User Manual

eVolution 3e
®

International Version
Preface
Revision M of this user manual: Part Number EVM500041 (Ventilator, User Manual, International Version)
November-2022.

© 2022 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.
This document is intended to provide information to an international audience outside of the US.
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 or

EVL100500-HP-NF

• eVolution 3e Ventilator, T System PN: EVL100500 – T or

EVL100500-T-NF
 Each model, when shipped will be configured with the latest software for that model.
 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.,
EVL100500– HP)
 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.,
EVL100500 – T)
 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
60 Empire Drive
Lake Forest, CA 92630
Tel: +1 949 900 1917
Fax: +1 949 900 1905
www.event-medical.com

EVM500041, Rev M eVolution® 3e Series User Manual (International 2

 Table of Contents

Table of Contents
TABLE OF CONTENTS..................................................................................................................................................................... 3
1. INTRODUCTION TO THE EVOLUTION 3E VENTILATOR ...................................................................................................... 12
1.1 INTENDED USE ....................................................................................................................................................................................................................... 12
1.2 CONTRAINDICATIONS: ........................................................................................................................................................................................................... 12
1.3 FREQUENT USE FUNCTIONS:.................................................................................................................................................................................................. 12
1.4 SAFETY ................................................................................................................................................................................................................................... 12
1.5 WARNINGS, CAUTIONS AND BASIC SAFETY INFORMATION ................................................................................................................................................... 13
1.5.1 Copyright Notice .............................................................................................................................................................. 18
1.5.2 Trademark Notice ............................................................................................................................................................ 18
1.5.3 Notice of Conformity, Compliance and Approvals ........................................................................................................... 18
1.5.4 Electromagnetic Compatibility ........................................................................................................................................ 18
1.5.5 CE Notified Body .............................................................................................................................................................. 19
1.5.6 Classification ................................................................................................................................................................... 19
1.5.7 Regulatory Notice ............................................................................................................................................................ 19
1.5.8 Transport ......................................................................................................................................................................... 19
1.5.9 Storage ............................................................................................................................................................................ 19
1.6 DEVICE LABELS AND SYMBOLS ............................................................................................................................................................................................... 19
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 ........................................................................................................................................................ 31
1.8.9 Tube Compensation (optional software) ......................................................................................................................... 32
1.8.10 NCPAP+ Mode Settings*.................................................................................................................................................. 34
1.8.11 Hi FlowO2 (Optional Software) ....................................................................................................................................... 34
1.8.12 Apnea Backup Settings .................................................................................................................................................... 35
1.8.13 Configuration Screen Setting Options (Config) ................................................................................................................ 35
1.8.14 Monitored Data / Displayed Patient Values .................................................................................................................... 36
1.8.15 Graphics: Real-Time Curves ............................................................................................................................................. 44
1.8.16 Alarm Limit Settings ........................................................................................................................................................ 45
1.8.17 Alarms by Priority ............................................................................................................................................................ 46
1.8.18 SBT Mode Settings........................................................................................................................................................... 48
1.9 TECHNICAL SPECIFICATIONS .................................................................................................................................................................................................. 48
1.9.1 Power and Gas Supply ..................................................................................................................................................... 48
1.9.2 Environmental Data ........................................................................................................................................................ 49
1.9.3 Physical Data ................................................................................................................................................................... 49
1.9.4 Technical Data ................................................................................................................................................................. 49
1.9.5 Technical Data: Capnography Sensors ............................................................................................................................ 50
1.9.6 Compliance and Approvals .............................................................................................................................................. 50
1.9.7 Electromagnetic Compatibility Declaration ..................................................................................................................... 50
2 PREPARING THE VENTILATOR FOR USE ............................................................................................................................ 55
2.1 VENTILATOR SETUP................................................................................................................................................................................................................ 55
2.2 POWER SUPPLY ...................................................................................................................................................................................................................... 56
2.3 AC MAINS SUPPLY .................................................................................................................................................................................................................. 56
2.4 DC (EXTERNAL BATTERY) SUPPLY ........................................................................................................................................................................................... 57
2.5 DC (INTERNAL BATTERY) POWER SUPPLY .............................................................................................................................................................................. 57
2.6 ON AND OFF POWER SWITCH ................................................................................................................................................................................................ 58
2.7 GAS SUPPLY ........................................................................................................................................................................................................................... 58
2.8 HIGH PRESSURE BASED SYSTEM: CONNECTING TO OXYGEN AND AIR SUPPLY ...................................................................................................................... 59
2.9 OPTIONAL, TURBINE BASED SYSTEM: CONNECTING TO OXYGEN SUPPLY ............................................................................................................................. 59

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2.10 ETHERNET AND NURSE CALL .................................................................................................................................................................................................. 60
2.10.1 Ethernet Connection (RJ45 connector) ............................................................................................................................ 60
2.10.2 CliniNet® Server ................................................................................................................................................................ 60
2.10.3 Nurse Call Connection (RJ12 connector) .......................................................................................................................... 60
2.11 BREATHING CIRCUIT .............................................................................................................................................................................................................. 61
2.11.1 Nasal Prongs.................................................................................................................................................................... 61
2.11.2 Exhalation System ........................................................................................................................................................... 62
2.11.3 Humidification Devices .................................................................................................................................................... 63
2.11.4 Nebulizer Use and Placement .......................................................................................................................................... 63
2.12 TUBING SUPPORT ARM OPTIONS: ......................................................................................................................................................................................... 63
2.13 CAPNOGRAPHY (MAINSTREAM / SIDESTREAM) SENSORS ..................................................................................................................................................... 64
2.13.1 Classifications .................................................................................................................................................................. 64
2.13.2 IRMA Mainstream CO2Sensor ......................................................................................................................................... 65
3 OPERATION ..................................................................................................................................................................... 70
3.1 VENTILATOR CONTROLS ........................................................................................................................................................................................................ 70
3.1.1 Standby Key ..................................................................................................................................................................... 71
3.1.2 O2 ⬆Key (%O2 Increase Key or 100% O2 Key) ................................................................................................................. 72
3.1.3 Manual Breath Key .......................................................................................................................................................... 72
3.1.4 Alarm Silence Key ............................................................................................................................................................ 72
3.3 CALIBRATION ......................................................................................................................................................................................................................... 73
3.4 START UP PROCESS ................................................................................................................................................................................................................ 73

4 GRAPHICAL USER INTERFACE ........................................................................................................................................... 74

4.1 GENERAL DESCRIPTION .......................................................................................................................................................................................................... 74
4.2 DEFINITIONS AND REFERENCES ............................................................................................................................................................................................. 74
4.3 DEVICES AFFECTED ................................................................................................................................................................................................................ 74
4.4 PHILOSOPHY (USER INTERFACE) ............................................................................................................................................................................................ 74
4.4.1 Graphic User Interface Navigation .................................................................................................................................. 74
4.4.2 Adjusting and Confirming Control Setting ....................................................................................................................... 78
4.4.3 Touch Screen Bypass Feature .......................................................................................................................................... 79
4.5 SAFETY ................................................................................................................................................................................................................................... 80
4.5.1 Screen Display Defaults to Main Screen (2 minute rule).................................................................................................. 80
4.5.2 Time Outs and Unaccepted Changes ............................................................................................................................... 81
4.5.3 Control Setting Limit (Soft Boundary) Feature ................................................................................................................ 81
5 VENTILATOR SET UP......................................................................................................................................................... 84
5.1 POWER UP SCREEN ................................................................................................................................................................................................................ 84
5.2 PATIENT SELECTION SCREEN - NEW PATIENT AND PREVIOUS PATIENT ................................................................................................................................. 84
5.2.1 Patient Option and Patient Setup .................................................................................................................................... 85
5.2.2 Ideal Body Weight Calculator .......................................................................................................................................... 86
5.2.3 Flow Sensor ON/OFF........................................................................................................................................................ 87
5.2.4 Humidification Type ........................................................................................................................................................ 87
5.2.5 Pre-Patient Tests ............................................................................................................................................................. 87
5.2.6 Calibrations ..................................................................................................................................................................... 89
5.2.7 Accept Button .................................................................................................................................................................. 89
5.3 SETTINGS TAB ........................................................................................................................................................................................................................ 89
5.3.1 Current Settings Screen ................................................................................................................................................... 89
5.3.2 Proposed Settings Screen ................................................................................................................................................ 90
5.3.3 Choosing a Mode and Breath Type ................................................................................................................................. 91
5.3.4 Right Panel: Current & Proposed Settings Selections ...................................................................................................... 93
5.3.7 Smart Sigh™ .................................................................................................................................................................... 97
5.3.8 Trend Data Settings ......................................................................................................................................................... 97
5.3.10 Activating Ventilation ...................................................................................................................................................... 99
5.3.11 Vital Capacity (VC) ........................................................................................................................................................... 99
5.3.12 SBT Mode ............................................................................................................................................................................. 99
5.4 HOME TAB ........................................................................................................................................................................................................................... 103
5.5 DATA TAB ............................................................................................................................................................................................................................. 105
5.5.1 Monitored Data: Parameters and Definitions ............................................................................................................... 105
5.5.2 Trended Data................................................................................................................................................................. 108
5.6 ALARMS TAB ........................................................................................................................................................................................................................ 110
5.6.1 Alarm Auto Set Feature ................................................................................................................................................. 110

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 Table of Contents
5.6.2 Alarm Setting Parameters ............................................................................................................................................. 112
5.6.3 Event Log ....................................................................................................................................................................... 114
5.6.4 Alarm Signals ................................................................................................................................................................. 114
5.6.5 Alarm Levels .................................................................................................................................................................. 115
5.6.6 Alarm Silence Key .......................................................................................................................................................... 115
5.6.7 Alarm Definitions ........................................................................................................................................................... 115
5.6.8 About Diagnostic Alarm Messages................................................................................................................................ 121
5.6.9 Disconnection Alarms .................................................................................................................................................... 121
5.6.10 Technical Failures Alarms .............................................................................................................................................. 125
5.6.11 Alarm Reset and Clearing Inactive (Latched) Alarms .................................................................................................... 126
5.6.12 Hazards Based on User / Device Errors ......................................................................................................................... 126
5.7 CAPNOGRAPHY .................................................................................................................................................................................................................... 128
5.7.1 Warnings and Cautions ................................................................................................................................................. 130
5.7.2 Capnography Waveforms and SBCO2 Curves ............................................................................................................... 132
5.8 CONFIG TAB ......................................................................................................................................................................................................................... 133
5.8.1 Monitors ........................................................................................................................................................................ 136
5.8.2 Compliance Comp .......................................................................................................................................................... 136
5.8.3 O2 Sensor: ..................................................................................................................................................................... 136
5.8.4 Low Flow O2 (Blower Based System)............................................................................................................................. 137
5.8.5 Audio / Visual ................................................................................................................................................................ 137
6 CALIBRATIONS AND CLEANING ...................................................................................................................................... 139
6.1 CALIBRATION OPTIONS ........................................................................................................................................................................................................ 139
6.1.1 Zero Flow Sensor Calibration ......................................................................................................................................... 140
6.1.2 Pre-Patient Tests ........................................................................................................................................................... 140
6.1.3 O2 Sensor Calibration .................................................................................................................................................... 142
6.1.4 EXH Flow Sensor Calibration ......................................................................................................................................... 143
6.2 CLEANING AND STERILIZATION ............................................................................................................................................................................................ 143
6.2.1 Patient Breathing Circuit and Nebulizers....................................................................................................................... 144
6.2.2 Humidification Devices .................................................................................................................................................. 144
6.2.3 Ventilator Exterior ......................................................................................................................................................... 144
6.2.4 Touch Screen LCD Display .............................................................................................................................................. 144
6.2.5 Exhalation Flow Sensor ................................................................................................................................................. 144
6.2.6 Exhalation System and Diaphragm ............................................................................................................................... 145
6.2.7 Manual Cleaning: .......................................................................................................................................................... 146
7. SPARE PARTS ................................................................................................................................................................. 148
8. PREVENTATIVE MAINTENANCE ...................................................................................................................................... 150
8.1 COOLING FAN FILTER ........................................................................................................................................................................................................... 150
8.2 AIR INLET FILTER .................................................................................................................................................................................................................. 151
8.3 OXYGEN SENSOR .................................................................................................................................................................................................................. 151
8.4 INTERNAL BATTERY .............................................................................................................................................................................................................. 152
8.4.1 Replacement of Internal Batteries (Turbine Model) ...................................................................................................... 152
8.4.2 Replacement of Internal Battery (High Pressure Model) ............................................................................................... 153
8.5 FUSES ................................................................................................................................................................................................................................... 153
8.6 ALARM TEST PROCEDURE .................................................................................................................................................................................................... 153
8.6.1 Alarms Functionality Tests ............................................................................................................................................ 154
8.7 DISPOSAL ............................................................................................................................................................................................................................. 155

9. MONITORED PARAMETERS, MANEUVERS AND GRAPHICS DISPLAY ................................................................................ 157

9.1 MONITORED PARAMETERS .................................................................................................................................................................................................. 157
9.2 DATA TAB ............................................................................................................................................................................................................................. 157
9.2.1 Respiratory Mechanics .................................................................................................................................................. 159
9.2.2 Static Compliance and Resistance Measurements ........................................................................................................ 161
9.2.3 Auto Peep Measurement ............................................................................................................................................... 161
9.2.4 Real-Time Curves Graphics Display ............................................................................................................................... 161
9.3. MANEUVERS ........................................................................................................................................................................................................................ 167
9.3.1 Suction Support ............................................................................................................................................................. 168
9.3.2 P0.1 Maneuver .............................................................................................................................................................. 170
9.3.3 PiMax Maneuver ........................................................................................................................................................... 172
9.3.4 Inspiratory Hold Maneuver............................................................................................................................................ 173

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9.3.5 Expiratory Hold Maneuver............................................................................................................................................. 174
9.4 LUNG MODEL ....................................................................................................................................................................................................................... 174
9.5 WEANING TARGET TOOL ...................................................................................................................................................................................................... 176

10. THEORY OF OPERATION ................................................................................................................................................. 178

10.1 VENTILATION MODES .......................................................................................................................................................................................................... 178
10.1.1 Volume Controlled Continuous Mandatory Ventilation (V-CMV) ...................................................................................... 178
10.1.2 Volume Controlled Synchronized Intermittent Mandatory Ventilation (V-SIMV) Mode............................................. 180
10.1.3 Pressure Controlled Continuous Mandatory Ventilation (P-CMV) Mode........................................................................... 181
10.1.4 Pressure Controlled Synchronized Intermittent Mandatory Ventilation (P-SIMV) Mode .............................................. 183
10.1.5 Volume Targeted Ventilation (VTV) Modes ................................................................................................................... 184
10.1.6 Pressure Regulated Volume Control Continuous Mandatory Ventilation (PRVC-CMV) Mode ....................................... 184
10.1.7 Pressure Regulated Volume Control Synchronized Intermittent Mandatory Ventilation (PRVC-SIMV) Mode .......... 185
10.1.8 PRVC-PS/VS Mode ......................................................................................................................................................... 186
10.1.9 Pressure Support Ventilation (PS/CPAP) Mode ............................................................................................................. 187
10.1.10 Spontaneous Positive Airway Pressure Ventilation/ Airway Pressure Release Ventilation (SPAP/APRV) Mode ........... 188
10.1.11 NCPAP+ Mode ............................................................................................................................................................... 190
10.1.12 Auto Control Mode ........................................................................................................................................................ 191
10.1.13 Non-Invasive Ventilation (NIV) Settings ........................................................................................................................ 198
10.1.14 Breath Triggering (All Modes) ....................................................................................................................................... 198
11. TERMS, ABBREVIATIONS AND DEFINITIONS ................................................................................................................... 200
12. PNEUMATIC SCHEMATIC................................................................................................................................................ 205
13. INDEX ............................................................................................................................................................................ 207
14. E-MAIL CONTACTS ......................................................................................................................................................... 209

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 Index of Figures

Index of Figures
FIGURE 1: INSTALLING O2 SENSOR ........................................................................................................................................................ 55
FIGURE 2: CALIBRATE OXYGEN SENSOR SCREEN ............................................................................................................................... 56
FIGURE 3: POWER SUPPLY SOCKET....................................................................................................................................................... 57
FIGURE 4: DC, EXTERNAL BATTER SOCKET .......................................................................................................................................... 57
FIGURE 5: ON/OFF SWITCH ...................................................................................................................................................................... 58
FIGURE 6: HIGH PRESSURE O2 AND AIR INLET ..................................................................................................................................... 59
FIGURE 7: HIGH PRESSURE O2 INLET FIGURE 8: LOW PRESSURE O2 INLET ................................................................................ 59
FIGURE 9: COMMUNICATION PORTS, ETHERNET AND NURSE CALL ................................................................................................. 60
FIGURE 10: NURSE CALL CONNECTOR PIN ASSIGNMENTS ................................................................................................................ 61
FIGURE 11: BREATHING CIRCUIT ............................................................................................................................................................ 61
FIGURE 12: NCPAP PRONGS .................................................................................................................................................................... 62
FIGURE 13: EVOLUTION 3E EXHALATION VALVE SYSTEM ................................................................................................................... 63
FIGURE 14: FLEX ARM ASSEMBLY ........................................................................................................................................................... 64
FIGURE 15: ATTACHING THE IRMA MAINSTREAM CO2 SENSOR TO THE BREATHING CIRCUIT ..................................................... 65
FIGURE 16: ZERO CO2 SENSOR CALIBRATION SELECTION ................................................................................................................ 66
FIGURE 17: PERFORMING A ZERO CO2 SENSOR CALIBRATION ......................................................................................................... 67
FIGURE 18: ATTACHING THE ISA SIDESTREAM CO2 SENSOR TO THE VENTILATOR ....................................................................... 68
FIGURE 19: ATTACHING THE SIDESTREAM CO2SENSOR AND SAMPLE LINE ................................................................................... 70
FIGURE 20: EVOLUTION 3E FRONT PANEL ............................................................................................................................................. 71
FIGURE 21: STANDBY KEY OPTIONS ....................................................................................................................................................... 72
FIGURE 22: EVOLUTION POWER UP & PATIENT SETUP SCREEN ....................................................................................................... 73
FIGURE 23: GRAPHIC USER INTERFACE ................................................................................................................................................ 75
FIGURE 24: GRAPHIC USER INTERFACE, MODE SELECTION .............................................................................................................. 75
FIGURE 25: STANDBY NOT VENTILATING (SAFETY MESSAGE) ........................................................................................................... 81
FIGURE 26: CONTROL SETTING LIMIT (SOFT BOUNDARY) FEATURE ................................................................................................. 82
FIGURE 27: POWER UP SCREEN ............................................................................................................................................................. 84
FIGURE 28: PATIENT SELECTION SCREEN – STARTUP SCREEN ........................................................................................................ 84
FIGURE 29: NEW PATIENT STARTUP SCREEN ....................................................................................................................................... 85
FIGURE 30: IBW PATIENT STARTUP SCREEN ........................................................................................................................................ 86
FIGURE 31: PREVIOUS PATIENT STARTUP SCREEN ............................................................................................................................. 86
FIGURE 32: IDEAL BODY WEIGHT SCREEN ............................................................................................................................................ 87
FIGURE 33: PATIENT SETUP PAGE .......................................................................................................................................................... 87
FIGURE 34: HUMIDIFICATION TYPE SELECTION OPTION ..................................................................................................................... 87
FIGURE 35: PRE-PATIENT SYSTEM TESTS ............................................................................................................................................. 88
FIGURE 36: CALIBRATION OPTIONS ........................................................................................................................................................ 89
FIGURE 37: CURRENT SETTINGS SCREEN............................................................................................................................................. 90
FIGURE 38: PROPOSED SETTINGS SCREEN .......................................................................................................................................... 90
FIGURE 39: MODE TYPE / MODE SELECTIONS ...................................................................................................................................... 91
FIGURE 40: NEBULIZER SCREEN ............................................................................................................................................................. 96
FIGURE 41: SMART SIGH SECTION .......................................................................................................................................................... 97
FIGURE 42: TREND DATA SETTINGS ....................................................................................................................................................... 98
FIGURE 43: TUBE COMPENSATION SETTINGS ...................................................................................................................................... 98
FIGURE 44: TUBE COMPENSATION WAVEFORM ................................................................................................................................... 99
FIGURE 45: SBT SETTINGS SCREEN ..................................................................................................................................................... 100
FIGURE 46: SBT AUTOMATIC EVENT MARKERS .................................................................................................................................. 103
FIGURE 47: HOME TAB ............................................................................................................................................................................ 103
FIGURE 48: DATA TAB ............................................................................................................................................................................. 105
FIGURE 49: TRENDING WAVEFORM AND PARAMETER SELECTION SCREENS ............................................................................... 108
FIGURE 50: ALARMS SCREEN ................................................................................................................................................................ 110
FIGURE 51: EVENT LOG .......................................................................................................................................................................... 114
FIGURE 52: REAL-TIME GRAPHICS (CAPNOGRAMS) ........................................................................................................................... 132
FIGURE 53: REAL-TIME GRAPHICS (SBCO2CURVES) .......................................................................................................................... 133
FIGURE 54: CONFIG SCREEN ................................................................................................................................................................. 133
FIGURE 55: MONITORS............................................................................................................................................................................ 136
FIGURE 56: COMPLIANCE COMPENSATION ......................................................................................................................................... 136
FIGURE 57: O2 SENSOR – HIGH PRESSURE SYSTEM ......................................................................................................................... 137
FIGURE 58: LOW FLOW O2 – OPTIONAL, BLOWER BASED SYSTEM ................................................................................................. 137
FIGURE 59: AUDIO / VISUAL OPTIONS ................................................................................................................................................... 138
FIGURE 60: CALIBRATIONS..................................................................................................................................................................... 139

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 Index of Figures

FIGURE 61: CALIBRATE EXHALATION FLOW SENSOR ZERO OFFSET .............................................................................................. 140
FIGURE 62: PRE-PATIENT TESTS SCREEN ........................................................................................................................................... 141
FIGURE 63: SYSTEM TEST FAILURE MESSAGE ................................................................................................................................... 141
FIGURE 64: CALIBRATE OXYGEN SENSOR SCREEN ........................................................................................................................... 142
FIGURE 65: CALIBRATE EXHALATION FLOW SENSOR SCREEN ........................................................................................................ 143
FIGURE 66: EXHALATION FLOW SENSOR ............................................................................................................................................. 145
FIGURE 67: EXHALATION VALVE SYSTEM ............................................................................................................................................ 145
FIGURE 68: EXHALATION VALVE SYSTEM COMPONENTS ................................................................................................................. 147
FIGURE 69: EXHALATION SYSTEM ASSEMBLY 1 ................................................................................................................................. 147
FIGURE 70: EXHALATION SYSTEM ASSEMBLY 2 ................................................................................................................................. 148
FIGURE 71: EXHALATION SYSTEM ASSEMBLY 3 ................................................................................................................................. 148
FIGURE 72: FAN FILTER AND COVER .................................................................................................................................................... 151
FIGURE 73: AIR INLET HEPA FILTER ...................................................................................................................................................... 151
FIGURE 74: O2 SENSOR .......................................................................................................................................................................... 152
FIGURE 75: INTERNAL BATTERIES (TURBINE UNIT) ............................................................................................................................ 152
FIGURE 74: INTERNAL BATTERY (HIGH PRESSURE UNIT) ................................................................................................................. 153
FIGURE 77: FUSE .................................................................................................................................................................................... 153
FIGURE 78: SELECTING A MONITORING PARAMETER ........................................................................................................................ 157
FIGURE 79: BASIC MONITORED PARAMETERS.................................................................................................................................... 158
FIGURE 80: MECHANICS MONITORED PARAMETERS ......................................................................................................................... 158
FIGURE 81: WEANING MONITORED PARAMETERS ............................................................................................................................. 159
FIGURE 82: FLOW AND PRESSURE WAVEFORMS CSTAT, RINSP & REXP ....................................................................................... 161
FIGURE 83: HOME SCREEN GRAPHICS DISPLAY ................................................................................................................................ 163
FIGURE 84: LOOP WINDOWS (LEFT PANEL) ......................................................................................................................................... 164
FIGURE 83: WAVEFORM CONFIGURATION ........................................................................................................................................... 164
FIGURE 84: FREEZING GRAPHICS ......................................................................................................................................................... 166
FIGURE 85: TREND DISPLAY .................................................................................................................................................................. 167
FIGURE 86: TREND CONFIGURATION.................................................................................................................................................... 167
FIGURE 87: SELECTING MANEUVERS ................................................................................................................................................... 168
FIGURE 88: SUCTION SUPPORT MANEUVER SELECTION .................................................................................................................. 168
FIGURE 91: SUCTION SUPPORT PREPARATION PHASE ..................................................................................................................... 169
FIGURE 90: SUCTION SUPPORT PATIENT DISCONNECTED PHASE .................................................................................................. 169
FIGURE 91: SUCTION SUPPORT POST OXYGENATION PHASE ......................................................................................................... 170
FIGURE 92: P0.1 MANEUVER .................................................................................................................................................................. 171
FIGURE 95: P0.1 MANEUVER MEASUREMENT GRAPH ........................................................................................................................ 171
FIGURE 96: PIMAX MANEUVER .............................................................................................................................................................. 173
FIGURE 97: INSPIRATORY HOLD MANEUVER ...................................................................................................................................... 174
FIGURE 98: EXPIRATORY HOLD MANEUVER........................................................................................................................................ 174
FIGURE 99: LUNG MODEL LOCATION .................................................................................................................................................... 175
FIGURE 100: LUNG COMPLIANCE IMAGES AND RANGES ................................................................................................................... 175
FIGURE 101: LUNG MODEL RESISTANCE IMAGES AND RANGES IN MANDATORY MODES ........................................................... 176
FIGURE 102: LUNG MODEL RESISTANCE IMAGES AND RANGES IN SPONTANEOUS MODES ....................................................... 176
FIGURE 103: WEANING TARGET TOOL LOCATION .............................................................................................................................. 177
FIGURE 104: WEANING TARGET TOOLS FOR DIFFERENT TYPE OF PATIENTS. .............................................................................. 177
FIGURE 105: V–CMV MODE ..................................................................................................................................................................... 179
FIGURE 106: V-SIMV MODE ..................................................................................................................................................................... 180
FIGURE 107: P-CMV MODE...................................................................................................................................................................... 182
FIGURE 108: P–SIMV MODE .................................................................................................................................................................... 183
FIGURE 109: SPONT MODE ..................................................................................................................................................................... 187
FIGURE 110: SPAP MODE........................................................................................................................................................................ 189
FIGURE 111: ADAPTIVE WEANING CRITERIA, VE ASSURED. ............................................................................................................. 193
FIGURE 112: CURRENT SETTINGS STANDARD CRITERIA .................................................................................................................. 193
FIGURE 113: CURRENT SETTINS, ADVANCE CRITERIA. ..................................................................................................................... 194
FIGURE 114: AUTO CONTROL WINDOWS ............................................................................................................................................. 196
FIGURE 115: AUTO CONTROL STATISTICS ........................................................................................................................................... 197
FIGURE 116: AUTO CONTROL SETTINGS.............................................................................................................................................. 198
FIGURE 117: HIGH PRESSURE SYSTEM, PNEUMATIC SCHEMATIC................................................................................................... 205
FIGURE 118: OPTIONAL, TURBINE BASED SYSTEM, PNEUMATIC SCHEMATIC ............................................................................... 206

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 Index of Tables

Index of Tables

TABLE 1: REVISION HISTORY ................................................................................................................................................................... 10

TABLE 2: EMC DECLARATION – EMISSIONS (VENTILATOR) ................................................................................................................ 50
TABLE 3: EMC DECLARATION – IMMUNITY ............................................................................................................................................. 50
TABLE 4: EMC DECLARATION – ELECTROMAGNETIC IMMUNITY ........................................................................................................ 51
TABLE 5: EMC DECLARATION – RECOMMENDED DISTANCES ............................................................................................................ 53
TABLE 6: HOME SCREEN ELEMENT DESCRIPTIONS ............................................................................................................................. 75
TABLE 7: SOFT BOUNDARY SETTING LIMIT............................................................................................................................................ 82
TABLE 8: MAX BOUNDARY SETTING LIMIT ............................................................................................................................................. 83
TABLE 9: PATIENT SELECTION – NEW SETTINGS ................................................................................................................................. 85
TABLE 10: SETTINGS DESCRIPTION ........................................................................................................................................................ 91
TABLE 11: RIGHT PANEL: CURRENT & PROPOSED SETTING SELECTIONS ....................................................................................... 94
TABLE 12: SETTING BAR: SETTING SELECTIONS .................................................................................................................................. 96
TABLE 13: SBT SETTINGS ....................................................................................................................................................................... 102
TABLE 14: MONITORING TAB DESCRIPTIONS ...................................................................................................................................... 105
TABLE 15: DATA PARAMETER DEFINITIONS......................................................................................................................................... 105
TABLE 16: TREND SCREEN SETTING DESCRIPTIONS......................................................................................................................... 108
TABLE 17: TREND PARAMETERS ........................................................................................................................................................... 109
TABLE 18: ALARMS SETTINGS DESCRIPTIONS .................................................................................................................................... 110
TABLE 19: AUTO SET FEATURE – ALARM SETTING ADJUSTMENT RULES ....................................................................................... 111
TABLE 20: ALARM SETTING PARAMETER DEFINITIONS ..................................................................................................................... 113
TABLE 21: ALARMS SETTINGS DESCRIPTIONS .................................................................................................................................... 114
TABLE 22: ALARM SIGNALS .................................................................................................................................................................... 114
TABLE 23: HIGH PRIORITY ALARMS ...................................................................................................................................................... 115
TABLE 24: MEDIUM PRIORITY ALARMS ................................................................................................................................................. 118
TABLE 25: INFORMATION MESSAGES ................................................................................................................................................... 120
TABLE 26: DISCONNECTION ALARM CODES ........................................................................................................................................ 121
TABLE 27: HAZARDS BASED ON USER / DEVICE ERRORS ................................................................................................................. 126
TABLE 28: CAPNOGRAPHY: WARNINGS AND CAUTIONS.................................................................................................................... 130
TABLE 29: CONFIG SCREEN SETTINGS ................................................................................................................................................ 134
TABLE 30: CALIBRATION DESCRIPTIONS ............................................................................................................................................. 139
TABLE 31: EMC DECLARATION – ELECTROMAGNETIC IMMUNITY .................................................................................................... 148
TABLE 32: PREVENTIVE MAINTENANCE SCHEDULE ........................................................................................................................... 150
TABLE 33: ALARM TEST SETTINGS ........................................................................................................................................................ 154
TABLE 34: WAVEFORM SCALE RANGES ............................................................................................................................................... 164
TABLE 35: LOOPS SCALE RANGES ........................................................................................................................................................ 165
TABLE 36: P0.1 AUTOMATIC TERMINATION CRITERIA ........................................................................................................................ 172
TABLE 37: VENTILATION MODES ........................................................................................................................................................... 178
TABLE 38: V–CMV SETTINGS .................................................................................................................................................................. 179
TABLE 39: V–SIMV SETTINGS ................................................................................................................................................................. 181
TABLE 40: P–CMV SETTINGS .................................................................................................................................................................. 182
TABLE 41: P–SIMV SETTINGS ................................................................................................................................................................. 183
TABLE 42: PRVC–CMV SETTINGS .......................................................................................................................................................... 185
TABLE 43: PRVC–SIMV SETTINGS ......................................................................................................................................................... 186
TABLE 44: VS SETTINGS ......................................................................................................................................................................... 186
TABLE 45: PS MODE SETTINGS (CPAP + PS) ........................................................................................................................................ 188
TABLE 46: SPAP SETTINGS..................................................................................................................................................................... 189
TABLE 47: AUTO CONTROL SETTINGS .................................................................................................................................................. 197
TABLE 48: ABBREVIATIONS .................................................................................................................................................................... 204
TABLE 49: E-MAIL CONTACT DETAILS ................................................................................................................................................... 209

9 eVolution® 3e Series User Manual (International Version) EVM500041, Rev M

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 31 – Aug - 2016
Updated for 3rd 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

Updated for software 6.4.00, to include: 2 mL Vt (Neonate Option),

Ryan Dailey G Weaning Target Tool, Lung Model, Breath Trigger icon, and addition of 05-Mar-2019
Driving Pressure monitor.

Updated for software 6.4.01

• Eliminating waveform expansion when Lung Model and
H Waveforms simultaneously running in 1 window 20–Jun-2019
Jeffrey Huang
• NIV settings
• Patient triggered breaths – Yellow
Update to format and general corrections
• Update to referenced standards
• Update to Authorized Representative
• Updated Electromagnetic Compatibility Declaration
Updated Notified Body Identification
Susan Gonzalez I 07 Jan 2020
Updated Authorized Representative

Susan Gonzalez J Changed 180 lpm to 200 lpm in sections 1 and 10. 27 Feb 2020

Facundo Bermejo K Updated for software v6.5.00 16 Mar 2020

Rich Nguyen • New Auto Control
• Black GUI
• Alarm bar function update
• Changed patient types from 2 types to 3 types
• Added SBT function
• Added Vital Capacity (VC)
• Added Stress Index (SI)

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 Section 1 Introduction to the eVolution 3e Ventilator
• Weaning Target Tool update
• Added Flow Sensor OFF function

Facundo Bermejo L Update section 1.8.5 and Tidal Volume and Target Tidal Volume and 19 April 2021
section 1.8.6.

Renata Pitscheneder M Updated for software v6.5.03 1 November 2022

• Added Inspirated Minute Volume (Vi)
• Added Power
• Added Overdistention index (C20/C)
• Added Elastance (E)
• Added Man. Rate
• Added Total Work of Breathing (WOBT)
Updated sections 1.8.14, 1.8.16, 2.2, 2.10.2, 5.2.3, 5.2.5, 5.2.6, 5.3.3,
5.5.1, 5.5.2.1, 6.1, 9.3.4, 9.4
Added sections 1.5.8, 1.5.9, 2.1.1

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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 eVolution 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
interface 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 eVolution 3e 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 nsp 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 draw your attention specifically to the remaining dangers associated with proper
use and to emphasize important technical requirements.

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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

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Section 1 Introduction to the eVolution 3e Ventilator

• General Warning and Caution Information

To ensure proper ventilator operation and avoid the possibility of physical injury, only qualified
medical personnel should attempt to set up the ventilator and administer treatment with the
ventilator.
In case of ventilator failure, the lack of immediate access to appropriate alternative means of
ventilation can result in patient death. An alternative source of ventilation, such as a self- inflating
manual bag resuscitator (as specified in ISO 10651-4 with mask) should always be available
when using the ventilator.
If any damage to the ventilator is apparent, its life-supporting function can no longer be
guaranteed. Stop using the ventilator immediately and use an alternate form of ventilation.
The ventilator system is not intended to be a comprehensive monitoring device and does not
activate alarms for all types of conditions. For a detailed understanding of ventilator operations,
be sure to thoroughly read this manual before attempting to use the ventilator system.
Do not add attachments or other components or sub-assemblies to the ventilator breathing
system can change the pressure gradient across the ventilator breathing system and that such
changes to the ventilator breathing system can adversely affect the ventilator performance
Nebulization or humidification can increase the resistance of breathing system filters and that
the operator needs to monitor the breathing system filter frequently for increased resistance and
blockage.
Ventilator accuracy can be affected by the gas added by use of an external nebulizer.
To prevent patient injury, do not make unauthorized modifications to the ventilator.
The audio alarm volume level is adjustable. The operator should set the volume at a level that
allows the operator to distinguish the audio alarm above background noise levels.
Preventive maintenance, 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.
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 Section 1 Introduction to the eVolution 3e Ventilator

• 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 main 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.
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Section 1 Introduction to the eVolution 3e Ventilator

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.

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 Section 1 Introduction to the eVolution 3e Ventilator

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 EN/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 EN/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 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

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Section 1 Introduction to the eVolution 3e Ventilator

1.5.1 Copyright Notice

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

1.5.2 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 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/ISO 80601-2-55: 2011 o ISO 5356-1 o IEC 62366:2007
o IEC 60601-1-6: 2010 o EN/IEC 60601-1: 2012
o IEC 80601-2-12: 2011 o EN/IEC 60601-1-2: 2014
o ASTM F1100-90 o IEC 62304: 2006

1.5.4 Electromagnetic Compatibility

The ventilator system complies with the requirements of EN/IEC 60601-1-2 (EMC Collateral
Standard) including the E-field susceptibility requirements at a level of 10 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 the service manual.

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 Section 1 Introduction to the eVolution 3e Ventilator

1.5.5 CE Notified Body

SGS

1.5.6 Classification

CE classification: classified as protection class II, Type B, internally IEC 60601-1

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.

1.5.8 Transport
Handle with care at transport. Don’t stack during transport. eVolution must be shipped
securely packaged.
During intrahospital transport:
• Make sure the unit is securely attached to the cart
• Make sure all accessories are securely attached to the unit
• Make sure the battery is fully charged
• Avoid tipping the cart

1.5.9 Storage
Don’t stack during storage. When the eVolution is in storage, keep it connected to mains AC to
maintain full charge in the batteries. Make sure temperature is -20 – 70 ºC and humidity is 10-
95% during storage.

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

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Section 1 Introduction to the eVolution 3e Ventilator

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

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Device Labels and Symbols

External User Interface

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 EN/IEC 60101-1

Hot Surface

Do Not Twist

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

Max O2 200 l/min The Oxygen inlet port label is positioned next to the Oxygen inlet port.
2 – 6 bar (29 – 86 psi)

Max Air 200 l/min Air inlet port label is positioned next to the Air inlet port.
2 – 6 bar (29 – 86 psi)

O2 0.3 – 2 bar (5 – 29psi) Low pressure Oxygen inlet port label

(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

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Section 1 Introduction to the eVolution 3e Ventilator

Device Labels and Symbols

External User Interface

AC–Input: AC input connection

100 -240VAC • 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

Device Labels and Symbols

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.

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Device Labels and Symbols

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, Medical electrical equipment Part 2-12: Particular requirements for basic safety
and essential performance of critical care ventilators, the ventilator’s essential performance
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requirements are given by the following items which are specified in this section:
1.1.1.1. Ventilator tidal volume and airway pressure accuracy delivery;
1.1.1.2. High and Low oxygen alarms;
1.1.1.3. High and Low pressure alarms;
1.1.1.4. High and Low expiratory minute volume alarms;
1.1.1.5. Occlusion alarm;
1.1.1.6. Gas supply alarm (Air and O2);
1.1.1.7. 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/CPAP Spontaneous Ventilation

(SPONT)
PRVC-PS/VS
NOTE: PS = CPAP + PS and VS = CPAP + VS
SPAP/APRV
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/APRV
Spontaneous PS/CPAP
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

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Breath Types by Control Variable

Control Variable Breath Type Mode Selections
modes
Spontaneous PRVC-PS/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: 30 to 138 kg
Pediatric IBW: 2.5 to 75 kg
Infant* IBW: 0.2 to 6.0 kg

1.8.6 Patient Startup Settings

New Patient Startup Settings Setting Ranges
Patient Height 46 to 250 cm
Adult 130 to 250 cm (default:150 cm)
Pediatric 46 to 180 cm (default:100 cm)
Infant* 46 to 61 cm (default: 50 cm)
IBW
0.2 to 138 kg
Ideal Body Weight
Adult 30 to 138 kg
Pediatric 2.5 to 75 kg
Infant* 0.2 to 6 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

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Standard Mode Settings Setting Ranges

Pediatric 1 to 120 b/min
Infant* 1 to 150 b/min
Accuracy:
0 to 100 b/min ± 1 b/min
100 b/min

Tidal Volume and Target Tidal Volume

Adult 100 to 3000 ml
Pediatric 20 to 500 ml
Infant* 2 to 100 ml
Accuracy:(Compliance & BTPS Compensated)
2 to 4 ml ± 1 ml + 10%
5 to 40 ml ± 2 ml + 5%
41 to 3000 ml ± 10 ml + 5%

I-Time
All Patient Types 0.1 to 10 s
Accuracy:± 0.02 s

PEEP / CPAP
PEEP 0 to 50 cmH2O or
Adult: 0 to (100 cmH2O -
Pcontrol, Psupport)
Pediatric: 0 to (80 cmH2O
- Pcontrol, Psupport)
Infant: 0 to (60 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
Accuracy:± 10% or ± 2cmH2O whichever is greater

Psupport
0 to 100 cmH2O or
Psupport (100 cmH2O - PEEP),
whichever is less
Accuracy:± 10% or ± 2cmH2O whichever is greater

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Peak Flow Mandatory

(US philosophy configuration) (Flow Setting)
Adult 1.0 to 150 l/min
Pediatric 1.0 to 90 l/min
Infant* 1.0 to 60 l/min

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Standard Mode Settings Setting Ranges

Setting Ranges

Peak Flow Spontaneous

Flow available to patients during spontaneous breaths
(not settable)
Adult 1.0 to 200 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 to10.0 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
compensate for leaks automatically from:
0.0 to 60.0 l/min
Note: Leak Compensation disabled when Tube
Compensation is “on”

Base Flow

Base Flow = 3Lpm + Ftrig settings

(4Lpm when Trigger Type is
Pressure)

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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.

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Setting Ranges

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 Adult: 0.0 to 2.0s (default: 0.0 s)
Pediatric: 0.0 to 1.0s (default: 0.0 s)
Infant: 0.0 to 1.1s (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

Screen Lock / Unlock

Unlocked

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Standard Mode Settings Setting Ranges

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
Adult: 5 to (100 - Psup high) cmH2O
Pediatric: 5 to (80 - Psup high)
cmH2O
Infant: 5 to (60 - 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
Adult: 0 to (100 - Psup low) cmH2O
Pediatric: 0 to (80 - Psup low)
cmH2O
Infant: 0 to (60 - Psup low) cmH2O
Plow cannot be set > Phigh
Accuracy: ± 10% or ± 2cmH2O whichever is greater

Pressure Support at High PEEP

Psup High 0 to 100 cmH2O or
Adult: 0 to (100 - Phigh)
cmH2O
Pediatric: 0 to (80 -
Phigh) cmH2O
Infant: 0 to (60 - Phigh)
cmH2O
whichever is less
Phigh + Psup High will not exceed 100 cmH2O

Accuracy: ± 10% or ± 2cmH2O whichever is greater

Pressure Support at Low PEEP

Psup Low 0 to 100 cmH2O or
Adult: 0 to (100 - Plow)
cmH2O
Pediatric: 0 to (80 -
Plow) cmH2O
Infant: 0 to (60 - Plow)

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cmH2O
whichever is less

Plow + Psup Low will not exceed 90 cmH2O

Accuracy: ± 10% or ± 2cmH2O whichever is greater

Time at High PEEP

Thigh 0.1 to 59.8 s or 60 - Tlow
setting
(Thigh + Tlow) >= 0.4 seconds

Accuracy:± 0.2 s

Time at Low PEEP

SPAP Mode Settings Setting Ranges

Tlow 0.2 to 59.9 s or
60 - Thigh setting
(Thigh + Tlow) >= 0.4 seconds
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 5.3.9

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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%)

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)

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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 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)

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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
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
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Config. Screen Options Setting Ranges

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
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 120 cmH2O
Peak pressure during a breath

Accuracy: ± 10% or ± 2 cmH2O whichever is greater

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Pressure Values Monitored Data Ranges

Pmean 0 to 120 cmH2O

Averaged mean pressure

Accuracy: ± 10% or ± 2 cmH2O whichever is greater

PEEP 0 to 120 cmH2O

Pressure at end exhalation

Accuracy: ± 10% or ±02tocmH

120 O
2
cmH 2O
whichever is greater

Ptrach
Calculated peak tracheal -50 to 120 cmH20
pressure during a breath.
Available with the tube
compensation feature and
only calculated when tube
comp is on

0 to 120 cmH2O
Accuracy: ± 10% or ± 2 cmH2O whichever is greater

Pmin
Calculated peak end -50 to 120 cmH20
expiratory tracheal pressure
during a breath. Available
with the tube compensation
feature and only calculated
when tube comp is on.
Accuracy: ± 10% or ± 2 cmH2O whichever is greater

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%

Ve 0.00 to 99.0 l/min

Exhaled minute volume

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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

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%

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Volume / Flow / Oxygen Values Monitored Data Ranges

Leak 20 to 100%
Averaged calculated leak (1-Vte/Vti)

Accuracy: Derived: averaged calculated leak

(1-Vte/Vti)

PFi 0.0 to 200 l/min

Peak inspiratory flow

Accuracy:

PFe 0.0 to 200 l/min

Peak expiratory flow

Accuracy:

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%

Man. Rate 0 to 150 b/min

Moving average of the mandatory
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

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
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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

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Time Values Monitored Data Ranges

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)

Cdyn 0 to 300 ml/cmH2O

Dynamic compliance
Cdyn is the compliance of the lung at any given time during actual movement of air. It is
change in volume over (PIP – PEEP). Altered by lung, thoracic and airway resistance
Accuracy: Derived from Vt/(PIP - PEEP)

Rinsp (Ri) 0 to 1000 cmH2O/l/s

Inspiratory resistance of airways and tubes V–Mode only, Flow Pattern square
and Pause > 0.20 s

Rexp (Re) 0 to 1000 cmH2O/l/s

Expiratory resistance of airways and tubes V–Mode only, Flow Pattern any
and Pause > 0.20 s

Auto PEEP 0 to 100 cmH2O

Total PEEP - set PEEP = Auto PEEP
Accuracy: ± 10% or ± 2cmH2O whichever is greater

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Respiratory Mechanics Monitored Data Ranges

Pplateau 0 to 120 cmH2O
Plateau pressure
Accuracy: ± 10% or ± 2cmH2O whichever is greater

RSBI 0 to 3000 b/min/l

Adult patient: Rapid shallow breathing
index, calculated breathing rate divided
by tidal volume (RR/Vt = RSBI)
Pediatric and Neonatal patients: Rapid shallow 0 to 100 f/ml/Kg
breathing modified index, calculated breathing
rate divided by tidal volume IBW (RR/VtIBW =
RSBI)

Accuracy: Derived from (measured breathing rate

divided by Inspiratory tidal volume)

P0.1 -30 to 0 cmH2O

P0.1 also known as P100 is the Airway
Occlusion Pressure (Max Neg Insp Pressure)
during the first 100ms of inspiration effort

Accuracy: ± 10% or ± 2cmH2O whichever is greater

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.

Accuracy: ± 10% or ± 2cmH2O whichever is greater

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 (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

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Respiratory Mechanics Monitored Data Ranges

WOBimp 0.00 to 20.0 j/l
Work of breathing imposed

Accuracy: ± 10%

ΔP 0 to 120 cmH2O
Driving Pressure is the ratio of tidal volume
to (static) respiratory system compliance.
Calculation: ΔP = Plateau - PEEP
Accuracy: Derived from Plateau - PEEP
Power 0 to 150 Joules/min
The total mechanical power is defined as
total work/time.
Calculation: Power=RR x Vti x WOBtot
Accuracy: Derived from RR, Vti and WOBtot

C20/C 0 to 5
Overdistention index is the ratio of the
dynamic compliance during the last 20% of
Inspiration (C20) to the total dynamic
compliance (C).
Calculation: The slope of a line drawn
between 2 points of zero flow (the start and
the end of inspiration in this case) is
compared to the slope of a line drawn
during the last 20% of inspiration. If the C20
is less than the Cdyn, the ratio between
them is <1.0 indicating overdistension. A
ratio of greater than 1.0 indicates that the
PV loop can’t be used to assess over-
distension. This happens during PC
ventilation when the ventilator maintains a
constant inspiratory pressure.
Accuracy: Derived from Vt and Ppeak
Elastance 0.001 to 1.00 cmH2O/ml
Relationship between the difference of
pressure applied to the respiratory system
vs the tidal volume
Calculation: Elastance (E ) = (Ppeak –
PEEP) / (Vte)
Accuracy: Derived from Vt and Ppeak

WOBt 0.00 to 4.0 J/L

Total work of breathing. The work performed
to move gas through the ventilator’s valves,
breathing circuit, humidifier, the patient's
airways and to inflate the patient's elastic
lung-thorax. It is the change in airway
pressure (Paw) integrated over inspiratory
tidal volume (Vti) normalized to total
inspiratory tidal volume during the
inspiration time.

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Respiratory Mechanics Monitored Data Ranges

𝑡𝑡2
∫𝑡𝑡1 𝑃𝑃 𝑉𝑉̇ 𝑑𝑑𝑑𝑑
Calculation: 𝑊𝑊𝑊𝑊𝑊𝑊𝑇𝑇𝑇𝑇𝑇𝑇 = 𝑘𝑘
𝑉𝑉𝑡𝑡𝑡𝑡

Accuracy: Derived from Vt and Ppeak

SI -99.99 to 99.99
Stress Index provides a tool to monitor the
occurrence of tidal recruitment and over
distention. Stress Index is only available
during Volume modes with square
waveform.

1.8.15 Graphics: Real-Time Curves

Graphics: Real-Time Curves

Waveforms Waveforms Displayed on the Main Screen

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Graphics: Real-Time Curves

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 5 or Ppeak Low + 1 to 120 cmH2O

Ppeak Low 1 to 119 cmH2O or Ppeak High - 1

PEEP High 3 or PEEP Low + 1 to 50 cmH2O
PEEP Low 2 to 49 cmH2O or PEEP High - 1, or Off
Pmean High 1 or Pmean Low + 1 to 100 cmH2O
Pmean Low 0 to 99 cmH2O or Pmean High - 1, or Off

Volume Alarm Settings

Ve High 0.10 or Ve Low + 0.10 to 99.0 l/min
Ve Low 0.01 to 98.9 l/min or Ve High – 0.10, or Off
Vte High
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Standard
Adult 5 or Vte Low+5 to 3500 ml
Pediatric 2 or Vte Low+2 to 1000 ml
Neonate* 1 or Vte Low+1 to 300 ml
Vte Low
Adult 5 to 3490 ml or Vte High-5, or Off
Pediatric 2 to 995 ml or Vte High-2, or Off
Neonate* 1 to 298 ml or Vte High-1, or Off
Vti Limit
Adult 0 to 3500 ml or Off(default New Patients = 15ml/kg x IBW)
Pediatric 0 to 1000 ml or Off(default New Patients = 15ml/kg x IBW)
Neonate* 0 to 300 ml or Off(default New Patients = 15ml/kg x IBW)

Respiratory Rate Alarm Settings

Rate High 2 or Rate Low + 1 to 200 b/min
Rate Low 2 to 199 b/min or Rate High - 1

Oxygen Delivery Alarm Settings Automatic Setting

Ventilator software automatically sets alarm limit
High FiO2
to 7% above oxygen % setting.

Low FiO2 Ventilator software automatically sets alarm limit

to 7% below oxygen % setting.

Other Alarm Settings

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.

55 mmHg
PetCO2 High
Range: 2 (or 1 > PetCO2Low) to 150 mmHg

25 mmHg
PetCO2 Low
Range: 1 to 149 mmHg or 1 < PetCO2High, or Off

1.8.17 Alarms by Priority

Air Supply Oxygen Supply

Blower Occlusion
High Inh Pressure Low Inh Pressure

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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.

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1.8.18 SBT Mode Settings

SBT Mode Settings Additional settings specific to SBT

(Spontaneous Breathing Trial)

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

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

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

Esens Same as Esens referenced above.

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

Rise Time Same as Rise Time referenced above.

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

PS Tmax Same as PS Tmax referenced above.

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

O2 Same as O2 referenced above.

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

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

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Lithium Ion (Turbine Models)

Battery Type
Lead Acid(HP Models)
> 4 Hours (Turbine Models)
Battery Backup (with fully charged battery)
> 2 Hours (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)
29 – 86 psi clean, dry, and oil-free,
High pressure air inlet supply (HP model)
medical grad
180 l/min (STPD, dry and oil-free
Air inlet supply flow(HP model)
required)
5 – 29 psi clean, dry, and oil-free,
Low pressure oxygen inlet supply(Turbine model)
medical grade

1.9.2 Environmental Data

Operating temperature 5 – 40 °C
Storage temperature -20 – 70 °C
Operating Humidity 15% - 95% non-condensing
Storage Humidity 10% - 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%.

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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 internally powered, drip-proof equipment for
continuous operation

ASTM F1100-90, EN/IEC 60601-1,

EN/IEC 60601-1-2, IEC/ISO 80601-2-55,
Meets International Standards
IEC 62304, IEC 62366, IEC 60601-1-6,
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. Therefore,

RF Emissions CISPR 11 Group 1 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
Harmonic emissions domestic establishments and those directly connected to the
Class A
IEC 61000-3-2 public low voltage supply network that supplies buildings used for
domestic purposes
Voltage fluctuations/flicker
Complies
emissions IEC 61000-3-3

Table 3: EMC Declaration – Immunity

Guidance and Manufacturer's Declaration – Immunity

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.

IEC 60601 Test Compliance Electromagnetic Environment –

Immunity Test
Level Level Guidance
Electrostatic Floors should be wood, concrete or ceramic
+/- 8kV contact +/- 8kV contact
Discharge (ESD) tile. If floors are covered with synthetic
material, the relative humidity should be at
+/- 15kV air +/- 15kV air
IEC 61000-4-2 least 30%.

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Table 3: EMC Declaration – Immunity

Guidance and Manufacturer's Declaration – Immunity

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.

IEC 60601 Test Compliance Electromagnetic Environment –

Immunity Test
Level Level Guidance

+/- 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. 30 A/m 30 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 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 electromagnetic environment.

Immunity IEC 60601 Compliance

Electromagnetic Environment – Guidance
Test Test Level Level

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Table 4: EMC Declaration – Electromagnetic Immunity

Guidance and Manufacturer's Declaration – Electromagnetic Immunity

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 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
2.7 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.

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Table 4: EMC Declaration – Electromagnetic Immunity

Guidance and Manufacturer's Declaration – Electromagnetic Immunity

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 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 2.7 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.

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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.

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2 Preparing the Ventilator for Use

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.

2.1.1 Installing O2 sensor

Unpack, install and calibrate O2 sensor before using the ventilator. 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.

Figure 1: Installing O2
Sensor

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Figure 2: Calibrate Oxygen Sensor Screen

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 12VDC 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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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.
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 3: 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 4: DC, External Batter Socket

2.5 DC (Internal Battery) Power Supply

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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 for a minimum of 2 hours for
eVolution HP models and a minimum of 4 hours for the eVolution Turbine models. Actual
operating time is dependent on battery age, charge level, utilization frequency, and ventilator
settings.
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.
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 5: 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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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
29to 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 6: High Pressure O2 and Air Inlet

2.9 Optional, Turbine Based System: Connecting to

Oxygen Supply

Figure 7: High Pressure O2 Inlet Figure 8: Low Pressure O2 Inlet

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2.10 Ethernet and Nurse Call

Figure 9: 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

o CliniNet 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 CliniNet software allows any window PC to connect to a monitor several 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, event logs, 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.
o Trend data and event logs can be exported to Excel. Data can also be shared with HL7
protocol.
o CliniNet 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
[email protected] 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)
3 NO (Normal Open)

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4 Not in use
5 Common
6 Not in use
Figure 10: 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. 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 ASTM F1100-90 and ISO 5356-1 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 ASTM F1100-90, ISO 5356-1, EN1281-1 and EN12342.
The breathing circuit may include these components:

Figure 11: Breathing Circuit

2.11.1 Nasal Prongs

The breathing circuit can include a standard neonate / infant circuit with a wye, or a

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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 12: 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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Exhalation System Exhalation System

Cover Housing

Exhalation System Exhalation System

Diaphragm Locking Ring

Figure 13: 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, ISO 9360, ASTM F1100-90 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 ASTM F1100-90, , ISO 5356-
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.

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Tube
Tube
Mounting Holder
Flex Arm Holder
Bracket
Connection
Screw

Figure 14: 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 CO2sensor 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 CO2IRMA 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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• 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 CO2Sensor

2.13.2.1 IRMA Overview and Setup

Figure 15: 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.

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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 CO2sensor indicates that the CO2
monitor is being powered and properly connected.
• Zero CO2Sensor 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 16: 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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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 17: 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.

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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 18: Attaching the ISA Sidestream CO2 Sensor to the Ventilator

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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 CO2sensor:
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 CO2airway 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.

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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 19: Attaching the Sidestream CO2Sensor 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

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Figure 20: eVolution 3e Front Panel

Action Keys Navigation Keys & Op LED’s

An illuminated LED at the top of the device
Standby Key indicates there is an active alarm. This is in
addition to the audible and on screen
Press then select to place the vent in Standby, return
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.

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Figure 21: 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.
The manual breath function is active in all Modes except NCPAP+ when the rate is set to
Off.

3.1.4 Alarm Silence Key

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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.
(Exception for Battery Too Low, Imminent Shutdown and Connect AC Now)
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.
(Exception for Battery Too Low, Imminent Shutdown and Connect AC Now)

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 22: eVolution Power Up & Patient Setup Screen

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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

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Figure 23: Graphic User Interface

Graphic User Interface

Figure 24: 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
Patient Type
displayed in the top left section of the screen

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Table 6: Home Screen Element Descriptions

Display & Setting Description

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 Mode Current Mode field.
When the selected mode is AUTO Control and the patient has transitions to the
corresponding spontaneous mode, the Current Mode (PRVC-CMV and PRVC-PS) will
be displayed in bold blue.
BOLD RED: During Apnea Backup ventilation the Current Mode will be displayed in bold red.
A square information icon is located to the left of the current mode display.
For Mandatory delivered breaths, this icon will display a White “M” letter with a Blue
background, indicating that the current breath being delivered is a Mandatory breath.
This icon will display a White “M” letter with a Grey background during the expiratory
Patient Effort /
phase and until a new delivered breath.
Trigger Indicator
For Spontaneous delivered breaths this square icon will display a White “S” letter with
a Blue background, indicating that the current breath being delivered is a Spontaneous
breath. This icon will display a White “S” letter with a Grey background during the
expiratory phase and until a new triggered 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 is

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

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.

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Table 6: Home Screen Element Descriptions

Display & Setting Description

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
buttons for Monitors or Maneuvers. When selecting Monitors tab, the user can choose
to display; Loops (P/F loop, P/V loop, F/V loop) or the Lung (Lung Model).
 Each screens Left panel is used to display different but specific selections for
Left Display Panel that screen.
 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.

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Table 6: Home Screen Element Descriptions

Display & Setting Description

To the right of the settings bar, the following 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 screen and
LOCK / UNLOCK 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.

Touch Screen Input Method 1

Touch (field boarder changes to green)

Change value (turn knob)

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Accept value (touch field)

Touch Screen Input Method 2

Touch (field boarder changes to green)

Change value (turn knob)

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.

• When Touch Screen Bypass Feature is enabled, a yellow cursor will display around the currently
selected tab. Once the yellow cursor is displayed, users can use the scroll knob to navigate, select,
change and activate all settings and functions.

Yellow Box Selection

Scroll to field (turn knob)

Push to Select (push knob)

Change value (turn knob)

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Accept value (push knob)

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
 SCREENS (excluded)  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! messages
shown below is displayed to the user. 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.

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Figure 25: Standby Not Ventilating (Safety Message)

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 an
adjusted 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

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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

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
• Min value is at the lower-left corner
• Max value (Max Boundary) is at the lower-right corner
• A Soft Boundary is the point that the border changes from green color to light green color.

Figure 26: Control Setting Limit (Soft Boundary) Feature

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.
Soft Boundary
• The Soft Boundary setting limit (the point that the border changes from green color to
light green color) 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).
Max Boundary
• Max Boundary
o Similar to the Soft Boundary, the Max Boundary setting limit will display at the

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lower-right corner of the control. 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 following:

Table 8: Max Boundary Setting Limit

Control A Max Boundary Setting Limit
PEEP 50 cmH2O or (90 – Pcontrol) or (90 – Psupport) Whatever 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

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.
• 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.
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.

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.

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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

• 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

Figure 27: Power Up Screen

5.2 Patient Selection Screen - New Patient and Previous Patient

Figure 28: Patient Selection Screen – Startup Screen

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Table 9: Patient Selection – New Settings

Setting Description
Patient Option Selection Options:
 New
 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:
 HME
 Humidifier
 None
Pre-Patient Tests Circuit tubing compliance and circuit leak test are done
Calibrations Additional calibrations can be performed:
(see sections3.3 and 6.1for  Exhalation Flow Sensor Zero
additional calibration  System Test
instructions)
 O2 Sensor
 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 29: 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 30, pressing the ACCEPT button without establishing or manually
entering an IBW will result in the below message being displayed in the right panel above

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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 30: 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 31: 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.

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Figure 32: Ideal Body Weight screen

5.2.3 Flow Sensor ON/OFF

The user has the chance to turn the flow sensor OFF. This would be possible at the clinical configuration
screen. As default the flow sensor would be ON. However, if the user switches to OFF, then the
ventilator would keep it OFF even if the ventilator is turned OFF. Therefore, the next time the user turns
ON the ventilator, the unit would keep the flow sensor as it was set the last time by the user. Once the
flow sensor is turned OFF, the user cannot perform the EHX flow sensor calibration at the patient start
up page. See below at Figure 33 the clinical configuration screen with the setting of the Flow sensor.

Figure 33: Patient Setup page

5.2.4 Humidification Type

User can select humidity type:

Figure 34: Humidification Type Selection Option

5.2.5 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 Safety valve testing

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o “Back button” takes you to the Previous Screen

Pre-Patient System Tests will take approximately 20 seconds.

Figure 35: Pre-Patient System Tests

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5.2.6 Calibrations
Takes user to the Calibration options screen where you can perform the following:
• Circuit Check
o Sensor Zeroing: zeroing of the pressure sensors
o Compliance: Calculation of tubing compliance.
o Safety Valve: Safety valve checking
o Insp. and Exp. Resistance: Calculation of tubing resistance.
• O2 Sensor: Calibrates the O2 Sensor
• EXH Flow Sensor: Perform complete calibration of the exh flow sensor

Figure 36: Calibration Options

See sections3.3 and 6.1for 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.

5.2.7 Accept Button

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

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
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below.

Figure 37: 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 38: Proposed Settings Screen

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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-CPAP, 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/CPAP), Volume Support (PRVC-
PS/VS) or Spontaneous Positive Airway Pressure (SPAP/APRV).

Adult/pediatric
patients

Figure 40: Mode Type / Mode Selections for adult/pediatric patients

Neonatal patients

Figure 39: Mode Type / Mode Selections for neonatal patients

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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.

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5.3.4 Right Panel: Current & Proposed Settings Selections

Parameter Definition Range
Smart The Nebulizer generates flow, When the nebulizer is active, User selected
NebulizerTM 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)
Smart SIghTM The eVolution ventilators include a sigh feature that allows sigh Sigh On or Off
breaths to be delivered at a user-defined frequency, number Sigh Factor 0 to 50%
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.

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Parameter Definition Range

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
compensate for leaks automatically from:
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

Parameter Definition Range
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 100cmH2O or
phase. 1 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 150 l/min
and V-SIMV
Pediatric:
1 to 90 l/min

Neonate:
1 to 60 l/min

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Parameter Definition Range

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 100cmH2Oor
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 100cmH2O 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.

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Parameter Definition Range

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: 100 to 3000 ml
V-CMV, V-SIMV, PRVC-CMV, PRVC-SIMV, and VS.
Pediatric:
20 to 500 ml

Neonate:
2to 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 41: 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

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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 Orin 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 42: 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

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o Check Events
o Change to specific Trend

Figure 43: 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 44: 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%

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TC is applied to pressure targeted breaths (PC, PRVC, PS, VS, and 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 45: 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 Vital Capacity (VC)

Vital Capacity can be found under the Maneuvers tab within the Weaning button. This
maneuver measures the amount of air you can exhale after you inhale as deeply as possible.
Once selected it is active for 10 seconds. VC will measure the next patient triggered breath
to measure VC (ml). If completed, the value will be displayed on the Weaning page and will
take the place of the Ve parameter. PS Tmax is disabled during this maneuver. The maneuver
is automatically terminated after 10 seconds or if the maneuver has been completed. VC will
be disabled if Flow Sensor is set to Off. Alarms will be disabled during the maneuver duration.
A Volume/Time graph will be displayed as the maneuver has been started.

5.3.12 SBT Mode

The SBT mode and adjustable controls can be accessed from the Weaning button in the
Manuvers tab by pressing the SBT button. SBT setting information listed below in Table 1313.

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

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

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• SBT Mode Activation
o The SBT function is available from the Weaning button.
o If the SBT mode is active and a New (Proposed Mode) is activated, the SBT
mode will be terminated and SBT will have to be started again by the user.
o When the SBT Button is pressed the Right Panel loads the Trends, SBT
Alarms, Time Remaining and the START/STOP Button Figure 45.
o When the SBT Button is pressed the Left Panel loads the SBT Settings.
o Adjust the SBT mode settings as desired and when ready press the START
button to activate the SBT mode.
 When the SBT mode is activated, the SBT will be indicated at the top
left of the user interface, Status bar.
 When the SBT mode is activated, the time remaining counter will
start at the time equal to the SBT Time Interval setting and will
decrease in value displaying the actual elapsing time. When SBT
reaches 0:00:00, the SBT mode has completed and the Post-SBT
mode will resume.
 During Post-SBT, you are allowed to preform your Weaning
parameters, p0.1, PiMax and VC to be logged in the Weaning Report
Summary/SBT Report HX.
 Once Post-SBT has been completed the Right Panel will show a
Weaning Report Summary.
 While the SBT mode is active, if the STOP button is pressed or the
maneuver is terminated or the maneuver completes, the Pre-SBT
mode will resume and the time remaining counters value will change
to display 0:00:00.
 The default screen will show the Weaning Target Tool (section 5.12.)

Figure 46: SBT Settings Screen

• SBT Report Summary and Weaning Report Summary

o Below results are not indicators that the patient is ready for any type of
intervention. This simply helps with presenting organized information to view
the weaning of values of the patient.
o Date and Time are recorded with each Report Summary.
o Report Summaries may be saved and viewed in the Report HX button.
o All Summaries are saved per patient. Once New Patient has been selected
then all results will be cleared.

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

Parameter Column Results

Rate • 2 min column – averages the last 5 breaths before the 2-
minute mark of the SBT trial. Those results will be the
displayed values.
• End column – averages the last 5 breaths before the SBT
trial completes. Those results will be the displayed values.
• 12-28 bpm the third column will display a Green indicator.
• Any other value the third column will display a Yellow
indicator.
Vte • 2 min column – averages the last 5 breaths before the 2-
minute mark of the SBT trial. Those results will be the
displayed values.
• End column – averages the last 5 breaths before the SBT
trial completes. Those results will be the displayed values.
• Within +/- 20% of tidal volume of the 2 min value then the
third column will display a Green indicator.
• Outside of that range then the third column will display a
Yellow indicator.
Ve • 2 min column – averages the last 5 breaths before the 2-
minute mark of the SBT trial. Those results will be the
displayed values.
• End column – averages the last 5 breaths before the SBT
trial completes. Those results will be the displayed values.
• Within +/- 20% of tidal volume of the 2 min value then the
third column will display a Green indicator.
• Outside of that range then the third column will display a
Yellow indicator.
RSBI • If the value is less than or equal to 105, the third column will
display a Green indicator.
• If the value is greater than 105 the indicator shall be Yellow.
P0.1 Results taken from Post-SBT.
PiMax Results taken from Post-SBT.
VC Results taken from Post-SBT.

• SBT Mode Settings

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

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Table 13: SBT Settings
Parameter Definition Setting Range
O2 O2 level when SBT mode is active. 21 to 100 %
Default = Set Non-SBT mode O2 unless
changed by User.
PEEP PEEP level when SBT mode is active. 0 to 30 cmH2O
Default = Set Non-SBT mode PEEP unless
changed by User.
Psupport Default = IBW based default or Set Non-SBT 0 to 30 cmH2O
mode Psupport unless changed by User.
Esens Default = IBW based default or Set Non-SBT 10 to 80 %
mode Esens unless changed by User.
Rise Time Default = IBW based default or Set Non-SBT 1 to 20
mode Rise Time unless changed by User. 1 = Slow and
20 = Fast
PS Tmax Default = IBW based default or Set Non-SBT Adult:
mode PS Tmax unless changed by User. 0.50 to 5.0 s
Pediatric:
0.50 to 5.0 s
Neonate:
0.15 to 3.0 s
SBT Time The user defined duration the SBT mode will be 15 to 120 min
active once started.
Default = 30 min unless changed by User
NOTE: SBT Time cannot be adjusted while the
SBT mode is active
SBT Only Alarm Settings

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

900 b/min/l or OFF

RSBI Low Medium priority alarm 5 to 895 b/min/l or

(5 < RSBI High) or OFF

Rate High Medium priority alarm 2 or (1 > Rate Low) to

80 b/min or OFF

Rate Low Medium priority alarm 1 to 79 b/min or

(1 < Rate High) or OFF

• SBT Trend Automatic Event Marker

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

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Figure 47: SBT Automatic Event Markers

SBT Feature Completed

SBT Feature Started SBT Feature Canceled
Successfully

• SBT Mode Termination Criteria

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

5.4 Home TAB

Figure 48: Home Tab

Setting Description
Patient Type The current Patient Type is displayed above the current mode
Current Mode The current ventilation mode is displayed

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Patient Effort / Trigger A square information icon is located to the left of the current mode
Indicator and alternates display of blue or grey background colors depending
on the type of delivered breath (“M” for Mandatory or “S” for
Spontaneous 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 Monitors (P/V loop, F/V loop, P/F
loop, or Lung Model) 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

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5.5 Data TAB

Figure 49: 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

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Table 15: Data Parameter Definitions

Parameter Definition Unit
Pmean Measured average airway pressure over the breath cmH2O
cycle
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 %
PFi 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 (Ri) Inspiratory flow resistance cmH2O/l/s
Rexp (Re) Expiratory flow resistance cmH2O/l/s
Pplateau Plateau pressure cmH2O
ΔP Driving Pressure cmH2O
RSBI Rapid Shallow Breathing Index (Adult patients) b/min/l
Rapid Shallow Breathing modified Index (Pediatric f/ml/Kg
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and neonatal patients)

P0.1 Airway Occlusion Pressure during the first 100ms cmH2O

Ptrach Calculated peak pressure at the end of ETT cmH2O
Pmin Calculated end expiratory pressure at the carina cmH2O
Cdyn Dynamic compliance, lung stiffness ml/cmH2O
Vi Inspired minute volume l/min
Power Mechanical power Joules/min
C20/C Overdistention index
Elastance Relationship between the difference of pressure cmH2O/ml
applied to the respiratory system vs the tidal volume
Man. Rate Mandatory respiratory rate b/min
WOBt Total work of breathing Joules/l

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Table 15: Data Parameter Definitions

Parameter Definition Unit
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
Stress Index (SI) Stress Index is only available during Volume modes
with square waveform.
Stress Index provides a tool to monitor the occurrence
of tidal recruitment and over distention.

All monitored spirometry measurements are corrected and displayed in BTPS

units.

5.5.2 Trended Data

Figure 50: Trending Waveform and Parameter Selection Screens

Setting Description
Trend Data Allows user to view 1, 2 or 3 trend graphs of any of 24selectabletrended
parameters as shown below.

Table 16: Trend Screen Setting Descriptions

5.5.2.1 Trended Parameters

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Table 17: Trend Parameters

Parameter Definition Unit
Pmean Measured average airway pressure over the breath cmH2O
cycle
Ppeak Peak pressure 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 %
PFi Peak Inspiratory Flow l/min
PFe Peak Expiratory Flow l/min
O2 Fraction of Inspired Oxygen %
Ti/Ttot Ratio of Inspiratory time to Total respiratory cycle %
time
Cstat Static compliance ml/cmH2O
Rinsp (Ri) Inspiratory flow resistance cmH2O/l/s
Rexp (Re) Expiratory flow resistance cmH2O/l/s
RCe Time constant s
Pplateau Plateau pressure cmH2O
ΔP Driving Pressure cmH2O
RSBI Rapid Shallow Breathing Index (Adult patients) b/min/l
Rapid Shallow Breathing modified Index (Pediatric f/ml/Kg
and neonatal patients)
P0.1 Airway Occlusion Pressure during the first 100ms cmH2O
Ptrach Calculated peak pressure at the end of ETT cmH2O
Cdyn Dynamic compliance, lung stiffness ml/cmH2O

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Vi Inspired minute volume l/min

Power Mechanical power Joules/min
C20/C Overdistention index
WOB Total work of breathing Joules/l
WOBimp Work of breathing imposed Joules/l
SI Stress Index

5.6 Alarms TAB

Figure 51: 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

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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
Current Settings mode is V-CMV.
Vi High All other modes: monitored ExpMinVol + 50%
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 ExpMinVol - 50%
All other modes no adjustment will be
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.
All other modes no adjustment will be
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.
All other modes no adjustment will be
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.

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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
PEEP Low Automatic limits (all modes): set PEEP - 2 cmH20, (SPAP: During Standby, PEEP Low alarm will
set Plow be updated as defined.
-2cmH2O)
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
does not change Leak alarm limit.
Vti Limit Auto Set feature does not change Vti limit. During Standby, Auto Set feature
does not change Leak alarm limit.

5.6.2 Alarm Setting Parameters

You can access alarm limit settings under the Alarms Tab or touching the alarm bar when it
is active. 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).
When an active alarm shows up at the alarm bar and the user touches the alarm bar, the limit
that has been reached would be showed to the user to allow modification. This would allow
the user to change alarm limits if necessary.
As an example, when the following alarm is active:
And the user presses it, then the alarm would allow
a change of the high MV. The current monitored value would be showed in blue and the
current alarm limit in red.
In this example the high MV alarm is set at 4.7 l/min
when the current monitored value is at 5.58 l/min.
In order to change this, limit the user can press the limit, in this case :

Then a green rectangle would let the user know that

this alarm limit can be changed using the dial. A
modification to this limit is the same action of accessing it through the alarm screen.
Below some examples

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Ventilator software automatically sets high and low oxygen % alarms at 7%

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

Parameter Definition Unit

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

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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 52: 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 60601-1-8, EN475 and IEC 60417 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.

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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
(Exception for Battery Too Low, Imminent Shutdown and Connect AC Now)

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.

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Table 23: High Priority Alarms

High Priority
Description of Cause Ventilator Response
Alarm Messages

Low Inh Pressure Pressure cannot be attained in the patient Ventilation continues
breathing circuit, possible due to a leak or
disconnect.

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 ExpMinVol.
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:
In the event of Exh flow sensor error, the
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.

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Table 23: High Priority Alarms

High Priority
Description of Cause Ventilator Response
Alarm Messages

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.

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:
In the event of Exh flow sensor error, the
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:
In the event of Exh flow sensor error, the
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
Note: This alarm can only occur when the appropriate for patient
mainstream or sidestream CO2 sensor is in use. condition.

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
Ventilation continues. ventilator settings are
Note: This alarm can only occur when the appropriate for patient
mainstream or sidestream CO2 sensor is in use. 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
Ventilation continues. ventilator settings are
Note: This alarm can only occur when the appropriate for patient
mainstream or sidestream CO2 sensor is in use. condition.

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Table 23: High Priority Alarms

High Priority
Description of Cause Ventilator Response
Alarm Messages
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
Note: This alarm can only occur when the appropriate for patient
mainstream or sidestream CO2 sensor is in use. condition.

The monitored Valv/min value is too low

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

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

supply. will shutdown if not
connected to AC power.

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

supply. will shutdown if not
connected to AC power.

No HEPA Filter The HEPA filter is missing. (eVolution Ventilation continues

Turbine model only)

Replace HEPA Filter The HEPA filter is dirty and should be Ventilation continues
replaced. (eVolution Turbine model only)

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.

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Table 24: Medium Priority Alarms

Medium Priority Alarm Description of Error Ventilator Response

Message

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.

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
setting. Pressure support is limited
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
Ventilation continues 3. Replace CO2 sensor.

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Table 24: Medium Priority Alarms

Medium Priority Alarm Description of Error Ventilator Response

Message
The CO2airway 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.
Ventilation continues
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
Ventilation continues
A problem has been detected with the CO2 sample Replace Sample Line
Replace Sample Line
line.
Ventilation continues
CO2 sensor measurements are out of range or no Zero CO2 Sensor
Zero CO2 Sensor
reference
Ventilation continues
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
Ventilation continues. ventilator settings are
Note: This alarm can only occur when the appropriate for patient
mainstream or sidestream CO2 sensor is in use. condition.
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
Ventilation continues. ventilator settings are
Note: This alarm can only occur when the appropriate for patient
mainstream or sidestream CO2 sensor is in use. condition.

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

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Table 25: Information Messages

Information
Description of Information Ventilator Response
Message
connected.

Inverse I:ERatio 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. the O2 sensor cable is
Available 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 connection.
is disabled. Depending on the specific reason for the
loss of signal between the ventilator and the CO2 Connect and or replace
CO2 adaptor.
sensor, other related alarms may also be triggered.
Displays anytime the ventilator loses
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.

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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 PEEPsetting = > 5cmH2O AND breath
(Ppeak < PEEPsetting) for ≥ 8 breaths THEN
= Disconnection
Peak pressure below PEEP for long period
IF PEEPsetting = > 5cmH2O AND Spont breaths only
A2 (Ppeak < PEEPsetting OR 0.5cmH2O) for ≥ 61s
THEN Ppeak measured continuously
= Disconnection
No pressure in patient tubing system
Disconnection at ETT
IF PEEPsetting = < 5cmH2O AND Criteria for set PEEP< 5
A8
[(-1cmH2O < P2 < 2cmH2O) OR cmH2O
(-1cmH2O < P3 < 2cmH2O)] for ≥ 4 breaths or
40s 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 ≤ 300ms for ≥ 8 breathes) AND
Exh Flow sensor must be
(RateSetting ≤ 100 b/min OR PS OR VS) AND
A64 calibrated
(RateLowAlarmSetting < 30b/min) AND
(TexpSet ≥ 410ms) THEN Texp = measured expiratory
time. TexpSet = Calculated Te
=Disconnection
setting time
Neonate only: Very low exhaled volume
Disconnection after ET-tube
Neonate only:
IF (set Vt is >5ml) OR If VeLowAlarm setting = Off
A128
(set Pcontrol is > 5cmH2O) AND alarm is not active
(Vte ≤ 1ml for ≥ 16 breaths) AND
No Exh Flow Sensor Error THEN
=Disconnection

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Table 26: Disconnection Alarm Codes

Disc
Detection Criteria Remarks
No.
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 > LimitA512) for ≥ 4 breaths THEN In SPONT only spontaneous
breaths are treated
=Disconnection
In P-CMV and V-CMV only
A512 LimitA512: 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 ManInsp will reset the
counter
If (Pediatric or Adult) AND NIV
THEN this criteria is NOT active

Very low exhaled volume

Disconnection after ET-tube
IF Vte< LimitA1024) for ≥ 8 breaths AND
If VteLowAlarm setting = Off
PEEPsetting ≤ 4cmH2O AND
alarm is not active.
PEEPmeasured is ≤ (1cmH2O for Adult/Pedi OR
A1024 2cmH2O for Neonate) THEN=Disconnection
LimitA1024: For Neonate If PEEP setting =
< 2cmH2O alarm is not active
Adult: 20ml
Pediatric: 5ml
Neonate: 2ml
Very low exhaled volume
Disconnection after ET-tube
IF Vte< LimitV2048) for ≥ 8 breaths AND
PEEPsetting ≥ 5cmH2O AND
PEEPmeasured is ≤ (PEEPsetting – 3cmH2O) If VteLowAlarm setting = Off
A2048 THEN=Disconnection alarm is not active.
LimitA2048:
Adult: 35ml
Pediatric: 5ml
Neonate: 2ml
Detection of auto cycles (short exhalation time)
IF (Texp ≤ 250ms for ≥ 8 breathes) AND Texp measured during last
(RateSetting ≤ 100 b/min OR PS OR VS) AND breath
A4096 (RateLowAlarmSetting < 30b/min) AND
(TexpSet ≥ 410ms) THENIF (Vte ≤ 4ml, Neonate) If Peep is set < 5 cmH2O
OR(Vte ≤ 18ml, Adult/Pedi) THEN alarm is not active
=Disconnection

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Table 26: Disconnection Alarm Codes

Disc
Detection Criteria Remarks
No.
Monitored peep is low
Disconnection of Extubation
B4 IF PEEPsetting ≥ 4cmH2O AND Only active for Neonates
PEEPmeasured ≤2cmH2O for ≥ 8 breathsTHEN
= Disconnection
Detection of auto cycles (long exhalation time)
Disconnection of Extubation
IF (Texp ≤ 400ms for ≥ 8 breathes) AND Disconnection With Exp. Flow
(RateSetting ≤ 60 b/min OR PS OR VS) AND Sensor Error
(RateLowAlarmSetting< 30 b/min) AND IF (Texp ≤ 400ms for ≥ 8 breathes)
B8 (TexpSet ≥ 410ms) AND (Vte ≤ LimitB8) THEN AND (RateSetting ≤ 60 b/min OR
=Disconnection PS OR VS) AND
(RateLowAlarmSetting< 30b/min)
LimitB8:
AND (TexpSet ≥ 410ms)
Adult: 50ml THEN=Disconnection
Pediatric: 30ml
Neonate: 10ml
No rise in pressure at mandatory breath
Disconnection at ETT
IF (P2peak ≤ Pop-LowLimit) for ≥ 8 mandatory
breaths THEN =Disconnection
B16 Not active for SPONT Modes
Pop-LowLimit:
Adult: PEEPsetting+5cmH2O
Pediatric: PEEPsetting+5cmH2O
Neo/Infant: PEEPsetting+2cmH2O
Measured peep below setting
IF (PEEPmeasured ≤ PEEPsetting – 3cmH2O) for ≥ Disconnection With Exp. Flow
8 breaths AND PEEPsetting ≥ 5cmH2O AND Sensor Error
Vte ≤ LimitB32 THEN=Disconnection
B32 IF (PEEPmeasured ≤ PEEPsetting
LimitB32: – 3cmH2O) for ≥ 8 breaths AND
Adult: 30ml PEEPsetting ≥ 5cmH2O
Pediatric: 10ml THEN=Disconnection
Infant: 2ml
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 >
breaths THEN=Disconnection PEEPsetting + 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

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Table 26: Disconnection Alarm Codes

Disc
Detection Criteria Remarks
No.
Disconnect Detection by pressure in Pressure
Modes
B512 IF ((exhalation flow < 1l/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 fail. 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

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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
o 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

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Table 27: Hazards Based on User / Device Errors

Potential Hazard Cause Implication/Result Mitigation / Action

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)

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

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Table 27: Hazards Based on User / Device Errors

Potential Hazard Cause Implication/Result Mitigation / Action

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

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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.

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

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

5.7.1 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 CO2sensor 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.

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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.

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5.7.2 Capnography Waveforms and SBCO2 Curves

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.
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 52, when the Mainstream ETCO2sensor is attached,
any of the three waveforms can be configured to display PeCO2, FeCO2or VteCO2.

Figure 53: 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 the
Loops tab in the Home screen. The SBCO2 loops are not available for Sidestream sensor.

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Figure 54: Real-Time Graphics (SBCO2Curves)

5.8 Config TAB

Figure 55: Config Screen

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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

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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

Select an FiO2 for the horizontal axis
Follow the vertical line upward to the established minute volume
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.

NOTE: please turn the device off and on after changing the
language.
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.

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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 56: 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 57: 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

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Figure 58: 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 59: 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.

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Figure 60: Audio / Visual Options

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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 61: 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,calculates the circuit’s compliance factor
for volume compensation. and checks safety valve

O2 sensor Performs a two-point calibration of the oxygen sensor

EXH Flow Sensor Performs the Exhalation Flow Sensor calibration

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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 62: 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 and
the safety valve functioning. 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.

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Figure 63: 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 64: 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 65: 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.

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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 66: 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.

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• 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
(ASTM F1100-90, ISO 5356-1, 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 ASTM F1100-90, , ISO 5356-1, 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!

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Figure 67: 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.

Exhalation System Exhalation System

Cover Housing

Exhalation System Exhalation System

Diaphragm Locking Ring

Figure 68: Exhalation Valve System

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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

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Figure 69: Exhalation Valve System Components

Figure 70: Exhalation System Assembly 1

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Figure 71: Exhalation System Assembly 2

Figure 72: Exhalation System Assembly 3

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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

Table 31: EMC Declaration – Electromagnetic Immunity

 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

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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 and ISO 17664.

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 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.

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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 73: Fan Filter and Cover

8.2 Air Inlet Filter

Air Inlet HEPA filters are included on all eVolution Turbine ventilators.
The ventilator will provide an alarm, “Replace HEPA Filter” when the filter is
dirty and should be replaced. For more information see Table 23: High Priority
Alarms.
To replace the Air Inlet HEPA Filter see instructions below.

1. Remove the 5 screws and

washers on the Access Filter
and Batteries panel on the
back of the ventilator.
2. Pull the filter out of the Air
Inlet manifold using the tabs
attached to the filter.
3. Replace the filter according to
the directional markings on
the HEPA Filter.
4. Reattach the Access Filter and
Batteries panel on back of
ventilator and secure it with
the screws and washers.
Figure 74: Air Inlet HEPA 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.

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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 75: O2 Sensor

8.4 Internal Battery

Every Two Years or as required: Replace the Internal Batteries

Always replace both batteries at the same time (Turbine model).

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).

8.4.1 Replacement of Internal Batteries (Turbine Model)

1. Disconnect the A.C. power cord.
2. Loosen the five Philips head screws and washers that secure the Access Filter and
Batteries panel on the back of the ventilator.
3. Pull the tabs attached to the internal batteries to remove from enclosure.
4. Install the new batteries side by side, tab facing out from the left side of each battery.
Slide the batteries in as far as possible.
5. Install the back panel and secure it by installing the five head screws and washers.

Figure 76: Internal Batteries (Turbine Unit)

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8.4.2 Replacement of Internal Battery (High Pressure Model)

1. Disconnect the A.C. power cord.
2. Loosen the six Philips head screws and washers that secure the panel on the back of the
ventilator. You may need to remove the Air Inlet Filter to remove the panel. Do not remove
the screws; just loosen to slide the Air Inlet Filter off.
3. Slide the battery out of the battery tray and detach the connectors from the battery.
4. Install the new battery by connecting the battery connectors.
5. Slide the battery into the battery tray, connectors end first.
6. Install the back panel and secure it by installing the six screws and washers. Secure
the Air Inlet Filter, if removed.

Figure 77: Internal Battery (High Pressure Unit)

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 78: Fuse

8.6 Alarm Test Procedure

The alarm test procedures listed below comply with IEC 60601-1-8 recommendations. See section
1.5.3 for a list of product Compliance and Approvals.

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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

• Select the following 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 %
Vti Limit: 2500 ml

• 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.

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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 hours
for eVolution HP models and 4 hours for eVolution Turbine models, or more depending
on ventilator 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.

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• 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.

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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 79: 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.

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Figure 80: Basic Monitored Parameters

Figure 81: Mechanics Monitored Parameters

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Figure 82: 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 there is an 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 (Ri) measure the airflow resistance of the airways, circuit
tubing and lungs during inspiration. Ri 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 (Re) measure the airflow resistance of the airways, circuit
tubing and lungs during expiration. Re 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

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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 ΔP
 Driving Pressure is the ratio of tidal volume to (static) respiratory system compliance.
 Calculation: ΔP = Plateau - PEEP

o P0.1
 Occlusion Pressure at 100 ms. P0.1is 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)

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9.2.2 Static Compliance and Resistance Measurements

Controlled
Flow Inhalation Exhalation

Qendinsuff

Qplateau

Tpause
Tinhale Texhale
Resulting Tcycle
Pressure

Pendinsuff
Pplateau ΔP

PEEP

Figure 83: 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.

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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.

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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 yellow
throughout the inspiratory phase and light blue during the exhalation phase

Figure 84: 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 85: 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 86: 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.

Table 34: Waveform Scale Ranges

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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 0 – 900
-20 – 0 – 100
-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 87: 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.

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Figure 88: 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 89: Trend Configuration

9.3. Maneuvers
To access respiratory maneuvers, from the Home screen, touch the left panel Maneuvers tab.

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Figure 90: 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 91: 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 91.
 The ventilator will elevate the O2% in this phase (100% for Adult or SetO2+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 92: 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 93: Suction Support Patient Disconnected Phase

o Post Oxygenation Phase

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Figure 94: 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 pressP0.1.
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.

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Figure 95: 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 95, P0.1 = P2 –
P1)

Figure 96: 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)

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Figure 97: PiMax Maneuver

o P0.1 / PiMax
 P0.1 / Pimax are 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.

In Spont modes, Insp Hold is limited to protect the patient. The maximum amount of time will
be 0.25s, unless the user turns this safety limit OFF in Clinical configuration screen.

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Figure 98: 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.

Figure 99: Expiratory Hold Maneuver

9.4 Lung Model

The alveolar inspired Lung Model is located under the monitors tab. The second location of the Lung

Model is in the right panel. You will find the Lung Model symbol located as a tab on the left side
frame of the right panel. Once selected, the Lung Model will open up in the right panel. To close this,
select the tab again.

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An Information button is located next to the Lung Model symbol. When selected, a brief
description of the Lung Model appears. This information is shown in a yellow font color.

Figure 100: Lung Model Location

The Lung Model displays multiple parameters.

When operating under CMV and SIMV, the following parameters are displayed:
• Cstat
• Ri
• ΔP
• Pplateau
Note: Numeric values for Cstat and Ri will not be displayed in Neonatal patient sizes with IBW <2.5kg.

When operating under SPONT mode, the following parameters are displayed:
• Cdyn
• RCe
• Vt/kgIBW
• RSBI
• Rate Spont
Note: if Cstat and Rinsp would like to be obtained, the user must use the inspiratory hold
Compliance

Figure 101: Lung Compliance Images and Ranges

Resistance

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Figure 102: Lung Model Resistance Images and Ranges in mandatory modes

Figure 103: Lung Model Resistance Images and Ranges in spontaneous modes

9.5 Weaning Target Tool

The Weaning Target Tool is located within the Lung Model tab. To access the Weaning Target Tool,

select the hexagon symbol . This tool is only available in SPONT modes. When the Weaning
Target Tool is selected, it will display the following parameters:

• Rate Spont
• Vt/kgIBW
• RSBI (adult and pediatric patients)
• MAP (neonatal patients)
• PS
• PEEP
• O2

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Figure 104: Weaning Target Tool Location

The Weaning Target Tool displays the Height and IBW of the patient. Height and IBW are displayed as a
reminder to the clinician. This shows the patients inputted values. The age of the patient can be set as well.
By doing this, the ventilator will automatically set the Rate Spont setting according to a NIH scale, which is
based on Normal ranges of respiratory rate.

The yellow ball is the actual value of that parameter. Its position is related to the difference to the target
set by the user. By setting the inputted parameter, you are able to adjust the target value for your patient.
Since each patient is different, this tool allows for customization of each parameter for any patient. When
the yellow ball gets closer to the green target, it means the actual value is getting closer to the set target
value.
On the same ball the current monitored value is showed.
Depending on the type of patient the weaning target tool will show different goals. Below it is showed the
different Weaning Target tools

Figure 105: Weaning target Tools for different type of patients.

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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 Types Mode
Mode Description
Selections
 Pressure-Controlled Continuous Mandatory Ventilation P-CMV
 Volume-Controlled Continuous Mandatory Ventilation V-CMV
CMV
 Pressure Regulated Volume Control PRVC-CMV
Continuous Mandatory Ventilation

 Pressure-Controlled Synchronized P-SIMV

Intermittent Mandatory Ventilation
 Volume-Controlled Synchronized Intermittent V-SIMV
SIMV Mandatory Ventilation
 Pressure Regulated Volume Control PRVC-SIMV
Synchronized Intermittent Mandatory
Ventilation
 Pressure Support Ventilation (CPAP + PS) PS/CPAP
 Pressure Regulated Volume Control, pressure support PRVC-
ventilation - PRVC-PS PS/VS
SPONT  Spontaneous Positive Airway Pressure Ventilation SPAP/APRV
(dual PEEP mode)
 Nasal Continuous Positive Airway Pressure NCPAP+
(Nasal CPAP)
Auto Control  Minute volume assured (Ve assured) Ve assured
 Tidal volume assured (Vt assured) Vt assured
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.

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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 106: 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

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Table 38: V–CMV Settings

Setting Description Unit
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 107: V-SIMV Mode

Mandator

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),

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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 setting applies to the mandatory breaths.

Table 39: V–SIMV Settings

Setting Description Unit
O2 Percentage of oxygen in delivered volume. %
Rate Mandatory breaths per minute b/min
Vt Tidal volume delivered during inspiration (compliance ml
compensated)
PEEP/CPAP Positive end expiratory pressure/continuous positive airway cmH20
pressure, the pressure at the end of exhalation
Psupport For spontaneous breaths, pressure support (in addition to PEEP) cmH20

Flow (Peak Flow) Maximum inspiratory flow l/min

Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or
cmH20
Esens Exhalation Sensitivity for spontaneous breaths, the criterion for %
cycling from inspiration to exhalation as a percentage of
maximum peak inspiratory flow breath to breath

Rise time The rise to inspiratory pressure

Scale: 1 to 20 (1 = Slow and 20 = Fast)
Flow Pat. Flow pattern: Decelerating, Decelerating 50%, or Square.
Trigger Type Flow or Pressure l/min or
cmH20
NIV NIV can be turned On or Off in all modes
Pause Inspiratory pause, 0-2 seconds. s

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) measurements to be
obtained.
Leak Comp. Leak compensation (default setting is On) Up to l/min
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 10 % of the breath.
Exhalation time is never less than 20 % of the breath.
Maximum peak flow is 200 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 108: P-CMV Mode

Table 40: P–CMV Settings

Setting Description Unit

O2 Percentage of oxygen in delivered volume. %

Rate Mandatory breaths per minute. b/min
Ti Inspiration time. sec
PEEP/CPAP Positive end expiratory pressure/continuous positive airway cmH20
pressure, the pressure at the end of exhalation.
Pcontrol Inspiration pressure above PEEP cmH20
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes

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Table 40: P–CMV Settings

Setting Description Unit
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, 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 109: P–SIMV Mode

Table 41: P–SIMV Settings

Setting Description Unit
O2 Percentage of oxygen in delivered volume. %
Rate Mandatory breaths per minute. b/min
Ti Inspiration time. sec
PEEP/CPAP Positive end expiratory pressure/continuous positive airway cmH20
pressure, the pressure at the end of exhalation.
Pcontrol Inspiration pressure above PEEP cmH20
Psupport For spontaneous breaths, pressure support (in addition to cmH20
PEEP)
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20

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Table 41: P–SIMV Settings

Setting Description Unit
Esens Exhalation Sensitivity for spontaneous breaths, the %
criterion for cycling from inspiration to exhalation as a
percentage of maximum peak inspiratory flow breath to
breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes

PS Tmax PS Tmax is the max time limit control setting for all s
modes with a pressure support (PS) setting or PS based
breaths. PS Tmax functions as the inspiration
termination criteria for all PS based breaths. PS breaths
when delivered will terminate by flow, pressure and
time. Whichever termination criterion is met first will
cause the PS breath to cycle to exhalation.
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.
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

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 PRVC-PS/VS: Pressure Regulated Volume Control Pressure Support /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
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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 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

Setting Description Unit
O2 Percentage of oxygen in delivered volume. %
Rate Mandatory breaths per minute. b/min
Vt Tidal volume target. Inspiratory pressure will automatically ml
vary to attempt to achieve this tidal volume.
Ti Inspiration time. sec
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH20
airway pressure, the pressure at the end of exhalation.
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes
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 ranges to ensure that:
Inspiration time is never less that 100 ms.
Exhalation time is never less than 200 ms.

10.1.7 Pressure 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

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triggering during SIMV ventilation is described in page 84.

Table 43: PRVC–SIMV Settings

Setting Description Unit
O2 Percentage of oxygen in delivered volume. %
Rate Mandatory breaths per minute. b/min
Vt Tidal volume target. Inspiratory pressure will automatically ml
vary to attempt to achieve this tidal volume.
Ti Inspiration time. sec
PEEP/CPAP Positive end expiratory pressure/continuous positive airway cmH20
pressure, the pressure at the end of exhalation.
Psupport For spontaneous breaths, pressure support (in addition to cmH20
PEEP)
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20
Esens Exhalation Sensitivity for spontaneous breaths, the criterion %
for cycling from inspiration to exhalation as a percentage of
maximum peak inspiratory flow breath to breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes

PS Tmax PS Tmax is the max time limit control setting for all modes s
with a pressure support (PS) setting or PS based breaths.
PS Tmax functions as the inspiration termination criteria
for all PS based breaths. PS breaths when delivered will
terminate by flow, pressure and time. Whichever
termination criterion is met first will cause the PS breath to
cycle to exhalation.
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.
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

10.1.8 PRVC-PS/VS Mode

PRVC-PS/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.

Table 44: VS Settings

Setting Description Unit
O2 Percentage of oxygen in delivered volume. %

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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 airway cmH20
pressure, the pressure at the end of exhalation.
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20
Esens Exhalation Sensitivity for spontaneous breaths, the criterion %
for cycling from inspiration to exhalation as a percentage of
maximum peak inspiratory flow breath to breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes

PS Tmax PS Tmax is the max time limit control setting for all modes s
with a pressure support (PS) setting or PS based breaths.
PS Tmax functions as the inspiration termination criteria
for all PS based breaths. PS breaths when delivered will
terminate by flow, pressure and time. Whichever
termination criterion is met first will cause the PS breath to
cycle to exhalation.
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.
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

10.1.9 Pressure Support Ventilation (PS/CPAP) 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 110: SPONT Mode

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Table 45: PS Mode Settings (CPAP + PS)

Setting Description Unit
O2 Percentage of oxygen in delivered volume. %
PEEP/CPAP Positive end expiratory pressure/continuous positive airway cmH20
pressure, the pressure at the end of exhalation.
Psupport For spontaneous breaths, pressure support (in addition to cmH20
PEEP)
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20
Esens Exhalation Sensitivity for spontaneous breaths, the criterion %
for cycling from inspiration to exhalation as a percentage of
maximum peak inspiratory flow breath to breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes
PS Tmax PS Tmax is the max time limit control setting for all modes s
with a pressure support (PS) setting or PS based breaths.
PS Tmax functions as the inspiration termination criteria for
all PS based breaths. PS breaths when delivered will
terminate by flow, pressure and time. Whichever
termination criterion is met first will cause the PS breath to
cycle to exhalation.
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.
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

10.1.10 Spontaneous Positive Airway Pressure Ventilation/ Airway Pressure

Release Ventilation (SPAP/APRV) Mode
Spontaneous Positive airway Pressure Ventilation/ Airway Pressure Release Ventilation
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(SPAP/APRV), 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 111: 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

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Setting Description Unit

O2 Percentage of oxygen in delivered volume. %
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
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20
Esens Exhalation Sensitivity for spontaneous breaths, the criterion %
for cycling from inspiration to exhalation as a percentage of
maximum peak inspiratory flow breath to breath
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
H:L Ratio of time at high to low PEEP levels. x:x
H:L is only available when the SPAP Type Cycle + Ratio is
selected.
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes

PS Tmax PS Tmax is the max time limit control setting for all modes 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.
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.
SPAP Type Varies the type of controls in SPAP
(Cycle + Time), (Cycle + Ratio) or (Time Only)
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 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

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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 Auto Control Mode

Overview: Auto control is a positive pressure mode of mechanical ventilation that automatically controls
and provides a seamless automatic transition between controlled ventilation (PRVC-CMV) and
spontaneous ventilation (PRVC-PS) based on patient requirements and user settings.

As with every adaptive ventilation system, there are inputs to the system, outputs of the system and a
feedback that helps to control the system reducing the difference to the target. In this case the system is
the ventilator.

Auto Control’s inputs:

• Patient’s respiratory rate: The ventilator continuously monitors the activity of the patient. When
the patient is in PRVC-CMV the ventilator monitors the amount of trigger that the patient is doing.
When the patient is in PRVC-PS the ventilator monitors the spontaneous rate of the patient. Both
inputs modify the behavior of the ventilator.
• Patient’s tidal volume: The ventilator measures the exhalated tidal volume of the patient and
calculates the difference to the target volume. This difference would vary the level of inspiratory
pressure following the PRVC algorithm explained in other section of this manual.
• Patient’s inspiratory pressure: the level of the inspiratory pressure would change based on the
patient’s clinical conditions. In order to keep the patient in a safe zone of inspiratory pressure,
there is only a restricted area to change the level of pressure following the PRVC algorithm.
• Time: Auto Control measures several periods of time in order to modify the parameters and take
decisions. All these periods of time would be explained below (CMV hold, ATT)

Auto Control’s outputs:

• Mode of ventilation: Based on the inputs mentioned before, the ventilator would change modes
of ventilation. Initially it will begin with PRVC-CMV. If the clinical conditions of the patient improve
then the mode could change from PRVC-CMV to PRVC-PS. Of course, if the patient is in PRCV-
PS and the patient cannot keep the ventilation targets (Ve or Vt), then the ventilator would change
from PRVC-PS to PRVC-CMV. The algorithm would take into consideration all the inputs to
change the mode of ventilation. As soon as auto control is activated, the mode of ventilation
would be shown on the top of the ventilator screen as other modes of ventilation. When PRVC-
CMV or PRVC-PS are selected automatically by auto control mode, the auto control icon would
be showed next to the mode as follows:

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• Inspiratory pressure: Since Auto Control would change from PRVC-CMV to PRVC-PS and vice
versa if the patient needs more support, the level of pressure would change every breath trying
to get the lowest level of pressure that allows the volume target.
• Mandatory rate: When the patient is being ventilated with PRVC-CMV, the mandatory rate is
what the user selected. After CMV hold is elapsed and also ATT is OFF or Break time is
elapsed, then a trigger trial could begin (see below definition).

Trigger Trial:It is a defined as the process when the ventilator slowly reduces the mandatory support and
monitors the total breathing rate and the minute volume of the patient. If the patient can keep the total
breathing rate and the minute volume within a set range, then the ventilator would change modes.
The range of total breathing rate should be above “low Ve %” and below the high rate alarm. The range
of minute volume should also be above “low Ve %” multiplied by the Set Ve.

There are 2 possible selections of Auto Control:

• Vt assured: When Vt assured is selected the ventilator would try to wean the patient keeping
the Vt at target. Vt is one of the settings of the mode.

• Ve assured: When Ve assured is selected, the ventilator would try to wean the patient keeping
the minute volume at target. User sets the Ve (minute volume) as part of the setting. Then
based on the set rate the ventilator would get the current Vt target.

Auto Control would switch from PRVC-CMV to PRVC-PS depending on the

clinical conditions of the patient. Even when the patient is under PRVC-PS
the setting of rate is important since it could be used to calculate the Vt
target.

Under current settings, the first setting on the right it is called “criteria”. There are two possible choices:
Standard and advance criteria. Both choices, Standard and Advance,both have a set of variables that
defines how Auto control works. The main difference is that Standard has fixed variables and Advance
allows the user to set different values for each parameter. A change on this setting would change the
behavior of the algorithm. This will allow the user to set the ventilator based on what the user believes is
the best for the patient. Based on this setting, the behavior of the ventilator will emulate the protocol that
the user would normally follow, however now it will work automatically.

The group of variables that will affect the behavior of the ventilator can be found under the window
called “Adaptive Weaning Criteria”. Following is an explanation of each variable:

• Apnea (s): Maximum apnea time acceptable during ventilation.

• Ppeak Limit (cmH2O): Maximum Ppeak acceptable during ventilation. When the following icon is

showed; , then the max Ppeak acceptable would autoset at 5 cmH2O below the high Ppeak
limit alarm (see alarms section for more information)
• Low Ve% (%): Lowest Ve % acceptable during PS mode compared to set Ve at CMV mode.
• CMV hold (hours): This is the time the patient would stay at CMV. When this time has elapsed,
then the ventilator will begin a trigger trial (see below more information)
• Adaptive Trigger Trial (min): In case ATT is ON, the ventilator will monitor the activity of the
patient. In case the patient triggers breaths for 3 consecutive minutes in PRVC-CMV mode, then
the ventilator will begin to wean the patient. The trigger trials would be suspended for “Break time”
in case the weaning of the patient failed.

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Figure 112: Adaptive Weaning criteria, Ve assured.

Standard Criteria:
To begin the Auto Control, Standard criteria (Ve assured or Vt assured), please select the mode and standard
criteria and then press Start.
By default, Auto control is using this algorithm. Patient initially will be ventilated with PRVC-CMV
and will stay for the first 30 minutes. User could press the trigger trial button and begin a trigger
trial at any moment.
During these 30 minutes, the ventilator will start trigger trial anytime when Adaptive Trigger Trial
(ATT) detects a patient breath. The “Break time” is set at 30 at 30 minutes
After 30 minutes the patient will go through a process called trigger trial (explained before). If the patient can
maintain the minute volume and total breathing rate within the set range, then the ventilator will switch from
PRVC-CMV to PRVC-PS.
In case the patient is not able to keep the ventilation targets within the set range, then the patient will stay at
PRVC-CMV. The ventilator will adapt the setting shown on the adaptive weaning criteria window, based on
the history of the patient. The ventilator will increase the time for the next trigger trial if the patient fails.

Figure 113: Current Settings Standard criteria

Advanced criteria:
The other option to use Auto control is the advance criteria. This would allow the user to change all the
Adaptive weaning criteria variables. By default the initial setting would be the same as the Standard critieria
offers.

Apnea: This is the time that the ventilator would take as “apnea” when the patient has no breath during this
period. This value is the same value that is set at the alarm limits. If the alarm limit is changed, this parameter
will also be changed and vice versa. If the patient has no breath during this period, then the patient would
switch from PRVC-PS to PRVC-CMV.

Ppeak: PRVC changes the level of pressure trying to get a targer tidal volume. If the monitored volume is
below the target volume, then the pressure will increase (see PRVC mode for more information). If the
monitored volume is above the target volume, then the inspiratory pressure will be reduced. So this mode
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regulates the inspiratory pressure to achieve a target volume. The range of pressure where PRVC modulates
the inspiratory pressure is given indireclty by the level of PEEP + 10 cmH2O and the level of Ppeak set at this
parameter. By default is set at 5 cmH2O below the high pressure alarm. User could change this value.

Low Ve% / Low vt%: In case the user selects Ve assured, then this parameter would be Low Ve %. In case
the user sets Vt assured then this parameter would be Low Vt%. This is the lowest Ve or Vt% acceptable
during PS mode compared to set Ve or vt at CMV mode.
During Ve assured, the ventilator would compare the monitored Ve with the target Ve. During Vt assured the
ventilator will compare the monitored exhalated Vt with the target Vt. In case the patient cannot keep the
target levels, then the ventilator will switch over PRVC-CMV.

CMV hold: Set by default at 0.5 hs (30 minutes). If CMV hold is increased then the amount of time that the
patient will stay at PRVC-CMV would increase.

ATT Break time: If the ATT Break is different than OFF, when the patient triggers the ventilator for 3
consecutive minutes, then a trigger trial would begin. If the ATT break time is increased, then after a trigger
trial is performed without success, then the patient would stay more time at PRVC-CMV until the next trigger
trial. (the amount of time set under ATT break time). The user could also set ATT break time at OFF. In this
case if the patient would stay at PRVC-CMV the time set at CMV hold. ATT is an exit of PRVC-CMV in case
the patient has trigger activity.

Figure 114: Current settins, Advance Criteria.

To begin the Auto Control, Advanced criteria (Ve assured or Vt assured), please select the mode and
Advanced criteria and then press Start.
Auto Control would begin ventilation with PRVC-CMV (see detailed information of this mode in previous
sections). The patient would stay in this mode initially for 30 minutes by default. The time the patient stays at
PRVC-CMV is set by CMV hold (under Adaptive weaning criteria). After this time elapses the ventilator would
begin a trigger trial. The mandatory rate would be slowly reduced allowing the patient to adapt to this change
of mandatory support. As the mandatory rate is reduced and the patient begins to trigger and keeps the Ve
or Vt within the setting (Low Ve% or Low Vt% setting) the ventilator would switch from PRVC-CMV to PRVC-
PS.
If the patient is not able to keep the target of Ve or Vt, then the patient would stay at PRVC-CMV. CMV hold
will set the time between trigger trials.
In case the user would like to do a trigger trial, there is a button called Trigger Trial. When this button is
pressed, even if the CMV hold has not elapsed, the patient would go through a trigger trial.
Another way to allow the ventilator to do a trigger trial automatically is using the Adaptive Trigger trial (see
Adaptive Weaning Criteria Adaptive T. T.). If ATT is ON (use set a break time), then the ventilator would
constantly observe if there is activity of the patient. Then if the patient triggers at least one breath for 3
consecutive minutes, then the ventilator would automatically begin a trigger trial. If patient is not able to keep
the targets, then patient would stay at PRVC-CMV. In order to avoid another trigger trial, ATT allows to set a
Break time. By default, ATT is set at 30 minutes. This means that if the patient fails the trigger trial, even if

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there is activity, the patient would stay for 30 minutes at PRVC-CMV.
When Ve assured is selected and the mode is PRVC-PS, in order to calculate the Vt target the ventilator will
use the monitored spontaneous breathing rate. However, if the patient increases

Changing Criteria’s
It is possible for the user to change criteria from Standard to Advance and vice versa. In order to do that go to
“settings”, then “Auto Control”, then “Current Settings” and push the criteria button. By doing that the ventilator
would request confirmation opening a window as show on the below graphic.

If the user presses “Continue”, and then “Start”, then the ventilator will continue with the current mode of
ventilation using previous settings. If use press “ReStart” and then “start”, then ventilator will restart the whole
process again. In this last case the mode would be PRVC-CMV and the settings would be the default settings.

SBT advisory message

When patient is in Auto Control and being ventilated with PRVC-PS, the ventilator will analyze if the patient
meets conditions to proceed with a SBT. If those conditions are met, then the ventilator will activate the SBT
advisory message.
SBT Advisory Conditions are:

• FiO2<=50 %
• PEEP<= 8 cmH2O
• PS<= 10 cmH2O
• Monitored Ve >= set Ve (Ve assured)
• Monitored Vt >= set Vt (Vt assured)
• Set rate <+ total rate < High rate alarm
• Vt >= 5 ml/Kg IWB

“SBT advisory” message will appear with only one beep. It will disappear once user click off the green bar. It will
come back in 24 hours or when the Auto Control was restarted, whichever comes earlier

Auto Control Window

When this mode is selected a new window will be available for the user to evaluate the clinical situation of the
patient. This window shows the relation between the rate and the volume. If the user selects Ve assured, then
the window would show a graphical representation of rate (b/min) vs Vt (ml). If the user selects Vt assured,
then this window would show the rate (b/min) vs Ve (l/min) relationship.
The green curve will show all the possible combinations of the set volume. In case Ve assured, the green
curve will show all the Rate * Vt that provides the requested Ve for that patient. The target would be a certain
point of that curve showed as a green ball. A yellow star will show on the same window the patient’s rate and
vt. If patient is breathing spontaneously (PRVC-PS) then Vt and rate could vary constantly. The position of
the star on this window would change based on the current values of Vt and spontaneous rate of the patient.
To show previous position of the star, this window will show small yellow dots.
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Green ball will show targets

Yellow star will show the status of the patient

As it was explained before, the user would select Low vt% or Low Ve% (depending on the selection, Vt
assured or Ve assured). This is the lowest Ve % acceptable during PS mode compared to set Ve at CMV
mode. The yellow curve represents this parameter.
Not all the combinations of rate and volume would be safe for the patient. Therefore, a light blue rectangle is
showed as the patient’s safe zone called lung protective zone.
At the bottom of the screen the user would be able to see the amount of time the patient has been ventilated
in Spont mode or the time to elapse the CMV hold time A short explanation of all this representation would

be showed if the user press (information button).

Figure 115: Auto control Windows

Another window available when auto control is being used, Is the auto control statistics. Press the following
button to access it:

When pressed, the following window will open:

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Figure 116: Auto Control Statistics

On this window there are 2 pies that show in grey the % of time on mandatory mode (PRVC-CMV) and in
yellow the % of time the patient was ventilated in spontaneous mode (PRVC-PS). The first pie shows the total
time % since the patient was in Auto control mode. The second pie would show the last trends, this is how
the patient is doing over the last period. The period that the user would like to see can be set. On the above
example it was set at 1hrs however it could be set up to 8 hs..
In case the ventilator is also used in other modes of ventilation, then a white portion would be shown.
Also, on the left of each pie the user will see the amount of mode changes and the amount of trigger trials the
patient had over that period.
At the bottom of the screen the user would be able to see the amount of time the patient has been ventilated
in Spont mode or the time to elapse the CMV hold time.

Table 47: Auto Control Settings

Setting Description Unit
O2 Percentage of oxygen in delivered volume. %
Rate Mandatory breaths per minute. b/min
Vt (Vt assured Tidal volume target. Inspiratory pressure will automatically Ml
only)) vary to attempt to achieve this tidal volume.
Ve (Ve assured Minute volume target. Inspiratory pressure will automatically l/min
controonly) vary to attempt to achieve this minute volume.
Ti Inspiration time. Sec
PEEP/CPAP Positive end expiratory pressure/continuous positive cmH20
airway pressure, the pressure at the end of exhalation.
Ftrig or Ptrig Trigger sensitivity (flow or pressure) l/min or cmH20
Rise time The rise to inspiratory pressure
Scale: 1 to 20 (1 = Slow and 20 = Fast)
Trigger Type Flow or Pressure l/min or cmH20
NIV NIV can be turned On or Off in all modes
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

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. Trigger Trial Activates a trigger trial when user press it ON/OFF

The ventilator automatically limits the setting ranges to ensure that:

Inspiration time is never less than 100 ms. Exhalation time is never less than 200 ms.

Figure 117: Auto Control settings

10.1.13 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.

10.1.13.1 NIV Patient Interface

NIV is appropriate for use with a non-vented mask and requires a standard heated or non-
heated wire dual-limb breathing circuit.

Under certain conditions, leaks from vented masks can cause

auto-cycling and an inability to maintain the set PEEP level.
A qualified caregiver must evaluate whether settings and alarms
limits are clinically appropriate.
During NIV, these adjustments may be appropriate:
Adjust the trigger level to avoid auto-cycling and adjust the leak alarm
to avoid nuisance alarms.
Adjust Esens to ensure that inspiration terminates appropriately.
Adjust Rise time for greatest patient comfort.

10.1.14 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.

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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.

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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 Adaptative ventilation mode

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 (1 cmH O = 10 –3 bar) and (1.016 cmH O = 1 mbar or 1 hPa)
2 2

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)

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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
(1 ml = 10 –3 l)

Millimeter of mercury is a manometric non-SI unit of pressure

mmHg
(1 mmHg = 1 Torr) or (1 mmHg = 760 millimeters of mercury)

ms Millisecond
min Minute
NCPAP+ Nasal continuous positive airway pressure plus with rate and base flow
NIV Non-Invasive Ventilation
O2 Oxygen and or Delivery Concentration
+ O2% Apnea Backup Oxygen Setting
OI Oxygen Index
OID Object Identification Table
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

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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 (Re) Expiratory Resistance
Rinsp (Ri) Inspiratory Resistance

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 Section 11 Abbreviations

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
Vi 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

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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 48: Abbreviations

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 Section 12 Pneumatic Schematic

12. Pneumatic Schematic

Figure 118: High Pressure System, Pneumatic Schematic

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Figure 119: Optional, Turbine Based System, Pneumatic Schematic

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13. Index

Contact Information
Clinical Support..................................................................................
1 US Office Address ............................................................................ 2
US Office Fax ................................................................................... 2
Alarm Settings US Office Phone ............................................................................... 2
Standard............................................................................................. US Sales .............................................................................................
Alarms Control Settings
Auto Set Feature ................................................................................ Soft Boundary ....................................................................................
Reset Feature ............................................................................... 125 Display
Technical Faults................................................................................ 0 Freeze / Unfreeze ..............................................................................
Alarms Medium Priority Monitors ...................................................................................... 133
SBT High Rate ..................................................................................... Parameters .................................................................................. 133
Audible alarm Selecting Parameters .........................................................................
setting level .................................................................................. 134 eVolution Ventilator part numbers ...................................................... 2
Auto Control ........................................................................................... EXH Flow Sensor Calibration ............................................................ 142
Battery Exhalation Sensitivity (Esens) .................................................................
Status Bar Icon ................................................................................... Assembly ............................................................................. 146, 147
Breath Termination Exhalation valve cover
PS Tmax .............................................................................................. Manual cleaning .......................................................................... 145
Buzzer Exhalation Valve System .................................................................. 144
setting audible alarm level ........................................................... 134 EZ-Flow sensor
reusable ....................................................................................... 143
single patient use ........................................................................ 143
C
C20/C ......................................................................................................
F
Calibrations
Calibration Required Status Bar Icon ................................................. F/V Loop .................................................................................................
EXH Flow Sensor .......................................................................... 142 Graphics
New Patient ....................................................................................... Capnograms Screen ..................................................................... 127
O2 Sensor ............................................................................. 138, 141 Changing Scale...................................................................................
Pre-Patient Tests ................................................................ , 138, 139 Cleaning and sterilization ............................................................ 143
System Test .......................................................................... 138, 139 Humidification Type ...............................................................................
Zero Flow Sensor.......................................................................... 139
Capnograms Screen Graph Selection ................................................ 131
Left Panel SBCO2 Curves............................................................... 131 I
Right Panel Waveforms................................................................ 131
Capnography Maintenance .................................................................................... 138
Mainstream (IRMA) Sensor ................................................................ Alarm Tests ........................................................................................
Circuit compliance calculation .......................................................... 138 Manual Breath
Circuit sterilization ............................................................................ 142 Front Panel Key .................................................................................
Classification ........................................................................................... Mechanics
Cleaning and sterilization.................................................................. 142 Monitored Data .................................................................................
Clearing Alarms ................................................................................. 125 Mode description
CMV Auto Control ......................................................................................
Pressure ............................................................................................. Monitored Data
Communication Advanced ...........................................................................................
CliniNet Server ................................................................................... Monitoring Bar
Compliance Selecting Parameters .........................................................................
Cdyn ................................................................................................... Nebulizer setting .............................................................................. 133
Compliance Comp ............................................................................. 135 New Patient Startup ...............................................................................
Config. Screen ......................................................................................... Nurse call
Configuration Interface pin assignments .................................................................
Compliance Comp ........................................................................ 135
Trend Data .........................................................................................
Configuration Screen Settings........................................................... 133 O
Configuration Screens ............................................................... 132, 135
Configuring Graphic Display.................................................................... O2 ⬆ Key

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Status Bar Icon ................................................................................... Cycle(rate) setting .............................................................................

O2 Sensor Calibration ....................................................................... 141 SPAP/APRV Mode
O2 Sensor Off Description ........................................................................................
Status Bar Icon ................................................................................... Spare parts ....................................................................................... 148
O2 Sensor On/Off ............................................................................. 135 Specifications .........................................................................................
On/Off Button ......................................................................................... SPONT
Ordering parts................................................................................... 148 Startup
Overview of Features Patient Option ...................................................................................
CliniNet Server ................................................................................... System Test .............................................................................. 138, 139
Oxygen Sensor Calibration ................................................................ 141

T
P
Table of Contents ................................................................................. 3
P/V Loop ................................................................................................. Table of Tables .......................................................................................
Part Number ..................................................................................... 148 Technical Fault ..................................................................................... 0
1881 ............................................................................................. 148 TF-01 ................................................................................................ 0
EV200012 ..................................................................................... 148 TF-02 ................................................................................................ 0
EVL220008 ................................................................................... 148 TF-03 ................................................................................................ 0
EVL220047 ................................................................................... 148 TF-04 ................................................................................................ 0
EVL370017 ................................................................................... 148 TF-05 ................................................................................................ 0
EVL500501 ................................................................................... 148 TF-06 ................................................................................................ 0
F710616 ....................................................................................... 148 TF-07 ................................................................................................ 0
F910028 ....................................................................................... 148 TF-08 ............................................................................................ 125
F910037 ....................................................................................... 148 TF-10 ............................................................................................ 125
F910038 ....................................................................................... 148 TF-11 ............................................................................................ 125
MR 850 ......................................................................................... 148 TF-12 ............................................................................................ 125
MR370.......................................................................................... 148 Technical Specifications
RT 130 .......................................................................................... 148 EMC ...................................................................................................
RT 137 .......................................................................................... 148 Ventilation Modes
Part numbers .................................................................................... 148 Types & Selection ..............................................................................
Parts list ............................................................................................ 148 Ventilator
Patient Selection – New Settings ............................................................ Alarm Definitions ...............................................................................
Product Config Screen............................................................................... 132
Disposal .............................................................................................. Controls Adjustment .........................................................................
Product Specifications exterior cleaning .......................................................................... 145
Alarm High Priority............................................................................. GUI Navigation ..................................................................................
Regulated Volume Control Continuous Ventilator Modes
Mandatory Ventilation ( PRVC-CMV ) Mode ...................................... Activating...........................................................................................
Regulated Volume Control Synchronized Ventilator Settings
Intermittent Mandatory Ventilation ( PRVC-SIMV ) Mode ................ Apnea Backup ....................................................................................
Resistance
Expiratory (Rexp) ...............................................................................
Settings W
Base Flow ...........................................................................................
Settings Config. Screen (Technical) Warning
Password Access to User Config. ....................................................... CO2 monitor placement ....................................................................
Settings SBT Mode
Sigh
Status Bar Icon ...................................................................................
SIMV
Z
Pressure .............................................................................................
SPAP Mode Zero Flow Sensor .............................................................................. 139

EVM500041 Rev M eVolution®3e Series User Manual (International Version) 208

 Section 14E-mail Contacts

14. E-mail Contacts

Sales

International Sales: [email protected]

North American Sales: [email protected]

Service and Support

Customer Service: [email protected]

Technical Service: [email protected]

Clinical Support: [email protected]

Table 49: E-mail Contact Details

www.event-medical.com

209 eVolution®3e Series User Manual (International Version) EVM500041, Rev M