
6. CALIBRATIONS AND CLEANING ...................................................................................................................... 121
6.1. CALIBRATION OPTIONS .......................................................................................................................................... 121
6.1.1. Zero Flow Sensor Calibration ..................................................................................................................... 122
6.1.2. Pre-Patient Tests ....................................................................................................................................... 122
6.1.3. O2 Sensor Calibration ................................................................................................................................ 124
6.1.4. EXH Flow Sensor Calibration ..................................................................................................................... 125
6.2. CLEANING AND STERILIZATION ................................................................................................................................. 125
6.2.1. Patient Breathing Circuit and Nebulizers .................................................................................................. 126
6.2.2. Humidification Devices .............................................................................................................................. 126
6.2.3. Ventilator Exterior ..................................................................................................................................... 126
6.2.4. Touch Screen LCD Display .......................................................................................................................... 126
6.2.5. Exhalation Flow Sensor ............................................................................................................................. 126
6.2.6. Exhalation System and Diaphragm ........................................................................................................... 127
6.2.7. Manual Cleaning: ...................................................................................................................................... 128
7. SPARE PARTS ................................................................................................................................................. 131
8. PREVENTATIVE MAINTENANCE ...................................................................................................................... 132
8.1. COOLING FAN FILTER ............................................................................................................................................. 132
8.2. AIR INLET FILTER .................................................................................................................................................. 133
8.3. OXYGEN SENSOR .................................................................................................................................................. 133
8.4. INTERNAL BATTERY ............................................................................................................................................... 134
8.4.1. Removal of Internal Battery ...................................................................................................................... 134
8.5. FUSES ................................................................................................................................................................. 135
8.6. ALARM TEST PROCEDURE ....................................................................................................................................... 135
8.6.1. Alarms Functionality Tests ........................................................................................................................ 135
8.7. DISPOSAL ............................................................................................................................................................ 137
9. MONITORED PARAMETERS, MANEUVERS AND GRAPHICS DISPLAY ............................................................... 138
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Table of Contents
9.1. MONITORED PARAMETERS ..................................................................................................................................... 138
9.2. DATA TAB ........................................................................................................................................................... 138
9.2.1. Respiratory Mechanics .............................................................................................................................. 140
9.2.2. Static Compliance and Resistance Measurements .................................................................................... 141
9.2.3. Auto Peep Measurement ........................................................................................................................... 142
9.2.4. Real-Time Curves Graphics Display ........................................................................................................... 142
9.2.5. Graphics Color Display ............................................................................................................................... 143
9.3. MANEUVERS ........................................................................................................................................................ 147
9.3.1. Suction Support ......................................................................................................................................... 148
9.3.2. P0.1 Maneuver .......................................................................................................................................... 150
9.3.3. PiMax Maneuver ....................................................................................................................................... 152
9.3.4. Inspiratory Hold Maneuver ....................................................................................................................... 153
9.3.5. Expiratory Hold Maneuver ........................................................................................................................ 153
10. THEORY OF OPERATION ............................................................................................................................... 155
10.1. VENTILATION MODES .......................................................................................................................................... 155
10.1.1. Volume Controlled Continuous Mandatory Ventilation (V-CMV) Mode ................................................. 155
10.1.2. Volume Controlled Synchronized Intermittent Mandatory Ventilation (V-SIMV) Mode ......................... 157
10.1.3. Pressure Controlled Continuous Mandatory Ventilation (P-CMV) Mode ................................................ 158
10.1.4. Pressure Controlled Synchronized Intermittent Mandatory Ventilation (P-SIMV) Mode ....................... 160
10.1.5. Volume Targeted Ventilation (VTV) Modes ............................................................................................. 161
10.1.6. Pressure Regulated Volume Control Continuous Mandatory Ventilation (PRVC-CMV) Mode ................ 161
10.1.7. Press Regulated Volume Control Synchronized Intermittent Mandatory Ventilation (PRVC-SIMV) Mode
162
10.1.8. Volume Support Ventilation (VS) Mode .................................................................................................. 163
10.1.9. Pressure Support Ventilation (PS) Mode ................................................................................................. 164
10.1.10. Spontaneous Positive Airway Pressure Ventilation (SPAP) Mode ......................................................... 165
10.1.11. NCPAP+ Mode ....................................................................................................................................... 167
10.1.12. Non Invasive Ventilation (NIV) Settings ................................................................................................ 168
10.1.13. Breath Triggering (All Modes) ............................................................................................................... 168
11. TERMS, ABBREVIATIONS AND DEFINITIONS ................................................................................................. 170
12. PNEUMATIC SCHEMATIC .............................................................................................................................. 175
13. INDEX .......................................................................................................................................................... 177
14. E-MAIL CONTACTS ....................................................................................................................................... 184

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Index of Figures
Index of Figures
FIGURE 1: POWER SUPPLY SOCKET ................................................................................................................... 48
FIGURE 2: DC, EXTERNAL BATTER SOCKET ........................................................................................................ 48
FIGURE 3: ON/OFF SWITCH ............................................................................................................................... 49
FIGURE 4: HIGH PRESSURE O2 AND AIR INLET.................................................................................................... 50
FIGURE 5: HIGH PRESSURE O2 INLET................................................................................................................. 50
FIGURE 6: LOW PRESSURE O2 INLET ................................................................................................................. 50
FIGURE 7: COMMUNICATION PORTS, ETHERNET AND NURSE CALL ....................................................................... 51
FIGURE 8: NURSE CALL CONNECTOR PIN ASSIGNMENTS ..................................................................................... 52
FIGURE 9: BREATHING CIRCUIT .......................................................................................................................... 52
FIGURE 10: NCPAP PRONGS ............................................................................................................................ 53
FIGURE 11: EVOLUTION 3E EXHALATION VALVE SYSTEM ..................................................................................... 54
FIGURE 12, FLEX ARM ASSEMBLY ...................................................................................................................... 55
FIGURE 13: ATTACHING THE IRMA MAINSTREAM CO2 SENSOR TO THE BREATHING CIRCUIT ................................. 56
FIGURE 14: ZERO CO2 SENSOR CALIBRATION SELECTION ................................................................................... 57
FIGURE 15: PERFORMING A ZERO CO2 SENSOR CALIBRATION ............................................................................. 58
FIGURE 16: ATTACHING THE ISA SIDESTREAM CO2 SENSOR TO THE VENTILATOR ................................................ 59
FIGURE 17: ATTACHING THE SIDESTREAM CO2 SENSOR AND SAMPLE LINE .......................................................... 61
FIGURE 18: EVOLUTION 3E FRONT PANEL .......................................................................................................... 62
FIGURE 19: STANDBY KEY OPTIONS ................................................................................................................... 63
FIGURE 20: EVOLUTION POWER UP & PATIENT SETUP SCREEN ........................................................................... 64
FIGURE 21: GRAPHIC USER INTERFACE .............................................................................................................. 66
FIGURE 22: GRAPHIC USER INTERFACE, MODE SELECTION ................................................................................. 66
FIGURE 23: LINKED / DEPENDENT CONTROL SETTINGS ....................................................................................... 71
FIGURE 25: STANDBY NOT VENTILATING (SAFETY MESSAGE) .............................................................................. 72
FIGURE 26: CONTROL SETTING LIMIT (SOFT BOUNDARY) FEATURE...................................................................... 73
FIGURE 27: POWER UP SCREEN ........................................................................................................................ 75
FIGURE 28: PATIENT SELECTION SCREEN – STARTUP SCREEN ............................................................................ 75
FIGURE 29: NEW PATIENT STARTUP SCREEN ...................................................................................................... 76
FIGURE 30: IBW PATIENT STARTUP SCREEN ...................................................................................................... 77
FIGURE 31: PREVIOUS PATIENT STARTUP SCREEN .............................................................................................. 77
FIGURE 32: IDEAL BODY WEIGHT SCREEN .......................................................................................................... 78
FIGURE 33: HUMIDIFICATION TYPE SELECTION OPTION ....................................................................................... 78
FIGURE 34: PRE-PATIENT SYSTEM TESTS .......................................................................................................... 78
FIGURE 35: CALIBRATION OPTIONS .................................................................................................................... 79
FIGURE 36: CURRENT SETTINGS SCREEN........................................................................................................... 80
FIGURE 37: PROPOSED SETTINGS SCREEN ........................................................................................................ 80
FIGURE 38: MODE TYPE / MODE SELECTIONS ..................................................................................................... 81
FIGURE 39: NEBULIZER SCREEN ........................................................................................................................ 85
FIGURE 40: SMART SIGH SECTION ..................................................................................................................... 86
FIGURE 41: TREND DATA SETTINGS ................................................................................................................... 87
FIGURE 42: TUBE COMPENSATION SETTINGS ...................................................................................................... 87
FIGURE 43: TUBE COMPENSATION WAVEFORM ................................................................................................... 88
FIGURE 44: CURRENT SETTINGS SCREEN........................................................................................................... 88
FIGURE 45: AUTO CONTROL MODE TRANSITIONS ................................................................................................ 89
FIGURE 46: HOME TAB ...................................................................................................................................... 90
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Index of Figures
Index of Figures
FIGURE 47: DATA TAB ........................................................................................................................................ 91
FIGURE 48: TRENDING WAVEFORM AND PARAMETER SELECTION SCREENS .......................................................... 93
FIGURE 49: ALARMS SCREEN ............................................................................................................................. 94
FIGURE 50: EVENT LOG ..................................................................................................................................... 97
FIGURE 51: REAL-TIME GRAPHICS (CAPNOGRAMS) ........................................................................................... 114
FIGURE 52: REAL-TIME GRAPHICS (SBCO2 CURVES) ........................................................................................ 115
FIGURE 53: CONFIG SCREEN ............................................................................................................................ 115
FIGURE 54: MONITORS..................................................................................................................................... 118
FIGURE 55: COMPLIANCE COMPENSATION ........................................................................................................ 118
FIGURE 56: O2 SENSOR – HIGH PRESSURE SYSTEM ....................................................................................... 119
FIGURE 57: LOW FLOW O2 – OPTIONAL, BLOWER BASED SYSTEM ..................................................................... 119
FIGURE 58: AUDIO / VISUAL OPTIONS ............................................................................................................... 120
FIGURE 59: CALIBRATIONS ............................................................................................................................... 121
FIGURE 60: CALIBRATE EXHALATION FLOW SENSOR ZERO OFFSET .................................................................... 122
FIGURE 61: PRE-PATIENT TESTS SCREEN ......................................................................................................... 123
FIGURE 62: SYSTEM TEST FAILURE MESSAGE ................................................................................................... 123
FIGURE 63: CALIBRATE OXYGEN SENSOR SCREEN ............................................................................................ 124
FIGURE 64: CALIBRATE EXHALATION FLOW SENSOR SCREEN ............................................................................ 125
FIGURE 65: EXHALATION FLOW SENSOR ........................................................................................................... 127
FIGURE 66: EXHALATION VALVE SYSTEM .......................................................................................................... 127
FIGURE 67: EXHALATION VALVE SYSTEM COMPONENTS .................................................................................... 129
FIGURE 68: EXHALATION SYSTEM ASSEMBLY 1 ................................................................................................. 129
FIGURE 71: FAN FILTER AND COVER ................................................................................................................. 133
FIGURE 72: AIR INLET FILTER ........................................................................................................................... 133
FIGURE 73: O2 SENSOR .................................................................................................................................. 134
FIGURE 74: INTERNAL BATTERY ........................................................................................................................ 134
FIGURE 75: FUSE ............................................................................................................................................ 135
FIGURE 76: SELECTING A MONITORING PARAMETER .......................................................................................... 138
FIGURE 77: BASIC MONITORED PARAMETERS ................................................................................................... 139
FIGURE 78: MECHANICS MONITORED PARAMETERS ........................................................................................... 139
FIGURE 79: WEANING MONITORED PARAMETERS .............................................................................................. 140
FIGURE 80: FLOW AND PRESSURE WAVEFORMS CSTAT, RINSP & REXP ............................................................. 142
FIGURE 81: HOME SCREEN GRAPHICS DISPLAY ................................................................................................ 143
FIGURE 82, LOOP WINDOWS (LEFT PANEL) ....................................................................................................... 144
FIGURE 83: WAVEFORM CONFIGURATION.......................................................................................................... 144
FIGURE 84: FREEZING GRAPHICS ..................................................................................................................... 146
FIGURE 85: TREND DISPLAY ............................................................................................................................. 147
FIGURE 86: TREND CONFIGURATION ................................................................................................................. 147
FIGURE 87: SELECTING MANEUVERS ................................................................................................................ 148
FIGURE 88: SUCTION SUPPORT MANEUVER SELECTION ..................................................................................... 148
FIGURE 89: SUCTION SUPPORT PREPARATION PHASE ....................................................................................... 149
FIGURE 90: SUCTION SUPPORT PATIENT DISCONNECTED PHASE ....................................................................... 149
FIGURE 91: SUCTION SUPPORT POST OXYGENATION PHASE ............................................................................. 150
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Index of Figures
Index of Figures
FIGURE 92: P0.1 MANEUVER ........................................................................................................................... 151
FIGURE 93, P0.1 MANEUVER MEASUREMENT GRAPH ........................................................................................ 151
FIGURE 94, PIMAX MANEUVER ........................................................................................................................ 153
FIGURE 95, INSPIRATORY HOLD MANEUVER ..................................................................................................... 153
FIGURE 96, EXPIRATORY HOLD MANEUVER ...................................................................................................... 154
FIGURE 97: V–CMV MODE .............................................................................................................................. 156
FIGURE 98: V-SIMV MODE .............................................................................................................................. 157
FIGURE 99: P-CMV MODE .............................................................................................................................. 159
FIGURE 100: P–SIMV MODE ........................................................................................................................... 160
FIGURE 101: SPONT MODE ............................................................................................................................ 164
FIGURE 102: SPAP MODE .............................................................................................................................. 166
FIGURE 103: HIGH PRESSURE SYSTEM, PNEUMATIC SCHEMATIC ....................................................................... 175
FIGURE 104: OPTIONAL, TURBINE BASED SYSTEM, PNEUMATIC SCHEMATIC ...................................................... 176
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Index of Tables
Index of Tables
TABLE 1: REVISION HISTORY ..............................................................................................................................12
TABLE 2: EMC DECLARATION – EMISSIONS (VENTILATOR) ...................................................................................42
TABLE 3: EMC DECLARATION – IMMUNITY ...........................................................................................................43
TABLE 4: EMC DECLARATION – ELECTROMAGNETIC IMMUNITY .............................................................................44
TABLE 5: EMC DECLARATION – RECOMMENDED DISTANCES ................................................................................45
TABLE 6: HOME SCREEN ELEMENT DESCRIPTIONS...............................................................................................66
TABLE 7: SOFT BOUNDARY SETTING LIMIT ...........................................................................................................73
TABLE 8: MAX BOUNDARY SETTING LIMIT ............................................................................................................74
TABLE 9: PATIENT SELECTION – NEW SETTINGS ..................................................................................................76
TABLE 10: SETTINGS DESCRIPTION .....................................................................................................................81
TABLE 11: RIGHT PANEL: CURRENT & PROPOSED SETTING SELECTIONS ..............................................................83
TABLE 12: SETTING BAR: SETTING SELECTIONS ..................................................................................................85
TABLE 13: HOME TAB DESCRIPTIONS ..................................................................................................................90
TABLE 14: MONITORING TAB DESCRIPTIONS ........................................................................................................91
TABLE 15: DATA PARAMETER DEFINITIONS ..........................................................................................................91
TABLE 16: TREND SCREEN SETTING DESCRIPTIONS ............................................................................................93
TABLE 17: TREND PARAMETERS .........................................................................................................................93
TABLE 18: ALARMS SETTINGS DESCRIPTIONS ......................................................................................................94
TABLE 19: AUTO SET FEATURE – ALARM SETTING ADJUSTMENT RULES ...............................................................95
TABLE 20: ALARM SETTING PARAMETER DEFINITIONS ..........................................................................................96
TABLE 21: ALARMS SETTINGS DESCRIPTIONS ......................................................................................................97
TABLE 22: ALARM SIGNALS .................................................................................................................................97
TABLE 23: HIGH PRIORITY ALARMS .....................................................................................................................98
TABLE 24: MEDIUM PRIORITY ALARMS ..............................................................................................................101
TABLE 25: INFORMATION MESSAGES .................................................................................................................103
TABLE 26: DISCONNECTION ALARM CODES .......................................................................................................104
TABLE 27: HAZARDS BASED ON USER / DEVICE ERRORS....................................................................................109
TABLE 28: CAPNOGRAPHY: WARNINGS AND CAUTIONS ......................................................................................112
TABLE 29: CONFIG SCREEN SETTINGS ..............................................................................................................116
TABLE 30: CALIBRATION DESCRIPTIONS ............................................................................................................121
TABLE 31: EMC DECLARATION – ELECTROMAGNETIC IMMUNITY .........................................................................131
TABLE 32: PREVENTIVE MAINTENANCE SCHEDULE .............................................................................................132
TABLE 33: ALARM TEST SETTINGS ....................................................................................................................135
TABLE 34: WAVEFORM SCALE RANGES .............................................................................................................145
TABLE 35: LOOPS SCALE RANGES ....................................................................................................................145
TABLE 36: P0.1 AUTOMATIC TERMINATION CRITERIA .........................................................................................152
TABLE 37: VENTILATION MODES .......................................................................................................................155
TABLE 38: V–CMV SETTINGS ...........................................................................................................................156
TABLE 39: V–SIMV SETTINGS ..........................................................................................................................158
TABLE 40: P–CMV SETTINGS ...........................................................................................................................159
TABLE 41: P–SIMV SETTINGS ..........................................................................................................................160
TABLE 42: PRVC–CMV SETTINGS ...................................................................................................................162
TABLE 43:PRVC–SIMV SETTINGS ...................................................................................................................163
TABLE 44: VS SETTINGS ..................................................................................................................................163
TABLE 45: PS MODE SETTINGS (CPAP + PS) ...................................................................................................165
®
Index of Tables
Index of Tables
TABLE 46: SPAP SETTINGS ............................................................................................................................. 166
TABLE 47: ABBREVIATIONS............................................................................................................................... 174
TABLE 48: E-MAIL CONTACT DETAILS ............................................................................................................... 184
®
Revision History
Revision History
Table 1: Revision History
Author REV Description of Changes Creation Date
Jeffrey Huang A Initial Draft 02 – Nov - 2015
Added software options.

Jeffrey Huang B 05 – Feb - 2016
(Neonatal, Suction Support, Tube Compensation)
Updated for software 5.0.1

Jeffrey Huang C Nebulizer time, Ptrach added, Pmin and Auto-PEEP replacing PEEPi 31 – Mar - 2016
and PEEPi-dyn
Added section 1.2, 1.4.4, 1.7.1, 1.8.5, 2.5, 2.13, 5.7

Updated section 1, 2, 4.3, 5, 6, 7, 8, 9, 10, 11
Jeffrey Huang D rd 31 – Aug - 2016
Updated for 3 Edition
Updated for EtCO2 option
Eliminated Heliox in section 1.5

Added section 1.8.11. Hi FlowO2
Jeffrey Huang E 11 – Oct - 2017
Added Alarm Selection
Settings tab updated
Updated for software 6.3.00

Jeffrey Huang F 08 – Aug – 2018
Updated GUI images
®
Section 1 Introduction to the eVolution 3e Ventilator
1. Introduction to the eVolution 3e Ventilator

This section briefly describes the eVolution 3e Turbine and eVolution 3e High Pressure Ventilator
Systems, safety information, and ventilator controls and indicators.
Reference this manual and the eVoluiton 3e Ventilator Systems Service Manual when performing any
maintenance on the ventilator.
1.1. Intended use

The eVolution Ventilator is intended for and designed to provide continuous and or intermittent
mechanical ventilation to patients requiring ventilatory support through invasive or non-invasive
interfaced and is suitable for use in the ICU, sub acute, long-term acute care, rehabilitation, and
emergency room, as well as, in hospital transport venues.
This product is intended for a wide range of patients from neonate to adult having body weights in
the range of 0.2 kg (0.44lb) or more who require pressure-based or volume-based continuous
respiratory support, as prescribed by an attending physician.
The eVolution3e ventilator system is a class IIb medical device to be used by trained and qualified
healthcare professionals in hospitals or healthcare facilities and intended for sale by or on the order
of a physician only.
CAUTION: US Federal law restricts this device to sale by or on the order of a physician only.
Only qualified and properly trained personnel should attempt to use, service, or
maintain the eVolution ventilator. Read this User Manual carefully and keep
available for reference.
The device is not to be used in the presence of flammable anesthetics.
Before operating the eVolution, check the ventilator for proper operation by
performing the System Test, Alarms Test and Calibration procedures described in
this manual.
1.2. Contraindications:
Do not operate the ventilator in a magnetic resonance imaging (MRI) environment.
1.3. Frequent Use 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.
1.4. Safety
The symbols below draws 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 intended to

prevent potential damage to the patient, caregiver or device.
• Explanatory notes and comments relevant to the eVolution ventilator.
1.5. Warnings, Cautions and Basic Safety Information
®
EVM500041 Rev F eVolution 3e Series User Manual (International Version) 14
• 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, cleaning and sterilization activities must be conducted in accordance
with the procedures and recommended intervals detailed in this manual to ensure prolonged
operation of the eVolution
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 eVolution 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.
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 system test, 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 eVolution 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 eVolution 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 eVolution
ventilator, and disconnect it from its gas and electrical sources.
Replacement of ventilator batteries by inadequately trained personnel could result in an
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 eVolution 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 eVolution 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 eVolution 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 eVolution 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 Masimo (sidestream CO2 sensor).
Use only Masimo 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 lift the ISA gas analyzer by the sampling line as it could disconnect from the ISA,
®
causing the ISA gas analyzer to fall on 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 probe zeroing will result in false gas readings.
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.
Do not sterilize or immerse Nomoline Family sampling lines in liquid.
User only airway T-adapters with the sampling point in the center of the adapter.
Strong scavenging suction pressure might affect the sample flow.
Due to the risk of patient cross-infection, always use a bacteria filter on the exhaust port side if
sample gas is intended to be re-breathed.
No modification of the CO2 monitoring devices is allowed.
CO2 sensors are not designed for MRI environments. During MRI scanning, place the
ventilator outside the MRI suite
• Capnography Sensors:
The IRMA airway adapters are non-sterile devices. Do not autoclave the devices as this will
damage them. Refer to IRMA Mainstream Gas Analyzer and ISA Sidestream Gas Analyzer
User Guides for cleaning instructions.
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 eVolution 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 eVolution ventilator. Do not
use the eVolution 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 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.
1.5.1. Copyright Notice

Copyright © 2010 to 2018 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.
1.5.2. Trademark Notice

eVolution, Inspiration 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.
1.5.3. Notice of Conformity, Compliance and Approvals

The eVolution 3e Series Ventilator was developed in accordance with pertinent international
standards and FDA guidelines.
o The eVolution 3e Series Ventilators are manufactured within an EN ISO 13485:2016
Council Directive 93/42/EEC, Annex II, Article 1 certified quality management system.
The eVolution 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 IEC 601-1:2012 o EN60601-1:2012
o IEC 601-1-2:2014 o EN60601-1-2:2014
o ISO 6061-2-12:2011 o EN 794-1
o ASTMF1100-90 o EN 46001
o ASTM F1054-87 o ISO 13485
o ISO 5356-1
o IEC 60601-1-6:2010
1.5.4. 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 3 volts per meter, at
frequencies from 80 MHz to 2.7 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.
1.5.5. CE Notified Body

SGS UK
1.5.6. Classification
CE classification: classified as protection class I, Type BF, internally IEC 60601-1:2012
powered drip-proof adult / pediatric ventilator for continuous operation.
1.5.7. Regulatory Notice

CAUTION: US Federal Law restricts the sale of this device except by or on the order of a
physician.
1.6. Device Labels and Symbols

These device labels and symbols appear on the eVolution 3e Series Ventilators.
Device Labels and Symbols
External User Interface
On/Off switch
% O2 Increase key
Manual Inspiration key / Mandatory breath
On / Off / Standby key
Alarm Silence / Mute key
An illuminated LED at the top of the device indicates there is an active

alarm. This is in addition to the audible and on screen visual alarm.
Front Panel: Vent Inop indicator
Front Panel: Mains power connected indicator
®

The “Nebulizer” label is position next to the Nebulizer nipple connector.
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 eVolution 3e Series Ventilator.
Earth Ground
Designates type BF equipment per IEC 601-1
Hot Surface
Do Not Twist
IPX1 Indicates the degree of protection (drip-proof) by the enclosure.
Max O2 180 l/min The Oxygen inlet port label is positioned next to the Oxygen inlet port.
2 – 6 bar (29 – 86 psi)
Max Air 180 l/min Air inlet port label is positioned next to the Air inlet port.
2 – 6 bar (29 – 86 psi)
Low pressure Oxygen inlet port label

O2 0.3 – 2 bar (5 – 29psi)
(Available on the Turbine Based System)
DC–Input: DC input connection

12VDC
• The “DC Input” label is positioned to the left of the DC input
168W connection port.
14A
®

AC–Input: AC input connection

90 -264VAC • The “AC Input” label is positioned to the left of the AC input
47/63 Hz connection port.
120VA
100V: 2.4A
240V: 1.2A
Fuse: T250V 3.15AH
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
eVolution 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
Indicates WEEE (Waste Electrical and Electronic Equipment) Registration

per EU WEEE Reg. No. IE 00761, Directive, 2002/96/EC
Door Push / Open Label
Indicates the internal compressor is not installed.
Door Push / Open Label

Graphical User Interface
Product Sticker: Designates the device is a Turbine ventilator
Product Sticker: Designates the device is a Dual High Pressure ventilator

with High pressure Air and Oxygen gas source connections.
®

Graphical User Interface
High Priority Alarm message
Medium Priority Alarm message
Information (low) Priority Alarm message
Alarm OFF: Alarm message if 1 or more alarms are turned OFF
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
Internal battery charge status
• When on internal battery this icon will be displayed in the top right of
the user interface.
On battery backup
Indicates the settings and screen are locked

Lock / Unlock control is located at the top right of all user screens and
allows the user to lock or unlock the screen.
1.7. 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.
1.8. Clinical Specifications

This section provides specifications for the eVolution 3e Series Ventilators.
• * Neonatal ranges available ONLY if Neonatal software option is installed.
• Pressures are shown on the eVolution 3e series ventilators 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.
1.8.1. 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 and O2);
• Battery alarm management
1.8.2. 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 NOTE: PS = CPAP + PS and VS = CPAP + VS
SPAP is equivalent to APRV (CareFusion)
NCPAP+* NOTE:
and BiLevel (Covidien).
Hi FlowO2 N/A
High Flow Oxygen Therapy
1.8.3. Breath Type by Control Variables

Breath Types by Control Variable
Control Variable Breath Type Mode Selections
Volume Mandatory V–CMV

Volume–controlled breaths
Mandatory + Spontaneous V–SIMV
Mandatory + Pressure–controlled (PS) breaths
Pressure Mandatory P–CMV

Pressure –controlled breaths
Mandatory + Spontaneous P–SIMV

Mandatory + Pressure–controlled (PS) breaths SPAP
Spontaneous PS
Pressure –controlled (PS) & NCPAP+ (PC) breaths NCPAP+*
Dual Mandatory PRVC–CMV

Pressure Regulated Volume Targeted Pressure-controlled breaths
Volume Control
and Mandatory + Spontaneous PRVC–SIMV
Volume Support Mandatory + Pressure–controlled (PS) breaths
®
Breath Types by Control Variable

Control Variable Breath Type Mode Selections
modes
Spontaneous VS
Volume Targeted Pressure–controlled (VS) breaths
1.8.4. Other Ventilation Mode Options

Description Other Mode Options
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 (optional software)

(compensates for the patient’s artificial Tube Comp.
airway imposed resistance)
1.8.5. Patient Types by Ideal Body Weight

Patient Type Ideal Body Weight
Adult IBW: 41 to 138 kg
Pediatric IBW: 5.0 to 40 kg
Infant* IBW: 0.2 to 4.9 kg
1.8.6. Patient Startup Settings

New Patient Startup Settings Setting Ranges
Patient Height 15 to 250 cm
Adult 136 to 250 cm (default: 150 cm)
Pediatric 48 to 134 cm (default: 100 cm)
Infant* 15 to 46 cm (default: 42 cm)
IBW
0.2 to 138 kg
Ideal Body Weight
Adult 41 to 138 kg
Pediatric 5.0 to 40 kg
Infant* 0.2 to 4.9 kg
Gender Male, Female
Humidifier, HME, None
Humidification Type
(default: HME)
1.8.7. Standard Mode Settings

Standard Mode Settings Setting Ranges
Respiratory Rate
Adult 1 to 60 b/min
®

Pediatric 1 to 120 b/min
Infant* 1 to 150 b/min
Accuracy:
0 to 100 b/min ± 1 b/min
> 100 b/min ± 2%
Tidal Volume and Target Tidal Volume

Adult 300 to 3000 ml
Pediatric 20 to 500 ml
Infant* 5 to 100 ml
Accuracy: (Compliance & BTPS Compensated)
5 to 49 ml ± 2 ml + 10%
50 to 3000 ml ± 10 ml + 10%
I-Time
All Patient Types 0.1 to 10 s
Accuracy: ± 0.02 s
PEEP / CPAP
PEEP 0 to 50 cmH2O or
0 to (90 cmH2O - Pcontrol,
Psupport),
whichever is less
Accuracy: ± 10% or ± 2cmH2O whichever is greater
Pcontrol
1 to 100 cmH2O or
Pcontrol (100 cmH2O - PEEP),
whichever is less
Psupport
0 to 100 cmH2O or
Pcontrol (100 cmH2O - PEEP),
whichever is less
Peak Flow Mandatory

(US philosophy configuration) (Flow Setting)
Adult 1.0 to 120 l/min
Pediatric 1.0 to 90 l/min
Infant* 1.0 to 60 l/min
®

Accuracy: ± 10%
Peak Flow Spontaneous

Flow available to patients during spontaneous breaths (not settable)
Adult 1.0 to 180 l/min
Pediatric 1.0 to 90 l/min
Infant* 1.0 to 60 l/min
Accuracy: ± 10%
Peak Flow Turbine Output

Up to 300 l/min
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)
Infant* 0.1 to 10.0 l/min (default: 1 l/min)
With flow triggering enabled, there is a background pressure trigger level of 2 cmH2O.
Pressure Trigger (Ptrig)

Adult 0.2 to 20.0 cmH2O
Pediatric 0.2 to 15.0 cmH2O
Infant* 0.1 to 10.0 cmH2O
(default: 2.0 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
Note: Leak Compensation disabled when Tube
Compensation is “on”
Base Flow
The Base Flow is only available for
manual adjustment if Leak Comp is Base Flow = 3Lpm + Ftrig settings
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.
With NIV disabled, the system will compensate for leaks up to 25.0 l/min.
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
Infant* 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 0.0 to 2.0 s (default: 0.0 s)
Accuracy: ± 0.02 s
Oxygen
O2 21 to 100 %
% O2 Increase (button) 100% O2 for 3 min (adult/ped)
+20% for 3 min (neonatal)*
Accuracy (Delivery): ± (3 %) full scale
Suction Support (optional software)
Suction Support On/Off
(for complete details on Suction Support, see Section 9.3.1)
Rise Time 1 - 20
1 = Slow and 20 = Fast
Flow Pattern
Flow Pat. Decel (Decelerating), De50% (Decelerating 50%),
or Square
Exhalation Sensitivity
Esens 1 to 80 % of peak insp flow
Auto Control
Auto Control On or Off
Auto Time 3 to 60 sec
Screen Lock / Unlock
®
Unlocked
Locked
1.8.8. SPAP Mode Settings

SPAP is a dual PEEP mode which is equivalent to APRV (CareFusion) and BiLevel (Covidien)
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: ± 10% or ± 2 cmH2O whichever is greater
Low PEEP
Plow 0 to 50 cmH2O or
0 to Phigh or
0 to (100 - Psup low) cmH2O
Plow cannot be set > Phigh
Pressure Support at High PEEP

Psup High 0 to 100 cmH2O or
0 to (100 - Phigh) cmH2O
whichever is less
Phigh + Psup High will not exceed 100 cmH2O
Pressure Support at Low PEEP

Psup Low 0 to 100 cmH2O or
0 to (100 - Plow) cmH2O
whichever is less
Plow + Psup Low will not exceed 90 cmH2O
Time at High PEEP

Thigh 0.1 to 59.8 s or
60 - Tlow setting
Accuracy: ± 0.2 s
®
SPAP Mode Settings Setting Ranges

Time at Low PEEP
Thigh 0.2 to 59.9 s or
60 - Thigh setting
Accuracy: ± 0.2 s
Cycle
(Low PEEP to High PEEP cycles per minute)
Adult 1 to 60 c/min
Pediatric 1 to 120 c/min
Infant 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: Derived from accuracies for Thigh and Tlow
SPAP Setting Philosophy

SPAP Type
Cycle + Thigh Setting Cycle + Time
Cycle + H:L Ratio Cycle + Ratio
Tlow + Thigh Time Only
1.8.9. Tube Compensation (optional software)

Note: Leak Compensation disabled when Tube Compensation is “on”
For complete details on Tube Compensation, see Section 5.3.6

Tube Compensation Settings Additional Settings to Tube
Comp.
Tube Compensation
Tube Compensation On or Off (default = Off)
Tube Diameter 2.0 – 10.0 mm

Tube Type ETT or Trach (default = ETT)
TC Factor 1 – 100% (default = 80%)
®
Tube Compensation Settings Additional Settings to Tube

Comp.
Default Tube Diameter for New Patients
IBW 0.2 – 5 kg* 3.0 mm (allowable range 2.0 – 6.0)
IBW 5.1 – 10 kg 4.0 mm (allowable range 3.0 – 8.0)
IBW 11 – 40 kg 5.0 mm (allowable range 4.0 – 8.0)
IBW > 40 kg 7.5 mm (allowable range 5.0 – 10.0)
1.8.10. NCPAP+ Mode Settings*

(Optional Software, Neonatal)
NCPAP+ Mode Settings Additional settings specific to NCPAP+
NCPAP+ Pcontrol and I-Time settings display

NCPAP+ is only available for Infant 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+ Mode Settings Additional settings specific to NCPAP+
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
1.8.11. Hi FlowO2 (Optional Software)

Hi FlowO2 Settings
To access Hi FlowO2 under Mode Types you must be in Standby mode.
Pediatric and Adults Pediatric and Adults
(Default Settings: O2: 40%, Flow: 10 l/min)
O2% Range: 21 to 100 %

Flow Range: 2 to 80 l/min
Humidification is recommended for delivery of 4 l/min or greater.
Neonate Neonate
(Default Settings: O2: 40% Flow: 2l/min)
O2 Range: 21 to 100 %
Flow Range: 2 to 12 l/min
Humidification is recommended.
1.8.12. Apnea Backup Settings

Apnea Backup Settings Additional settings specific to Apnea backup
Apnea Backup Modes V–CMV; P–CMV; PRVC–CMV

User selected Breath type, mode and settings 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
(settings displayed depend on the selected apnea Default Settings
backup mode)
Ventilation Mode P–CMV
Rate Based on IBW setting
Vt Based on IBW setting
Flow Based on IBW setting
®
Apnea Backup Settings Additional settings specific to Apnea backup
Flow Pattern Decel

Pause 0.0 sec
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
1.8.13. Configuration Screen Setting Options (Config)

Config. Screen Options Setting Ranges
Humidification Type
Humidifier, HME, None
Alarm Options
© Full and Basic
Monitors
5 or 8
Select Number of parameters
displayed in the Monitoring Bar
Compliance Comp.
Compliance Compensation On or Off
Low Flow O2
(Turbine models)
© Low Flow O2; On or Off

© O2 Sensor; On or Off
O2 Sensor
(High pressure models)
O2 Sensor; On or Off
Audio / Visual
© Audio Level; 35-100%
© Screen Clicks On or Screen
Clicks Off
© LCD Brightness; 20-100%
Technical
®
Config. Screen Options Setting Ranges

Password Access To view or adjust the additional
Technical Settings enter the
access code is 2634 and press
OK or CANCEL to return to
previous screen.
Patient Height: cm or in
Keyboard: Standard or Generic
Alpha
1.8.14. Monitored Data / Displayed Patient Values

If the exhalation flow sensor is not available for any reason, 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 exhalation flow sensor will not be monitored and pressure
triggering will be enabled.
Pressure Values Monitored Data Ranges
Ppeak 0 to 100 cmH2O

Peak pressure during a breath
Pmean 0 to 120 cmH2O

Averaged mean pressure
PEEP 0 to 120 cmH2O

Pressure at end exhalation
Volume / Flow / Oxygen Values Monitored Data Ranges

Vte 0 to 3000 ml
Exhaled tidal volume Displayed as ---- with a flow
sensor error
Accuracy: 0 to 200 ml: ± (10 ml + 5%)

201 to 3000 ml: ± 10%
Vte Spont 0 to 3000 ml

Spontaneous exhaled tidal volume Displayed as ---- with a flow
sensor error
Accuracy: 0 to 200 ml: ± (10 ml + 5%)

201 to 3000 ml: ± 10%
Vti 0 to 3000 ml
Inspired tidal volume
Accuracy: 0 to 200 ml: ± (10 ml + 5%)
201 to 3000 ml: ± 10%
®
Volume / Flow / Oxygen Values Monitored Data Ranges

Ve 0.00 to 99.0 l/min
Exhaled minute volume
Accuracy: + 10%
Ve Spont 0.00 to 99.0 l/min

Spontaneous exhaled minute volume
Accuracy: + 10%
Vi 0.00 to 99.0 l/min

Inspired minute volume
Displays when there is a flow sensor error
Accuracy: + 10%
Vi Spont 0.00 to 99.0 l/min

Spontaneous inspired minute volume
Displays when there is a flow sensor error
Accuracy: + 10%
Leak 20 to 100%
Averaged calculated leak (1-Vte/Vti)
Accuracy: Derived: averaged calculated leak
(1-Vte/Vti)
PF 0.0 to 200 l/min

Peak inspiratory flow
Accuracy: ± 10%
PFe 0.0 to 200 l/min

Peak expiratory flow
Accuracy: ± 10%
O2 15 to 103 %
Monitored FiO2 Displayed as ---- if O2 sensor is
disabled.
Accuracy (monitored): ± 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%
Rate Spont 0 to 300 b/min

Measured spontaneous breaths per minute
®
Time Values Monitored Data Ranges
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: ± 0.2 s
E–Time (Te) 0.10 to 99.9 sec

Expiratory time
Accuracy: ± 0.2 s
I:E 1 : 99.0 to 99.0 : 1

Inspiratory to expiratory ratio
Accuracy: ± 0.1 s
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 Thigh and Tlow
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.
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)
®

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
Pplateau 0 to 120 cmH2O

Plateau pressure
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
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.
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
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%
1.8.15. Graphics: Real-Time Curves

Graphics: Real-Time Curves
Waveforms Waveforms Displayed on the Main Screen
The measurement and graphical representation of

Pressure + Time breath delivery pressure breath-to-breath over time.
Measured in cmH2O
The measurement and graphical representation of

Flow + Time breath delivery flow breath-to-breath over time.
Measured in l/min
The measurement and graphical representation of the

Volume + Time inspiratory tidal volume breath-to-breath over time.
Measured in ml
Loops Loops Displayed on the Main Screen
Pressure-Volume Loop
P / V Loop Measured cmH2O and ml
Pressure displayed on x-axis and volume on the y-axis
Flow-Volume Loop
F / V Loop Measured l/min and ml
Flow is displayed on the y-axis and volume on the x-axis
Pressure-Flow Loop
Measured cmH2O and ml
P / F Loop
Flow is displayed on the x-axis and pressure on the y-
axis
1, 2 or 3 curves OR 1 to 2 loops can be selected to display. The eVolution ventilator provides a
user configurable auto–scale or manual scale feature for each graphic displayed. Graphs
displayed in the right panel can be frozen and provide touch and scroll cursor control with cursor
X and Y axes values displayed.
1.8.16. Alarm Limit Settings
(Note: * Neonatal ranges available ONLY if Neonatal software option installed)
®
Standard
Pressure Alarm Settings

Ppeak High 1 or 1 > Ppeak Low to 95 cmH2O
Ppeak Low 0 to 94 cmH2O or 1 < Ppeak High
PEEP High 3 or 1 > PEEP Low to 50 cmH2O

PEEP Low 2 to 49 cmH2O or 1 < PEEP High, or Off
Pmean High 6 or 1 > Pmean Low to 50 cmH2O
Pmean Low 1 to 99 cmH2O or 1 < Pmean High, or Off
Volume Alarm Settings

Ve High 0.10 or 0.10 > Ve Low to 99.0 l/min
Ve Low 0.01 to 98.9 l/min or 0.10 < Ve High, or Off
Vte High
Adult 5 or 1 step > Vte Low to 2500 ml
Pediatric 2 or 1 step > Vte Low to 1000 ml
Neonate* 1 or 1 step > Vte Low to 300 ml
Vte Low
Adult 5 to 2490 ml or 1 step < Vte High, or Off
Pediatric 2 to 2495 ml or 1 step < Vte High, or Off
Neonate* 1 to 2498 ml or 1 step < Vte High, or Off
Vti Limit
Adult 0 to 2500 ml or Off (default New Patients = Off)
Pediatric 0 to 1000 ml or Off (default New Patients = Off)
Neonate* 0 to 300 ml or Off (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 limit
High FiO2
to 7% above oxygen % setting.
Ventilator software automatically sets alarm limit
Low FiO2
to 7% below oxygen % setting.
Other Alarm Settings Automatic Setting

Apnea (interval) 3 – 60 sec
Apnea (setting) On or Off
Leak Rate
20 – 100 %
(sets the leak percent level for alarm)
Automatically adjusts alarm settings based on
AUTO SET
current monitored values or settings depending
(Auto sets alarm values) on mode.
®
Standard
55 mmHg
PetCO2 High
Range: 2 (or 1 > PetCO2 Low) to 150 mmHg
25 mmHg
PetCO2 Low Range: 1 to 149 mmHg or 1 < PetCO2 High, or
Off
1.8.17. Alarms by Priority
Air Supply Oxygen Supply
Blower Occlusion
High inh Pressure Low Inh Pressure
Apnea Disconnection
High MV Low MV
High O2 Pressure Low O2 Pressure

High O2 Conc Low O2 Conc
High VT Low VT
TF-XXX
Battery Too Low
(see section 5.6.10.)
High O2% Imminent Shutdown
Low O2% Connect AC Now

High O2 Inlet Pressure High Pressure
Low Air Supply Low Pressure
Battery Low Vti Limit Reached

Volume Not Delivered High Leak Rate
High Rate Low Rate
High PEEP Low PEEP
Check Pcontrol / Pmax Check Psupport / Pmax

Over Temperature
Battery Not Available Battery In Use

®
Flow Sensor Error Inverse I:E Ratio
Nebulizer Not Available Increase O2 not avail
Audible AC power disconnect / reconnect

tone.
1.9. Technical Specifications:

1.9.1. Power and Gas Supply
AC input 90 to 240 VAC (47 – 63 Hz)
Power consumption 120 VA (W)
DC input VDC 12
Lithium Ion (Turbine Models)
Battery Type
Lead Acid (HP Models)
> 120 min (Turbine Models)
Battery Backup (with fully charged battery)
> 30 min (HP Models)
Approximately:
Recharge Time 7 hours (Turbine Models)
4 hours (HP Models)
29 – 86 psi clean, dry, and oil-free,
High pressure oxygen inlet supply
medical grad
180 l/min (STPD, dry and oil-free
Oxygen inlet supply flow
required)
High pressure air inlet supply (HP model)
medical grad
180 l/min (STPD, dry and oil-free
Air inlet supply flow (HP model)
required)
Low pressure oxygen inlet supply (Turbine model)
medical grade
1.9.2. Environmental Data

Operating temperature 5 – 40 °C
Storage temperature -10 – 60 °C
Operating Humidity 15% - 95% non-condensing
Storage Humidity 5% - 95% RH non-condensing
Operating altitude 11,600 ft (3,536 m) above sea level
1.9.3. Physical Data

14 x 14 x 12 in or
Width x depth x height (ventilator)
35.5 x 35.5 x 30.5 cm
®
39 lbs (17.7 kg) (Turbine Models)

Weight
36 lbs (16.3 kg) (HP Models)
Noise Level ≤ 55 dBa
1.9.4. Technical Data

Maximum operating pressure 95 cmH2O controlled by high alarm setting
Pressure measurements are made by solid-state

pressure transducers positioned to monitor
Measuring and display devices
internal operating, inspiratory, and expiratory
circuit pressures
Flow measurements are made by one of three hot
wire flow sensors, and are integrated with time to
Flow and volume measurement 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
Oxygen measurement inspiratory manifold to measure the delivered
oxygen concentrations from 15 to 103%.
Display All data appears on a touch screen enabled color

Touch Screen liquid crystal display (LCD)
1.9.5. Technical Data: Capnography Sensors

For complete Technical specification for IRMA Mainstream Gas Analyzer and ISA Sidestream Gas
Analyzer please see User Guides and Technical Specifications.
1.9.6. Compliance and Approvals
Classified as protection class II, Type B,

IEC 60601-1:1988 + A1:1991+A2:1995 internally powered, drip-proof equipment for
continuous operation
IEC 601-1/ EN60601-1, IEC 601-1-2,

EN60601-1-2, EN794-1, ASTMF1100-90,
Meets International Standards
IEC 60601-2-12: 1988, ASTM F1054-87,
ISO 5356-1
1.9.7. Electromagnetic Compatibility Declaration

Table 2: EMC Declaration – Emissions (ventilator)
Guidance and Manufacturer's Declaration – Electromagnetic Emissions
The ventilator is intended for use in the electromagnetic environment specified below.
The user of the ventilator should assure that it is used in such an environment.
Emissions Test Compliance Electromagnetic Enforcement – Guidance
The ventilator uses RF energy for its internal function.

RF Emissions CISPR 11 Group 1 Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment
RF Emissions CISPR 11 Class A The system is suitable for use in all establishments, including
domestic establishments and those directly connected to the
®
Table 2: EMC Declaration – Emissions (ventilator)

public low voltage supply network that supplies buildings used
Harmonic emissions
Class A for domestic purposes
IEC 61000-3-2
Voltage fluctuations/flicker
Complies
emissions IEC 61000-3-3
Table 3: EMC Declaration – Immunity
Guidance and Manufacturer's Declaration – Immunity

The user of the ventilator should assure that it is used in such an environment.
IEC 60601 Test Compliance Electromagnetic Environment –

Immunity Test
Level Level Guidance
Electrostatic Floors should be wood, concrete or ceramic
+/- 6kV contact +/- 6kV contact
Discharge (ESD) tile. If floors are covered with synthetic
material, the relative humidity should be at
+/- 8kV air +/- 8kV air
IEC 61000-4-2 least 30%.
+/- 2kV for power +/- 2kV for power

Electrical Fast
supply lines. supply lines.
Transient/burst Mains power quality should be that of a
typical hospital environment
+/- 1 kV for +/- 1 kV for
IEC 61000-4-4
Input/output lines Input/output lines
+/- 1kV +/- 1kV

Surge differential mode differential mode
Mains power quality should be that of a
typical hospital environment
IEC 61000-4-5 +/- 2 kV common +/- 2 kV common
mode mode
Voltage dips, <5% Ut <5% Ut Mains power quality should be that of a

short interruptions (>95% dip in Ut ) (>95% dip in Ut ) typical hospital environment. If the user of
and voltage for a 0.5 cycle for a 0.5 cycle the ventilator requires continued operation
variations on during power mains interruptions, it is
power supply 40% Ut 40% Ut recommended that the ventilator be
input lines. (60% dip in Ut) for (60% dip in Ut) powered from an external battery.
5 cycles for 5 cycles
IEC 61000-4-11
70% Ut 70% Ut
(30% dip in Ut) for (30% dip in Ut)
25 cycles for 25 cycles
5% Ut 5% Ut
(>95% dip in Ut ) (>95% dip in Ut )
for 5 sec for 5 sec
Power Frequency
(50/60 Hz) Power frequency magnetic fields should be
magnetic field. 3 A/m 3 A/m at levels characteristic of a typical location in
a typical hospital environment.
IEC 61000-4-8
Note: Ut is the a.c. mains voltage prior to application of the test level.
®
Table 4: EMC Declaration – Electromagnetic Immunity
Guidance and Manufacturer's Declaration – Electromagnetic Immunity

The user of the ventilator should assure that it is used in such an electromagnetic environment.
Immunity IEC 60601 Compliance

Electromagnetic Environment – Guidance
Test Test Level Level
Portable and mobile RF communications equipment

should be used no closer to any part of the ventilator,
including cables, than the recommended separation
distance calculated from the equation applicable to the
Conducted frequency of the transmitter. Recommended separation
3 Vrms 150
RF distance
kHz to 80 MHz
3 Vrms EMC Declaration – Recommended Separation
outside ISM
IEC Distance
bands (a)
61000-4-6
10 Vrms
10 Vrms
150 kHz to
80 kHz in
Radiated RF
IEC 61000-4-
3 10 V/m
10 V/m
80 MHz to
2.5 GHz
Where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation distance in meters (m) (b)
Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey. (c) should be
less than the compliance level in each frequency range. (d) Interference may occur in the vicinity of
equipment marked with the following symbol.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected
by absorption and reflection from structures, objects and people.
(a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.795 MHz;
13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz
(b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range of 80
MHz to 2.5 GHz are intended to decrease the likelihood that mobile/portable communication equipment could cause
interference if it is inadvertently brought in to the patient areas. For this reason, an additional factor of 10/3 is used in
calculating the recommended separation distances for transmitters in these ranges.
®
Guidance and Manufacturer's Declaration – Electromagnetic Immunity

The user of the ventilator should assure that it is used in such an electromagnetic environment.
Immunity IEC 60601 Compliance

Electromagnetic Environment – Guidance
Test Test Level Level
(c ) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the ventilator is used exceeds the
applicable RF compliance level above, the ventilator should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the ventilator.
(d) Over the frequency range of 150 kHz to 80 MHz, field strengths should be less than 1V/m.
Table 5: EMC Declaration – Recommended Distances
Recommended Separation distances Between Portable and Mobile RF Communications Equipment

and the eVolution Ventilator
The ventilator is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The use of the ventilator can help to prevent electro-magnetic disturbances by maintaining the
minimum distance between portable and mobile RF communications equipment prior (transmitters) and
the ventilator as recommended below, according to the maximum output of power of the communications
equipment.
Separation Distance According to Frequency of Transmitter (meters)
Rated 150 kHz to 80 MHz 150 kHz to 80 MHz

Maximum 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Outside ISM Bands in ISM Bands
Output of
Power of
Transmitter
(watts)
0.01 0.12 0.12 0.12 0.23
0.1 0.38 0.38 0.38 0.74
1 1.2 1.2 1.2 2.3
10 3.8 3.8 3.79 7.4
100 12 12 12 12
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: The ISM (industrial, scientific and medical) bands between 150 Hz and 80 MHz are 6.765 MHz to
6.795 MHz; 13.553 MHz to 13.567 MHz; 26..957MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz
NOTE 3: An additional factor of 10/3 is used in calculating the recommended separation distance for
transmitters in the ISM frequency bands between 150 KHz and 80 MHz and in the frequency range
80MHz to 2.5 GHz to decrease the likelihood that mobile/portable communications equipment could
cause interference if it is advertently brought into patient areas.
®
Table 5: EMC Declaration – Recommended Distances
Recommended Separation distances Between Portable and Mobile RF Communications Equipment

and the eVolution Ventilator
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagations affected by
absorption and reflection from structures, objects and people.
®
Section 3 Operation
2. Preparing the Ventilator for Use

The eVolution ventilator should only be assembled, operated and tested by
trained and qualified professionals.
Two people are required to assemble the eVolution 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.
2.1. Ventilator Setup

The eVolution ventilator includes the ventilator and cart assembly (purchased separately).
Assemble the ventilator cart according to the enclosed instructions, and then attach the
ventilator to the cart.
The eVolution ventilator also includes instructions for use and assembly.
2.2. Power Supply

The eVolution can be powered from an AC mains supply or DC supply (internal or optional
external battery).
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 Supply

Before powering on the ventilator, check that its operating voltage (100-240 V AC, 47-63 Hz)
corresponds to local mains voltage).
Use a grounded three-pole cable for the mains power cord, and install the mains plug into a
grounded socket. Only use 5x20mm, 3.15AT fuses with ceramic tube for replacement, which
complies with IEC 60127-2/5. Only use power supply cords that comply with IEC 245 Code 53
or IEC 227 Code 53.
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Section 3 Operation
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 eVolution 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 eVolution 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%.
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 eVolution
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.
Figure 1: Power Supply Socket
2.4. DC (External Battery) Supply

The ventilator can operate from a 12 V DC external battery. The DC input connector on the
back panel of the ventilator is designed for use only with the External Battery and charger
specified in the spare parts list in section 7 of this manual.
Figure 2: DC, External Batter Socket
2.5. DC (Internal Battery) Power Supply
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Section 3 Operation
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.
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 eVolution 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 eVolution 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%.
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 eVolution
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.
2.6. On and Off Power Switch

Power the eVolution ventilator on or off by using the protected On/Off Switch located on the
back panel of the ventilator.
Figure 3: On/Off Switch
Check that all cables and tubes are correctly installed and that the ventilator is connected to an
appropriate power source.
2.7. Gas Supply

The eVolution Ventilator is equipped with oxygen supply connection fittings.
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Section 3 Operation
The gas supply hose used for oxygen 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 and 5 to 29 psi (0.3 to 2 bar)
for the Low flow O2 inlet.
Use medically pure oxygen only.
Oil impairs the individual ventilator components' ability to operate. Oxygen
supplies must be completely oil-free. Fault-free operation cannot otherwise
be guaranteed.
Warning: pure oxygen combined with oil is highly explosive!
2.8. High Pressure Based System: Connecting to Oxygen and Air

Supply
Oxygen Air
connection connection nut
Supply pressure Supply pressure
29 to 86 psi 29 to 86 psi
(2 to 6 bar) (2 to 6 bar)
Figure 4: High Pressure O2 and Air Inlet
2.9. Optional, Turbine Based System: Connecting to Oxygen

Supply
Figure 5: High Pressure O2 Inlet Figure 6: Low Pressure O2 Inlet
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Section 3 Operation
2.10. Ethernet and Nurse Call
Figure 7: Communication ports, Ethernet and Nurse Call
2.10.1. Ethernet Connection (RJ45 connector)

The Ethernet communication port is used to upload software updates via a standard RJ45
Ethernet cable.
2.10.2. CliniNet® Server and Virtual Report™

o The CliniNet Server provides for static or DHCP IP address assignment and MAC
address registration for easy wireless or direct Ethernet network integration. It has been
tested on the latest high security CISCO network architecture.
o Virtual Report Software, after installation on a network-enabled computer, provides
access to the any eVolution or Inspiration ventilator connected to the
network. Depending on network configuration, the ventilators can be accessed from
anywhere in the hospital or the world if the clinician has access to the network from
outside the hospital.
o Virtual Report software allows any window PC to connect to an monitor up to 8
eVolution or Inspiration ventilators on one screen at the same time and provides
clinicians with real-time monitoring and quick viewing access of all ventilator settings,
monitored parameters, active alarms, real-time curves, trend data, device location,
device ID, patient ID, network settings, diagnostic information, as well as eVent Medical
contact and support information. So if an alarm or setting change occurs on a
ventilator, that information it is instantly displayed on the computer. Each of the 8
monitor windows can be expanded for additional viewing options or easily changed to
view additional ventilators on the network.
o Virtual Report provides an encrypted data stream and multi level password protection to
ensure device and patient information are secure.
®
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.
2.10.3. Nurse Call Connection (RJ12 connector)

The Nurse Call interface allows the ventilator to connect to a remote alarm system. Nurse
Call pin assignments (floating contacts):
Pin Function Nurse Call Port
1 Not in use
2 NC (Normal Closed) 1
3 NO (Normal Open)
51
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eVolution 3e Series User Manual (International Version) 6 EVM500041, Rev F
Section 3 Operation
4 Not in use
5 Common
6 Not in use
Figure 8: Nurse Call Connector Pin Assignments
2.10.3.1. Nurse Call Specification

Maximum Switching Voltage: 125 VDC/ 150 VAC
Maximum Switching Capacity: 30 W, 60 VA
2.11. Breathing Circuit

This section describes attaching patient breathing circuits to the ventilator (Figure 9). This
section also includes information on specific components, including nasal prong interfaces, the
exhalation system, humidification devices and nebulizer.
To prevent possible cross contamination, always use a bacteria filter that

complies with ASTMF1100-90, F1054-87 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 System Test
Use the eVolution ventilator only with standard breathing circuits (single patient use or
reusable) that comply with international standards ASTMF1100-90, F1054-87, ISO 5356-1,
EN794-1, EN1281-1 and EN12342.
The breathing circuit may include these components:
Figure 9: Breathing Circuit
2.11.1. Nasal Prongs

The breathing circuit can include a standard neonate / infant circuit with a wye, or a
®
Section 3 Operation
standard neonate/infant circuit with neonate / infant nasal prongs replacing the wye (Figure
10). Use of a proximal pressure line with the eVolution ventilators is not required when using
nasal prong interfaces. NCPAP+ mode is appropriate for use with most nasal prong
systems as shown below.
Argyle Infant Nasal Prongs

F&P Infant Nasal Prongs
nasal prong systems that attach to a circuit wye
INCA Infant Nasal Prongs Hudson Infant Nasal Prongs

Figure 10: NCPAP Prongs
Attach the nasal prong interface to the circuit as required. Cap or close any open pressure
ports on the nasal prong interface as the eVolution NCPAP+ mode does not require use of a
proximal pressure line.
2.11.2. Exhalation System
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Section 3 Operation
Exhalation System Exhalation System

Cover
Housing

Diaphragm Locking Ring
Figure 11: eVolution 3e Exhalation Valve System
2.11.3. Humidification Devices

Any humidification device used with the ventilator must comply with international standards,
including EN8185-1, ISO9360, ASTMF1100-90, F1054-87, and ISO 5356-1.
2.11.4. Nebulizer Use and Placement

Use the eVolution 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. 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 5.3.6 for additional Nebulizer instructions.
The Nebulizer outlet provides a nebulizer flow of 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.
To start nebulization, select Smart Nebulizer from the ventilator Config tab. See section
5.3.6 for additional information.
The nebulizer function is not available during Neonate ventilation.
2.12. 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.
®
Section 3 Operation
Tube
Tube
Mounting Holder Holder
Flex Arm Bracket
Connection
Screw
Figure 12, Flex Arm Assembly
2.13. Capnography (Mainstream / Sidestream) Sensors

The eVolution ventilator is designed to work with the Masimo IRMA (mainstream) and ISA
(Sidestream) Capnography sensors and adapters. The eVolution’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
Masimo CO2 adaptor attached to the ventilator. Both IRMA and ISA sensors adaptors have
indirect contact with patient.
• When the Masimo 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, single path, two-channel non-dispersive
infrared (NDIR) gas bench, 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 eVolution 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 eVolution ventilator to another, even
during ventilation.
2.13.1. Classifications
IRMA Mainstream Gas Analyzer:
• According to the degree of protection against harmful ingress of water or particulate
matter: - IP44
• According to sterility: The IRMA system contains no sterile parts.
• According to the mode of operation: CONTINUOUS OPERATION
• According to the degree of protection against electric shock: The IRMA probe is
classified as DEFIBRILLATION-PROOF TYPE BF APPLIED PART
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Section 3 Operation
• The combination of a medical backboard device and IRMA shall be considered a ME

SYSTEM.
ISA Sidestream Gas Analyzer:

• According to sterility: The ISA system contains no sterile parts.
• According to the mode of operation: CONTINUOUS OPERATION
• According to the degree of protection against electric shock: Nomoline Family sampling
lines are classified as DEFIBRILLATION-PROOF TYPE BF APPLIED PART
• The combination of ISA and medical backboard device shall be considered a ME SYSTEM.
2.13.2. IRMA Mainstream CO2 Sensor

2.13.2.1. IRMA Overview and Setup
Figure 13: 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 13. 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 13.
• 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 13.
Avoid direct contact with the patient, and use insulation material if needed.
®
Section 3 Operation
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.
• 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 14.
Figure 14: 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 3 Operation
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 15.
Figure 15: Performing a Zero CO2 Sensor Calibration
2.13.2.2. 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 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.
®
Section 3 Operation
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.
2.13.3. ISA Sidestream CO2 Sensor

2.13.3.1. 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 16.
The ISA sensor comes with a side rail-mounting bracket as shown below in Figure 16
and allows for easy side rail mounting.
ISA
Mounting Sensor
Allen Bracket
Wrench
Slide ISA Sensor into

module rail mounting
bracket
Figure 16: Attaching the ISA Sidestream CO2 Sensor to the Ventilator
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Section 3 Operation
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.
Replace airway adapter if rainout/condensation occurs inside adapter.
The IRMA probe is not intended to be in patient contact.
If, for whatever the reason, the IRMA probe is in direct contact with any parts of
the infant’s body, an insulation material shall be placed between the IRMA probe
and the body.
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.
• Connect a Nomoline Family sampling line to the ISA analyzer input connector.
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.
2.13.3.2. 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.
®
Section 3 Operation
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).
Figure 17: Attaching the Sidestream CO2 Sensor and Sample Line
3. Operation
The eVolution ventilator must be operated only by clinicians qualified to assess
the patient’s condition and treatment.
3.1. Ventilator Controls
®
Section 3 Operation
Figure 18: eVolution 3e Front Panel
Action Keys Navigation Keys & Op LED’s

An illuminated LED at the top of the device
Standby Key Indicates indicates there is an active alarm.
This is in addition to the audible and on
Press then select to place the vent in Standby, return screen visual alarm.
to patient startup screen or cancel
On the Front Panel:

% O2 Increase Key
A green LED indicates Device is connected
Delivers 100% oxygen (Adult, Pedi) or 20% above to an AC power supply.
set O2 (Neonate) for 3 minutes and activates an
automatic calibration of the oxygen sensor
On the Front Panel:

Manual Breath Key
A red LED will illuminate with a vent inop
Delivers mandatory breaths
condition
Alarm Silence Key

Press once to silences currently active alarms for two minutes. Any new alarms will sound.
Press and Hold for 2 sec to silence all alarms for two minutes.
(Exception for Battery Too Low, Imminent Shutdown and Connect AC Now)
Touch screen or Knob turns to highlight fields and keys (current selections are highlighted), and pushing the knob
selects a field or confirms selections
3.1.1. Standby Key

Pressing the Standby Key will load the following selection screen.
®
Section 3 Operation
Figure 19: Standby Key Options
o Patient Setup: Selecting this option will stop ventilation and load the patient setup
screen.
o Standby: Selecting this option will stop ventilation, place the device in standby and
load the main screen. Standby displays in the upper left corner below the date and
time.
o Cancel: Selecting this option will close this screen, ventilation continues uninterrupted
and the previous screen will load.
3.1.2. 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 3 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.
After three minutes the delivered oxygen reverts to its original setting. Pressing 100% O2
before the interval is complete turns O2 ⬆ delivery off and the delivered oxygen reverts back
to its original setting. Oxygen related alarms are silenced during the 100% 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/Pedi patients only).
3.1.3. Manual Breath Key

Pressing the Manual Key delivers a mandatory breath during the next expiratory phase. A
Manual Breath indicator appears in the Status Bar when a manual breath is delivered.
During a manual breath, the patient cannot trigger a breath. For Mandatory patient
triggered breaths and Manual breaths a 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.
3.1.4. Alarm Silence Key

®
Section 3 Operation
Alarm Pause/Silence: Pressing the Alarm Silence Key silence key silences
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 remains latched on the display screen until
the condition is resolved. If a new alarm event occurs an alarm will sound and
display. Pressing the alarm silence key again will deactivate the current alarm
silence session.
Alarm Off: Pressing and holding the Alarm Silence Key for two seconds will
disable all alarms from sounding for two minutes. If a new alarm event occurs
no alarm will sound but all alarms will display. Pressing the alarm silence key
again will deactivate the Alarm Off session.
3.2. Cleaning Recommendations

Dampen a soft cloth with a nonabrasive glass cleaner and wipe down the screen of the
eVolution Ventilator after every use or as needed. See Section 6.2
• 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.
Preventive maintenance, cleaning and sterilization activities must be

conducted in accordance with the procedures and recommended intervals
detailed in this manual to ensure prolonged operation of the eVolution
ventilator.
3.3. Calibration
Prior to installation, the eVolution ventilator should receive a full system and touch screen
calibration for higher precision. For additional information, please refer to the eVolution
Technical Service Manual. See index for keyword calibration to view specific calibration
criteria. See Section 6.1 for additional information on system calibrations.
3.4. Start Up Process

When you turn on the ventilator, the Power Up screen appears briefly and you are
automatically taken to the Patient Selection Screen.
Figure 20: eVolution Power Up & Patient Setup Screen

®
Section 4 Graphical User Interface
4. Graphical User Interface

4.1. General Description
The user provides input to the eVolution ventilator’s microprocessor system through a touch
screen, membrane keys, and the press-and-turn knob.
The eVolution ventilator touch screen is an easy touch pressure-sensitive module.
4.2. Definitions and References

UI: User Interface
GUI: Graphical User Interface
TS: Touch Screen
PIB Product Information Bulletin
TIB Technical Information Bulletin
CIB Clinical Information Bulletin
The term Touch Screen refers to the front LCD screen of the eVolution, which is configured
with touch screen functionality.
The following information provides a general understanding of the touch screen functionality for
the eVolution ventilator.
4.3. Devices Affected

• eVolution 3e (Turbine) Part Number: EVL100500
• eVolution 3e (HP) Part Number: EVL100500-HP
• The eVolution when shipped will be configured with the latest software for that model.
• You must be familiar with using the touch screen and knobs to select, activate and
confirm parameters.
(For additional technical information, please refer to the eVolution Technical Service
manual)
4.4. Philosophy (User Interface)

4.4.1. Graphic User Interface Navigation
The top portion of the Touch Screen allows 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 21: Graphic User Interface
Graphic User Interface
Figure 22: Graphic User Interface, Mode Selection
Table 6: Home Screen Element Descriptions
Display & Setting Description
The Patient Type (Adult, Pediatric or Infant) is visible from all user screens and is displayed in
Patient Type 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 the ventilator is in Standby, the word Standby is displayed bold blue in the Current
Current Mode 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.
The Status Bar is used to display criteria based indicator icons which inform the user of
specific conditions or events as follows.
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
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.
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.
Cal Required Indicates that calibration is required
A Battery icon is displayed with % charge status in the event of AC power

disconnection as defined below.
Battery Icon Internal Battery Meter Icon: When the ventilator has lost AC power and
switches to internal DC power, the internal battery meter icon displays
and the current charge % level are shown on the Battery Icon.
The current date and time is visible from all user screens and is displayed in the top
Current Date and left 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 and positioned below the
Status Bar on the Home screen as well as all other user screens.
Navigation Tabs (Home, Settings, Alarms, Config)
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
High Priority Medium Priority Information Priority
Display
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.
Monitoring Bar © By default 5 monitored parameters are displayed on the Monitoring Bar. The
user can choose to have five (5) or eight (8) monitored parameters displayed
on the Monitoring Bar.
© The number of monitored parameters displayed on the Monitoring Bar can be
adjusted on the Config. screen Graphics page under Audio/Visual Monitors.
The Left display panel is visible from all user screens and is positioned to the Left of
the Right display panel. From the Home screen, user can click on Left Panel toggle
button and choose to display; P/F loop, P/V loop, F/V loop or the Maneuvers panel.
© Each screens Left panel is used to display different but specific selections for
that screen.
Left Display Panel
© The last selected left panel will remain selected until changed or New Patient is
started.
Loop Display (Line Colors)
© Mandatory breaths: (red = inspiration) and (light blue = exhalation)
© Spontaneous breaths: (yellow = inspiration) and (light blue = exhalation)
The Right display panel is visible from all user screens and is positioned to the right
of the left display panel. From the Home screen, user can view configurable options
of 1, 2 or 3 waveforms, or 1, 2 or 3 loops.
© User can use the right panel toggle buttons to choose the order of waveforms
Right Display Panel or loop display.
Waveform and Loop Display (Line Colors)
© Mandatory breaths: (red = inspiration) and (light blue = exhalation)
© Spontaneous breaths: (yellow = inspiration) and (light blue = exhalation)
The commonly adjusted settings specific to the current or selected proposed mode
Settings Bar are displayed on the settings bar and allow users quick access to change these
parameters.
®
To the right of the settings bar, the flowing action button options will be available as
described below.
START Button: At startup prior to mode activation from all user screens accept the
Current Settings screen, a grey START button will be displayed. Pressing the grey
START button will load the Current Setting Screen and the button will change to
green, indicating the mode can then be activated.
During ventilation, when selecting a new mode of ventilation from the Settings Tab,
the Proposed Settings screen loads and a green START button displays in the
START bottom right of the screen,
Note: There is a 2 minute timeout feature associated with non-activated mode
selections as follows:
© A mode selection (during ventilation or startup) will remain in the selected state
for 2 minutes post user interaction. If this 120 second time frame elapses
before the next user interaction, the Settings screen will revert back to the
Current or default mode and settings.
Once START is pressed or upon navigation away from the Proposed Settings
screen, the green START button will automatically change to the Unlock icon.
UNLOCK / LOCK: Once a mode is activated the Unlock button will display in its
place indicating the screen is not locked. Pressing the Unlock button locks the
LOCK / UNLOCK screen and the Lock button displays indicating the screen is locked. To unlock the
screen press the Lock button, the screen will unlock and the Unlock button will again
display.
Alarm Silence / Alarm Silence / Alarms Pause: The icons for Alarm Silence/Pause will display in
Alarms Pause the lower right hand corner of the screen.
4.4.2. 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 For controls with numerical values, turn the knob to the left to decrease the value or to
the right to increase the value.
o For controls with alpha (word) values, the knob can be turned in either direction to
cycle through the controls setting options.
4.4.2.1. Touch Screen Input Method 1
Touch (field boarder changes to green)
Change value (turn knob)
®
Accept value (touch field)
4.4.2.2. Touch Screen Input Method 2
Touch (field boarder changes to green)
Accept value (push knob)
4.4.3. 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)
®
Accept value (push knob)
4.4.4. Linked / Dependent Control Settings

A setting that displays the eVent logo indicates that it is linked to one or more other
setting(s). For example (Figure 23), nebulizer time is linked to whether the nebulizer is on or
off. Nebulizer time can be selected and adjusted if the nebulizer is off but will switch back to
the eVent Logo once the change is accepted. When the Nebulizer is activated (set to On)
the linked / dependent setting value will display and provides an additional visual indication
the feature has been activated.
Figure 23: Linked / Dependent Control Settings
4.5. Safety
4.5.1. Screen Display Defaults to Main Screen (2 minute rule)
During ventilation, the ventilator’s UI display will automatically change to the Home Screen
two minutes (120 seconds) post user interaction. This rule applies to all ventilation
screens/windows with the exception of those listed below.
Screens/Windows excluded from 2-minute rule
ð SCREENS (excluded) ð WINDOWS/MENUS (excluded)
Home All Home Screen windows
Monitoring All Monitoring Data windows
Engineering All Trend Data windows
During Standby: Prior to mode activation, the ventilator will be in the Standby mode. While
in Standby, the graphics panel on the Home screen will display the standby safety message
(Standby NOT Ventilating!) as shown below in Figure 24. While the ventilator is in Standby,
the ventilator’s UI display will automatically change to the Home screen two minutes (120
®
seconds) post user interaction. This ensures the Standby NOT Ventilating! message as
shown below is displayed to the user.
Figure 24: Standby Not Ventilating (Safety Message)
This means while the ventilator is in Standby, if the user navigates to any non-engineering
screen, the screen will automatically change to the Home screen two minutes (120 seconds)
post user interaction.
Once the user activates ventilation, the Home screen functionality returns to normal as
defined above. If the user places the ventilator back into the Standby mode this message
will display on the Home screen graphics right panel and the Standby two minute rule
applies.
4.5.2. Time Outs and Unaccepted Changes

The eVolution ventilator has an automatic timeout safety feature and return to previous
settings to prevent accidental or unaccepted changes.
4.5.2.1. Timeouts
A mode selection (during ventilation or startup) will remain in the selected state for 60
seconds post user interaction. If this 60 second time frame elapses before the next
user interaction, the Settings screen will revert back 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.
4.5.2.2. 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).
4.5.3. Control Setting Limit (Soft Boundary) Feature

Specific controls have been updated with a setting value (soft boundary) limitation. 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 a
adjusted to a higher value.
o The Control Setting Limit (Soft Boundary) applies to PEEP, Pcontrol, Psupport, Plow,
Phigh, Psup Low and Psup High setting controls. Because the eVolution 3e
Ventilators are PEEP compensated, as PEEP is increased the Control Setting Limit
(Soft Boundary) for Pcontrol will change based on the PEEP setting. The SPAP
specific control Plow and Psup Low as well as Phigh and Psup High also have this
dependent relationship.
o As defined below in Table 7, the Control Setting Limit (Soft Boundary) for each setting
®
is provided.
§ The Soft Boundary will be reached when one of the applicable controls is
selected and adjusted to a value of:
Table 7: Soft Boundary Setting Limit

Control A Control B Soft Boundary
PEEP + Pcontrol = 50 cmH2O
PEEP + Psupport = 50 cmH2O
Plow + Psup low = 50 cmH2O
Phigh + Psup high = 50 cmH2O
4.5.3.1. When the user selects one of the setting controls, the control will display
in its selected state with the following visual markers.
• A WHITE arrow will display on the controls green border
• A Soft Boundary ORANGE line will display on the controls green border
• A Max Boundary RED line will display on the controls green border
Figure 25: Control Setting Limit (Soft Boundary) Feature
4.5.3.2. WHITE Arrow

• The WHITE arrows position along the green border when the control is selected and
adjusted will be relative to the controls setting value.
o This means as the control is adjusted, the WHITE arrow will move along the
green border in relation to the controls setting value.
4.5.3.3. Soft Boundary ORANGE Line
• The Soft Boundary setting limit (ORANGE line) for Control A and Control B
depends on each controls setting value at the time the other control is adjusted and
the Soft Boundary will be reached when either setting reaches (Control A +
Control B = 50 cmH2O). For Example:
o If PEEP is set at 20 cmH2O and Pcontrol is also set to 20 cmH2O
§ When the user selects PEEP, the soft boundary setting limit for PEEP
would be 30 cmH2O. Because PEEP (30) + Pcontrol (20) = 50 cmH2O
(30 + 20 = 50).
§ Using the same example for Pcontrol, (if PEEP is set to 20 cmH2O):
When the user selects Pcontrol, the soft boundary setting limit for
Pcontrol would be 30 cmH2O. Because PEEP (20) + Pcontrol (30) = 50
cmH2O (20 + 30 = 50).
4.5.3.4. Max Boundary RED Line
• Max Boundary RED Line
o Similar to the Soft Boundary, the Max Boundary setting limit (RED Line) will
display along the green border relative to that controls maximum setting limit.
The maximum setting limit for any control is the point at which the setting value
®
cannot be increased any further. The Max Boundary setting limits are as a
follows.
Table 8: Max Boundary Setting Limit

Control A Max Boundary Setting Limit
PEEP 50 cmH2O or (90 – Pcontrol) or (90 – Psupport) whichever is smaller
Plow 50 cmH2O or 0 to Phigh AND 0 to (90 – Psup low)
Phigh 50 cmH2O or Plow to 50 AND 5 to (90 – Psup high)
Pcontrol 90 cmH2O or (90 – PEEP) whichever is smaller
Psupport 90 cmH2O or (90 – PEEP) whichever is smaller
Psup low 90 cmH2O or (90 – Plow) whichever is smaller
Psup high 90 cmH2O or (90 – Phigh) whichever is smaller
4.5.3.5. When the controls soft boundary is reached

• The control settings value will stop at the soft boundary and cannot be increased
above the soft boundary until 2 seconds has elapsed.
• The WHITE arrow will change to an ORANGE arrow and will remain ORANGE while
at the Soft Boundary. The arrow will change back to WHITE once it has moved
passed the soft boundary.
• If the user adjusts the control setting value equal to the soft boundary and does not
try to exceed the soft boundary setting limit, no beep will sound and the user can
accept the current setting if desired.
• If the user attempts to adjust the control setting to a value greater than the soft
boundary setting limit:
o the setting value will remain equal to the soft boundary setting limit for 2
seconds. After 2 seconds has elapsed, the controls setting values can be
adjusted to a value greater than the soft boundary.
o the System will make a low priority alarm beep sound as follows:
§ The first (initial) BEEP will sound at (Soft Boundary + 1 click-turn of the
Rotary Knob) and then another beep will sound every 1 click/turn of the
knob.
4.5.3.6. When the controls Max boundary is reached
• The control settings value will stop at the max boundary and cannot be increased
above the max boundary.
• The WHITE arrow will change to a RED arrow and will remain RED while at the Max
Boundary. The arrow will change back to WHITE once it has moved off the Max
boundary.
4.5.4. 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
impact the functionality of the Touch Screen. Use your finger or a special pen with a
rounded point.
The Touch Screen is a resistive 4-wire type, and, therefore, it is fully functional with any
gloves the user may wear.
®
Section 5 Ventilator Set Up
5. Ventilator Set Up
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. Power Up Screen

The welcome screen displays the current software and hardware versions of the ventilator.
• WELCOME
SCREEN
• eVent Medical Logo
• eVolution Ventilator
Logo
• Bars of arch light up
one by one from
small to large and
are timed with boot-
up sequence
• Indicated Self Test
in progress
• SW Version Number
• FPGA Version
Figure 26: Power Up Screen
5.2. Patient Selection Screen - New Patient and Previous Patient
Figure 27: Patient Selection Screen – Startup Screen
®
Table 9: Patient Selection – New Settings

Setting Description
Patient Option Selection Options:
ü New
ü Previous.
Ideal Body Weight Calculator Patient Height and Gender are used to automatically calculate the
patients Ideal Body Weight.
IBW can be manually set by the user if desired.
Humidification Type Selection Options:
ü HME
ü Humidifier
ü None
Pre-Patient Tests Circuit tubing compliance and circuit leak test are done
Calibrations Additional calibrations can be performed:
(see sections 3.3 and 6.1 for ü Exhalation Flow Sensor Zero
additional calibration ü System Test
instructions)
ü O2 Sensor
ü Exhalation Flow Sensor Calibration
Accept Takes user to Settings screen
5.2.1. Patient Option and Patient Setup

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 or you can enter
the IBW manually. The initial default ventilator settings are based on calculated or manually
entered IBW.
Figure 28: New Patient Startup screen
New patient: An Ideal Body Weight Must be Entered
For New Patient Startup, IBW is a required setting that must be entered before the Home
screen will load.
As shown below in Figure 29, pressing the ACCEPT button without establishing or manually
entering an IBW will result in the below message being displayed in the right panel above
®
the ACCEPT button. The IBW is used to establish initial ventilator and alarm settings and
therefore is required before the settings screen will load.
Figure 29: IBW Patient Startup screen
Previous patient:
Retains ventilator parameters at previous settings based on saved input. Ideal Body Weight
and Humidification setting can be verified and changed here if necessary. User may also
access and perform calibrations; Exhalation Flow Sensor Calibration, Systems Test and O2
Sensor Calibration at this time.
Figure 30: Previous Patient Startup screen
5.2.2. Ideal Body Weight Calculator

Inputs for patient height and gender are used to calculate Ideal Body Weight or IBW can be
manually set by the user.
®
Figure 31: Ideal Body Weight screen
5.2.3. Humidification Type

User can select humidity type:
Figure 32: Humidification Type Selection Option
5.2.4. Pre-Patient Tests

Takes user to the Pre-patient Test screen where you can perform the following.
o Tubing Compliance and Leak test
o An automatic zeroing of the exhalation flow sensor is also performed
o “Back button” takes you to the Previous Screen
Pre-Patient System Tests will take approximately 20 seconds.
Figure 33: Pre-Patient System Tests
®
5.2.5. Calibrations
Takes user to the Calibration options screen where you can perform the following:
o Zero Flow Sensor: zeroing of the exhalation flow sensor
o System Tests: Tubing Compliance and Leak test
o O2 Sensor Cal.: Calibrates the O2 Sensor
o EXH Flow Sensor: performs a complete calibration of the flow sensor
Figure 34: Calibration Options
See sections 3.3 and 6.1 for additional calibration instructions.
• It is recommended to perform both, O2 Sensor Calibration and EXH Flow

Sensor Calibration when replacing the O2 Sensor or Flow Sensor, respectively.
5.2.6. 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.
5.3. Settings Tab

5.3.1. Current Settings Screen
At Startup or resuming from Standby, the Current Settings screen will be displayed as
shown below.
®
Figure 35: Current Settings Screen
5.3.2. Proposed Settings Screen

During ventilation is a new Mode Selection button or the Mode Type button is pressed, the
Proposed Settings screen will load as show below.
Figure 36: Proposed Settings Screen
®
Setting Description
Mode Settings Panel Set mode CMV → P-CMV or V-CMV or PRVC-CMV; SIMV →P-SIMV
or V-SIMV or PRVC-SIMV; SPONT → PS or VS or SPAP
Current Settings Panel Set advanced parameter settings (parameters displayed dependent
on mode selected) Includes Smart Nebulizer, Sigh, Tube Comp. and
Apnea Backup.
Basic Parameter Setting Bar

Set basic parameter settings (parameters displayed are dependent
on mode selected)
Monitored Patient Parameters
Bar Display five (5) or eight (8) user-selectable monitoring values.
START Initiates ventilation on user set parameters, switches to Home Screen
Table 10: Settings Description
5.3.3. Choosing a Mode and Breath Type

To choose a Mode, user selects CMV, or SIMV, or SPONT, or Hi FlowO2 from the Mode
Setting Panel.
Once the Mode is selected, user selects breath type desired: Pressure (P), Volume (V),
Pressure Regulated Volume (PRVC), Pressure Support (PS), Volume Support (VS) or
Spontaneous Positive Airway Pressure (SPAP).
Neonate patient type

Figure 37: Mode Type / Mode Selections
Once the Mode and Breath Type are selected, review and adjust all settings
(Current/Proposed, Apnea Backup and Alarm settings) as required. Only the setting
applicable to the selected mode will be displayed.
The user must select desired advanced parameter settings from the Advanced Parameter
panel, and the desired basic parameter settings from the basic parameter 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 back the previous settings.
®
5.3.4. Right Panel: Current & Proposed Settings Selections

Parameter Definition Range
Auto Control Auto Control is a feature in which the eVolution ventilator On or Off
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. See section 10 (Theory of Operation) for a more
detailed description.
Auto Control Auto Control Time sets the length of time with no 3 – 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.
Smart The Nebulizer generates flow, When the nebulizer is active, User selected
TM
Nebulizer gas delivery to the patient is compensated to ensure that Nebulizer time (Off, 1
breath parameters (volume, flow and FIO2) are not affected. to 480 min, increments
of 1 min. Default 20
min)
User selected interval
time (Off, 1 to 480 min,
increments of 1 min)
TM
Smart SIgh The eVolution ventilators include a sigh feature that allows Sigh On or Off
sigh breaths to be delivered at a user-defined frequency, Sigh Factor 0 to 50%
number and breath amplitude. of volume or pressure
setting
Sigh Interval: 20 to
200 breaths
Number of sighs: 1 to
6
Apnea Backup A function that provides backup ventilation after the set On or Off
apnea time has been reached without breath triggering
attempts. If Apnea Backup has been set to Off, then the will
be triggered based on the Apnea time setting.
User Selectable Modes:
P-CMV, V-CMV and PRVC-CMV
Esens Exhalation trigger sensitivity. The percent of peak inspiratory 1 – 80 % of peak flow
flow at which the ventilator cycles from inspiration to
exhalation
Applies to spontaneous breaths.
Flow Pat Sets the Inspiratory Flow pattern for breath delivery. Applies Square, Decel 50%,
to Volume Control mandatory breaths only. Decelerating
Trigger User can select Flow trigger or Pressure Trigger. Flow or Pressure
H:L An SPAP setting that defines a ratio of time at high and low 1:59 to 59:1
PEEP levels.
Applies to SPAP mode only: Cycle + Ratio
NIV An advanced parameter setting in all modes that allows user On or Off
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 0.5 to 5.0 s
based breaths. PS Tmax functions as the inspiration
termination criteria for all PS based breaths. PS Pediatric:
breaths when delivered will terminate by flow, pressure 0.5 to 5.0 s
and time. Whichever termination criterion is met first
Neonate:
will cause the PS breath to cycle to exhalation. 0.15 to 3.0 s
NOTE: 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.
Rise time Rise time or ramp speed controls the time required for 1 to 20
inspiratory pressure to rise to the set (target) pressure. 1 = Slow and
Applies to all pressure breaths; P-CMV, P-SIMV, PS, SPAP, 20 = Fast
PRVC-CMV, PRVC-SIMV, VS
SPAP Type Sets configuration for SPAP ventilation settings Time Only,
Cycle + Time,
Cycle + Ratio
Ventilator will automatically compensate for baseline leaks On or Off
during ventilation
Leak If ON and NIV is set to Off the eVolution 3e will 0 to 25 l/min
Compensation compensate for leaks automatically from:
If ON and NIV is set to ON the eVolution 3e will 0 to 60 l/min
Base Flow Available ONLY if Leak Compensation is set to Off. Sets the Base Flow = 3Lpm +
base flow available in the system for flow triggering. Ftrig settings
Table 11: Right Panel: Current & Proposed Setting Selections
5.3.5. Setting Bar: Current & Proposed Settings Selections

Cycle This is an SPAP (dual PEEP mode) setting that specifies how Adult:
many times per minute the ventilator will cycle from low 1 to 60 c/min
PEEP to high PEEP. Transitions between high and low
PEEP levels are synchronized with the patient’s spontaneous Pediatric:
respirations. 1 to 120 c/min
Applies to SPAP mode only: Cycle + Time and Cycle + Ratio
Neonate:
1 to 150 c/min
Oxygen Oxygen concentration to be delivered. 21 to 100 %
(%) Applies to all breaths in all modes.
Pcontrol Pressure above PEEP to be applied during the inspiratory 1 to 100 cmH2O or
phase. 2 to (100 cmH2O –
Applies to mandatory breaths in P-CMV and P-SIMV PEEP),
whichever is less
Flow Peak inspiratory flow setting. Adult:
Applies to volume-controlled mandatory breaths in V-CMV 1 to 120 l/min
and V-SIMV
Pediatric:
1 to 90 l/min
Neonate:
1 to 60 l/min
®

Ftrig Flow trigger sets the patient inspiratory flow that triggers a Adult:
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 Pediatric:
vary when automatic leak compensation is On 0.1 to 15.0 l/min
NOTE: Adjusting Ftrig changes ventilator sensitivity to patient
effort. In case of auto-triggering, check the ventilator and Neonate:
breathing circuit before increasing the Ftrig setting. 0.1 to 10.0 l/min
Ptrig Pressure trigger sets the patient inspiratory pressure that Adult:
triggers a breath. Applies to all modes except NCPAP+. 0.2 to 20.0 cmH2O
NOTE: Adjusting Ptrig changes ventilator sensitivity to patient
effort. In case of auto-triggering, check the ventilator and Pediatric:
breathing circuit before increasing the Ptrig setting. 0.2 to 15.0 cmH2O
Neonate:
0.1 to 10.0 cmH2O
PEEP/CPAP PEEP (positive end expiratory pressure) and CPAP 0 to 50 cmH2O or
(continuous positive airway pressure), baseline pressures 0 to (90 cmH2O –
applied during the expiratory phase. Pcontrol, Psupport),
Applies to all breaths in all modes except SPAP whichever is less
Phigh Sets the value of the baseline pressure during Thigh. Applies 5 to 50 cmH2O or
to SPAP mode only. Plow to 50 cmH2O or
5 to (90 - Psup high)
Pause Sets the time (in seconds) that inspiration is paused after set 0 to 2 sec
tidal volume has been delivered. Applies to Volume Control
mandatory breaths only.
Plow Sets the value of the baseline pressure during Tlow. 0 to 50 cmH2O or
0 to Phigh or
Applies to SPAP mode only. 0 to (100 - Psup low)
Psup high A positive airway pressure setting in SPAP. Pressure (above 0 to 100 cmH2O or
Phigh) to be applied to a patient-triggered breath during the 0 to (100 - Phigh)
Thigh phase in SPAP. Applies to all Thigh cycles in SPAP whichever is less
mode. Phigh + Psup High will not exceed 90 cmH2O
Psup low A positive airway pressure setting in SPAP. Pressure (above 0 to 90 cmH2O or
Plow) to be applied to a patient-triggered breath during the 0 to (90 - Plow)
Tlow phase in SPAP. Applies to all Tlow cycles in SPAP whichever is less
mode. Plow + Psup Low will not exceed 90 cmH2O
Psupport Pressure (above PEEP/CPAP) to be applied to a patient 0 to 100 cmH2O or
triggered breath during the inspiratory phase. 0 to (100 cmH2O –
Applies to spontaneous breaths in SIMV and PS modes. PEEP),
whichever is less
Rate Respiratory rate sets the number of mandatory breaths Adult:
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
Thigh Duration of Phigh airway pressure level. 0.1 to (60 - Tlow
Applies to all Phigh phases in SPAP setting)
Ti Set inspiratory time allowed to deliver a mandatory breath. 0.1 to 10.0 sec
Applies to P-CMV, P-SIMV, PRVC-CMV and PRVC-SIMV
breaths only.
®

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

Applies to volume controlled or volume targeted breaths only: 300 to 3000 ml
V-CMV, V-SIMV, PRVC-CMV, PRVC-SIMV, VS.
Pediatric:
20 to 500 ml
Neonate:
5 to 100 ml
+O2 Available only in Apnea Backup settings. Sets the FiO2 used 10-80 %
during Apnea Backup. FiO2 delivered equals Current FiO2
plus number chosen in +02 setting.
Table 12: Setting Bar: Setting Selections
5.3.6. Smart Nebulizer™

Select Smart Nebulizer under the Settings Tab. The Smart Nebulizer screen allows you to;
o Turn the Nebulizer On/Off
o Set the Nebulization Time
o Set a Nebulization Interval On/Off
§ Set an Interval Time (this is the time to elapse between
nebulizations)
Figure 38: Nebulizer Screen
• The nebulizer is Volume and Flow compensated only, FiO2 is compensated +/- 10 %
during nebulizer use.
• Optional Blower Base System: The nebulizer function is not available when high
pressure O2 is not available. The nebulizer is Volume and Flow compensated only,
FiO2 is not compensated during nebulizer use.
®
During the nebulization time, the nebulizer valve opens synchronous to inspiration to
provide pressure for an external medication nebulizer.
The nebulizer jet driveline and disk filter attach to the Nebulizer nipple connector on the
ventilator front panel. Section 5.3.6 of this manual describes how to operate the nebulizer.
The Nebulizer outlet provides a pressure of 14 to 22 psi, which generates a nebulizer flow of
6 l/min. The nebulizer function is not active when low flow O2 is being used. High pressure
Oxygen is required to power the nebulizer. The nebulizer is volume and flow compensated.
In all modes, inspired tidal volume (Vti) is calculated from delivered volume (Vtd)
compensated by tubing compliance volume and nebulizer volume in real time as follows:
o Vti = Vtd – Vcompliance + Vnebulizer
Smart Nebulizer feature will be disabled and the “Nebulizer Not Available” information
message will display to the user when:
o the High pressure oxygen supply is not available
o or In V-Modes and VTV-Modes if
§ Vt setting – Vnebulizer + Vcompliance = < 100ml
o During nebulizer activation or use when delivered flow drops below 5 l/min.
5.3.7. Smart Sigh™

Select the Smart Sigh key under the Settings Tab. User may configure the following;
o Turn the Sigh Function On/Off
o Choose a Sigh Factor, 0–50% (breath type is based on current ventilator breath type)
o Set a Sigh Interval, every 20-200 breaths
o Choose number of sighs breaths to be delivered, 1-6
Figure 39: Smart Sigh Section
5.3.8. Trend Data Settings

Select Trend Data Settings under the Home Tab. The Trend Data Settings screen allows
you to;
o Select the number of Trend graphs to display on the Trend Screen.
o Insert Event markers
®
o Check Events
o Change to specific Trend
Figure 40: Trend Data Settings
5.3.9. Tube Compensation (optional software)

Tube Compensation (TC) compensates for the resistance associated with an artificial airway
(ETT or Trach tube) by continuously calculating tracheal pressure. TC unloads the
resistance imposed by the breathing tube during inspiration by increasing the airway
pressure (if necessary).
When TC is activated, the ventilator automatically calculates the pressure drop across the
breathing tube. The ventilator then adjusts the airway pressure to deliver the set pressure
(PC or PS setting) to the distal (carinal) end of the breathing tube.
TC is accessed from the “Settings” tab. Caregiver is required to set:

• TC “On/Off”
• Tube Type (ETT or Trach)
• Tube I.D.
• TC % (amount of calculated resistance to be compensated)
Figure 42: Tube Compensation Settings
TC default selections are as follows:
• TC: Off
• Tube Type: ETT
• Tube Diameter (new patient):
o IBW 0.2 – 5 kg* 3.0 mm (allowable range 2.0 – 6.0)
o IBW 5.1 – 10 kg 4.0 mm (allowable range 3.0 – 8.0)
o IBW 11 – 40 kg 5.0 mm (allowable range 4.0 – 8.0)
o IBW > 40 kg 7.5 mm (allowable range 5.0 – 10.0)
• TC Factor: 80%
TC is applied to pressure targeted breaths (PC, PRVC, PS, VS, SPONT). The Pressure
®
waveform will display both airway pressure (solid line) and calculated tracheal pressure
(dotted line). Both pressure waveforms will also be displayed for volume control breaths,
but no compensation is applied.
Maximum pressure for a TC breath is: (1)

o 30 cmH2O above CPAP or PC/PS setting
OR
o 5 cmH2O below the High Pressure Alarm (Ppeak) setting.
A dotted line will be displayed 5 cmH2O below the High Pressure Alarm setting to
represent the pressure limit for TC breaths (based on alarm setting).
Figure 43: Tube Compensation Waveform
5.3.10. Activating Ventilation

Once the parameter selections / adjustments have been made, the user must press the
START button to start ventilation. Once ventilation is activated, the HOME screen will
automatically display.
5.3.11. Auto Control Settings

Auto Control is a special feature available in all CMV modes that provide 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 an intelligent strategy for earlier 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.
Figure 44: Current Settings Screen
®
The application of this ventilator strategy may be beneficial in effectively and efficiently
liberating patients from the ventilator.
Auto Control utilizes standard ventilation modes already in use to provide a means of
ventilating patients who have variable but often depressed respiratory drive in a more safe
and synchronous manner. Users can select Auto Control On as an alternative to apnea
ventilation.
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, exceeding the set Auto Control time interval, the ventilator
switches from the spontaneous mode back to the original CMV mode without alarming.
o Mode Transitions When Auto Control is On:
§ P–CMV – transitions to - PS – transitions to – P–CMV
§ V–CMV – transitions to - VS – transitions to – V–CMV
§ PRVC–CMV – transitions to - VS – transitions to – PRVC–CMV
PRVC–CMV VS P–CMV PS V–CMV VS
Current Related Current Related Current Related
Settings Settings Settings Settings Settings Settings
O 2: O 2: O 2: O 2: O2 O 2:
Rate: Rate: Rate: Rate: Rate Rate:
Vt: Vt: Ti: Ti: Vt Vt:
Ti: Ti: PEEP: PEEP: PEEP Ti:
PEEP: PEEP: Pcontrol: Pcontrol: Psupport Pcontrol:
Ftrig: Based Ftrig: Based Psupport: Psupport: Flow Psupport:
on on
Ptrig: Ptrig: Ftrig: Based Ftrig: Based Ftrig: Based Ftrig: Based
Trigger Trigger
on on on on
type type Ptrig: Ptrig: Ptrig: Ptrig:
Trigger Trigger Trigger Trigger
Esens: Esens: type type type type
Rise Time Rise Time Esens Esens Esens Esens
Trigger: Trigger: Rise Time: Rise Time: Rise Time Rise Time
NIV: NIV:
Trigger: Trigger: Flow Pat. Flow Pat.
PS Tmax PS Tmax
NIV: NIV: Trigger Trigger
Auto Control: Auto Control:
PS Tmax PS Tmax NIV NIV
Auto Control Auto Control
time: time: Auto Control: Auto Control: Pause PS Tmax
Leak Comp: Leak Comp: Auto Control Auto Control Auto Control Auto Control
time: time: Auto Control Auto Control
Leak Comp: Leak Comp: Time Time
Leak Comp. Leak Comp.
Figure 45: Auto Control Mode Transitions
Auto Control Time interval is the user adjustable apnea time limit in Auto Control). Auto
Control time intervals are typically set significantly shorter than typical apnea backup time
intervals since the goal of Auto Control is to allow a seamless transition between the CMV
mode and spontaneous mode and help reduce the need for staff intervention as breathing
drive changes.
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 turns apnea ventilation
Off automatically. If Auto Control is deactivated, apnea ventilation is automatically turned
back on.
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
5.4. Home TAB
Figure 46: Home Tab
Setting Description
Patient Type The current Patient Type is displayed above the current mode
Current Mode The current ventilation mode is displayed
Patient Effort / Trigger A round information icon is located to the right of the current mode
Indicator displays patient triggered breaths and manual breaths.
Status Bar The displays specific conditions or events
Battery Icon A Battery icon is displayed when AC power is disconnect
Current Date and Time The current date and time is displayed on the top left
Navigation Tabs The navigation tabs to access the Home, Settings, Alarms and
Config screen display below the Status Bar.
Alarm Bar The Alarm Bar displays active or latched (inactive) alarms in order
by priority from right to left.
Monitoring Bar The monitoring bar displays five, eight or ten patient monitored
parameters
Left Display Panel The Left display panel displays P/V loop, F/V loop, P/F loop or
Maneuvers
Right Display Panel The Right display panel displays 1, 2 or 3 waveforms
Settings Bar The commonly adjusted settings specific to the current or selected
proposed mode
START START Button to start ventilation
LOCK / UNLOCK LOCK / UNLOCK: Pressing the LOCK button locks the screen and
pressing the UNLOCK button unlocks the screen
Table 13: Home Tab Descriptions
5.5. Data TAB
®
Figure 47: Data Tab
Setting Description
Monitoring Data Allows user to view 3 tabs of monitored data; Basic, Advanced and
Mechanics
Table 14: Monitoring Tab Descriptions
5.5.1. Monitored Data: Parameters and Definitions

See section 9 for additional monitoring parameter information
Table 15: Data Parameter Definitions

Parameter Definition Unit
Ppeak Measured peak airway pressure cmH2O
Pmean Measured average airway pressure during inspiration cmH2O
PEEP Measured positive end expiratory pressure cmH2O
®

Vti Inspiratory tidal volume, measured ml
Vte Expiratory tidal volume, measured ml
Vte Sp. Spontaneous Expiratory tidal volume, measured ml

volume of air exhaled during spontaneous breaths
only
Ve Minute ventilation, measured volume of air delivered l/min
over one minute, mandatory and spontaneous
breaths included
Ve Spont Spontaneous minute ventilation, measured volume of l/min
air delivered during spontaneous breaths only
Rate Measured number of breaths over one minute, b/min
includes mandatory and spontaneous breaths
Rate Sp. Measured number of spontaneous breaths delivered b/min
over one minute
Ti Measured Inspiratory Time s
Te Measured Expiratory Time s
Leak Measured leak flow displayed as a percentage %
PF Peak Inspiratory Flow l/min
PFe Peak Expiratory Flow l/min
O2 Fraction of Inspired Oxygen %
I:E Ratio of inspiratory time to expiratory time xx:xx
H:L Ratio of Time High to Time Low in SPAP xx:xx
Ti/Ttot Ratio of Inspiratory time to Total respiratory cycle %
time
Spont % 1h Ratio of spontaneous respiratory rate to total %
respiratory rate over the previous one hour
Spont % 8h Ratio of spontaneous respiratory rate to total %
respiratory rate over the previous eight hours
Cstat Static compliance ml/cmH2O
Auto PEEP A measure of residual pressure at end exhalation cmH2O
Rinsp Inspiratory flow resistance cmH2O/l/s
Rexp Expiratory flow resistance cmH2O/l/s
Pplateau Plateau pressure cmH2O
RSBI Rapid Shallow Breathing Index b/min/l
P0.1 Airway Occlusion Pressure during the first 100ms cmH2O
PiMax Maximum negative inspiratory pressure against an cmH2O
occluded airway (cmH2O), an indicator of inspiratory
muscle strength. Not available for neonatal/infant
patients.
®

P0.1 / PiMax Airway occlusion pressure (P0.1) divided by maximal %
inspiratory pressure (%).
This is 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.
RCe Expiratory Time Constant s
WOBimp Work of Breathing Imposed j/l
• All monitored spirometry measurements are corrected and displayed in BTPS

units.
5.5.2. Trended Data
Figure 48: Trending Waveform and Parameter Selection Screens
Setting Description
Trend Data Allows user to view 1, 2 or 3 trend graphs of any of 24 selectable trended
parameters as shown below.
Table 16: Trend Screen Setting Descriptions
5.5.2.1. Trended Parameters
Table 17: Trend Parameters
Y Axis Y Axis
Trends Label
Units
Trends Label
Units
Peak Pressure Ppeak cmH2O Expiratory Time Te s
Plateau Pressure Pplateau cmH2O Leak Leak %
Mean Airway Pressure Pmean cmH2O Static Compliance Cstat ml/cmH2O
®
Table 17: Trend Parameters
Y Axis Y Axis
Trends Label
Units
Trends Label
Units
Positive End Expiratory

PEEP cmH2O Inspiratory Resistance Rinsp cmH2O/l/s
Pressure
Inspired Tidal Volume Vti ml Expiratory Resistance Rexp cmH2O/l/s
Exhaled Tidal Volume Vte ml Oxygen O2 %
Minute Volume Ve l/min Peak Flow Rate PF l/min
Spontaneous Minute
Ve Spont l/min Expired Peak Flow Rate PFe l/min
Volume
Spontaneous Exh Tidal Rapid Shallow Breathing
Vte Spont l/min RSBI b/min/l
Volume Index
Inspiratory Time to Total
Respiratory Rate Rate b/min Ti/Ttot %
Breath Duration
Spontaneous Expiratory Time
Rate Spont b/min RCe s
Respiratory Rate Constant
Work of Breathing
Inspiratory Time Ti s WOBimp
Imposed
5.6. Alarms TAB
Figure 49: Alarms Screen
Setting Description
Alarms Settings Set appropriate alarm parameters.
Auto Set Sets upper and lower limits automatically based on current measured
parameters
Table 18: Alarms Settings Descriptions
5.6.1. Alarm Auto Set Feature

Sets upper and lower limits automatically based on Setting and current measured
parameters
®
o For NCPAP+ mode, the Auto Set Alarm feature has no affect because all settable
alarms on the Alarms screen are disabled in NCPAP+ Mode.
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 volume) During Standby, Ve High and Vi High
+ 50%, alarm setting will only be updated if
All other modes: monitored Exp Min Vol + 50% Current Settings mode is V-CMV.
Vi High
All other modes no adjustment will be
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
Current Settings mode is V-CMV.
Vi Low All other modes: monitored Exp Min Vol - 50%
made.
Vte High Automatic limits: (V-CMV, V-SIMV, PRVC-CMV, PRVC- During Standby, Vte High alarm
SIMV, VS: Set tidal volume + 50%), setting will only be updated if Current
All other modes: monitored tidal volume + 50% Settings mode is V-CMV, PRVC-
CMV, V-SIMV, PRVC-SIMV or VS.
Uses inspiratory tidal volume (Vti) if Exh flow sensor is
disabled. All other modes no adjustment will be
If Vte / Vti High alarm limit is set to OFF, Auto Set feature made.
will not change Vte / Vti High alarm limit.
Vte Low Automatic limits: (V-CMV, V-SIMV, PRVC-CMV, PRVC- During Standby, Vte Low alarm
SIMV, VS: Set tidal volume - 50%), setting will only be updated if Current
All other modes: monitored tidal volume - 50% Settings mode is V-CMV, PRVC-
CMV, V-SIMV, PRVC-SIMV or VS.
Uses inspiratory tidal volume (Vti) if Exh flow sensor is
disabled. All other modes no adjustment will be
made.
Rate High Automatic limits: (V-CMV, P-CMV, PRVC-CMV: set rate + During Standby, Rate High alarm
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.
made.
Rate Low Automatic limits: (V-CMV, P-CMV, PRVC-CMV: Set rate - During Standby, Rate Low alarm
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.
made.
Ppeak High Automatic limits: (V-CMV, V-SIMV, PRVC-CMV, PRVC- During Standby, Ppeak High alarm
SIMV, VS: monitored Ppeak + 10 cmH20), (P-CMV, P- setting will only be updated if Current
SIMV: set Pcontrol + set PEEP + 10 cmH20), Settings mode is P-CMV, P-SIMV,
(PS: set Psupport + set PEEP + 10 cmH20), PS or SPAP.
(SPAP: set Phigh + Psup high + 10 cmH2O) All other modes no adjustment will be
made.
Ppeak Low Automatic limit (all modes): set PEEP +1 cmH20, (SPAP: During Standby, Ppeak Low alarm
set Plow +1cmH2O) will be updated as defined.
PEEP High Automatic limits (all modes): set PEEP + 3 cmH20, During Standby, PEEP High alarm
(SPAP: set Phigh +3cmH2O) will be updated as defined.
PEEP Low Automatic limits (all modes): set PEEP - 2 cmH20, (SPAP: During Standby, PEEP Low alarm will
set Plow be updated as defined.
-2cmH2O)
®
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
Pmean High Automatic limits: + 10 cmH2O from measured Pmean During Standby, Auto Set feature
does not change Pmean High.
Pmean Low Automatic limits: - 10 cmH2O from measured Pmean During Standby, Auto Set feature
does not change Pmean Low.
Leak Auto Set feature does not change Leak alarm limit. During Standby, Auto Set feature
does not change Leak alarm limit.
Tapnea Auto Set feature does not change Apnea time limit. During Standby, Auto Set feature
Vti Limit Auto Set feature does not change Vti limit. During Standby, Auto Set feature
5.6.2. Alarm Setting Parameters

You can access alarm limit settings under the Alarms Tab. The Alarm limits screen shows
the current alarm limits and allows you to make changes. The minimums and maximums of
the individual alarm limits are related (the minimum limit is always smaller than the
maximum limit).
• Ventilator software automatically sets high and low oxygen % alarms at 7%

above and below the FIO2 setting. This is an internal (invisible) setting.

Ve High Minute Volume High Alarm Limit l/min
Ve Low Minute Volume Low Alarm Limit l/min
Vte High Exhaled Tidal Volume High Alarm Limit ml
Vte Low Exhaled Tidal Volume Low Alarm Limit ml
Rate high Respiratory Rate High Alarm Limit b/min
Rate low Respiratory Rate Low Alarm Limit b/min
Ppeak High Peak Inspiratory Pressure High Alarm Limit cmH2O
Ppeak Low Peak Inspiratory Pressure Low Alarm Limit cmH2O
PEEP High Peak End Expiratory Pressure High Alarm Limit cmH2O
PEEP Low Peak End Expiratory Pressure Low Alarm Limit cmH2O
Pmean High Mean Pressure High Alarm Limit cmH2O
Pmean Low Mean Pressure Low Alarm Limit cmH2O
Leak Leak rate (1-Vte/Vti) displayed as a percent %
Apnea time Apnea Time Limit s
Vti Limit Inspiratory Tidal Volume High Limit ml
Table 20: Alarm Setting Parameter Definitions
5.6.3. Event Log

Under the Alarms Tab, select Event Log. The Event log lists the last one thousand (1,000)
events in order of occurrence. All events are time and Date stamped. The log can be
®
filtered to present events by:

• ID to view all Events in order of occurrence.
• Type, to view specific types of events such as Setting changes or Alarm events all
together.
• Event to view specific events such as the High Pressure alarm or PEEP setting all
together.
Figure 50: Event Log
Setting Description
Event Log Records the last one thousand (1,000) events. The Event Log is
accessed under the Alarms Tab. The Event Log stores the last one
thousand (1,000) events. Data can be filtered by Date, Type and
Event.
Table 21: Alarms Settings Descriptions
5.6.4. Alarm Signals

All audible and visual alarms comply with IEC 60601-1-1-8, EN475 and IEC 60417-5576
recommendations.
Table 22: Alarm Signals

Alarm Audible
Visual signal Comments
priority signal
Nurse call enabled, alarms cannot be cancelled or

Message on red
5 removed from display until resolved. Once resolved
background, alarm
High repeated the alarm message continues to be displayed in the
indicator flashes at 2
signals alarm bar until the user touches the inactive alarm
Hz.
message.
Nurse call enabled, alarm cannot be cancelled or
Message on yellow
3 removed from display until resolved. Once resolved
background, alarm
Medium repeated the alarm message continues to be display in the
indicator flashes at 0.5
signals alarm bar until the user touches the inactive alarm
Hz.
message.
Message on green Nurse call disabled, message is displayed until
1
Information background, no alarm cancelled by touching the notification message on
signal
indicator. the alarm bar.
Alarms are always displayed in order of priority from left to right across the top of the
screen. Informational messages are only shown once per occurrence.
Once an alarm condition is corrected, the alarm message will latch (remain displayed) 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.
5.6.5. 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 is set to 100% and can be adjusted by the
user. The alarm volume level is accessed for adjustment under the Configuration (Config)
Tab.
5.6.6. Alarm Silence Key
To silence an active alarm for two minutes: Press and release the Alarm Silence
Key. A new alarm condition cancels the alarm silence. Pressing and holding the
Alarm Silence Key for 2 seconds silences all current and new alarms for 2
minutes
During an alarm silence, all current and new alarms are visually displayed with their
corresponding alarm priority message on the Alarm bar until resolved and canceled as
described above in Table 22.
5.6.7. Alarm Definitions

This section lists descriptions and ventilator response to possible alarm conditions.
Table 23: High Priority Alarms

High Priority
Description of Cause Ventilator Response
Alarm Messages
Air Supply The air supply has been interrupted. Ventilation continues with
100% Oxygen, if
This alarm applies to the HP models only.
connected to an oxygen
high pressure gas source.
Oxygen Supply The oxygen supply has been interrupted. Ventilation continues with
air supply (21%).
Blower The Blower/Turbine gas supply has been Ventilation continues with
interrupted due to a blower failure. 100% Oxygen, if
connected to an oxygen
This alarm applies to the blower/turbine
high pressure gas source.
models only.
Occlusion Pressure at the start of inspiration is too Ventilation continues with

high. inspiration valve closed.
High Inh Pressure Patient system pressure has reached the Ventilator immediately
high pressure alarm setting. switches to exhalation.
Ventilation continues but
pressure is limited at the
alarm setting.
Low Inh Pressure Pressure cannot be attained in the patient Ventilation continues
breathing circuit, possible due to a leak or
disconnect.
®

High Priority
Alarm Messages
Apnea The set Apnea alarm time has elapsed Device will look for
without a patient triggered or mandatory patient’s next inspiratory
breath being delivered as set on the Alarm effort. After two
Settings screen Apnea time setting. consecutive spontaneous
breaths the Apnea alarm
silences and the Apnea
alarm message will latch.
Note:
If apnea backup settings
are set to an Apnea
Backup mode (NOT
OFF), this alarm does not
display as the Apnea
Backup Active alarm will
display because the
Apnea Backup mode will
become active.
Low MV Exhaled minute volume is too low compared Ventilation continues

with the set alarm limit for Exp Min Vol.
Note:
In the event of Exh flow sensor error, the
alarm pertains to the inspired minute
volume (Vi)
High MV Exhaled minute volume is too high Ventilation continues

compared with the set alarm limit for
ExpMinVol.
Note:
alarm pertains to the inspired minute
volume (Vi)
Disconnect Disconnection of patient Ventilation continues
Low O2 Conc Inspiratory O2 concentration is too low. Ventilation continues

Possible causes: gas mixing system error,
O2 cell faulty, monitor value too low
compared with the control value, O2 sensor
calibration should be performed.
High O2 Conc Inspiratory O2 concentration is too high. Ventilation continues

Possible causes: gas mixing system error,
O2 cell faulty, monitor value too high
compared with the control value, O2 sensor
calibration should be performed.
®

High Priority
Alarm Messages
Low O2 Pressure The oxygen supply has been interrupted. Ventilation continues with
Blower supply (21%).
Possible causes: oxygen supply not
available while 100% O2 is being
administered or O2 calibration has been
started.
High O2 Pressure The oxygen inlet pressure exceeded max Ventilation continues with
level. Blower supply (21%).
Low VT Exhaled tidal volume is too low compared Ventilation continues

with the set alarm limit for Vte.
Note:
alarm pertains to the inspired breath volume
(Vti)
High VT Exhaled tidal volume is too high compared Ventilation continues

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

PetCO2 Low Check patient and ensure
compared with the set PetCO2 low alarm limit. that alarm limits and
appropriate for patient
Note: This alarm can only occur when the
condition.
The monitored exhaled VetCO2 value is too low

VteCO2 Low Check patient and ensure
compared with the set VetCO2 low alarm limit. that alarm limits and
Note: This alarm can only occur when the appropriate for patient
condition.
The monitored Val value is too low compared

Valv Low Check patient and ensure
with the set Val Low alarm limit.
Ventilation continues. that alarm limits and
ventilator settings are
mainstream or sidestream CO2 sensor is in use. condition.
®

High Priority
Alarm Messages
The monitored Valv/min value is too low
Valv/min Low compared with the set Valv/min low alarm limit. Check patient and ensure
Ventilation continues. that alarm limits and
ventilator settings are
TF-XX A technical error has occurred See section 5.6.10 for a

detailed description of
TF-XX error handling
related to Air/O2 Insp flow
sensor failure.
Battery Too Low AC power disconnected. Critical battery Ventilation continues but
supply. will shutdown if not
connected to AC power.
Imminent Shutdown AC power disconnected. Critical battery Ventilation continues but

Connect AC Now AC power disconnected. Critical battery Ventilation continues but

Table 24: Medium Priority Alarms
Medium Priority Alarm Description of Error Ventilator Response

Message
High Rate Respiratory rate is too high when compared with Ventilation continues
the high rate alarm limit.
Low Rate Respiratory rate is too low when compared with Ventilation continues
the low rate alarm limit.
Low PEEP Patient system PEEP pressure is too low Ventilation continues
compared with the set alarm limit for PEEP Low.
High PEEP Patient system PEEP pressure is too high Ventilation continues
compared with the set alarm limit for PEEP High.
Over Temperature The temperature inside the device is too high. Ventilation continues.
High Leak Rate Monitored value for Leak % is too high compared Ventilation continues
with the set alarm limit for Leak %.
Battery Low Internal battery voltage is too low. Ventilation continues

Make sure that there is an alternate source of
power available.
®

Message
Volume Not Delivered Upper limit of operational pressure for VTV Ventilation continues.
ventilation reached, further increase not possible
(Pop high = Ppeak alarm – 5mbar) Volume delivered is maybe
too low
Vti Limit Reached Delivered volume is being limited by Vti Limit Ventilation continues with
alarm settings delivered volume limited.
Check Pcontrol / Pmax Pcontrol and/or high-pressure alarm settings are Ventilation continues
incorrect i.e. Pcontrol > high-pressure alarm
setting. 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 Ventilation continues
incorrect i.e. Psupport > high-pressure alarm
Pressure support is limited
setting.
at the high-pressure alarm
setting until the settings are
corrected.
Low ATM Pressure Barometric pressure lower than low limit of 9.5 psi Ventilation continues
High ATM Pressure Barometric pressure higher than high limit of 16 Ventilation continues
psi
Heater Faulty Heater temperature exceeds high limit Heater is turned off and
ventilation continues
The CO2 sensor measurements are out of range 1. Verify correct airway
Ck. CO2 Sensor
Possible cause: Software Error, Hardware Error, adapter installation.
Motor Error, Calibration lost, O2 sensor error 2. Perform CO2 sensor
Ventilation continues calibration.
3. Replace CO2 sensor.
CO2 sensor hardware issue, out of calibration 1. Verify correct sensor
CO2 Sensor Accuracy?
Possible cause: N20 outside range, O2 outside installation.
range, CO2 outside range, An agent is outside 2. Perform CO2 sensor
range, Temperature outside range, Pressure calibration.
outside range, Agent unreliable
3. Replace CO2 sensor.
Ventilation continues
The CO2 airway adapter is missing, occluded or 1. Verify correct airway
Ck.CO2 Adaptor
installed incorrectly adapter installation.
Possible cause: Missing adapter, O2 port 2. Verify correct sampling
failure/clogged line installation.
3. Replace Adaptor
The CO2 sample line is missing or not connected 1. Verify correct airway
Ck. Sample Line
Ventilation continues adapter installation.
2. Verify correct sampling
line installation.
3. Replace sample line
A problem has been detected with the CO2 airway Replace CO2 airway
Replace CO2 Adaptor
adaptor. adaptor
®

Message
A problem has been detected with the CO2 sample Replace Sample Line
Replace Sample Line
line.
CO2 sensor measurements are out of range or no Zero CO2 Sensor
Zero CO2 Sensor
reference
The monitored Val value is too high compared with Check patient and ensure
Valv High the set Val high alarm limit. that alarm limits and
The monitored Valv/min value is too high Check patient and ensure
Valv/min High compared with the set Valv/min high alarm limit. that alarm limits and
Table 25: Information Messages
Information
Description of Information Ventilator Response
Message
Battery Not Available The internal battery is not available. Ventilation Continues
Possible causes: battery flat, battery missing, faulty
cable connections.
Battery In Use The internal battery is in use. Ventilation Continues

Possible causes: Main power supply not connected
or unavailable.
Flow Sensor Error Exhalation flow sensor failure: Device switches over to a
hardware/disconnected/malfunctioning/reading out of pressure trigger mode.
range Exhaled volume
measurement switches to
Inspired volumes.
Nebulizer Not Nebulizer is not available. The nebulizer is switched

Available off.
Possible cause: Flow delivered is too low to allow
nebulizer function. High pressure oxygen source not
connected.
Inverse I:E Ratio Ventilation settings have been set to an inverse ratio Ventilation continues
(Exhalation time > Inhalation time)
100% O2 Not The O2↑key was pressed when no oxygen source is Ventilation continues
Available available
The internal Oxygen sensor is disconnected or 1. Check to make sure
O2 Sensor Not depleted.
Available the O2 sensor cable is
Displays each time at patient startup, if the O2 sensor
connected and
is depleted or disconnected. undamaged.
Ventilation Continues. 2. Replace O2 sensor
There is no signal from the CO2 sensor. This 1. Verify CO2 adaptor
No CO2 Sensor
message is not shown if the CO2 monitoring feature
®
Table 25: Information Messages
Information
Description of Information Ventilator Response
Message
is disabled. Depending on the specific reason for the connection.
loss of signal between the ventilator and the CO2
Connect and or replace
sensor, other related alarms may also be triggered. CO2 adaptor.
Displays anytime the ventilator looses
signal/communication with an IRMA or ISA sensor.
5.6.8. About Diagnostic Alarm Messages

o There are two types of errors: Malfunctions and Alarms.
§ Malfunctions are related to technical failures.
§ Alarms are related to operation conditions failure or mismatch.
o Alarms are categorized as High Priority, Medium Priority, and Low Priority.
o Both Alarms and Malfunctions are logged in the Events Log.
o No error messages are displayed for Malfunctions. Error messages are displayed
only for the alarms during Ventilation Mode with exception of three alarms that can be
announced during Standby Mode: Low O2 inlet pressure alarm (disabled in the
eVolution High Pressure System) , High O2 inlet pressure alarm, and Low battery
alarm.
5.6.9. Disconnection Alarms

When a Disconnection Criteria is violated, the Disconnection high priority alarm will be
triggered to display and audibly sound and will captured on the Event Log. The Event Log
will also display the Disconnection Number (Disc No.) associated with the specific
Disconnection Criteria violated.
o Disconnection A
§ If the criteria for a Disconnection A alarm is violated, the disconnection number
assigned to that criteria will be displayed in “Set” column on the Event Log.
o Disconnection B
§ If the criteria for a Disconnection B alarm is violated, the disconnection number
assigned to that criteria will be displayed in “Monitor” column on the Event Log.
Table 26: Disconnection Alarm Codes
Disc
Detection Criteria Remarks
No.
Peak pressure below PEEP
Disconnection in inspiratory limb
Disconnection around Wye piece Ppeak measured during last
A1
IF PEEP setting = > 5 cmH2O AND breath
(Ppeak < PEEP setting) for ≥ 8 breaths THEN
= Disconnection
Peak pressure below PEEP for long period
IF PEEP setting = > 5cmH2O AND Spont breaths only
A2 (Ppeak < PEEP setting OR 0.5cmH2O) for ≥ 61s
THEN Ppeak measured continuously
= Disconnection
®

Disc
No.
No pressure in patient tubing system
Disconnection at ETT
IF PEEP setting = < 5 cmH2O AND Criteria for set PEEP < 5
A8
[(-1 cmH2O < P2 < 2 cmH2O) OR cmH2O
(-1 cmH2O < P3 < 2 cmH2O)] for ≥ 4 breaths or
40 s THEN = Disconnection
Pressure drop in the inspiratory limb too high
(Additional criteria)
A16
IF (P3Peak < P2Peak / 3) for ≥ 4 breaths THEN
= Disconnection
Pressure drop in the inspiratory limb too high
(Additional criteria)
A32
IF (actP3peak < actP2peak / 3) for ≥ 30s THEN
= Disconnection
Texp measured during last
Detection of auto cycles with longer Texp times
breath
IF (Texp ≤ 300 ms for ≥ 8 breathes) AND
Exh Flow sensor must be
(Rate Setting ≤ 100 b/min OR PS OR VS) AND
A64 calibrated
(Rate Low Alarm Setting < 30 b/min) AND
(Texp Set ≥ 410 ms) THEN Texp = measured expiratory
time. Texp Set = Calculated
= Disconnection
Te setting time
Neonate only: Very low exhaled volume
Disconnection after ET-tube
Neonate only:
IF (set Vt is > 5 ml) OR If Ve Low Alarm setting = Off
A128
(set Pcontrol is > 5 cmH2O) AND alarm is not active
(Vte ≤ 1 ml for ≥ 16 breaths) AND
No Exh Flow Sensor Error THEN
= Disconnection
Vti depends on Ppeak
measurement. It is compensated
by compliance and nebulizer
Mandatory and spontaneous
Very high delivered volume (Pressure breaths only) breaths are counted separately
IF (Vti > Limit A512) for ≥ 4 breaths THEN In SPONT only spontaneous
breaths are treated
= Disconnection
In P-CMV and V-CMV only
A512 Limit A512: mandatory breaths are treated
Adult: 2500ml 4 good mandatory breaths without
spontaneous breath in between
Pediatric: 700ml will reset the counter for bad
Neonate: 120ml spontaneous breaths
Pressing Man Insp will reset the
counter
If (Pediatric or Adult) AND NIV
THEN this criteria is NOT active
®

Disc
No.
Very low exhaled volume
IF Vte < Limit A1024) for ≥ 8 breaths AND
If Vte Low Alarm setting = Off
PEEP setting ≤ 4 cmH2O AND
alarm is not active.
PEEP measured is ≤ (1 cmH2O for Adult/Pedi OR
A1024 2 cmH2O for Neonate) THEN = Disconnection
Limit A1024: For Neonate If PEEP setting =
< 2cmH2O alarm is not active
Adult: 20ml
Pediatric: 5ml
Neonate: 5ml
Very low exhaled volume
IF Vte < LimitV2048) for ≥ 8 breaths AND
PEEP setting ≥ 5 cmH2O AND
PEEP measured is ≤ (PEEP setting – 3 cmH2O) If Vte Low Alarm setting = Off
A2048 THEN = Disconnection alarm is not active.
Limit A2048:
Adult: 35ml
Pediatric: 5ml
Neonate: 5ml
Detection of auto cycles (short exhalation time)
IF (Texp ≤ 250ms for ≥ 8 breathes) AND Texp measured during last
(Rate Setting ≤ 100 b/min OR PS OR VS) AND breath
A4096 (Rate Low Alarm Setting < 30 b/min) AND
(Texp Set ≥ 410ms) THEN IF (Vte ≤ 4ml, Neonate) If Peep is set < 5 cmH2O
OR (Vte ≤ 18ml, Adult/Pedi) THEN alarm is not active
= Disconnection
Monitored peep is low
Disconnection of Extubation
B4 IF PEEP setting ≥ 4 cmH2O AND Only active for Neonates
PEEP measured ≤2 cmH2O for ≥ 8 breaths THEN
= Disconnection
Detection of auto cycles (long exhalation time)
Disconnection of Extubation
IF (Texp ≤ 400 ms for ≥ 8 breathes) AND Disconnection With Exp. Flow
(Rate Setting ≤ 60 b/min OR PS OR VS) AND Sensor Error
(Rate Low Alarm Setting < 30 b/min) AND IF (Texp ≤ 400 ms for ≥ 8
B8 (Texp Set ≥ 410 ms) AND (Vte ≤ Limit B8) THEN breathes) AND (Rate Setting ≤ 60
= Disconnection b/min OR PS OR VS) AND
(Rate Low Alarm Setting < 30
Limit B8:
b/min) AND (Texp Set ≥ 410 ms)
Adult: 50ml THEN = Disconnection
Pediatric: 30ml
Neonate: 10ml
®

Disc
No.
No rise in pressure at mandatory breath
Disconnection at ETT
IF (P2peak ≤ Pop-Low Limit) for ≥ 8 mandatory
breaths THEN = Disconnection
B16 Not active for SPONT Modes
Pop-Low Limit:
Adult: PEEP setting+5 cmH2O
Pediatric: PEEP setting+5 cmH2O
Neo/Infant: PEEP setting+2 cmH2O
Measured peep below setting
IF (PEEP measured ≤ PEEP setting – 3 cmH2O) for Disconnection With Exp. Flow
≥ 8 breaths AND PEEP setting ≥ 5 cmH2O AND Sensor Error
Vte ≤ Limit B32 THEN = Disconnection
B32 IF (PEEP measured ≤ PEEP
Limit B32: setting – 3cmH2O) for ≥ 8 breaths
Adult: 30ml AND PEEP setting ≥ 5cmH2O
Pediatric: 10ml THEN = Disconnection
Infant: 5ml
Target pressure not reached (- Additional criteria for For pressure controlled
pressure controlled breaths) breaths only
B64 Disconnection at expiratory port One good volume breath
IF (P2peak ≤ Pressure Setting – 5 cmH2O) for ≥ 8 resets counter (Ppeak > PEEP
breaths THEN = Disconnection setting + 5 cmH2O)
Disconnection Detection by volume in Pressure

Modes For Neonates If Vte Low Alarm
B256 setting = Off, alarm is not
IF ( Vti/10 > Vte ) AND ( P-Mode ) for 4 breaths active.
THEN = Disconnection
Disconnect Detection by pressure in Pressure
Modes
B512 IF ((exhalation flow < 1 l/min) AND (PS ) for 5s) OR
( exhalation pressure < 0.3 cmH2O ) AND
( inhalation pressure < target pressure ) AND
((P-Mode) for 4 breaths) THEN = Disconnection
Disconnection Detection by volume in Volume
Modes For Neonates If Vte Low Alarm
B4096 setting = Off, alarm is not
IF ( Vti/10 > Vte ) AND ( V-Mode ) for 4 breaths active.
THEN = Disconnection
Disconnection Detection by pressure in Volume

Modes
B8192 IF ((exhalation flow < 1l/min ) AND ( VS) for 5s ) OR

((exhalation pressure < 0.3 cmH2O ) AND
( inhalation pressure < target pressure ) AND
( V-Mode ) for 4 breaths ) THEN = Disconnection
5.6.10. Technical Failures Alarms

o TF-01 Audio Malfunction
®
§ Software announces Audio Malfunction technical failure if writing to or reading from

the audio codec fails any time an audio level or sound request command is sent to the
codec.
o TF-02 Blower Malfunction
§ Software declares Blower Failure, if during ventilation, a blower alarm is activated and
no connected oxygen supply is detected.
o TF-03 POST Failure
§ Software declares POST technical failure alarm when one or more of the POST
diagnostic tests fails. POST is performed during the startup of the system.
o TF-04 Software Watchdog Expiration
§ Software implements a watchdog expiration detection algorithm to detect software
watchdog expiration due to any software process crash/freeze and declares a Technical
Failure condition.
o TF-05 Hardware Watchdog Expiration
§ Software implements a watchdog expiration detection algorithm to detect when the
external hardware watchdog circuit timed out (expiration) and declares a Technical
Failure condition.
o TF-06 Air Inhalation Sensors CRC Failure
§ Software tests the CRC integrity of the nonvolatile stored configurations of the Air
Inhalation Flow Sensors during system startup. A technical failure is declared if the data
of the sensor is corrupted. This test is performed during system initialization (startup)
only.
o TF-07 NVRAM CRC Failure
§ Software shall trigger a Technical Failure if the calculated CRC of any NVRAM stored
configuration (calibrations, settings, etc) data structure does not match the stored CRC.
This check is performed at power-up only when loading the stored configurations and
settings.
o TF-08 Air Inhalation Sensor Failure
§ Software tests the Air Inhalation Flow Sensor during system startup to detect sensor
failures, and declares a technical failure. During ventilation the technical failure is
declared if Air Inhalation flow sensor failure is detected and O2 is not available.
o TF-10 Extremely Low Internal Battery Charge
§ Software monitors the remaining charge of the internal battery when the system is
power by it and declares a technical failure for extremely low charge (below 10%.)
o TF-11 O2 Inhalation Sensors CRC Failure
§ Software tests the CRC integrity of the nonvolatile stored configurations of the Oxygen
Inhalation Flow Sensors during system startup, and declares a technical failure if the
data of the sensor is corrupted.
o TF-12 O2 Inhalation Sensor Failure
§ Software tests the Oxygen Inhalation Flow Sensors during system startup to detect
sensor failures, and declares a technical failure.
5.6.11. Alarm Reset and 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 Alarm Reset – Batch Clearing of All Latched Alarms
§ To clear all inactive (latched) alarms at one time, press and hold any latched
alarm for 2 seconds and all latched alarms will be removed from the alarm bar.
5.6.12. Hazards Based on User / Device Errors

Table 27: Hazards Based on User / Device Errors
Potential Hazard Cause Implication/Result Mitigation / Action
Soft key / membrane key Mechanical or SW fault, Device fully or partially EMC and ESD testing
failure ESD Damage, EMC inoperable
Interference Contact Biomed
LCD failure LCD failure, video controller LCD remains dark, no Main LED and Audible
failure, background lighting information for user. alarms
failure or end of life, ESD,
cable, driver failure. Unusable device Contact Biomed
Life of the Press & Turn

Device cannot be Heavy use or wear on Unable to change/set
operated Press & Turn knob settings. knob exceeds life of the
device
Rotary encoder Knob

provides full functionality to
Touch Screen User input no longer UI (press O2 key and
Software, Hardware failure Standby key at the same
functionality failure accepted by touch screen
time)
Contact Biomed
Device unintentionally ON/OFF button is on rear

Power switch accidentally switched on/off, if and covered. System
User mistake
toggled ON/OFF connected to patient, may alarms until silenced by
cause severe injury user.
User uncertain, incorrect Wrong language selected in User does not understand Language-specific manuals
operation configuration labeling and labeling. User training.
Wrong gas mixture Oxygen High and Low

Incorrect supply gases Hospital mistake
delivered to patient alarms.
Information on correct
Missing particle filter in Possible contamination.
Service tech/user maintenance in service and
the gas input Device can become faulty.
user manual.
Information on correct
Dust and dirt may enter into
No fan filter User misuse maintenance in service and
device housing.
user manual.
Information on correct set

Patient breathing circuit up in User manual. Labels
(Insp/Exp) mixed up on User misuse None on device at Inspiratory (to
device patient port) and Expiratory
(from patient port)
®
Table 27: Hazards Based on User / Device Errors
Potential Hazard Cause Implication/Result Mitigation / Action
User manual and on screen

Flow sensor calibration Faulty calibration, default
User mistake menu instructs on correct
faulty values used
calibration procedures
Software fails calibration

and disregards faulty data if
out of range.
Software sets calibration
Flow sensor calibration Faulty calibration, default
User mistake data to factory default if
faulty or not calibrated values used.
data integrity test failed
during POST.
Software indicates
Calibration Needed
Reduced response time to User manual specifies use

Insufficient warnings of Failure or Improper clinician
side effect or non by trained clinician
side effects settings of alarms.
awareness by clinician
Setting of conflicting Lack of user knowledge or Inappropriate patient Safe setting limits
ventilation parameters simple entry mistakes ventilation
Setting of conflicting Lack of user knowledge or Inappropriate patient Detailed setting instructions
ventilation parameters simple entry mistakes ventilation in User manual
Inappropriate setting of Lack of user knowledge or Inappropriate patient Safe setting limits
VTV parameters simple entry mistakes ventilation
Inappropriate setting of Lack of user knowledge or Inappropriate patient Detailed setting instructions
VTV parameters simple entry mistakes ventilation in VTV User manual.
5.7. 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 eVolution 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 eVolution ventilator is designed to work with the Masimo IRMA (mainstream) and ISA
(Sidestream) Capnography sensors and adapters. The eVolution’s Capnography software is
designed with plug-n-play functionality and will recognize which sensor (IRMA or ISA) is
Masimo CO2 adaptor attached to the ventilator.
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 eVolution 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 eVolution’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 eVolution ventilator to another, even "on
the fly," during ventilation.
When the Masimo 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.
®
§ 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.
5.7.1. Warnings and Cautions

Table 28: 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, and halogenated hydrocarbons
can influence the CO2 measurements. The eVolution ventilators
automatically compensate for oxygen.
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 lift the ISA gas analyzer by the sampling line as it could disconnect
from the ISA, causing the ISA gas analyzer to fall on 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.
®
Table 28: 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.
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 Masimo (sidestream CO2
sensor).
Use only Masimo 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 damaged sensors or cables.
Do not sterilize or immerse sensors.
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 probe zeroing will result in 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.
®
5.7.2. Capnography Waveforms and SBCO2 Curves

The eVolutionventilator is designed to work with the Masimo IRMA (mainstream) and ISA
(Sidestream) Capnography sensors and adapters. The eVolution’s Capnography software
is designed with plug-n-play functionality and will recognize which sensor (IRMA or ISA) is
Masimo CO2 adaptor attached to the ventilator.
5.7.2.1. Volumetric and EtCO2 Real-Time Waveforms

To view the eVolution 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 51, when the Mainstream ETCO2 sensor is attached,
any of the three waveforms can be configured to display PeCO2, FeCO2 or VteCO2.
Figure 51: Real-Time Graphics (Capnograms)
5.7.2.2. SBCO2 Real-Time Curves

To view the eVolution 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.
®
SBCO2
Curve
Selection
PCO2 / Vte
Curve
FCO2 / Vte
Curve
Figure 52: Real-Time Graphics (SBCO2 Curves)
5.8. Config TAB
Figure 53: Config Screen
®
Table 29: Config Screen Settings
Setting Value Description
Humidification HME, Humidifier, The triple action scroll allows one of three selection options:
Type None § 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 when using the ventilator with a test lung and an
unheated, non-humidified circuit.
Ventilator software uses the selected humidity type to calculate an
accurate BTPS factor for volume ventilation compensation
Smart On/Off, Nebulizer can be manually turned On or Off and configured for set
Nebulizer™ On Time, nebulization time and at a user defined interval.
Interval On/Off,
Interval Time
Smart Sigh™ On/Off, Sigh can be manually turned On or Off and configured for sigh
Sigh Factor, amplitude, sigh interval, and sigh number for single or multiple
Sigh Frequency, sighs.
Sigh Number
Alarm Option Full/Basic User may change alarm options between Full and Basic.
Full: High and Low (Ve, VTe, RR, Ppeak, and PEEP or Pmean),
Leak, Apnea and Vti Limit. Under Standby, you may change the
Alarm Selection under User Configuration between PEEP and
Pmean.
Basic: High (Ppeak, Ve, RR), Low Ve, Apnea and Leak
Monitors 5, 8 User configures how many monitored parameters can be viewed
on the top Monitored Parameter Bar
Compliance On/Off User can turn compliance compensation On or Off.
Compensation Default setting is On
O2 Sensor On/Off User can turn the O2 Sensor On or Off.
Default setting is On
Low Flow O2 On/Off User can turn Low Flow Inlet O2 Pressure On or Off.
Available on the Note, when Low Flow O2 is Activated:
Blower Based - Low O2 Pressure alarm will be activate if O2 inlet pressure <1.5 psi
System Only
®
Table 29: Config Screen Settings
Setting Value Description
When the Low Flow Inlet O2 feature is enabled, connect a low flow oxygen source to the eVolution’s low
flow O2 inlet port and adjust flow as required to achieve desired FiO2. The graph shown in the figure below
provides a general reference to determine a starting point for the low flow setting. To achieve FiO2 delivery
of 100%, the flow rate of the low flow gas source will need to be 1-2 l/min higher than the ventilators peak
flow rate. Low O2 Pressure Alarm will be activated if O2 inlet pressure <1.5 psi.
Graphs ranges and setting relationships based on minimum peak flow settings Adjust flow as required to
achieve desired FiO2
To Find Low Flow Oxygen Input Flow Rate

1. Select an FiO2 for the horizontal axis
2. Follow the vertical line upward to the established minute volume
3. Follow the horizontal line to the low flow O2 input at the left vertical axis
Audio/LCD Audio Level 35- User can configure Audio volume

level 100% User can turn Screen Clicks On or Off
Screen Clicks User can adjust the LCD screens brightness
On/Off
LCD Brightness
20-100%
Technical Technical Provides password restricted access to view System
Screen Settings Information and adjust device language, date and time
settings. The Technical Settings access code is 2634.
Patient Height: cm or in
Keyboard: Standard or Generic Alpha
The Engineering section requires a separate password to

access.
Engineering
Screens
NOTE: please reference Technical Service Manual to
explain access to these password protected screens.
5.8.1. Monitors
®
Select Monitors under the Config Tab. The Monitors selection screen allows you to;
o Select the number of monitored parameters to display in the monitoring bar above the
left and right panels as shown below.
Figure 54: Monitors
5.8.2. Compliance Comp

Select Compliance Comp under the Config Tab / Clinical. The Compliance Comp selection
screen allows you to;
o Disable or Enable the system to compensate for the compliance of the circuit and
attached accessories. By default, Compliance Comp is On.
Figure 55: Compliance Compensation
5.8.3. O2 Sensor:
Select O2 Sensor under the Config Tab. The O2 Sensor screen allows you to;
o Turn the O2 Sensor On/Off
®
Figure 56: O2 Sensor – High Pressure System
5.8.4. Low Flow O2 (Blower Based System)

Select Low Flow O2 Sensor under the Config Tab / Technical / User Configuration to:
o Turn the Low Flow O2 Pressure On/Off
o Turn the O2 Sensor On/Off
Figure 57: Low Flow O2 – Optional, Blower Based System
5.8.5. Audio / Visual

Select Audio / Visual under the Config Tab. The Audio / Visual selection screen allows you
to;
o Set the Audio level for all audible alarms. Default is 100% unless changed by the
user.
o Enable or Disable Screen click. Screen clicks when enabled cause the ventilator to
sound an audible click when any button or control is pressed. Default is Off unless
changed by the user.
o Adjust the screens brightness level. Default is 100% unless changed by the user.
®
Figure 58: Audio / Visual Options
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Section 6 Calibrations and Cleaning
6. Calibrations and Cleaning

This section describes maintenance for the eVolution, including calibration, cleaning, periodic
maintenance, alarms test, and disposal.
Only trained personnel should perform maintenance procedures.
6.1. Calibration Options
The System Test and Alarms Test should always be performed before using
the ventilator.
When you turn on the ventilator, the Startup screen appears. From the Startup screen, select
CALIBRATIONS. At the Calibrations screen, you can select a calibration to perform.
Figure 59: Calibrations
Table 30: Calibration Descriptions
Calibration
Description
Procedure
Zero Flow sensor Performs a zeroing calibration of the exhalation flow sensor
System Test Checks patient circuit for leaks and calculates the circuit’s compliance
factor for volume compensation.
O2 sensor Performs a two-point calibration of the oxygen sensor
EXH Flow Sensor Performs the Exhalation Flow Sensor calibration
®
6.1.1. Zero Flow Sensor Calibration

This test executes the process of calibrating the zero offset of the exhalation flow sensor. It
determines the sensor reading in a zero flow condition and saves it as the zero reading and
offsets the rest of the scale by that amount.
This process is required every time the sensor is replaced, or there is drift.
Figure 60: Calibrate Exhalation Flow Sensor Zero Offset
The Calibrate Exhalation F - S Zero Offset screen allows the service technician to zero the
internal exhalation flow sensor. Information on the screen gives step by step instructions on
how to perform this task. This calibration is performed if an exhalation flow sensor is
replaced, an exhalation flow related repair is made, or if incorrect exhalation volumes are
observed. A Calibration Successful message is displayed when the calibration is complete.
Press the SAVE button to save the calibration information. A Save calibration data
successfully message appears when the date is saved. For additional information, see
eVolution Technical Service Manual.
Perform the following steps to calibrate Exhalation F-S Zero Offset:

1. Verify the patient circuit is not connected to the ventilator and that no flow or flow
disturbance is exerted around the area of the exhalation flow sensor.
2. Select START
Normal acceptable values for Exhalation Flow Sensor Zero Offset is between 47 - 53
6.1.2. Pre-Patient Tests

The system test is used to verify the integrity of the patient tubing system components.
Running the test will allow the operator to quantify and eliminate any leakage from the
patient tubing system prior to clinical patient use. In addition to leakage, the system test will
also measure the total compliance of the patient tubing system. The measured system
compliance factor will then be used to compensate volume delivery on a breath by breath
basis in order to ensure accurate volume delivery.
®
Figure 61: Pre-Patient Tests Screen
1. Attach the complete patient tubing system to the ventilator.
2. When ready block the circuit wye and select ‘OK’ to begin the System test procedure.
The series of tests require the wye piece be closed or blocked.
3. On completion of the test, the device will report a pass as ‘OK’ accompanied by
leakage rate. A failure will be reported with a specific error number to prompt further
investigation.
It is recommended that a system test be performed prior to starting

ventilation, with circuit changes and while troubleshooting leaks.
6.1.2.1. Dual fault system test failure screen

If the user attempts to enter ventilation after a failed system test, the user is presented
with a notification / decision screen which states:
Figure 62: System Test Failure Message
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Selecting Bypass allows the user to proceed to ventilation and the previous (last
successful) System tests tubing compliance will be used. This response is then stored
as a log entry.
Selecting Cancel takes the user back to the Patient Startup screen.
Make the desired changes and perform the System test again.
• When ready, select ‘OK’ in order to begin the System test procedure.
• Repeat procedure following the on screen instructions as defined above.
• Upon completion of the test, the device will report a pass as ‘OK’, a failure will be
reported with a specific error number to prompt further investigation.
6.1.3. O2 Sensor Calibration

The Oxygen sensor calibration will permit the operator to perform a calibration of the integral
O2 measurement system prior to use and as required thereafter.
Perform this calibration only when replacing the O2 Sensor.
Figure 63: Calibrate Oxygen Sensor Screen
Oxygen sensor calibration is performed as follows:

o On the New patient Startup screen or on the Calibration Screen from the Previous
patient Startup screen, select O2 Sensor Cal.
o When ready, unblock the circuit wye and select START in order to begin the O2
Sensor Calibration test procedure.
o The device will run the automated two-point calibration automatically and report an
overall pass as ‘OK’ or a failure with a specific error number to prompt further
investigation.
®
o Once complete then press ‘BACK’. Results automatically save.

o STOP may be pressed to terminate a started calibration. Until completed, the last
successful O2 Sensor calibration results will be used for O2 measurement.
6.1.4. EXH Flow Sensor Calibration
Perform this calibration only when replacing the Flow Sensor.
Figure 64: Calibrate Exhalation Flow Sensor Screen
The Calibrate Exhalation Flow Sensor screen allows the service technician or medical staff
to calibrate the internal exhalation flow sensor. Information on the screen gives step by step
instructions on how to perform this task. This calibration is performed if an exhalation flow is
replaced or if incorrect exhalation volumes are observed. A Calibration Successful
message is displayed when the calibration is complete.
After the completion of each calibration, the Patient Startup screen is updated with the
status for each, and a time and date stamp for each to indicate when it was completed.
6.2. Cleaning and Sterilization

Perform all cleaning carefully and according to all applicable regulations to ensure that the
eVolution ventilator functions safely and effectively.
Follow manufacturer guidelines and maintenance instructions explicitly, using

only specified parts. Clean and 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.
®
• Because cleaning, sanitation, and disinfection practices vary widely among

health care institutions. It is not possible for eVent Medical to specify or require
specific practices that will meet all needs, or to be responsible for the
effectiveness of cleaning, sterilization, and other practices carried out in the
patient care setting. This manual only gives general guidelines for cleaning,
disinfecting, and sterilizing. It is the user’s responsibility to ensure the validity
and effectiveness of the actual methods used.
6.2.1. Patient Breathing Circuit and Nebulizers

Clean and sterilize reusable patient circuit components according to manufacturer
recommendations.
o Replace and dispose of single patient use items between patients according to
manufacturer instructions.
Use only patient circuits and nebulizers that comply with relevant international standards
(ASTMF1100-90, F1054-87, ISO 5356-1, EN794-1, EN1281-1 and EN12342).
6.2.2. Humidification Devices

Clean and sterilize reusable active humidifiers according to manufacturer recommendations.
o Replace and dispose of single use passive humidification devices according to
manufacturer recommendations
Use only humidification devices that comply with relevant international standards
(EN 8185-1, ISO 9360 ASTMF1100-90, F1054-87, ISO 5356-1, EN794-1, EN1281-1 and
EN12342).
6.2.3. Ventilator Exterior

Clean the exterior of the ventilator after every use: wipe down the surface with isopropyl
alcohol or other suitable antibacterial or germicidal agent. Clean the entire surface,
including gas connections, water traps and mains cable.
o Do not try to clean or sterilize the inside of the ventilator. The materials and design of
the internal parts do not require sterilization.
6.2.4. Touch Screen LCD Display

Dampen a soft cloth with a nonabrasive glass cleaner and wipe down the screen of the
eVolution Ventilator after every use or as needed.
o Most glass cleaners or bleach-based cleaners are fine to use on touch screen
surfaces.
o Do not use any vinegar-based solutions.
o Handle the touch screen with care and avoid using gritty cloths to prevent scratches.
6.2.5. Exhalation Flow Sensor

Follow the below “Manual Cleaning” Instructions.
The sensor cannot be autoclaved!

Life cycle of the sensors is limited. It can be used as long as calibration in
the evaluation unit is possible.
Do not clean inside of the sensor in a mechanical way, with compressed air
or jet of water because this will lead to damage of the thin measuring wires!
®
Figure 65: Exhalation Flow Sensor
Cleaning Hot Wire Flow Sensor: ONLY clean the expiratory hot wire flow sensor using an
Ethanol solution 70% pre-soaking solution:
o Prepare an Ethanol solution 70% pre-soaking solution or equivalent
o Immerse the part to be cleaned in the prepared solution for 2-5 minutes making sure
that Exhalation Flow Sensor is submerged in the solution, and agitate periodically.
o Remove the part from the solution after 2-5 minutes and rinse immediately by
immersing in at least 1 gallon of sterile distilled water at 20-30 degrees Celsius (68-86
degrees Fahrenheit). Leave the part in the rinsing bath for 1-2 minutes, agitating it
periodically to ensure thorough rinsing.
o Visually inspect the part after removing it from the rinse to ensure that no debris
remains on the part.
o Clean the flow sensor following two (2) disinfection cycles with Ethanol solution 70%
§ Replace the flow sensor if the sensor is still contaminated
o Let air dry in room air
6.2.6. Exhalation System and Diaphragm

Cleaning the exhalation system cover between patients
o Follow the below “Manual Cleaning” instructions.
Replace the cover if damaged or after fifty (50) cleaning cycles.
Cleaning the exhalation diaphragm between patients

o Follow the below “Manual Cleaning” Instructions.
Replace the diaphragm if damaged or after ten (10) cleaning cycles.

Cover Housing

Diaphragm Locking Ring
Figure 66: Exhalation Valve System
®
6.2.7. Manual Cleaning:

Cleaning the Exhalation Valve System: ONLY the following four (4) parts are cleanable
using an enzyme pre-soaking solution: The Exhalation Valve Housing, Cover and Locking
Ring, and The Exhalation Valve Diaphragm:
o Prepare an enzyme based pre-soaking solution such as MetriCide OPA (made by
Metrex Research Corp, Romulus, MI) or equivalent in accordance with manufacturer's
instructions, using the MetriCide Solution Testing Strips to verify the concentration
level.
o Immerse the instrument completely in MetriCide OPA Plus Solution. Soak the
instruments in MetriCide OPA Plus Solution for 12 minutes at a minimum temperature
of 20°C (68°F) or higher for high-level disinfection.
o Remove the part(s) from the solution after 12 minutes and rinse immediately by
immersing in at least 9 liters of sterile distilled water. Leave the part in the rinsing bath
for 1-2 minutes, agitating it periodically to ensure thorough rinsing.
o Repeat the procedure TWO additional times for a total of THREE rinses. The volume
of water used in EACH rinse should be at least 9 liters.
o Flush and Dry Flush all channels with 70% isopropyl or ethyl alcohol, then air dry.
o Visually inspect the part after removing it from the rinse to ensure that no debris
remains on the part.
Assembly Procedure: Refer to Figure 67, Figure 68, Figure 69 and Figure 70
1. Place the Exhalation Membrane ( 1 ) on top of the Exhalation Valve Manifold ( 2 ).
Ensure that the membrane is facing up (text facing down).
2. Place the Exhalation Valve Locking Ring ( 3 ) on the top of the Exhalation Valve
Manifold and Exhalation Membrane, making sure the ring alignment tabs are
properly aligned with the Exhalation Valve Manifold. See Figure 68
3. Place the Exhalation Valve Cap ( 4 ) onto the top of the Exhalation Valve and
twisting the cap clockwise to tighten. Assure the Valve Cap is aligned with the
Exhalation Valve Manifold before tightening.
4. Make sure the O-Ring ( 5 ) is secured in the O-ring groove on the outlet (proximal)
side of the Exhalation Valve Manifold.
5. Insert the Exhalation Flow Sensor ( 6 ) onto the outlet (proximal) end of the
Exhalation Valve Manifold – make sure the flow sensor is fully seated onto the
Exhalation Valve Manifold.
6. Connect the Flow Sensor Cable ( 7 ) to the Exhalation Flow Sensor by aligning the
cable pins to the flow sensor connection port (Do Not Twist)
7. Insert the Exhalation Filter ( 8 ) onto the inlet (distal) end of the Exhalation Valve
Manifold – make sure the filter is fully seated onto the Exhalation Valve Manifold
®
Figure 67: Exhalation Valve System Components
Figure 68: Exhalation System Assembly 1
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Section 7 Spare Parts
7. Spare Parts
Description Part Number
F&P, Adult, Disposable Circuit RT 137
F&P Pediatric, Disposable Circuit RT 130
F&P, Humidifier, Reusable MR 850
Portex Breathing Filter, Disposable EVL220008
Hudson, Nebulizer, Micro Mist, Disposable 1881
F&P, Humidifier Chamber, Disposable MR370
Flow Sensor (Exhaled), Reusable EVL370017
Galvanic Oxygen Sensor F910028
AC Power Cord, US, Reusable EVL220047
eVolution Yearly PM Kit, Disposable EVL500501
Flex Circuit Support Arm, Reusable F710616
High Pressure Oxygen Hose, Reusable F910038
High Pressure Air Hose, Reusable F910037
Test Lung Kit, Adult EV200012
§ Use only eVent Medical accessories listed in the above table.

§ Ventilator basic safety and essential performance can be compromised with non-
original eVent Medical accessories
®
Section 8 Preventative Maintenance
8. Preventative Maintenance
Perform all cleaning, disinfection and sterilization carefully and according to all applicable
regulations to ensure the ventilator functions safely and effectively.
Only trained personnel should perform preventive maintenance according to

these instructions.
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 and or sterilize 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 sterilization technique on a single part may
damage the part.
To prevent damage to ESD-sensitive components, always follow ESD
guidelines when servicing and handling components inside the ventilator.
§ The cleaning section of this manual complies ISO 14937 second edition 2009-10-15
and ISO 17664 first edition 2004-03-01.
Perform these preventive maintenance procedures on the eVolution at the following intervals.
Table 32: Preventive Maintenance Schedule
Interval Maintenance procedure

Every 250 hours or as required Clean or replace the cooling fan filter (Figure 71).
Every year or as required Replace the cooling fan filter,

Replace the air inlet filter.
Replace the oxygen sensor.
Run a performance verification test.
Every two years or as required Replace the internal batteries.

Note: Both batteries must be replaced at the same time.
As required Replace fuses.
8.1. Cooling Fan Filter

Clean or Replace Cooling Fan Filter Every Year or as required
Check the Cooling Fan Filter regularly for blockages and contamination and
clean as required.
®
1. Use a small flat-blade

screwdriver to pry the filter
retainer from Fan Guard.
2. Replace the fan filter or

wash it under running water.
Do not reinstall the cleaned
filter until it is completely
dry
3. Push the filter retainer back

into the Fan Guard.
Figure 71: Fan Filter and Cover
8.2. Air Inlet Filter

Clean or Replace Air Inlet Filter Every Year or as required
Check the Air Inlet Filter regularly for blockages and contamination and
clean as required.
1. Carefully grasp the Air Inlet

Filter element.
2. Pull the filter element out of

the Air Inlet manifold.
3. Replace the filter or wash it

under running water. Do not
reinstall the cleaned filter until
it is completely dry.
4. Reinsert the filter in the Air

Inlet Manifold.
Figure 72: Air Inlet Filter
8.3. Oxygen Sensor

Replace Oxygen Sensor Every Year or as required
Use recommended replacement oxygen sensors only. Always calibrate the

oxygen sensor after replacement.
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.
®
1. Carefully disconnect the

oxygen sensor cable.
2. Twist the oxygen sensor

counterclockwise and remove.
3. Twist a new sensor clockwise

into place.
4. Connect the cable to the new

sensor.
5. Replace the cover and

retighten the screws.
Figure 73: O2 Sensor
8.4. Internal Battery

Every Two Years or as required: Replace the Internal Battery
Always replace both batteries at the same time.

Use recommended replacement batteries only.
Always perform the System Test and Alarms Test after replacing the
batteries.
Calibrate internal batteries following replacement (see the eVolution
Service Manual).
Figure 74: Internal Battery
8.4.1. Removal of Internal Battery

1. Disconnect the A.C. power cord.
2. Use a # 2 Philips screwdriver to loosen the four screws and washers that secure the
back panel battery tray.
3. Slide tray that holds internal batteries out of the enclosure.
4. Loosen the fastening brackets that secure the batteries to the tray by removing the
two Philips head screws and lock washers and two M4 hex nuts and M4 lock
washers.
5. Remove the batteries from the battery connectors.
6. Install the new batteries by connecting the battery connectors. Orient each battery
®
with the grooved side facing away from the battery tray wall.
7. Place the batteries in the battery tray and secure the battery brackets by installing the
screws, nuts and washers.
8. Install the battery tray in the ventilator and secure it by installing the four Philips head
screws and washers.
8.5. Fuses
As Required: Replace Fuses
1. Unplug the A.C. power cord.
2. Push down the clip between

the two fuses and pull out the
fuse box.
3. Replace the fuses with 3.15A,

T type, H (breaking capacity)
250V.
4. Reinstall the fuse box.
Figure 75: Fuse
8.6. Alarm Test Procedure

The alarm test procedures listed below comply with EN 794-1 recommendations. See section
1.5.3 for a list of product Compliance and Approvals.
Follow these instructions to test ventilator operation and the alarms identified below before
attaching the eVolution ventilator to a patient.
8.6.1. Alarms Functionality Tests

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 alarm
o Air supply/Low air alarm
o Apnea backup active alarm
o Power source transition
o Battery low and battery flat
1. Select the following alarm settings
Table 33: Alarm Test Settings

Mode Settings Alarm Settings
®
Table 33: Alarm Test Settings

Mode Settings Alarm Settings
Mode: V–CMV Apnea time: 20 s
Trigger: Flow Rate High: 100 b/min
Resp: 10 b/min Rate Low: 1 b/min
Vt: 500 ml Ppeak High 40 cmH2O
PEEP: 5 cmH2O Ppeak Low: 3 cmH2O
Pause: 0s Ve High: 50 l/min
Oxygen%: 21 % Ve Low: 2 l/min
Insp flow pattern: Square Vte High: 1000 ml
Peak flow: 45 l/min Vte Low: 200 ml
Ftrig: 3 l/min PEEP High: 8 cmH2O
NIV: Off PEEP Low: 3 cmH2O
Leak Comp: On Leak: 100 %
Auto Control: Off Vti Limit: 2500 ml
2. Perform the following alarm tests:

High pressure alarm test: Allow the ventilator to cycle at the above settings with a
test lung (Puritan-Bennett part number 612 or equivalent) 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.
Low pressure, Disconnection, 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.
Oxygen supply/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
Oxygen% setting back to 21%.
Air supply/Low air pressure alarm test: Disconnect or clamp-off the air supply line.
Verify that the air supply alarm sounds immediately, and that the Low Air Pressure
alarm sounds within a few breaths. Reconnect or remove the clamp allowing air
pressure to return to normal.
Continuous High pressure alarm test: Change the Ppeak High alarm to 20 cmH2O
and block the expiratory limb of the circuit. Verify that the High pressure alarm sounds
within two breaths, and that the alarm is continuous until you unblock the circuit.
Unblock the circuit and change the Ppeak High alarm back to 40 cmH2O.
Apnea backup active alarm test: Change the apnea interval setting to 10 seconds
and respiratory rate setting to 5 b/min. Verify that the Apnea backup active alarm
sounds and apnea ventilation begins within 20 seconds (an Apnea indicator appears in
the upper right corner of the screen during apnea ventilation). Change the respiratory
rate back to 10 b/min.
Power source transition: Disconnect the mains power cord and verify that an audible
tone sounds immediately. Verify that the ventilator begins battery operation without
®
interrupting ventilation (a battery icon and estimated capacity are displayed in the lower
left corner of the screen during battery operation). Reconnect the mains power cord
and verify that the AC power indicator is on.
Battery low and battery flat alarm: If testing of the internal battery is desired, assure
that the battery is fully charged to greater than 95%. Disconnect the AC mains and
operate the ventilator on 21%. The ventilator should operate for approximately 2-4
hours or more depending on settings. Assure that a medium priority low battery alarm
sounds as the ventilator discharges to a low value. Assure high priority battery too low
alarm sounds and cannot be silenced. Assure that a high priority Imminent shutdown
and connect ac now alarm sounds and cannot be silenced. The ventilator should
continue to run until the ventilator detects a “Battery Flat” condition. The ventilator
should turn off at this time and immediately emit a continuous high pitch Vent Inop
alarm for a minimum of one minute. (The Vent Inop alarm will actually continue
alarming for much longer than 1 minute). The ventilator will use an external battery
first if attached until it is depleted and then switch to the internal battery.
High FIO2 alarm: 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 raise the high value. Assure that the
high O2 alarm sounds within a few minutes.
The alarms test procedure is complete.
8.7. Disposal
To dispose of the ventilator and its components and accessories, the user must:
• Deliver the device, free of charge and duty paid, to the manufacturer for disposal,
• Surrender the device to a licensed private or public collection company, or
• Properly recycle or dispose of the parts.
All disposals must be according to the applicable local regulations. Consult the responsible
authorities for guidance and requirements. Recycling and disposal procedure must not:
• Pose risk to human health.
• Damage the environment.
• Cause a noise or odor nuisance.
• Damage the surroundings or landscape.
The galvanic oxygen sensor cell may 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.
®
Section 9 Monitored Parameters, Maneuvers and Graphics Display
9. Monitored Parameters, Maneuvers and Graphics Display

9.1. Monitored Parameters
Monitored parameters are displayed at all times during ventilation; these numeric values are
displayed at the top of screen when navigating to any tab. To select a parameter to be displayed
touch the heading where you wish the parameter displayed in the parameters bar. A list of
parameters will be displayed and select the desired parameter from the list by touching it and the
parameter viewing bar will be updated.
Figure 76: Selecting a Monitoring Parameter
The number of monitored parameters displayed can be configured to display 5 or 8

parameters. To reconfigure the monitored parameters, select Monitors in the Config tab then
choose the desired number of parameters.
9.2. Data Tab

All monitoring parameters can be viewed in the data tab. Three windows are available: Basic,
Mechanics and Weaning.
®
Figure 77: Basic Monitored Parameters
Figure 78: Mechanics Monitored Parameters
®
Figure 79: Weaning Monitored Parameters
9.2.1. Respiratory Mechanics

Respiratory mechanics provide quantitative values of the condition of the lungs. Mechanics
values derived by the eVolution ventilator are tubing compliance compensated.
o Cstat
§ Static compliance (Cstat) measures the stiffness of the lung and 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 Pplateau – PEEP serves as the denominator and delivered
tidal volume less compliance compensation is the numerator. Cstat = Vt/(Stable
PIP – PEEP if any) or Vt/(Pplateau – PEEP if any)
§ To perform a manual static compliance measurement the ventilator should be in a
volume mode with a square wave flow pattern. The square waveform provides
zero flow when inspiratory pressure is reached and therefore a static measurement
can be taken. From the Home screen Left Panel loops window scroll until the
maneuver window is displayed. Press Insp. Hold. If a there is a inspiratory plateau
for greater than 200 milliseconds and a flow of less than 5 liters per minute a Cstat
value will be measured.
§ It should be noted that if a patient is making respiratory effort during the maneuver
it may alter measured values and give erroneous measurement of lung compliance.
o Rinsp
§ Inspiratory Resistance (Rinsp) measure the airflow resistance of the airways, circuit
tubing and lungs during inspiration. Rinsp is automatically calculated during V-
Modes only if the Flow Pattern is set to Square with a Pause set to > 0.20 s.
o Rexp
§ Expiratory Resistance (Rexp) measure the airflow resistance of the airways, circuit
tubing and lungs during expiration. Rexp is automatically calculated during V-
Modes only if the Flow Pattern is set to Any with a Pause set to > 0.20 s.
o Auto PEEP
§ Auto PEEP measures end expiratory pressure exceeding the set value for PEEP,
also known as intrinsic PEEP or inadvertent PEEP. Auto PEEP = Total PEEP – Set
PEEP and is calculated after a user initiated Exp hold is performed. Hold times will
®
affect calculated value. When hold is released, the The PEEP sample
measurement just before terminating hold is used as total PEEP.
o Pplateau
§ Plateau Pressure is calculated in all modes after a user initiated Insp hold is
performed and in V-Modes if a Pause of > 0.1 s is set.
o RSBI
§ Rapid Shallow Breathing Index is derived from the measured breathing rate divided
by Insp tidal volume.
o P0.1
§ Occlusion Pressure at 100 ms. P0.1 is also known as P100 and is the maximal
slope of the airway pressure drop (Max negative Inspiratory pressure) during the
first 100 ms when the airway is occluded. P0.1 indicates the patient’s respiratory
drive and efforts.
o PiMax
§ Maximum negative inspiratory pressure against an occluded airway (cmH2O), an
indicator of inspiratory muscle strength. Not available for neonatal/infant patients.
o P0.1 / PiMax
§ Airway occlusion pressure (P0.1) divided by maximal inspiratory pressure (%).
o WOBimp
§ Work of Breathing Imposed (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. When a patient is actively initiating a
breath the airway pressure is decreased slightly to signal the ventilator to
commence inspiration. Imposed work of breathing is the work required by the
patient to overcome the resistance imposed by the breathing apparatus in order to
initiate a breath. As such, WOBimp is only measured during patient initiated
breaths and it is the change in airway pressure (Paw) integrated over tidal volume
(Vti) normalized to total inspiratory tidal volume.
o RCe
§ Expiratory Time Constant (RCe) is monitored and trended parameter 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.
§ RCe is determined using the calculated method which allows easy calculation of
RCe breath to breath in all modes and is proven to be an accurate approximation of
actual RCe. 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 by breath as the relationship (ratio) between Vte and PFe at 75% of the
maximum expiratory volume.
§ Calculated Expiratory Time Constant: Vte / PFe = 1 Time Constant (s)
9.2.2. Static Compliance and Resistance Measurements
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Controlled
Flow Inhalation Exhalation
Qendinsuff
Qplateau
Tpause
Tinhale Texhale
Resulting Tcycle
Pressure
Pendinsuff
Pplateau ΔP
PEEP
Figure 80: Flow and Pressure Waveforms Cstat, Rinsp & Rexp
9.2.3. Auto Peep Measurement

To perform an Auto PEEP measurement, in the loops window scroll to the maneuver window.
Press Exp. Hold. IF there is any Auto PEEP is present a measurement will be displayed. The
value displayed for Auto PEEP is a measure of PEEP in excess of set PEEP. If no auto PEEP
exists the measurement will remain 0. Similar to compliance and resistance measurements,
respiratory effort by the patient during the maneuver will lead to erroneous measurements.
9.2.4. Real-Time Curves Graphics Display

The Home screen by default displays several real time color graphics. The right panel of the
Home screen, displays a Flow-Time waveform on the top of the panel and a Pressure-time
waveform on the bottom. The left panel defaults to display a Flow-Volume loop.
9.2.4.1. Clinical Applications of Real-Time Ventilator Graphics
Real-time loops and curves can illustrate how settings may affect the patient:
• The pressure-volume loop can show changing compliance or resistance values, and
can be used to assess the suitability of PEEP and Vt settings.
• The flow-volume loop can show changes in inspiratory or expiratory peak flow, and
can be used to assess the effectiveness of bronchodilator therapy during pressure
breaths or spontaneous breathing.
• The pressure-flow loop provides an additional reference loop.
• The pressure-time waveform can help assess pressure settings or triggering
thresholds.
• The flow-time waveform can be used to assess peak spontaneous flows during
spontaneous breathing before and after bronchodilator therapy.
®
• The flow-time curve can also be used to detect intrinsic PEEP (also known as occult
or auto PEEP), when expiratory flows do not reach baseline before the next breath.
The ventilator displays measured circuit PEEP above the PEEP setting, identifying
intrinsic PEEP.
• To determine if there is additional pressure in the lungs, select Exp. Hold during active
exhalation. This allows gas in the patient’s lungs to equilibrate with the circuit
pressure, and the ventilator displays the equilibrated total PEEP and Auto PEEP at
the next update: total measured PEEP - set PEEP = Auto (intrinsic) PEEP.
9.2.5. Graphics Color Display

The color graphic display provides useful information about each breath delivery. The Home
screen displays the current mode in the top left hand corner, directly to the right, is a light that
indicates inspiration. A red light indicates a machine delivered breath and a green light
indicates a patient triggered breath. This light is continuous during the inspiration phase of
both machine delivered and spontaneous breaths.
On the graphics display, mandatory breaths are red during the inspiratory phase of a breath.
The exhalation phase of the breath is displayed in blue. Spontaneous breaths are green
throughout the inspiratory phase and light blue during the exhalation phase
Figure 81: Home Screen Graphics Display
9.2.5.1. Configuring Graphic Display

The left panel on the Home screen displays loops. Pressing the Loop heading (F/V) on
the touch screen will change the loop from Flow-Volume to a Pressure-Volume loop.
Touching the P/V icon will change the panel to a maneuver screen. The controls to
perform and Inspiratory hold and expiratory hold are found on the Maneuver screen.
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Flow Volume Loop Pressure Volume Loop Pressure Flow Loop
Maneuvers Screen
Figure 82, Loop Windows (Left Panel)
Touching the waveform heading in the right panel of the Home screen will select the
different waveforms to display. The waveforms will scroll through Flow-Time, Pressure-
Time or Volume-Time when the heading is touched.
The waveforms panel can be configured to display one, two or three waveforms at one
time. The same panel can be configured to display one or two loops instead of
waveforms.
To change the waveforms you select the Waveform tabs. Each time you select the tab it
will change the number of waveforms on the right panel. Displaying 1 to 3 waveforms.
Figure 83: Waveform Configuration
9.2.5.2. Changing the Scale of Graphic Display

The scale of the graphs on the Home screen by default auto scale, whereby, the eVolution
ventilator automatically sets the scale which best fits the graphs on display. The eVent
Medical logo near the y axis denotes that auto scaling is active.
To change the scale of the graphic display touch the y axis of the graph, touching the y
axis again will scroll to the next scale range.
The time scale, along the x axis of the graph, defaults to six seconds divided into one
second intervals. To change the time scale, touch the x axis and the time scale will
change to the following time interval. Continuing to touch the x axis will scroll though the
different time scales.
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Table 34: Waveform Scale Ranges

Y Axis Y Axis X Axis X Axis
Waveforms
Scale Units Scale Units
-5 – 0 – 15
-5 – 0 – 30 0–6
-10 – 0 – 50 0 – 12
Pressure cmH2O seconds
-20 – 0 – 80 0 – 30
-60 – 0 – 140 0 – 120
Auto Scale
0 – 10
0 – 20
-10 – 0 – 50 0–6
0 – 200 0 – 12
Volume ml seconds
0 – 900 0 – 30
0 – 2000 0 – 120
0 – 3000
Auto Scale
-6 – 0 – 6
-20 – 0 – 15 0–6
-80 – 0 – 40 0 – 12
Flow -100 – 0 – 80
l/min seconds
0 – 30
-200 – 0 – 200 0 – 120
Auto Scale
Table 35: Loops Scale Ranges

Y Axis Y Axis X Axis X Axis
Loops
Scale Units Scale Units
-6 – 0 – 6 -10 – 0 – 50
-20 – 0 – 15 0 – 180
Flow + Volume -80 – 0 – 40 l/min 0 – 900 ml
-100 – 0 – 80 0 – 2000
-200 – 0 – 200 0 – 3000
0 – 10
0 – 20
-5 – 0 – 25
-10 – 0 – 50
Pressure + -10 – 0 – 50
0 – 180 ml cmH2O
Volume -20 – 0 – 100
0 – 900
-60 – 0 – 120
0 – 2000
0 – 3000
9.2.5.3. Freezing the Graphic Display

Touching the right panel graphic display outside the x axis and y axis will freeze the
graphic display. When the waveforms are frozen a cursor and an unfreeze icon will be
displayed on the graph. The cursor can moved along the graph by touching any point on
the graph or by touching the cursor and dragging the cursor to the desired spot or by
rotating the scroll (rotary) knob. The numeric values of the y and x axis where the cursor
intersects the waveform are displayed in each corresponding graph.
To unfreeze the waveforms touch the unfreeze icon. Loops freeze at the same time as
the waveforms. The freeze/unfreeze feature is available only in the right panel graphic
displays.
The scale cannot be adjusted while the cursor is displayed.
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Figure 84: Freezing Graphics
9.2.5.4. Trending Parameters

Monitored parameters can be displayed in a trend for an epoch of time up to the last 72
hours. Trends are accessed in the Home tab by selecting Trend Data. Touching the
graph outside the x and y axis displays a cursor. The cursor can be moved to any point
on the graph by touching and dragging the cursor to the point desired. Numeric values of
the point where the cursor intersects the graph are displayed on the corresponding graph.
To change the time scale of the trend, touch the x axis. Each time the x axis is touched
the time scale will change to the next time interval. The different time scales available are:
0-60 minutes, 0-6 hours, 0-12 hours, 0-24 hours, 0-36 hours and 0-72 hours.
To change the scale of the parameter displayed, touch the y axis. Each touch of the y
axis will scroll to the next scale. The scale cannot be adjusted while the cursor is
displayed.
®
Figure 85: Trend Display
Up to three trended parameters can be displayed at one time. The configuration of the
trend display is accessed in the Trend tab. Select the Trend tab and it will change the
number of waveforms from 1 to 3.
To change the trended parameter touch the heading of the graphic trend, a list of all the
trended parameters will be displayed. Select the parameter desired and the trend display
will be updated.
Figure 86: Trend Configuration
9.3. Maneuvers
To access respiratory maneuvers, from the Home screen, touch the left panel Maneuvers tab.
®
Figure 87: Selecting Maneuvers
9.3.1. 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 88: Suction Support Maneuver Selection
9.3.1.1. 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 89.
§ 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
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disconnection is not detected within 120s, the O2% will return to original set.
Figure 89: Suction Support Preparation Phase
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 90: Suction Support Patient Disconnected Phase
o Post Oxygenation Phase
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Figure 91: 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.
9.3.2. P0.1 Maneuver

The P0.1 maneuver measures the pressure drop during the first 100 ms of an inspiratory effort
with an occluded airway, and is an indicator of patient respiratory drive. To start the maneuver,
and perform a P0.1 maneuver press P0.1.
Once the patient initiates a breath, the maneuver is complete and normal ventilation resumes.
During the maneuver a window will appear asking to save P0.1. You can select OK or Cancel.
This value will be saved if OK is selected in the monitored bar.
®
Figure 92: P0.1 Maneuver
9.3.2.1. P0.1 Maneuver Details

• When the user presses the P0.1 button, P0.1 maneuver will not commence until the
ventilator cycles into exhalation. Then the ventilator’s inspiratory valve will close and
the airway pressure drop produced by and inspiratory effort will be measured during
100 ms.
o Expiratory valve will continue to maintain PEEP
• The 100 ms time interval starts when a negative pressure of 0.5 cmH2O below PEEP
is measured. (This pressure value PEEP – 0.5 cmH2O = P1)
• The second pressure value (P2) is measured a 100 ms and the occlusion pressure
P0.1 is the difference between P2 – P1. (As shown below in Figure 93, P0.1 = P2 –
P1)
Figure 93, P0.1 Maneuver Measurement Graph
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• Once P2 is reached:
o the P0.1 maneuver is complete and the P0.1 monitored parameter will update to
display the measured P0.1 value.
o the inspiratory valve opens
o the current modes breath type will be delivered and normal ventilation will
resume
o The P0.1 value for each P0.1 maneuver performed will be recorded in the Event
Log for review.
9.3.2.2. P0.1 Automatic Termination Criteria
• As a safety precaution the P0.1 maneuver once started will automatically terminate
(STOP) based on the following IBW specific time based criteria.
o This means if the P0.1 maneuver is started and the patient fails to generate the
negative pressure (P1) within the background Patient Type (IBW defined)
specific time based criteria, the P0.1 maneuver will automatically terminate
(STOP) and normal ventilation will resume.
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 36: P0.1 Automatic Termination Criteria
9.3.2.3. Alarm Handling During P0.1 Maneuver

The Apnea alarm and Rate Low alarm will be temporarily disabled when the P0.1
maneuver is active. When the maneuver is completed or the user manually stops the
maneuver these alarms will automatically be re-enabled.
9.3.3. PiMax Maneuver

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, select the PiMax
and hold the button to close the inspiratory valve and open the exhalation valve. The patient
can exhale and during the maneuver time and the most negative value achieved during any
inspiratory effort will be recorded and displayed as the PiMax value for that maneuver.
When the maneuver time elapses (maximum time 40 seconds), PiMax indicates the maximum
inspiratory pressure and normal ventilation resumes.
o The PiMax monitored parameter will display the PiMax value for that maneuver.
o The PiMax value for each PiMax maneuver performed will be recorded in the Event Log
for review.
o When PiMax is held, the PiMax maneuver will not commence until the ventilator cycles
into exhalation and the minimum expiratory time of 200 ms has elapsed then the
Inspiratory valve closes and provides no base flow, the expiratory valve will remain
active to maintain PEEP and allow the patient to exhale.
o PiMax = Pend – PEEP
§ This means if the measured PEEP is 5 cmH2O and the patient’s negative
inspiratory pressure (Pend) is -25 cmH20 then PiMax = -25 cmH2O – 5 cmH2O or
PiMax = -30 cmH2O. (PiMax = Pend + PEEP)
®
Figure 94, PiMax Maneuver
o P0.1 / PiMax
§ 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.
9.3.4. Inspiratory Hold Maneuver

Touch and hold the Insp. Hold button to hold ventilation at the end of the next inspiration for up
to 30 seconds. Normal ventilation resumes when you release the button or after 30 seconds,
whichever occurs first. The ventilator automatically calculates static compliance (Cstat) during
an inspiratory hold.
Inspiratory hold is not available during NCPAP+ mode.
Figure 95, Inspiratory Hold Maneuver
9.3.5. Expiratory Hold Maneuver

Touch and hold the Exp. Hold button to hold ventilation at the end of the next exhalation for up
to 30 seconds. Normal ventilation resumes when you release the button or after 30 seconds,
whichever occurs first. The ventilator automatically calculates Total PEEP and Auto PEEP
during an expiratory hold.
Expiratory hold is not available during NCPAP+ mode.
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Figure 96, Expiratory Hold Maneuver
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Section 10 Theory of Operation
10. Theory of Operation

The eVolution 3e ventilator is electrically powered and microprocessor-controlled device with a
pneumatically controlled active exhalation valve and three hot-wire flow sensors.
The eVolution utilizes an internal gas source on the turbine model and dual high pressure gas
sources on the HP model and dual-valve (PSOL) technology for precise breath delivery and lower
work of breathing. This section describes ventilation modes and monitored values for the
eVolution ventilator.
10.1. Ventilation Modes

The eVolution ventilator offers these ventilation modes:
Table 37: Ventilation Modes

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 PRVC-CMV
Mandatory Ventilation
§ Pressure-Controlled Synchronized Intermittent P-SIMV

Mandatory Ventilation
§ Volume-Controlled Synchronized Intermittent Mandatory V-SIMV

SIMV
Ventilation
§ Pressure Regulated Volume Control Synchronized PRVC-SIMV

Intermittent Mandatory Ventilation
§ Pressure Support Ventilation (CPAP + PS) PS
§ Volume Support Ventilation (CPAP + VS) VS
SPONT § Spontaneous Positive Airway Pressure Ventilation (dual SPAP

PEEP mode)
§ Nasal Continuous Positive Airway Pressure (Nasal NCPAP+

CPAP)
Hi FlowO2 § High Flow Oxygen Therapy N/A
10.1.1. 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. A higher
Peak Flow setting 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 either set Tidal
Volume, Peak Flow or Rate 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 97: V–CMV Mode
Table 38: 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 compliance ml
compensated).
PEEP/CPAP Positive end expiratory pressure/continuous positive airway cmH20
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 cmH20
Flow Pat. Flow pattern: decelerating, decelerating 50%, or square
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes
Pause Inspiratory pause, 0-2 seconds. s
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 3-60seconds.
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Table 38: V–CMV Settings

Leak Comp. Leak compensation (default setting is On) l/min
Up to 25 l/min with NIV set to Off
Up to 60 l/min 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.
10.1.2. Volume Controlled Synchronized Intermittent Mandatory Ventilation (V-

SIMV) Mode
Volume controlled Synchronized Intermittent Mandatory Ventilation (V-SIMV) mode, is a
mixture of spontaneous and mandatory 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
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 98: V-SIMV Mode
Mandatory
breath
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 peak
flow settings applies to the mandatory breaths.
Table 39: V–SIMV Settings

Rate Mandatory breaths per minute b/min
Vt Tidal volume delivered during inspiration (compliance ml
compensated)
pressure, the pressure at the end of exhalation
Psupport For spontaneous breaths, pressure support (in addition to cmH20
PEEP)
Flow (Peak Flow) Maximum inspiratory flow l/min
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.
Pause Inspiratory pause, 0-2 seconds. s
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.
termination of the patient’s breath and allow vital capacity
(VC) measurements to be obtained.
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).
10.1.3. Pressure Controlled Continuous Mandatory Ventilation (P-CMV) Mode

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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.
Increasing Pcontrol or Ti should result in an increase in delivered tidal volume depending on
the compliance and resistance of the patient circuit and patient. If changes occur to the
compliance and/or resistance of the patient circuit or patient this may affect the delivered tidal
volume.
Figure 99: P-CMV Mode
Table 40: P–CMV Settings


Rate Mandatory breaths per minute. b/min
Ti Inspiration time. sec
Pcontrol Inspiration pressure above PEEP cmH20
breaths based on patient effort. Apnea time is adjustable 3-
60seconds.
®
Table 40: P–CMV Settings

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 is greater than or equal to PEEP + 2 cmH20.
10.1.4. Pressure Controlled Synchronized Intermittent Mandatory Ventilation

(P-SIMV) Mode
Pressure Controlled synchronized Intermittent Mandatory Ventilation (P-SIMV) mode, is a
mixture of spontaneous and mandatory ventilation. Mandatory breaths are pressure-
controlled, and spontaneous breaths are pressure supported.
Figure 100: P–SIMV Mode
Table 41: P–SIMV Settings

Pcontrol Inspiration pressure above PEEP cmH20
PEEP)
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
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Table 41: P–SIMV Settings

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.
termination of the patient’s breath and allow vital capacity (VC)
10.1.5. 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. 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 set at that starting pressure.
During VTV 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.
10.1.6. 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 and for a duration of 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 per breath 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 eVolution ventilator delivers a standard P-CMV breath at 10 cmH2O
above the set PEEP for the set Ti. Compliance is measured and for the next 5 breaths
pressure changes up to 10cmH20 can occur till the target Vt is achieved.
Once uniform ventilation occurs in PRVC-CMV, in the event of a Disconnection Alarm, the
eVolution 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 42: PRVC–CMV Settings


Vt Tidal volume target. Inspiratory pressure will automatically ml
vary to attempt to achieve this tidal volume.
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH20
airway pressure, the pressure at the end of exhalation.
breaths based on patient effort. Apnea time is adjustable
3-60seconds.
The ventilator automatically limits the setting ranges to ensure that:
• Inspiration time is never less that 100 ms.
• Exhalation time is never less than 200 ms.
10.1.7. 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 in
page 79. The spontaneous breaths in PRVC-SIMV can be pressure supported. Breath
triggering during SIMV ventilation is described in page 84.
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Table 43:PRVC–SIMV Settings

PEEP)
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
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.
NOTE: 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)
10.1.8. 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 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. Volume Support is delivered in a spontaneous
mode only and so is not available in SIMV.
Table 44: VS Settings

®

PS Tmax functions as the inspiration termination criteria
for all PS based breaths. PS breaths when delivered will
10.1.9. 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 101: SPONT Mode
®
Table 45: PS Mode Settings (CPAP + PS)

PEEP)
PS Tmax functions as the inspiration termination criteria for
all PS based breaths. PS breaths when delivered will
10.1.10. 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 dwell time 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.
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.
10.1.10.1. Spontaneous Breaths in SPAP Mode
Figure 102: SPAP Mode
10.1.10.2. 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 46: SPAP Settings
®

Cycle Cycle rate from high to low PEEP levels. c/min
Cycle is only available when SPAP Type; Cycle + Time or
Cycle + Ratio are selected.
Phigh High PEEP level cmH20
Plow Low PEEP level cmH20
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 cmH20
Psup low Level of pressure support in addition to low PEEP cmH20
H:L Ratio of time at high to low PEEP levels. x:x
H:L is only available when the SPAP Type Cycle + Ratio is
selected.
PS Tmax PS Tmax is the max time limit control setting for all modes with a s
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)
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.
10.1.11. 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 an infant 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.
10.1.12. Non Invasive Ventilation (NIV) Settings

Non Invasive Ventilation (NIV) is an adjunct to ventilation available in all modes on the
eVolution ventilator. Selecting NIV and verifying the Leak Compensation setting is set to On,
the eVolution will automatically compensate for leaks in the patient circuit up to a maximum of
60 l/min. The increased leak tolerance when NIV is selected provides more effective
ventilation and better patient comfort when using a non invasive 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.
10.1.12.1. 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:
o Adjust the trigger level to avoid auto-cycling and adjust the leak alarm
to avoid nuisance alarms.
o Adjust Esens to ensure that inspiration terminates appropriately.
Adjust Rise time for greatest patient comfort.
10.1.13. Breath Triggering (All Modes)

The eVolution ventilator offers pressure and flow triggering in all invasive modes as well as
NIV. Pressure triggering is based on information from an internal pressure sensor. 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 control), 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 3cmH2O a breath is initiated.
®
If Flow trigger is selected, a breath will initiate when a patient effort decreases the bias flow in
the circuit equal to the value set by the flow sensitivity (Ftrig control). With Leak
Compensation On, bias flow is equal to the value of the current measured leak flow rate plus 4
l/min.
®
Section 11 Abbreviations
11. 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
Centimeter of water pressure
cmH2O –3
(1 cmH2O = 10 bar) and (1.016 cmH2O = 1 mbar or 1 hPa)
Cstat Static Compliance

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
FiO2 Fraction of inspired oxygen (oxygen concentration)
Ftrig Flow Trigger level
GUI Graphical User Interface
GUI Graphical user interface
Hectopascal
hPa
(1 hPa equals 1 mbar, which equals 1.016 cmH2O)
®
Term Definition
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 automatically
Leak Comp
compensate for leaks during ventilation.
Milibar
mbar
(1 mbar equals 1 hPa, which equals 1.016 cmH2O)
Milliliter
ml –3
(1 ml = 10 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
+ O 2% Apnea Backup Oxygen Setting
OI Oxygen Index
OID Object Identification Table
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
Pause Inspiratory Pause Time Setting
P–CMV Pressure Control Continuous Mandatory Ventilation
®
Term Definition
Control pressure, inspiratory pressure above PEEP delivered during a
Pcontrol
pressure-controlled breath (Pressure above PEEP)
PEEP Peak End Expiratory Pressure
PEEP Positive end expiratory pressure (Peak End Expiratory Pressure)
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
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
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)
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)
Ptrig Pressure Trigger level
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
®
Term Definition
RS232 Serial interface
Rapid Shallow Breathing Index
RSBI
(Calculated respiratory rate divided by tidal volume)
s Second
SNMP Simple Network Management Protocol
SPAP Spontaneous Positive Airway Pressure
SPONT Spontaneous Ventilation (CPAP + PS)
Square Square Flow Pattern (Ramp)
STPD Standard temperature and pressure, dry
Tapnea Apnea Alarm Time Setting
Target Vt Target tidal volume (a VTV mode setting in PRVC and VS)
Te Expiratory Time
TF Technical fault
Thigh Time at high PEEP level (SPAP mode setting)
Ti Set or Monitored inspiration time
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
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)
VDC Volt, direct current

Ve Exhaled Minute Volume
Ve Spont Spontaneous Exhaled Minute Volume
Ve Inspired Minute Volume (displays if the flow 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
®
Term Definition
Vte Exhaled Tidal Volume
Vti Inspiratory Tidal Volume
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 47: Abbreviations
®
Section 12 Pneumatic Schematic
12. Pneumatic Schematic
Figure 103: High Pressure System, Pneumatic Schematic
®
Section 12 Pneumatic Schematic
Figure 104: Optional, Turbine Based System, Pneumatic Schematic
®
Section 13 Index
13. Index
Status Bar Icon ............................................................. 67
Battery External ................................................................ 48
1 Breath Termination
PS Tmax ........................................................................ 28
100% O2 Key ......................................................... 20, 62, 63 Breath Triggering ...................................................... 27, 171
Breathing circuit ............................................................... 52
NCPAP+ patient interface ............................................. 52
Buzzer
A
setting audible alarm level ......................................... 119
Abbreviations and Definitions ........................................ 173
Activating Ventilation ....................................................... 89
Advanced Monitored Parameters .................................. 142
C
Alarm Definitions ............................................................ 100
Alarm LED Lamp ............................................................... 62 Calibration ...................................................................... 124
Alarm Level ..................................................................... 100 Calibrations
Alarm limits screen ........................................................... 98 Calibration Required Status Bar Icon ........................... 67
Alarm Log .......................................................................... 99 EXH Flow Sensor ......................................................... 128
Alarm Setting Parameter Definitions ................................ 99 EXH low Sensor .......................................................... 124
Alarm Settings New Patient ............................................................ 77, 79
Standard ....................................................................... 39 O2 Sensor ..................................................... 63, 124, 127
Alarm Signals .................................................................... 99 Pre-Patient Tests .................................................... 77, 79
Alarm Silence ........................................................ 20, 62, 63 Previous Patient ........................................................... 80
Alarm Silence Key ........................................................... 100 System Test ........................................................ 124, 125
Alarm test settings ......................................................... 138 Zero Flow Sensor ........................................................ 124
Alarm Tones ...................................................................... 99 Capnograms Screen Graph Selection
Alarm Volume ................................................................. 100 Left Panel SBCO2 Curves ............................................. 117
Alarms Right Panel Waveforms .............................................. 117
Auto Set Feature .......................................................... 97 Capnography
Diagnostic Messages .................................................. 106 Mainstream (IRMA) Sensor .......................................... 56
Disconnection Alarms ................................................ 106 Mainstream Sensor Connection ................................... 56
High Priority ............................................................... 100 Mainstream Sensor Position (Circuit Wye) ................. 58
Information (low) Priority .......................................... 105 Sensor Calibration ........................................................ 57
Medium Priority ......................................................... 103 Sidestream (ISA) Sensor ............................................... 59
Reset Feature ............................................................. 111 Sidestream Adapter Position (Circuit Wye) .................. 60
Technical Faults .......................................................... 110 Sidestream Sensor Connection .................................... 59
Alarms Screen ................................................................... 96 Warnings and Cautions ........................................ 60, 115
Alarms Settings Descriptions ...................................... 97, 99 Changing Settings ............................................................. 69
Alarms test ............................................................... 13, 140 Circuit compliance calculation ........................................ 124
Alarms Test Procedure ................................................... 138 Circuit sterilization .......................................................... 129
Apnea Backup ................................................................... 83 Cleaning ...................................................................... 15, 64
Modes .......................................................................... 32 Cleaning and sterilization ............................................... 128
Settings ........................................................................ 32 Clearing Alarms ............................................................... 111
Status Bar Icon ............................................................. 67 CMV
Apnea O2 .......................................................................... 86 Pressure ..................................................................... 161
Audible alarm Volume ....................................................................... 158
setting level ................................................................ 119 Communication
Auto Control ......................................................... 28, 83, 89 CliniNet Server ............................................................. 51
Modes .......................................................................... 90 Ethernet ....................................................................... 51
Status Bar Icon ............................................................. 67 Nurse Call ..................................................................... 51
Auto PEEP ................................................................. 37, 146 Virtual Report Remote Monitoring .............................. 51
Auto Peep Measurement ............................................... 145 Compliance
Automatic Leak Compensation .................................. 27, 84 Cstat ............................................................................. 36
Compliance Comp ........................................................... 121
Config. Screen ................................................................... 33
B Configuration
Compliance Comp ...................................................... 121
Trend Data ................................................................. 150
Base Flow .................................................................... 27, 84
Configuration Screen Settings ........................................ 118
Basic and Advanced Parameter Selections ....................... 83
Configuration Screens ............................................ 118, 121
Basic Monitored Data ..................................................... 142
Configuring Graphic Display ........................................... 146
Battery
Connecting to Air Supply .................................................. 50
®
Section 13 Index
Connecting to Low Flow O2 Inlet ..................................... 50 Flow Pattern ............................................................... 28, 83

Connecting to Oxygen Supply ........................................... 50 Flow Trigger (Ftrig) ........................................................... 27
Contact Information Flow-time waveform ...................................................... 145
Clinical Support .......................................................... 187 Freezing Graphics ........................................................... 149
Customer Service ....................................................... 187 FromPatient Port .............................................................. 22
International Sales ..................................................... 187 Front panel keys ............................................................... 62
Technical Service ........................................................ 187 F-V loop .......................................................................... 145
US Office Address ........................................................... 2
US Office Fax .................................................................. 2
US Office Phone ............................................................. 2 G
US Sales ...................................................................... 187
Control Settings Gas Supply ........................................................................ 49
Max Boundary .............................................................. 74 Air Inlet ......................................................................... 50
Soft Boundary .............................................................. 73 Low Flow O2 Inlet ......................................................... 50
Current and Proposed Settings ........................................ 83 Gender Specific GUI Colors ............................................... 71
Cycle ................................................................................. 84 Graphical User Interface ................................................... 65
Cycle (SPAP Mode Rate) ................................................... 30 Graphics
Capnograms Screen ................................................... 117
Changing Scale ........................................................... 147
D flow-time curve .......................................................... 145
Freeze / Unfreeze ....................................................... 148
Date and Time Display ...................................................... 67 F-V loop ...................................................................... 145
Device Labels and Symbols ............................................... 20 Loops ............................................................................ 38
Disconnection Alarms ..................................................... 106 pressure-time curve ................................................... 145
Display P-V loop ...................................................................... 145
Freeze / Unfreeze ....................................................... 148 Real-Time Curves ......................................................... 38
Monitors .................................................................... 120 Trend Data ................................................................. 149
Parameters ................................................................. 120 Waveforms ................................................................... 38
Selecting Parameters ................................................. 141 Graphics Colour Display .................................................. 146
Trend Data ................................................................. 149 GUI
Trend Settings .............................................................. 87 Gender Specific Colors ................................................. 71
Disposal .......................................................................... 140
H
E
High Low Ratio .................................................................. 83
Electromagnetic Compatability ........................................ 42 High Pressure Alarm Setting ............................................. 39
Environmental Data .......................................................... 41 High Priority Alarm Messages ........................................... 40
Esens% ........................................................................ 28, 83 HL 83
Event Log .......................................................................... 99 HL Ratio ............................................................................ 30
e V o l u 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 Humidification devices ..................................................... 54
EXH Flow Sensor Calibration .......................................... 124 cleaning and sterilization ........................................... 129
Exhalation Sensitivity (Esens) ........................................... 28 Humidification Type ................................................... 33, 79
Exhalation Sensitivity% ..................................................... 83
Exhalation System
Assembly ............................................................ 132, 133 I
Manual cleaning ......................................................... 131
Exhalation valve cover IBW ................................................................................... 77
Manual cleaning ......................................................... 131 IBW Calculator .................................................................. 78
sterilization ................................................................ 130 Ideal Body Weight ............................................................ 77
Exhalation Valve System ................................................. 130 Index of Figures ............................................................... 7
Expiratory Time Constant (RCe) ....................................... 37 Information Priority Alarm Messages ............................... 40
EZ-Flow sensor Insp Time .......................................................................... 85
reusable ..................................................................... 129 intrinsic PEEP .................................................................. 146
single patient use ....................................................... 129 Introduction ...................................................................... 13
I-Time (Ti) ......................................................................... 26
F
L
F/V Loop ......................................................................... 147
FiO2 .................................................................................. 84 Labels ................................................................................ 20
Flow .................................................................................. 84 Leak Comp ........................................................................ 84
®
Section 13 Index
Leak Compensation .................................................... 27, 84 Ppeak ............................................................................ 34

Lock / Unlock .................................................................... 23 Pplateau ....................................................................... 37
Loops ................................................................................ 38 Pressure Values ............................................................ 34
Loops Scale Ranges ......................................................... 148 Rate .............................................................................. 35
Low Flow O2 ............................................... 33, 50, 119, 122 Rate Spont .................................................................... 35
Low Pressure Alarm Setting .............................................. 39 RCe (expiratory time constant) .................................... 37
Respiratory Mechanics ................................................. 36
Rexp ............................................................................. 37
M Rinsp ............................................................................. 37
RSBI .............................................................................. 37
Main Screen ...................................................................... 91 Spont% 1h (% of spont breaths for the last 1 hr) ......... 36
Main Screen Element Descriptions .................................. 66 Spont% 8h (% of spont breaths for the last 8 hrs) ........ 36
Maintenance .................................................................. 124 Ti/Ttot .......................................................................... 36
Alarm Tests ................................................................ 138 Time Values .................................................................. 35
Replace Air Inlet Filter ................................................ 136 Ve 35
Replace Cooling Fan Filter .......................................... 135 Ve Spont ....................................................................... 35
Replace Fuses ............................................................. 138 Vi 35
Replace Internal Battery ............................................ 137 Vi Spont ........................................................................ 35
Replace Oxygen Sensor .............................................. 136 Volume / Flow Values .................................................. 34
Maneuvers ...................................................... 147, 151, 155 Vte ................................................................................ 34
P0.1 ...................................................................... 94, 144 Vti ................................................................................. 34
P0.1 (Airway Occlusion Maneuver) .............................. 37 WOBimp (work of breathing imposed) ........................ 38
P0.1 Measurement ..................................................... 151 Monitoring ........................................................................ 95
Performance Details ........................................... 151, 155 Monitoring Bar
PiMax ................................................................... 95, 144 Selecting Parameters ................................................. 141
PiMax (Max Insp Pressure) ........................................... 37 Monitoring Data ............................................................. 141
PiMax Measurement .................................................. 155 Monitoring Parameters .................................................. 141
Suction Support .......................................................... 151 Monitoring Screen ............................................................ 92
Manual Breath Monitoring Screen Setting Descriptions ..................... 92, 93
Front Panel Key ............................................................ 20
Status Bar Icon ............................................................. 67
Manual Breath Key ..................................................... 62, 63 N
Mechanics
Monitored Data ......................................................... 143 Nasal CPAP mode description (NCPAP+) ........................ 170
Mechanics Monitored Parameters ................................. 143 Nasal prongs ..................................................................... 52
Mode description NCPAP+ Mode
P-CMV ........................................................................ 161 Flow setting .................................................................. 31
P-SIMV ........................................................................ 163 I-Time setting ............................................................... 31
SPAP ........................................................................... 168 Pcontrol setting ............................................................ 31
SPONT ........................................................................ 167 PEEP/CPAP setting ................................................. 31, 32
V-CMV ........................................................................ 158 Rate setting ............................................................ 31, 32
V-SIMV ....................................................................... 160 NCPAP+ patient interface ................................................. 52
Modes, Theory of operation ........................................... 158 Nebulizer .................................................................... 54, 86
Monitored Data Gas delivery compensation when active ................ 54, 83
Advanced ................................................................... 142 Port Label ..................................................................... 21
Auto PEEP ..................................................................... 37 Status Bar Icon ............................................................. 67
Basic ........................................................................... 142 Volume Compensation ................................................. 87
Cstat ............................................................................. 36 Nebulizer Settings ........................................................... 119
Definitions .................................................................... 93 New Patient Startup ......................................................... 76
E-Time (Te) ................................................................... 36 NIF (See PiMax) ................................................................ 37
HL Ratio ........................................................................ 36 NIV ...................................................................... 27, 83, 171
IE Ratio ......................................................................... 36 Status Bar Icon ............................................................. 67
I-Time (Ti) ..................................................................... 36 Non Invasive Ventilation (NIV) Settings .......................... 171
Leak .............................................................................. 35 Nurse call
Mechanics .................................................................. 143 Interface pin assignments ............................................ 51
O2 35 warning ........................................................................ 15
P0.1 .............................................................................. 37
P0.1/PiMax ................................................................... 37
PEEP ............................................................................. 34 O
PF 35
PFe ............................................................................... 35 O2 ⬆ Key
PiMax ........................................................................... 37 Status Bar Icon ............................................................. 67
Pmean .......................................................................... 34 O2 Increase Key ................................................................ 63
®
Section 13 Index
O2 Sensor Calibration ..................................................... 127 Turbine ....................................................................... 179

O2 Sensor Off Power and Gas supply ...................................................... 41
Status Bar Icon ............................................................. 67 Power Supply
O2 Sensor On/Off ........................................................... 121 AC Power ...................................................................... 47
On/Off Button .................................................................. 20 DC Power ...................................................................... 48
On/Off Key ........................................................................ 49 Power Switch .................................................................... 20
Operation ......................................................................... 61 Power Up Screen .............................................................. 76
Ordering parts ................................................................ 134 Pressure Regulated Volume Control Continuous
Overview of Features Mandatory Ventilation ( PRVC-CMV ) Mode .............. 164
CliniNet Server ............................................................. 51 Pressure Regulated Volume Control Synchronized
Virtual Report Remote Monitoring .............................. 51 Intermittent Mandatory Ventilation ( PRVC-SIMV )
Oxygen .............................................................................. 84 Mode .......................................................................... 165
Oxygen (O2) ...................................................................... 28 Pressure Trigger (Ptrig) ..................................................... 27
Oxygen Sensor Calibration ............................................. 124 Pressure triggering ......................................................... 171
Pressure units ................................................................... 23
Pressure-time waveform ................................................ 145
P Preventative Maintenance ............................................. 135
Preventive Maintenance Schedule ................................. 135
Product
P/V Loop ......................................................................... 147
Disposal ...................................................................... 140
P0.1
Product Specifications
Maneuver Details ....................................................... 151
Alarm Settings .............................................................. 38
P0.1 Maneuver ....................................................... 153, 156
Alarms High Priority ..................................................... 40
P0.1 See Maneuvers ......................................................... 37
Alarms Information Priority ......................................... 40
Part Number
Apnea Backup Settings ................................................. 32
1881 ........................................................................... 134
Breath Triggering ......................................................... 27
EVL100500 ................................................................... 65
Breath Types by Control Variable ................................ 24
EVL100500-HP .............................................................. 65
Cart Dimensions ........................................................... 41
E V L 1 0 0 5 0 0 - H P - A ...................................................... 2
Cart Weights ................................................................. 41
E V L 1 0 0 5 0 0 - H P - A - N F ............................................... 2
Configuration Screen Options ...................................... 33
E V L 1 0 0 5 0 0 - T - A ......................................................... 2
Electromagnetic Compatability .................................... 42
E V L 1 0 0 5 0 0 - T - A - N F .................................................. 2
Environmental Data ..................................................... 41
EVL220008 ................................................................. 134
Monitored & Displayed Data ....................................... 34
EVL220047 ................................................................. 134
Operating Temperature ............................................... 41
EVL370017 ................................................................. 134
Patient Startup Options ............................................... 25
EVL500501 ................................................................. 134
Patient Types ................................................................ 25
EVL510014 ..................................................................... 2
Physical Data ................................................................ 41
F710616 ............................................................... 54, 134
Power & Gas Supply ..................................................... 41
F910028 ..................................................................... 134
SPAP Mode Settings ..................................................... 29
F910037 ..................................................................... 134
Storage Temperature ................................................... 41
F910038 ..................................................................... 134
Technical Data .............................................................. 42
MR370 ........................................................................ 134
Ventilation Modes ........................................................ 24
RT130 ......................................................................... 134
Ventilator Dimensions .................................................. 41
RT137 ......................................................................... 134
Ventilator Weight ......................................................... 41
RT850 ......................................................................... 134
PRVC–CMV Settings ........................................................ 165
Part numbers .................................................................. 134
PRVC–SIMV Settings ....................................................... 166
Parts list .......................................................................... 134
PS Made Settings ............................................................ 168
Patient Selection – New Settings ...................................... 77
PS Tmax ............................................................................ 28
Patient Selection Screen ................................................... 76
P–SIMV Mode ................................................................. 163
Pause .......................................................................... 28, 85
P-SIMV mode description ............................................... 163
P-CMV mode description ................................................ 161
P–SIMV Settings .............................................................. 163
Pcontrol ...................................................................... 26, 84
Psup High .................................................................... 29, 85
Peak Flow ................................................................... 26, 84
Psup Low ..................................................................... 29, 85
PEEP .................................................................................. 85
Psupport ..................................................................... 26, 85
PEEP / CPAP ...................................................................... 26
P-V loop .......................................................................... 145
Phigh ..................................................................... 29, 30, 85
Physical Data .................................................................... 41
PiMax ................................................................................ 37
Maneuver Details ....................................................... 155 R
Plateau .............................................................................. 28
Plateau Pressure ............................................................... 37 Rapid shallow breathing index (RSBI) ............................... 37
Plow ............................................................................ 29, 85 Rate ............................................................................ 25, 85
Pneumatic Schematic Real-Time Curves
Dual High Pressure ..................................................... 178 Loops ............................................................................ 38
®
Section 13 Index
Waveforms ................................................................... 38 HL Ratio ........................................................................ 30

Real-Time Curves Graphics Display ................................ 145 Phigh ...................................................................... 29, 30
Resistance Plow ............................................................................. 29
Expiratory (Rexp) .......................................................... 37 Psup High ..................................................................... 29
Inspiratory (Rinsp) ........................................................ 37 Psup Low ...................................................................... 29
Respiratory Mechanics ................................................... 143 Rate .............................................................................. 30
Revision History ................................................................ 12 SPAP Type .................................................................... 30
Rise Time .......................................................................... 84 Thigh ............................................................................ 29
Tlow .............................................................................. 30
Setup ................................................................................ 47
S Sigh
Status Bar Icon ............................................................. 67
Safety .......................................................................... 13, 72 SIMV
Standby Screen ............................................................ 72 Pressure ..................................................................... 163
Screen Lock / Unlock ........................................................ 23 Volume ....................................................................... 160
Settings Slop ................................................................................... 84
Auto Control ................................................................. 28 Smart Nebulizer .......................................................... 54, 86
Base Flow ..................................................................... 27 Smart Sigh ................................................................. 87, 119
Current Settings Screen ............................................... 80 SPAP Mode ....................................................................... 29
Exhalation Sensitivity (Esens) ....................................... 28 Cycle (rate) setting ....................................................... 30
Flow Pattern ................................................................. 28 Description ................................................................. 168
Flow Trigger ................................................................. 27 HL Ratio setting ............................................................ 30
I-Time (Ti) ..................................................................... 26 Phigh setting .......................................................... 29, 30
Leak Comp .................................................................... 27 Plow setting .................................................................. 29
Max Boundary .............................................................. 74 Psup High setting ......................................................... 29
NIV ............................................................................... 27 Psup Low setting .......................................................... 29
Oxygen (O2) .................................................................. 28 SPAP Type (philosophy) setting .................................... 30
Thigh setting ................................................................. 29
Pause ............................................................................ 28
Tlow setting .................................................................. 30
Pcontrol ........................................................................ 26
SPAP mode description .................................................. 168
Peak Flow ..................................................................... 26
SPAP Settings .................................................................. 169
PEEP / CPAP ................................................................. 26
SPAP Typ ........................................................................... 84
Plateau ......................................................................... 28
SPAP Type ......................................................................... 30
Pressure Trigger ........................................................... 27
Spare parts ..................................................................... 134
Proposed Settings Screen ............................................ 80
Specifications .................................................................... 23
PS Tmax ........................................................................ 28
SPONT
Psupport ....................................................................... 26
PS 167
Rate .............................................................................. 25
SPAP ........................................................................... 168
Screen Lock/Unlock ...................................................... 28
VTV ............................................................................. 166
Soft Boundary .............................................................. 73
SPONT mode description ................................................ 167
Tidal Volume ................................................................ 26
Spontaneous Breaths in SPAP Mode .............................. 169
Timeouts ...................................................................... 73
Standard ........................................................................... 25
Unaccepted Changes .................................................... 73
Standby Key ...................................................................... 62
Settings Alarm Settings Standard
Standby Screen ................................................................. 72
Ppeak High ................................................................... 39
Standby Selection ............................................................. 62
Ppeak Low .................................................................... 39
Starting ventilation ........................................................... 64
Settings Apnea Backup
Startup
Default Settings ............................................................ 32
Patient Option .............................................................. 77
Modes .......................................................................... 32
Startup screen .................................................................. 64
Settings Config. Screen (Clinical)
Static Compliance and Resistance Measurements ......... 144
Humidification Type ..................................................... 33
Status Bar Icon
Settings Config. Screen (Technical)
100% O2 (Adult/Pedi) .................................................. 67
Password Access to User Config .................................. 34
Apnea Backup .............................................................. 67
Settings Description .......................................................... 82
Auto Control ................................................................. 67
Settings NCPAP+ Mode
Battery in use ............................................................... 67
Flow .............................................................................. 31
Calibration Required .................................................... 67
I-Time ........................................................................... 31
Manual Breath ............................................................. 67
Max Flow to PEEP setting ............................................. 31
Nebulizer ...................................................................... 67
Pcontrol ........................................................................ 31
NIV ................................................................................ 67
PEEP/CPAP ............................................................. 31, 32
O2 Sensor Off ............................................................... 67
Rate ........................................................................ 31, 32
Sigh ............................................................................... 67
Settings Screen ................................................................. 80
Sterilization
Settings SPAP Mode
exhalation valve cover ............................................... 130
Cycle ............................................................................. 30
®
Section 13 Index
Suction Support
Activation ................................................................... 152
U
Disconnect Phase ...................................................... 152
Post Oxygenation Phase ............................................. 153 User Interface ................................................................... 62
Preparation Phase ...................................................... 152 Alarm Message Display ................................................ 68
Symbols ...................................................................... 13, 20 Battery Icon .................................................................. 67
System Test ...................................................... 13, 124, 125 Controls Dual Fault Philosophy .................................... 69
Current Mode Display .................................................. 67
Date and Time Display ................................................. 67
Left Display Panel ......................................................... 68
T Lock Unlock Button ...................................................... 69
Monitor Bar .................................................................. 68
Table of Contents ............................................................ 3 Navigation Tabs ............................................................ 68
Table of Figures ............................................................... 7 Patient Effort (Trigger) Indicator .................................. 67
Table of Tables .............................................................. 10 Patient Type Display ..................................................... 66
Technical Data .................................................................. 42 Settings Bar .................................................................. 68
Technical Fault Status Bar ..................................................................... 67
TF-01 .......................................................................... 110 Touch Screen Bypass Feature ...................................... 70
TF-02 .......................................................................... 110
TF-03 .......................................................................... 110
TF-04 .......................................................................... 110
TF-05 .......................................................................... 110
V
TF-06 .......................................................................... 110
TF-07 .......................................................................... 110 V–CMV Mode ................................................................. 159
TF-08 .......................................................................... 111 V-CMV mode description ............................................... 158
TF-10 .......................................................................... 111 V–CMV Settings .............................................................. 159
TF-11 .......................................................................... 111 Ventilation Modes
TF-12 .......................................................................... 111 Types & Selection ......................................................... 82
Technical Faults .............................................................. 110 Ventilator
Technical Specifications Alarm Definitions ....................................................... 100
EMC .............................................................................. 42 Alarm Message Display ................................................ 68
Terms and Definitions .................................................... 173 Alarm Priority ............................................................... 99
Theory of operation ........................................................ 158 Alarm Settings .............................................................. 99
NCPAP+ ...................................................................... 170 Alarms ........................................................ 100, 103, 105
P-CMV ........................................................................ 161 Alarms Screen .............................................................. 96
PRVC-CMV .................................................................. 164 Breath Types by Control Variable ................................ 24
PRVC-SIMV ................................................................. 165 Calibrations ............................................................ 77, 80
PS 167 Config Screen ............................................................. 118
P-SIMV ........................................................................ 163 Controls Adjustment .................................................... 69
SPAP ........................................................................... 168 Controls Dual Fault Philosophy .................................... 69
V-CMV ........................................................................ 158 Event Log ...................................................................... 99
VS 166 exterior cleaning ........................................................ 129
V-SIMV ....................................................................... 160 GUI Navigation ............................................................. 65
VTV ............................................................................. 164 Main Screen ................................................................. 91
Thigh ........................................................................... 29, 85 Mode Types and Mode Selection ................................. 24
Ti 85 Monitored Data ............................................................ 93
Tidal Volume ..................................................................... 86 Monitoring Screen ....................................................... 92
Tidal Volume (Vt) .............................................................. 26 Patient Option .............................................................. 77
Tlow ............................................................................ 30, 86 Patient Startup Options ............................................... 25
To Patient Port ................................................................. 22 preparation for use ...................................................... 47
Touch Screen .................................................................... 65 Settings Screen ............................................................. 80
Touch Screen Bypass Feature ........................................... 70 Setup ............................................................................ 76
Touch Screen Calibration .................................................. 64 Standard Mode Settings ............................................... 25
Touch Screen Philosophy ................................................. 65 Startup Screens ............................................................ 76
Trend Data ........................................................................ 96 Touch Screen Bypass Feature ...................................... 70
Trend Settings .................................................................. 87 Trends Screen ............................................................... 95
Trended Parameters ......................................................... 96 Ventilator Controls
Trending Parameters ...................................................... 149 Action keys ................................................................... 62
Trends Screen ................................................................... 95 Navigation keys ............................................................ 62
Trigger .............................................................................. 83 Ventilator Controls ........................................................... 62
Trigger Type ...................................................................... 27 Dual Fault Philosophy ................................................. 126
Unaccepted Changes .................................................... 73
Ventilator Modes
Activating ..................................................................... 89
®
Section 13 Index
Ventilator Set Up .............................................................. 76 Rise Time ...................................................................... 84

Ventilator Settings Setting Bar Setting Options .......................................... 84
Apnea Backup .............................................................. 83 SPAP Type .................................................................... 84
Apnea O2 ..................................................................... 86 Thigh ............................................................................ 85
Auto Control ........................................................... 83, 89 Tidal Volume ................................................................ 86
Base Flow ..................................................................... 84 Tlow .............................................................................. 86
Current & Proposed ..................................................... 83 Trigger .......................................................................... 83
Cycle ............................................................................. 84 Volume Support Ventilation ( VS ) Mode ....................... 166
Esens% ......................................................................... 83 Volume Targeted Ventilation (VTV) Modes .................... 164
Flow Pattern ................................................................. 83 V-SIMV mode description ............................................... 160
HL Ratio ........................................................................ 83
Insp Time ...................................................................... 85
Leak Comp .................................................................... 84 W
NIV ............................................................................... 83
O2 ................................................................................. 84 Warning
Pause ............................................................................ 85 CO2 monitor placement ............................................... 56
Pcontrol ........................................................................ 84 Waveform Scale Ranges ................................................. 148
Peak Flow ..................................................................... 84 Waveforms ....................................................................... 38
PEEP ............................................................................. 85 Work of Breathing Imposed (WOBimp) ............................ 38
Phigh ............................................................................ 85
Plow ............................................................................. 85
Psup high ...................................................................... 85
Psup low ....................................................................... 85
Z
Psupport ....................................................................... 85
Rate .............................................................................. 85 Zero Flow Sensor ............................................................ 124
®
Section 13 Index
14. E-mail Contacts
Sales
International Sales: international.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 48: E-mail Contact Details
www.event-medical.com
®

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Preface

© 2010 – 2018 eVent Medical All rights reserved.

• eVolution 3e Ventilator, HP System PN: EVL100500 – HP

• eVolution 3e Ventilator System PN: EVL100500 – T

United States Europe

1.1. INTENDED USE ........................................................................................................................................................ 13

2.10.3. Nurse Call Connection (RJ12 connector) .................................................................................................... 51

Author REV Description of Changes Creation Date

Jeffrey Huang A Initial Draft 02 – Nov - 2015

Added software options.

Updated for software 5.0.1

Added section 1.2, 1.4.4, 1.7.1, 1.8.5, 2.5, 2.13, 5.7

Eliminated Heliox in section 1.5

Updated for software 6.3.00

1. Introduction to the eVolution 3e Ventilator

1.1. Intended use

1.3. Frequent Use Functions:

Warning and Caution Symbol: Information or directions/warnings intended to

• Explanatory notes and comments relevant to the eVolution ventilator.

1.5. Warnings, Cautions and Basic Safety Information

• General Warning and Caution Information

• Before Using the Ventilator

• Monitoring and Alarms

• Fire and Other Hazards

• Service and Testing

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

causing the ISA gas analyzer to fall on the patient.

1.5.1. Copyright Notice

1.5.2. Trademark Notice

1.5.3. Notice of Conformity, Compliance and Approvals

Standards to which conformity is declared

1.5.4. Electromagnetic Compatibility

1.5.5. CE Notified Body

1.5.7. Regulatory Notice

1.6. Device Labels and Symbols

Manual Inspiration key / Mandatory breath

On / Off / Standby key

Alarm Silence / Mute key

An illuminated LED at the top of the device indicates there is an active

Front Panel: Vent Inop indicator

Front Panel: Mains power connected indicator

Device Labels and Symbols

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

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

Ethernet Ethernet connection port

Nurse call connection port

Refer to instruction manual

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

Designates type BF equipment per IEC 601-1

IPX1 Indicates the degree of protection (drip-proof) by the enclosure.

Low pressure Oxygen inlet port label

DC–Input: DC input connection

Device Labels and Symbols

AC–Input: AC input connection

O2 Sensor Oxygen sensor location

Device serial number

Inspiratory gas flow to the patient from the ventilator

Expiratory gas flow from the patient to the ventilator

Do not obstruct! Do not obstruct port or outlet

Indicates WEEE (Waste Electrical and Electronic Equipment) Registration

Door Push / Open Label

Indicates the internal compressor is not installed.

Door Push / Open Label