Event Medical Evolution Service Manual PDF

eVolution™ V entilator System
A Clinician Focused Product
Service Manual
eVolution
Ventilator
System
Page 2 of 232 eVolution Ventilator Service Manual – EVL510001 Rev. C v.0 May 2010
eVolution Ventilator ™
Service Manual
This manual applies to:
The eVolution ventilator PN: EVL100500
Illustrations in this manual apply to the eVolution ventilator.

Installed software / firmware versions are displayed upon power up on the initial screen.
United States Europe
eVent Medical, Inc.

eVent Medical Limited 0120
971 Calle Amanecer, Suite 101 Unit 29 Glenrock Business Park
San Clemente, CA 92673 Ballybane, Galway
United States Ireland
Tel: +1 949 360 8368

Fax: +1 949 360 1924
www.event-medical.com
For technical assistance please contact eVent Medical at:
service@event-medical.com
eVolution Ventilator Service Manual – EVL510001 Rev. C v.0 Feb 2010 Page 3 of 232
TABLE OF CONTENTS
PREFACE..................................................................................................................................................15
INTRODUCTION ................................................................................................................................................................. 15
COPYRIGHT INFORMATION ............................................................................................................................................. 15
GENERAL INFORMATION ..................................................................................................................17
PRODUCT DESCRIPTION AND INTENDED USE ...........................................................................................................17
SAFETY INFORMATION ..................................................................................................................................................... 18
DEVICE LABELS AND SYMBOLS ...................................................................................................................................... 19
THE EVOLUTION PRODUCT LABELS: .............................................................................................................................21
RESPONSIBILITIES AND GUARANTEES ...........................................................................................................................22
PRODUCT SPECIFICATIONS .............................................................................................................. 23
ELECTROMAGNETIC COMPATIBILITY DECLARATION ...............................................................................................33
TOOLS, TEST EQUIPMENT AND MATERIALS (RECOMMENDED) ..............................................................................38
THEORY OF OPERATION................................................................................................................... 39
OVERVIEW OF OPERATION ............................................................................................................................................. 39
Pneumatic Theory of Operation ................................................................................................................................. 40
Gas supply systems........................................................................................................................................................40
High and Low Pressure Oxygen Inlets ...................................................................................................................... 40
Inlet Filters (F1, F2) ......................................................................................................................................................41
Inlet O2 Check Valves (CV1 and CV2) ..................................................................................................................... 41
Oxygen Regulator (Reg1) ............................................................................................................................................. 42
Blower..............................................................................................................................................................................43
Gas Delivery System ..................................................................................................................................................... 43
Proportional Valves (PV1 / PV2)............................................................................................................................... 44
Flow Sensor (FS1 / FS2).............................................................................................................................................. 44
Check Valve (CV3)........................................................................................................................................................45
Oxygen Sensor (FIO2 sensor)...................................................................................................................................... 46
Safety Valve (SV) ...........................................................................................................................................................47
Safety Valve Solenoid (Sol 2) ....................................................................................................................................... 47
Check Valve (CV4)........................................................................................................................................................48
Crossover Valve (Sol1).................................................................................................................................................. 48
Check Valves (CV5 and CV6) ..................................................................................................................................... 49
Exhalation System .........................................................................................................................................................49
Bacteria Filter (F3).........................................................................................................................................................50
Heat Exchanger (H1) .................................................................................................................................................... 50
Exhalation Flow Sensor (FS3) ..................................................................................................................................... 51
Exhalation Valve (EV).................................................................................................................................................. 51
Low Flow Regulator (LFR).......................................................................................................................................... 52
Nebulizer System ...........................................................................................................................................................52
Nebulizer Valve (SV4) .................................................................................................................................................. 52
Electronic System ..........................................................................................................................................................55
Power Input Components ............................................................................................................................................... 55
Power On/Off Switch.................................................................................................................................................... 55
Power Supply.................................................................................................................................................................56
Internal Battery Pack ....................................................................................................................................................56
External D.C. Power Socket......................................................................................................................................... 57
Power Management Board ............................................................................................................................................. 58
Power Management....................................................................................................................................................... 58
eVolution Ventilator Service Manual – EVL510001 Rev. C v.0 May 2010 Page 5 of 232
Blower Motor Board ...................................................................................................................................................... 59
Interface Board...............................................................................................................................................................60
Control Board................................................................................................................................................................61
Backlight Inverter ..........................................................................................................................................................62
LCD Panel...................................................................................................................................................................63
Front Panel Membrane Switch....................................................................................................................................... 63
Encoder switch...............................................................................................................................................................64
Touch Screen..................................................................................................................................................................64
Alarm Light Board ....................................................................................................................................................... 65
SELF TESTS AND USER CONFIGURATION SCREENS.................................................................. 67
POWER ON SELF TEST (POST)....................................................................................................................................... 67
USER CALIBRATION........................................................................................................................................................... 68
Zero Flow Sensor ..........................................................................................................................................................71
Calibrate Exhalation F - S Zero Offset...................................................................................................................... 72
System Leak Test and Compliance Calculation ........................................................................................................ 73
System Leak Test ..........................................................................................................................................................74
Perform Tubing Compliance Test ................................................................................................................................... 74
O2 Sensor Calibration................................................................................................................................................... 74
Exhalation Flow Sensor ................................................................................................................................................76
User Configuration Screens ......................................................................................................................................... 78
System Pneumatic ..........................................................................................................................................................83
Power Status..................................................................................................................................................................85
System Logs...................................................................................................................................................................86
System Miscellaneous .....................................................................................................................................................88
ENGINEERING SCREENS....................................................................................................................91
SYSTEM PNEUMATIC ......................................................................................................................................................... 92
POWER STATUS .................................................................................................................................................................... 94
SYSTEM LOGS ..................................................................................................................................................................... 95
Alarm Log .......................................................................................................................................................................96
Calibration Log...............................................................................................................................................................96
Settings Log ....................................................................................................................................................................97
SYSTEM MISCELLANEOUS ................................................................................................................................................ 97
CALIBRATION ..................................................................................................................................................................... 99
Air Valve calibration......................................................................................................................................................99
Calibration Process: .....................................................................................................................................................100
Oxygen Valve calibration ...........................................................................................................................................101
Exhalation Valve calibration ......................................................................................................................................102
O2 Sensor Calibration.................................................................................................................................................104
Exhalation Flow Sensor..............................................................................................................................................105
Touch Screen Calibration ...........................................................................................................................................107
System Test...................................................................................................................................................................108
System Leak Test ........................................................................................................................................................108
Perform Tubing Compliance Test .................................................................................................................................109
System Leak Test ........................................................................................................................................................110
Exhalation F-S Zero Offset ........................................................................................................................................111
Calibrate Exhalation F - S Zero Offset....................................................................................................................111
PERFORMANCE VERIFICATION...................................................................................................... 113
WHEN TO RUN TESTS .....................................................................................................................................................114
TEST EQUIPMENT AND SERVICE MATERIALS ............................................................................................................115
CLEANING AND INSPECTION ........................................................................................................................................115
TEST EQUIPMENT SET UP ..............................................................................................................................................116
TESTING ORDER ..............................................................................................................................................................116
1. Set-Up...................................................................................................................................................................117
FPGA ........................................................................................................................................................................117
POST .........................................................................................................................................................................117
Speaker .......................................................................................................................................................................117
Alarm LED...............................................................................................................................................................117
Fan .............................................................................................................................................................................117
Software.......................................................................................................................................................................117
Hours..........................................................................................................................................................................117
Pre-Patient System Tests..............................................................................................................................................117
Calibrate Oxygen Sensor .............................................................................................................................................117
2. Electrical Safety Testing ....................................................................................................................................118
3. Functional Tests..................................................................................................................................................118
Pneumatic Analyzer ....................................................................................................................................................118
Oxygen Inlet regulator..................................................................................................................................................119
Inhalation Air Valve ..................................................................................................................................................119
High Pressure Inhalation Oxygen Valve......................................................................................................................119
Low Flow Oxygen Inlet ...............................................................................................................................................120
Flow, Air and Exhalation ..........................................................................................................................................120
Flow, Oxygen and Exhalation ....................................................................................................................................120
Safety valve ..................................................................................................................................................................121
Exhalation valve .........................................................................................................................................................121
Nebulizer Solenoid ......................................................................................................................................................121
Crossover Valve...........................................................................................................................................................122
Internal battery ............................................................................................................................................................122
Heater .........................................................................................................................................................................122
Buzzer.........................................................................................................................................................................122
Manual Key.................................................................................................................................................................124
O2↑ (100% O2) Key..................................................................................................................................................124
Nurse Call ..................................................................................................................................................................124
4. Performance Verification Tests........................................................................................................................124
Oxygen Concentration Accuracy...................................................................................................................................124
5. Volume Accuracy (Vti/Vte/RR)......................................................................................................................125
Pressure Accuracy (Pcontrol/PEEP) .......................................................................................................................128
Alarm Operation Tests ...............................................................................................................................................131
Troubleshooting Performance Verification ............................................................................................................134
ALARM MESSAGES AND DIAGONSTIC ERROR MESSAGES........................................................137
ALARM SIGNALS ...............................................................................................................................................................137
ALARM LEVELS .................................................................................................................................................................137
ALARM SILENCE KEY......................................................................................................................................................138
ALARM LOG ......................................................................................................................................................................138
ALARM DEFINITIONS ......................................................................................................................................................138
High Priority Alarms ...................................................................................................................................................138
Medium Priority Alarms .............................................................................................................................................140
Information Messages.................................................................................................................................................141
About Diagnostic Messages.......................................................................................................................................141
Startup Mode: .............................................................................................................................................................141
Standby Mode:.............................................................................................................................................................142
PREVENTATIVE MAINTENANCE.................................................................................................... 145
Every Year or as required: Clean or Replace Cooling Fan Filter.........................................................................145
Every Year or as required: Clean or Replace Air Inlet Filter................................................................................146
Every Year or as required: Replace oxygen sensor ................................................................................................146
Every Two Years or as required: Replace the Internal Battery ............................................................................147
As Required: Replace Fuses .......................................................................................................................................148
SERVICE AND REPAIR........................................................................................................................149
REPAIR SAFETY ................................................................................................................................................................149
REPAIR GUIDELINES .......................................................................................................................................................149
CLEANING .........................................................................................................................................................................150
ELECTRICAL CABLES AND PNEUMATIC CONNECTION ...........................................................................................150
ESD CONTROL .................................................................................................................................................................150
General Information ...................................................................................................................................................150
Procedures and Precautions.......................................................................................................................................150
REPAINTING .....................................................................................................................................................................151
NONCONFORMING PARTS AND RETURN AUTHORIZATION NUMBERS (RGA) ..................................................151
REPLACEMENT PARTS .....................................................................................................................................................151
POST REPAIR AND TESTING ..........................................................................................................................................151
REPAIR DOCUMENTATION AND RECORDS ................................................................................................................151
PATIENT SYSTEM AND ACCESSORIES ..........................................................................................................................151
SERVICING PROCEDURES - REMOVAL/INSTALLATION ...........................................................................................152
Ventilator Stand ...........................................................................................................................................................152
AC power ......................................................................................................................................................................152
Air Inlet Filter, Main ...................................................................................................................................................152
Fan Air Inlet Filter.......................................................................................................................................................152
Internal Batteries..........................................................................................................................................................152
Oxygen Sensor .............................................................................................................................................................152
Top Enclosure..............................................................................................................................................................152
Front enclosure – Removal........................................................................................................................................153
Rotary Control Knob ..................................................................................................................................................153
Front Panel Membrane Switch..................................................................................................................................153
Display Assembley.......................................................................................................................................................153
Control Board...............................................................................................................................................................154
Interface ........................................................................................................................................................................154
Backlight Inverter ........................................................................................................................................................154
LCD Panel ....................................................................................................................................................................154
AlarM Light Board ......................................................................................................................................................154
Rear Panel .....................................................................................................................................................................154
Battery Tray assembly .................................................................................................................................................155
Power Manifold Assembly .........................................................................................................................................155
Blower Motor Board ...................................................................................................................................................155
Power Management Board.........................................................................................................................................155
Power Supply................................................................................................................................................................156
Exhalation Valve module ...........................................................................................................................................156
Heat Exchanger............................................................................................................................................................156
Exhalation Flow Sensor..............................................................................................................................................157
Exhalation Valve Assembly .......................................................................................................................................157
Exhalation Valve Diaphagm ......................................................................................................................................157
Nebulizer Manifold .....................................................................................................................................................157
Exhalation Low Flow Regulator (LFR)....................................................................................................................157
Safety Valve Module....................................................................................................................................................158
Safety Valve Diaphram ...............................................................................................................................................158
Safety Valve Check valve............................................................................................................................................158
Inhalation Module Assembley ...................................................................................................................................158
Flow Sensor FS1 & FS2..............................................................................................................................................159
Air Valve (PV2)............................................................................................................................................................159
High pressure inhalation module (PV1)...................................................................................................................159
Oxygen Filter................................................................................................................................................................159
Oxygen Regulator ........................................................................................................................................................160
Crossover solenoid SOL 1 .........................................................................................................................................160
Safety valve solenoid SOL 2 ......................................................................................................................................160
Blower Assembly .........................................................................................................................................................160
PARTS LIST ............................................................................................................................................ 161
VENTILATOR ASSEMBLY, MODEL EVL 100000.........................................................................................................163
SERVICE PARTS LIST ........................................................................................................................................................203
CONSUMABLE PARTS LIST ..............................................................................................................................................208
COMMUNICATION INTERFACE ..................................................................................................... 209
ETHERNET CONNECTION (RJ45 CONNECTOR).........................................................................................................209
NURSE CALL PORT CONFIGURATION .........................................................................................................................209
SOFTWARE INSTALLATION INSTRUCTION ................................................................................. 211
USING THE DOWNLOAD TOOL ....................................................................................................................................211
Introduction..................................................................................................................................................................211
Environment Compatibility .......................................................................................................................................211
Required Equipment and Files ..................................................................................................................................212
Download Procedure: Upgrading Existing Application........................................................................................213
Troubleshooting Download Failure .........................................................................................................................217
FORMS ....................................................................................................................................................221
EVOLUTION VENTILATOR – PERFORMANCE VERIFICATION RECORD..................................................222
INDEX .........................................................................................................................................................................231
TABLE OF FIGURES
Figure 1: eVolution Serial Number Label ..........................................................................................................21
Figure 2: eVolution Manufactured For Label ...................................................................................................21
Figure 3: eVolution Caution Label......................................................................................................................21
Figure 4: eVolution Date of Manufacture Label...............................................................................................21
Figure 5: Pneumatic Diagram ..............................................................................................................................40
Figure 6: Pneumatic/Mechanical Tubing Diagram ..........................................................................................53
Figure 7: eVolution System Wiring Diagram ....................................................................................................54
Figure 8: eVolution Electrical Block Diagram ..................................................................................................66
Figure 9: User Calibration Screen – New Patient.............................................................................................69
Figure 10: Pre-Patient System Test Screen ........................................................................................................69
Figure 11: Pre-Patient Calibrations Screen – New patient ..............................................................................70
Figure 12: User Calibration Screen – Previous Patient....................................................................................70
Figure 13: Pre-Patient Calibrations Screen – Previous ....................................................................................71
Figure 14: Calibrate Exhalation F - S Zero Offset ...........................................................................................72
Figure 15: Calibrate Oxygen Sensor Test Screen..............................................................................................75
Figure 16: Settings ................................................................................................................................................78
Figure 17: Config Screen.....................................................................................................................................78
Figure 18: Technical Settings Screen ..................................................................................................................80
Figure 19: Language Setting Screen ....................................................................................................................81
Figure 20: Time and Date Setting Screen ..........................................................................................................81
Figure 21: Technical Settings - Engineering Password...................................................................................82
Figure 22: Engineering Screen.............................................................................................................................83
Figure 23: System Pneumatic Screen ..................................................................................................................84
Figure 24: Power Status Screen ...........................................................................................................................85
Figure 25: System Logs Screen ............................................................................................................................86
Figure 26: Alarm Log Screen ...............................................................................................................................87
Figure 27: Calibration Log ...................................................................................................................................87
Figure 28: Settings Log Screen ............................................................................................................................88
Figure 29: System Miscellaneous Screen............................................................................................................88
Figure 30: Engineering Screen.............................................................................................................................91
Figure 31: System Pneumatic Screen ..................................................................................................................92
Figure 32: Power Status Screen ...........................................................................................................................94
Figure 33: System Logs Screen ........................................................................................................................... 95
Figure 34: Alarm Log Screen .............................................................................................................................. 96
Figure 35: Calibration Log Screen...................................................................................................................... 96
Figure 36: Setting Log Screen ............................................................................................................................. 97
Figure 37: System Miscellaneous Screen ........................................................................................................... 97
Figure 38: Calibration Screen .............................................................................................................................. 99
Figure 39: Calibrate Air Valve Screen................................................................................................................ 99
Figure 40: Calibrate Oxygen Valve Screen...................................................................................................... 101
Figure 41: Calibrate Exhalation Valve Screen ................................................................................................ 102
Figure 42: Calibrate Oxygen Sensor Screen.................................................................................................... 104
Figure 43: Calibrate Exhalation Flow Sensor Screen .................................................................................... 105
Figure 44: Touch Screen Calibration Screen .................................................................................................. 107
Figure 45: System Test Screen .......................................................................................................................... 108
Figure 46: System Leak Test Screen................................................................................................................. 109
Figure 47: Calibrate Exhalation F - S Zero Offset Screen............................................................................ 111
Figure 48: Electrical Safety Test Set-Up.......................................................................................................... 118
Figure 49: Pneumatic Analyzer Set-Up............................................................................................................ 119
Figure 50: Adult Patient Circuit Set-Up .......................................................................................................... 122
Figure 51 - Fan Filter and Cover ...................................................................................................................... 145
Figure 52: O2 Sensor.......................................................................................................................................... 146
Figure 53: O2 Sensor.......................................................................................................................................... 146
Figure 54: Internal Battery................................................................................................................................. 147
Figure 55: Fuse .................................................................................................................................................... 148
Figure 56: Communication ports, Ethernet and Nurse Call ........................................................................209
Figure 57: Back Panel, RJ12 Nurse Call Connector ...................................................................................... 209
Figure 58: Firmware Version Screen................................................................................................................ 212
LIST OF TABLES
Table 1: Configurable Attributes.........................................................................................................................79
Table 2: System Pneumatic Screen Parameters/Ranges..................................................................................93
Table 3: System Miscellaneous Screen Paramaters/Ranges ............................................................................98
Table 4: Calibration/Performance Testing Schedule.................................................................................... 114
Table 5: Test Equipment & Service Materials Table..................................................................................... 115
Table 6: Initial settings....................................................................................................................................... 123
Table 7: Volume Accuracy Test Settings - 1................................................................................................... 125
Table 10: Volume Accuracy Test Settings - 4 ................................................................................................ 127
Table 11: Pressure Accuracy Test Settings ..................................................................................................... 128
Table 12: Alarm Operation Test Settings ....................................................................................................... 131
Table 13: Apnea Backup Test Settings............................................................................................................ 133
Table 14: Alarm Signals ..................................................................................................................................... 137
Table 15: Preventive Maintenance Schedule .................................................................................................. 145
1
Section
PREFACE
INTRODUCTION
This manual is intended to provide the necessary information required to service and maintain the eVent
Medical eVolution™ ventilator system. It is intended for use by certified biomedical engineers or engineers
with equivalent experience in the maintenance of respiratory life support equipment. It is highly
recommended that engineers wishing to undertake the maintenance of the eVolution ventilator system attend
a technical training seminar with eVent Medical or authorized local agents.
COPYRIGHT INFORMATION
First edition (Rev. A1 v.01) of this Service manual: Part Number EVL510001 eVolution® Ventilator Service
Manual, English International – Feb/2010.
© 2010 eVent Medical, Inc. All rights reserved.
No part of this Service 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 the prior written
permission of eVent Medical.
Intended for use with the eVolution ventilator, this manual is subject to technical modification and may be
revised or replaced by eVent Medical at any time without prior notice. We recommend you have the most
current version of this manual.
The ventilator should be operated, serviced and calibrated by trained professionals. US Federal Law restricts
this device to sale by or on the order of a physician.
Smart Sigh and Smart Nebulizer are trademarks of eVent Medical. eVolution is a registered trademark of
eVent Medical. Other acronyms and products referenced in this manual may be trademarked by separate
companies.
Upon request, eVent Medical may provide certain technical, operation, sales and marketing information that
assists clinicians and trained service professionals.
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.
2
Section
GENERAL INFORMATION
This section of the manual is intended to provide introductory information concerning the eVolution
ventilator system; along with a brief product description, specifications, a tooling and maintenance summary
and an introduction to the ventilator’s controls and indicators.
The information within is not intended as a sole source of reference and is intended for use in conjunction
with the eVolution User Manual. Both manuals must be referenced when performing any maintenance to the
system.
PRODUCT DESCRIPTION AND INTENDED USE
The eVolution® Ventilator is intended for and suitable for use in the ICU, sub acute, long-term acute
care, rehabilitation, and emergency room, as well as, in hospital transport venues. Specifically, the
eVolution Ventilator is designed for adult and pediatric patients needing ventilatory support, as
prescribed by an attending physician. This device is intended for and designed to provide continuous
and or intermittent mechanical ventilation to patients requiring ventilatory support through invasive or
non-invasive interfaces. The ventilator is a class IIb medical device intended for use by qualified,
trained personnel under the direction of a physician.
The eVolution includes these features:
User-selected oxygen concentration
Volume, volume targeted pressure or pressure-based breaths delivered in controlled,
synchronized intermittent mandatory or spontaneous modes
Flow and or pressure breath triggering
Apnea monitoring and Apnea backup ventilation system
Numeric and waveform display of user-defined ventilator data
Respiratory mechanics monitoring
Smart Sigh™ breaths delivered at user-defined frequency and breath amplitude
User-defined Smart Nebulizer™ functions
Prioritized alarm system
Spontaneous Positive Airway Pressure (SPAP)
Non Invasive Ventilation (NIV) available in all modes
Auto Control
Integrated Air source
User configurable GUI
¾ 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.
¾ The device is not to be used in the presence of flammable anesthetics.
¾ Before operating the eVolution, check the ventilator for proper operation by
performing the System Test, Alarms Test and Calibration procedures described
in this manual.
SAFETY INFORMATION
The symbols below draw your attention specifically to the remaining dangers associated with proper use
and to emphasize important technical requirements.
¾ Information or directions/warnings intended to prevent potential
damage to the patient, caregiver or device.
¾ Explanatory notes and comments relevant to the eVolution ventilator.
¾ The eVolution should only be operated and maintained by personnel with

appropriate technical and clinical training. All patients requiring ventilation
must be monitored appropriately by competent medical personnel.
¾ US Federal Law restricts this device to sale by or on the order of a physician.
¾ 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.
¾ To avoid any potential fire hazard, keep all matches, lighted cigarettes, and
other sources of ignition away from the device.
¾ Ensure that an alternate source of ventilation is always available when using
the eVolution ventilator.
¾ When the eVolution ventilator is connected to an external device, the power
cord should be in use to ensure proper grounding.
¾ Check the remote alarm system (nurse call) is activated before leaving the
patient unattended.
¾ Do not replace any accessories or other parts of the eVolution while a
patient is being ventilated.
¾ Do not use the eVolution ventilator unless an internal battery with at least a
minimal charge is installed.
¾ If the eVolution has been stored for an extended period, recharge the battery
before use.
¾ Maintenance must be conducted in compliance with all relevant safety
regulations.
¾ Repairs, assembly and use must be conducted by trained personnel; and the
ventilator must be checked by trained personnel annually.
¾ A bacteria filter can be placed between the ventilator’s To Patient outlet and
the patient breathing circuit to prevent cross contamination.
¾ Do not sterilize the eVolution ventilator.
¾ 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.
¾ Do not operate the ventilator positioned next to a curtain that could block
the flow of cooling air, thereby causing the equipment to overheat.
¾ Adding attachments or other components or subassemblies to the ventilator
breathing system may cause the pressure gradient to increase across the
ventilator breathing system, measured with respect to the patient connection.
¾ To avoid electrical shock while servicing the ventilator, be sure to disconnect
the ventilator from all power sources.
¾ The eVolution ventilator complies with the requirements of IEC 60601-1-2
(EMC 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 standard, certain transmitting devices (cellular
phones, walkie-talkies, cordless phones, paging transmitters etc.) emit radio
frequencies that could potentially interrupt ventilator operation if located
close to the ventilator. Practitioners must be aware that radio frequency
emissions are additive, and the ventilator must be located a sufficient distance
from transmitting devices to avoid interruption.
¾ Do not operate the ventilator in a magnetic resonance imaging (MRI)
environment.
¾ Consult with your institution’s biomedical engineering department in case of
interrupted ventilator operation, and before relocating any life support
equipment.
¾ 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.
DEVICE LABELS AND SYMBOLS

These device labels and symbols appear on the eVolution ventilator.
On/Off switch
Alarm Silence 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.
Running on external power source
Internal battery charge status
On battery backup
Indicates the settings and screen are not locked
Indicates the settings and screen are locked
Nebulizer nipple connector
Front Panel: A green LED indicates device is

connected to mains
Ethernet Ethernet connection port
RS232 RS232 connection port
Nurse call connection port
Refer to manual for Information, directions and

or warnings intended to prevent potential harm
or damage to the patient, caregiver and device.
Earth Ground
Designates type B equipment per IEC 601-1
IPX1
Indicates the degree of protection (drip-proof) by
the enclosure.
O2 2-6 bar (30-90 psi) High pressure Oxygen inlet port label
O2 .3 – 2 bar (5 – 30psi) Low pressure Oxygen inlet port label
DC –Input:
12VDC
168W
DC input connector
14A
AC –Input:
90 -240VAC
47/63 Hz
120VA AC input connector
100V: 2.4A
240V: 1.2A
Fuse: 250V 3.15AT
O2 Sensor Oxygen sensor location

SN: Device serial number
Gas flow to patient from ventilator
Gas flow from patient to ventilator
Do not obstruct! Do not obstruct port or outlet
TH Indicates WEEE (Waste Electrical and Electronic

E Equipment) Registration per EU WEEE Reg. No. IE
00761, Directive, 2002/96/EC
EV
OLUTION PRODUCT LABELS:
Figure 1: eVolution Serial Number Label
Figure 2: eVolution Manufactured For Label
Figure 3: eVolution Caution Label
Figure 4: eVolution Date of Manufacture Label
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.
3
Section
PRODUCT SPECIFICATIONS
This section provides specifications for the eVolution ventilator.
Pressures are shown on the eVolution in cmH2O, mbar and Hectopascals (hPa). 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.
Ventilation Modes Assisted Control Mandatory CMV

Ventilation
Synchronized Intermittent SIMV
Mandatory Ventilation
Spontaneous Ventilation SPONT
Auto-control Auto-control)
Noninvasive Ventilation NIV
Breath Types Volume-controlled breaths V–CMV, V–
SIMV
Pressure-controlled breaths P–CMV, P–
SIMV, PS
Volume Targeted Pressure- PRVC-CMV,
controlled breaths PRVC-SIMV, VS
(Pressure Regulated Volume
Control) & (Volume Support)
Dual Level PEEP breaths SPAP
(Spontaneous Positive Airway
Pressure)
Patient Types Adult and Pediatric
Apnea Backup User selected Breath type and
settings, OFF
P-CMV; V-CMV; PRVC-CMV
Breath Triggering Pressure triggering (-0.5) – (-20)
cmH2O
Flow triggering 0.5 – 20 l/min
Additional Settings Respiratory Rate 1 – 120 b/min
Accuracy: 0 to 100 b/min (± 1 b/min), > 100
b/min + 2%
Tidal Volume 50 – 2000 ml
Accuracy: 50 to 2000 ml: ± (compliance &
(10 ml + 5%) BTPS
compensated)
PEEP / CPAP 0 – 40 cmH2O
Accuracy: ± (2 cmH2O + 4%)
Pcontrol 0 – 80 cmH2O
Accuracy: ± (2 cmH2O +
4%)
Psupport 0 – 60 cmH2O
Accuracy: ± (2 cmH2O + 4%)
Peak Flow Mandatory
5 - 120 l/min
Accuracy: ±10%
Peak Flow Spontaneous
1 – 180 l/min
Accuracy: ±10%
Leak Comp On or Off
Automatic Leak
Compensation
Base Flow 2.5 – 25 l/min
Settable at this range only when automatic leak
comp is set to Off and NIV is set to Off.
Base Flow 2.5 – 60 l/min
Settable at this range only when NIV is set to On
and automatic leak comp is set to Off.
I–Time (Ti) 0.02 – 4 sec
I : E Ratio 1 : 99.9 – 99.9 : 1
Ti, Tp and Te Accuracy: < 10.0 seconds ±0.01 s
≥ 10.0 seconds ±0.1 s
NIV On or Off
Non-Invasive ventilation can be enabled in all
modes.
Pause (insp plateau) 0 – 2 sec
Oxygen (FiO2) 21 – 100 %
Blender or Low
flow
Accuracy (Delivery): ± (3 %) full scale
Rise time settings 10 (Fast), 5
(Med) or 1 (Slow)
Flow pattern Decelerating,
Decelerating
50%, or Square.
Exhalation sensitivity 10 – 80 % of
(Esens %) peak flow
Auto Control On or Off
Time (s) 3 – 60 sec
(used in Auto Control)
Apnea Backup Settings

Apnea backup modes Adult or Apnea backup modes: V-CMV; P-CMV;
Pediatric PRVC-CMV, OFF
+O2% This setting establishes the
percentage increase to FiO2 to be
added to the main oxygen setting
during Backup Ventilation.
Configuration Screen Settings Humidity type None, HME,
Warm Humidified
Smart Nebulizer™ On or Off;
User selected
duration (1-480
minutes,
increments of 1
minute)
User selected
interval (1-480
minutes,
increments of 1
minute)
Smart Sigh™ On or Off; 0 – 50%
of volume or
pressure setting
Sigh Interval; 20-
200 breaths
Number of sighs
per time; 1-6
Graph Settings Waveforms; 1, 2, or
3 displayed
Loops; 1 or 2
displayed
Trend Data Settings 1, 2 or 3 trends
displayed
Monitors 5, 8 or 10 displayed
Compliance Comp. Compliance
Compensation On
or Off
Blower 100% On
or Off
Low Flow O2 Low Flow O2; On
or Off
O2 Sensor; On or
Off
Audio/LCD Level Audio Level; 35-
100%
Screen Clicks On or
Screen Clicks Off
LCD Brightness;
20-100%
SPAP Mode Settings Phigh 5 to 50 or
Plow to 50 or
5 to (80-Psup high)
Plow 0 to 50 AND
0 to Phigh AND
0 to (80-Psup low)
Psup High 0 to (80 – Phigh
setting) cmH20
Phigh + Psup High will not exceed 80 cmH2O
Psup Low 0 to (80 – Plow
setting) cmH20
Plow + Psup Low will not exceed 80 cmH2O
Thigh 0.1 to (60 - Tlow
setting) s
Tlow 0.2 to 59.9 s (max
60 – Thigh setting)
Cycles/min 1 – 120 c/min
H : L (see time values) 1:59 to 59:1
Monitored / Displayed Patient Pressure Values
Values Ppeak 0 – 100 cmH20
(peak pressure during a Accuracy: ± 2
breath) cmH20 + 4%
PEEP 0 – 100 cmH20
(pressure at end Accuracy: ± 2
exhalation) cmH20 + 4%
Pmean 0 – 100 cmH20
(averaged mean pressure) Accuracy: ± 4
cmH20 + 4%
Volume / Flow Values
Vte 0 – 3000 ml
(exhaled tidal volume) Accuracy: 0 – 40
ml ± (2ml + 5%);
41 – 3000 ml ±
(10 ml + 5%)
Volume / Flow Values
Vti 0 – 3000 ml
(tidal volume delivered) Accuracy: 0 – 40
ml ± (2ml + 5%);
41 – 3000 ml ±
(10 ml + 5%)
Ve 0 – 99 l/min
(exhaled minute volume) Accuracy: ± (0.01
l/min + 5%)
Leak 20 – 100%
Time Values
Resp Rate 0 – 150 b/min
(measured mandatory and Accuracy: 0 –
spontaneous breaths per 100 b/min (± 1
minute) b/min), > 100
b/min + 2%
I–Time (Ti) 0.1 – 99.9 sec
(inspiration time) Accuracy: ± 0.01
sec
Expiratory Time (Te) 0.1 – 99.9 sec
Accuracy: ± 0.01
sec
I : E, calculated only 1 : 99.9 – 99.9 : 1
Ti/Ttot 1 – 99.9%
H:L 1 : 599 – 299 : 1
Ratio of time at
high and low
PEEP levels
when SPAP is
active
Spont% 1h 0 – 100 %
Percentage of
spontaneous
breaths for the
last 1 hour
Spont% 8h 0 – 100 %
Percentage of
spontaneous
breaths for the
last 8 hours
Respiratory Mechanics
Cstat 0-300 ml/cmH20
(static compliance, lung Accuracy: ± 10%
stiffness)
Rinsp 0 – 1000
(inspiratory resistance of cmH20/l/sec
airways and tubes)
Rexp 0 – 1000
(expiratory resistance of cmH20/l/sec
airways and tubes)
Auto PEEP 0 – 100 cmH20
(Actual PEEP – set PEEP) Accuracy: ± 2
cmH20 + 4%
Pplateau 0 – 100 cmH20
Accuracy: ± 2
cmH20 + 4%
RSBI 0 – 3000 b/min/l
(Measured breathing rate
divided by Insp tidal volume)
(RR/Vt = RSBI)
Real Time Curves
Pressure + Time Pressure over
time: measured
internally in
cmH20
Flow + Time Flow over time:
measured
internally in
l/min
Volume + Time Volume over
time: measured
internally in ml
P – V Loop Pressure-volume
loop: measured
internally in
cmH20 and ml.
Pressure
displayed on x-
axis and volume
on the y-axis
F – V Loop Flow-volume
loop: measured
internally in
l/min and ml.
Flow is displayed
on the y-axis and
volume on the x-
axis
One, two or three curves OR one to two loops
can be selected to display. The eVolution
ventilator provides a user configurable auto–scale
or manual scale feature for each graphic
displayed.
Delivered FiO2 Oxygen 15 - 103
inspiratory oxygen %
concentration Accuracy: ± 3%
of full scale
Alarm Limit Settings Pressure Alarms
Ppeak High 5 or 1 > Ppeak
Low to 85
cmH2O
Ppeak Low 1 – 84 cmH2O or
1 < Ppeak High
PEEP High 3 or 1 > PEEP
Low to 50
cmH2O
PEEP Low 2 to 49 cmH2O
or 1 < PEEP
High, or Off
Volume Alarms
Ve High 0.1 or 0.1 > Ve
Low to 99.0
l/min
Ve Low 0.1 to 98.9 l/min
or 0.1 < Ve
High, or Off
Vte High 10 or 2 > Vte
Low to 2500 ml
Vte Low 2 to 2495 ml or 2
< Vte High, or
Off
Vti Limit 50 to 2500 ml, or
Off
Respiratory Rate Alarms
Resp rate High 2 or 1 > Rate
Low to 120
b/min
Resp rate Low 1 to 119 b/min
or 1 < Rate High
Oxygen Delivery Alarm Automatic
Setting
High FiO2 Ventilator
software
automatically sets
alarm limit to 7%
above oxygen %
setting.
Low FiO2 Ventilator
software
automatically sets
alarm limit to 7%
below oxygen %
setting.
Apnea (interval) 3 – 60 sec
Leak rate 20 – 100 %
(minimum leak allowed)
AUTO SET See the Section
(Auto sets alarm values) Alarm Limit
Settings in the
eVolution Service
Manual for
detailed Auto Set
alarm key
function and
Auto alarm
setting
adjustments.
Alarm Priority High Priority Alarms
Apnea Battery Flat
Disconnection Occlusion
High Pressure Low Pressure
High Minute Volume Low Minute
Volume
High Oxygen Low Oxygen
High Oxygen Inlet Pressure Low Oxygen
Inlet Pressure
High Tidal Volume Low Tidal
Volume
Medium Priority Alarms
Battery Low Vti Limit
Reached
Volume Not Delivered High Leak Rate
High frequency Low frequency
PEEP Low PEEP High
Check Pcontrol / Pmax Check Psupport
/ Pmax
High Temperature High external
voltage
Information Messages Alarms
Battery Not Available Battery In Use
Flow Sensor Error Inverse Ratio Set
Nebulizer Not Available
Nebulizer Not Available
Power and Gas Supply AC input 90 to 240 VAC
(47 – 63 Hz)
DC input VDC 12
Battery Backup (with fully > 120 min
charged battery)
High pressure oxygen inlet 30 – 90 psi clean,
supply dry, and oil-free
medical grade
Low pressure oxygen inlet 5 – 30 psi clean,
supply dry, and oil-free
medical grade
Environmental Data Operating temperature 5 – 40 °C
Storage temperature -10 – 60 °C
Operating Humidity 15% - 95% non-
condensing
Storage Humidity 5% - 95% RH
non-condensing
Operating altitude 11,600 ft (3,536
m) above sea
level
Physical Data Width x depth x height 14 x 14 x 12 in or
(ventilator) 35.5 x 35.5 x 30.5
cm
Weight 35 lbs or 15.9 kg
Noise Level ≤ 55 dBa
Technical Data Maximum limited pressure 90 cmH20 via a
dedicated
pressure relief
valve
Maximum operating pressure 80 cmH20
controlled by
high pressure
alarm setting
Measuring and display Pressure
devices measurements
are made by
solid-state
pressure
transducers
positioned to
monitor internal
operating,
inspiratory, and
expiratory circuit
pressures
Flow and volume Flow
measurement measurements
are made by one
of three hot wire
flow sensors, and
are integrated
with time to
calculate
inspiratory and
expiratory
volumes. Flow
and volume
measurement
ranges are
according to
monitored data
specifications
Oxygen measurement A galvanic cell is
positioned in
parallel to the
inspiratory
manifold to
measure the
delivered oxygen
concentrations
from 0 to 103%.
Display All data appears
Touch Screen on a touch
screen enabled
color liquid
crystal display
(LCD)
Compliance and Approvals IEC 60601-1:1988 + Classified as
A1:1991+A2:1995 protection class I,
Type B, internally
powered, drip-
proof equipment
for continuous
operation
Meets International IEC 601-1/
Standards EN60601-1, IEC
601-1-2,
EN60601-1-2,
EN794-1,
ASTMF1100-90,
IEC 60601-2-12:
1988, ASTM
F1054-87, ISO
5356-1
ELECTROMAGNETIC COMPATIBILITY DECLARATION
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 only for its internal
function. Therefore, its RF emissions are very low
RF Emissions CISPR 11 Group 1 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,
Harmonic emissions including domestic establishments and those directly
Class A
IEC 61000-3-2 connected to the public low voltage supply network
Voltage that supplies buildings used for domestic purposes
fluctuations/flicker Complies
emissions IEC 61000-3-3
Guidance and Manufacturer's Declaration - Immunity
the ventilator should assure that it is used in such an environment.
IEC 60601 Compliance
Immunity Test Electromagnetic Environment - Guidance
Test Level Level
Electrostatic +/- 6kV +/- 6kV Floors should be wood, concrete or ceramic
Discharge (ESD) contact contact tile. If floors are covered with synthetic
material, the relative humidity should be at
IEC 61000-4-2 +/- 8kV air +/- 8kV air least 30%.
+/- 2kV for +/- 2kV for Mains power quality should be that of a
power supply power supply typical hospital environment
Electrical Fast
lines. lines.
Transient/burst
+/- 1 kV for +/- 1 kV for
IEC 61000-4-4
Input/output Input/output
lines lines
+/- 1kV +/- 1kV Mains power quality should be that of a
differential differential typical hospital environment
Surge
mode mode
IEC 61000-4-5 +/- 2 kV +/- 2 kV
common mode common mode
Voltage dips, <5% Ut <5% Ut Mains power quality should be that of a
short (>95% dip in (>95% dip in typical hospital environment. If the user of
interruptions and Ut ) for a 0.5 Ut ) for a 0.5 the ventilator requires continued operation
voltage variations cycle cycle during power mains interruptions, it is
on power supply recommended that the ventilator be powered
input lines. 40% Ut 40% Ut from an external battery.
(60% dip in Ut) (60% dip in Ut)
IEC 61000-4-11 for 5 cycles for 5 cycles
70% Ut 70% Ut
(30% dip in Ut) (30% dip in Ut)
for 25 cycles for 25 cycles
5% Ut 5% Ut
(>95% dip in (>95% dip in
Ut ) for 5 sec Ut ) for 5 sec
Power Frequency
(50/60 Hz) Power frequency magnetic fields should be at
magnetic field. 3 A/m 3 A/m 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.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
the ventilator should assure that it is used in such an electromagnetic environment.
Immunity IEC 60601 Compliance
Test Test Level Level Electromagnetic Environment-Guidance
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.
RF
Recommended separation distance:
IEC 3 Vrms 150
61000-4-6 kHz to 80
3 Vrms
MHz outside
ISM bands
(a)

10 Vrms
10 Vrms
150 kHz to
80 kHz in
Radiated
RF

IEC 61000- 10 V/m

4-3 10 V/m

80 MHz to
2.5 GHz

where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
distance in meters (m) (b)
Field strengths from fixed RF transmitters, as

determined by an electromagnetic site survey.
(c) should be less than the compliance level in each
frequency range (d)
Interference may occur in the vicinity of equipment
marked with the following symbol.

NOTE 1: At 80 MHz and 800 MHz, the higher frequency applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
(a) The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6.765
MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz
to 40.70 MHz.
(b) The compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the
frequency range of 80 MHz to 2.5 GHz are intended to decrease the likelihood that
mobile/portable communication equipment could cause interference if it is inadvertently brought
in to the patient areas. For this reason, an additional factor of 10/3 is used in calculating the
recommended separation distances for transmitters in these ranges.
(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.
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 80 150 kHz to 80 80 MHz to 800 800 MHz to 2.5 GHz
Maximum MHz Outside ISM MHz in ISM Bands MHz
Output of Bands
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.
NOTE 4: These guidelines may not apply in all situations. Electromagnetic propagations affected
by absorption and reflection from structures, objects and people.
TOOLS, TEST EQUIPMENT AND MATERIALS (RECOMMENDED)
Description Manufacturer / Part No.
Test Equipment:
Pneumatic Analyzer TSI Certifier FA Plus or equivalent
Electrical Safety Tester Local Supply
Desktop / Laptop PC Local Supply
Category 6 Crossover Cable eVent Medical, EVL370018-SPE or equivalent
Adult Tubing System Local supply
Pediatric Tubing System Local Supply
Test Lung, Kit Local supply
High Pressure Oxygen Source Local Supply (medical grade)
External Power source Local supply
Isopropyl Alcohol Cleaner Local Supply
Description Manufacturer / Part No.

Hand Tools:
Flat Bladed Screwdriver Local Supply
Philips Screwdriver No 1, 2, Local Supply
1.5 mm Allen Wrench Local Supply
4 mm Open End Wrench Local Supply
11 mm Socket Wrench Local Supply
Static Dissipative Service Kit Local Supply
4
Section
THEORY OF OPERATION
This section is provided to detail the operational theory of the eVolution ventilator system. It includes an
overview of the ventilator operation and discusses in detail the operational principals of both the pneumatic
and electronic systems. This section also describes the operation of the ventilator’s firmware in interfacing
and controlling the two systems.
OVERVIEW OF OPERATION
The eVolution Ventilator System consists of two major systems; the pneumatic system and the electronic
system. These systems combine under advanced software control to deliver respiratory support at operator
determined parameters. The pneumatics, under the control of the microprocessor, supplies conditioned air
and oxygen to the patient system. The electronic system applies and supervises the power sources and
provides electronic control of the ventilator’s components.
Oxygen enters the unit from either an external source via the high pressure oxygen connector or a low
pressure oxygen connector. The gas is conditioned to remove particulate matter. A regulator decreases the
oxygen to a consistent level and supplies it to the oxygen servo-controlled proportional valve. The oxygen is
then routed through an internal hot-wire flow sensor and on to a manifold. If low pressure O2 is used, that
gas is delivered directly to the same O2 proportional valve.
Filtered air is supplied by means of an internal high efficiency blower system. Air is routed to the air servo-
controlled proportional valve then through an internal hot-wire flow sensor and on to a manifold.
From the manifold gas is delivered through the patient safety valve to the patient port. Feedback from the
internal flow sensors, pressure transducers and patient settings, controls the breath delivery and monitoring.
Exhaled gas is directed through a heater and an active expiratory proportional valve. This is used to regulate
pressure levels during inspiration and exhalation.
Ventilation parameters are programmed by the operator using a rotary encoder in conjunction with the touch
sensitive user interface display and dedicated keys on the ventilator front panel.
Power to operate the device may come from AC mains, an external 12VDC battery, an external 12 VDC
power source, or from internal batteries. In the event of a loss of AC mains the unit is powered from the
external battery (if available) or from the internal batteries.
PNEUMATIC THEORY OF OPERATION
Figure 5: Pneumatic Diagram

The eVolution series ventilator pneumatic system may be categorized into the following subsystems. These
subsystems are described in detail within this section of the manual:
• Gas Inlet/Supply System
• Gas Delivery System
• Safety Valve system
• Oxygen Monitoring System
• Nebulizer System
• Exhalation System
GAS SUPPLY SYSTEMS

The gas supply system permits the connection of high and low pressure oxygen sources to the
ventilator via the high-pressure and low-pressure oxygen connectors for increasing oxygen
concentration levels and utilizes an internal blower to draw in room air for delivery to the patient and to
pilot ventilator subsystems.
HIGH AND LOW PRESSURE OXYGEN INLETS
The eVolution ventilator is supplied in its standard configuration with one DISS (Diameter Indexed
Safety System) high-pressure fitting for the connection of medical grade oxygen.
High Pressure O2 inlet Low Pressure O2 inlet
INLET FILTERS (F1, F2)

Located downstream of the high and low pressure oxygen inlet connectors is a sintered bronze impact filter.
The impact filter (F1) collects any particulate matter greater than approximately 40 microns.
The Air supply inlet filter is a foam filter (F2) used to remove particulate matter from the ambient air
upstream of the blower. This filter is to be regularly checked and cleaned.
Oxygen Filter (F1) Air Filter (F2)

¾ Failure to replace and/or clean the air inlet filter at the prescribed
maintenance interval may compromise the operation of components
downstream of the system. If the device is to be operated in a location
where the oxygen source is known to be susceptible to moisture and/or
contaminants, additional measures must be taken. In such instances the
manufacturer strongly recommends the use of additional upstream filters
and/or water traps.
INLET O2 CHECK VALVES (CV1 AND CV2)

The high pressure inlet check valve (CV1) is built into the DISS connector and prevents oxygen from flowing
out of the high pressure port when low pressure oxygen is connected to the low pressure port.
The inline check valve (CV2) prevents oxygen from flowing out of the low pressure port when high pressure
oxygen is connected to the high pressure port.
Check Valve (CV1) Check Valve (CV2)
OXYGEN REGULATOR (REG1)

The relieving type regulator, located immediately after the filter (F1), limits the pressure of the oxygen
supply to 20 PSI and supplies it to the oxygen servo-controlled proportional valve.
Oxygen Regulator (Reg1)
BLOWER
The internal high efficiency blower system draws room air in through the air filter (F2) and supplies it
to the air servo-controlled proportional valve. The electric brushless motor blower provides the air
source for inhalation and is the pressure source for the exhalation and safety valves.
Blower
GAS DELIVERY SYSTEM
The gas delivery system consists of an oxygen proportional valve, with a corresponding hot wire flow
sensor, and an air proportional valve, with a corresponding hot wire flow sensor.
Gas Delivery System
PROPORTIONAL VALVES (PV1 / PV2)
The oxygen proportional valve (PV1) and the air proportional valve (PV2) are microprocessor
controlled precision servo valves that use feedback from both internal flow sensors (FS1/FS2) and the
internal pressure measurement transducers (P2/P3) to control all breath delivery parameters to the
patient. Gas delivered from these valves is routed to the patient tubing system via the safety valve.
The precision proportional valves are controlled by Pulse Width Modulation (PWM). Each valve is
controlled independently. As PWM is increased, the valves open proportionally, allowing more gas to
flow through them. As the controlling PWM is decreased, the valves close proportionally and flow
through them decreases. All aspects of breath delivery are regulated by the PV1/PV2 combinations
using feedback from the internal breath delivery flow transducers FS1/FS2 and pressure transducer
P2/P3. PV1 remains fully closed when the FIO2 setting is 21% and is only utilized as the FIO2 setting
is increased. Conversely, PV2 remains fully closed when the FIO2 setting is 100% and only utilized as
the FI02 setting is decreased.
PV1 and PV2 differ slightly as PV2 has a bleed air port on the top of the valve. This port is used to
bleed a small amount of air from the blower between breaths and during no-flow periods to keep the
blower from overheating.
Proportional Valve (PV1) Proportional Valve (PV2)
FLOW SENSOR (FS1 / FS2)

Flow delivered through the inspiratory proportional valves PV1/PV2 is monitored by the internal flow
measurement system. The internal flow measurement system is comprised of two precise mass flow
meters (FS1/FS2), positioned at the outlet of PV1/PV2. Gas flow passing through FS1/FS2 is
accurately measured and that feedback is used by the microprocessor to regulate the operation of the
proportional valves (PV1/PV2) for flow delivery to the patient port. Each flow transducer contains
two sensors, one for sensing flow and the other for measuring temperature.
Each sensor has a separate non-linear voltage output. To determine the mass-flow rate of the gas
passing through the flow transducer, the voltage output of each sensor must be measured and then
used by the ventilator’s microprocessor to process the flow transducer outputs.
Calibration constants unique to each flow transducer are stored on an EEPROM chip on the unit.
These are read by the microprocessor at power up and used in the flow calculation.
Flow Sensor (FS1) Flow Sensor (FS2)
CHECK VALVE (CV3)

The check valve (CV3) is located downstream of the outlets of the oxygen and air flow sensors. The
check valve prevents oxygen from flowing back into the air flow sensor and proportional valve when
the oxygen flow is greater than the air flow.
Check Valve (CV3)
OXYGEN SENSOR (FIO2 SENSOR)
The oxygen sensor measures the delivered oxygen concentration. The sensor along with its flow
diverter is located in the gas delivery path immediately before the patient port.
The oxygen monitoring system provides the operator with an indication of the oxygen percentage being
delivered to the patient. The oxygen sensor uses galvanic fuel cell technology to develop an output voltage
which is proportional to the partial pressure of oxygen in the sampled gas. The microprocessor uses this
information to display the measured oxygen percentage on the monitoring screen and to evaluate whether
alarm thresholds have been violated. A preset alarm is activated when the monitored oxygen percentage falls
outside of the allowed range. The manufacturer recommends replacement of the oxygen sensor after every
12 months of operation, or as required. The oxygen sensor is calibrated using the automated function
available on the User calibration screen. Oxygen delivery is achieved by a sophisticated software algorithm
that sends the user selected oxygen setting to the microprocessor. The microprocessor then adjusts the
oxygen proportional valve (PV1) and the air proportional valve (PV2) to deliver the correct oxygen/air ratio.
The oxygen sensor only monitors the gas mixture. It does not control oxygen delivery.
Oxygen Sensor (FIO2 sensor)
SAFETY VALVE (SV)
To protect the patient during abnormal operation, the ventilator has a safety valve. The safety valve provides
the patient with an open breathing path from ambient air in the event of an emergency. This allows the
patient to breath through an open air port and exhale through the open exhalation valve. The safety valve
uses pressure from the blower to fill a diaphragm to close the exhaust port. The pressure in the diaphragm is
controlled by a 3 way solenoid.
Safety Valve (SV)
SAFETY VALVE SOLENOID (SOL 2)

The safety valve solenoid is a three-way valve that, when energized, directs the safety valve pilot pressure
from either the blower or the oxygen regulator to the safety valve. When the solenoid is de-energized, it
blocks the pilot pressure and opens the safety valve to atmosphere. In the system, it is located next to the
crossover solenoid but is easily identified by its open port to atmosphere.
Safety Valve Solenoid (Sol2)
CHECK VALVE (CV4)
Check valve four is located downstream of the safety valve (SV) just prior to the To Patient port. The
valve prevents the patient’s exhaled gases from flowing back though the ventilator when the Safety
Valve (SV) is open.
Check Valve (CV4)
CROSSOVER VALVE (SOL1)

The crossover valve is an on/off solenoid which, when activated, directs O2 inlet pressure to the safety
valve and exhalation valve controllers. If the blower fails during operation, the safety valve and
exhalation valve can still operate if an O2 source is connected to the ventilator.
Crossover Valve (SOL1)
CHECK VALVES (CV5 AND CV6)
The check valve CV5 is located on the pressure port of the air valve (PV2.) It allows air from the blower to
be used to pilot the safety valve and LFR and prevents oxygen from flowing back into the blower when
oxygen is used to pilot the safety valve and LFR.
The check valve CV6 is located at the outlet of the crossover solenoid. When the crossover solenoid is
energized it allows oxygen to be used to pilot the safety valve and LFR and it prevents air from flowing out
through the ambient port when the crossover solenoid is de-energized and air is used to pilot the safety valve
and LFR.
Check Valve (CV5) Check Valve (CV6)

EXHALATION SYSTEM
The exhalation systems function is to seal the patient system during the inspiratory phase of ventilation.
During the expiratory phase of ventilation, the exhalation system opens to allow the patient to exhale and,
when required, maintain the prescribed PEEP level.
The exhalation system is comprised of a bacterial filter (F3), a heater, a mass flow meter (FS3), and the
exhalation valve (EV). The exhalation valve is controlled, using feedback from the internal pressure
transducers P2/P3. During exhalation, only as much control is applied to the valve as is required to maintain
the operator set level of PEEP.
With the exhalation valve fully de-energized, as might result in the event of a critical error being detected, the
exhalation valve functions as an expiratory check valve to compliment the safety valve operation. During this
Safety Valve Open (SVO) condition, any inspiration effort from the patient pulls the exhalation membrane
closed on its seat. Any patient expiratory effort displaces the exhalation membrane from its seat allowing
exhaled gases to exhaust to atmosphere.
Exhalation System
BACTERIA FILTER (F3)
The bacteria filter in the exhalation path reduces contamination of the flow sensor and exhalation valve. Its
filtration efficiency is >99.9%. The media is electrostatically charged polypropylene. Its dead space is 44mL.
Bacteria Filter (F3)

HEAT EXCHANGER (H1)
The heater consists of a heat exchange cylinder that mounts in a C-clamp, equipped with a thermofoil heating
element. The heater maintains the patients exhaled gas temperature to prevent condensation of any moisture
vapor. The heater temperature is controlled to 60 degrees C.
Heat Exchanger (H1)
EXHALATION FLOW SENSOR (FS3)
The exhalation flow sensor is a mass flow meter that is positioned immediately at the outlet of the heat
exchanger. Gas flowing through FS3 is accurately measured and that feedback is used by the
microprocessor to display the patient spirometry. The dual hot wire flow sensor works with an
Exhalation Flow Module. The module drives the hot-wire sensor and generates a signal proportional to
the actual flow dependent power consumption of the heated wire. Using a calibration curve, this value
can be converted into the actual flow value. The compensation wire in the flow sensor is thereby used
to compensate the influence of the gas temperature on the measured signal.
Exhalation Flow Sensor (FS3) Exhalation Flow Module
EXHALATION VALVE (EV)

The exhalation valve uses pressure from the blower to fill a diaphragm and seal the exhaust port. The valve
pressure is controlled by an LFR controller. In the deactivated state, the valve is open to ambient. In the
activated state, the valve can close up to 100cmH2O.
The operation of the exhalation valve is microprocessor regulated using feedback from the internal pressure
transducer P2/P3.
Exhalation Valve (EV)
LOW FLOW REGULATOR (LFR)
The LFR is an electronically controlled proportional regulator. It is a closed loop control unit that
incorporates two proportional valves, a manifold, and control circuitry including a pressure sensor. The
LFR module is not serviceable in the field and should not be opened.
Low Flow Regulator (LFR)

NEBULIZER SYSTEM
The eVolution ventilator incorporates a pneumatic, microprocessor controlled, smart nebulizer system. The
inlet source to the internal nebulizer is high or low pressure O2 gas at the operator set oxygen level. During
inspiration the nebulizer solenoid is energized diverting gas through the nebulizer circuit. The Nebulizer
outlet provides a pressure of 14 to 22 psi, which typically generates a nebulizer flow of 6 to 8 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 compensated, but not oxygen compensated.
NEBULIZER VALVE (SV4)

The nebulizer solenoid is a two-way, normally closed, valve. When nebulization is required, SV4 is switched
on during the inspiratory phase allowing gas flow to the nebulizer circuit.
Nebulizer Solenoid (Sol 4)
Figure 6: Pneumatic/Mechanical Tubing Diagram
Figure 7: eVolution System Wiring Diagram
ELECTRONIC SYSTEM
The eVolution ventilator electronic system can be powered by one of three available electrical power sources;
AC mains, the internal battery or an external DC power source (i.e. external battery or external 12 VDC
power supply). During operation, the microprocessor controls the ventilators pneumatic breath delivery
system and carries out continuous monitoring of breath delivery parameters. The system allows the operator
to program required settings via the touch screen interface, the keyboard, and Encoder switch.
The electronic system is comprised of the following major component parts:
Power Input Components

The power input components are comprised of the ventilator power cord and a medical grade power inlet
receptacle incorporating a line filter. The inlet filter is suitable to accommodate AC line voltages of 90-
264VAC 47-63 Hz, and is fused at 3.15 amperes to accommodate both the high and low voltage ranges.
Power Entry Module

Power On/Off Switch
The Power Switch is a rocker switch on back panel with two positions—ON (I) and OFF (O). The
ventilator goes on when the PwrSw signal (power switch ON) goes high. Power is turned off to the
ventilator when PwrSw signal goes low (power switch OFF). The power switch is protected from
unintentional actuation by a power switch safety guard.
Power Switch
Power Supply
The power supply is a medical grade supply with true auto ranging characteristics. It is rated for a supply
voltage range of 90-240VAC 50/60 Hz. The power supply provides a single regulated 24VDC output routed
to the Power Management PCB. Other voltages required for operation are generated on the Power
Management PCB.
The power supply also incorporates power fail circuitry which provides an output signal to the Control PCB
in the event of a loss, or decrease, in AC supply conditions.
Power Supply Module
Internal Battery Pack

In the event of a loss of the AC supply, the internal battery assembly provides temporary back-up power.
The batteries are comprised of two 14.4 VDC Ni ion cells, connected in parallel at the Power Management
Board. The internal battery assembly is rated at 6.6 amp/hours. With a full charge, the internal battery
should sustain ventilator operation for a minimum of 120 minutes. The ventilator charges the internal
batteries any time the AC. Mains is connected. The ventilator takes a minimum of two hours to charge the
internal batteries from depleted to more than 25% charge in order to operate the ventilator without a Low
Battery alarm. It takes approximately six hours to fully charge the internal batteries.
The manufacturer recommends replacement of the internal battery assembly every 24 months or as required.
Failure to follow this recommendation may compromise the availability of battery back-up. Any time the
ventilator is plugged into an active AC mains supply the ventilator charges the internal battery assembly.
Both batteries must be replaced at the same time.
Internal Battery Pack
External D.C. Power Socket

To supplement the AC mains and the internal battery, the operator has the option of using an external 12
VDC battery or an external 12 VDC power source. An external D.C. power socket is provided on the
ventilators rear panel to allow connection of the external battery or external 12VDC power source. No
battery charging from the D.C. socket is available. No external battery is available from eVent Medical, Inc.
All external D.C. sources connected to the eVolution Ventilator must meet the ventilators rating of 12Vdc at
14A.
External D.C. Power Socket
Power Management Board
The Power Management board is mounted just above the Power Supply and below the Motor Controller
Board.
J1 J2
A.C. to D.C. Control
Power Supply Board
J3 J4
Power Switch Blower
Motor Board
J5 J6
External D.C. Interface
Power Board
J7
D.C. to D.C.
J8
Power
Battery 1
Supply
J9
Battery 2
J10
Not Used
J2 J11
Control Board Control Board
POWER MANAGEMENT
The power processor monitors the three available power sources at all times and controls the switching
between them. The AC Mains always takes highest priority and powers the device whenever available. In the
event AC Mains are lost or unavailable the device attempts to switch to the external DC supply (if available)
and then to the internal batteries
The Power board is responsible for the internal battery charging and monitoring functions. The internal
battery is under charge at all times when either AC Mains or the external DC source is connected to the
ventilator, regardless of whether it is switched on.
Blower Motor Board
The Blower Motor Board is mounted above the Power Management Board in the stack of boards above the
Power Supply.
The Blower Motor Board is a three phase brushless DC motor controller with hall sensors and drivers. The
board communicates with the Control Board FPGA to control the blower speed.
J6 J8
Hall Sensor Control Board
J7 J1
Motor Drive Power Management Board
Interface Board
The Interface Board is mounted on the back of the ventilators front panel assembly. Circuitry located on the
Interface board is responsible for interfacing the Control Board with all of the solenoids, pressure
transducers, oxygen sensor, and exhalation heat exchanger. It also provides feedback to the main
microprocessor on the Control Board.
J18 J10 J1 J21 J7 J22 J3 J14
FS1/FS2 O2 Sensor LRF Exh. Sol 2/Sol 3 Sol 1 PV1/PV2 Control
Heater Board
J13
Power
P2 P3 P1
Management
Board
A description of the critical functions of the Interface Board is described in the text below.
Flow Sensor Interfaces

There are two inhalation flow sensors: air and oxygen. Flow information from the inhalation flow
sensors are provided by separate hot-wire flow sensor boards. The outputs from these boards include
an analog flow line and a device temperature line, which are connected to the ADC on the Interface
board. There are also connections from the Control board CPU (via the FPGA) to EEPROMs on
each flow sensor, which contain calibration data for each sensor.
Oxygen Sensor
The analog signal from the oxygen sensor is converted to a digital signal for the FPGA on the
Controller Board.
Valve and Solenoid Drivers

Analog drivers are provided to the valves and solenoids with CPU (software) control via the Control
board FPGA. The valves have current sensing and this is used for current control of the valves with
the PI controller in the FPGA. In this way software specifies the current setting and the PI controller
moves the valve to maintain that current setting. The valves controlled in this manner are the
exhalation valve, (through the LFR) and the two inhalation valves, PV1 and PV2.
Exhalation Heater
The signal to drive the exhalation heater passes through the Interface Board and the heater temperature
signal is converted from analog to digital then sent to the Control Board.
Pressure Sensors
There are three pressure sensors: inhalation, exhalation, and oxygen. Each sensor has a digital interface
that connects to the FPGA on the Control board.
Control Board
The Control Board provides overall ventilator operations and breath delivery. It also controls the user
interface (display, touch screen, and front panel membrane), alarm LED, speaker/buzzer, exhalation flow
sensor, barometric pressure/temperature and external communications (internet, Nurse call, etc). Please refer
to the Electrical Block diagram (at the end of this section) for details. The Control Board communicates with
the Interface Board, Blower Motor Board, and Power Management Board.
S1 J4 J39
J13 J15 J14 J36 J8 Membrane
Hardware Reset Switch CPLD
Panel Front-
CPU Debug Boot Alarm PPU JTAG
Left
JTAG LED
J46 J20
Membrane Touch
Panel Front- Screen
Right
J18 J21
LCD Drive Backlight
Inverter
J23 J9
Power Nurse Call
Management
Board
J1 J34
Ethernet Not Used
J33
Not used
J16 J6 J5 J11 J40 J42 J24 J37 J7

Fan Mute Speaker/ Rotary Blower Exh. Power Not Interface
Buzzer Encoder Motor Flow Management Used Board
Board Sensor Board
Board
A description of the critical functions of the Control Board is described in the text below:
Microprocessor
An Atmel AT91RM9100 microcontroller is the central processing unit (CPU) for the Control Board.
All major control of the ventilator is done from this microprocessor. This microprocessor also controls
the user interface (display, touch screen and panel buttons) and external communications.
Memory
The CPU has two external memory sections: SDRAM and Flash. The Flash contains the entire
software code for the board including the boot code. A total of 16 Mbytes of Flash memory is
available. Software normally moves data to the much faster SDRAM memory. The CPU has 64 Mbytes
of SDRAM on a 32 bit data bus. An option is available to install larger size SDRAM devices for 128
Mbytes total. The CPU has two devices of 1Mbytes each of battery-back-up SRAM. This RAM is a
non-volatile memory for storage of configuration data and to provide some amount of data logging
capability.
FPGA
The system has one FPGA used for interface between the CPU and many other devices including
interfaces with the valves and solenoid drivers, the sensors, the ADC and other peripheral devices. The
FPGA interfaces to the CPU as a group of memory mapped registers on the CPU’s memory bus. This
FPGA is the Xilinx Spartan-3 XC3S400.
Real Time Clock
A real time clock device (Dallas/Maxim DS3232) is connected to the CPU through the CPU’s two-
wire interface port. This device is battery backed-up.
Ethernet Port
An Ethernet is provided on the Control board for communication between the eVolution®CPU and a
PC computer. This Ethernet port has a primary function to download the CPU software code and the
FPGA configuration code into the CPU’s main flash device—to easily update the programmable
firmware.
Nurse Call
For a hospital nurse call connection, an electromechanical relay is provided. This nurse call relay is
switched under CPU control.
Barometer Device
A device on the Control board is provided to determine the barometric pressure. This device also
measures the temperature at the Control board.
Backlight Inverter
The Backlight Inverter receives a single 12VDC from the Control Board. The Inverter Board has dual
outputs to drive the dual backlights used on the display of the ventilator.
CN1
CN2
Control
LCD
Board
LCD Panel
The display panel is a color LCD module composed of the amorphous silicon thin film transistor liquid
crystal display (a-Si TFT LCD) panel structure with driver LSIs for driving the TFT (Thin Film Transistor)
array and backlight. Screen resolution is 800 x 600.
Front Panel Membrane Switch

The user interface Front Panel Membrane Switch incorporates a total of four keys which permit the user to
select 100% O2, Manual inspiration, Standby and Alarm silence. Additionally, the Front Panel incorporates a
red LED used to visually indicate vent Inop and a green LED used to indicate when AC Mains power is
applied to the device.
Encoder switch
The operation of the Encoder switch and knob permits the operator to select and change ventilation modes
and settings. The Encoder switch is a 16 position rotary encoder permitting navigation and adjustment of
ventilator settings.
Encoder Switch Knob
Touch Screen
The touch screen is a pressure sensitive module mounted to the devices Front Panel. It consists of a four
wire resistive array embedded in two polymer planes. The ventilator constantly scans the array for resistive
changes caused by compressing the two planes until they touch.
Touch Screen
Alarm Light Board
The LED Board is a three color LED board assembly for indicating ventilator alarm conditions. The
three colors indicate the following: Red for high priority alarms, yellow for medium priority alarms
and green for low priority alarms or informational messages.
Alarm Light Board
Figure 8: eVolution Electrical Block Diagram
5
Section
SELF TESTS AND USER

CONFIGURATION SCREENS
This section of the manual provides a detailed description of the ventilator’s self-testing functions and
screens. Some troubleshooting information relevant to these self test functions is added for convenience at
each stage.
POWER ON SELF TEST (POST)
Power On Self Test, or POST as it is commonly referred to, is performed each time the ventilator is switched
on. Following switch on, the software loading/self test screen is displayed as shown in the below figure
During Startup Mode, the following is executed in sequence: 1) POST and 2) Loading Configuration Data
from NVRAM.
1) POST executes the following diagnostic tests:
FPGA test
DRAM test
FLASH memory CRC test
Display controller test
Audio test
CPU watchdog test
If one or more of these tests fails, a corresponding error is passed as POST Malfunction to the next
Standby Mode to be handled (see Standby Mode below.) In Standby Mode, the following actions are
taken for any POST Malfunction:
The ventilator is still functional.
The POST malfunction event is logged in the Events Log along with a number indicating
the particular failing test.
No error messages are displayed on the screen.
A dimmed flashing red light is activated and cannot be canceled.
The audio alarm is activated and cannot be silenced.
2) Loading Config Data from NVRAM:
Touch screen configuration
System settings
Air valve calibration table
Oxygen valve calibration table
Exhalation valve calibration table
Exhalation Flow Sensor Zero Offset value
Exhalation Flow Sensor calibration table
Oxygen sensor data
System test saved data
Status of required calibration needed
Instrument settings (Audio level, LCD brightness, language, date format, time format)
In the event a problem is detected during the Startup Mode, the device records an error message specific to
the condition detected. For information on Startup error messages reference the ALARM MESSAGES and
DIAGNOSTIC ERROR Messages section of this manual.
USER CALIBRATION
User calibration functions are provided to allow the user to configure and check the ventilator prior to
operating it. These functions may be accessed through the normal start up screen two different ways.
If New is selected under the Patient Option menu, Pre-Patient Tests or Calibrations are available.
See Figure 9.
Figure 9: User Calibration Screen – New Patient
If New is chosen from the Patient Option menu, selecting the Pre-Patient Tests button performs three tests
automatically, the System Leak Test, Tubing Compliance, and the EXH F-S Zero Flow Offset. See Figure 10.
Figure 10: Pre-Patient System Test Screen
Selecting the Calibrations button allows each of the calibrations to be run independently. See Figure 11.
Figure 11: Pre-Patient Calibrations Screen – New patient
If Previous is selected under the Patient Option menu the Calibrations is available. See Figure 12.
Figure 12: User Calibration Screen – Previous Patient
If Previous is chosen from the Patient Option menu, each of the listed calibrations may be launched
and run independently by selecting the Calibrations button. See Figure 13.
Figure 13: Pre-Patient Calibrations Screen – Previous

Four User Calibrations are available:
1. Zero Flow Sensor
2. System Test
3. O2 Sensor Cal.
4. EXH Flow Sensor
ZERO FLOW SENSOR

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 or sensor board is replaced.
Figure 14: Calibrate Exhalation F - S Zero Offset
CALIBRATE EXHALATION F - S 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.
The sensor control is designed to allow 200 milliseconds for the zero-offset to complete. The sensor module
indicates to the software whether the process completed successfully or not. The calibration operation fails if
the sensor auto zero offset process did not finish successfully; otherwise, the process waits for 10 seconds
and records the returned value from the sensor and considers it the new sensor reading corresponding to
zero flow. An offset from the previous value is calculated and applied to the previous calibration table to
adjust the other values according to the new offset. The sensor value corresponding to zero flow must be 47-
53. The user can abort the calibration ant any time by selecting STOP. A * Calibration Cancelled * massage is
displayed and the last calibration offset value is used.
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.
3. The software starts the automated procedure to calibrate the exhalation flow sensor zero offset.
4. The Sensor controller board reads the sensor value.
5. If the sensor board fails to get a value within range from the sensor in 200 milliseconds, the sensor
board sends a status message with zero offset failure flag set and the calibration fails.
6. If the sensor board reads a value within range from the sensor within 200 milliseconds, it sends a
message that includes that value along with a zero offset flag cleared and the calibration passes.
7. If the software receives a successful message from the sensor board, it parses the value from it as the
new zero offset value and displays a ! Calibration Successful ! message and the new zero offset value.
8. If the software receives a failure message from the sensor board, it repeats the process by resending
the zero offset command. In case of repeated failure, the software keeps repeating the process for a
maximum time of 30 seconds. If the failure persists, the software displays a * Calibration Error *
message.
Normal acceptable values for Exhalation Flow Sensor Zero Offset are between 47 - 53.
SYSTEM LEAK TEST AND COMPLIANCE CALCULATION

The System Test is run by the user in order to verify the integrity of the patient tubing system
components and also to allow the ventilator to calculate circuit compliance. Running the system test
allows the operator to quantify any leakage from the patient tubing system or internal related component
prior to clinical patient use.
In addition to leakage, the system test also measures the total compliance of the patient tubing system.
The calculated system compliance (ml/cmH2O) factor is used to compensate volume delivery on a
breath by breath basis in order to ensure accurate volume delivery.
The system test must be performed when the patient tubing system or components are replaced. Failure
to perform the System Test as required may lead to leaks or incorrect compliance factors influencing
breath delivery and monitoring functions.
Figure 15: System Test screen
System Leak Test
1. Attach the complete patient tubing system to the ventilator.
2. Block the circuit wye and select START TEST to begin the System Test procedure. The series of
tests require the wye piece to be closed or blocked for the duration of the tests.
3. The blower is run at full speed.
4. The inhalation valve is opened and the exhalation valve is closed.
5. Pressure at the inhalation pressure transducer is measured. If pressure does not reach 30 cmH2O or
higher within three seconds, the test fails and reports Test Failed! Leak test pressurize cannot reach
desire level. This typically indicates there is a large leak.
6. If pressure reaches 30 cmH2O or higher within 3 seconds or less, the pressure is acceptable and
recorded as the P1 value. The test moves on to measure the leak if there is any.
7. The inhalation valve is closed to trap the accumulated pressure in the patient circuit.
8. Any leak is measured by waiting for 3 seconds then measuring the pressure at the inhalation pressure
transducer and recording it as P2. If ((P2-P1)/time) < 3 cmH2O, the leak rate is acceptable and the
test passes.
9. On completion, the device reports a pass as Test completed successfully accompanied by leak rate.
10. If ((P2-P1)/time) > 3 cmH2O a failure is reported with a specific error message to prompt further
investigation.
a. A very large leak displays Test failed! Leak test pressurize cannot reach desire level.
b. Leaks larger than 3 cmH2O/second but small enough to pressurize the circuit displays Test
failed! System leak is too high.
Perform Tubing Compliance Test
1. The exhalation valve is opened to release pressure.
2. The exhalation valve is close and the inhalation valve is opened to flow to 3.5 l/min.
3. If no pressure at all has built up after 3 seconds; then the test fails and displays Test failed! Leak test
pressurize cannot reach desire level.
4. If pressure builds but does not reach 40 cmH2O or higher within three seconds, the test fails and
displays Test failed! Leak test pressurize cannot reach desire level.
5. If the pressure reaches 40 cmH2O, the compliance is calculated: Measured volume during the 3
seconds / difference in pressure between the start and end of the 3 second period. The test reports
Test completed successfully along with the date and time and the tubing compliance is displayed.
O2 Sensor Calibration
The Oxygen Sensor calibration permits the operator to perform a calibration of the integral O2
measurement system prior to use and as required there after. The device performs a two point
calibration procedure using 21% oxygen (air only) then 100% oxygen. Perform the oxygen sensor
calibration between each patient use and following replacement of the oxygen sensor or a related repair.
Failure to perform oxygen sensor calibration as required may lead to inaccuracies in the monitored
oxygen percentage.
Oxygen sensor calibration is run by the user in order to define the performance characteristics of the
internal oxygen sensor prior to use. The calibration data derived during this procedure is stored in
NVRAM and used during normal operation to ensure accurate measurement of the patient inspired FiO2
level.
Note:
Oxygen sensor calibration requires the use of a high or low pressure oxygen supply.
Figure 16: Calibrate Oxygen Sensor Test Screen

Oxygen sensor calibration is performed as follows:
1. On the New Patient Startup screen or on the Previous Patient Startup screen, select Calibrations.
2. Select O2 Sensor Cal.
4. Open the circuit wye and select START TEST to begin the O2 Sensor Cal. test procedure.
5. The pressure at the oxygen pressure transducer (P1) is measured. If no oxygen supply is present, the
calibration fails and displays * Calibration Failed! No O2 Supply *
6. The oxygen valve is closed.
7. The air valve is opened to flow 25 l/min. for one minute.
8. The average voltage output of the oxygen sensor is measured over the one minute period and the
final average value is recorded as value 1(for 21% O2).
9. If an oxygen supply is present, the air valve is closed and the oxygen valve is opened to flow 6
l/min. for one minute.
11. If value 1 is < minimum sensor value for 21% O2 (equal to sensor connected) or value 1 > value 2,
then calibration fails for the 21% O2 and * Calibration Failed ! Bad O2 Sensor * is displayed.
12. If value 2 is < minimum sensor value of 30 mV for 100% O2, then calibration failed for 100%O2
and * Calibration Failed ! Bad O2 Sensor * is displayed.
13. If there is no failure, calibration passes. The value 1 measurement is saved as the sensor reading for
21% O2 and value 2 as sensor reading for 100% O2. The device reports a pass as ! Calibration
Successful !
14. Once the test is complete, press SAVE to store the results. Save calibration data successfully is
displayed.
15. CANCEL may be selected to terminate the calibration. * Calibration Cancelled * is displayed and the
last successful O2 Sensor calibration results are used for O2 measurement.
Exhalation Flow Sensor
The Calibrate Exhalation Flow Sensor screen allows the service technician 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 sensor is replaced or if
incorrect exhalation volumes are observed. A Calibration Successful message is displayed when the
calibration is complete.
Figure 17: Calibrate Exhalation Flow Sensor screen

Calibrate Exhalation Flow Sensor:
1. Connect the To Patient port to the From Patient port using a short length of patient circuit
tubing.
2. Select START to initiate the automated calibration process.
3. Select STOP at any time during the calibration to abort the process.
4. The software performs the Exhalation F - S Zero Offset process. If the auto zero process is
successful (see Zero Flow Sensor), the software automatically saves the new value without
user’s intervention. If the process fails the software returns the sensor to normal mode and
declares a calibration failure.
5. The blower is set to maximum speed, the inhalation valve is closed, and the exhalation valve is
opened in preparation for the next calibration step, building the calibration table.
6. The calibration table consists of three (3) ranges:
a. 0 to 1 l/min in 0.1 l/min. steps with a total of 10 steps held for 5 seconds each.
b. 1 to 10 l/min. in 1 l/min. steps with a total of 10 steps held for 5 seconds each.
c. 10 to 200 l/min. in 10 l/min. steps with a total of 20 steps held for 5 seconds each.
7. For every calibration step the software commands the inhalation valve to open to provide the
current step flow. It waits 5 seconds for the flow to stabilize, then records the flow value of the
inhalation flow sensor, and records the ADC (Analog to Digital Converter) value of the
exhalation flow sensor. Both values are recorded in the corresponding calibration table for that
step and the recorded exhalation flow value corresponds to the flow value obtained from the
inhalation flow sensor. During each step of the process three values are displayed.
a. INH Valve Command: The PWM signal applied to the Inhalation valve.
b. Desired Flow: The target flow value.
c. Inhalation Flow: The actual flow value from the inhalation flow sensor.
8. If the software fails to get a digital value from the exhalation flow sensor for any step it declares
calibration failure.
9. The calibration process proceeds through each of the three ranges in the same manner
described above.
10. During the third range, if the flow is still increasing as the inhalation valve command increases,
the process continues step by step until either the final step of 200 l/min. is reached or the
measured flow is no longer increasing. If the inhalation valve command has reached its
maximum (20000) but the measured flow is not increasing for 60 seconds, the software
determines this is the final calibration step. If the flow is < 160 l/min., the calibration process
is declared a failure. If the flow is ≥ 160 l/min. it is recorded as the last value and the
calibration process finishes successfully.
11. If the total cumulative calibration process time exceeds 150 seconds (maximum zero offset time
(30) + maximum blower speed validation time (30) + maximum sensor calibration time (90),
the software declares calibration failure.
12. If the process finished successfully, a ! Calibration Successful ! message is displayed.
13. Press the SAVE button to save the calibration information. A Save calibration data successfully
message appears.
Acceptable values:
ADC: 0 to 1023 (practical values: 45 to 1023)
Flow: 0 to 200 L
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.
USER CONFIGURATION SCREENS
The user configuration screens allow the user to configure a number of attributes to their desired setting.
From either Patient Startup screen, select ACCEPT to access the Standby screen.
On the Standby screen, select the Config tab to access the User Configuration screens.
Figure 18: Settings
Figure 19: Standby Config Screen
The Config screen allows the operator to configure attributes specific to how the ventilator operates and is
monitored during normal ventilation. The attributes which may be adjusted are defined below:
None
Humidification Type HME
Humidifier
Nebulizer On/Off
Time (min) 1-480
Smart Nebulizer
Interval On/Off
Time (min) 1-480
Sigh On/Off
Smart Sigh
Sigh Factor (%) 0-50
Graphics Selection
Graph Settings Waveforms Loops
Number of Display 1-3 Number of Display 1-2
Trend Data Setting Number of Display 1-3
Monitors Number of Display 5-8-10
Compliance Compensation On/Off
Compliance Comp.
Blower 100% On/Off
Low Flow Inlet O2 Pressure On/Off
Low Flow O2
O2 Sensor On/Off
Audio Level (%) 35-100
Audio/LCD Level Screen Clicks On/Off
LCD Brightness (%) 20-100
System Information
Ventilator Running Blower Running Hours
Technical
Hours Total (h) Total (h)
Technical Settings
Table 1: Configurable Attributes
Figure 20: Technical Settings Screen – Code
The Technical Settings screen requires a password to gain access. The password is 0123. Enter the password
and select OK.
Figure 21: Technical Settings Screen - Activate

The Technical Settings screen has three menu items available to set the language, date and time, or enter the
Engineering screens. All three are only available if the ventilator is in the Standby mode. Once ventilation has
begun, only the Engineering button is available.
Figure 22: Language Setting Screen
The set language screen allows the user to select from the languages available.
Figure 23: Time and Date Setting Screen

The Set Date / Time screen allows the user to select the appropriate date and time for their location.
Selecting the Engineering button on the Technical Settings screen opens another window that requires a code
to access the Engineering screens. The code is 4567.
Figure 24: Technical Settings - Engineering Password
Enter the code and select OK to advance to the Engineering screen.
Figure 25: Engineering Screen
The Engineering screen has four menu items available:

1. System Pneumatic
2. Power Status
3. System Logs
4. System Misc
System Pneumatic
The System Pneumatic screen shows real time values for many pneumatic components and can be accessed
and viewed during normal ventilator operation. No values can be changed from this screen under this menu.
Figure 26: System Pneumatic Screen
The following parameters may be observed:
Parameter Range Parameter Range Parameter Range
Air Flow 0-200 LPM O2 High Press 0-100 psi Air Valve Current 0-1200 mA
O2 Flow 0-200 LPM Heliox Hi Press cmH2O O2 Valve Current 0-1200 mA
Heliox Flow LPM O2 Level 21 to 100 % Heliox Valve Current mA
EXH Flow 0-200 LPM Air Flow Temp -20.5 to 70 C Spare Sensor
INH Pressure -60-140 cmH2O O2 Flow Temp -20.4 to 70 C Blower Speed 0-45000 RPM
EXH Pressure -60-140 cmH2O Heliox Flow Temp C Measured Base Flow 0-25 LPM
Leak Compensation 0-60 LPM
Crossover Valve On/Off INH Auto-Zero On/Off Nebulizer Sol On/Off
Safety Valve On/Off EXH Auto-Zero On/Off Nurse Call On/Off
Air Valve 0-32767 PWM Heliox Valve PWM Oxygen Valve 0-32767 PWM
0-2000 mA mA 0-2000 mA
Blower Speed 0-45000 RPM Exhalation Valve 0-16383 PWM Oxygen Percent 21-100 %
Power Status
The Power Status screen allows the user to monitor the condition of the ventilators internal batteries. A
battery icon in the upper right corner of the screen indicates the ventilator is operating on the internal
battery and the percentage of estimated power remaining is displayed. The icon is present on all screens
while the internal battery is in use.
The internal battery unit in eVolution consists of two (2) Lithium-Ion cells. The Power Status screen
shows the status of each cell:
Voltage (mV): The voltage in milliVolts. Range from 0 mV to 17000 mV. Normal value range is
from 1100 mV to 16600 mV.
Current (mA): The current of the battery in milliAmps. The value is negative if the battery is
discharging (when system is powered by the battery) and positive when the battery is charging. Range
from -9000 mA to +16000 mA.
Avg Current (mA): The running average of current measured from each battery.
Temperature (C): Each cell internal temperature is displayed in degrees Celsius. Range from -2 to
324º C. The battery operating range is -10-75ºC. An internal thermo fuse opens at 93ºC and renders
the battery unusable.
Avg Run Time (min): The remaining run time of each battery cell in minutes estimated based on the
average discharge. This value is not guaranteed and changes constantly according to the current
consumption. The value shows 16535 (unlimited) when battery is not the power source.
Figure 27: Power Status Screen
System Logs
The System Logs screen allows the service technician to check all log entries at once or the Alarm log, the
Settings Log, or the Calibration log individually. These logs are useful in observing the history of all
setting changes, alarms or calibrations. The following information can also be observed on this screen.
1. CRC: Cyclic Redundancy Check displays number of the Application firmware.
2. Instrument Hours: Displays the hours accumulated while the ventilator is unit powered on from any
source.
3. Blower Hours: Displays the hours accumulated while the blower is running.
4. Select Log: Allows the user to select a specific log criterion to display from the following: All Logs,
Alarm Log, Calibration Log, or Settings Log.
5. Left island (left pane) of the display shows the items in the selected log sorted by time of events in
descending order
6. Right island (right pane) of display area: when an event is selected in the left pane, shows all the
system settings associated with each event saved at the time the event occurred.
Figure 28: System Logs Screen
Each type of log is described here:
Alarm Log
Figure 29: Alarm Log Screen
ID Time Date: A sequential number, time and date is assigned to each log entry.
Type: Indicates if the event is an alarm or malfunction.
Event Set Monitor: Lists the alarm setting is violated, the alarm setting, and the monitored value.
Calibration Log
Figure 30: Calibration Log
ID Time Date: A sequential number, time and date is assigned to each log entry.
Type: Indicates the log entry is a calibration.
Event Set Monitor: Lists the calibration selected and the status of the calibration, the monitor field
is not used.
Settings Log
Figure 31: Settings Log Screen
ID ☆ Time ☆ Date: A sequential number, time and date is assigned to each log entry.
Type: Indicates the log entry is a settings change.
Event ☆ Set ☆ Monitor: Lists the setting adjusted and the value or choice selected, the monitor field is
not used.
System Miscellaneous
The System Miscellaneous screen shows real time values for many electronic components and can be
accessed and viewed during normal ventilator operation. No values can be changed from this screen under
this menu.
Figure 32: System Miscellaneous Screen
The following parameters may be observed:
Parameter Range Parameter Range Parameter Range ADC

normal
10500 – 16900 mV
Ext. Battery HME Filter Detected Yes / No Backlight Control 0-105
disconnected
< 4500 mV
Batt. Charger 0-1700 mV OverCur Air Valve Yes / No Heater Current 0-833 mA 0-27306
normal 0-65535
10500 – 16900 mV
Battery 1 OverCur O2 Valve Yes / No Heater Actual Temp 0-100 C
disconnected
< 4500 mV
normal
10500 – 16900 mV OverCur Hel Valve
Battery 2 Yes / No Heater On / Off
disconnected
< 4500 mV
Bar. Pressure 0.14-15.95 psi OverCur Heater Yes / No Heater Target Temp 0.0 - 100.0 C
Bar.
-40-85 ºC Backlight On / Off Heater power Level 0.0 - 20.0 W
Temperature
6
Section
ENGINEERING SCREENS
This section of the manual is intended to provide the trained service technician with details of how to access
and use the Engineering screens as a means of testing and troubleshooting the device. Access to the service
screen is available only from the Patient Startup screen. While viewing the Patient Startup screen press both
the O2↑ and Manual keys.
Note: Many of the screens listed here are also accessible from the Technical screen found
under the Config tab during normal ventilation.
Figure 33: Engineering Screen
The Engineering screen gives access to the following screens:
System Pneumatic Exhalation Valve

Power Status O2 Sensor Calibration
System Logs Exhalation Flow Sensor
System Miscellaneous System Test
Calibration System Leak Test
Air Valve Tubing Compliance Test
Oxygen Valve EXH F-S Zero Offset
SYSTEM PNEUMATIC
Figure 34: System Pneumatic Screen

The System Pneumatic screen allows the service technician to control and observe a number of the
components and circuits within the pneumatic and electronic systems. The screen is split between the upper
halve used for displaying system measurements, and the lower half used to actuate or control components.
Each of the pneumatic valves and associated electronic circuits within the system may be energized in order
to confirm correct operation. To perform a test to a given pneumatic component, follow this procedure:
Enable the Master Switch
Select the valve or combination of valves, as required to meet your testing goals. Proportional valves
may be cycled through their full control range.
Observe the reaction in the patient circuit and the monitored values in the upper half of the screen.
Note: The Oxygen Percent slide control in the lower right hand corner of this screen does not
control the oxygen or air valves and therefore does not control oxygen concentration. The slider
must be adjusted to the appropriate oxygen concentration so the exhalation flow sensor can
compensate for gas density changes and accurately measure flow.
The following parameters may be observed or adjusted:

Parameter Range Parameter Range Parameter Range
Air Flow 0-200 LPM O2 High Press -6.7-260 psi Air Valve Current 0-1200 mA
O2 Flow 0-200 LPM Heliox Hi Press cmH2O O2 Valve Current 0-1200 mA
Heliox Flow LPM O2 Level 21-100 % Heliox Valve Current mA
EXH Flow 0-200 LPM Air Flow Temp -20.5-70 C Spare Sensor
-72.5-427.5
INH Pressure O2 Flow Temp -20.4-70 C Blower Speed 0-4500 RPM
cmH2O
-72.5-427.5
EXH Pressure Heliox Flow Temp C Measured Base Flow 0-25 LPM
cmH2O
Leak Compensation 0-60 LPM
Crossover Valve ON / OFF INH Auto-Zero Sol ON / OFF Nebulizer Sol ON / OFF
Safety Valve ON / OFF EXH Auto-Zero Sol ON / OFF Nurse Call ON / OFF
0-32767 0-32767
Air Valve Heliox Valve Oxygen Valve 0-32767 PWM
PWM PWM
0-16383
--------------╫------------- 0-8192 PWM --------------╫------------- --------------╫------------- 0-8192 PWM
PWM
CLOSED OPEN 0-2000 mA CLOSED OPEN 0-2000 mA CLOSED OPEN 0-2000 mA
0-45000 0-16383
Blower Speed Exhalation Valve Oxygen Percent
RPM PWM
--------------╫------------- 0-100 % --------------╫------------- 0-100 % --------------╫------------- 21-100 %
SLOW FAST CLOSED OPEN
Master Switch ON / OFF
Table 2: System Pneumatic Screen Parameters/Ranges
POWER STATUS
Figure 35: Power Status Screen
The Power Status screen allows the user to monitor the condition of the ventilators internal batteries. A
battery icon in the upper right corner of the screen indicates the ventilator is operating on the internal battery
and the percentage of estimated power remaining is displayed. The icon is present on all screens while the
internal battery is in use.
The internal battery unit in eVolution consists of two (2) Lithium-Ion cells. The Power Status screen shows
the status of each cell:
Voltage (mV): The voltage in milliVolts. Range from 0 V to 17000 V

Current (mA): The current of the battery in milliAmps. The value is negative if the battery is
discharging (when system is powered by the battery) and positive when the battery is charging. Range
from -9000 mA to +16000 mA.
Avg Current (mA): The running average of current measured from each battery.
Temperature (C): Each cell internal temperature is displayed in degrees Celsius. Range from -2 to
324º C. The battery operating range is -10-75ºC. An internal thermo fuse opens at 93ºC and renders
the battery unusable.
Avg Run Time (min): The remaining run time of each battery cell in minutes estimated based on the
average discharge. This value is not guaranteed and changes constantly according to the current
consumption. The value shows 16535 (unlimited) when battery is not the power source.
SYSTEM LOGS
Figure 36: System Logs Screen
The System Logs screen allows the service technician to check the Alarm log, the Settings Log,
Calibration log. These logs are useful in observing the history and logs of all setting changes, alarms or
calibrations. The Instrument Hours and the Blower Hours can also be observed on this screen.
1. CRC: Cyclic Redundancy Check displays number of the Application firmware.

2. Instrument Hours: Displays the hours accumulated while the ventilator is unit powered on from any
source.
3. Blower Hours: Displays the hours accumulated while the blower is running.
4. Select Log: Allows the user to select a specific log criterion to display from the following: All Logs,
Alarm Log, Calibration Log, or Settings Log.
5. Left island (left pane) of the display shows the items in the selected log sorted by time of events in
descending order
6. Right island (right pane) of display area: when an event is selected in the left pane, shows all the
system settings associated with each event saved at the time the event occurred.
Each type of log is described as follows:
ALARM LOG
Figure 37: Alarm Log Screen

Type: Indicates if the event is an alarm or malfunction.
Event ☆ Set ☆ Monitor: Lists the alarm setting is violated, the alarm setting, and the monitored
value.
CALIBRATION LOG
Figure 38: Calibration Log Screen

Type: Indicates the log entry is a calibration.
Event ☆ Set ☆ Monitor: Lists the calibration selected and the status of the calibration, the monitor
field is not used.
SETTINGS LOG
Figure 39: Setting Log Screen

Type: Indicates the log entry is a settings change.
Event ☆ Set ☆ Monitor: Lists the setting adjusted and the value or choice selected, the monitor
field is not used.
SYSTEM MISCELLANEOUS
The System Miscellaneous screen shows real time values for many electronic components and can be
accessed and viewed during normal ventilator operation. Some values can be changed from this screen under
this menu.
Figure 40: System Miscellaneous Screen
The following parameters may be observed or adjusted:
Parameter Range Parameter Range Parameter Range ADC
normal
10500 – 16900 HME Filter
Ext. Battery Yes / No Backlight Control 0 - 105
mV disconnected Detected
< 4500 mV
-----------╫---------- 0-100 %
DARK BRIGHT
Batt. OverCur Air 0-

0-17000 mV Yes / No Heater Current 0-833 mA
Charger Valve 27306
normal 0-
10500 – 16900 OverCur O2 65535
Battery 1 Yes / No Heater Actual Temp 0-100 C
mV disconnected Valve
< 4500 mV
normal
OverCur Hel
10500 – 16900
Battery 2 Valve Yes / No Heater On / Off
mV disconnected
< 4500 mV
Bar. OverCur 0.0 -
-0.14-15.95 psi Yes / No Heater Target Temp
Pressure Heater 100.0 C
Clear Over current -----------╫---------- 0-65535
COOL WARM
Bar. 0.0 - 20.0
-40-85 ºC Backlight On / Off Heater power Level
Temperature W
-----------╫---------- 0-255
Table 3: System Miscellaneous Screen Parameters/Ranges
CALIBRATION
Figure 41: Calibration Screen

The Calibration screen allows the service technician to select any of the following items and calibrate
each individually. This is helpful for troubleshooting and for repair.
AIR VALVE CALIBRATION
Figure 42: Calibrate Air Valve Screen
The Calibrate Air Valve screen allows the service technician to calibrate the air valve (PV2).
Information on the screen gives step by step instructions on how to perform this task. This
calibration is performed if an air metering related repair is made or if incorrect 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.
Calibration Process:
1. Open the To patient port to atmosphere.
2. Select START to launch the automatic calibration procedure.
4. The air valve, oxygen valve, and exhalation valve are closed.
5. The blower is set to maximum speed (45000 rpm.)
6. If the blower does not reach target speed in maximum 10 seconds, the process fails.
7. Warm up the valve: increase PWM by 200 every 100 millisecond up to 30000, then warm down
the valve by decreasing the PWM command by 200 every 100 milliseconds until 0.
8. Check for flow leak in valve: if a flow leak greater than 50 ml is detected, the process fails.
9. The calibration range consists of 45 points (from 0 to 200 LPM.) For each calibration point,
the valve is commanded by the default PWM command, then the PWM command is adjusted in
a closed loop control algorithm to control the flow such that it reaches the target flow of the
corresponding calibration point over 60 seconds.
10. When the target flow of this calibration point is reached, the actual PWM of this step is
recorded, the new step is displayed in the new calibration table, and the process moves to the
next step.
11. If the flow does not increase over 150 l/min. as the process moves to higher calibration steps, it
is considered the final step.
12. If any step below 150 l/min. is not achieved within 50 trials, the process fails. Any failure in the
process displays a Calibration error.
13. Select SAVE to accept and save the new data or click Back << to ignore and exit the screen.
Acceptable values:
PWM: 0 to 32767 (practical values: 4000 to 32767)
Flow: 0 to 200 L
OXYGEN VALVE CALIBRATION
Figure 43: Calibrate Oxygen Valve Screen
The Calibrate Oxygen Valve screen allows the service technician to calibrate the oxygen valve
(PV1). Information on the screen gives step by step instructions on how to perform this task. This
calibration is required if an oxygen metering related repair is made or if incorrect 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.
1. Open the To patient port to atmosphere.
4. The air valve, oxygen valve, and exhalation valve are closed
5. Check oxygen source pressure. If the pressure is not in valid range (20 to 40 psi), the process
fails.
6. Warm up the valve: increase PWM by 200 every 100 millisecond up to 30000, then warm down
the valve by decreasing the PWM command by 200 every 100 milliseconds until 0.
7. Check for flow leak in valve: if flow leak greater than 50 ml detected, the process fails.
8. If no leak was detected, proceed. The calibration range consists of 45 points (from 0 to 200
LPM.)
9. For each calibration point, the valve is commanded by the default PWM command, then the
PWM command is adjusted in a closed loop control algorithm to control the flow such that it
reaches the target flow of the corresponding calibration point over 60 seconds.
10. When the target flow of this calibration point is reached, the actual PWM of this step is
recorded, the new step is displayed in the new calibration table, and the process moves to the
next step.
11. If the flow does not increase over 150 l/min. as the process moves to higher calibration steps, it
is considered the final step.
14. If any step below 150 l/min. is not achieved within 50 trials, the process fails. Any failure in the
process displays a Calibration error.
Acceptable values:
PWM: 0 to 32767
Flow: 0 to 200 L
EXHALATION VALVE CALIBRATION
Figure 44: Calibrate Exhalation Valve Screen
The Calibrate Exhalation Valve screen allows the service technician to calibrate the exhalation valve
(EV). Information on the screen gives step by step instructions on how to perform this task. This
calibration is performed if an exhalation metering related repair is made or if incorrect exhaled
volumes are observed. This calibration must be performed each time an exhalation diaphragm is
replaced. This calibration must also be performed if the LFR is replaced. 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.
1. Connect the To Patient port to the From Patient port using a single patient circuit tube.
4. Safety valve is closed, exhalation valve is opened, oxygen valve is closed.
5. The blower is set to maximum speed (45000 rpm.)
6. Open air valve.
7. Determine exhalation valve lift off position: start with maximum PWM command (16383)
where the valve is fully open and pressure equals zero, gradually reduce PWM until the first
increase in pressure over zero is measured. The corresponding PWM is the lift off position.
8. If lift off position is found, proceed to calibration steps. Calibration starts at 0 pressure
(maximum PWM, valve fully open.)
9. For every calibration step, the exhalation valve PWM command is decreased slowly (i.e. valve is
being closed slowly) until the desired pressure is measured; then, the corresponding PWM and
pressure values for that calibration point are recorded and displayed on the new calibration
table.
Acceptable values:
PWM: 0 to 16383
Flow: 0 to 200 L
O2 SENSOR CALIBRATION
Figure 45: Calibrate Oxygen Sensor Screen

The Oxygen sensor calibration permits the operator to perform a calibration of the integral O2 measurement
system prior to use and as required there after. The device performs a two point calibration procedure using
21% oxygen (air only) then 100% oxygen. Perform the oxygen sensor calibration between each patient use
and following replacement of the oxygen sensor or a related repair. Failure to perform oxygen sensor
calibration as required may lead to inaccuracies in the monitored oxygen percentage.
Oxygen sensor calibration is run by the user in order to define the performance characteristics of the internal
oxygen sensor prior to use. The calibration data derived during this procedure is stored in NVRAM and used
during normal operation to ensure accurate measurement of the patient inspired FiO2 level.
Note:
Oxygen sensor calibration requires the use of a high or low pressure oxygen supply.
Oxygen sensor calibration is performed as follows:
1. On the New Patient Startup screen or on the Previous Patient Startup screen, select Calibrations.
2. Select O2 Sensor Cal.
4. Open the circuit wye and select START TEST to begin the O2 Sensor Cal. test procedure.
5. The pressure at the oxygen pressure transducer (P1) is measured. If no oxygen supply is present,
the calibration fails and displays * Calibration Failed! No O2 Supply *
6. The oxygen valve is closed.
7. The air valve is opened to flow 25 l/min. for one minute.
9. If an oxygen supply is present, the air valve is closed and the oxygen valve is opened to flow 6
l/min. for one minute.
11. If value 1 is < minimum sensor value for 21% O2 (equal to sensor connected) or value 1 > value
2, then calibration fails for the 21% O2 and * Calibration Failed ! Bad O2 Sensor * is displayed.
12. If value 2 < minimum sensor value of 30 mV for 100% O2, then calibration failed for 100%O2
and * Calibration Failed ! Bad O2 Sensor * is displayed.
13. If there is no failure, calibration passes. The value 1 measurement is saved as the sensor reading
for 21% O2 and value 2 as sensor reading for 100% O2. The device reports a pass as !
Calibration Successful !
14. Once the test is complete, press SAVE to store the results. Save calibration data successfully is
displayed.
15. CANCEL may be selected to terminate the calibration. * Calibration Cancelled * is displayed
and the last successful O2 Sensor calibration results are used for O2 measurement.
EXHALATION FLOW SENSOR
Figure 46: Calibrate Exhalation Flow Sensor Screen
The Calibrate Exhalation Flow Sensor screen allows the service technician 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.
Calibrate Exhalation Flow Sensor:
1. Connect the To Patient port to the From Patient port using a short length of patient circuit
tubing.
2. Select START to initiate the automated calibration process.
4. The software performs the Exhalation F - S Zero Offset process. If the auto zero process is
successful (see Zero Flow Sensor), the software automatically saves the new value without
user’s intervention. If the process fails the software returns the sensor to normal mode and
declares a calibration failure.
5. The blower is set to maximum speed, the inhalation valve is closed, and the exhalation valve is
opened in preparation for the next calibration step, building the calibration table.
6. The calibration table consists of three (3) ranges:
a. 0 to 1 l/min in 0.1 l/min. steps with a total of 10 steps held for 5 seconds each.
b. 1 to 10 l/min. in 1 l/min. steps with a total of 10 steps held for 5 seconds each.
c. 10 to 200 l/min. in 10 l/min. steps with a total of 20 steps held for 5 seconds each.
7. For every calibration step the software commands the inhalation valve to open to provide the
current step flow. It waits 5 seconds for the flow to stabilize, then records the flow value of the
inhalation flow sensor, and records the ADC (Analog to Digital Converter) value of the
exhalation flow sensor. Both values are recorded in the corresponding calibration table for that
step and the recorded exhalation flow value corresponds to the flow value obtained from the
inhalation flow sensor. During each step of the process three values are displayed.
a. INH Valve Command: The PWM signal applied to the Inhalation valve.
b. Desired Flow: The target flow value.
c. Inhalation Flow: The actual flow value from the inhalation flow sensor.
8. If the software fails to get a digital value from the exhalation flow sensor for any step it declares
calibration failure.
9. The calibration process proceeds through each of the three ranges in the same manner
described above.
10. During the third range, if the flow is still increasing as the inhalation valve command increases,
the process continues step by step until either the final step of 200 l/min. is reached or the
measured flow is no longer increasing. If the inhalation valve command has reached its
maximum (20000) but the measured flow is not increasing for 60 seconds, the software
determines this is the final calibration step. If the flow is < 160 l/min., the calibration process
is declared a failure. If the flow is ≥ 160 l/min. it is recorded as the last value and the
calibration process finishes successfully.
11. If the total cumulative calibration process time exceeds 150 seconds (maximum zero offset time
(30) + maximum blower speed validation time (30) + maximum sensor calibration time (90),
the software declares calibration failure.
12. If the process finished successfully, a ! Calibration Successful ! message is displayed.
13. Press the SAVE button to save the calibration information. A Save calibration data successfully
message appears.
Acceptable values:
ADC: 0 to 1023 (practical values: 45 to 1023)
Flow: 0 to 200 L
TOUCH SCREEN CALIBRATION
Figure 47: Touch Screen Calibration Screen
The Touch Screen Calibration screen allows the service technician to perform a touch screen
calibration. This is necessary if the touch screen is replaced or if there is an issue with areas not aligning
with touch inputs. It is a six point calibration requiring the operator to touch the screen to initiate the
calibration and then touch each of the numbers displayed on the screen. A Calibration Passed message
is displayed when the calibration is complete.
SYSTEM TEST
Selecting the System Test button accesses the Pre-Patient System Tests screen and allows the service
technician to perform the system test. This is different from Pre-patient system test. This executes Leak test
and Compliance test only, while Pre-patient system test launched from pre-patient screen executes exhalation
flow sensor zero offset as well. Information on the screens gives step by step instructions on how to perform
this task. This test is used to verify the integrity of the patient tubing system components and also to allow
the ventilator to calculate circuit tubing compliance. Running the system test allows the operator to quantify
any leakage from the patient tubing system or internal related component prior to clinical patient use. A
System Test Successful message is displayed when the calibration is complete.
Figure 48: System Test Screen

System Leak Test
2. Block the circuit wye and select START TEST to begin the System Test procedure. The series of
tests require the wye piece to be closed or blocked for the duration of the tests.
5. Pressure at the inhalation pressure transducer is measured. If pressure does not reach 30 cmH2O or
higher within three seconds, the test fails and reports Test Failed! Leak test pressurize cannot reach
desire level. This typically indicates there is a large leak.
8. Any leak is measured by waiting for 3 seconds then measuring the pressure at the inhalation pressure
transducer and recording it as P2. If ((P2-P1)/time) < 3 cmH2O, the leak rate is acceptable and the
test passes.
9. On completion, the device reports a pass as Test completed successfully accompanied by leak rate.
investigation.
Perform Tubing Compliance Test

1. The exhalation valve is opened to release pressure.
2. The exhalation valve is close and the inhalation valve is opened to flow to 3.5 l/min.
3. If no pressure at all has built up after 3 seconds; then the test fails and displays Test failed! Leak test
pressurize cannot reach desire level.
4. If pressure builds but does not reach 40 cmH2O or higher within three seconds, the test fails and
displays Test failed! Leak test pressurize cannot reach desire level.
5. If the pressure reaches 40 cmH2O, the compliance is calculated: Measured volume during the 3
seconds / difference in pressure between the start and end of the 3 second period. The test reports
Test completed successfully along with the date and time and the tubing compliance is displayed.
Figure 49: System Leak Test Screen
System Leak Test
System Leak Test executes the leak test only. The test is the same as the one used in the Pre-patient system
test and the System Test. The Pre-patient system test launched from the pre-patient screen executes the Leak
Test, Compliance Test and exhalation flow sensor zero offset automatically and the tests cannot be run
separately. The System Test launched from any menu executes the System Leak Test and the Compliance
Test.
Under this menu the user may run the System Leak Test independent of all other tests.

2. Block the circuit wye and select START TEST to begin the System Test procedure. The series
of tests require the wye piece be closed or blocked for the duration of the tests.
5. Pressure at the inhalation pressure transducer is measured. If pressure does not reach 30
cmH2O or higher within three seconds, the test fails and reports * System Test Failed * . This
typically indicates there is a large leak.
8. Measuring the leak is done by waiting for 3 seconds then measuring the pressure at the
inhalation pressure transducer and recording it as P2. If ((P2-P1)/time) > 3 cmH2O, the leak
rate is acceptable and the test passes.
9. On completion, the device reports a pass as Test completed successfully accompanied by leak
rate.
investigation.
Exhalation F-S Zero Offset
Figure 50: Calibrate Exhalation F - S Zero Offset Screen
CALIBRATE EXHALATION F - S 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.
The sensor control is designed to allow 200 milliseconds for the zero-offset to complete. The sensor module
indicates to the software whether the process completed successfully or not. The calibration operation fails if
the sensor auto zero offset process did not finish successfully; otherwise, the process waits for 10 seconds
and records the returned value from the sensor and considers it the new sensor reading corresponding to
zero flow. An offset from the previous value is calculated and applied to the previous calibration table to
adjust the other values according to the new offset. The sensor value corresponding to zero flow must be 47-
53. The user can abort the calibration ant any time by selecting STOP. A * Calibration Cancelled * message
is displayed and the last calibration offset value is used.
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.
3. The software starts the automated procedure to calibrate the exhalation flow sensor zero offset.
4. The Sensor controller board reads the sensor value.
5. If the sensor board fails to get a value within range from the sensor in 200 milliseconds, the
sensor board sends a status message with zero offset failure flag set and the calibration fails.
6. If the sensor board reads a value within range from the sensor within 200 milliseconds, it sends a
message that includes that value along with a zero offset flag cleared and the calibration passes.
7. If the software receives a successful message from the sensor board, it parses the value from it as
the new zero offset value and displays a ! Calibration Successful ! message and the new zero
offset value.
8. If the software receives a failure message from the sensor board, it repeats the process by
resending the zero offset command. In case of repeated failure, the software keeps repeating the
process for a maximum time of 30 seconds. If the failure persists, the software displays a *
Calibration Error * message.
Normal acceptable values for Exhalation Flow Sensor Zero Offset are between 47 - 53.
7
Section
PERFORMANCE VERIFICATION
This section of the manual is provided to allow the trained service technician to complete performance
verification testing. This testing is required periodically and post repair to ensure operation of the device to
the manufacturer’s specifications.
Note:
The eVolution Series Ventilator is manufactured with accurate pneumatic and electronic test
equipment and in a controlled environment. The following test specifications were established
with the test equipment specified in this section.
The procedures in this section do not apply to ventilator accessories. Refer to the user and
technical manuals of the accessories. Malfunctioning accessories may affect some ventilator
functions and may result in false test results.
WHEN TO RUN TESTS
The performance verification procedure and certain relevant tests should be run periodically or after a service
action has been performed as defined below:
Calibration Performance Tests
EXH F-S Zero Offset
6 Pressure Accuracy
EXH Flow Sensor
4 Oxygen Accuracy
5 Volume Accuracy
Exhalation Valve
Oxygen Sensor
3 Functional Tests
7 Alarm Operation
2 Electrical Safety
Touch Screen
Oxygen Valve
1 Set-Up (POST)
System Test
Air Valve
Interval/ Service Performed
Annually following preventive

X X X X X X X X X X
maintenance
Control Board X X X X X X X X X X X X X X
LCD Panel X X X
Interface Board X X X X X X X X X X X X X X
Power Management Board X X X X X X X X X X X X X X
Power Supply X X X X
Blower Motor Board X X X X X X X X X X
Backlight Inverter X X X
Exhalation Flow Module X X X X X X X X X X
Speaker/Buzzer X X X
Proportional Valve (PV1) X X X X X X X X X X
Proportional Valve (PV2) X X X X X X X X X X X
Oxygen Flow Sensor (FS1) X X X X X X X X X X
Air Flow Sensor (FS2) X X X X X X X X X X X
Exhalation Flow Sensor X X X X X X
Expiratory Valve/ Diaphragm X X X X
Low Flow Regulator (LFR) X X X X X X X X X
Safety Valve/Diaphragm X X X X
Nebulizer Solenoid (Sol,3) X X X X X X X X
Safety Valve Solenoid (Sol, 2) X X X X X X X X
Crossover Solenoid (Sol, 1) X X X X X X X X
O2 Regulator (Reg1) X X X X X X
Front Panel Membrane Switch X X X X
Rotary Encoder X X X X
Oxygen Sensor X X X X
Table 4: Calibration/Performance Testing Schedule
TEST EQUIPMENT AND SERVICE MATERIALS
Description Manufacturer / Part No
Ventilator Calibration Analyzer TSI Certifier FA Plus or equivalent
Electrical Safety Tester Local supply
Digital Multi-meter (DMM) Local supply
Stop Watch or equivalent Local supply
Adult Tubing System Local Supply
Test Lung Local Supply
High Pressure Oxygen Source Local Supply (medical grade)
High Pressure Oxygen Hose Local Supply
Low Pressure Oxygen Hose Local Supply
Nurse Call Test Box F910254
eVolution Ventilator Performance
eVent Medical Inc.
Verification Record
Table 5: Test Equipment & Service Materials Table
CLEANING AND INSPECTION
WARNING:
To prevent transmission of disease, use universal precautions when handling any contaminated
filters, HME or other patient accessories.
CAUTION:
To prevent damage to ESD sensitive components, always follow ESD guidelines when servicing
and handling components inside the ventilator.
NOTE
If you find any problems during the preliminary ventilator inspection, correct them before
proceeding with the performance verification. Failure to correct such problems may affect the
remainder of the performance verification procedure.
Clean and inspect the ventilator by the following means:

• Clean the ventilator exterior using appropriate germicidal or antibacterial agent. Clean all exterior
surfaces including gas connections, water traps and the mains cord.
• Remove and inspect the ventilator’s fan inlet filter, clean or replace it as is necessary.
• Verify the oxygen fittings are securely attached to the ventilator. Inspect the air inlet filter and clean
or replace it as is necessary.
• Open the ventilator chassis and inspect for cleanliness, as necessary clean its interior using an ESD
safe vacuum cleaner.
• Visually inspect the ventilators interior and exterior for any obvious problems such as missing or
broken parts; loose assemblies, disconnected wires, connectors or tubes. Repair as necessary prior to
performing the performance verification procedure.
TEST EQUIPMENT SET UP
Prior to commencing the performance verification procedure any test equipment used should be examined.
Check each device is in full working order and, as appropriate, has a valid calibration certificate.
If using an integrated ventilator calibration analyzer please ensure the device is allowed a minimum of 15
minutes warm up time prior to use. Only on completion of the warm up time should any self calibration
(zero calibration, O2 sensor calibration, etc.) be attempted.
TESTING ORDER
In order to ensure a systematic performance verification and logical fault diagnosis perform these tests in the
order given. If you need to repeat a test, the current control settings are fully defined at the beginning of each
individual test. Record all the test results on the eVolution Ventilator Performance Verification Record.
NOTE:
To locate the cause of any malfunction or test failure you should refer to the troubleshooting
information provided in the Diagnostic Error Codes and Alarms section of this manual.
Follow these general guidelines when running the performance verification procedure:
• If you note a problem during the performance verification, verify that you have followed all
procedures correctly, and that all required settings are correct, before attempting to perform any
repairs on the device.
• When making changes to ventilator settings, be aware that because of the interrelationships between
some settings, you may not always be able to make changes in the indicated sequence.
• For convenience any user configurable alarms should be set to maximum and minimum ranges
available, this reduces the occurrence of nuisance alarms during the performance verification.
• Use the alarm silence key as required during the performance verification procedure to mute any
alarms should they occur.
• Except for the pressing the alarm silence key, do not alter the control settings during the test
procedures unless specifically instructed to do so.
• Refer to the Service and Repair section of this manual for service and repair information, and the
Parts List section for identification of repair parts. When repairs have been completed repeat the test
in full.
NOTE:
The procedures described here do not verify the performance of any accessories items
(humidifiers, monitors, etc) which may be running with the ventilator system. Verify the
performance of any such items using appropriate procedures within the applicable operation and
service instructions.
1. SET-UP
Connect the AC power source to the Ventilator.
Connect Oxygen source (50 psig) to the ventilator.
Connect and adult patient circuit to the ventilator.
Switch the ventilator ON.
FPGA
1.1. Record the FPGA version. Note: the FPGA version only appears on the initial startup screen.
POST
1.2. Verify the ventilator completes the Power On Self Test (POST)
Speaker
1.3. Verify the speakers are working during POST.
Alarm LED
1.4. Verify the top alarm LED is blinking and changing color during POST.
Fan
1.5. Verify the cooling fan is drawing air into the unit when the ventilator is turned on.
Software
1.6. Record the software versions displayed on the Patient Startup screen.
Hours
Select Previous for Patient Option.
Select ACCEPT.
Select the Config tab.
Select the Technical button.
Enter the password 0,1,2,3.
Select OK.
Select the Engineering button.
Enter the password 4,5,6,7.
Select OK.
Select the System Logs button.
1.7. Record the Instrument Hours.
1.8. Record the Blower Hours.
Select << BACK
Select << BACK
Press the Standby key.
Select the Patient Setup button.
Select the Pre-Patient Tests button.
Select START TEST
Pre-Patient System Tests
1.9. Record the Tubing Compliance
1.10. Record the Leak value.
Select << BACK
Calibrate Oxygen Sensor
Select the O2 Sensor Cal. button.
Select START TEST
1.11. Record the results.
Select << BACK
Ensure the ventilator has warmed up for 5 minutes before continuing the testing.
2. ELECTRICAL SAFETY TESTING

The electrical safety test is performed in order to verify that ground resistance and earth leakage current are
within acceptable safe limits. This test is performed whenever the ventilator is opened for service, annually or
more frequently, should local regulations require it. Below shows the basic set up for the test along with
appropriate test points.
Ventilator
Safety Tester
Test Probe
Electrical
Safety
Tester
Vent
Mains
Cable
Figure 51: Electrical Safety Test Set-Up

Perform the electrical safety test procedure as follows:
Plug the mains cable of ventilator into the appropriate receptacle on the electrical safety tester.
Verify the ventilator is switched ON.
Clip the ground test probe of the electrical safety tester to the ground stud on the rear panel of the
ventilator.
Initiate a ground resistance test in the appropriate manner and observe the display on the electrical safety
tester for the test result.
The ground resistance test value must be <0.2Ω.
2.1. Record the ground resistance value.
Initiate a leakage current check in both forward and reverse polarities.
2.2. Record the forward current leakage value.
2.3. Record the reverse current leakage value.
The earth leakage current test value must be <300μA for both forward and reverse polarities.
Switch the ventilator OFF and disconnect it from the electrical safety tester.
3. FUNCTIONAL TESTS
Pneumatic Analyzer
Switch on the pneumatic analyzer and ensure that a warm up period of at least 15 minutes is allowed
prior to proceeding. Perform any required calibration procedures on the test device including any flow,
pressure or oxygen sensor calibrations. During the performance verification, measurements are taken
from the pneumatic analyzer for volume, pressure, respiratory rate and oxygen. For convenience,
configure the analyzer so all these parameters appear on one screen. To ensure the accuracy of volume
measurements during the performance verification the pneumatic analyzer must be configured to
measure in ATP (atmospheric temperature and pressure) mode. The gas type must be air/O2 and if
available the inspiratory and expiratory trigger levels should be set to 1 l/min.
Remove the adult patient circuit from the ventilator.

Connect the pneumatic analyzer as shown in Figure 52.
Figure 52: Pneumatic Analyzer Set-Up

Switch the ventilator ON.
Enter the New Patient Startup Screen.
Press both the O2↑ and the Manual keys to enter the Engineering screen.
Oxygen Inlet regulator
Select the System Pneumatic button.
3.1. Verify the O2 High Pressure displayed is 21psi (+2 psi/-1 psi) and record the measured value.
Inhalation Air Valve
Turn the Master Switch ON
Turn ON the Safety Valve.
Set the Blower Speed slider control to the FAST position.
Set the Air Valve slider control to the OPENED position.
3.2. Verify the air flow reading from the pneumatic analyzer is > 180 l/min and record the measured
value.
Set the Air Valve slider control back to the CLOSED position.
3.3. Verify the air flow reading from the pneumatic analyzer is ≤ 0.05 l/min and record the measured
value.
Set the Blower Speed slider control back to the SLOW position.
High Pressure Inhalation Oxygen Valve
Verify the Safety Valve is ON.
Turn the Crossover Valve ON.
Set the Oxygen Valve slider control to the OPENED position.
3.4. Verify the oxygen flow reading from pneumatic analyzer is > 180 l/min and record the measured
value.
Set the Oxygen Valve slider control back to the CLOSED position.
3.5. Verify the oxygen flow reading from the pneumatic analyzer is ≤ 0.05 l/min and record the
measured value.
Low Flow Oxygen Inlet
Disconnect the high pressure oxygen supply.
Connect a low pressure (20 psig) oxygen supply to the Low O2 inlet port.
Verify the Crossover Valve is OFF.
Set the Blower Speed to the FAST position.
Set the Oxygen Valve slider control to the OPENED position.
3.6. Verify the maximum oxygen flow reading from pneumatic analyzer ≥ 75 l/min and record the
measured value.
Set the Blower Speed to the SLOW position.
Disconnect the low pressure oxygen supply.
Reconnect the high pressure (50 psig) oxygen supply to the O2 high pressure inlet port.
Flow, Air and Exhalation
Connect the outlet of the pneumatic analyzer to the From Patient port with a breathing circuit tube.
Turn the Crossover Valve OFF.
Set the Oxygen Percent slider control to 21%.
Set the Blower Speed to the FAST position.
Adjust the Air Valve slider control so the flow reading on the pneumatic analyzer is 30 l/min. Fine
adjustments can be made by touching the slider control and then turning the knob.
3.7. Record the Air Flow and EXH Flow displayed on the System Pneumatic screen.
Adjust the Air Valve slider control so the flow reading on the pneumatic analyzer is 60, and 90 l/min.
3.8. Record the Air Flow and EXH Flow displayed on the screen for 60 l/min.
Flow, Oxygen and Exhalation
Adjust the Oxygen Valve slider control so the flow reading on the pneumatic analyzer is 30 l/min. Fine
adjustments can be made by touching the slider control and then turning the knob.
3.10. Record the O2 Flow and EXH Flow displayed on the System Pneumatic screen.
Adjust the Oxygen Valve slider control so the flow reading on the pneumatic analyzer is 60, and 90
l/min.
3.11. Record the O2 Flow and EXH Flow displayed on the screen for 60 l/min.
Safety valve
Disconnect the patient tubing and pneumatic analyzer from the ventilator.
Set the Blower speed slider control to the FAST position.
Set the Air Valve slider control to the OPEN position.
Block the outlet of the To Patient port.
3.13. Verify the INH Pressure increases to >100 cmH2O and record the measured value.
Turn the Safety Valve button to OFF.
3.14. Verify the INH Pressure drops to < 55 cmH20 and record the measured value.
Exhalation valve
Connect the To Patient port with the From Patient port using a single tube.
Turn the Safety Valve ON.
Set the Exhalation Valve slider control to the OPEN position.
Set the Blower Speed slider control to the FAST position.
Set the Air Valve slider control to the OPEN position.
Set the Exhalation Valve slider control to the CLOSED position.
Verify the INH Pressure increases to >100 cmH2O.
Verify the EXH Pressure increases to >100 cmH2O.
3.15. Record the measured values.
Set the Exhalation Valve slider control to the OPENED position.
Verify the INH Pressure drops to < 55 cmH20.
Verify the EXH Pressure drops to < 55 cmH20.
3.16. Record the measured values.
Set the Blower speed slider control to the SLOW position.
Set the Air Valve slider control to the CLOSED position.
Nebulizer Solenoid
Turn the Nebulizer Sol ON.
3.17. Using the pneumatic analyzer, verify the flow coming from the nebulizer port is 7±2 l/min. and
record the measured value.
Turn the Nebulizer Sol OFF.
Crossover Valve
Turn the Safety Valve OFF
Move the Oxygen Valve slider control slightly to the OPEN position to achieve a low flow.
Block the To Patient port and verify the INH Pressure is vented to atmosphere through the safety valve.
Continue to block the To Patient port and turn the Safety valve ON.
3.18. Verify the INH Pressure increases to >100 cmH2O and record the measured value.
Select <<BACK to leave the System Pneumatic screen.
Internal battery
Disconnect the AC source from the ventilator.
3.19. Verify the internal battery icon is displayed in the upper right hand corner of screen and record
the results.
Re-connect the AC source to the ventilator.
Verify the internal battery icon has disappeared.
Heater
Select the System Misc button to enter the System Miscellaneous screen.
Set the Heater Power Level slider control to 20.0 W.
Set the Heater Target Temp slider control to 5 degrees C above the Heater Actual Temp value.
Turn the Heater ON.
3.20. Verify the Heater Current rises to >500mA and record the measured value.
3.21. Verify the Heater Actual Temp rises to the Heater Target Temp and record the measured value.
Turn the Heater OFF.
Buzzer
Switch the ventilator OFF and start the stop watch.
3.22. Verify the alarm sound is constant for > 120 seconds and record the measured value.
Press the Alarm Silence button to cancel the alarm.
Connect the adult patient circuit, pneumatic analyzer and test lung as shown in Figure 53.
Figure 53: Adult Patient Circuit Set-Up
Switch the ventilator ON and enter the settings from the following table:
New Patient Startup

Patient Option New
Patient Height 150 cm
IBW 50 kg
Gender Male
Frame Medium
Humidification Selection None
Mode
Mode Type CMV
Mode Selection V-CMV
Current Settings
Flow Pat. Decel.
Trigger Press
NIV% Off
Pause 0.0 s
Auto Control Off
Leak Comp. On
Apnea Backup Off
O2 30%
Rate 15 b/min
VT 400 ml
PEEP 0 cmH2O
Flow 45 l/min.
Ptrig -5.0 cmH2O
ALARMS
High 99.0
Ve l/min
Low Off
High 2500
Vte ml
Low Off
High 120
Rate b/min
Low 1
High 85
Ppeak cmH2O
Low 1
High 50
PEEP cmH2O
Low Off
Leak 100 %
Apnea 60 s
Vti Lim 2500 ml
Table 6: Initial settings
Select Activate to commence ventilation. Allow a minimum of 10 breaths to be delivered before
attempting to record any measurements.
Verify the machine cycles with no alarms. If any alarms are active adjust the limits as necessary to
eliminate the alarm(s).
Manual Key
Press the Manual key on the front panel.
3.23. Verify the ventilator delivers a manual breath and record the results.
O2↑ (100% O2) Key
Set the O2 = 21%, then press the O2↑ button once and start the stop watch.
3.24. On the numeric screen of the pneumatic analyzer verify the displayed O2% concentration is in
the range 100 ± 3% for 5 minutes.
3.25. Verify the O2% returns to 21% after the 5 minute time period and record the results.
Nurse Call
Plug the nurse call test adaptor into the nurse call port located on the back of ventilator.
Connect the DMM test probes to the nurse call adaptor box.
Put the positive probe into the Normally Open (NO) port of the nurse call adaptor box.
Put the Negative probe into the Common (Com) port of the nurse call adaptor box.
Set the DMM to the check continuity test (Ohms test.)
3.26. Verify the DMM indicates OPEN - no continuity is indicated on the DMM.
Disconnect the breathing circuit tube from the ventilator to trigger the Disconnect Alarm.
3.27. Verify the DMM indicates CLOSED - less than 10 ohms is indicated by the DMM.
Reconnect the breathing circuit to the ventilator.
Put the positive probe into the Normally Closed (NC) port of the nurse call adaptor box.
Put the Negative probe into the Common (Com) port of the nurse call adaptor box.
3.28. Verify the DMM indicates CLOSED - less than 10 ohms is indicated by the DMM.
Disconnect the breathing circuit tube from the ventilator to trigger the Disconnect Alarm.
3.29. Verify the DMM indicates OPEN- no continuity is indicated on the DMM.
Reconnect the breathing circuit to the ventilator.
4. PERFORMANCE VERIFICATION TESTS

Oxygen Concentration Accuracy
Verify the ventilator is using the patient settings from Table 6.
4.1 Wait for a minute then verify and record O2 concentration displayed on the oxygen analyzer.
Set the O2 % to 60%.
Set the O2 % to 90%.
5. VOLUME ACCURACY (VTI/VTE/RR)
Set ventilator per Table 7settings.
New Patient Startup
Patient Option New
IBW 5 kg
Gender Male
Frame Medium
Mode
Mode Type SIMV
Mode Selection V-SIMV
Current Settings
Esens 20%
Rise Time. 10
Flow Pat. Decel.
Trigger Press
NIV Off
Pause 0.0 s
Leak Comp. On
Apnea Backup Off
O2 21%
Rate 40 b/min
Vt 50ml
PEEP 5 cmH2O
Psupport 10 cmH2O
Flow 10 l/min
Ptrig -5.0 cmH2O
Table 7: Volume Accuracy Test Settings - 1
5.1. On the numeric screen of the pneumatic analyzer verify the delivered tidal volume (Vti) is in the
range 50ml ± 12.5ml.
5.2. On the UUT monitoring screen verify the exhaled tidal volume (Vte) is in the range 50ml ±
12.5ml.
5.3. On the numeric screen of the pneumatic analyzer verify the delivered respiratory rate (Rate) in
the range 40 b/min. ± 1b/min.
Record the test results on the performance verification record.
Set ventilator per Table 8 settings.
Current Settings
Rate 30 b/min
Vt 100ml
Flow 20 l/min
range 100ml ± 15ml.
15ml.
the range 30 b/min ± 1b/min.
New Patient Startup
Patient Option New
IBW 17 kg
Gender Male
Frame Medium
Mode
Mode Type SIMV
Current Settings
Esens 20%
Rise Time. 10
Flow Pat. Decel.
Trigger Press
NIV Off
Pause 0.0 s
Leak Comp. On
Apnea Backup Off
O2 21%
Rate 15 b/min
Vt 600 ml
PEEP 5 cmH2O
Psupport 10 cmH2O
Flow 45 l/min
Ptrig -5.0 cmH2O
40ml.
Current Settings
Rate 8 b/min
Vt 1000 ml
60ml.
PRESSURE ACCURACY (PCONTROL/PEEP)
New Patient Startup

Patient Option New
IBW 50 kg
Gender Male
Frame Medium
Mode
Mode Type CMV
Mode Selection P-CMV
Current Settings
Rise Time. 10
Trigger Press
NIV Off
Auto Control Off
Leak Comp. On
Apnea Backup Off
O2 21%
Rate 8 b/min
Ti 3.0 s
PEEP 0 cmH2O
Pcontrol 2 cmH2O
Ptrig -5.0 cmH2O
Table 11: Pressure Accuracy Test Settings
6.1 On the numeric screen of the pneumatic analyzer, verify the displayed peak airway pressure is in
the range 2 cmH2O ± 0.2 cmH2O and record the measured value.
Make the following parameter changes:

Pcontrol 20 cmH2O
Allow a minimum of 10 breaths to be delivered before attempting to record any measurements.
6.2 On the numeric screen of the pneumatic analyzer verify the displayed peak airway pressure is in

Pcontrol 40 cmH2O
6.3 On the numeric screen of the pneumatic analyzer verify the displayed peak airway pressure is in

Ti 1.0 s
Pcontrol 10 cmH2O
6.4 On the numeric screen of the pneumatic analyzer verify the displayed PEEP pressure is in the
range 0 cmH2O ± 1.0 cmH2O and record the measured value.

PEEP 10 cmH2O

PEEP 20 cmH2O

PEEP 40 cmH2O

PEEP 5 cmH2O
Flow Trigger, Ftrig
Select the Settings tab.
Set the Trigger to Flow.
Set the Ftrig to 3.0 l/min.
Manually trigger the ventilator by compressing the test lung and slowly releasing it.
6.8 Verify the ventilator delivers a patient triggered breath and record the results.
Pressure Trigger, Ptrig

Select the Settings tab.
Set the Trigger to Press.
Set the Ptrig to -3.0cmH2O
Manually trigger the ventilator by compressing the test lung and slowly releasing it.
6.9 Verify the ventilator delivers a patient triggered breath and record the results.
ALARM OPERATION TESTS
New Patient Startup

Patient Option New
IBW 50 kg
Gender Male
Frame Medium
Mode
Mode Type SIMV
Current Settings
Esens 20%
Rise Time. 10
Flow Pat. Decel.
Trigger Press
NIV Off
Pause 0.0 s
Leak Comp. On
Apnea Backup Off
O2 40%
Rate 15 b/min
Vt 400 ml
PEEP 5 cmH2O
Pcontrol 10 cmH2O
Flow 45 l/min
Ptrig -5.0 cmH2O
Table 12: Alarm Operation Test Settings
Oxygen Gas Source, High

Verify a high pressure oxygen source is connected to the ventilator.
Select the AUTO SET button under the Alarms tab to adjust the alarm limits.
Verify the machine cycles with no alarms. If any alarms are active use the AUTO SET button to
adjust the limits as necessary to eliminate the alarm(s).
Disconnect the high pressure oxygen hose from the source and observe the UUT for its response.
After a number of cycles verify that a high priority alarm is enunciated and that it is accompanied by a
flashing alarm LED and a Low O2 Pressure alarm message. Verify that ventilation continues
uninterrupted.
After an additional number of cycles verify that a high priority alarm is enunciated and it is accompanied
by a flashing alarm LED and a Low O2 Conc alarm message. Verify that ventilation continues
uninterrupted.
Reconnect the high pressure oxygen hose to the source and verify that after a number of breaths each of
the above alarm conditions reset.
6.10 Record the test result on the performance verification record.
Press the Standby key and select standby.
Oxygen Gas Source, Low

Remove the high pressure oxygen source from the ventilator and connect a low pressure oxygen source.
Disconnect the low pressure oxygen hose from the source and observe the UUT for its response.
After a number of cycles verify that a high priority alarm is enunciated and that it is accompanied by a
flashing alarm LED and a Low O2 Pressure alarm message. Verify that ventilation continues
uninterrupted.
After an additional number of cycles verify that a high priority alarm is enunciated and it is accompanied
by a flashing alarm LED and a Low O2 Conc alarm message. Verify that ventilation continues
uninterrupted.
Reconnect the high pressure oxygen hose to the source and verify that after a number of breaths each of
the above alarm conditions reset.
Occlusion
Remove the To Patient tubing limb of the circuit from the Patient wye and occlude it so that no air can
pass through.
Verify multiple alarms activate including the occlusion alarm. It may be necessary to view the Event Log
under the Alarms tab.
Verify no breaths are delivered during the occlusion.
Reconnect the patient tubing and verify the alarm conditions reset.
Disconnect
Remove the test lung from the patient wye outlet and leave the port open to atmosphere.
Verify that after a small number of breaths the high priority audible alarm is enunciated. Further verify
that it is accompanied by a flashing alarm LED and the Disconnect alarm message is visible on
screen.
6.13 Record the test results on the performance verification record.
Alarm Silence
Press the Alarm Silence button.
Confirm the audible alarm is silenced but the visual alarm indicators remain active.
Press the Alarm Silence button again and confirm the audible alarm is active once more and the visual
alarm indicators remain active.
Press the Alarm Mute button once again and confirm the audible alarm is silenced and after a period of
108-132 seconds is active once more.
Reconnect the test lung to the patient wye.
Verify the Disconnect and all appended alarm conditions reset after a number of breaths.
High Inh Pressure

Remove the test lung from the patient wye and occlude the open port.
Verify that after a small number of breaths the high priority audible alarm is annunciated. Verify it is
accompanied by a flashing alarm LED, the High Inh Pressure alarm message is visible on screen
and that breath delivery truncates upon hitting the high pressure alarm limit.
Remove the occlusion from the patient wye and reconnect the test lung.
Verify that after a small number of breaths all alarm conditions auto reset.
Apnea Backup
Select the Settings tab to access the Apnea Settings button and enter the Apnea Backup Settings screen.
Set ventilator Apnea Backup parameters per Table 13.
Apnea Backup P-CMV
Apnea Backup Settings
Ti 1.0 s
PEEP 5 cmH2O
Pcontrol 20 cmH2O
Resp rate 15 b/min
Rise time 10
+O2 10%
Tapnea 20 s
Table 13: Apnea Backup Test Settings
Select ACCEPT.
Change the Current Mode Type to and SPONT and leave the remaining settings at their existing levels.
Select ACTIVATE to initiate the mode change.
Verify that after a period of 17-23 seconds a high priority audible alarm is enunciated and it is
accompanied by the alarm LED and an Apnea alarm message on the screen.
Verify that apnea back up ventilation is initiated at the settings programmed from the table above.
Use the test lung to simulate two patient inspiratory efforts within a 10 second period.
Verify that apnea backup ventilation discontinues and that SPONT mode is restored.
6.16 Record the test result in the performance verification record.
TROUBLESHOOTING PERFORMANCE VERIFICATION
Test Description Corrective Action
Volume Accuracy:
Tidal Volume Readings (VTI) Tidal Volume Readings Out of 1. Perform system test with the
Range High/Low pneumatic analyzer in line to
calculate the system compliance
and leak
2. Verify correct compliance and
resistance in use on lung
simulator
Exhaled Tidal Volume Exhaled Tidal Volume Reading 1. Perform system test with the
Readings (VTE) Out of Range High/Low pneumatic analyzer in line to
and leak
2. Ensure correct orientation of
exhalation sensor
3. Perform Exh flow sensor
calibration
4. Replace Exh flow sensor
Respiratory Rate Readings Respiratory Rate Readings out 1. Verify trigger type and setting
of range high/low. (Auto- 2. Perform system test to ensure
cycling) no leakage from system
3. Re-zero pressure transducers
4. Replace Sensor board
Pressure Accuracy:
Inspiratory Pressure Inspiratory Pressure readings 1. Perform system test with the
Readings out of range High/Low pneumatic analyzer in line to
and leak.
2. Re-zero Flow Sensor Zero Offset
3. Replace Interface board pcb
PEEP Pressure Reading PEEP Pressure out of range 1. Perform system test with the
pneumatic analyzer in line to
and leak.
2. Re-zero F-S Zero Offset
3. Replace exhalation valve.
Oxygen Delivery:
Pneumatic analyzer O2 O2 reading out of range on 1. Perform full two point calibration
Reading pneumatic analyzer. of Pneumatic analyzer O2 sensor
Vent O2 Reading O2 reading out of range on 1. Perform calibration of the
ventilator. ventilators O2 sensor.
2. Check for O2 flow thru vent
3. Replace O2 sensor
Alarm Operation:
Disconnect Disconnect alarm is not active 1. Ensure that test lung has been
removed from the wye
2. Verify that alarm settings are
appropriate
Alarm Silence Alarm silence is not active 1. Press alarm silence key again
and verify appearance of icon in
display screen
2. Check Keypad/lexan connections
High Pressure High pressure alarm is not 1. Ensure that the wye is fully
active occluded.
2. Verify that alarm settings are
appropriate
Apnea Apnea alarm is not active 1. Verify the ventilator settings
2. Ensure that device is set to Spont
mode and that apnea parameters
are appropriately set
3. Observe monitored data and
ensure that monitored respiratory
rate is 0
Apnea Back Up Apnea back up ventilation is 1. Verify the ventilator settings
not active. 2. Ensure that apnea back up is set
to On
3. Observe monitored data and
ensure that monitored respiratory
rate is 0
Gas Sources:
O2 Supply Alarm O2 supply alarm not active 1. Ensure that O2 supply has been
disconnected
Low O2 supply O2 supply pressure to low 1. Ensure that low O2 pressure is
connected and set to correct
pressure
2. Check CV1 for operation
Blower error Blower pressure too low 1. Check blower for operation
8
Section
ALARM MESSAGES AND DIAGONSTIC

ERROR MESSAGES
This section describes audible and visual alarm signals, alarm mute, the alarm log, and alarm handling.
ALARM SIGNALS
All audible and visual alarms comply with IEC 60601-1-1-8, EN475 and IEC 60417-5576
recommendations.
Alarm Audible
priority Visual signal signal Comments
High Message on red 5 repeated Nurse call enabled, alarm cannot be cancelled or
background, alarm signals removed from display until resolved. Once resolved the
indicator flashes at 2 alarm message continues to be displayed in the alarm
Hz. bar until the user touches the inactive alarm message.
Medium Message on yellow 3 repeated Nurse call enabled, alarm cannot be cancelled or
background, alarm signals removed from display until resolved. Once resolved the
indicator flashes at 0.5 alarm message continues to be display in the alarm bar
Hz. until the user touches the inactive alarm message.
Information Message on green 1 signal Nurse call disabled, message is displayed until cancelled
background, no alarm by touching the notification message on the alarm bar.
indicator.
Table 14: Alarm Signals
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.
Touch the Alarm notification area to clear the alarms from view.
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 Tab.
ALARM SILENCE KEY
To silence an active alarm for two minutes: Press and release the Alarm
Silence Key. A new alarm condition cancels the alarm silence. Pressing and
holding the Alarm Silence Key for 2 seconds silences all current and new alarms
for 2 minutes
During an alarm silence, all current and new alarms are visually displayed with their corresponding
alarm priority message on the Alarm bar until resolved and canceled as described in Table 14.
ALARM 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
Type, this allows the user to view all Alarm events together.
ALARM DEFINITIONS
This section lists descriptions and ventilator response to possible alarm conditions.
HIGH PRIORITY ALARMS

High Priority Alarm
Description of Error Ventilator Response
Message
High Inh Pressure Patient system pressure has reached Ventilator immediately switches to
the high pressure alarm setting. exhalation. Ventilation continues but
pressure is limited to the alarm setting.
Low Inh Pressure Pressure cannot be attained in the Ventilation continues.
patient breathing circuit, possible due
to a leak or disconnect.
Apnea Time The set apnea interval has elapsed Device looks for patient’s next inspiratory
without a patient triggered or effort. After two consecutive spontaneous
mandatory breath being delivered as breaths the ventilator switches over to
set in the Apnea backup settings normal ventilation.
screen. Note:
If apnea backup is switched to off in the
apnea backup settings screen, apnea alarm is
triggered but back up ventilation does not
occur.
High Priority Alarm
Message
Disconnect Disconnection of patient Ventilation continues
Occlusion Pressure at the start of inspiration is The Inspiratory valve closes, safety valve
too high. opens and exhalation valve opens until
patient pressure returns to baseline. Then
ventilation continues.
High Tidal Volume Exhaled tidal volume is too high Ventilation continues
compared with the set alarm limit for
Vte.
Note:
If exhalation flow sensor fails, inspired
breath volume (Vti) is shown instead.
Low Tidal Volume Exhaled tidal volume is too low Ventilation continues
Vte.
Note:
breath volume (Vti) is shown instead.
High Minute Volume Exhaled minute volume is too high Ventilation continues
Ve High.
Note:
minute volume (Vi Low) is shown
instead.
Low Minute Volume Exhaled minute volume is too low Ventilation continues
Ve Low.
Note:
minute volume (Vi Low) is shown
instead.
High Oxygen Inspiratory O2 concentration is too Ventilation continues
high.
Possible causes: gas mixing system
error, O2 cell faulty, monitor value too
high compared with the control value,
O2 sensor calibration required.
Low Oxygen Inspiratory O2 concentration is too Ventilation continues with Blower supply
low. (21%).
Possible causes: gas mixing system
error, O2 cell faulty, monitor value too
low compared with the control value,
O2 sensor calibration required.
High Oxygen Inlet Pressure The oxygen inlet pressure exceeded Ventilation continues with Blower supply
maximum level. (21%).
Low Oxygen Inlet Pressure The oxygen supply is interrupted. Ventilation continues
Possible causes: oxygen supply not
available while 100% O2 is being
administered or O2 calibration is
started.
High Priority Alarm
Message
Blower Blower did not reach set speed within Ventilation switches to 100% O2 if
the defined time. available: if not ventilator switched to Vent
Inop mode.
Battery Flat Internal rechargeable battery is flat Ventilation continues
MEDIUM PRIORITY ALARMS

Medium Priority Description of Error Ventilator Response
Alarm 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.
PEEP Low Patient system PEEP pressure is too low Ventilation continues
compared with the set alarm limit for PEEP
Low.
PEEP High Patient system PEEP pressure is too high Ventilation continues
compared with the set alarm limit for PEEP
High.
High Temperature The temperature inside the device is too high. Ventilation continues.
High Leak Rate Monitored value for Leak % is too high Ventilation continues
compared 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 Volume delivered is maybe too low
(Pop high = Ppeak alarm – 5mbar)
Vti Limit Reached Delivered volume is being limited by Vti Limit Ventilation continues with delivered
alarm settings volume limited.
Low ATM Pressure Barometric pressure lower than low limit of 9.5 Ventilation continues
psi
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
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 pressure trigger mode. Exhaled
out of range volume measurement switches
to Inspired volumes.
Nebulizer Not Available Nebulizer is not available. The nebulizer is switched off.
Possible cause: Flow delivered is too low to
allow nebulizer function. High pressure
oxygen source not connected.
Inverse Ratio Set Ventilation settings have been set to an inverse Ventilation continues
ratio (Exhalation time > Inhalation time)
100% O2 Not Available The O2↑key was pressed when no oxygen Ventilation continues
source is available
NVRAM Battery Low Coin Lithium battery on the control board that Ventilation continues
supplies the nonvolatile memory is very low
ABOUT DIAGNOSTIC MESSAGES

There are two types of errors: Malfunctions, and Alarms.
Malfunctions are related to technical failures. Alarms are related to operation conditions failure or mismatch.
Alarms are categorized as High Priority, Medium Priority, and Low Priority.
Both Alarms and Malfunctions are logged in the Events Log.
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, High O2 inlet pressure alarm, and Low battery alarm.
Startup Mode:
During Startup Mode, the following is executed in sequence: 1) POST and 2) Loading Configuration Data
from NVRAM.
1) POST executes the following diagnostic tests:

FPGA test
DRAM test
FLASH memory CRC test
Display controller test
Audio test
CPU watchdog test
If one or more of these tests fails, a corresponding error is passed as POST Malfunction to the next
Standby Mode to be handled (see Standby Mode below.) In Standby Mode, the following actions are
taken for any POST Malfunction:
The ventilator is still functional.
The POST malfunction event is logged in the Events Log along with a number indicating
the particular failing test.
No error messages are displayed on the screen.
A dimmed flashing red light is activated and cannot be canceled.
The audio alarm is activated and cannot be silenced.
2) Loading Config Data from NVRAM:

Touch screen configuration
System settings
Air valve calibration table
Oxygen valve calibration table
Exhalation valve calibration table
Exhalation Flow Sensor Zero Offset value
Exhalation Flow Sensor calibration table
Oxygen sensor data
System test saved data
Status of required calibration needed
Instrument settings (Audio level, LCD brightness, language, date format, time format)
The following errors are detected and passed as a Configuration Data Bad Malfunction to the next
Standby mode to be handled:
If the CRC (Cyclic Redundancy Check) of any NVRAM configuration was wrong or
Inhalation air or O2 flow sensor initialization fails because of corrupt EEPROM data, the
default data is used instead, and a NVRAM error is logged into the Events Log with an ID
number indicating the particular corrupt configuration in the list above. No error messages
are displayed for this situation.
The following errors are detected and passed as a System Out of Calibration Malfunction to the next
Standby mode to be handled:
When loading the Status of required calibration needed, if the O2 sensor, Flow sensor, or
System Tests, are found to need calibration, this is indicated on the New Patient Setup
Screen along with the last time calibration was completed. Any other device that is out of
calibration is indicated on the Calibration Screen.
Standby Mode:
The Standby Mode handles POST Malfunctions (diagnostic test failures) and NVRAM Configuration Data
Bad Malfunctions as described above. In addition, Standby Mode constantly monitors the following system
malfunctions and three (3) operation alarms:
1) System (technical) malfunctions:
a. A Software Malfunction occurs when an erroneous software value is detected any where in
the code.
b. A Hardware Malfunction occurs for any of the following:
i. Blower Failure and no O2 inlet connected.
ii. Audio Read Failure.
iii. Audio Write Failure
c. A Software Watchdog Expiration Malfunction occurs when the software watchdog timer
expires.
d. A Sensor Failure Malfunction occurs if the inhalation air or O2 flow sensor initialization fails.
e. A Battery Low Malfunction occurs any time the battery charge < 10% if running on battery.
Actions:
For c and e above, the ventilator is put in Vent-Inop mode.
For all other technical malfunctions, an audible alarm that cannot be silenced is announced,
and a red light flashes constantly. No messages are displayed. The malfunction is logged in
the Events Log along with the ID of the error.
9
Section
PREVENTATIVE MAINTENANCE
¾ Only trained personnel should perform preventive maintenance
according to these instructions.
Perform these preventive maintenance procedures on the eVolution at the following intervals.
Interval Maintenance procedure

Every 250 hours or as Clean or replace the cooling fan filter and air inlet filter.
required
Every year or as required Replace the cooling fan filter,

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

required Note: Both batteries must be replaced at the same time.
As required Replace fuses.
Table 15: Preventive Maintenance Schedule
EVERY YEAR OR AS REQUIRED: CLEAN OR REPLACE COOLING FAN FILTER

¾ Check the Cooling Fan Filter regularly for blockages and contamination
and clean as required.
1. Use a small flat-blade

screwdriver to pry the filter
retainer from Fan Guard.
2. Replace the fan filter or
wash it under running
water. Do not reinstall the
cleaned filter until it is
completely dry.
3. Push the filter retainer back
into the Fan Guard.
Figure 54 - Fan Filter and Cover
EVERY YEAR OR AS REQUIRED: CLEAN OR REPLACE AIR INLET FILTER
¾ Check the Air Inlet Filter regularly for blockages and
contamination and clean as required.
1. Carefully grasp the Air Inlet

Filter element.
2. Pull the filter element out
of the Air Inlet manifold.
3. Replace the filter or wash it
under running water. Do
not reinstall the cleaned
filter until it is completely
dry.
4. Reinsert the filter in the Air
Inlet Manifold.
Figure 55: Air Inlet Filter
EVERY YEAR OR AS REQUIRED: REPLACE OXYGEN SENSOR

¾ Use recommended replacement oxgen sensors only. Always
calibrate the oxygen sensor after replacement.
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 56: O2 Sensor
EVERY TWO YEARS OR AS REQUIRED: REPLACE THE INTERNAL BATTERY
¾ Always replace both batteries at the same time.
¾ Use recomended replacement batteries only.
¾ Always perform the System Test and Alarms Test after
replacing the batteries.
¾ Calibrate internal batteries following replacement (see the
eVolution Service Manual).
Figure 57: Internal Battery
1. Disconnect the A.C. power cord.

2. Use a # 2.Philips screwdriver to loosen the four screws and washers that secure the back panel
battery tray.
3. Slide tray that holds internal batteries out of the enclosure.
4. Loosen the fastening brackets that secure the batteries to the tray by removing the two Philips
head screws and lock washers and two M4 hex nuts and M4 lock washers.
5. Remove the batteries from the battery connectors.
6. Install the new batteries by connecting the battery connectors. . Orient each battery with the
grooved side facing away from the battery tray wall.
7. Place the batteries in the battery tray and secure the battery brackets by installing the screws,
nuts and washers.
8. Install the battery tray in the ventilator and secure it by installing the four Philips head screws
and washers.
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 58: Fuse
10
Section
SERVICE AND REPAIR

This section of the manual describes how to repair the ventilator’s major subassemblies and their
components.
REPAIR SAFETY
When servicing the eVolution ventilator system, be sure to familiarize yourself with and adhere to all
posted and stated safety warning and caution labels on the ventilator and its components. Failure to
adhere to such warnings at all times may result in injury or property damage.
To prevent patient injury, do not use the ventilator if it requires repair. To prevent personal injury or
death, do not attempt any service to the ventilator while a patient or other person is connected to it.
To prevent electric shock hazard, always ensure that all electrical power has been removed
from the device prior to commencing service. This statement requires that not only AC power
is removed but also the device’s internal batteries and any external DC source is also removed
as applicable. Additionally, always remove any oxygen source attached to the ventilator.
If the device must be serviced with the power connected, be careful to avoid electrical shock. At all
times, follow accepted safety practices for electrical equipment when performing any repairs. To
prevent possible personal injury, always ensure that high pressure air and oxygen sources have been
removed, never attempt to push or pull a ventilator installed on its stand with the brakes set, and always
ensure the brakes are set to prevent inadvertent movement when performing service.
REPAIR GUIDELINES
The following general guidelines should be considered at all times when performing service:
Follow repair safety guidelines at all times.
Always ensure the correct tools are used when performing service.
Use only recommended tools, test equipment, service materials, and parts when servicing
the ventilator.
When performing service, take precautions to prevent dirt and other particles from entering
the ventilator interior, particularly the pneumatic manifold assemblies.
Inspect any removed parts including those removed to gain access to a suspected faulty
component. Inspect and clean the exposed area behind removed parts as required. Clean
any removed parts to facilitate further inspection.
Investigate and determine the cause of any detected abnormality.
Repair the unit or consult your local eVent Medical technical support location for assistance
on unsolved problems.
Replace or repair any parts which are found to be worn, missing, damaged, cracked,
incorrect, or otherwise show signs of any physical abnormalities.
CLEANING
If needed, follow these general cleaning guidelines when cleaning the ventilator during servicing. The
procedures for periodic cleaning and sterilization of the ventilator and accessories are listed in the
eVolution ventilator system User Manual. Specific procedures for periodic cleaning and inspection
done during the ventilators performance verification are listed in the relevant section of this Service
Manual.
Clean ventilator exterior surfaces before disassembly. Use isopropyl alcohol, a bactericidal
agent, or a mild detergent and warm water solution; combined with a clean, lint-free cotton
cloth.
Do NOT apply liquid cleaner directly to the surface of the ventilator. Apply liquid cleaners
to the cloth, then wipe the ventilator and accessories clean.
Vacuum ventilator interior using ESD-safe equipment.
Do NOT clean the ventilator interior with high pressure air.
During disassembly, clean parts as necessary with one of the above cleaners. Any
excessively dirty items which cannot be cleaned should be replaced.
ELECTRICAL CABLES AND PNEUMATIC CONNECTION
To ensure correct reassembly of the device, take note of, or label wire and tube positions before
disconnecting parts. Make sure that all tubes and harnesses are correctly installed and do not interfere
with and cannot be damaged by any moving parts.
ESD CONTROL
It is important to follow appropriate ESD control procedures whenever the ventilator system is being
serviced.
GENERAL INFORMATION
ESD can permanently damage ESD-sensitive microelectronic components or assemblies when they are
handled and even when no direct contact is made with the component or assembly. ESD damage may not
be immediately apparent, however, ESD damage will show up at a later time, either as a premature failure of
a component or assembly, or as an intermittent failure, which can be difficult and time consuming to locate.
PROCEDURES AND PRECAUTIONS

Follow these minimum procedures and precautions to prevent ESD damage to the ESD sensitive
microelectronic components and assemblies of the EVolution ventilator system.
Use a personnel grounding system. Before opening the ventilator enclosure, ensure that a personnel
grounding system (incorporating wrist strap, static-dissipative mat and ground cord) is worn correctly
and is properly connected to reliable ground.
Follow correct procedures for use of static dissipative mat. Place tools, test equipment and the
ESD sensitive device on the mat before starting any repairs. Conduct all work from the mat. NEVER
place nonconductive items on the mat.
Handle ESD-sensitive components properly. Do NOT handle ESD-sensitive component
connection points, connector pins, leads or terminals.
Keep nonconductive materials away from work space. Static charges from nonconductive material
may not be removed by grounding. Items of this nature should be kept well clear of the work space
when handling ESD sensitive devices.
Follow correct procedures for static shielding bags. Store and transport all ESD sensitive devices in the
shielding bags at all times except when being worked on. NEVER place more than one ESD sensitive device
in a static shielding bag. NEVER place static generating nonconductive material inside a static shielding bag
with an ESD sensitive device. Place any faulty ESD sensitive devices in a static shielding bag immediately
after removal to prevent additional damage. Close and seal the bag to ensure that the shield is effective.
REPAINTING
Before repainting or touching up the ventilator, smooth out the area with fine sandpaper, and make
sure it is free from any grease, corrosion, or dust. Remove the part to be painted or mask off the
surrounding area to prevent over-spray or spills.
NONCONFORMING PARTS AND RETURN AUTHORIZATION
NUMBERS (RGA)
When investigating reported problems, identify the cause of the failure and repair or replace the
component as necessary. Any failed, nonconforming parts, should be retained until the subject device
has been successfully repaired. Following completion of the repair, any non-conforming parts should
be returned to the manufacturer to allow failure analysis to be performed.
To arrange for return of non-conforming parts, contact the manufacturer or your local dealer. The
dealer requests and receives a returns authorization number (RGA) from the manufacturer. Prior to
dispatch, non-conforming parts should be suitably packaged with a copy of any relevant service
documentation enclosed. The return authorization number provided by the manufacturer should be
clearly marked on all shipping documentation and on the exterior of the packaging.
REPLACEMENT PARTS
To order correct parts, identify the ventilator’s model and serial number. Then using the Service Parts
List section of this manual and identify the part number. Retain the part to be replaced until the
replacement part is obtained, and compare the two for compatibility.
Note: The exploded parts diagrams are for reference only not all parts are available to order.
Use the Service Parts List for part(s) ordering.
POST REPAIR AND TESTING
After successfully completing any ventilator repair, the following should be done prior to returning
it to normal operation:
Visually verify that all pneumatic and electrical parts are properly connected and that all parts
are properly installed.
Verify that connections are secure and that parts are securely attached. Listen for any
uncharacteristic sounds (pneumatic leaks, vibrations, grinding, etc). Be sure that the cooling fan
and casters move freely.
Check for any unusual odors.
Run the appropriate portions of the performance verification procedure as indicated in the
Performance Verification section of this manual.
On completion of any ventilator repair, run any necessary calibration procedures.
REPAIR DOCUMENTATION AND RECORDS
For convenience, a Service Record/Warranty Claim Form has been provided in this manual. Repairs or any
work performed on the device should be recorded on these or similar documents.
A completed copy of this record must be communicated to eVent Medical or your local distributor.
PATIENT SYSTEM AND ACCESSORIES
For maintenance of the patient system and accessory items, consult the eVolution ventilator system User
Manual and refer to the applicable accessory manuals.
SERVICING PROCEDURES - REMOVAL/INSTALLATION
VENTILATOR STAND
Ensure the brakes have been engaged to the casters on the base of the stand.
Ensure all accessory items, tubing system, gas supply hoses and electrical source cables, have been removed
from the ventilator.
Remove the two thumbscrews securing the ventilator to the cart.
Lift the ventilator off and set it on its feet on a secure surface.
AC POWER
Remove the power cord retainer.
Disconnect the AC power cord from the AC inlet module.
AIR INLET FILTER, MAIN

Remove the foam filter by pulling down and outward.
Replace or clean it as necessary as per the Preventative Maintenance Schedule.
FAN AIR INLET FILTER

Pry the filter retainer from the Fan Guard using a small flat-blade screwdriver.
Replace the fan filter or wash it under running water. Do not reinstall the cleaned filter until it is
completely dry.
Push the filter retainer back into the Fan Guard.
Replace or clean as necessary as per the Preventative Maintenance Schedule.
INTERNAL BATTERIES
Remove the four screws and washers that secure the back panel battery tray.
Slide the tray that holds the internal batteries out of the enclosure.
Remove the fastening brackets that secure the batteries to the tray by removing the two Philips head screws
and lock washers and two M4 hex nuts and M4 lock washers.
Remove the batteries from the battery connectors.
Note the orientation of the battery harness. Set the battery pack aside.
Replace every 24 months or as necessary.
OXYGEN SENSOR
Loosen the thumbscrews securing the oxygen panel door on the right side of the ventilator.
Remove the connector from the oxygen sensor.
Grip the O2 cell and rotate it counter-clockwise to disengage it from the pneumatic assembly.
Replace every 12 months or as necessary.
TOP ENCLOSURE
Ensure the ventilator is positioned on a secure flat surface.
Loosen the oxygen panel door.
Remove the four screws securing the two mounting rails to the sides of the ventilator chassis.
Remove the four retaining screws, two on each side lower edge, and two screws with washers that attach the
front enclosure recessed in the upper corners.
Lift the top enclosure off and place it aside.
FRONT ENCLOSURE – REMOVAL
Remove the top enclosure.
Tilt the ventilator onto its side and remove the two recessed screws and washers that secure the bottom lip of
the front enclosure to the ventilator chassis. Set the ventilator upright and disconnect the touch screen ribbon
connector from J20 on the Control Board. Loosen the four captive screws that secure the front enclosure to
the chassis. Two are located under the top lip of the chassis and two are accessed through the sides of the
chassis. Slide the front enclosure forward to access the front panel membrane switch connectors and the
rotary encoder connector. Disconnect the connectors and place the front enclosure aside.
ROTARY CONTROL KNOB

Remove the top and front enclosures.
Loosen the set screw securing the knob to the rotary encoder using a hex driver.
Remove the nut and washer from the shaft of the rotary control knob using a nut driver or wrench.
Remove the rotary control knob from the top cover enclosure retaining all mounting hardware.
FRONT PANEL MEMBRANE SWITCH

Caution: This procedure renders the front panel membrane switch unusable. Ensure you have a
replacement available before proceeding.
Peel the membrane switch off the front enclosure.
Clean any residual adhesive from the front panel.
DISPLAY ASSEMBLEY
Remove the two screws and washers located in the top edge of the display assembly that secure it to the main
chassis.
Tilt the display assembly forward on its hinges to access all the electrical and pneumatic connections.
Disconnect the following from the Control Board:
J23 Power Management Board cable J40 Blower Motor Board
J1 Ethernet J42 Exh. Flow Sensor Board
J16 Fan J24 Power Management Board
J5 Speaker / Buzzer J9 Nurse Call
Disconnect the following from the Interface Board:
J18 FS1/FS2 J7 Sol2 / Sol3
J10 O2 Sensor J22 Sol1
J1 LFR J3 PV1 / PV2
J21 Exh. Heater J13 Power Management Board
Caution: Do not disconnect the pneumatic lines from the pressure transducers on the Interface
Board. Doing so may damage the pressure transducers and require replacement of the
Interface Board.
Trace the pneumatic tube from P2 to the safety valve and disconnect it from the safety valve.
Cut the pneumatic tube near the pressure transducer port.
Trace the pneumatic tube from P1 to the adapter and disconnect it there.
Tilt the Display assembly upright and move it away from the ventilator chassis.
Place the display assemble on a grounded static dissipative mat.
CONTROL BOARD
Remove the top enclosure, front enclosure and display assembly.
Disconnect the following from the Control Board:
J46 Front Panel Membrane Switch Right J21 Backlight Inverter
J18 LCD Drive J39 Front Panel Membrane Switch Left
J7 Interface Board J36 Alarm LED
Remove the eight screws and washers that secure the Control Board to the display assembly frame.
Place the Control Board on a grounded static dissipative mat or in a static shielding bag.
INTERFACE
Disconnect the J14 Control Board ribbon cable.
Remove the six screws and washers that secure the Interface Board to the display assembly frame.
Place the Interface Board on a grounded static dissipative mat or in a static shielding bag.
BACKLIGHT INVERTER
Disconnect the Control Board cable at CN1.
Disconnect the LCD Backlight cable at CN2.
Place the Inverter Board on a grounded static dissipative mat or in a static shielding bag.
LCD PANEL
Remove the top enclosure and front enclosure.
chassis.
Tilt the display assembly forward on its hinges to access the electrical connections.
Disconnect the LCD Data cable from J18 on the Control Board.
Disconnect the LCD Backlight cable from CN2 on the Backlight Inverter Board.
Remove the four screws and washers that secure the LCD panel to the display assembly frame.
Place the LCD Panel on a grounded static dissipative mat or in a static shielding bag.
ALARM LIGHT BOARD

Disconnect the alarm light board cable from J36 on the Control Board.
Remove the two screws, washers and nuts that secure the alarm light board to the display assembly frame.
Place the Alarm Light Board on a grounded static dissipative mat or in a static shielding bag.
REAR PANEL
Remove the five screws and washers that secure the back panel.
Tilt the back panel away from the ventilator to access the cable and tubing connections.
Disconnect the buzzer at the cable connector.
Disconnect the fan at the cable connector.
Disconnect the low pressure oxygen tube from the back panel barbed fitting.
Disconnect the Ethernet cable.
Disconnect the nurse call connector at the cable connector.
Disconnect the external DC source connector cable from J5 on the Power Management Board.
Disconnect the On/Off switch cable from J3 on the Power Management Board.
Disconnect the AC inlet cable from the Power Supply.
Set the rear panel aside.
Replace its components as necessary.
BATTERY TRAY ASSEMBLY

Remove the rear panel.
Remove the four screws and washers that secure the battery tray assembly.
Disconnect the two connectors of the battery harness from J8 and J9 on the power management board.
Set the battery tray assembly aside.
POWER MANIFOLD ASSEMBLY

Remove the battery tray assembly.
Tilt the ventilator on its side and locate and remove the two screws and washers that secure the power
manifold assembly to the floor of the chassis.
Tilt the ventilator back upright.
chassis.
Tilt the display assembly forward on its hinges to access all the electrical and pneumatic connections and
make way for removing the power manifold assembly.
Locate and remove the three screws and washers that secure the power manifold assembly to the side wall of
the chassis.
Locate and cut the appropriate cable ties that secure any cables or tubing to the power management
assembly.
Disconnect the control board cable from J2 on the power management board.
Disconnect the interface board cable from J6 on the power management board.
Disconnect the blower cable from the cable connector.
Lift the power module assembly out of the ventilator and set it on a grounded static dissipative mat.
BLOWER MOTOR BOARD

chassis.
Tilt the display assembly forward on its hinges to access the blower motor board.
Disconnect the blower cable from J6 and J7 on the blower motor board.
Disconnect the control board cable from J8 on the blower motor board.
Disconnect the power management cable from J1 on the blower motor board.
Remove the four screws and washers that secure the blower motor board to the blower driver bracket.
Place the blower motor board on a grounded static dissipative mat or in a static shielding bag.
POWER MANAGEMENT BOARD

chassis.
Tilt the display assembly forward on its hinges to access the blower motor board.
Remove the blower motor board.
Remove the two screws and washers that secure the blower driver bracket and lift it out of the way.
Disconnect the following from the power management board:
J1 A.C. to D.C. Power Supply J11 Control Board
J3 Power Switch J7 D.C. to D.C. Power Supply
J5 External D.C. Power J6 Interface Board
J8 Battery 1 J4 Blower Motor Board
J9 Battery 2 J2 Control Board
J2 Control Board
Remove the four screws and washers that secure the power management board to the power manifold
bracket.
Place the blower motor board on a grounded static dissipative mat or in a static shielding bag.
POWER SUPPLY
Remove the power manifold assembly.
Disconnect the three power management cables from the power supply.
Remove the four hex nuts and washers that secure the power supply to the power supply mounting plate.
Remove the four screws and washers that secure the power supply to the power manifold bracket.
Place the power supply on a grounded static dissipative mat or in a static shielding bag.
EXHALATION VALVE MODULE

chassis.
Tilt the display assembly forward on its hinges to access the interface board.
Disconnect the exhalation heater cable from J21 on the interface board.
Disconnect the exhalation flow sensor cable from the exhalation flow module.
Open the exhalation compartment door.
Slide the exhalation module out until it stops.
Cut the necessary tie wraps to allow the exhalation module to slide out of the ventilator.
Release the slide lever under the exhalation rail and slide the exhalation module completely out of the
ventilator.
Disconnect the exhalation valve pilot pressure tube from the exhalation valve.
Disconnect the exhalation pressure tube from the exhalation valve.
Note the location and orientation of the cables, tubes and tie wraps for reinstalling the exhalation module.
HEAT EXCHANGER
Grasp the heat exchanger and lift it out of the heater C-clamp bracket.
Slide the heat exchanger off of the exhalation flow sensor.
Slide each of the heat cylinder outlet caps off the heat cylinder. Note the orientation of the two outlet caps.
The male cap faces the front of the ventilator and the female cap faces into the ventilator and connects to the
exhalation flow sensor. The male cap has one O-ring that seals when the cap is pressed onto the heat
cylinder. The female cap has two O-rings, one to seal the heat cylinder and one to seal the flow sensor.
EXHALATION FLOW SENSOR
Disconnect the exhalation flow sensor cable from the exhalation flow sensor.
Caution: Do not twist the flow sensor cable while disconnecting it from the flow sensor. Doing so
may damage the flow sensor or require replacement of the flow sensor cable.
Slide the flow sensor out of the exhalation valve manifold.
EXHALATION VALVE ASSEMBLY

Lift the exhalation valve out of the exhalation valve stop brackets.
EXHALATION VALVE DIAPHAGM

Lift the exhalation valve out of the exhalation valve stop brackets.
Rotate the exhalation valve cap counterclockwise to access the exhalation valve seat cap.
Lift the seat cap out of the exhalation valve manifold.
Remove the exhalation valve diaphragm.
NEBULIZER MANIFOLD
Disconnect the nebulizer solenoid at the cable connector.
Cut the tie wrap and remove the nebulizer tube.
Remove the two screws and washers that secure the nebulizer manifold to the ventilator chassis.
EXHALATION LOW FLOW REGULATOR (LFR)

Remove the nebulizer manifold.
Disconnect the exhalation pilot pressure tube from the port 2 of the LFR.
Disconnect the input pressure tube from port 1 of the LFR.
Disconnect the LFR cable at the cable connector.
Tilt the ventilator over on its side.
Locate and remove the two screws and washers that secure the LFR to the ventilator chassis.
Set the ventilator upright.
Lift the LFR out of the chassis.
Caution: Do not attempt to repair the LFR it is not field serviceable. Replace the LFR if necessary.
SAFETY VALVE MODULE

Remove the oxygen sensor.
Disconnect the safety valve pilot pressure tube.
Disconnect the inspiration pressure tube.
Disconnect the inhalation module outlet elbow fitting.
Tilt the ventilator over onto its side.
Locate and remove the four screws and washers that secure the safety valve to the ventilator chassis.
Set the ventilator upright.
Lift out the safety valve module.
SAFETY VALVE DIAPHRAM

Remove the safety valve module.
Note: The safety valve diaphragm, seat cap and cap are all interchangeable with the corresponding
parts of the exhalation valve. Therefore, their part numbers and descriptions are the same.
Rotate the safety (exhalation) valve cap counterclockwise to access the safety (exhalation) valve seat cap.
Lift the seat cap out of the safety valve manifold.
Remove the safety (exhalation) valve diaphragm.
SAFETY VALVE CHECK VALVE

Remove the safety valve module.
Remove the set screw from the safety valve manifold.
Slide out the inhalation patient port.
Remove the check valve.
INHALATION MODULE ASSEMBLEY

chassis.
Tilt the display assembly forward on its hinges to access the inhalation module.
Disconnect the following pneumatic connections:

Air flow sensor outlet tube SOL1 Crossover valve ambient port tube
Oxygen flow sensor outlet tube LFR pressure tube
P1 Pressure transducer tube Air valve inlet tube
Nebulizer tube
Safety valve pilot pressure tube
Disconnect the following electrical connections:
FS1 Oxygen flow sensor SOL 2 Safety valve solenoid
FS2 Air flow sensor PV2 Air Valve
SOL 1 Crossover valve PV1 Oxygen Valve
Remove the four screws and washers that secure the Inhalation assembly to the blower assembly.
Lift the inhalation assembly out of the ventilator.
FLOW SENSOR FS1 & FS2

chassis.
Remove the inhalation module.
Remove the two screws and washers that secure the barbed outlet flow sensor adapter to the inhalation plate.
Slide the adapter off the flow sensor.
Slide the flow sensor out of the inhalation valve and note the direction of flow for re-installation.
Remove the TSI screen disc from the inhalation valve and note its orientation for re-installation.
AIR VALVE (PV2)

chassis.
Remove flow sensor FS2.
Disconnect the pilot pressure tube from the barbed fitting on the valve manifold.
Remove the four screws and washers that secure the valve to the inhalation plate.
HIGH PRESSURE INHALATION MODULE (PV1)

chassis.
Remove flow sensor FS1.
Remove the pilot pressure tubes attached to the barbed tee fitting attached to the proportional solenoid
manifold.
Remove the four screws and washers that secure the high pressure inhalation module assembly to the
inhalation plate.
OXYGEN FILTER
Remove the rear panel
Remove two Allen head screws, and washers, one on each side of the oxygen inlet manifold.
Remove the bronze filter.
Replace the filter with the course side toward the oxygen source.
OXYGEN REGULATOR
Remove the rear panel
Remove two Allen head screws, and washers, one on each side of the oxygen inlet manifold.
Remove the bronze filter.
Remove the regulator by removing the two Allen head screws and washers that secure it to the proportional
valve manifold.
CROSSOVER SOLENOID SOL 1

chassis.
Disconnect the crossover solenoid cable.
Twist the solenoid counterclockwise to remove it from the solenoid manifold.
SAFETY VALVE SOLENOID SOL 2

chassis.
Disconnect the safety valve solenoid cable.
Twist the solenoid counterclockwise to remove it from the solenoid manifold.
BLOWER ASSEMBLY
chassis.
Disconnect the blower cable.
Remove the top housing foam.
Remove the inlet path housing foam.
Lift out the blower and tubing assembly.
11
Section
PARTS LIST
This section shows the entire ventilator system. Figures show ventilator subassemblies and their component
parts. A numeric Service Parts List is included at the end of this section, to assist in the identification of the
correct components.
Note: The exploded parts diagrams are for reference only not all parts are available to order.
Use the Service Parts List for part(s) ordering.
VENTILATOR ASSEMBLY, MODEL EVL 100000
Item Number Part Number Description
1 EVL100000 Evolution Ventilator, English
Ventilator Assembly, Model EVL 100000
Item
PART NUMBER DESCRIPTION QTY.
No
1 EVL250001-004 * M3x.5x8, PHILLIPS PAN HEADMACHINE SCREW, SS 6
2 EVL250002-001 * M3, SPRING LOCK WASHER 6
4 EVL250001-003 * M3x.5x6, PHILLIPS FLAT HEAD MACHINE SCREW, SS 4
5 EVL250001-009 * M4x.7x6, PHILLIPS PAN HEAD MACHINE SCREW, SS 2
6 EVL250001-027 * M6x1x60, HEX SOCKET FLAT HEAD MACHINE SCREW, SS 4
7 EVL220004 * SPACER, 3/4 O.D. x .257 I.D. x 1.5 L 4
8 EVL200006 RAIL, HANDLE 2
9 EVL210018 * ASSY, ENCLOSURE, FRONT 1
10 EVL220022 LANYARD, 6IN 1
11 EVL200002 * ENCLOSURE, BACK 1
12 EVL200049 PORT, EXHAUST, EXHALATION 1
13 EVL220025 * EMI GASKET, 0.090IN OD 1
14 EVL200004 ENCLOSURE SIDE PANEL, O2 SENSOR 1

* The part(s) may not be available to order individually. Reference the Service Parts List for the correct part
number(s).
Assembly, Front Enclosure EVL210018
Item
No
1 EVL200001 * ENCLOSURE, FRONT 1
2 EVL200075 RING, KNOB ENCODER 1
3 EVL200074 ENCODER KNOB, GREY 1
4 EVL220033 MEMBRANE SWITCH, FRONT PANEL 1
5 F730715 ENCODER, ROTARY 1
6 EVL250001-021 * M3x.5x16, HEX SOCKET SET SCREW,SS 1
7 EVL220031 * DOUBLE SIDED TAPE, TOUCH SCREEN GASKET 1
8 EVL370005-SPE TOUCH SCREEN, FUJITSU 1
11 EVL200005 * LIGHT PIPE, FRONT PANEL 1

number(s).
ITEM Part No DESCRIPTION QTY

NO.
M4x.7x6mm, BUTTON HEAD, HEX SOCKET, MACHINE

1 EVL250001-010 * 3
SCREW, SS
4 EVL250001-002 * M4 SPRING LOCK WASHER 12
7 EVL370016-SPE BOARD, EXH FLW SNSR, OEM FLOW A 1
8 EVL210015 * ASSY, POWER MANIFOLD 1
9 EVL210017 * ASSY, DISPLAY 1
10 EVL220030 FILTER, AIR INLET 1
11 EVL210014 * ASSY, BACK PANEL 1
13 EVL210016 * ASSY, BATTERY TRAY 1
number(s).
Assembly, Power Manifold EVL210015
Item
No
1 EVL350003-PCB POWER MANAGER BOARD 1
2 EVL370008-SPE POWER SUPPLY, XP 1
3 EVL250003-002 * HEX NUT, STYLE 1, M4X0.7, SS 4
4 EVL350004-PCB BLOWER MOTOR BOARD 1
5 EVL200016 BRACKET, POWER MANIFOLD 1
6 EVL200017 BRACKET, BLOWER DRIVER 1
7 EVL200018 MOUNTING PLATE, POWER SUPPLY 1
11 EVL250001-012 * M4x.7x8mm, PHILLIPS PAN HEAD MACHINE SCREW, SS 2

number(s).
Assembly, Display EVL210017
Item
No
2-56x0.188, MALE-FEMALE THREADED HEX
1 EVL250047 * 2
STANDOFF, Al
3 EVL350001-PCB CONTROL BOARD 1
4 EVL370004-SPE LCD, NEC DISPLAY 1
5 EVL350002-PCB INTERFACE BOARD 1
6 EVL370007-SPE INVERTER BOARD 1
7 EVL310003-CBL CABLE, LCD DATA 1
9 EVL250002-004 * #2, SPRING LOCK WASHER 2
10 EVL250001-018 * 2-56 x 3/16 PHILLIPS PAN HEAD MACHINE SCREW, SS 2

number(s).
Assembly, Back Panel EVL210014 1 of 2
Item
No
1 EVL250001-008 * SCREW, SHOULDER, M4 x 5mmSL x 5mmSOD 1
3 EVL200048 BACK PANEL, VENTILATOR 1
4 EVL370009-SPE POWER ENTRY MODULE, HG1 1
5 EVL370012-SPE SWITCH, ROCKER 1
6 EVL220018 POST, GROUND 1
7 EVL310026-CBL RECEPTACLE, POWER B3M 1
8 EVL310030 CONNECTOR, NURSE CALL, HIROSE 1
9 EVL220027 RECEPTACLE, MOLEX RJ45 ETHERNET ADAPTER 1
10 EVL200013 SAFETY GUARD, ROCKER SWITCH 1
11 EVL220029 BARBED, THRU-WALL COUPLING, ¼ ID TUBE 1
12 EVL370011-SPE NON-RESETABLE FUSE 2
number(s).
Assembly, Back Panel EVL210014 2 of 2
Item
No

2 EVL310007-SPE COOLING FAN, 60mm 1
3 EVL370013-SPE FAN FILTER AND RETAINER 1
4 EVL370019-SPE AUD SIG DEVICE 1
5 EVL220038 COVER, FOR DB9F/HD15F SHLD 3
6 EVL250001-020 * 4-40 x 0.5, PHILLIPS PAN HEAD MACHINE SCREW, SS 6
7 EVL250003-004 * HEX NUT, STYLE 1, 4-40 SS 6
9 EVL250003-002 * HEX NUT, STYLE 1, M4x0.7, SS 4
10 EVL310022-CBL CABLE, POWER ON_OFF 1
11 EVL310027-CBL CABLE, POWER ENTRY MODULE 1
12 EVL310006-CBL CABLE, BUZZER, SPEAKER 1
number(s).
Assembly, Battery Tray EVL210016
Item
No
1 EVL370006-SPE BATTERY, LITHIUM ION 2
2 EVL310024-CBL BATTERY CONNECTORS WITH CABLES 2
5 EVL200036 FOAM, BATTERY LENGTH 1
6 EVL200035 TRAY, BATTERY 1
7 EVL200040 BRACKET, BATTERY CBL RSTR 1
8 EVL200041 FOAM, BATTERY CABLE BRKT 1
9 EVL200039 BRACKET, SUPPORT, BATTERY 1
10 EVL200038 FOAM, BATTERY BRACKET 2
11 EVL200037 BRACKET, SUPRT, BATT W_THD STD 1
12 EVL250014 CABLE CLAMP, 0.375in OD, NYLON OR EQUAL 1
15 EVL250069 * ZIP TIE, 4 IN 2
number(s).
ITEM Part No DESCRIPTION QTY

NO.
M3x.5x6, PHILLIPS PAN HEAD MACHINE SCREW,
1 EVL250001-002 * 2
SS

M4x.7x8mm, PHILLIPS PAN HEAD MACHINE
4 EVL250001-012 * 8
SCREW, SS
M4x.7x6mm, BUTTON HEAD, HEX SOCKET,
5 EVL250001-010 * 2
MACHINE SCREW, SS
6 EVL210002 * ASSY, EXHALATION MODULE 1
7 EVL210001 * ASSY, SAFETY VALVE MODULE 1
8 EVL210005 * ASSY, INHALATION MODULE 1
9 F910028 GALVANIC OXYGEN SENSOR 1
10 EVL210019 * ASSY, NEBULIZER MANIFOLD 1

* The part(s) may not be available to order individually. Reference the Service Parts List for the correct
part number(s).
Assembly, Exhalation Module EVL210002
Item
No
1 EVL200028 PLATE, EXHALATION RAIL 1
2 EVL210003 * ASSY, EXHALATION VALVE 1
3 EVL370017-SPE FLOW SENSOR, EXHALATION, SPIROQUANT 1
4 EVL220041-SPE CONNECTOR, EXH FLW SNSR 1
5 EVL220008 BACTERIA FILTER, EXHALATION PATH 1
6 EVL200033 STOP BRACKET, HEAT EXCHANGER 2
7 EVL200032 STOP BRACKET, EXHALATION VALVE 2
8 EVL220015 HEATER C-CLAMP BRACKET, WITH HEATER PAD 1

M4x.7x6mm, BUTTON HEAD, HEX SOCKET,MACHINE
9 EVL250001-010 * 2
SCREW, SS 2
13 EVL250004-007 * O -RING, AS568-132, SILICONE, SHORE A, 60-70 2
14 EVL200031 CAP, HEAT CYLINDER, FEMALE OUTLET 1
15 EVL250004-006 * O -RING, AS568-118, SILICONE, SHORE A, 60-70 1
16 EVL200030 * CAP, HEAT CYLINDER, MALE OUTLET 1
17 EVL220016 CYLINDER, HEAT EXCHANGER 1
number(s).
Assembly, Exhalation Valve EVL210003
Item
No
1 EVL200022 MANIFOLD, EXHALATION VALVE 1
2 EVL200010 DIAPHRAM, EXHALATION VALVE 1
3 EVL200023 CAP, SEAT, EXH VALVE 1
4 130013-01 CAP, EXHALATION VALVE 1
5 EVL250004-006 * O-RING, AS568-118, SILICONE, SHORE A, 60-70 1
6 EVL250006 BARBED TUBE FITTING, .0625 TUBE ID, 10-32 THREADED 1
number(s).
Assembly, Safety Valve Module EVL210001
Item
No
1 EVL200021 MANIFOLD, SAFETY VALVE 1
2 EVL200027 PATIENT PORT, INHALATION 1

HEXAGON SOCKET SET SCREW FLAT POINT, BS 4168
3 EVL250001-011 * 1
M4x6mm, SS
4 EVL250004-005 * O-Ring, 2.5mm x 25mm ID, BUNA-N, 60-70 DUROMETER 1
5 EVL200010 DIAPHRAM, EXHALATION VALVE 1
6 EVL200023 CAP, SEAT, EXH VALVE 1
7 EVL200024 CAP, EXHALATION VALVE 1
8 EVL250004-004 * O-RING, 2mmx18mm, BUNA-N, 60-70 DUROMETER 1
9 EVL220012 S-1459 SPRING, .562 O.D. x .518 I.D. x .50 FREE 1
10 EVL200071 CHECK VALVE 1
11 EVL250006 BARBED TUBE FITTING, .0625 TUBE ID, 10-32 THREADED 1
12 EVL220045 FLOW DIVERTER, O2 SENSOR 1
number(s).
Assembly, Inhalation Module EVL210005 1 of 2
Item
No
3 EVL210008 * ASSY, INHALATION MODULE, HP 1
4 EVL200011 FITTING, ELBOW 90 DEG, 5/8 ID 3
5 EVL200012 FITTING, STRAIGHT 3
6 EVL220019 FITTING, BARBED, 10-32 X .125 1
7 EVL220035 INHALATION VALVE, AIR 1
8 EVL210011 * ASSEMBLY, BLOWER 1
9 EVL220023 TUBING, STRAIGHT, 5/8IDx1.00" 1
10 EVL220026 FITTING, BARBED ELBOW, .125 BARB X .25- 28M 1

Not
EVM200002 TUBE, MUFFLER, 1/8IDx10" 1
Shown
number(s).
Assembly, Inhalation Module EVL210005 2 of 2
Item
No
4 EVL220023 SILICONE TUBE, 5/8"ID X .78" 1
6 EVL210010 * ASSY, CHECK VALVE, T FITTING 1
7 EVL210006 * ASSY, SOLENOID MANIFOLD 1
8 EVL370015-SPE O2 FLOW SENSOR, HP, TSI 1
9 EVL370014-SPE AIR FLOW SENSOR, LP, TSI 1
10 EVL220014 TSI SCREEN DISK 2
11 EVL200069 BARBED OUTLET, FLOW SENSOR ADAPTER 2
12 EVL250001 * 006 M3x.5x20, PHILLIPS PAN HEAD MACHINE SCREW, SS 2
number(s).
Assembly, Inhalation Module High Pressure EVL210008
Item
No
1 EVL220017 REGULATOR 1
2 EVL220003 FILTER, BRONZE, .625D x 0.125, 40 MICRON 1
3 EVL250001-013 * M4x.7x8mm, HEX SOCKET HEAD CAP MACHINE SCREW, SS 2
4 EVL250001-014 * M4x0.7x25mm, SHCS, SS 2
5 EVL220021 FITTING, BARBED, .25x.125 NPT 1
6 EVL220005 CONNECTOR, O2, DISS, W/ CHECK VALVE, SS 1
7 EVL200014 MANIFOLD, OXYGEN INLET 1
8 EVL220024 FITTING, BARBED TEE, 1/8 ID TUBE x 10-32 ADAPTER 1

O-RING, 1.5 mm x 20mm x 23mm, BUNA-N, 60-70
9 EVL250004-003 * 1
DUROMETER
O-RING, 1.5mm x 15.5mm x 18.5 mm, BUNA-N, 60-70
10 EVL250004-001 * 1
DUROMETER
11 EVL220034 INHALATION VALVE, O2 1
number(s).
Assembly, Blower EVL210011
Item
No
1 EVL200043 PLATE, INHALATION 1
2 EVL200066 FOAM HOUSING, TOP 1
3 EVL200067 FOAM HOUSING, INLET PATH 1
4 EVL200068 FOAM HOUSING, BOTTOM 1
5 EVL220042 * BLOWER, 2.4" 1
6 EVL200063 COVER, MUFFLER, BLOWER 1
9 EVL220023 SILICONE TUBE, 5/8"ID X 2.00" 1
10 EVL250069 * ZIP TIE, 4 IN 1
12 EVL200055 ADAPTER, INLET MUFLER 1
15 EVL250001-007 * M3x.5x25 PHILLIPS PAN HEAD MACHINE SCREW 2
number(s).
Assembly, Solenoid Manifold EVL210006
Item
No
1 EVL200025 MANIFOLD, SOLENOIDS 1
2 EVL220010 SOLENOID, CROSS OVER, 2-WAY 1
3 EVL220024 FITTING, BARBED T, 1/8 TUBE ID x 10-32 W/ GASKET 1
5 EVL220011 MINI SOLENOID, SAFETY VALVE 1
Assembly, Check Valve T Fitting EVL210010
Item
No
1 EVL200019 CHECK VALVE HOUSING, T FITTING 1
2 EVL200071 CHECK VALVE 1
3 EVL250004-004 * O-RING, 2mmx18mm, BUNA-N, 60-70 DUROMETER 1
number(s).
Assembly, Nebulizer Manifold EVL210019
Item
No
1 EVL200008 MANIFOLD, NEBULIZER PORT 1
2 EVL250004-002 * O-RING 1.5mm x 13mm x 16mm BUNA-N 1
3 EVL200076 NEBULIZER NIPPLE 1
5 EVL220009 SOLENOID, NEBULIZER 1
6 EVL250001-003 * M1.7x.35x12mm, PHILLIPS PAN HEAD MACHINE SCREW, SS 2
number(s).
Item
No
1 EVL220020 * FEET, PLASTIC 4
3 EVL220006 DOOR LATCH, CATCH 1
4 EVL200003 DOOR, ENCLOSURE FRONT 1
5 EVL310029-CBL SPEAKER, 40mm 1
6 EVL310033-CBL ASSEMBLY, CABLE ALARM LED 1
7 EVL220013 RAIL, EXHALATION 1
9 EVL220006 DOOR LATCH, KEEPER 1
10 EVL250003-001 * HEX NUT, STYLE 1, M3x.5, SS 2
11 EVL250001-016 * M6x1x20 PHILLIPS PAN HEAD MACHINE SCREW, SS 4
12 EVL200044 FRAME, VENTILATOR 1
17 EVL250001-005 * M3x.5x8, SOCKET HEAD CAPSCREW, SS 4
20 EVL250001-019 * 4-40X.187, PHILLIPS PAN HEADMACHINE SCREW, SS 2
21 EVL220036 LFR, EXHALATION 1

22 EVL200007 HINGE, DOOR 2
number(s).
SERVICE PARTS LIST
Item FRU / PKG
Part Number Description
Number (Not For Sale)
Enclosure, Front EVL200001-DWG
4 Wires Resistive Touchscreen EVL370005-SPE
1. EVL2000001-88 Tape, Double Sided, Touch Screen Gasket EVL220031
Membrane Switch, Front Panel EVL220033
Light Pipe, Front Panel EVL200005-DWG
Enclosure, Back EVL200002-DWG
2. EVL200002-DWG-88
Gasket, EMI, 0.090in OD EVL220025-SPE
3. EVL200003-DWG Door, Enclosure, Front
4. EVL200004-DWG Enclosure, Side Panel
5. EVL200006 Rail, Handle
6. EVL200007 Hinge, Door
7. EVL200008 Manifold, Nebulizer
8. EVL200010 Diaphragm, Exhalation
9. EVL200011 Fitting, Elbow, 90 Deg
10. EVL200012 Fitting, Straight, .866 OD x .669 ID
11. EVL200013 Guard, Safety, Rocker Switch
12. EVL200014 Manifold, Oxygen Inlet
13. EVL200016 Bracket, Power Manifold
14. EVL200017 Bracket, Blower Driver
15. EVL200018 Plate, Mounting, Power Supply
16. EVL200021 Manifold, Safety Valve
17. EVL200022 Manifold, Exhalation
18. EVL200023 Cap, Seat, Exhalation Valve
19. EVL200024 Cap, Threaded, Exhalation Valve
20. EVL200025 Manifold, Solenoids
21. EVL200027 Port, Patient, Inhalation
22. EVL200028 Plate, Exhalation Rail
23. EVL200030 Cap, Heat Cylinder, Male Outlet
24. EVL200031 Cap, Heat Cylinder, Female Outlet
25. EVL200032 Stop Bracket, Exhalation Valve
26. EVL200033 Stop Bracket, Heat Exchanger
27. EVL200035 Tray, Battery
28. EVL200036 Foam, Battery, Length
29. EVL200037 Bracket, Support, Battery w_Thd Stud
30. EVL200038 Foam, Battery, Bracket
31. EVL200039 Bracket, Support, Battery
32. EVL200040 Bracket, Battery, Cable Restrainer
33. EVL200041 Foam, Battery Cable Bracket
SERVICE PARTS LIST
Item FRU / PKG
34. EVL200042 Plate, Mounting, Control Board
35. EVL200043 Plate, Inhalation
36. EVL200044-DWG Frame, Ventilator
37. EVL200048 Back Panel, Ventilator
38. EVL200049 Port, Exhaust, Exhalation
39. EVL200055 Adapter, Inlet Muffler
40. EVL200063 Blower Case, External Housing
41. EVL200066 Foam Housing, Top
42. EVL200067 Foam Housing Inlet Path
43. EVL200068 Foam Housing Bottom
44. EVL200069 Barbed Adapter, Flow Sensor
Fitting, T, Check Valve Housing EVL200019
Fitting, Barb, Check Valve EVL200020
45. EVL210010 Diaphragm, Check Valve EVL200071 EVL200034
Pin, Check Valve EVL200070
O-Ring, 2mmx18mmID, BUNA-N, 60-70
EVL250004-004
Durometer
Fitting, Barb, Check Valve EVL200020
Diaphragm, Check Valve EVL200034
EVL200071
46. Pin, Check Valve EVL200070
EVL250004-004
Durometer
47. EVL200074 Encoder Knob, Grey
48. EVL200075 Encoder Knob Ring
49. EVL200076 Nebulizer Nipple
50. EVL220003-SPE Filter, Bronze, .625 DIA x .125, 40 Micron
51. EVL220004-SPE Spacer, Alum, .75 OD x .257 ID x 1.5 L
52. EVL220005-SPE Connector, O2, DISS, w-Check Valve, SS
53. EVL220006-SPE Latch, Door
54. EVL220009 Solenoid, Nebulizer
55. EVL220010-SPE Solenoid, Crossover, 2 way
56. EVL220011-SPE Solenoid, Safety Valve, 3 way
57. EVL220012-SPE Spring, .562 OD x .518 ID x .50 Free Length
58. EVL220013-SPE Rail, Exhalation
59. EVL220014-SPE Screen Disk, TSI
60. EVL220015 Bracket, Heater C-Clamp, w/Heater Pad
61. EVL220016 Cylinder, Heat Exchanger
62. EVL220017-SPE Regulator
63. EVL220018-SPE Post, Ground
64. EVL220019-SPE Fitting, Barbed, 10-32 x .125
SERVICE PARTS LIST
Item FRU / PKG
65. EVL220020-SPE-44 Bumper, Plastic, w/Unthreaded Through Hole Package of 10
66. EVL220021-SPE Fitting, Barbed, .25 x .125 NPT
67. EVL220022-SPE Lanyard, 6 inch
68. EVL220023-44 Tubing, Straight, 5/8inch ID
Fitting, Barbed Tee, .125 ID Tube x 10-32
69. EVL220024-SPE
Adapter
70. EVL220026 Fitting Barbed Elbow, 1/8"Barb x1/4-28M
71. EVL220027-SPE Receptacle, Molex RJ45 Ethernet
72. EVl220028-SPE Check Valve, Low O2
73. EVL220029-SPE Barbed Thru-wall coupling, 1/4" ID
74. EVL220033 Membrane Switch, Front Panel
75. EVL220034 Valve, Inhalation, O2
76. EVL220035 Valve, Inhalation, Air
77. EVL220036 LFR, Exhalation
78. EVL220037 Crossover Circuit
79. EVL220038-SPE Cover, DB9F/HD15F SHLD
80. EVL220041-SPE Connector, Exhalation Flow Sensor
81. Blower, 2.4 in. EVL220042
82. Foam Housing Inlet Path EVL200067
83. Foam Housing Bottom EVL200068
84. EVL220042-88 Fitting, Elbow, 90 Deg EVL200011 (x4)
85. Fitting, Straight, .866 OD x .669 ID EVL200012 (x 5)
86. Tubing, Straight, 5/8inch ID EVL220023 (x 2)
87. Zip Tie, 4 in. EVL250069
88. EVL220045 Flow Diverter, O2 Sensor
89. EVL250001-002-44 M3x0.5x6, Phillips Pan head Machine Screw, SS Package of 10
M3x.5x6, Phillips Flat Cntrsnk Hd Machine
90. EVL250001-003-44
Screw, SS
Package of 10
91. EVL250001-004-44 M3x.5x8, Phillips Pan Head Machine Screw, SS Package of 10
92. EVL250001-005-44 M3x0.5x8, SHCS, SS Package of 10
93. EVL250001-006-44 M3x20, Phillips Pan Head Machine Screw, SS Package of 10
94. EVL250001-007-44 M3x0.5x25, Phillips Pan Head Machine Screw Package of 10
95. EVL250001-008-44 M4x5mmSLx5mmSOD, Shoulder Screw, SS Package of 10
M4x0.7x6, Button Head Hex Socket, Machine
97. EVL250001-010-44
Screw, SS
Package of 10
Hexagon Socket Head Set Screw, Flt Pt, BS 4168
98. EVL250001-011-44
M4x6mm, SS
Package of 10
M4x.7x8mm, Hex Socket Head Cap Machine
100. EVL250001-013-44
Screw, SS
Package of 10
101. EVL250001-014-44 M4x0.7x25mm SHCS, SS Package of 10
SERVICE PARTS LIST
Item FRU / PKG
102. EVL250001-015-44 M4x.7x30, Phillips Pan Head Machine screw, SS Package of 10
103. EVL250001-016-44 M6x1x20, Phillips Pan Head Machine Screw, SS Package of 10
104. EVL250001-018-44 2-56x3/16, Phillips Pan Head Machine Screw, SS Package of 10
105. EVL250001-019-44 4-40x3/16, Phillips Pan Head Machine Screw, SS Package of 10
106. EVL250001-020-44 4-40x.05, Phillips Pan Head Machine Screw, SS Package of 10
107. EVL250001-021-44 M3x05x16, Hex Socket Set Screw, SS Package of 10
M6x1x60, Hex Socket Flat Cntrsnk Hd Machine
108. EVL250001-027-44
Head Screw, SS
Package of 10
109. EVL250002-001-44 M3 Spring Lock Washer Package of 10
112. EVL250002-004-44 #2 Spring Lock Washer Package of 10
113. EVL250003-001-44 Hex Nut, Style 1, M3x0.5, SS Package of 10
114. EVL250003-002-44 Hex Nut Style 1, M4x0.7. SS Package of 10
115. EVL250003-003-44 Hex Nut Style 1, M16x1.0, SS Package of 10
116. EVL250003-004-44 Hex Nut, Style 1, 4-40, SS Package of 10
117. EVL250004-002-44 O-Ring 1.5mmx13mm Package of 10
O-Ring, 1.5x20x23mm, Buna-N, 60-70
118. EVL250004-003-44
Durometer
Package of 10
119. EVL250004-004-44
Durometer
Package of 10
O-Ring, 2.5mmx25mmID, BUNA-N, 60-70
120. EVL250004-005-44
Durometer
Package of 10
121. EVL250004-006-44 O-Ring, As568-118 Silicone, Shore A, 60-70 Package of 10
122. EVL250004-007-44 O-Ring, As568-132, Silicone, Shore A, 60-70 Package of 10
123. EVL250005-001-44 Tube, Silicone, 1/8"IDx1/4"OD, Blue Package of 12” length
124. EVL250005-002-44 Tube, Silicone, 1/16"IDx1/8"OD, Blue Package of 32” length
125. EVL250005-004-44 Tube, Silicone, 1/16"IDx1/8"OD, RED Package of 12” length
126. EVL250005-005-44 Tube, Silicone, 1/8"IDx1/4"OD, Clear/White Package of 48” length
127. EVL250005-006-44 Tube, Tygon PVC, 1/16"IDx3/16"OD, Clear Package of 12” length
128. EVL250005-007-44 Tube, Tygon PVC, 1/18"IDx1/4"OD, Clear Package of 24” length
Tube, Tygon PVC, Braid-Reinforced, 1/4"
129. EVL250005-008-44
IDx7/16OD
Package of 12” length
Fitting, Barbed, 1/16 ID Tubex 10-32 adapter,
130. EVL250006
W/gskt
131. EVL250014 Cable loop Clamp, 0.375in OD, Nylon or Equal
132. EVL250047-44 Standoff, 2-56x0.188L, AL
Reducing Coupling, Barbed, 1/8"ID-1/16"ID,
133. EVL250062
PC or Equal
134. EVL250064 Barbed Tee, 1/8" ID tube, Nylon or Equal
135. EVL250069-44 Zip Tie, 4 in. Package of 10
136. EVL310001-CBL Assembly, Cable Inh Air O2 Valves
SERVICE PARTS LIST
Item FRU / PKG
137. EVL310003-CBL Assembly, Cable, LCD Data
138. EVL310004-CBL Assembly, Cable, Control Board Power
139. EVL310005-CBL Assembly, Cable, Membrane
140. EVL310007-CBL Assembly, Fan with Cable, eVent
141. EVL310008-CBL Assembly, Cable Power Management Interface
142. EVL310009-CBL Assembly, Cable, Knob Encoder
143. EVL310010-CBL Assembly, Cable Backlight
144. EVL310011-CBL Assembly, Cable, Nurse Call Extension
145. EVL310012-CBL Assembly, Cable, Link
146. EVL310013-CBL Assembly, Cable, Speakers and Buzzer
147. EVL310014-CBL Assembly, Cable, O2 Sensor
148. EVL310015-CBL Assembly, Cable, Exhalation Valve
149. EVL310016-CBL Assembly, Cable, Blower Motor Interface
150. EVL310017-CBL Assembly, Cable, Fans to CB
151. EVL310018-CBL Assembly, Cable, Exh Flow Board
152. EVL310019-CBL Assembly, Cable, Misc Valves
153. EVL310020-CBL Assembly, Cable, Inh Flow Sensor, Air, O2
154. EVL310021-CBL Assembly, Cable, Cross Over Valve
155. EVL310022-CBL Assembly, Power On_Off Cable, eVent
Assembly, Cable Power Management Main
156. EVL310023-CBL
Supply
157. EVL310024-CBL Assembly, Cable, Battery
158. EVL310025-CBL Assembly, Cable, Power Management DC Boost
159. EVL310026-CBL Assembly, DC Power Socket with Cable, eVent
160. EVL310027-CBL Assembly, Cable, Power Entry Module
161. EVL310029-CBL Assembly, Speaker with Cable, eVent
162. EVL310030-CBL Assembly, Cable, Nurse Call Conn with Cable
163. EVL310031-CBL Assembly, Cable, Interface Board Power
164. EVL310032-CBL Assembly, Cable, Blower Board Power
165. EVL310034 Assembly, Cable Extension, Blower Motor
166. EVL350001-PCB Control Board
167. EVL350002-PCB Interface Board
168. EVL350003-PCB Power Management Board
169. EVL350004-PCB Blower Power Board
170. EVL370001-SPE Category 5E Patch Cord
171. EVL370004-SPE TFT Color LCD Module
172. EVL370007-SPE Inverter
173. EVL370008-SPE AC and DC Input 24V Power Supply
174. EVL370009-SPE Module, Power Entry
175. EVL370011-SPE Fuse, Non-resettable, SPT 5x20
SERVICE PARTS LIST
Item FRU / PKG
176. EVL370012-SPE Switch, Power Rocker, Miniature
177. EVL370014-SPE Sensor, Air Flow, TSI
178. EVL370015-SPE Sensor, O2 Flow, TSI
179. EVL370016-SPE Module, Exhalation Flow, Sensatronic
180. EVL370019-SPE Audio Signal Device, Panel Mount, 3-7VDC
eVolution Ventilator Software: Application,
181. EVL400001-APP
V1.0.05/1.1.05
182. EVL500000-IN Label, eVolution Ventilator
183. EVL500002-IN Manufacture for
184. EVL500003-IN eVolution Caution Label
185. EVL500004-IN eVolution Date of Manufacture Label
EVL250005-005 X10”
186. EVM200002 TUBE, MUFFLER, 1/8”IDX10”
EVM200003
187. F730715 Encoder, 6.5 cable
CONSUMABLE PARTS LIST

1. EVL220008-SPE Filter, Bacteria, Portex
2. EVL220030 Filter, Air Inlet
3. EVL370006-SPE Rechargeable Smart Lithium Ion Battery Pack
4. EVL370013-SPE Fan Guard, Filter, Retainer
5. EVL370017-SPE Sensatronic Exhalation Flow Sensor
6. F910028 Galvanic Oxygen Sensor
12
Section
COMMUNICATION INTERFACE
The following section describes the nurse call and communication ports.
Figure 59: Communication ports, Ethernet and Nurse Call
ETHERNET CONNECTION (RJ45 CONNECTOR)

The Ethernet communication port used to upload software updates via a standard RJ45 Ethernet cable.
NURSE CALL PORT CONFIGURATION
The nurse call port allows the ventilator to be connected to a remote alarm system. Nurse call pin
assignments (floating contacts) are shown in below. Activation/ deactivation of a high or medium priority
alarm causes the nurse call relay to change state. Maximum 5VDC 100 mA.
Pin Function
1 Not in use
2 NC (Normal Closed)
3 NO (Normal Open)
4 Not in use
5 Common
6 Not in use 6 1
Figure 60: Back Panel, RJ12 Nurse Call Connector
13
Section
SOFTWARE INSTALLATION
INSTRUCTION
These instructions describe the procedure of installing the Application firmware on the eVolution Ventilator
that already has another compatible and functional application. This process is performed using the
eVolution Firmware Download Tool.
WARNING
In order to ensure proper operation and avoid the possibility of physical injury, only qualified
personnel should attempt to service, perform installations, or make other authorized modifications
to the ventilator.
USING THE DOWNLOAD TOOL

INTRODUCTION
The eVolution Firmware Download Tool, part number EVL400007-DLTxx, is used for downloading
binary files to the flash memory of eVolution ventilators via the Ethernet port. This tool comprises one
executable file (.exe) which runs on PC computers with Windows operating systems.
ENVIRONMENT COMPATIBILITY
The tool is an executable file (.exe), thus it is PC compatible and runs under the Windows environment.
The table below shows the Windows versions compatible with each of the download tool versions in
the scope of this document.
Tool Version Compatible PC Compatible eVolution

Operating Systems Firmware
EVL400007-DLT12 version 1.2 Windows 7, Vista, XP Boot Code 1.0.0,
Downloader 1.0.0,
Application 1.1.05 or earlier
EVL400007-DLT13 version 1.3 Windows 7, Vista, XP Boot Code 1.0.2,
Downloader 1.0.2,
Application 1.1.10 or later
The compatibility between the tool and the eVolution firmware environment is explained as follows:
If the eVolution unit has Downloader 1.0.0, it can talk to Download Tool 1.2, and can take
Application version 1.1.05 or earlier only.
If the eVolution unit has Downloader 1.0.2, it can talk to Download Tool 1.3, and can take
Application version 1.1.10 or later only.
Refer to the figure below to determine firmware versions on your ventilator.
Figure 61: Firmware Version Screen

Boot Code Downloader Application
REQUIRED EQUIPMENT AND FILES

The target eVolution Ventilator unit the firmware shall be downloaded to.
A PC computer with Windows operating system (see Environment Compatibility)
The executable file of eVolution Firmware Download Tool, part number EVL400007-
DLT12 or EVL400007-DLT13, depending on the environment (see Environment
Compatibility)
A cross-over Ethernet cable CAT5 or higher such as eVent CAT6 cross-over cable part
number EVL370018-SPE
The binary file of the Application that shall be downloaded (Appl_x.x.xx.bin)
DOWNLOAD PROCEDURE: UPGRADING EXISTING APPLICATION
This scenario applies when downloading a new, compatible application binary file to an eVolution unit
that is already installed and has another compatible working version of the eVolution Application
firmware (see Environment Compatibility to determine which Application versions are compatible with
which system environment, i.e. Downloader and Boot Code to determine which download tool version
is suitable).
WARNING
Do NOT disconnect the Ethernet cable while downloading
Do NOT turn off or disconnect power while downloading
1. Verify the eVolution unit is off.

2. Verify the unit is connected to the AC power source.
3. Copy the executable file of the download tool, and the binary file (.bin) of the application that
you want to download somewhere on the PC.
4. Configure an Ethernet Adapter on the PC with a static IP address: 192.168.1.x where x can be
any number other than 10 between 2 and 254.
5. Connect the cross-over Ethernet cable between the Ethernet port of the eVolution unit and the
PC Ethernet adapter port.
6. Power ON the eVolution unit (verify it is powered by the AC power source) and wait until it
finishes the startup process.
7. Run the download tool (the executable file.)
8. Select Next >> to proceed to the steps of selecting the binary file that you want to download.
9. Browse to the location of the binary file of the application firmware that you want to download.
10. Select Next >>.
11. Select Ethernet for connection port.

12. Enter the IP address 198.168.1.10 (default.)
13. Select Next >>.
14. Select Yes to confirm that you want to download the Application Firmware.
(1) Progress bar
(2) Information
message
15. If the transfer starts successfully, you will see a progress bar indicating the transfer process.
16. If the transfer finishes successfully, you will see a message under the transfer bar stating:
Programming flash. If the transfer fails, repeat the process from the beginning. Programming
the flash takes about 2 minutes from the time you see the message Programming flash. The
screen should be frozen during this period and would not respond to user interaction. When
the flash programming finishes successfully, the touch screen is alive again and responds to
interaction. The download tool indicates the download was successful as shown in the
following figure:
17. If the programming fails, a Failure error popup message appears as in the following figure. You
can repeat the process from the beginning.
TROUBLESHOOTING DOWNLOAD FAILURE

Connection problem during Data Transfer:
If a connection problem occurs while the tool is transferring the file, the error popup message shown
earlier appears.
The tool window during data transfer looks like the figure below. The progress bar states: Transferring
image and the Information Message field states: Transfer data…
Consequence:
The system is still functions on the old application if you reboot it. No data loss incurred.
Solution:
Try the installation procedure again from the beginning.
Flash programming failure:

An error message appears while the Flash Programming process is proceeding. The download tool
window looks like the figure below. The information Message states: Programming flash…
Consequence:
The original application is lost. The ventilator is rendered nonfunctional and there is no application to
load when rebooting.
Solution:
a) On system using Downloader version 1.0.0 (using Download Tool version 1.2):
The application cannot be reinstalled by the user. Contact eVent Medical, Inc. at:
service@event-medical.com for instructions.
b) On system using Downloader version 1.0.2 or later (using Download Tool version 1.3 or later):
1. Prepare the unit for downloading as explained in 6.4 items 1 to 5
2. Power up the unit, you will get an error message at the eVent Logo screen stating: Application
Fail, Application need reinstall
3. Start the Download tool.
4. Start downloading the Application as described in 6.4 (you can download either your original
old application or the new upgrade one.)
14
Section
FORMS
For your convenience and use you will find on the following pages a Service Record/Warranty Claim form.
You should complete this document when performing any service procedures on the eVolution Ventilator
system.
You will also find a Performance Verification Record to use with the Performance Verification section of this
manual.
Completed field Service Record/Warranty Claim forms should be forwarded as appropriate to the following
location:
Worldwide:
eVent Medical, Inc.
971 Calle Amanecer
Suite 101
San Clemente CA, 92673
United States of America.
Phone: +1 949 492 8368

Fax: +1 949 492 8382
service@event-medical.com
EVOLUTION VENTILATOR – PERFORMANCE VERIFICATION RECORD
Customer Model:
Name: Serial Number:
Address: Next PM Due:
Phone:
e-mail:
Test # Test Name Recorded Data Requirement Pass Y / N

1. SET-UP
1.1. FPGA Version
1.2. Self Test Status: Ventilator completes POST Yes No
1.3. Speaker Speaker sounds during POST. Yes No
Alarm LED flashing and changing
1.4. Alarm LED Yes No
color.
1.5. Fan Fan is drawing air into the ventilator. Yes No
1.6. Software Versions: _ _
Boot Code Downloader Application
1.7. Instrument Hours:
1.8. Blower Hours:
1.9. ml/cmH20 Compliance Yes No
System Test
1.10. cmH2O/s Leak Yes No
1.11. Oxygen Sensor Yes No
2. ELECTRICAL SAFETY TESTS
2.1. Ground Resistance Ω <0.2 OHM Yes No
2.2. Forward Current Leakage μA <300μA Yes No
2.3. Reverse Current Leakage μA <300μA Yes No
3. FUNCTIONAL TESTS
21 psi
3.1. Oxygen Inlet regulator psi Yes No
+2 psi/-1 psi
3.2. l/min > 180 l/min Yes No
Inhalation Air Valve
3.3. l/min ≤ 0.05 l/min Yes No
3.4. High Pressure Inhalation l/min > 180 l/min Yes No
3.5. Oxygen Valve l/min ≤ 0.05 l/min Yes No
3.6. Low Flow Oxygen Inlet l/min ≥ 75 l/min Yes No
Test # Test Name Recorded Data Requirement Pass Y / N
Air Flow EXH Flow Air Flow EXH Flow
27-33
3.7. 28-31 l/min Yes No
Flow, Air and l/min
Exhalation 54-66
3.8. 57-63 l/min Yes No
l/min
81-99
3.9. 86-95 l/min Yes No
l/min
Oxygen
Oxygen Flow EXH Flow EXH Flow
Flow
27-33
3.10. 28-31 l/min Yes No
Flow. Oxygen l/min
and Exhalation 54-66
3.11. 57-63 l/min Yes No
l/min
81-99
3.12. 86-95 l/min Yes No
l/min
3.13. cmH2O > 100 cmH2O Yes No
Safety Valve
3.14. cmH2O < 55 cmH2O Yes No
INH INH EXH
EXH Pressure
Pressure Pressure Pressure
> 100 > 100
3.15. cmH2O cmH2O Yes No
Exhalation cmH2O cmH2O
Valve < 55 < 55
3.16. cmH2O cmH2O Yes No
cmH2O cmH2O
3.17. Nebulizer Solenoid l/min 7±2 l/min Yes No
3.18. Crossover Solenoid cmH2O > 100 cmH2O Yes No
The internal battery icon is displayed in the upper
3.19. Internal Battery Yes No
right hand corner of screen.
3.20. Heater Current rises to >500mA. Yes No
Heater
3.21. Heater Actual Temp rises to the Heater Target Temp. Yes No
3.22. Buzzer s > 120 s Yes No
3.23. Manual Key The ventilator delivers a manual breath. Yes No
The displayed O2% concentration is in the range 100 ± 3%
3.24. O2↑ (100% Yes No
for 5 minutes.
O2) Key
3.25. The O2% returns to 21% after the 5 minute time period. Yes No
3.26. Nurse Call The DMM indicates Open with no active alarms. Yes No
Normally
3.27. Open (N.O.) The DMM indicates Closed with an active alarm. Yes No
3.28. Nurse Call The DMM indicates Closed with no active alarms. Yes No
Normally
3.29. Closed (N.C.) The DMM indicates Open with an active alarm. Yes No
4. PERFORMANCE VERIFICATION TESTS
4.1. % 27%-33% Yes No
Oxygen
4.2. % 57%-63% Yes No
Concentration
4.3. % 87%-93% Yes No
Volume Accuracy
5. (Vti/Vte/RR)
Recorded Data Requirement Pass Y / N
5.1. Vti (Analyzer) ml 50ml ± 12.5 ml Yes No
5.2. Vte (Ventilator) ml 50ml ± 12.5 ml Yes No
5.3. RR (Analyzer) b/min 40 b/min ± 1 b/min Yes No
5.4. Vti (Analyzer) ml 100ml ± 15 ml Yes No
5.5. Vte (Ventilator) ml 100ml ± 15 ml Yes No
5.6. RR (Analyzer) b/min 30. b/min ± 1 b/min Yes No
Pressure
6. Accuracy Recorded Data Requirement Pass Y / N
(Pcontrol/PEEP)
6.1. cmH2O 2 cmH2O ± 0.2 cmH2O Yes No
Pcontrol
6.6. PEEP cmH2O 20 cmH2O ± 2.0 cmH2O Yes No
6.8. Flow Trigger, Ftrig The ventilator delivers a patient triggered breath. Yes No
6.9. Pressure Trigger, Ptrig The ventilator delivers a patient triggered breath. Yes No
7. ALARM OPERATION TESTS
A high priority alarm is enunciated. A flashing
alarm LED, a Low O2 Pressure alarm message,
Oxygen Gas Source,
7.1. and a Low O2 Conc alarm message are displayed Yes No
High
while ventilation continues uninterrupted.
All alarm conditions reset.
A high priority alarm is enunciated. A flashing
alarm LED, a Low O2 Pressure alarm message,
Oxygen Gas Source,
7.2. and a Low O2 Conc alarm message are displayed Yes No
Low
while ventilation continues uninterrupted.
Multiple alarms activate including the occlusion
7.3. Occlusion alarm. The ventilator enters the occlusion mode. Yes No
Alarm conditions reset.
The high priority audible alarm is enunciated
7.4. Disconnect accompanied by a flashing alarm LED and the Yes No
Disconnect alarm message.
The audible alarm is silenced but the visual alarm
indicators remain active.
The audible alarm is active once more and the
7.5. Alarm Silence visual alarm indicators remain active. Yes No
The audible alarm is silenced for 108-132
seconds.
The high priority audible alarm is annunciated
accompanied by a flashing alarm LED. The
High Inh Pressure alarm message is visible on
7.6. High Inh Pressure Yes No
screen and breath delivery truncates upon hitting
the high pressure alarm limit.
All alarm conditions auto reset.
After 17-23 seconds a high priority audible alarm
is enunciated accompanied by the alarm LED
and an Apnea alarm message.
7.7. Apnea Backup Yes No
Apnea back up ventilation has been initiated.
Apnea backup ventilation discontinues and that
SPONT mode is restored
Test Record Completed by:
Service Representative: ________________________________________ Date: ________________________
Service Record/Warranty Claim Form
Service Report / Warranty Claim Form
Form Number: QUALITY-0008 Revision Number: 09 Page of
Tracking Number:
Service / Warranty Information

Date Created: *Service Type:
Requested By: Customer Reference:
Request Received Via: PO Number:
If Other, explain: RGA Number:
Customer / Distributor Details
*Name: Address:
Company: City:
Title or Department: State/Province:
*Phone Number: Postal Code:
Contact Email Address: Country:
Hospital Name: Hospital Address:
Equipment Details
Model: *Serial Number:
FPGA (pre svc) FPGA (post svc)

eVolution Start up Screen eVolution Start up Screen
*Ventilator Hours:
Total Running Hours Compressor (Inspiration)
(Inspiration) Blower (eVolution) Hours:
Instrument Hours
(eVolution)
eVolution Software eVolution Software

(pre svc) (post svc)
Downloader-Boot Code-Application Downloader-Boot Code-Application
example 1.0.0-1.0.0-1.1.06 example 1.0.0-1.0.0-1.1.06
*SW Version (pre svc): *SW Version (post svc):
Inspiration only Inspiration only
Power SW (pre svc): Power SW (post svc):
Inspiration only Inspiration only
MiniWeb SW (pre svc): MiniWeb SW (post svc):
Date of Installation: *Date of Event:
Details of Work Performed
Service Description:
Please give a full description
of the service performed.
Include the following
information if applicable:
PM due date, error codes,
alarm details, reported
problems, and failure
conditions
Resolution:
Describe actions taken to
resolve the problem
Tracking Number:
Details of Patient Involvement (Death OR Serious Injury; DORSI)

*Was there a patient involvement? Yes No
*Did Death or Serious Injury occur? Yes No
*Was medical intervention required? Yes No
Other relevant information:
Condition of patient at the time of event and current condition:
Name and Contact details of medical professional confirming DORSI:
Supporting Documentation:
Service / Warranty Resolution Details
Resolution Details:
Tracking Number:
Parts Used During Service / Repair

Warranty
Part Number Description of Part SN Removed SN Installed Claim
(Y/N)
Return this Form and Parts to:

Supporting eVent Medical, Inc. T: +1.949.492.8368
Documentation: 971 Calle Amanecer
Suite 101 F: +1.949.492.8382
San Clemente, CA
92673
USA
For Internal Use Only:
Service Reviewed By: Name Date Signoff Status
INDEX
A L
Alarm Light Board...................................................................... 65 Labels............................................................................................ 19
Alarm Limit Settings................................................................... 29 LCD Panel ................................................................................... 63
Alarm Priority.............................................................................. 30 Low Flow Regulator (LFR) ....................................................... 52
Alarms test ................................................................................... 18
Apnea Backup ............................................................................. 23 M
Memory ........................................................................................ 62
B
Microprocessor............................................................................ 61
Backlight Inverter ....................................................................... 62 Modes ........................................................................................... 23
Bacteria Filter (F3)...................................................................... 50 Monitored Data........................................................................... 26
Barometer Device ....................................................................... 62
Blower .......................................................................................... 43 N
Blower Motor Board .................................................................. 59 Nebulizer System ........................................................................ 52
Breath Triggering ........................................................................ 23 Nebulizer Valve (SV4)................................................................ 52
Nurse call
C
warning.................................................................................... 18
Check Valve (CV4) ..................................................................... 48 Nurse Call .................................................................................... 62
Control Board ............................................................................. 61
Crossover Valve (Sol1)............................................................... 48 O
Overview of Operation.............................................................. 39
D
Oxygen Regulator (Reg1)........................................................... 42
Device Labels and Symbols....................................................... 19 Oxygen Sensor ............................................................................ 60
E P
Electronic System ....................................................................... 55 Patient Types ............................................................................... 23
Encoder switch ........................................................................... 64 Physical Data ............................................................................... 31
Environmental Data................................................................... 31 Pneumatic Diagram .................................................................... 40
Ethernet Port............................................................................... 62 Pneumatic Theory of Operation............................................... 40
eVolution Electrical Block Diagram ........................................ 66 Pneumatic/Mechanical Tubing Diagram................................. 53
eVolution System Wiring Diagram........................................... 54 Power and Gas supply................................................................ 31
Exhalation Heater....................................................................... 60 Power Input Components ......................................................... 55
Exhalation System ...................................................................... 49 Power Management .................................................................... 58
Exhalation Valve (EV) ............................................................... 51 Power Management Board ........................................................ 58
External D.C. Power Socket ..................................................... 57 Power On Self Test (POST)...................................................... 67
Power On/Off Switch ............................................................... 55
F Power Supply............................................................................... 56
Flow Sensor (FS1 / FS2) ........................................................... 44 Pressure Sensors.......................................................................... 60
Flow Sensor Interfaces............................................................... 60 Product Description and Intender Use.................................... 17
FPGA ........................................................................................... 62 Product labels .............................................................................. 21
Front Panel Membrane Switch ................................................. 63 Product Specifications................................................................ 23
Alarm Priority ........................................................................ 30
G Alarms ..................................................................................... 29
Gas Delivery System .................................................................. 43 Apnea Settings ....................................................................... 24
Gas supply systems..................................................................... 40 Apnea Ventilation.................................................................. 23
Auto Alarm............................................................................. 29
H Breath Triggering................................................................... 23
Breath Types .......................................................................... 23
Heat Exchanger (H1) ................................................................. 50
Cart Dimensions.................................................................... 31
High and Low Pressure Oxygen Inlets.................................... 40
Cart Weights........................................................................... 31
I Environmental Data.............................................................. 31
High Priority Alarms............................................................. 30
Inlet Filters (F1, F2) ................................................................... 41 Medium Priority Alarms ....................................................... 30
Inlet O2 Check Valves (CV1 and CV2)................................... 41 Monitored & Displayed Data............................................... 26
Intended Use ............................................................................... 17 Operating Temperature ........................................................ 31
Interface Board ........................................................................... 60 Physical Data.......................................................................... 31
Internal Battery Pack.................................................................. 56 Power & Gas Supply............................................................. 31
Special Screen Functions ................................................25, 26
Storage Temperature............................................................. 31
Technical Data ....................................................................... 31 Special Screen .............................................................................. 25
Ventilation Modes ................................................................. 23 Symbols ..................................................................................18, 19
Ventilator Dimensions.......................................................... 31 System Test .................................................................................. 18
Ventilator Weight .................................................................. 31
Proportional Valves (PV1 / PV2) ............................................ 44 T
R Technical Data............................................................................. 31
THEORY OF OPERATION .................................................. 39
Real Time Clock.......................................................................... 62 Tools, Test Equipment and Materials (recommended) ......... 38
Touch Screen ............................................................................... 64
S
V
Safety............................................................................................. 18
Safety Valve (SV)......................................................................... 47 Valve and Solenoid Drivers ....................................................... 60
Safety Valve Solenoid (Sol 2)..................................................... 47 Ventilation Modes
SPAP Mode ................................................................................. 26 Additional Settings................................................................. 23

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eVolution™ V entilator System

A Clinician Focused Product

Illustrations in this manual apply to the eVolution ventilator.

United States Europe

eVent Medical, Inc.

Tel: +1 949 360 8368

For technical assistance please contact eVent Medical at:

¾ Explanatory notes and comments relevant to the eVolution ventilator.

¾ The eVolution should only be operated and maintained by personnel with

DEVICE LABELS AND SYMBOLS

Alarm Silence key

An illuminated LED at the top of the device

Internal battery charge status

Indicates the settings and screen are not locked

Indicates the settings and screen are locked

Nebulizer nipple connector

Front Panel: A green LED indicates device is

Nurse call connection port

Refer to manual for Information, directions and

Designates type B equipment per IEC 601-1

O2 Sensor Oxygen sensor location

Gas flow from patient to ventilator

Do not obstruct! Do not obstruct port or outlet

TH Indicates WEEE (Waste Electrical and Electronic

Figure 1: eVolution Serial Number Label

Figure 2: eVolution Manufactured For Label

Figure 3: eVolution Caution Label

Figure 4: eVolution Date of Manufacture Label

Ventilation Modes Assisted Control Mandatory CMV

Apnea Backup Settings

RF Emissions CISPR 11 Class A

Field strengths from fixed RF transmitters, as

Description Manufacturer / Part No.

Figure 5: Pneumatic Diagram

GAS SUPPLY SYSTEMS

INLET FILTERS (F1, F2)

Oxygen Filter (F1) Air Filter (F2)

INLET O2 CHECK VALVES (CV1 AND CV2)

OXYGEN REGULATOR (REG1)

Oxygen Regulator (Reg1)

Gas Delivery System

Proportional Valve (PV1) Proportional Valve (PV2)

FLOW SENSOR (FS1 / FS2)

Flow Sensor (FS1) Flow Sensor (FS2)

CHECK VALVE (CV3)

Check Valve (CV3)

Oxygen Sensor (FIO2 sensor)

Safety Valve (SV)

SAFETY VALVE SOLENOID (SOL 2)

Safety Valve Solenoid (Sol2)

Check Valve (CV4)

CROSSOVER VALVE (SOL1)

Crossover Valve (SOL1)

Check Valve (CV5) Check Valve (CV6)

Bacteria Filter (F3)

Heat Exchanger (H1)

Exhalation Flow Sensor (FS3) Exhalation Flow Module

EXHALATION VALVE (EV)

Exhalation Valve (EV)

Low Flow Regulator (LFR)

NEBULIZER VALVE (SV4)

Nebulizer Solenoid (Sol 4)

Power Input Components

Voltage (mV): The voltage in milliVolts. Range from 0 V to 17000 V