Ivent 101 TRM PDF

Rendered PDF File Page 1 of 256 DOC0684758, Rev:4
Electronic Signature Information
Name DOC0684758
Revision 4
Type Controlled Document
Title iVent101 TRM
Originator 100035630_erez__dahan
Name Reason For Change File Size (Bytes)

iVent101ServiceManualM3.doc 36940288
Route Signer Status Comments Completion Date

R-4653831 100035630_erez__dahan Author approve 3 Aug 2011 14:21:04 GMT
R-4653831 100037347_michael__smadja Approve Approved 3 Aug 2011 18:13:47 GMT
R-4653831 100035647_shlomi__deler Approve reviewed 3 Aug 2011 14:34:51 GMT
R-4653831 100035604_uri__goldberg Approve Approved 4 Aug 2011 11:43:21 GMT
* Printed versions are For Reference Only *

Released
iVent101 / ClevAir
Technical Reference Manual
iVent101 Technical Reference Manual Part Number SM-101-02

Revision 3 August 2011
Copyright© 2011 by VersaMed™ Medical Systems
0473
Released
VersaMed iVent101 Technical Reference Manual
Owner’s Record
The model number and serial number of your iVent101 are on the rear panel of your ventilator. Record the serial number in the
space provided below to have this information should you need to call for service or support.
Model Number:
Serial Number:
iVent101 is a registered trademark of VersaMed Medical Systems
ClevAir is a registered trademark of MPV TRUMA Ltd.

Other brand names or product names used in this manual are trademarks or registered
trademarks of their respective holders.
Released
II M1186102, Revision 3, 2011

Important
The information contained in this Technical Reference manual pertains only to those
models of products which are marketed by VersaMed as of the effective date of this
manual or the latest revision thereof. This Technical Reference manual was prepared for
exclusive use by VersaMed service personnel in light of their training and experience as
well as the availability to them of parts, proper tools and test equipment. Consequently,
VersaMed provides this Technical Reference manual to its customers purely as a
business convenience and for the customer's general information only without warranty
of the results with respect to any application of such information. Furthermore, because
of the wide variety of circumstances under which maintenance and repair activities may
be performed and the unique nature of each individual's own experience, capacity, and
qualifications, the fact that customer has received such information from VersaMed
does not imply in anyway that VersaMed deems said individual to be qualified to
perform any such maintenance or repair service. Moreover, it should not be assumed
that every acceptable test and safety procedure or method, precaution, tool, equipment
or device is referred to within, or that abnormal or unusual circumstances, may not
warrant or suggest different or additional procedures or requirements.
This manual is subject to periodic review, update and revision. Customers are cautioned
to obtain and consult the latest revision before undertaking any service of the
equipment. Comments and suggestions on this manual are invited from our customers.
Send your comments and suggestions to the Manager of Technical Communications,
Datex-Ohmeda, ohmeda Drive, PO Box 7550, Madison, Wisconsin 53707
CAUTION
Servicing of this product in accordance with this Technical Reference manual should
never be undertaken in the absence of proper tools, test equipment and the most
recent revision to this service manual which is clearly and thoroughly understood.
Technical Competence
The procedures described in this Technical Reference manual should be performed by
trained and authorized personnel only. Maintenance should only be undertaken by
competent individuals who have a general knowledge of and experience with devices of
this nature. No repairs should ever be undertaken or attempted by anyone not having
such qualifications.
VersaMed strongly recommends using only genuine replacement parts, manufactured
or sold by VersaMed for all repair parts replacements.
Read completely through each step in every procedure before starting the procedure;
any exceptions may result in a failure to properly and safely complete the attempted
procedure.
Released
M1186102, Revision 3, 2011 III

SAFETY Before attempting to service or test the iVent-101 ventilator

read this manual and the Operator manual, to familiarize
with all the Cautions and Warnings.
Authorized Representative in the European Community
Obelis S.A.
Av. de Tervuren 34, bte 44
B-1040 Brussels
Belgium
Tel: +32-2-732-59.54
Fax: +32-2-732-60.03
Manufacture Address
VersaMed Medical Systems
P.O.B. 5011, Ornat Bldg.
Hasharon Ind. Park,
Kadima 60920
Israel
VersaMed, a General Electric Company, doing business as GE Healthcare.

Released
IV M1186102, Revision 3, 2011

Released
M1186102, Revision 3, 2011 V


Released
VI M1186102, Revision 3, 2011

Released
M1186102, Revision 3, 2011 VII


Released
VIII M1186102, Revision 3, 2011

Released
M1186102, Revision 3, 2011 IX


Released
X M1186102, Revision 3, 2011

Table of Contents
iVent101 / ClevAir .........................................................................................I

Technical Reference Manual .........................................................................I
Section 1: Introduction.................................................................................1
1.1. Summary of Contents.....................................................................1
1.2. General Description........................................................................2
1.3. Looking at the iVent101/ ClevAir....................................................4
1.4. Cautions and Warnings...................................................................7
1.5. Environmental Specifications .......................................................11
1.6. Standards and Safety Requirements.............................................12
1.7. Indicator Lights.............................................................................14
1.8. Symbols and Labels ......................................................................14
1.8.1. Front Panel Labeling ...............................................................................14
1.8.2. Back Panel Labeling – Connectors...........................................................16
1.8.3. Filter Side ...............................................................................................17
1.8.4. Nameplate .............................................................................................17
Section 2: Installation and Setup ...............................................................20
1. The Information screen .................... Error! Bookmark not defined.
2. Enabling the O2 Sensor .................... Error! Bookmark not defined.
3. Technical Logbook ............................ Error! Bookmark not defined.
4. Circuit Compensation ....................... Error! Bookmark not defined.
2.1. Understanding the Power Sources ...............................................20
2.1.1. Integrated Battery..................................................................................21
2.1.2. Power Source .........................................................................................21
Released
M1186102, Revision 3, 2011 XI

2.2. Patient Circuit...............................................................................23

2.2.1. Circuit Accessories..................................................................................26
2.3. Air Inlet Filter ...............................................................................27
2.4. Connecting the Ventilator to an Oxygen Source ...........................27
2.5. Powering Up the Ventilator ..........................................................29
2.5.1. Shutting Down the Ventilator .................................................................31
2.6. Choosing Ventilator Location .......................................................32
Section 3: Theory of Operation ..................................................................34
3.1. System Operation Overview.........................................................34
3.2. The Pneumatic System .................................................................34
3.2.1. Air Inlet Filter .........................................................................................38
3.2.2. Pneumatic Unit Enclosure ......................................................................38
3.2.3. Turbine Assembly ...................................................................................39
3.2.4. Proportional Outlet Valve (POV).............................................................39
3.2.5. High Pressure Box...................................................................................41
3.2.6. Inspiratory Flow and Pressure Measurements........................................41
3.2.7. Inspiratory One Way Valve .....................................................................43
3.2.8. Patient Tubing System............................................................................43
3.2.9. Exhalation System and One Limb Accessory ...........................................44
3.2.10. Exhalation Flow and Pressure Measurements ........................................44
3.2.11. Exhalation Valve .....................................................................................46
3.2.12. Oxygen Measurement System................................................................46
3.2.13. Oxygen Supply........................................................................................47
3.3. Electronic System .........................................................................48
3.3.1. On/Off Switch.........................................................................................49
3.3.2. Power Input Components.......................................................................50
3.3.3. Power Supply Assembly..........................................................................50
3.3.4. External DC Power..................................................................................50
3.3.5. Integrated Battery and Gas Gauge..........................................................51
Released
XII M1186102, Revision 3, 2011

3.3.6. Gas Gauge Interface PCB ........................................................................52

3.3.7. Backup Battery .......................................................................................52
3.3.8. Main PCB................................................................................................53
3.3.9. External Interfaces .................................................................................54
3.3.10. Pneumatic Unit PCB................................................................................54
3.3.11. Interface PCB..........................................................................................54
3.3.12. LCD Touch Panel.....................................................................................54
3.3.13. Backlight Inverter PCB ............................................................................55
3.3.14. Front Panel LEDs.....................................................................................55
3.3.15. Main Alarm Speaker ...............................................................................55
3.3.16. Cooling System.......................................................................................55
3.4. The iVent101/ ClevAir Software ...................................................56
Section 4: Service and General Settings Screens........................................57
4.1. The Information screen ................................................................57
4.2. General Configuration Screen.......................................................58
4.2.1. Accessing the General Configuration Screen...........................................58
4.2.2. Setting the Display parameters...............................................................59
4.2.3. Settings the Sound Levels .......................................................................60
4.2.4. Setting the Auto Screen Lock Time .........................................................61
4.2.5. Setting the Time and Date ......................................................................63
4.3. Clinical Configuration Screen........................................................64
4.3.1. Accessing the Clinical Configuration Screen............................................64
4.3.2. Enabling the O2 Sensor ...........................................................................64
4.4. Service Screens.............................................................................66
4.4.1. Expert Services Screen............................................................................67
4.4.2. Accessing the services screens................................................................69
4.4.3. Accessing the Expert Services Screen......................................................69
4.4.4. Technical Info Screen .............................................................................70
4.4.5. Software Update ....................................................................................72
4.4.6. Patient Configuration .............................................................................74
Released
M1186102, Revision 3, 2011 XIII

4.4.7. Settings the Language ............................................................................75

4.4.8. Resetting Therapy Time Counter ............................................................76
4.4.9. Copy Log File ..........................................................................................77
4.4.10. Setup Configuration ...............................................................................77
4.4.11. Enable TCP/IP .........................................................................................78
4.4.12. Languages Package Update ....................................................................79
4.4.13. Copy Stored Data ...................................................................................80
Section 5: Testing Procedures ....................................................................82
5.1. Patient Tube Testing Procedure ...................................................82
5.2. Ventilator Verification Test...........................................................85
5.2.1. When to run VVT....................................................................................85
5.2.2. Required Equipment: .............................................................................85
5.2.3. Accessing the VVT ..................................................................................85
5.2.4. Pneumatic Unit test................................................................................86
5.2.5. Power Tests............................................................................................95
5.2.6. Sound Devices Test...............................................................................101
5.2.7. Alarm LED Test .....................................................................................103
5.3. Completing the VVT Procedure ..................................................104
Section 6: Calibration Procedures ............................................................108
6.1. Calibration Overview ..................................................................108
6.2. Calibration Requirements...........................................................108
6.3. Accessing Calibration..................................................................109
6.4. Factory Calibration Procedures ..................................................109
6.4.1. Factory Sensors Calibration ..................................................................110
6.4.2. Turbine Calibration...............................................................................111
6.4.3. POV Factory Calibration........................................................................113
6.4.4. PU Resistance Factory Calibration ........................................................114
6.5. Service Calibration Procedures...................................................115
6.5.1. When to Run Calibration ......................................................................115
Released
XIV M1186102, Revision 3, 2011

6.5.2. Sensors Calibration...............................................................................115

6.5.3. O2 Calibration .......................................................................................117
6.5.4. Battery Calibration ...............................................................................120
6.6. Touch Screen Calibration............................................................121
6.7. Troubleshooting Calibrations .....................................................123
Section 7: Performance Verification ........................................................125
7.1. Cleaning and Inspection .............................................................125
7.2. Test Equipment Set Up ...............................................................126
7.3. Performance Verification Tests ..................................................126
7.3.1. Performance Tests ...............................................................................127
7.3.2. Alarms Tests.........................................................................................129
Section 8: Troubleshooting ......................................................................133
8.1. General Service Procedure .........................................................133
8.1.1. Information Gathering..........................................................................133
8.1.2. Diagnostics ...........................................................................................134
8.1.3. Preliminary Verification Procedures .....................................................134
8.2. Service Notices ...........................................................................134
8.2.1. Service Notice Numbers .......................................................................135
8.3. System Alarms............................................................................138
8.4. General Errors ............................................................................143
Section 9: Planned Maintenance..............................................................147
9.1. Cleaning and Routine Planned Maintenance ..............................147
9.2. Planned Maintenance ................................................................148
9.2.1. Every 6 Months ....................................................................................149
9.2.2. Every 12 Months ..................................................................................150
9.2.3. Every 2 years ........................................................................................150
9.2.4. Every 3 years ........................................................................................150
9.2.5. Every 15,000 Running Hours or 4 years ................................................151
Section 10: Service and Repair .................................................................153
Released
M1186102, Revision 3, 2011 XV

10.1. Service General Information.......................................................153

10.1.1. Repair Safety ........................................................................................153
10.1.2. Repair Guidelines .................................................................................154
10.1.3. Cleaning ...............................................................................................155
10.1.4. Electrical Cables & Pneumatic Connections ..........................................155
10.1.5. Electro-Static Discharge (ESD) Control ..................................................155
10.1.6. Non-conforming Parts ..........................................................................156
10.1.7. Replacement Parts ...............................................................................157
10.1.8. Post Repair ...........................................................................................157
10.1.9. Repair Documentation .........................................................................157
10.1.10. Patient System and Accessories........................................................157
10.2. Recommended Service Tooling and Materials............................158
10.3. Service & Repair Procedures ......................................................158
10.3.1. Inlet Filter Replacement .......................................................................159
10.3.2. Exhalation Valve/Membrane Replacement...........................................160
10.3.3. Two limb to One Limb configuration changeover .................................163
10.3.4. One limb to Two limb configuration changeover ..................................164
10.3.5. O2 Sensor / Cork Installation ................................................................165
10.3.6. Mains AC fuse replacement..................................................................166
10.3.7. Power Pack Replacement .....................................................................167
10.3.8. Top Enclosure Replacement .................................................................168
10.3.9. Filter Housing Replacement..................................................................170
10.3.10. Main Enclosure.................................................................................170
10.3.11. Fans Replacement ............................................................................172
10.3.12. Main PCB Replacement ....................................................................173
10.3.13. Pneumatic Unit Replacement ...........................................................176
10.3.14. Backup Battery Replacement............................................................184
10.3.15. Real Time Clock (RTC) Battery Replacement .....................................185
10.3.16. Speaker Replacement .......................................................................186
Released
XVI M1186102, Revision 3, 2011

10.3.17. O2 sensor harness replacement .......................................................187

10.3.18. Pump/Solenoid harness replacement ...............................................188
10.3.19. Power Supply Unit Replacement.......................................................190
10.3.20. Back Panel Assembly Replacement ...................................................192
10.3.21. Base Assembly Replacement ............................................................193
10.3.22. Exhalation valve base replacement...................................................196
10.3.23. Verification Tests for the new parts ..................................................197
Section 11: Spare Parts.............................................................................199
11.1. Hardware version .......................................................................199
11.2. Ventilator’s Part List ...................................................................199
11.2.1. Ventilator’s System ..............................................................................199
11.2.2. Main Assemblies ..................................................................................200
11.2.3. Spare parts ...........................................................................................202
11.2.4. Accessories...........................................................................................206
11.2.5. Maintenance Kits .................................................................................207
11.2.6. iVent Software .....................................................................................208
Appendix A: Planned Maintenance Check list .........................................209
Appendix B: Previous SW versions related procedures ...........................212
1. The Information screen ..............................................................212
2. Enabling the O2 Sensor ...............................................................213
3. Technical Logbook ......................................................................214
4. Circuit Compensation .................................................................215
5. Manual Battery Gas Gauge Update Procedure ...........................217
1.1 Charging Procedure..................................................................................217
1.2 CDC (Charge- Discharge- Charge) Procedure ............................................218
Appendix C: iVent101 Version 2.0 upgrade kit instructions ....................221
Appendix D: Compliance with Section 6 of IEC 60601-1-2 .......................222
Section 12: Index ......................................................................................227
Released
M1186102, Revision 3, 2011 XVII


Released
XVIII M1186102, Revision 3, 2011

Table of Illustrations
Figure 1.1: The iVent101/ ClevAir (front view) 4
Figure 1.2: The iVent101/ ClevAir (rear view) 6
Figure 2.1: The power cord connected to the ventilator 22
Figure 2.2: The power cord wrapped around the handlers 23
Figure 2.3: Two limb patient circuit connected 25
Figure 2.4: One limb connection 26
Figure 2.5: Air Inlet filter 27
Figure 2.6: Low Flow O2 connector 28
Figure 2.7: Low Flow O2 connector with locking nut 28
Figure 2.8: The O2 Connector Inlet on the ventilator 28
Figure 2.9: Oxygen tubing with the connector 29
Figure 2.10: Oxygen tubing with fasten connectors 29
Figure 2.11: ClevAir Splash screen 30
Figure 2.12: iVent101 splash screen 30
Figure 2.13: Main screen 31
Figure 3.1: Pneumatic schematic diagram of two limb configuration 36
Figure 3.2: Pneumatic schematic diagram of one limb configuration 37
Figure 3.3: Pneumatic module 39
Figure 3.4: Proportional Outlet Valve (POV) 40
Figure 3.5: Inspiratory flow sensor 43
Figure 3.6: Two limb configuration – exhalation Block 45
Figure 3.7: One limb configuration – exhalation block 45
Figure 3.8: Internal exhalation valve 46
Figure 3.9: Electronic system block diagram 49
Figure 3.10: Integrated battery 51
Figure 3.11: Gas gauge interface PCB 52
Figure 3.12: Backup battery 52
Figure 3.13: Main PCB 53
Figure 4.1: The Information screen 57
Released
M1186102, Revision 3, 2011 XIX

Figure 4.2: Brightness panel 59

Figure 4.3: Sound levels panel 60
Figure 4.4: Auto screen lock panel 61
Figure 4.5: Set date and time panel 63
Figure 4.6: Enable O2 Panel 65
Figure 4.7: Services screen 66
Figure 4.8: Expert Services screen 67
Figure 4.9: Advanced services screen 68
Figure 4.10: Select view screen 69
Figure 4.11: Services password screen 70
Figure 4.12: Technical Info screen 71
Figure 4.13: Software update box 73
Figure 4.14: Patient configuration screen 75
Figure 4.15: Languages configuration screen 76
Figure 4.16: Restart GUI confirmation box 76
Figure 4.17: Therapy Time reset box 77
Figure 4.18: The Language Update Box 80
Figure 4.19: Copy stored data box 80
Figure 5.1: Patient tube testing screen (Two limb configuration) 83
Figure 5.2: Patient tube testing screen (One limb configuration) 83
Figure 5.3: VVT screen 86
Figure 5.4: Pressure test VVT screen (Two limb configuration) 87
Figure 5.5. Pressure test VVT screen (One limb configuration) 87
Figure 5.6: Flow test VVT screen (Two limb configuration) 89
Figure 5.7. Flow test VVT screen (one limb configuration) 89
Figure 5.8: Leak test VVT screen Two limb configuration) 91
Figure 5.9. Leak test VVT screen (one limb configuration) 91
Figure 5.10: AC connected test VVT screen 96
Figure 5.11: External connected test screen 97
Figure 5.12: External disconnect test VVT screen 98
Released
XX M1186102, Revision 3, 2011

Figure 5.13 Internal connected test 100

Figure 5.14: Charger test VVT 101
Figure 5.15: Codec Test Screen 102
Figure 5.16: Piezo Test Screen 102
Figure 5.17: HW WD Buzzer Test Screen 103
Figure 5.18: Alarm LED Test Screen 103
Figure 5.19: End of VVT procedure 104
Figure 6.1: Calibration Screen 109
Figure 6.2: Sensor Calibration Screen 110
Figure 6.3: Save Calibration Box 111
Figure 6.4: Factory calibration one limb adapter 112
Figure 6.5: Turbine Factory Screen 112
Figure 6.6: Turbine Factory Screen 113
Figure 6.7: The PU Resistance Factory Calibration screen 114
Figure 6.8: Sensor Calibration Screen 116
Figure 6.9: O2 100% Calibration Service screen (Two Limb Configuration) 117
Figure 6.10. O2 100% Calibration Service screen (One Limb Configuration) 118
Figure 6.11: O2 21% Service Calibration screen (Two limb configuration) 119
Figure 6.12. O2 21% Service Calibration screen (One limb configuration) 119
Figure 6.13: Battery Calibration Screen 120
Figure 6.14: Battery Calibration Done Screen 121
Figure 6.15: Battery Calibration Failed Screen 121
Figure 6.16. TS Calibration screen 122
Figure 8.1: Service Notice screen 135
Figure 10.1: Inlet Filter 160
Figure 10.2: The Exhalation Cover on the lower panel 160
Figure 10.3: Unlocking the exhalation valve lever 161
Figure 10.4: Releasing the exhalation valve 161
Figure 10.5: The Exhalation Valve 161
Figure 10.6: The Exhalation valve membrane 162
Released
M1186102, Revision 3, 2011 XXI

Figure 10.7: O2 Sensor Compartment / Cover 165

Figure 10.8. Mains AC fuse 166
Figure 10.9: Power Pack Mounting 168
Figure 10.10. Top Enclosure Screw Locations 169
Figure 10.11: Top Enclosure Components 170
Figure 10.12 Main Enclosure Mounting 171
Figure 10.13. Cooling Fans Assembly 172
Figure 10.14: Fans screws location 173
Figure 10.15. Cables connection mapping 174
Figure 10.16. Tubes connection mapping 175
Figure 10.17. Pneumatic unit identification 176
Figure 10.18. Pneumatic Unit Mounting 177
Figure 10.19. Pneumatic rev.1 Unit tubes mapping 178
Figure 10.20. Pneumatic Unit Rev. 1 tubing connectors 179
Figure 10.21. Pneumatic Unit rev.2 tubes mapping 180
Figure 10.22. Pneumatic Unit Rev.2 tubing connectors 183
Figure 10.23. Back Up Battery Location 185
Figure 10.24: RTC Battery Location 186
Figure 10.25: Solenoid revisions identification 188
Figure 10.26: Solenoid location 189
Figure 10.27. Pump/Solenoid harness mapping 190
Figure 10.28. Power Supply mounting 192
Figure 10.29: Power supply location 195
Figure 10.30: Exhalation Valve base revisions 196
Figure 11.1: Ventilator’s System 199
Figure 11.2: Main Assembly 200
Figure 11.3. Prior to SW 2.0 Information screen 212
Figure 11.4: Enable O2 Panel 213
Figure 11.5: Technical logbook 214
Figure 11.6: Tube Compliance Calibration Screen (Two limb configuration) 215
Released
XXII M1186102, Revision 3, 2011

Figure 11.7. Tube Compliance Calibration Screen (One limb configuration) 216
Figure 11.8: Tube Resistance Calibration Screen (Two limb configuration) 216
Figure 11.9. Tube Resistance Calibration Screen (One limb configuration) 217
List of Tables
Table 1-1: Front panel components 5
Table 1-2: Back Panel Components 6
Table 1-3: Indicators Lights 14
Table 1-4: Upper panel symbols 15
Table 1-5: Lower panel symbols 16
Table 1-6: Back panel labeling 16
Table 1-7: Filter side icons 17
Table 1-8: Nameplate icons 18
Table 2-1: Power source icons 21
Table 6-1: Calibration Troubleshooting 123
Table 8-1: Service Notices Numbers 135
Table 8-2: System Alarms 139
Table 8-3: General Error 143
Table 9-1: Cleaning and Routine Planned Maintenance (performed by the operator)147
Table 9-2: Planned Maintenance 148
Table 10-1: Service tooling and materials 158
Table 10-2: Pneumatic unit rev. 2 tubing table 181
Table 10-3: Verification tests for new parts 197
Table 11-1: Ventilator’s System 199
Table 11-2: Main Assemblies 201
Table 11-3: Spare Parts 202
Table 11-4: Accessories 206
Table 11-5: Maintenance Kits 207
Table 11-6: iVent Software 208
Released
M1186102, Revision 3, 2011 XXIII

This page is intentionally left blank

Released
XXIV M1186102, Revision 3, 2011

Introduction
Section 1: Introduction
The information in this manual refers both the ivent101 by
VersaMed, and ClevAir by MPV TRUMA
The information in this manual describes the service, maintenance
and test procedures for the iVent101/ ClevAir ventilator system. It is
intended to assist in maintaining the optimal functional operation
and safety of the device.
This technical reference manual should only be used by authorized
VersaMed or MPV certified technicians. Should you require further
information on becoming a VersaMed or MPV certified technician,
please contact your local VersaMed or MPV representative.
The information in this manual is not intended as a sole source of
reference and has been intended for use in conjunction with the
iVent101/ ClevAir Operators Manual. Both manuals should be
referenced when performing any maintenance to the system.
The contents of this document are not binding. If any significant
difference is found between the product and this document, please
contact VersaMed for further information. Some earlier hardware or
software versions may not be fully supported by this manual.
VersaMed reserves the right to modify the product without
amending this document or advising the user.
1.1. Summary of Contents

For your convenience the iVent101/ ClevAir technical reference
manual is comprised of the following chapters:
 Section 1: Introduction – Provide a basic introduction to the
product and clarification of important safety issues.
 Section 2: Installation and Setup – A summary of the steps which
should be followed on the product prior to its first use with a
patient.
 Section 3: Theory of Operation – Provides a detailed technical
description of the product in order to facilitate methodical
troubleshooting of the system.
 Section 4: Service and General Settings Screens – Provides a
summary of the service and configuration screens.
 Section 5: Testing Procedure– Provides a summary of the OVT, VVT,
and associated troubleshooting information.
 Section 6: Calibration Procedures – Provides a summary of
calibration procedures and associated troubleshooting information.
Released
M1186102, Revision 3, 2011 1

 Section 7: Performance Verification – Provides a summary of

performance tests required following repair.
 Section 8: Troubleshooting– Provides a summary of all alarms and
general errors and associated troubleshooting information.
 Section 9: Planned Maintenance – Provides a summary of the
planned maintenance for the device.
 Section 10: Service and Repair – Provides a detailed installation
procedures for all of the device’s major assemblies.
 Section 11: Spare Parts – Provides an illustrated repair parts and
accessories list .
1.2. General Description

The iVent101/ ClevAir is a microprocessor-controlled ventilator,
intended for the home-care environment. It is compact, portable and
feature-rich, supporting both invasive and noninvasive needs.
The iVent101/ ClevAir ventilator is easy to use and enables rapid
control and continuous real-time monitoring of the patient's
ventilation. The ventilation parameters and alarm settings are fully
adjustable and may be saved for future use. With its bright, well-
organized and easy-to-read touch-screen, the iVent101/ ClevAir
ventilator displays pressure and flow waveform data in a full array of
graphical and numerical modes.
The iVent101/ ClevAir ventilator supports the following ventilation
modes:
 A/C volume control
 A/C pressure control
 A/C PRVC
 SIMV volume control
 SIMV pressure control
 SIMV PRVC
 Adaptive Bi-Level
 Adaptive Bi-Level VG
 CPAP/PSV
 CPAP/PSV VG
Released
2 M1186102, Revision 3, 2011

Introduction
In addition, the iVent101/ ClevAir ventilator has the following

advanced features:
 Default parameters selection according to the patient type to
enable a quick setup
 Determining and delivering Inspiratory Peak Flow Rate according to
a target mandatory tidal volume, typically maintaining a 1:2 ratio.
 Determining and delivering respiratory cycle time to sustain 1:2 I:E
ratio
 Enabling a leak-tolerance for facemask ventilation or other
specialized high-leak tube ventilation.
 Enabling Easy Exhale, an exhale mode, which reduces the expiratory
work of breathing.
 Software or language pack upgrade by means of USB flash drive.
Released
M1186102, Revision 3, 2011 3

1.3. Looking at the iVent101/ ClevAir
Figure 1.1: The iVent101/ ClevAir (front view)

Released
4 M1186102, Revision 3, 2011

Introduction
Table 1-1: Front panel components
ITEM NUMBER DESCRIPTION
1 Exhalation exhaust
2 Proximal pressure connector
(one limb configuration only)
3 Exhalation valve connector
(one limb configuration only)
4 Inspiratory port
5 LCD touch screen
6 Activity LED
7 Battery LED
8 Alarm LED
9 Expiratory port (Two limb configuration only)
10 Air inlet filter
Released
M1186102, Revision 3, 2011 5

9 8 7 6 5 4 3
2
10
1
11
12
14
13
Figure 1.2: The iVent101/ ClevAir (rear view)
Table 1-2: Back Panel Components
ITEM NUMBER DESCRIPTION
1 O2 inlet connector
2 External DC connector
3 On/ Off button
4 Remote alarm connector
5 MMC/SD memory card slot (future)
6 SpO2 connector (future)
7 LAN connector (future)
8 USB connector
9 Fuse
10 RS232 connector and cover
11 AC connector
12 AC cable strain relief
13 Power pack mounting screws
14 Power pack
Released
6 M1186102, Revision 3, 2011

Introduction
1.4. Cautions and Warnings
Warnings and cautions appear in bold, with a sign.
The iVent101/ ClevAir ventilator is a life-sustaining device. Do not rely solely

on the ventilator’s performance. Always make sure an alternative means of
ventilation is available. It is mandatory that the patient receives frequent
and adequate clinical supervision.
To ensure patient safety, an appropriately trained caregiver should monitor

ventilation. Qualified personnel should also determine whether the patient
requires an alternative means of ventilation in the event of ventilator
malfunction.
In case of any unexpected change in the performance of the

ventilator, any unexpected event or for assistance in setting up, using
or maintaining the ventilator, contact qualified service personnel.
VersaMed and MPV TRUMA cannot be held responsible for incidents caused
by this device unless the installation, maintenance or modification are
made by an authorized and trained person (in particular, training for
handling of products sensitive to electro-static discharge must include a
section on the use of ESD protected devices), using original spare parts and
respecting quality assurance and traceability rules approved by VersaMed
or MPV TRUMA.
The iVent101/ ClevAir should be used with a bacteria filter to protect the
patient
Take special care to ensure that liquids do not spill or seep into the
ventilator. Clean the exterior with a damp cloth only.
When nebulizing medications with the iVent101 (dual limbs configuration),

use a HEPA filter, connected between the exhalation limb of the patient
circuit and the exhalation port of the ventilator to protect the exhalation
valve
Do not perform ventilation with medicinal substance without a filter

connected to the exhalation valve. Ventilating without a filter may cause
damage to the ventilator.
When connecting attachments to the ventilator, make sure that the

ventilator’s weight is not supported by the attachment.
This may cause ventilation performance deterioration or damage to the
ventilator.
“Risks and Precautionary Measures related to Phthalates:

This instruction pertains to the phthalate symbol marked on the device or
its packaging. If this device is used for the treatment of children, or
Released
M1186102, Revision 3, 2011 7

treatment of pregnant or nursing women; please note that the following

types of procedures may increase the risk of exposure to phthalates:
Exchange transfusion in neonates, total parenteral nutrition in neonates,
multiple procedures in sick neonates, haemodialysis in peripuberal males,
male foetus and male infant of pregnant women, and lactating women; and
massive blood infusion into trauma patients. Although these procedures
have the potential for increased risk of exposure, conclusive evidence of
human health risks has not been established. As a precautionary measure,
to reduce the potential for unnecessary exposures to phthalates, the
product must be used in accordance with the instructions for use, and
practitioners should refrain from using this product beyond the period of
time the product is medically necessary or needed.”
Using the iVent101/ ClevAir ventilator in combination with devices such as

humidifiers or filters can increase the pressure gradient across the
breathing system. Make sure that such devices do not excessively increase
resistance to the airflow provided by the iVent101/ ClevAir ventilator.
Do not directly connect the iVent101/ ClevAir ventilator to a high pressure

oxygen supply. Use an oxygen regulator, and do not exceed the 20 L/min
flow.
Close the oxygen valve on the flow meter prior to disconnecting the oxygen
from the iVent101/ ClevAir ventilator.
Do not connect the O2 supply when equipment is not in use
Do not cover the iVent101/ ClevAir ventilator while it is in use. Make sure
that the unit is positioned so that its inlet ports are open to freely
circulating air.
During infant ventilation with a high sensitivity, false triggers may occur in
certain clinical conditions. In this case, it is recommended to decrease the
sensitivity (to set its number higher).
During infant ventilation, in certain clinical conditions, Vt accuracy might

exceed + 10cc.
The iVent101/ ClevAir ventilator must not be operated immediately

following storage or transport outside the recommended operating
conditions.
Do not use the iVent101/ ClevAir ventilator in an explosive atmosphere.
Your ventilator is an electronic instrument. Any electronic instrument is

subject to electrical interference. Electrical interference in excess of 20 V/m
may prevent your ventilator from working properly.
Released
8 M1186102, Revision 3, 2011

Introduction
The iVent101/ ClevAir ventilator shall not be used with flammable agents
and flammable anesthetics.
If another device interferes with your ventilator:

Television sets, cordless or cellular telephones, microwave ovens, air
conditioners, food processors, and other appliances can be sources of
electrical interference. In the event that you experience interference, the
following steps may be taken to eliminate it:
Do not place your ventilator near other appliances.
Do not plug the ventilator into the same AC electrical outlet or into the
electrical outlets on the same circuit as other appliances.
Do not place the ventilator cables near other appliances.
If your ventilator causes interference with another device:

If the ventilation equipment causes harmful interference to other devices, you
are encouraged to correct the interference by one or more of the following
measures:
Reorient the antenna on the affected device, such as, radio, television, or
cordless phone.
Move the device away from the ventilator.
Connect the equipment to an outlet which is on a different circuit than
the affected device.
Consult the dealer or an experienced radio/TV technician for help.
The remote alarm should be considered secondary to the ventilator’s

primary alarm system.
Verify the remote alarm device functionality before use
The remote alarm connector should be connected to a nurse station device

on a low voltage less than 24Vdc and compliant with IEC 60601-1
Released
M1186102, Revision 3, 2011 9

Do not clean the ventilator with cleaning agents containing ammonium

chloride, other chloride compounds that contains more than 2%
glutaridenyde or abrasive cleannence. Using these cleaning agents may
damage the plastic components in the iVent101/ ClevAir.
Before connecting the patient to the ventilator with a new patient

circuit, you must perform a complete Patient Circuit Compensation and
Patient Tubing Tests (OVT). To perform Patient Tubing Test refer to
section 5.1
When the patient circuit type is changed (from an adult circuit to a

pediatric and vice versa), patient circuit compensation must be
performed prior to using the new patient circuit. To perform the Patient
Circuit Compensation Test refer to section Error! Reference source not
found..
Only medically pure oxygen should be used for operation of the device.
Anesthetics and potentially explosive gasses may not be used.
To avoid any potential fire hazard, keep all matches, lighted cigarettes
and other sources of ignition away from the device.
Do not replace any accessories or other parts of the iVent101/ ClevAir

while a patient is being ventilated.
If you notice that the iVent101/ ClevAir is damaged in any way, its life
supporting function can no longer be guaranteed. Stop ventilation with
the defective device immediately and use an alternate form of
ventilation.
Maintenance work must always be carried out in compliance with all

relevant safety regulations. Repairs, assembly and use should only be
carried out by VersaMed certified personnel.
To ensure that your device continues to perform to specification all

manufacturer prescribed maintenance guidelines should be followed
and the device should be checked by trained personnel on a minimum of
an annual basis.
To avoid electrical shock while servicing the ventilator, be sure to

disconnect the device from all AC and DC power sources prior to
undertaking maintenance.
Only official MPV TRUMA or VersaMed replacement parts should be

used for service. Failure to comply may seriously impair the ventilators
performance, safety or reliability.
In accordance with the important information described herein, always

comply with applicable national and local safety regulations.
Released
10 M1186102, Revision 3, 2011

Introduction
When opening the iVent101/ ClevAir for service always exercise
appropriate ESD (electrostatic discharge) precautions. Refer to section
10.1.5: Electro-Static Discharge (ESD) Control.
Responsibility for the safe function of this equipment reverts to the

owner or user in all cases where an unauthorized person performs
service or repair and when the equipment is not used for its intended
purpose.
Alteration or repair of the iVent101/ ClevAir beyond the scope of the

service and maintenance instructions, or by anyone other than an
authorized MPV TRUMA or VersaMed service person, could result in the
product's failure to perform as designed.
During the reassembly of the iVent101/ ClevAir or any of its

subcomponents inspect and reconnect all electrical grounds that have
been previously disconnected.
On completion of any servicing always perform verification tests, as

described in Section 7:Performance Verification
.
1.5. Environmental Specifications

 Operating Temperature: 5 to 40°C
 Storage Temperature (without the battery and O2 sensor): -
20 to +60°C
 Battery Storage: -20 to +35°C
Note: In long term storage it is advised to store the batteries
between -20°C to 35°C to reduce self-discharge and to avoid
frequent maintenance.
 Relative Humidity: 10% to 95%
 Operating Altitude: -440m to 3500m (600 hPa to 1100 hPa)
 Water resistance: IP 311
 Atmospheric Pressure: 430 - 825 mmHg (up to 15,000 feet)
 Vibration and Shock: ETSI EN 300 019-2-7 V3.0.1
1
IP 31 refers to (3) protection against tools, thick wires etc. greater than 2.5 mm (1) Degree of fluid
ingress protection provided by the enclosure (drip-proof).
Released
M1186102, Revision 3, 2011 11

1.6. Standards and Safety Requirements

The iVent101 meets the applicable safety requirements per the
standards below:
ASTMF1100-90 Standard Specification for ventilators

intended for use in critical care
ASFMF1246-91 Standard Specifications for electrically
powered home care ventilators.
IEC60601-1: 1988 Medical Electrical Equipment – General
+A1:1991 requirements for safety
EN60601-
1:1990+A1:1993+
A21995+A13:1996
EN 60601-1-2:2001 Electromagnetic Compatibility (EMC)
IEC 60601-1-2:2005
* ISO 10651-2 : 2004 Lung Ventilators for medical use –
Particular requirements for Home Care
Ventilators dependent patients
** ISO 10651-6 : 2004 Lung Ventilators for medical use - Home-
care ventilatory support devices
IEC60601-2-12:2001 Medical Electrical equipment- particular
requirements for the safety of lung
ventilators – critical care ventilator
IEC 60601-1-8:2003 General requirements for safety: test and
guidance for alarm system in medical
electrical equipment/system
IEC60601-1-6:2004 Medical electrical equipment usability
ISO 14971 Medical devices – Application of risk
management to medical devices
CAN/ CSA C22.2 Medical electrical equipment Part 1 -
601.1-1190 General requirements for safety
CAN/ CSA C22.2 Medical electrical equipment part 2 –
no. 601.2.12.92 particular requirements for ventilators
UL 60601-1:2003 Medical Electrical Equipment, part 1:
General requirements for safety
Released
12 M1186102, Revision 3, 2011

Introduction
*The iVent101/ ClevAir with the Two limb configuration complies
with the requirements of ISO 10651-2: 2004.
** The iVent101/ ClevAir with the One limb configuration complies
with the requirements of ISO 10651-6: 2004.
Released
M1186102, Revision 3, 2011 13

1.7. Indicator Lights

The indicator lights, located on the front panel of the iVent101/
ClevAir ventilator (Figure 1.1), indicate the status of the iVent101/
ClevAir ventilator.
Table 1-3: Indicators Lights
NAME COLOR WHEN ACTIVE
Activity Green
Battery  Yellow: Charging
Yellow blinking: slow charge or the battery in cool-
down mode
 Blue: In conjunction with the battery status
indicators (see Understanding the Power Sources,
page 20) indicates charging completion.
Alarm Red
1.8. Symbols and Labels

The following symbols and labels for warnings and connectors are
found on the iVent101/ ClevAir ventilator:
1.8.1. Front Panel Labeling

The labeling on the front panel of the iVent101/ ClevAir ventilator
includes the following:
 Upper Panel Symbols, refer to Table 1-4.
 Lower Panel Symbols, refer to Table 1-5.
Released
14 M1186102, Revision 3, 2011

Introduction
1.8.1.1. Upper Panel Symbols

The symbols on the upper panel of the iVent101/ ClevAir ventilator
are listed in Table 1-4:
Table 1-4: Upper panel symbols
FUNCTION ICON/ SYMBOL LOCATION
VersaMed Logo or Above the touch

MPV TRUMA Logo screen, to the
right.
Ventilator Name: Above the touch

screen, to the left.
IVent101 or ClevAir
GE Logo Below the touch

screen, in the
middle.
On/Off Light
On the right side of

Alarm Light
the LEDs.
Battery Charge light
To Patient Below the

inspiratory port.
Released
M1186102, Revision 3, 2011 15

1.8.1.2. Lower Panel Symbols

The symbols in Table 1-5 appear on the lower panel of the iVent101/
ClevAir ventilator.
Table 1-5: Lower panel symbols
Expiratory Port (Only On the plastic

for the two limb model) panel below the
pipes.
Exhalation Valve On the plastic

panel below the
Proximal Pressure pipes.
Two limb model
only
1.8.2. Back Panel Labeling – Connectors

The symbols in Table 1-6 appear on the back panel of the iVent101/
ClevAir ventilator.
Table 1-6: Back panel labeling
On/Off Button Above the power

switch
RS232 Left side of the
RS232 connector
USB Above the USB
connector
LAN Above the LAN
connector
AC Left side, below
the AC connector
Released
16 M1186102, Revision 3, 2011

Introduction
Voltage, Current, 100-240V Below the AC label

Frequency AC 2A
50-60Hz
Ext DC Battery Above the Ext DC
connector
O2 Inlet Left side of the O2
inlet connector
Remote Alarm \ Below the Remote
Alarm connector
SpO2 Above the SpO2
connector
Fuse Below the Fuse
connector
MMC Card Below the MMC
connector
1.8.3. Filter Side

The following label appears below the filter.
Table 1-7: Filter side icons
Filter – Do not obstruct Centered, below

the filter.
1.8.4. Nameplate
The nameplate is attached underneath the ventilator and contains
the following symbols and information:
Released
M1186102, Revision 3, 2011 17

Table 1-8: Nameplate icons
FUNCTION ICON/ WORDING
Ventilator Name
Ivent101 or ClevAir
Manufacturer:
VersaMed or
MPV TRUMA
Date of manufacturing
Barcode
Class 2 – Double Isolation

(electrical)
Type BF – Body Floating
S/N
Read this book prior to
use.
CSA/UL
Only for iVent101
CE Mark
Caution: Text: “Caution: US federal law restricts

this device to sale by or on order of a
physician.”
IP 312
Do Not Discard – per
WEEE directive
2
IP 31 refers to (3) protection against tools, thick wires etc. greater than 2.5 mm (1) Degree of fluid
ingress protection provided by the enclosure (drip-proof).
Released
18 M1186102, Revision 3, 2011

Introduction

Released
M1186102, Revision 3, 2011 19

Section 2: Installation and Setup

This section explains the installation and setup procedures for the
iVent101/ ClevAir and comprises the following subjects:
 Understanding the Power Sources - section 2.1 below.
 Power Source – section 2.1.2.
 Patient Circuit – section 2.2.
 Air Inlet Filter – section 2.3.
 Connecting the Ventilator to an Oxygen Source – section 2.4.
 Powering Up the Ventilator - section 2.5.
 Choosing Ventilator Location – section 2.6.
After powering up the ventilator for the first time charge the ventilator
until the icon appears.

.
2.1. Understanding the Power Sources

The iVent101/ ClevAir ventilator has three power sources that
support ventilation:
 External alternating current (AC)
 External direct current (DC)
 Integrated battery
In addition the iVent101 has one backup power source.
Both the AC and DC input (refer to
Figure 1.2) are located on the back panel of the ventilator.
Before connecting the ventilator to an AC or DC outlet, verify that the

external power supply is the correct voltage and frequency.
If the power cord is damaged, worn, or frayed, replace it immediately.

Table 2-1 displays icons that indicate the power status of the
iVent101/ ClevAir ventilator.
Released
20 M1186102, Revision 3, 2011

Installation and Setup

Table 2-1: Power source icons
ICON DESCRIPTION REMARKS
AC power is connected. The AC power icon

appears in green.
AC power is disconnected.
External DC is connected The External DC icon

without AC power connected. appears in green.
.
External DC is disconnected or
connected while AC power is
connected.
Indicates end of charge The Battery icon appears
in full green with a ‘+’ sign
on it.
Integrated battery status Full green indicates high
indicating the current battery capacity while full
estimated capacity of the gray indicates very low
battery. capacity.
All or part of the battery
icon appears in green.
2.1.1. Integrated Battery

When the iVent101/ ClevAir ventilator detects an external power
loss, it switches to the integrated battery. When fully charged, the
integrated battery provides 4 hours of power, depending on the
ventilation conditions and settings.
Use only integrated batteries supplied by VersaMed.
2.1.2. Power Source

To connect the ventilator to a power source:
1. Make sure that the socket end of the power cord is plugged into the
power cord connector on the back of the ventilator.
2. Verify that the Strain relief is locking the power cord.
Released
M1186102, Revision 3, 2011 21

Figure 2.1: The power cord connected to the ventilator
3. Plug the other end of the cord into a wall outlet. The Battery Charging
LED should light up.
The battery is charged only if the integrated battery is
connected, the ventilator is plugged into external power source,
and the yellow LED is light. If the ventilator is plugged in and the
Battery Charging LED is not lit, verify the connection to both the
ventilator and the electrical outlet.
Blinking yellow light indicates that the ventilator is in slow
charge mode, due to high ambient or battery temperatures. If
the light blinks in standard ambient temperatures (less than
30°C) when the battery is cool, it may indicate a battery or
charger malfunction.
Note: If the light continues to blink for more than 3 hours in standard
ambient temperature (less than 30ºC) the battery may have
been heated by the ventilator operation. Replace the battery
and let it cool for two hours before attempting to recharge
again.
For a list of possible Battery charging LED, refer to section 1.7:
Lights.
Note: While operating, keep the ventilator plugged in whenever
possible.
Note: When not connected, wrap the power cord around the
battery screws on the back panel, as shown in Figure 2.2.
Note: When the ventilator is not in use for over a month it is
recommended to disconnect the battery and store it separately from
the device.
Released
22 M1186102, Revision 3, 2011

Figure 2.2: The power cord wrapped around the handlers
2.2. Patient Circuit

The patient circuit is the tubing that carries the air from the
ventilator to the patient. The iVent101/ ClevAir ventilator supports
both One limb and Two limb patient circuits. The functionality of
both is similar except that the Two limb patient circuit includes the
ability to measure the expiratory volume.
Note: When ventilating against high-resistance or with high leak, it is
recommended to use a two limb patient circuit configuration.
Disposable one limb and two limb patient circuits are intended for a
single patient use only.
Reuse may cause a risk of cross-contamination, affect the measurement

accuracy and/or system performance, or cause a malfunction as a result
of the product being physically damaged due to cleaning, disinfection,
re-sterilization and/or reuse.
Reusable one limb and two limb patient circuits should be handled
according to their manufacturer’s specifications.
The patient circuit has to be inspected every day to:
 Make sure there are no cracks or holes in the hose.
 Be certain that all the connections are secure and free from leaks.
Released
M1186102, Revision 3, 2011 23

Use a pediatric circuit when ventilating a pediatric or infant patient.
When the patient circuit type is changed (from an adult circuit to a pediatric
and vice versa), patient circuit compensation must be performed prior to
using the new patient circuit.
Before connecting the patient to the ventilator with a new patient circuit,
you must perform a complete Ventilation Circuit Test. To perform the test,
refer to section 5.1: Patient Tube Testing Procedure.
To prevent water and/or secretions from entering the pressure sensor

tubing while using single limb circuits, always keep the patient pressure
line tilted upward.
When ventilating against high resistance (for example, when ventilating an

infant) or with high leak it is recommended to use a dual limb setup, as the
readings during exhalation allow for improved ventilation performance.
If the patient circuit is obstructed there may be auto triggers generated

against the obstruction.
Note: A Bacteria filter can be connected to the patient wye, in
accordance with local procedures and regulations.
To connect a Dual limb Patient Circuit:
1. Connect the patient circuit tubing to the inspiratory outlet port (refer
to Figure 1.1) by twisting and pushing it until it is firmly in place.
2. Connect the second tube to the expiratory port (refer to Figure 1.1)
by twisting and pushing it until it is firmly in place.
3. Perform Patient Tube Test before starting ventilation with a new
Patient Circuit.
Note: Whenever a patient circuit brand or type (such as a
patient circuit used for adult patients to one used for pediatric
patients) is changed a patient circuit compensation procedure
should be performed.
For Patient Circuit Compensation Test refer to section Error!
Reference source not found..
For Patient tube test refer to section 5.1.
Released
24 M1186102, Revision 3, 2011

Figure 2.3: Two limb patient circuit connected
The ventilator must be configured in order to change from One limb

to Two limb configuration, or vice versa. To change the patient circuit
configuration refer to section 4.4.6: Patient Configuration.
To connect a One limb Patient Circuit:
1. At one end of the patient circuit, connect the Exhalation valve and the
Proximal pressure tube according to the manufacturer’s instructions.
2. Connect the Exhalation valve tube to the Exhalation valve, according
to the manufacturer’s instructions.
3. Connect the other end of the patient circuit tube to the Inspiratory
Outlet port (refer to Figure 1.1) by twisting and pushing it until it is
firmly in place.
4. Connect the proximal pressure tube to the proximal pressure
connector on the ventilator (identified by the icon).

5. Perform a Patient Circuit Compensation and Patient Tube Test before
starting ventilation with a new Patient Circuit.
For Patient Circuit Compensation Test refer to section Error!
Reference source not found..
For Patient tube test refer to section 5.1.
Released
M1186102, Revision 3, 2011 25

Figure 2.4: One limb connection
2.2.1. Circuit Accessories

The following components may be attached to the patient circuit as
accessories:
 Heat and Moisture Exchanger (HME)
 Heated Humidification
Note: Heated humidifiers can be associated with excess water
accumulation in the expiratory side of the patient circuit. Elevating
the expiratory side of the circuit above the expiratory valve should
be avoided in this circumstance. A large bolus of water pushed into
the expiratory valve can cause occlusion of the pressure sensing
tubes interfering with ventilator performance. A water trap in the
circuit when using heated humidifiers is recommended and can
reduce the likelihood of this occurrence.
To connect a heated humidifier:
1. Connect the corrugated tubing from the humidifier to the Inspiratory
Port on the front panel of the iVent101/ ClevAir ventilator (refer to
Figure 1.1).
2. Refer to the humidifier operator's manual to complete the
humidifier setup.
Note: Follow the manufacturer's instructions for operating the
humidifier.
Released
26 M1186102, Revision 3, 2011


2.3. Air Inlet Filter
Do not operate the iVent101/ ClevAir ventilator without a filter.
The iVent101/ ClevAir utilizes an Air Inlet filter that prevents the
entry of any substance greater than 5 microns.
Figure 2.5: Air Inlet filter
Note: The air inlet filter must be replaced for every 1 month of
operation.
Verify that the air inlet filter is firmly attached by turning all the way
clockwise.
To replace the Air Inlet filter refer to section 10.3.1: Inlet Filter
Replacement.
2.4. Connecting the Ventilator to an Oxygen Source

The iVent101/ ClevAir ventilator uses oxygen from a low-pressure
oxygen source such as an oxygen concentrator or a flow meter. The
low-pressure oxygen supply is connected to the iVent101/ ClevAir
ventilator through an O2 Adaptor.
Do not connect the iVent101/ ClevAir ventilator to a high-pressure

oxygen supply.
The low pressure O2 should not exceed the following parameters:
 Flow: 20 L/min
Released
M1186102, Revision 3, 2011 27

There are 2 different O2 connector types: Low Flow O2 connector

type and Low Flow O2 connector with locking nut type.
Figure 2.6: Low Flow O2 connector Figure 2.7: Low Flow O2 connector with
locking nut
Verify that oxygen source is closed and that there is no pressure in the
tube prior to connecting the oxygen tubing to the ventilator.
Keep the Oxygen connector clean and dry.

To connect a low pressure oxygen supply with a Low Flow O2
connector, used with various tubes diameters up to 5mm ID:
1. Connect the Oxygen source tubing to the connector. Verify that you
are using a standard grade oxygen tube, compatible with low
pressure O2 application.
2. Connect the O2 connector to the O2 connector inlet in the back
panel.
Figure 2.8: The O2 Connector Inlet on the ventilator

Released
28 M1186102, Revision 3, 2011


To connect a low pressure oxygen supply with a Low Flow O2 connector
with locking nut, used with a standard 3-3.5mm ID and 6-6.5mm
OD:
1. Unfasten the locking nut from the O2 connector.
2. Connect the oxygen source tubing to the connector (as shown in
Figure 2.9 below. Verify that you are using a standard grade oxygen
tube, compatible with low pressure O2 application.
Figure 2.9: Oxygen tubing with the connector
3. Lock the tube to the O2 connector in place by fastening the locking

nut to the connector (as shown in Figure 2.10 below).
Figure 2.10: Oxygen tubing with fasten connectors
4. Connect the O2 connector to the O2 connector inlet in the back

panel.
To release the O2 connector:

1. Close the O2 source.
2. Press the Thumb Latch on the side of connector and pull the
connector (refer to Figure 2.8 above).
2.5. Powering Up the Ventilator

To power up the iVent101/ ClevAir ventilator:
Released
M1186102, Revision 3, 2011 29

 Push in the power button for several seconds to power up the

iVent101/ ClevAir. The power button is located on the back panel of
the ventilator. (Refer to
Figure 1.2) The iVent101/ ClevAir ventilator starts up in the
following stages:
After several seconds, a splash screen will be displayed on the touch
screen.
Figure 2.11: ClevAir Splash screen
Figure 2.12: iVent101 splash screen
As the system starts up, a small cursor appears.

After several more seconds the Main screen is displayed.
Released
30 M1186102, Revision 3, 2011

Figure 2.13: Main screen
2.5.1. Shutting Down the Ventilator

To shut down the iVent101/ ClevAir ventilator:
 To shut down the iVent101/ ClevAir ventilator, push in the power
button for several seconds while the ventilator is in the Standby
mode. You can force a complete shutdown of the ventilator while
ventilating by pressing the power button for 25 seconds.
When you force a shutdown during ventilation, a red alert screen
appears accompanied by a high pitch sound to warn that continued
pressing the power button will shut down the iVent101/ ClevAir.
Released
M1186102, Revision 3, 2011 31

2.6. Choosing Ventilator Location

The iVent101/ ClevAir should be placed on a solid surface so that the
cooling air can flow through the vents in the lower chassis without
obstruction.
When selecting a location for the ventilator, it is important that the
alarms can be heard. Before using the ventilator, you need to test
how well the alarms can be heard in every location of the home.
To choose a location for the ventilator:
6. Put the ventilator where it will be used most.
7. Plug the ventilator into a wall outlet.
8. Verify that the patient circuit is not connected to the iVent101/
ClevAir.
9. Turn on the ventilator and start ventilation. An alarm condition will
occur, and an audible alarm will sound.
10. Go to each part of the house and verify that the alarm is audible.
Identify any activities or devices that make loud sounds (e.g., radio,
television, tools and appliances), operate those devices, and verify
that you are still able to hear the ventilator’s alarm.
11. The alarm volume can be adjusted as needed. For more information
refer to section 4.2.3 Error! Reference source not found..
Released
32 M1186102, Revision 3, 2011


Released
M1186102, Revision 3, 2011 33

Section 3: Theory of Operation

This section of the manual describes the operational theory of the
iVent101/ ClevAir ventilator system. It includes an overview, the
operational principals of the pneumatic and electronic system, and a
description of how the device’s firmware interacts with the hardware
in certain applications.
3.1. System Operation Overview

The iVent101/ ClevAir is a microprocessor-controlled ventilator,
intended for the home-care environment. It includes a high power,
high reliability pneumatic system which incorporates a turbine, a
proportional outlet valve, and flow and pressure transducers. The
ventilator’s electronic system is built around a main circuit board
design supporting ventilation and GUI functions. The ventilation
process is controlled by the ventilator’s software, which controls the
pneumatic module via the electronic module.
3.2. The Pneumatic System

The pneumatic system design for the iVent101/ ClevAir is built
around a modular and compact pneumatic engine.
Ambient air is drawn into the device through the inlet filter and
manifold. Oxygen can be added, if required, through the low
pressure connector on the device’s rear panel. Oxygen may be
supplied from any low pressure source. The FiO2 is monitored
downstream by the oxygen sensor.
Inspiratory force is generated by a brushless DC motor turning the
impeller of the turbine. The turbine combined with the proportional
outlet valve (POV), and the flow and pressure sensors control the
volume and pressure to ensure ventilation at the set parameters.
The core of the pneumatic system - the turbine, the POV, and the
flow sensor – is surrounded by the pneumatic enclosure. The
enclosure, constructed from stainless steel, is lined with sound
deadening material and designed to reduce the noise caused by the
turbine motor and the passage of air.
Released
34 M1186102, Revision 3, 2011

Theory of Operation
Patient gas is delivered from the pneumatic system to the patient

through the patient tubing system. The device may be configured to
work with either a One or Two limb tubing system as per regional or
individual requirements.
Devices which are configured for Two limb patient tubing systems
contains a full exhalation system including an expiratory flow sensor,
patient pressure sensor, and an internal exhalation valve (refer to
Figure 3.1). Devices configured for One limb operation have a
simplified exhalation block that only provides connection for
proximal pressure and for exhalation valve inflation pressure (refer
to Figure 3.2).
The iVent101/ ClevAir pneumatic system includes the following
items:
 Air Inlet Filter – section 3.2.1.
 Pneumatic Unit Enclosure – section 3.2.2.
 Turbine Assembly – section 3.2.3.
 Proportional Outlet Valve (POV) – section 3.2.4.
 High Pressure Box – section 3.2.5.
 Inspiratory Flow and Pressure Measurements – section 3.2.6
 Inspiratory One Way Valve – section 3.2.7.
 Patient Tubing System – section 3.2.8.
 Exhalation System and One Limb Accessory – section 3.2.9.
 Exhalation Flow and Pressure Measurements – section 3.2.10.
 Exhalation Valve – section 3.2.11.
 Oxygen Measurement System – section 3.2.12.
 Oxygen Supply – section 3.2.13.
Released
M1186102, Revision 3, 2011 35

Figure 3.1: Pneumatic schematic diagram of two limb configuration

Released
36 M1186102, Revision 1, 2009

Theory of Operation
Figure 3.2: Pneumatic schematic diagram of one limb configuration

Released
M1186102, Revision 1, 2009 37

3.2.1. Air Inlet Filter

All ambient air entering the pneumatic system of the iVent101/ ClevAir
is drawn through the inlet filter and manifold. The inlet filter provides
highly efficient filtration of any particle matter exceeding 5 microns. The
manifold provides a conduit through which the filtered air passes to the
pneumatic system.
3.2.2. Pneumatic Unit Enclosure

The pneumatic unit enclosure encases the entire inspiratory pneumatics
of the iVent101/ ClevAir. The enclosure serves two purposes during the
operation of the device:
The enclosure is lined with a highly efficient sound deadening foam
material, which in conjunction with the high pressure box, renders the
inspiratory pneumatics virtually silent.
In addition, the large surface area of the pneumatic enclosure serves to
assist in the dissipation of heat, which is generated by the operation of
the turbine and the POV. The cooling airflow generated by the device’s
dual cooling fan is drawn through vents on the lower enclosure of the
device, up and around the pneumatic enclosure providing cooling of its
surfaces.
Released
38 M1186102, Revision 3, 2011

Theory of Operation
Flow Sensor
Sample Lines
Flow Sensor &
Check Valve
Turbine
Proportional
Assembly
Outlet Valve
High Pressure
Box
Pneumatic
Enclosure
Figure 3.3: Pneumatic module
3.2.3. Turbine Assembly

The inspiratory gas flow to be delivered to the patient is generated by
the turbine assembly. The turbine is comprised of a brushless DC motor
rotating an impeller at high speed. The impeller draws ambient air from
the pneumatic enclosure and delivers it onward through the
proportional outlet valve.
The speed and output of the turbine is controlled and regulated by the
software and the proportional outlet valve using feedback from the flow
and pressure sensors. A hall sensor array on the motor portion of the
turbine provides feedback on the motor speed to the software.
3.2.4. Proportional Outlet Valve (POV)

Positioned at the turbine outlet, the Proportional Outlet Valve (POV) is
designed to assist in the regulation of the flow and pressure output from
the turbine during breath delivery.
Released
M1186102, Revision 3, 2011 39

As shown in Figure 3.4, the POV acts as a flapper or gate valve, operating
between two outlet ports. The main outlet port opens into the high
pressure box and onward to the patient system. The second outlet port
opens the high pressure box allowing it to vent into the pneumatic
enclosure.
Figure 3.4: Proportional Outlet Valve (POV)
The position of the valve can be adjusted using a high reliability stepper
motor. The effective range of movement that the valve goes through is
approximately 90 degrees, and with an actuation speed, from fully open
to closed, of approximately 50ms.
In the open position the valve allows almost unrestricted flow to pass
from the turbine to the high-pressure box. In the fully closed position
the turbine flow is fully restricted, and the pressure within the high-
pressure box is release to the PU ambient through the bypass port.
The proportional outlet valve design also incorporates an optical sensor.
An interrupter is mounted to the shaft of the motor matching the size
Released
40 M1186102, Revision 3, 2011

Theory of Operation
and position of the valve’s flapper. The optical sensor is used during the
POV calibration to confirm the extent of the flapper’s movement, and
during operation as a basis for controlling the flapper’s movement and
position.
3.2.5. High Pressure Box

Patient gas passing through the turbine and the POV is conveyed onward
through the high pressure box. The High pressure box serves three
primary purposes:
Firstly, the high-pressure box includes a number of chambers lined with
sound deadening material that reduce the noise level.
Secondly, it is used to help dissipate heat away from the gas before it is
passes to the patient.
Lastly, the high-pressure box serves as a reservoir for supplemental
oxygen should it be required. Oxygen flow is introduced to the
connector on the rear panel from where it passes into the high-pressure
box. The O2 accumulates during exhalation and is delivered to the
patient during inspiration along with the ambient air.
In addition, the high-pressure box is used as the sampling point for the
turbine pressure.
3.2.6. Inspiratory Flow and Pressure Measurements

Inspiratory flow and volume are measured using a strut and flow sensor
design concept. The pneumatic enclosure includes a strut in the path
between the high-pressure box and the patient connector. As flow is
passed through the system from the turbine and POV, the strut induces
a pressure drop.
The pressure differential forces a proportional sample of flow to pass
through the first sample line (IF1), on through the flow sensor (UXX)
located at the Main PCB, and back into the system through the second
sample line (IF2). The actual flow through the system is directly
proportional to the sample flow. The flow measurement is used as
feedback to regulate the operation of the inspiratory pneumatics.
Turbine pressure is sampled at the high-pressure box and then conveyed
to the turbine pressure transducer located on the Main PCB. The turbine
Released
M1186102, Revision 3, 2011 41

pressure measurement is used as a feedback to regulate the operation

of the inspiratory pneumatics.
Released
42 M1186102, Revision 3, 2011

Theory of Operation
Sample O2 to Sample Flow

Sensor to Sensor
One Way
Valve
Strut Area
Figure 3.5: Inspiratory flow sensor
3.2.7. Inspiratory One Way Valve

The inspiratory one-way valve is also located in the pneumatic enclosure
and is part of the inspiratory flow strut. The one-way valve is oriented to
allow inspiratory flow to pass out of the device and into the patient
tubing system. During exhalation the verification action of the valve
ensures the passage of the exhaled gasses out through the exhalation
limb and/or valve.
3.2.8. Patient Tubing System

The patient tubing system for the iVent101/ ClevAir can be configured
with software and the appropriate hardware for either One limb or Two
limbs configurations. The hardware differences on the device are
described in the following sections.
The Two limb configuration is comprised of an inspiratory tubing limb,
and an expiratory limb, with the two joined at the wye piece.
The One limb configuration is consists of a single length of main tubing.
At the proximal end of the main tubing are an external exhalation valve
and a proximal pressure sample port. From these items two smaller bore
tubes carry proximal pressure and exhalation inflation pressure
respectively to and from the device.
It is always recommended, regardless of the configuration, that a
bacterial grade filter will be placed at the ventilator outlet to ensure the
Released
M1186102, Revision 3, 2011 43

purity of the gas passing to the patient. Humidification requirements will

add items and complexity to the two system types.
3.2.9. Exhalation System and One Limb Accessory

Depending on the required patient tubing configuration for the
iVent101/ ClevAir the device is equipped with either a full exhalation
system or a One-limb accessory. Both of these components connect to
the system at the exhalation manifold.
In the Two-limb configuration, the device includes a full exhalation
system that consists of an exhalation valve, an expiratory flow sensor,
and a patient pressure (exhalation) measurement port.
In the One limb configuration the device includes only a connection for
the patient pressure (proximal) and the exhalation valve inflation
pressure.
3.2.10. Exhalation Flow and Pressure Measurements

Depending on the ventilator’s configuration, the patient exhalation
volume and pressure are measured by the system.
Monitoring of the patient pressure is performed either distally, when
the device is in Two limb configuration, or proximally when it is
configured as One limb. In each case, the pressure sample is conveyed
through the exhalation manifold and on to the Patient Pressure
Transducer located on the Main PCB.
Monitoring of the patient’s exhaled volume is conducted only when the
device is in Two-limb configuration. Exhaled volume is measured using a
strut and flow sensor design concept. The exhalation system includes a
strut which will induces a pressure drop across the expiratory flow.
The pressure differential forces a proportional sample of the exhaled
flow to pass through the first sample line, on through the flow sensor
located at the Main PCB, and back into the system through the second
sample line (as shown in Figure 3.6). The actual flow through the system
is directly proportional to the sample flow. The flow measurement is
used as feedback for integration of the patient’s exhaled volume.
Released
44 M1186102, Revision 3, 2011

Theory of Operation
Figure 3.6: Two limb configuration – exhalation Block
Figure 3.7: One limb configuration – exhalation block

Released
M1186102, Revision 3, 2011 45

3.2.11. Exhalation Valve

Depending on the ventilator’s configuration the exhalation valve is
located internally within the exhalation system (Two limb configuration),
or proximally at the patient end of the tubing system (One limb
configuration).
In each case, the inflation pressure required to close the exhalation
valve originates back at the high pressure box in the inspiratory
pneumatics. From the high pressure box it routes through the hold
solenoid valve and exhalation manifold and then on to the exhalation
valve. The pressure applied forces the exhalation membrane to be
displaced closing off the expiratory path.
Figure 3.8: Internal exhalation valve
3.2.12. Oxygen Measurement System

Depending on the iVent101/ ClevAir configuration, it may be equipped
with a galvanic fuel cell for measurement of FiO2 (fraction of inspired
oxygen). To measure the FiO2 a continuous sample of patient gas is
drawn from the inspiratory strut in the pneumatic module. The sample
gas reacts with the electrolyte within the galvanic cell producing an
output voltage proportional to the FiO2 level. From the oxygen sensor
the sample flow passes onward and return to the pneumatic enclosure.
Released
46 M1186102, Revision 3, 2011

Theory of Operation
3.2.13. Oxygen Supply
The iVent101/ ClevAir can be configured to enable supplemental oxygen
to be introduced to the gas destined for the patient. The system requires
oxygen from a regulated low pressure source such as flow meter or
oxygen concentrator. The oxygen flow is introduced through the
connector on the rear panel of the device (refer to
Figure 1.2) and feeds directly into the pneumatic module enclosure,
which serves as an oxygen reservoir. Accumulated oxygen is then drawn
by inspiratory pneumatics and on to the patient circuit.
Released
M1186102, Revision 3, 2011 47

3.3. Electronic System

The electronic system designed for the iVent101/ ClevAir incorporates
one main circuit board supporting all of the ventilator’s functions. The
Main circuit board is supplemented by five smaller function specific
circuit boards, power supply and the LCD touch panel.
The heart of the system, located on the Main PCB is an OMAP CPU
containing an integrated ARM (processor) and DSP (digital signal
processor). An FPGA (field programmable gate array) is used by the CPU
to control the pneumatic, and other peripheral systems. An ADC (Analog
to digital converter) has up to 16 channels available for receiving
ventilation, patient, environmental, and system conditions from the
transducers as well as current and voltage samples.
Power is supplied to the system from one of four available power
sources using a power selection system: mains supply, external DC,
integrated battery and a backup battery, in this order of priority. Power
is then supplied onward to the system via power rails under software
and hardware control.
The electronic system of the iVent101/ ClevAir comprises the following:
 Power Input Components - section 3.3.2.
 Power Supply Assembly – section 3.3.3.
 External DC Power – section 3.3.4.
 Integrated Battery and Gas Gauge – section 3.3.5.
 Gas Gauge Interface PCB – section 3.3.6.
 Backup Battery – section 3.3.7.
 Main PCB – section 3.3.8.
 External Interfaces – section 3.3.9.
 Pneumatic Unit – PCB – section 3.3.10.
 Interface PCB – section 3.3.11.
 LCD Touch Panel – section 3.3.12.
 Backlight Inverter PCB – section 3.3.13.
 Front Panel LED’s – section 3.3.14.
 Main Alarm Speaker – section 3.3.15.
 Cooling System – section 3.3.16.
Released
48 M1186102, Revision 3, 2011

Theory of Operation
Figure 3.9: Electronic system block diagram
3.3.1. On/Off Switch

The iVent101/ ClevAir incorporates a momentary push-button switch on
its rear panel (refer to
Figure 1.2) for switching the device on and off. A soft turn off design
prevents accidental turn off while ventilating, by allowing the software
to control the shut down procedure
In the event that the device is currently ventilating, a warning message
appears on the GUI advising the operator first to pause the ventilation.
In Stand-by mode the CPU performs a shutdown in an orderly fashion.
Released
M1186102, Revision 3, 2011 49

If the On/ Off switch is pressed for a prolonged period (more than 25
seconds), the system shuts down immediately. This facilitates an
emergency shutdown in the event there is no response from the touch
screen.
3.3.2. Power Input Components

External AC Power is connected to device via the AC inlet module. A slow
blow fuse is included in the onward AC line to the power supply which is
accessible at the rear panel (refer to
Figure 1.2).
3.3.3. Power Supply Assembly

The iVent101/ ClevAir incorporates an OEM medical power grade power
supply module. The power supply provides a constant output of
25.5VDC across a full range of input voltage (90VAC – 264VAC, 47 –
63Hz).
3.3.4. External DC Power

The iVent101/ ClevAir may be run from an external DC power source
through a connection located at the device’s rear panel (refer to
Figure 1.2). Typically, external DC power is provided to the device by an
external battery, but other sources meeting its input requirements of
24VDC (up to 5A) may also be used. External DC power is the second
highest priority power source to the ventilator and if available powers
the device in the event of AC power loss. A pin on the External DC input
connector signals the system to engage the integrated battery charger.
This way a non-diminishing DC source such as a generator can be used to
charge the integrated battery.
Released
50 M1186102, Revision 3, 2011

Theory of Operation
3.3.5. Integrated Battery and Gas Gauge

The iVent101/ ClevAir contains an integrated battery pack which will
sustain operation when the AC mains or external DC is not available. The
standard integrated battery, supplied with each device, has a nominal
capacity of 2.7Ah (ampere hours), which can sustain the device for up to
4 hours (refer to the note below). The option of an extended integrated
battery also exists. This item has a nominal capacity of 4.5 Ah and will
sustain the device for up to 6.5 hours (refer to the note below). Both
battery types use a NiMH (Nickel Metal Hydride) chemistry, which has a
proven history of reliability in homecare ventilation.
Included within the enclosure for each of the integrated battery types is
a Gas Gauge PCB used to monitor and maintain a record of the battery
pack’s currently available capacity. The gas gauge measures the current
flowing into and out of the battery by measuring the voltage drop across
a sensing resistor.
Integrated batteries and gas gauges are replaced as single field replacement
units, independent replacement should not be attempted.
Note: The maximum run time listed is based on a new fully charged
battery, in optimal condition and running under nominal ventilation
settings.
Figure 3.10: Integrated battery

Released
M1186102, Revision 3, 2011 51

3.3.6. Gas Gauge Interface PCB

The Gas Gauge Interface PCB is a simple interconnection board between
the integrated battery and the Main PCB. This circuit uses a high quality
and high reliability connector to support multiple insertions and
extractions of a battery pack.
Figure 3.11: Gas gauge interface PCB Figure 3.12: Backup battery
3.3.7. Backup Battery

The electronic system design incorporates a small backup battery. The
backup battery is used to power the CPU and peripherals in the event of
a total loss of power, whether intentional, as in a hot swap, or
unintentional when a battery is fully depleted.
The backup battery can neither sustain ventilation nor graphical user
interface operation but it can provide power to the CPU and a piezo
buzzer used as an audible alarm backup. On restoration of primary
power, if the backup battery has not yet been depleted, the device
returns immediately to its previous operation.
The backup battery is a lithium-ion polymer battery with a nominal
capacity of 580mAh, and is expected to provide power to the system,
under these conditions, for up to 5 minutes.
Released
52 M1186102, Revision 3, 2011

Theory of Operation
3.3.8. Main PCB
The Main PCB provides the vast majority of the functions fundamental
to the operation of the device. The following primary system functions
are performed by the Main PCB:
 Ventilation control and GUI: OMAP
 HW control: FPGA
 Power Management System
 Watchdog
 ADC (Analog Digital Converter)
 Flow and Pressure Transducers
 External Interfaces
Figure 3.13: Main PCB

Released
M1186102, Revision 3, 2011 53

3.3.9. External Interfaces

The Main PCB includes interfaces to support Ethernet, RS232, SpO2 and
USB communication methods. Only the USB communication port is
utilized for field applications.
In addition to the communication interfaces, the Main PCB also includes
a MMC/SD memory card slot. The use of this card slot is reserved for
future product development.
3.3.10. Pneumatic Unit PCB

A circuit board is Included inside the pneumatic unit. It performs the
following functions:
 The Pneumatic Unit PCB communicates the PU version information
to the software enabling the software controls to be optimized for
the applicable hardware.
 The PCB records the running hours for the turbine.
 A temperature measurement circuit on the board continuously
monitors the internal temperature of the pneumatics.
The Pneumatic Unit PCB may only be replaced as a part of the complete
pneumatic unit.
3.3.11. Interface PCB

The Interface PCB is responsible for providing the interconnection
between the main processing parts of the graphical user interface
components. Control signals to and from the Main PCB pass through the
interface PCB and are relayed onward via cables to the LCD Display,
Touch Panel and Front Panel LEDs.
3.3.12. LCD Touch Panel

The graphical user interface for the iVent101/ ClevAir is designed around
the LCD touch panel. The touch panel incorporates a 7 inch VGA display
with an integrated touch panel. The touch panel uses a resistive
technology to sense and respond to the operator interaction with the
device.
Released
54 M1186102, Revision 3, 2011

Theory of Operation
3.3.13. Backlight Inverter PCB

The Backlight Inverter PCB is responsible for generating the high voltage
alternating current that is required to illuminate the backlight, which is
integral to the LCD touch panel. The backlight inverter receives a low
power DC supply from the Main PCB, and after inversion outputs,
approximately 550Vrms.
3.3.14. Front Panel LEDs

Three LEDs indicators are mounted on the top enclosure:
A LED indicating ventilator activity (green when the device is on)
A LED indicating battery charging status as follow:
Amber – indicating on charging.
Blue – In conjunction with the battery status indicators (see
Understanding the Power Sources, section 2.1) indicates charging
completion.
An alarm indicator LED (red whenever an alarm condition is active).
3.3.15. Main Alarm Speaker

The iVent101/ ClevAir is equipped with two audible means for notifying
the operator. The primary among these is the main alarm speaker. All
alarm conditions in the iVent101/ ClevAir are prioritized and
accompanied with the appropriate alarm sound (as per requirements of
EN475). In the event of a failure in the main alarm speaker the device
also has a piezo alarm located on the Main PCB which serves as a
backup.
3.3.16. Cooling System

The iVent101 incorporates dual cooling fans in order to ensure adequate
cooling is provided for the entire system. The fans are positioned on the
enclosure at the cooling outlet vents. Cooling airflow enters the system
through unfiltered cooling vents on bottom chassis of the device.
Cooling air flow is then drawn up and around the pneumatic enclosure
over the Main PCB and exits through the outlet vents.
Released
M1186102, Revision 3, 2011 55

3.4. The iVent101/ ClevAir Software

The iVent101/ ClevAir is a microprocessor driven, software controlled
ventilator platform. The software for the iVent101/ ClevAir has a
modular structure with individual modules performing the following
primary tasks:
 Controls and manages the entire ventilation process, controlling the
device’s breath delivery pneumatics via their interaction with the
electronic system.
 Provides overall control and management of the system.
 Manages the error handling in the ventilator system, detecting error
conditions and initiating the appropriate responses.
 Enables operator interaction with the graphical user interface by means
of the LCD touch panel.
 Controls the power management of the system.
 Through the service module manages maintenance and calibration
procedures.
Released
56 M1186102, Revision 3, 2011

Service and General Settings Screens
Section 4: Service and General Settings Screens

This section will describe the Information, General Configuration, and
Services screens of the iVent101. These screens provide the technical
information of the ventilator, and enable configuration, testing,
calibration, and updating of the iVent101.
4.1. The Information screen

To open the Information Screen:
1. Tap the Information ( ) button, located on the lower left side of the
screen.
Figure 4.1: The Information screen
The Information screen contains the following information:

 Software Version – The current software version installed on the
device.
 Therapy Time – View the time the ventilator has been in use by a
specific patient and reset the use timer of the ventilator
Note: This timer is resettable through the expert service menu under therapy time tab.
 Langpack Version – Display which langpack is installed on the iVent
 Last Calibration – Lists the date and time when the calibration
procedure was last performed.
 Last VVT – Lists the date and time when the VVT procedure was
performed and succeeded.
Released
M1186102, Revision 3, 2011 57

4.2. General Configuration Screen

The General Configuration screen enables the operators and technician
to configure the following settings:
 Display – Setting the touch screen brightness and enabling the flip
screen option. Refer to section 4.2.2
 Sounds Levels – Setting the alarms and buttons sounds levels.
Refer to section 4.2.3
 Screen lock – setting the time for the screen lock. Refer to
section 4.2.4.
 Date and Time – Setting the time and date of the device. Refer to
section 4.2.5.
4.2.1. Accessing the General Configuration Screen

To access the iVent101 General Configuration screens:
1. From the Main screen tap Menu – General Config. The General
Configuration screen is displayed. The screen displays the last settings
that were applied.
2. On the left side of the screen, tap the button corresponding to the item
which you want to configure. The display on the right side changes
accordingly.
3. Change the settings and click Accept to confirm the changes and close
the screen.
Released
58 M1186102, Revision 3, 2011

4.2.2. Setting the Display parameters

You can change the screen brightness and set it to the level that is
suitable for the optimal user visibility and patient comfort. Lowering the
brightness also increases the battery life.
Note: Changing the brightness affects all of the views and screens
displayed on the touch screen.
To change the screen brightness:
1. In the General Configuration screen tap Display. The Brightness slider is
displayed on the right panel.
Figure 4.2: Brightness panel
2. Tap the left and right icons to change the brightness level. The slider
displays the brightness level accordingly.
3. Tap Accept all to save the settings and close the screen.
You can enable the flip screen option to allow viewing the iVent screen even
when the iVent is placed on the rear panel.
To enable Flip screen option
1. In the General Configuration screen tap enable and verify the green
indicator moved to enable
2. Tap Accept all to save the settings and close the screen
Released
M1186102, Revision 3, 2011 59

4.2.3. Settings the Sound Levels

You can adjust the button volume (the sound heard when tapping a
button) and the alarm’s sound.
Always ensure that the main alarm is clearly audible after
lowering the alarm sound level. If the alarm sound level is not
sufficient the sound level MUST be increased.
To set the sound levels:

1. In the General Configuration screen tap Sounds Levels. On the right
panel two sliders are displayed: Button Volume and Alarm Volume.
Figure 4.3: Sound levels panel
2. Tap the up or down arrows on each slider to change the sound level. The
slider displays the changed sound level accordingly.
3. Tap Accept to save the settings and close the screen.
Note: setting the button Volume to zero will mute the buttons sound
completely.
Released
60 M1186102, Revision 3, 2011


4.2.4. Setting the Auto Screen Lock Time
The default setting of the automatic screen lock is 3 minutes. You can
change the time before the screen lock is activated to between 1 to 60
minutes, or to disable it.
Notes:
1. When an alarm is activated it will appears on all the screens with the
brightness set as defined in the Set Brightness panel.
2. Using the screen saver may provide longer operating time while using
the battery power source.
To change the auto lock screen settings:
1. In the General Configuration screen tap Screen Lock. The lock screen
slider is displayed on the right panel.
Figure 4.4: Auto screen lock panel
2. Tap the up and down arrows to change the screen lock time. The slider
displays the changed time accordingly.
Select the Disable Auto Lock to enable or disable the screen lock (works
as a toggle). When the box is selected the automatic activation of the lock
screen is disabled.
If you enabled the screen lock the screen saver options are displayed.
Note: the screen-saver options are not available when the Auto Lock is
disabled.
3. Select the Enable Screen Saver box to enable or disable the screen-saver
(works as a toggle). When the box is selected the screen saver is
enabled.
4. Tap the relevant screen saver option you want: Dim or Screen Off.
Released
M1186102, Revision 3, 2011 61


Released
62 M1186102, Revision 3, 2011

4.2.5. Setting the Time and Date

You can set the date and the time of the iVent101. Setting the time and
date changes the date display in the Main screen and in the logbooks.
To set the date & time:
1. In the General Configuration screen tap Date & Time. The Set Date and
Time panel is displayed on the right side of the screen.
Figure 4.5: Set date and time panel
2. Tap the up or down arrows of the settings that you want to change: Year,
Month, Day, Hour, or Minute.
Note: When changing the date, it may be possible to select a non-valid
date (such as 31-Feb). The ventilator, however, will not accept it, and the
date will remain the same.
3. Verify that the date and time you have inserted are the correct ones.
4. Verify that the green indicator is lit under the desired date format
5. Tap Accept all to save the settings and close the screen.
6. Examine the time and date display at lower right side of the Main screen
to verify that the date and time have been changed and that they are
correct.
Released
M1186102, Revision 3, 2011 63

4.3. Clinical Configuration Screen

The Clinical Configuration screen enables the operators and technician
to configure the following settings:
 Timing Preferences – Setting the desired timing preferences
option. Refer to section 4.10.1 in the User Manual
 Profiles – Setting number of preset profiles to be used. Refer to
section 4.10.2 in the User Manual
 Enable O2 – Enabling the O2 sensors and monitoring. Refer to
section 4.3.1.
4.3.1. Accessing the Clinical Configuration Screen

To access the iVent101 Clinical Configuration screens:
1. From the Main screen tap Menu – Clinical Config. The Clinical
Configuration screen is displayed. The screen displays the last settings that
were applied.
2. On the left side of the screen, tap the button corresponding to the item
which you want to configure. The display on the right side changes
accordingly.
3. Change the settings and click Accept to confirm the changes and close
the screen.
4.3.2. Enabling the O2 Sensor

By default the Oxygen sensors, and associated FiO2 monitoring and
alarms are disabled, in order to prevent false O2 alarms. In applications
where the FiO2 monitoring is needed you can enable the oxygen
measuring sensors, which provides monitoring and associated alarms for
the delivered FiO2.
Notes:
1. Not all iVent101 models are supplied with an O2 sensor.
2. If O2 monitoring is enabled and no O2 sensor is installed the
ventilator will activate a "Missing O2 sensor" alarm.
To enable the O2 functionality:
1. In the Clinical Configuration screen tap Enable O2. The Enable O2 box is
displayed on the right panel.
Released
64 M1186102, Revision 3, 2011

Figure 4.6: Enable O2 Panel
2. Tap the box to select or clear it (works as a toggle). When the box is
selected the O2 functionality is enabled.
Released
M1186102, Revision 3, 2011 65

4.4. Service Screens

The Services screen provides the technician with a means to
troubleshoot, to calibrate, to test, and to update the software and
configuration of the device.
The Service screen is divided to two types, “User” & “Expert” screen,
depending on the desired service action.
Note: Not applicable for units with SW prior to 2.0
Technicians should select the Expert Services option:
Figure 4.7: Services screen

Released
66 M1186102, Revision 3, 2011

4.4.1. Expert Services Screen
Figure 4.8: Expert Services screen
The Expert Services screen contains the following options:

 Calibrations: Opens the Calibrations screen, which the technician may
use to perform periodic calibration of the ventilator’s pneumatic
system and transducers, tubing system, and O2 system if enabled.
Refer to Section 6: Calibration Procedures. On the right side of the
Calibrations button, the time and date when the last calibration was
performed is displayed.
 VVT: Opens the VVT screen, which the technician can use to perform a
VVT (Ventilator Verification Tests) procedure. Refer to section 5.2:
Ventilator Verification . On the right side of the VVT button, the last
time and date when the VVT was performed is displayed.
 Technical Info: Opens the Technical Info screen, which provides the
hardware and software attributes of the ventilator. The screen also
displays the time, date, and status of the most recent tests and
calibrations. On the right side of the Technical Info button, the PU
working hours are displayed. Refer to Section 4.4.4.
 SW Update: Initiates the SW update procedure. On the right side of the
Software Update button the last time the SW was updated is
displayed. See Section 4.4.5.
 Patient Configurations – Enables the technician to switch between One
limb or Two limbs configuration. On the right side of the Patient
Released
M1186102, Revision 3, 2011 67

Configuration button the current configuration is displayed. Refer to

Section 4.4.6.
 Languages – Enables the technician to alter the ventilator’s current
operating language. Refer to section 4.4.7.
 Therapy Time3 – Present the Therapy Time counter and enable
resetting the counter. Refer to section 4.4.8
 Advanced– Opens the Advanced Services screen, refer to Figure 4.9
below. The Advanced Services screen enables access of further service
functions, which includes:
 Copy Log Files – Enables errors and events to be uploaded to the USB
flash drive (Disk on Key). Refer to section 4.4.9.
 Setup Configuration – Enables uploading specific models configuration to
the device. Refer to section 4.4.10.
 Enable TCP/IP – Providing a connection to the ventilator through the
Ethernet connector. Refer to section 4.4.11
 Languages Update – Enables uploading new languages packages to the
device. Refer to section 4.4.12.
 Copy Stored Data3 – Enables copying stored data to a USB flash drive.
Figure 4.9: Advanced services screen
3
Not applicable for units with SW version prior to 2.0
Released
68 M1186102, Revision 3, 2011

4.4.2. Accessing the services screens

The service screen access button is available under Basic, Night and
Clinical View
Access to the Clinical View is locked to prevent accidental changes in
settings. To unlock access put your finger on the three dots on the left
side of the View Bar and drag your finger to the right. The icon changes
to enabled, tap it to open Clinical View
To access the clinical view:
1. Tap on the View button
2. View select screen is appeared
Slide to the right
Figure 4.10: Select view screen
3. Tap, hold and slide from left to right the slider on the bottom
(Three dots mark the slider start position)
4. Completing the slide will enable the Clinical View option
4.4.3. Accessing the Expert Services Screen

The Expert Services screen is password protected, preventing an
unauthorized entry to sensitive procedures such as VVT and calibration.
Released
M1186102, Revision 3, 2011 69

To access the Expert Services screen:

1. Ensure that the ventilator is in Clinical view or switch to it.
2. On the iVent101 Main screen tap Menu – Services – Expert Services. The
Services Password screen is displayed.
Figure 4.11: Services password screen
3. Type the password: 1907

4. Tap Enter. The Services screen is displayed (refer to Figure 4.8).
Note Different SW versions may have different passwords. Consult the

Technical Notes regarding the correct password.
4.4.4. Technical Info Screen

The Technical Info screen displays various technical information
regarding the ventilator hardware and software configuration, and tests
and calibrations procedures which have been performed on the
ventilator.
To open the Technical Info screen:
 On the Services screen tap the Technical Info button to open the
Technical Info screen.
Released
70 M1186102, Revision 3, 2011

Figure 4.12: Technical Info screen
The following information is displayed in the Technical Info screen:

 Board Serial Number – The serial number of the Main PCB board.
 PU Board Serial Number: The serial number of the pneumatic unit.
 Board R&D Version – The version of the Main PCB board.
 PU Board R&D Version – The version of the pneumatic unit.
 Board Eng Version – The manufacturing version number of the Main
PCB board.
 PU Board Eng Version – The manufacturing version number of the
Pneumatic Unit PCB.
device and the SW update status
Note: In previous versions the update status always appears as “Not
Performed.”
 Total PU Working Hours – The total working hours of the ventilator’s
pneumatic system.
performed. On the right side the status of the last VVT is displayed:
succeeded or failed.
 Last OVT – The last time that OVT procedure was performed. On the
right side the status of the last OVT is displayed: succeeded or failed.
Released
M1186102, Revision 3, 2011 71

4.4.5. Software Update

The Software Update button initiates the process of updating the
software version.
This section describes in details the complete software update
procedure, including a number of preparatory steps.
Note SW Version 2.0 prevents downgrading to an earlier versions to
prevent data loss
4.4.5.1. Preparation for Software Update:

The Software updated packages are available by means of disk. Refer to
section 11.2.6: iVent Software
A technical bulletin accompanies each new software release defining the
changes included. Verify that the SW you upgrade is according to the
version specified in the Technical bulletin.
To prepare the software update:
1. Download the iVent101 software file (RAR archive file with tar.gz ending)
to a convenient location on your hard drive.
2. Insert a USB flash drive (memory stick) into your computer.
Note: Make sure to use the USB flash drive that is supplies with the
technician kit
3. From your computer open Explorer and browse to view the USB flash
drive contents.
4. Remove any previous iVent101 software version from the USB flash
drive.
5. Create a new folder on the USB flash drive called ‘iVent’.
Note: The ‘iVent' folder name is case sensitive. Verify that the name is
written correctly.
6. Open the software archive using WINRAR or a similar software, and
extract its content to the iVent folder on the USB flash drive.
Released
72 M1186102, Revision 3, 2011


4.4.5.2. Software Update Procedure
Verify that you have new iVent101 software version before starting the
update process.
To update the iVent SW version:
1. Insert the USB flash drive to the USB port of the ventilator. Refer to
Figure 1.2: The iVent101/ ClevAir (rear view).
2. Enter the Services screen as described in section4.4.2.
3. On the Services screen tap the Software Update. The SW Update box is
displayed.
Figure 4.13: Software update box
4. Tap Update.
The ventilator locates the software installer within the USB flash
drive and starts the update.
The update process may take up to 15 minutes during which time
the device should be left undisturbed. During the update procedure
the device displays a blank screen for a period of time.
Note: SW versions > 1.2.3 will display progress bar during
installation
During the update, the device emits a continuous beep from the
buzzers, which is normal part of the process.
Note: when the process is complete, no confirmation box is displayed
and you are returned to the Main screen.
Note: If after the 15 minutes the device fails to reboot and operate as
normal remove the USB flash drive, reboot and verify that the device
Released
M1186102, Revision 3, 2011 73

operates. Verify the SW version in the Information screen. If the SW was

not updated you can then restart the update procedure
5. Remove the USB flash drive from the USB port.
6. In the event that the software update is interrupted and the device left
without operating system contact your VersaMed technical support
representative.
After SW update you MUST perform Calibration and VVT

procedures before starting ventilation.
Note: The Services password may have change with the new SW.
Consult the Technical Notes or VersaMed representative.
4.4.6. Patient Configuration

The iVent101 can work with One limb or Two limb patient circuit
configuration. The patient configuration must be set according to the
device hardware configuration and the type of circuit being used.
To replace the hardware configuration, refer to section 10.3.3 and
section 10.3.4 .
In a One limb configuration the breath delivery is controlled using
internal flow and pressure measurements. The patient pressure is
monitored proximally and the exhalation valve rive is provided via a
connector on the front of the ventilator.
In a Two limb configuration, the breath delivery is also controlled using
internal flow and pressure measurements. The patient pressure and
exhaled flow (volume) are monitored distally inside the exhalation
compartment.
As each configuration uses different array of measurements attempting
to ventilate with the wrong configuration set will result in incorrect
measurements and redundant alarms.
To change the patient configuration:
1. On the Services screen tap Patient Configuration. The Patient
Configuration screen is displayed.
Released
74 M1186102, Revision 3, 2011

Figure 4.14: Patient configuration screen
2. Tap the check box which reflects the ventilator’s hardware setup, either
One Limb or Two Limbs.
3. Tap Accept. The patient configuration is changed accordingly.
4.4.7. Settings the Language

The Languages Configuration screen enables the technician to configure
the language of the device interface.
Since the GUI will restart to apply the language change, the
ventilator has to be in Standby mode. Pause the ventilation before
changing the language setting.
To set the iVent101 Language:

1. In the Services screen tap Languages. The Languages Configuration
screen is displayed.
Released
M1186102, Revision 3, 2011 75

Figure 4.15: Languages configuration screen
2. Tap the language you want. The language is highlighted.

3. Tap Accept. A message is displayed, informing that the GUI must be
restarted.
Figure 4.16: Restart GUI confirmation box
4. Tap Restart. After a few seconds the GUI is restarted with the configured
language.
If you tap Cancel, next time the GUI is restarted it will start with
the language you have selected during the Set language process.
4.4.8. Resetting Therapy Time Counter

Therapy Time present the total working hours of the ventilator’s
pneumatic unit since the last reset of the Therapy Time counter reset.
Released
76 M1186102, Revision 3, 2011


To reset the Therapy Time counter:
1. In the Expert Services screen tap the Therapy Time button to
open the Therapy Time screen.
Figure 4.17: Therapy Time reset box
2. Tap the reset button in order to reset the Therapy Time counter
4.4.9. Copy Log File

The Copy Log File button initiates the process of copying a log file to a
USB flash drive (memory stick). Since the logbook memory has a limited
capacity, copying the log files enables the technician to send for
investigation older events logs.
To copy log files:
1. Insert USB Flash drive (Disk on Key) to the USB port (refer to
Figure 1.2).
technician kit
2. On the Services screen tap the Advanced… button. The Advanced
Services screen is displayed.
3. Tap the Copy Log Files button.
The device verifies that a USB flash drive is connected. It creates a
new folder ‘101logs’ and copies the files into it.
4.4.10. Setup Configuration

Setup Configurations screen enables to set up different configurations
for the ventilator, enabling or disabling various options.
Released
M1186102, Revision 3, 2011 77

The Setup configuration packages are available by means of disk or USB

flash drive.
Note: This procedure cannot be performed during ventilation.
To configure the setup:
1. Download the Setup configuration file (RAR file) to a convenient location
on your hard drive.
technician kit
drive contents.
4. Create a new folder on the USB flash drive called ‘Setup’.
Note: The ‘Setup’ folder name is case sensitive. Verify that the name is
written correctly.
5. Copy the encrypted file containing the configuration for the target device
to an USB flash drive (Disk on Key), into the Setup folder.
6. Insert the USB flash drive with the “Setup Configuration” folder into the
USB Port (see
Figure 1.2).
7. On the Services screen tap the Advanced… button. The Advanced
Services screen is displayed.
8. Tap the Setup Configuration button.
9. The Setup Configuration box is displayed.
The device verifies that a USB flash drive is connected. It starts
loading the configuration files from the USB flash drive.
The setup procedure takes several minutes during which time the
device should be left undisturbed. When the setup procedure is
complete the device restarts and the Main screen will redisplayed.
During restart the device will emits continuous beeping noise from
the buzzers.
4.4.11. Enable TCP/IP

For factory use only.
Released
78 M1186102, Revision 3, 2011


4.4.12. Languages Package Update
The languages updated packages are available by means of disk.
A technical bulletin accompanies each new Languages Package release
defining the changes included. Verify that the Languages Package you
upgrade is according to the version specified in the Technical bulletin.
The languages package is a separated package, and can be updated
without Software update.
The Language update package described below as two steps procedure:
preparation for the package update, and the update procedure.
To prepare for Language Package update:
1. Download the Language Package file (RAR file) to a convenient location
on your hard drive.
technician kit
drive contents.
4. Create a new folder on the USB flash drive called ‘iVent’.
Note: The ‘iVent’ folder name is case sensitive. Verify that the name is
written correctly.
5. Open the Language Package archive using WINRAR or a similar software,
and extract its content to the iVent folder on the USB flash drive.
Verify that you have new iVent101 Language Package version before
starting the update process.
Note: This procedure cannot be performed during ventilation.
To update the languages version:
1. Insert the USB flash drive to the USB port of the ventilator. Refer to
Figure 1.2: The iVent101/ ClevAir (rear view).
2. Enter the Services screen as described in section 4.4.2.
3. In the Service screen tap Advanced… - Languages Update. The
Languages Update box is displayed. The Language package is updated
automatically.
4. When the Language package has been updated the Restart button in the
message box will displayed.
Released
M1186102, Revision 3, 2011 79

Figure 4.18: The Language Update Box
5. Tap Restart. The iVent101 will restart with the new Language Package.
6. Remove the USB flash drive from the USB port.
4.4.13. Copy Stored Data

The system allows copying stored data to a USB flash drive (Thumb
drive).
To copy stored data:
1. Insert USB Flash drive (Disk on Key) to the USB port (refer to
Figure 1.2).
technician kit
2. On Advanced Services screen tap the Copy Stored Data button
to open the Copy Stored Data window
Figure 4.19: Copy stored data box

Released
80 M1186102, Revision 3, 2011

The device verifies that a USB flash drive is connected. It creates a new
folder ‘101DataStorage’ and copies the files into it.
Released
M1186102, Revision 3, 2011 81

Section 5: Testing Procedures

This section describes two sets of testing procedures, which are
performed periodically on the device:
 Patient Tube Testing (OVT) – Refer to section 5.1 below.
 VVT – Refer to section 5.2.
Use the items that are in the Technician Kit for performing the test procedures
in this section, You MUST use the exhalation valve included in the kit.
5.1. Patient Tube Testing Procedure

The Patient Tube Testing (also known as OVT -Operational Verification
Test) verifies the integrity of the patient circuit. This procedure must be
performed each time that the patient circuit is connected to the
iVent101, after VVT or calibration, and for troubleshooting purposes
when the ventilator performance suggests it may be necessary.
This procedure checks the system for leak as well as verifying that the
current patient circuit compensation is valid.
The Patient Tubing Test procedure takes approximately 30 seconds to
complete.
The Patient Tube Testing must not be performed while the device is
ventilating. The button is disabled when the device is ventilating.
Required Equipment:
 One Limb or Two limb patient circuit according to the configuration.
 22mm sealing cap
Test Procedure:
1. Ensure that device is powered up and in Standby mode.
2. Connect a patient circuit to the Inspiratory and Expiratory ports
accordingly (refer to Figure 1.1).
3. From the Main screen tap the (Patient Tube Testing) button.
The Patient Tube Testing screen is displayed.
Released
82 M1186102, Revision 3, 2011

Testing Procedures
Figure 5.1: Patient tube testing screen (Two limb configuration)
Figure 5.2: Patient tube testing screen (One limb configuration)
4. Seal off, using a 22mm sealing cap, the patient wye.

5. Tap Start. The patient tube testing proceeds automatically, and includes
the following steps:
The iVent energizes the motor, with a predefined RPM to reach
50cmH2O. When 50cmH20 is reached, the iVent opens the POV.
The following criteria are checked:
Patient Tube i. If the inspiration flow sensor reading is above 100 ml/s the
Testing pass Patient Tube Testing fails.
Criteria
ii. In Two limb configuration, if the exhalation flow sensors
reading is above 100 ml/s the Patient Tube Testing fails.
iii. If the blower pressure or the patient pressure does not reach
the target pressure, with accuracy limit of +4 cmH2O the
Patient Tube Testing fails.
Released
M1186102, Revision 3, 2011 83

6. The iVent closes the POV and activates the Hold solenoid.
7. The iVent reopens the POV.
The following criteria are checked:
i. If the inspiratory flow sensor reading is less than 1000ml/s the
Patient Tube
Testing pass
Patient Tube Testing fails.
Criteria ii. In Two limb configuration if the exhalation flow sensors
reading is less than 1000 ml/s the Patient Tube Testing fails.
8. The iVent will attempt to perform calibration of the compliance
(ml/cmH2O) and the resistance (cmH2O/lpm) of the patient tubing
system. Doing it by ventilate 10 times, and measures the tube
compliance.
9. When the test ends a message appears on the lower left side of the
screen: “Test passed successfully.”
10. Tap Save, and remove the 22mm sealing cap from the patient wye.
If the ventilator fails the Patient Tube Testing:

1. Verify that the patient wye and the exhalation valve are properly sealed.
2. Verify that the patient circuit is properly connected to the ventilator.
3. In Two limb configuration verify that the exhalation valve is correctly
assembled and seated.
4. In One limb configuration verify that the exhalation valve control and
proximal pressure tubes are connected properly.
5. Repeat the Patient Tube Testing
If, after doing all the above, the Patient Tube Testing fails:
1. Replace the patient circuit and repeat the test.
2. Replace the exhalation valve and repeat the test.
3. If fails: perform a Ventilator Ventilation Tests, refer to section 5.2:
Ventilator Verification below.
Released
84 M1186102, Revision 3, 2011

Testing Procedures
5.2. Ventilator Verification Test

The Ventilator Verification Test (VVT) is a set of tests designed to
confirm the functionality of the ventilator’s critical systems.
5.2.1. When to run VVT

The VVT procedure is recommended at the following intervals or after
performing the following procedures:
 Every time that “VVT Required” alarm pops up on the Main screen.
 Planned maintenance, following the replacement of the pneumatic unit
at 15,000 hours.
 Following any ventilator repair.
 Following software update.
 During troubleshooting of the device.
5.2.2. Required Equipment:

Refer to Table 10-1: Service tooling and materials for a list of the
equipment required to perform the performance the ventilator
verification tests.
Note: The technician kit includes Technician Exhalation Valve and Technician
Patient Circuit that are required for the service procedures
5.2.3. Accessing the VVT

The VVT procedures are accessed from the VVT screen, a sub-screen of
the Expert Services screen.
The VVT procedure must not be performed while the device is
ventilating. The VVT button is disabled when the device is ventilating.
To start the VVT:
1. Power up the ventilator.
2. Connect a patient circuit to the device.
3. Connect 2L Test Lung and Rp 20 Resistor to the circuit’s wye.
Released
M1186102, Revision 3, 2011 85

4. From the Clinical view tap Menu – Services – Expert Services (refer to
section 4.4.2)
5. In the Expert Services screen, tap VVT.
The VVT screen is displayed, as shown in Figure 5.3 below:
Figure 5.3: VVT screen
6. Select one of the following options:

 Tap Run All to perform the entire VVT procedure.
 To run a single section of the VVT tests tap the
arrow near the required section and then Start.
5.2.4. Pneumatic Unit test

The first VVT test option Pneumatic Unit verifies the correct operation
of the pneumatic components through a series of three tests:
 Pressure test
 Flow test
 Leak test
The following sections provide a detailed description of the test.
Note: Make sure sensors calibration has pass successfully prior to the
Pneumatic Unit test.
Released
86 M1186102, Revision 3, 2011

Testing Procedures
5.2.4.1. Pressure Test
The VVT pressure test verifies systematically the operation of the
following ventilator components:
 Proportional Outlet Valve (POV)
 Blower Motor
 Blower pressure sensor
 Patient pressure sensor
 Exhalation valve
The test procedure takes approximately 15 seconds to complete.
Test Procedure:
1. From the Pneumatic Unit screen tap the arrow near the Pressure Test.
The Pressure Test VVT screen is displayed.
Figure 5.4: Pressure test VVT screen (Two limb configuration)
Figure 5.5. Pressure test VVT screen (One limb configuration)
2. The Pressure Test VVT screen displays instruction on how to configure

the device and the test equipment..
Released
M1186102, Revision 3, 2011 87

3. Seal the patient wye with a 22mm sealing cap.

4. Tap Start when the patient wye has been sealed.
5. The turbine is accelerated to reach a predefined pressure.
6. POV test – the POV is opened and closed.
If the POV stuck, i.e. unable to reach either the fully open or fully
closed position, the test fails.
7. The POV is opened once more.
Pressure Test 8. Blower pressure test – the measured pressure should be within
pass criteria + 5cmH20 of the target pressure.
If the measured pressure falls outside this range the test fails.
9. Patient pressure test – the measured pressure should be within
+ 5cmH20 of the target pressure.
If the measured pressure falls outside this range (+ 5cmH20) the
test fails.
10. Exhalation test – the ventilator performs Easy Exhale.
If the measured patient pressure is found to be greater than 70% of
the target pressure the test fails.
5.2.4.2. Flow Test

VVT Flow Test verifies the operation of the following ventilator
components:
 Exhalation flow sensor
 Inspiration flow sensor
 Hold solenoid valve
The flow test requires the use of TSI flow meter. It is highly
recommended to power up the flow meter and allow it to warm up for a
minimum of 15 minutes prior to performing the tests.
The test procedure takes approximately 1 minute to complete.
Test Procedure:
The Flow test screen is displayed automatically when the Pressure test is
completed.
Released
88 M1186102, Revision 3, 2011

Testing Procedures
Figure 5.6: Flow test VVT screen (Two limb configuration)
Figure 5.7. Flow test VVT screen (one limb configuration)
1. The Flow Test screen displays instruction on how to configure the device
and test equipment.
2. When performing the Flow test with Two limb configuration, connect the
TSI to the expiratory port. Ensure that the flow arrow on the TSI is
oriented correctly using the extension tube.
When performing the flow test with One limb configuration, connect
the TSI to the inspiratory port using the extension tube. Ensure that
the flow arrow on the TSI is oriented correctly.
3. Connected the expiratory limb to the TSI outlet.
4. Connect the TSI power supply to the flow meter and connect it to the
mains supply.
5. Connect the serial cable from the TSI to the ventilator USB port using
appropriate USB adaptor.
6. Seal the patient wye with 22mm sealing cup.
Released
M1186102, Revision 3, 2011 89

7. Tap Start when the TSI is connected.

8. The motor runs in a series of predetermined RPM settings.
9. The iVent101/ ClevAir reads the flow and average the reading for each
set.
The test fails if any of the following criteria are met:
Flow Test  The TSI flow is below the minimum acceptable value for any of the RPM
pass settings.
criteria
 Inspiratory flow exceeds the TSI flow reading by +15%.
 Expiratory flow (Two limb configuration only) exceeds the TSI flow
reading by +15%.
5.2.4.3. Leak Test

VVT Leak Test verifies the operation of the following ventilator
components:
 One way valve
 Internal tubing
 Hold pump
 Hold solenoid valve
The leak test will take approximately 15 seconds to complete.
Released
90 M1186102, Revision 3, 2011

Testing Procedures
Test Procedure:
The Leak Test VVT screen is displayed automatically when the flow test
is completed.
Figure 5.8: Leak test VVT screen Two limb configuration)
Figure 5.9. Leak test VVT screen (one limb configuration)
1. The Leak Test screen displays instruction on how to configure the device
and test equipment.
Leak Test 2. Disconnect the TSI from the test setup and set aside.
Procedure
3. Connect the appropriate type of tubing system to the device.
4. Connect an Rp 20 resistor and 2L test lung to the wye.
5. Tap Start when the test lung is connected.
6. The ventilator delivers flow to the patient system and energizes the hold
pump and solenoid to seal the exhalation valve.
7. The Ventilator closes the POV and monitors the patient pressure and
inspiratory and expiratory flow sensors.
Released
M1186102, Revision 3, 2011 91

Leak test  If a negative flow is detected by the inspiratory flow sensor the test
pass fails, indicating a leak through the check valve.
criteria
 If the flow is detected by the expiratory flow sensor the test fails,
indicating a leak through the exhalation valve or problem in the hold
circuit.
8. When the test is completed, the VVT results for the Pneumatic Unit are
displayed on the right panel of the screen.
If the Pneumatic unit VVT fails:
TEST FAILED DESCRIPTION TROUBLESHOOTING
1. Make sure all tubes and TSI are
intact and well connected as
describe in the instructions.
2. Make sure the tube type that
connected to the device is
compatible with the tube
configuration settings in
Technical Config screen
1. Patient tube is not connected
(1 Limb / 2 Limbs).
properly.
3. Perform sensors calibration
2. Incorrect tube type.
(section 6.5.2) and then Perform
3. Inner tubes to the pressure VVT again.
sensors are not connected
4. If the test fails, run Factory
properly.
Pressure calibration – PU Devices (section
test 4. Blower pressure sensor is 6.4.4), and perform VVT again.
malfunctioning.
5. Replace the technician
5. Patient pressure sensor is exhalation valve (section 10.3.2).
malfunctioning.
6. If the test fails open the machine
6. POV is stuck. and verify that all tubes to the
7. Turbine is malfunctioning. pressure sensors are not kinked
and well connected and in the
correct place.
7. Replace the main PCB (section
10.3.12).
8. Replace the Pneumatic unit
(section 10.3.13).
1. If pressure test fails, see above.

Inlet
Inlet port filter is blocked. 2. Replace the inlet filter.
Pressure
Released
92 M1186102, Revision 3, 2011

Testing Procedures
1. Make sure that tubes and TSI are
intact and well connected as
describe in the instructions.
2. Make sure the tube type that
connected to the machine is
compatible with the tube
(1 Limb / 2 Limbs).
1. Patient tube is not connected 3. Replace the technician
properly. exhalation valve (section 10.3.2).
2. Incorrect tube type. 4. Perform sensors calibration
(section 6.5.2), and then perform
3. Occluded exhalation valve. VVT again.
4. Inner tubes to the flow sensors 5. If the test fails, run Factory
Flow are not connected properly.
calibration – PU Devices (section
Test 5. Inhale flow sensor is 6.4.4), and then perform VVT
malfunctioning. again.
6. Exhale flow sensor is 6. If the test fails open the device
malfunctioning. and verify that all tubes to the
flow sensors are not kinked and
well-connected and in the
correct place.
7. Replace the Pump/Solenoid
harness (section 10.3.18).
8. Replace the main PCB (section
10.3.12).
9. Replace the Pneumatic unit
(section 10.3.13).
Released
M1186102, Revision 3, 2011 93


1. Make sure that tubes and 2L test
lung are intact and well
connected as describe in the
instructions.
2. Make sure that the tube type
that connected to the machine
is compatible with the tube
(1 Limb / 2 Limbs).
3. Replace the technician
exhalation valve (section 10.3.2).
1. Patient tube is not connected
properly. 4. Perform sensors calibration
2. Incorrect tube type. (section 6.5.2), and then
perform VVT again.
3. Leakage in the exhalation valve.
5. If the test fails, run Factory
Leak 4. Inner tubes to the sensors are calibration – PU Devices (section
Test not connected properly.
6.4.4), and then perform VVT
5. Leakage in the Hold pump again.
/solenoid and tubing. 6. If the test fails open the device.
6. Hold solenoid is malfunctioning. Verify that all tubes to the flow
7. One-way valve has a leak. sensors, exhalation valve base
and Hold solenoid and pump are
not kinked and well-connected
and in the correct place.
7. Replace the Pump/ solenoid
harness PCB (section 10.3.18).
8. If the test fails replace the main
PCB (section 10.3.12).
9. If the test fails replace the
Pneumatic unit (section
10.3.13).
Released
94 M1186102, Revision 3, 2011

Testing Procedures
5.2.5. Power Tests

The VVT Power tests verify the following:
 iVent101 operation with all available power sources
 Source switching
 Integrated battery charging
A detailed description of each test is provide in following sections:
 AC Connected Test – section 5.2.5.1, below.
 External Connected Test – section 5.2.5.2.
 External Disconnected Test – section 5.2.5.3.
 AC Power Disconnected Test – section 5.2.5.4.
 Charger test – section 5.2.5.6.
Prior to performing the VVT Power test disconnect the Patient Circuit
from the ventilator.
5.2.5.1. AC Connected Test

The AC connected test verifies the operation of the device’s with mains
AC power is connected.
This test takes approximately 15 seconds to complete.
Test Procedure:
1. On the VVT screen tap the arrow near Power.
The AC power Connected Test screen is displayed.
Released
M1186102, Revision 3, 2011 95

Figure 5.10: AC connected test VVT screen
2. Tap Start.
3. The system runs two tests. .
The first test examines the AC power supply output, and fails if:
 AC power is not available at the mains outlet
 AC power does not reach the iVent101 due to malfunctioning
mains cable.
 AC power does not reach the power supply due to
malfunctioning internal wiring or burnt fuse.
 The output of the AC to DC power supply is not within the
AC power required range due to malfunctioning power supply or
test pass
criteria overload.
4. For the second test, the system disables all power sources except AC
power, and turns the turbine motor to full power.
The test fails if:
 The output of the AC to DC power supply is not within the required
range when fully loaded by the turbine.
Note: Since all other power sources are disabled, failure in this test will
cause the iVent101 to enter backup mode (touch screen turns off, a
continuous beep sounds) until power becomes available again.
5.2.5.2. External Connected Test

The External test verifies the operation of the device’s external battery,
if available.
The External Battery Connected Test requires the use of external DC
source. If an external DC source is not available the test should be
skipped.
This test takes approximately 15 seconds to complete.
Test Procedure
The External Connected VVT Test screen is displayed automatically
when the AC connected test is completed.
Released
96 M1186102, Revision 3, 2011

Testing Procedures
Figure 5.11: External connected test screen
1. Disconnect AC power.
2. Follow the onscreen instructions: connect an external DC source to the
iVent101.
3. Tap Start.
4. With AC unavailable, the iVent101/ ClevAir switches to external DC as
power source, and verifies the external DC is connected and within the
specified voltage range.
External The first test fails if:
battery
connected  External DC power is not connected.
pass criteria
 The External DC voltage is not between 19-33V.
5. For the second test the iVent101/ ClevAir disables the internal battery,
and turns the motor to full power.
The test fails if:
 External DC voltage is not between 19-33V when loaded by
the turbine.
Note: Since all other power sources are disabled or disconnected,

failure in this test will cause the iVent101 to enter backup mode (touch
screen turns off, a continuous beep sounds) until power becomes
available again.
5.2.5.3. External Disconnected test

The External Battery Disconnect test verifies the operation of the power
management circuit during switchover from external to Internal DC.
Released
M1186102, Revision 3, 2011 97

The External Connected Test requires the use of external DC source. If

an external DC source is not available the test should be skipped.
The test will take approximately 10 seconds to complete.
Test Procedure
The External Battery Disconnect Test VVT screen is displayed
automatically when the external battery test is completed.
Figure 5.12: External disconnect test VVT screen
1. Before starting this test, make sure a sufficiently charged internal battery
is inserted to the iVent101.
2. Follow the on screen instructions: connect the AC mains power and
disconnect the external source.
3. Tap Start.
4. The iVent101/ ClevAir disables the AC power.
With External DC disconnected, the system switches to the internal
battery. The test fails if the internal battery does not engage.
Released
98 M1186102, Revision 3, 2011

Testing Procedures
5.2.5.4. AC Disconnected Test

The AC Disconnect test verifies the operation of the power management
circuit during switchover from AC power to internal DC power.
This test will take approximately 5 seconds to complete.
Test Procedure
1. Before starting this test, make sure a sufficiently charged internal battery
is inserted to the iVent101.
2. Follow the onscreen instructions: disconnect the AC power cable from
the ventilator.
3. Tap Start.
4. The iVent101/ ClevAir verifies that the AC power is disconnected, and
disables the external DC rail.
With External AC disconnected and external DC disabled, the
system switches to the internal battery. The test fails if the internal
battery does not engage.
Note: Since all other power sources are disabled or disconnected, failure
in this test may cause the iVent101 to enter backup mode (touch screen
turns off, a continuous beep sounds) until power becomes available
again.
5.2.5.5. Internal Connected test

The Internal connected test VVT verifies the operation of the internal
battery.
This test will take approximately 5 seconds to complete.
Released
M1186102, Revision 3, 2011 99

Test Procedure:
1. The Internal connected test VVT screen is displayed automatically when
the AC disconnected test is completed.
Figure 5.13 Internal connected test
2. Follow the onscreen instructions: verify that the internal battery is

connected and the AC power source is disconnected.
3. Tap Start.
The test fails if the internal battery is not engaged.
Note: Since all other power sources are disabled or disconnected, failure
in this test may cause the iVent101 to enter backup mode (touch screen
turns off, a continuous beep sounds) until power becomes available
again.
5.2.5.6. Charger Test

The Charger test verifies the operation of the power management circuit
during the charging process, and additionally checks the integrated
battery itself.
This test will take 30 seconds to complete.
Test Procedure
The Charger Test VVT screen is displayed automatically when internal
connected test is completed.
Released
100 M1186102, Revision 3, 2011

Testing Procedures
Figure 5.14: Charger test VVT
1. Verify that the ventilator is connected to AC power, and tap Start.

2. The iVent101/ ClevAir disables the AC power and the External Battery
Charger Test (DC).
Procedure
If the Integrated Battery does not engaged, the test fails.
3. The iVent101/ ClevAir powers up the motor at maximum power for 4
seconds.
If the Integrated Battery voltage drops under load causing it to disengage
- the test fails.
4. The iVent101/ ClevAir enables the AC power and the external battery
(DC).
5. When the test is completed, the VVT results for the Power are displayed
on the right panel of the screen.
5.2.6. Sound Devices Test

The VVT Sound Devices tests verify the operation of the iVent speakers.
This procedure includes 3 tests:
1. Codec Test – Verify the operation of the iVent main speaker,
2. Piezo Test – Verify the operation of the iVent Piezo buzzer.
3. HW WD Buzzer Test – Verify the operation of the iVent Hardware
Watchdog buzzer.
Released
M1186102, Revision 3, 2011 101

Test procedure:
1. On the VVT screen tap the arrow near Sound Devices.
The Codec Test screen is displayed,
Figure 5.15: Codec Test Screen
2. Tap Start
3. A Sound is generated and confirmation box will appear, press Yes
if the sound is audible , fails if:
o The speaker is not connected to the main board
o The speaker is defected
4. The Piezo Test screen is displayed,
Figure 5.16: Piezo Test Screen
5. Tap Start
6. A Sound is generated and confirmation box will appear press Yes
o The buzzer is defected.
Released
102 M1186102, Revision 3, 2011

Testing Procedures
o Malfunction within the Main Board,
7. The HW WD Buzzer test VVT screen is displayed,
Figure 5.17: HW WD Buzzer Test Screen
8. Tap Start
9. A Sound is generated and confirmation box will appear press Yes
o The buzzer is defected.
o Malfunction within the Main Board,
5.2.7. Alarm LED Test

The VVT Alarm LED tests verify the operation of the iVent Alarm LED.
Test Procedure:
1. On the VVT screen tap the arrow near Alarm.
The Alarm LED Test screen is displayed,
Figure 5.18: Alarm LED Test Screen

Released
M1186102, Revision 3, 2011 103

2. Tap Start
3. The Alarm LED will blink in Red color and confirmation box will
appear, press Yes if the blinking LED is visible, fails if:
o LED Flat connector is not connected or defected
o Touch Cable is not connected or defected
o Malfunction within the Main Board
5.3. Completing the VVT Procedure

There are two ways to complete the VVT procedure:
 If you manually select which tests to perform, tap Close when you
finish running the tests. The VVT screen is closed.
 If you decide to run the entire tests, the VVT screen will closes
automatically and the results are displayed on the right side of the VVT
screen.
Figure 5.19: End of VVT procedure

Released
104 M1186102, Revision 3, 2011

Testing Procedures
If the Power VVT fails:
 AC power is not available  Check the AC mains power

at the mains outlet  Replace mains cable
 AC power does not reach  Check / replace the fuse (section
the iVent101 due to 10.3.6)
malfunctioning mains  Replace rear panel
cable.
 Replace power supply (section
 AC power does not reach 10.3.19)
AC connected
the power supply due to
test  Replace PCB board (section
malfunctioning internal
10.3.12)
wiring or burnt fuse.
 The output of the AC to DC
power supply is not within
the required range due to
malfunctioning power
supply or overload.
 Check DC source:
 voltage should be in the
range of 24 to 28V
 Output resistance should
 External DC power is not be below 0.8 ohm.
External connected.  Visually inspect DC cable
connected and connector for shorts
 The External DC voltage is
test or disconnections, and
not between 19-33V.
replace if needed.
 Replace the PCB board (section
10.3.12)
 Internal battery not  Check and replace internal

inserted or Internal battery battery (section 10.3.7).
malfunction  Check battery connection wiring.
External
disconnected  Battery connection wiring.  Replace the PCB board (section
test  Input selection system 10.3.12)
(main board) malfunction
Released
M1186102, Revision 3, 2011 105


malfunction  Check battery connection wiring,
AC
 Battery connection wiring. and replace if needed.
disconnected
test  Input selection system  Replace the PCB board (section
(main board) malfunction 10.3.12)

Internal malfunction  Check battery connection wiring,
connected  Battery connection wiring. and replace if needed.
test
 Input selection system  Replace the PCB board (section
(main board) malfunction 10.3.12)
malfunction  Check battery connection wiring,
Charger test  Battery connection wiring. and replace if needed.
 Input selection system or  Replace the PCB board (section
charger (main board) 10.3.12)
malfunction
Released
106 M1186102, Revision 3, 2011

Testing Procedures

Released
M1186102, Revision 3, 2011 107

Section 6: Calibration Procedures

This section provides a detailed overview of the calibration procedures
that must be performed periodically on the device. It also provides
troubleshooting information in the event that any problems occur while
running the procedures.
6.1. Calibration Overview

The calibration procedures are mainly automated procedures that the
service technician should perform at regular intervals or when the need
for calibration arises (refer to section 6.5.1 below).
The calibration procedures may require specific test instruments in some
cases, and technician intervention at certain points. In each case, the
required intervention is defined in the respective calibration window.
When running calibrations, with the exception of the oxygen sensor
calibration, it is generally considered good practice to perform each of
the calibration in the order in which they are displayed on screen. The
following calibration procedures can be performed from the calibration
screen:
 Factory Calibration procedures – refer to section 6.4.
 Service Calibration – refer to section 6.5.
6.2. Calibration Requirements

Refer to Table 10-1: Service tooling and materials for a list of the
equipment required to perform the calibration procedure.
Note: The technician kit includes Technician Exhalation Valve and
Technician Patient Circuit that are required for the service procedures
Use the items that are in the Technician Kit for performing the test procedures
in this section, You MUST use the exhalation valve included in the kit.
Note: It is recommended to perform VVT procedure (Section 5.2)

following the calibration of the iVent101.
Released
108 M1186102, Revision 3, 2011

Calibration Procedures
6.3. Accessing Calibration

The calibration menu is accessed from the Expert Service screen, which
is password protected. Refer to section 4.4.2
The calibration procedures cannot be initiated while ventilation is in
progress and the Calibration button is grayed out. Place the device in
Standby mode prior to proceeding.
 Tap Calibration to open the Calibrations screen.
Figure 6.1: Calibration Screen
Prior to performing the calibration procedures, power up the device and

allow it to ventilate for a minimum of 15 minutes in order to warm up.
Use a ventilation configuration that is suitable for the patient (patient
and tube type). If alarms occur during the warm up suspend the alarms
and ignore them until the calibration.
It is also recommended to power up the TSI flow analyzer and allow it to
warm up for the same period of time.
6.4. Factory Calibration Procedures

The factory calibrations procedures are intended to be run during the
device manufacturing, or after the replacement of:
 The Pneumatic Unit
 The Main PCB
The Factory Calibration procedures include two calibration procedures:
 Factory Sensors calibration, refer to section 6.4.1, below.
 Turbine calibration, refer to section 6.4.2, below.
Released
M1186102, Revision 3, 2011 109

 POV Factory calibration, refer to section 6.4.3.

 PU Resistance Factory calibration, refer to section6.4.4.
6.4.1. Factory Sensors Calibration

During sensors calibrations the software will attempt to perform
calibration of the device’s inspiratory and expiratory (if available) flow
sensors, and the turbine and patient pressure transducers.
To complete this calibration the device has to be connected to a TSI flow
analyzer through the patient tubing system, and a serial cable
connecting the TSI through a USB adapter to the USB port on the rear
panel of the device. The TSI connection depends on the tubing
configuration.
Calibration Procedure
1. Review the patient configuration setting (One or Two limb) and ensure
that that the appropriate hardware configuration is in use.
2. From the Calibration screen tap Sensors. The Sensors Calibrations screen
is displayed.
Figure 6.2: Sensor Calibration Screen
3. In Two limb configuration connect the TSI to the expiratory port using the
extension tube. Ensure that the flow arrow on the TSI is oriented
correctly.
Released
110 M1186102, Revision 3, 2011

Sensors Calibration – In One limb configuration, connect the TSI to the inspiratory port
Continues using the extension tube. Ensure that the flow arrow in the TSI is
oriented correctly.
It is recommended to connect a HME filter before the TSI when it
used in the calibration procedures.
mains supply.
5. Connect the serial cable from the TSI to the ventilator USB port on the
ventilator rear panel using appropriate USB adaptor (refer to
Figure 1.2).
Sensors Calibration – 6. Connect the appropriate patient tubing and seal it with 22mm sealing
Continues
cap.
7. When all the equipment is set, tap Start to commence the calibration
procedure.
8. The procedure now runs automatically performing a calibration for each
of the flow and pressure transducers in use with the current
configuration.
This procedure takes approximately 40 seconds to complete.
9. On completion the Save box is displayed.
Figure 6.3: Save Calibration Box
10. Tap Save to save the calibration results.

11. The calibration status is displayed on the Calibration screen.
6.4.2. Turbine Calibration

During the Turbine calibration procedure the software will calibrate the
device’s turbine assembly.
Note: If the unit is under one-limb configuration, use the 80mm silicone
tube attached to the technician kit as a jumper between the proximal
pressure line and the exhalation valve port as shown in Figure 6.4
Released
M1186102, Revision 3, 2011 111

Figure 6.4: Factory calibration one limb adapter
1. From the Factory Calibration screen tap PU Devices. The first calibration
screen, the Turbine Factory Calibration screen is displayed.
Figure 6.5: Turbine Factory Screen
2. Connect a 22mm adapter to the inspiratory port.

3. Seal the adaptor with a 22mm sealing cap.
4. When the equipment is set, tap Start to commence the calibration
procedure.
5. The procedure now runs automatically performing a calibration for the
turbine assembly.
6. On completion the POV Factory Calibration screen is displayed.
Released
112 M1186102, Revision 3, 2011

6.4.3. POV Factory Calibration
During Outlet Valve calibration the software will calibrate the device’s
proportional outlet valve (POV) assembly.
Note: If the unit is under one-limb configuration, use the 80mm silicone
tube attached to the technician kit as a jumper between the proximal
pressure line and the exhalation valve port as shown in Figure 6.4
1. The POV Factory Calibration screen appears automatically when the
Turbine Factory calibration is completed.
Figure 6.6: Turbine Factory Screen
2. Connect a 22mm adapter to the inspiratory port.

3. Seal the adaptor with a 22mm sealing cap.
procedure.
5. The procedure now runs automatically performing a calibration for the
POV assembly.
6. On completion the PU Resistance Factory Calibration screen is displayed.
Released
M1186102, Revision 3, 2011 113

6.4.4. PU Resistance Factory Calibration

During the pneumatic resistance calibration the software quantifies the
overall system resistance of the device’s pneumatic system. The
resulting resistance factor is used to compensate breath delivery during
normal operation.
1. The PU Resistance Factory Calibration screen appears automatically
when the POV Factory calibration is completed.
Figure 6.7: The PU Resistance Factory Calibration screen
2. Follow the onscreen instructions: connect a Two limb patient circuit, and
verify that the Wye is open, without a sealing cap, resistor, or Test lung.
process.
4. The procedure now runs automatically performing a resistance
calibration for the complete pneumatic system.
The procedure takes approximately 40 seconds to complete.
5. On completion the Save box is displayed, as shown in Figure 6.3.
7. The calibration status is displayed on the Calibration screen
Released
114 M1186102, Revision 3, 2011

6.5. Service Calibration Procedures
The service calibration procedures are part of the device maintenance.
These procedures include:
 Sensors Calibration, refer to section 6.5.2, below.
 Circuit Compensation, refer to section Error! Reference source not
found..
 O2 Calibration, refer to section 6.5.3.
6.5.1. When to Run Calibration

The Service calibration procedures are recommended at the following
intervals, or after performing the following procedures:
 After every year of ventilator operation.
 Every time that “calibration required” alarm message pops up on the
ventilator screen.
 Planned maintenance, following the replacement of the pneumatic
system at 15,000 hours.
 Following ventilator repairs.
 During troubleshooting of the device.
6.5.2. Sensors Calibration

During sensors calibrations the software will attempt to perform
calibration of the device’s inspiratory and expiratory (if available) flow
sensors, and the turbine and patient pressure transducers.
To complete this calibration the device has to be connected to a TSI flow
analyzer through the patient tubing system, and a serial cable
connecting the TSI through a USB adapter to the USB port on the rear
panel of the device. The TSI connection depends on the tubing
configuration.
1. Review the patient configuration setting (One or Two limb) and ensure
that that the appropriate hardware configuration is in use.
2. From the Calibration screen tap Sensors. The Sensors Calibrations screen
is displayed.
Released
M1186102, Revision 3, 2011 115

Figure 6.8: Sensor Calibration Screen

3. In Two limb configuration connect the TSI to the expiratory port using the
extension tube. Ensure that the flow arrow on the TSI is oriented
correctly.
Sensors Calibration –
Continues
In One limb configuration, connect the TSI to the inspiratory port
using the extension tube. Ensure that the flow arrow in the TSI is
oriented correctly.
It is recommended to connect a HME filter before the TSI when it
used in the calibration procedures.
mains supply.
5. Connect the serial cable from the TSI to the ventilator USB port on the
ventilator rear panel using appropriate USB adaptor (refer to
Figure 1.2).
Sensors Calibration – 6. Connect the appropriate patient tubing and seal it with 22mm sealing
Continues
cap.
7. When all the equipment is set, tap Start to commence the calibration
procedure.
8. The procedure now runs automatically performing a calibration for each
of the flow and pressure transducers in use with the current
configuration.
9. On completion the Save box is displayed, as shown in Figure 6.3.
Released
116 M1186102, Revision 3, 2011

6.5.3. O2 Calibration
During O2 calibration the software attempts to perform calibration of
the device’s internal FiO2 sensor against the maximum (100%) and
minimum (21%) oxygen levels. During normal operation the data is used
to ensure the accuracy of the FiO2 monitoring.
In addition to the intervals mentioned in section 6.5.1, the O2 calibration
should be performed after enabling the O2 sensor and when the FiO2
reading or alarms suggest that it may be necessary.
To perform the O2 Calibration in full only the patient circuit tubing
system, an oxygen flow (>99% purity) of 8 lpm (+1 lpm) and a low flow
O2 connector are required.
Calibration Procedure:
1. Review the device and ensure that the O2 sensor is installed and enabled.
You can enable the O2 sensor through the General Configuration screen.
2. From the Calibration screen select O2.
The O2 100% Service Calibration screen is displayed.
Figure 6.9: O2 100% Calibration Service screen (Two Limb Configuration)

Released
M1186102, Revision 3, 2011 117

Figure 6.10. O2 100% Calibration Service screen (One Limb Configuration)
3. Follow the onscreen instructions: seal the patient outlet with a 22mm
sealing cap.
4. Connect a low pressure oxygen source to the O2 inlet connector on the
O2 100% device’s rear panel (see
Calibration Figure 1.2).
5. Set the O2 flow meter to deliver a flow of 8 lpm (+ 1 lpm).
6. Tap Start.
The flow meter flushed the pneumatic system with O2. The system
calibrates the O2 sensor against the 100% O2 reference.
This procedure takes 120 seconds (2 minutes) to complete.
On completion, the O2 21% Service Calibration screen is displayed.

Released
118 M1186102, Revision 3, 2011

Figure 6.11: O2 21% Service Calibration screen (Two limb configuration)
Figure 6.12. O2 21% Service Calibration screen (One limb configuration)
7. Turn off and disconnect the low pressure oxygen source from the
device’s rear panel.
8. Tap Start.
The device is flushed with ambient air (21% O2) to remove the O2.
O2 21%
The system calibrates the O2 sensor against 21% O2 reference.
Calibration
This procedure takes 90 seconds (1.5 minutes) to complete.
On completion the Save box is displayed, as shown in Figure 6.3.
Released
M1186102, Revision 3, 2011 119

6.5.4. Battery Calibration

The Battery Calibration procedure allows the technician to perform
automated charge–discharge–charge cycle (CDC).
Battery Calibration should be performed periodically in order to check
the performance of the integrated battery, and to ensure accurate
monitoring of the battery’s capacity. During the procedure, the
integrated battery undergoes a complete charge-discharge-charge cycle
(CDC).
Note: Battery calibration procedure cannot be performed while

ventilating and in SW version prior to 2.0, if manual battery calibration is
required refer to Appendix B: section 0
Note: Calibration should be performed at room temperature (15- 27
Celsius)
Note: When the iVent101 is not in use for a long period it is
recommended to disconnect the integrated battery and store it
separately from the ventilator
This procedure will take approximately from 1 hour up to 3 days to
complete depending on room temperature and battery condition.
Calibration Procedure:
1. From the Calibration screen select Service Calibration then select the
Battery calibration.
The Battery Calibration screen is displayed.
Figure 6.13: Battery Calibration Screen

Released
120 M1186102, Revision 3, 2011

2. Tap Start.
3. The progress of the battery charging and discharging will be displayed
during the calibration process.
4. You will be informed when the calibration is successfully completed.
Battery Calibration completed screen is displayed
Figure 6.14: Battery Calibration Done Screen
5. If the calibration process fails a notice will be displayed
Figure 6.15: Battery Calibration Failed Screen
6. Tap Failure Details to view the reason for the failure.
6.6. Touch Screen Calibration

The touch screen calibration procedure should be performed after
opening and removing the device top enclosure, in order to keep the
touch screen intact. This procedure requires using the TS Calibration
tool, which is part of the Technician Tools pack.
Touch Screen Calibration Tool CD PN: M1231870
To calibrate the touch screen:
Released
M1186102, Revision 3, 2011 121

1. Extract the file TSCalibration.rar to a USB flash drive to a folder named

“iVent”.
Note: Pay attention that there’re 2 types of tools, one for SW prior to
2.0 and the other is for SW Version 2.0 and above.
2. Ensure the iVent101 is turned off.
3. Insert the USB flash drive with the TS Calibration tool loaded on it to the
USB port in the back of the iVent101 and power up the machine.
Note1: Make sure to use the USB flash drive that is supplies with the
technician kit
4. After a few seconds, the Calibration tool screen appears.
Figure 6.16. TS Calibration screen
5. Touch the sign appears on the top left corner. It will change its location
four times more, keep following it and press on it whenever it appears.
The last press will restart the iVent101 automatically.
6. Remove the USB flash drive from the USP port as soon as it performs
restart. You will identify the restart by the Splash screen, which will be
displayed.
Released
122 M1186102, Revision 3, 2011

6.7. Troubleshooting Calibrations

Table 6-1 lists troubleshooting of errors and failures which may have
occurred during calibration.
Table 6-1: Calibration Troubleshooting
CALIBRATION STEP DESCRIPTION TROUBLESHOOTING

1. Ensure that the patient
configuration is set correctly.
2. Ensure that the TSI is connected to
the correct tubing limb.
the USB port.
AC and that it has been powered up.
5. Ensure the vent and TSI have been
allowed adequate time to warm up.
Sensor Calibration
Sensor Calibration 6. Ensure that a 22mm sealing cap has
Failed
been applied at the wye connector.
7. Replace the technician exhalation
valve (section 10.3.2).
8. Check the patient system for leaks.
9. Check the internal tubing.
10. Replace the Main PCB (section
10.3.12).
11. Replace the Pneumatic unit (section
10.3.13).
1. Ensure that the patient
configuration is set correctly.
Circuit
Circuit 2. Ensure that the wye is blocked and
Compensation
Compensation opened at the correct time.
Failed
3. Check the patient system for leaks.
1. Ensure that the O2 sensor is
installed and has been enabled.
O2 Calibration O2 Calibration fastened securely.
(100%) Failed 3. Ensure that an O2 flow of 8 lpm
(+ 1 lpm) is connected at the rear
panel.
Released
M1186102, Revision 3, 2011 123

CALIBRATION STEP DESCRIPTION TROUBLESHOOTING

installed and has been enabled.
O2 Calibration O2 Calibration fastened securely.
(21%) Failed 3. Ensure that the O2 flow has been
disconnected from the rear panel.
4. Replace the O2 sensor.
1. Repeat Battery calibration process
Battery Calibration Battery Calibration
(section 6.5.4).
Failed
2. Replace the integrated battery.
Released
124 M1186102, Revision 3, 2011

Performance Verification
Section 7: Performance Verification

This section describes the performance verification procedures for the
iVent101/ ClevAir ventilator system. Performance verification is a series
of operational simulations designed to fully validate the critical functions
of the ventilator.
Use the items that are in the Technician Kit for performing the
test procedures in this section, You MUST use the exhalation
valve included in the kit.
NOTE: The ventilator system is manufactured with accurate pneumatic
and electronic test instruments in a controlled environment. As
field conditions vary, the veracity of the measurement
instruments may become less accurate.
NOTE: The following test specifications were established with the test
equipment, as specified in Table 1-1. If the accuracy of your
institution test equipment differs from those listed please make
allowances.
7.1. Cleaning and Inspection

WARNING To prevent transmission of disease, use personal protective
equipment when handling any contaminated filters, HME’s, or
other patient accessories
CAUTION To prevent damage to ESD sensitive components, always follow
ESD guidelines when servicing and handling components inside
the ventilator. Further information on this subject is provided in
section 10.1.5: Electro-Static Discharge (ESD) Control,.
NOTE If you encounter any problems during the preliminary ventilator
inspection, correct them before proceeding with performance
verification. Failure to correct such problems may affect the
remainder of the performance verification procedure.
Released
M1186102, Revision 3, 2011 125

Clean and inspect the ventilator by the following means:

1. Clean the ventilator’s exterior using an appropriate germicidal or
antibacterial agent. Clean, as necessary, all exterior surfaces including
gas connections and the mains cord.
2. Open the ventilator chassis and inspect for cleanliness, clean, as
necessary, its interior using an ESD safe vacuum cleaner.
3. Visually inspect the ventilator interior and exterior for any obvious
problems such as missing or broken parts, loose assemblies,
disconnected wires, connectors or tubes. Make repairs, as necessary,
prior to performing the performance verification procedure.
7.2. Test Equipment Set Up

Prior to commencing the performance verification procedure all test
equipment to be used should be examined. Verify that each device is in
full working order and, as appropriate, that they hold valid calibration
certificates.
7.3. Performance Verification Tests

In order to ensure a systemic performance verification and logical fault
diagnosis, it is recommended to perform these tests in the order
provided. These tests include:
 Performance Tests, section 7.3.1
 Alarms Tests, section 7.3.2
Carry out the following general guidelines when running performance
verification procedures:
1. If you note a problem during performance verification, verify that you
have followed all the procedures correctly, and that all of the required
settings are correct, before attempting to perform repairs on the device.
2. When making changes to the 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.
3. For convenience, all operator configurable alarms should be set to their
maximum and minimum available ranges. This reduces the occurrence of
nuisance alarms during the performance verification.
Released
126 M1186102, Revision 3, 2011

4. Use the alarm silence button as required during the performance
verification procedures to mute any alarms should they occur.
5. Except for use of the silence button, do not alter the control settings
during these procedures unless specifically instructed to do so.
6. If necessary refer to Section 10: Service and Repair for repair information,
and to Section 11: SPARE PARTS to identify repair parts. When repairs
are complete repeat the tests in full.
NOTE: To locate the cause of any malfunction or failed test procedure

you should refer to the troubleshooting information provided at
the end of this section and more comprehensively in section
Section 8: Troubleshooting.
Note The procedures described here within do not verify the
performance of any of the accessory items (humidifiers, remote
alarms, etc.), which may be running with the ventilator system.
Verify the performance of any such items using the appropriate
procedures described within the accompanying product manuals.
7.3.1. Performance Tests

The purpose of this procedure is to establish a clear method, in which
the iVent101 is tested in a detailed final inspection.
7.3.1.1. Exterior Inspection

Check the exterior of the ventilator (surface cleanliness, painting, and
color or glue leakage, broken parts, scratches or cracks; the front panel
fastening, filters – for cleanliness and easy exchangeability).
7.3.1.2. Check Software Version and date and time

1. Press on the Info button on the main screen.
2. Check that the software version is the last released version.
3. If Software version is not updated, update the version according to the
last technical bulletin.
4. Verify that the date and time are correct (local time)
Released
M1186102, Revision 3, 2011 127

7.3.1.3. Calibration
Perform Sensors Calibration as described in section 6.5.2, and Circuit
Compensation (applicable for SW version prior to 2.0) as described in
section Error! Reference source not found..
7.3.1.4. Patient tube testing

Perform the Patient tubing test as described is section 5.1.
7.3.1.5. VVT (Ventilator Verification Tests)

Perform VVT test as described in section 5.2.
7.3.1.6. O2 sensor calibration

If the O2 sensor is used, perform O2 sensor calibration as described in
section 6.5.3.
7.3.1.7. O2 System
Only if the O2 system is used you need to perform this test.
The purpose of this test is to verify the accuracy of the oxygen
percentage measurements. This accuracy of the oxygen measurement
should be + 3% absolute up to 30% FiO2, + 7% absolute between 30 -
60% FiO2.
1. Set parameters according to table below:
Patient Ventilation Rate Vt. Peep P. Sensitivity High Compliance Resistance
Type Mode Limit PIP (on TTL) (on TTL)
Alarm
Adult SIMV Vctrl 12 500 5 60 2 60 0.02 20
2. Connect the ventilator to the oxygen supply through flow meter
3. Connect an external oxygen analyzer to the ventilator inlet.
4. Start ventilation and adjust oxygen flow to 2 L/min
5. Wait for 2 minutes.
6. Record FiO2 measured by iVent-101 and external oxygen analyzer.
7. Repeat the test for the oxygen flow 4 L/min. Record the results of the
measurements.
Released
128 M1186102, Revision 3, 2011

8. Disable the O2 sensor: Menu>General Config>Enable O2, unmark,
Press Accept).
7.3.1.8. Log Book

Check that there are no Service Notices that appear in the Logbook
(MENU- Log Book) from the beginning of this procedure and till now.
7.3.2. Alarms Tests

The following tests verify the correct operation of a number of the
ventilator’s critical alarms conditions.
Test Procedure
1. Connect the ventilator to AC power and oxygen supply.
2. Power up the device and switch to clinical view.
3. Connect an Rp20 Resistor and 2L Test Lung to the wye connector.
4. Tap Menu – New Patient, and accept the default ventilation settings for
adult patient type.
5. Tap the (OVT) button and perform an OVT to verify the integrity
of the patient circuit.
6. When the OVT complete tap Start on the main screen to commence
ventilation.
Patient Disconnect:
1. Disconnect the Rp20 restrictor and the Test Lung from the patient circuit.
Verify that the Patient Disconnect alarm is activated.
4. Reconnect the Rp20 restrictor and Test Lung to the patient circuit. Verify
that the Patient Disconnect alarm stops automatically.
AC Disconnect:
1. Disconnect the AC cable from the ventilator. Verify that AC Disconnect
alarm is activated.
2. Reconnect the AC cable to the ventilator. Verify that the AC Disconnect
alarm stops automatically.
Low Minute Volume:
Released
M1186102, Revision 3, 2011 129

1. From the Main screen record the measured value for the Low Minute
Volume (M.vol).
2. Tap Settings – Alarms to open the Alarm Settings screen. Set the MV
alarm lower setting to a value above the measured value.
3. Tap Accept twice to close the Alarms Settings and Settings screen. Verify
that Low Minute Volume is activated one minute after Accept was
tapped.
4. Close the Alarm popup window and restore the alarm setting to its
default value. Verify that the alarm stops automatically after four
consecutive breaths.
High Pressure:
1. From the Main menu screen record the measure value for PIP.
2. Tap Setting – Alarms to open the Alarm Settings screen. Set the PIP
alarm high setting to a value below the measured value.
that PIP alarm is activated five seconds after Accept was tapped.
default value. Verify that the alarm stops automatically after one breath.
Released
130 M1186102, Revision 3, 2011

Low FiO2:
1. Connect the flow meter of the concentrator to the O2 connector on the
ventilator back panel (refer to section 2.4: Connecting the Ventilator to
an Oxygen Source).
2. On the concentrator adjust the flow to 5L per minute (refer to the
manufacturer’s instructions if needed). Wait a few seconds until the FiO2
value stabilizes.
3. From the Main screen record the measured value for the O2.
4. Tap Setting – Alarms to open the Alarm Settings screen. Set the FiO2
alarm low settings to value above the measured value.
that Low FiO2 alarm is activated one minute after Accept is tapped.
default value. Verify that the alarm stops automatically after four
breaths.
Apnea:
1. Tap Settings, and set the Rate to 2bpm.
2. Tap Accept. Verify that Apnea alarm is activated 20 seconds after Accept
is tapped, and the iVent101/ ClevAir switches to Apnea backup
ventilation.
3. Wait one minute and then squeeze the Test Lung three times to simulate
two subsequent patient initiated breaths. Verify that the Apnea alarm
stops and that the previous parameters are automatically restored.
4. Restore the Rate setting to its default value.
Released
M1186102, Revision 3, 2011 131


Released
132 M1186102, Revision 3, 2011

Troubleshooting
Section 8: Troubleshooting
This section details how to troubleshoot common problems and error
codes that may be encountered while operating the iVent101/ ClevAir
ventilator system.
DO NOT ATTEMPT TO SERVICE A VENTILATOR WHILE IT IS

CONNECTED TO A PATIENT.
Upon completion of a ventilator service, verify that the settings of

the ventilator are as they were before. Remind the patient or
caregiver that the settings need to be verified by a clinician or
against a prescription.
8.1. General Service Procedure

The following actions should be performed before any specific service
activities are decided and performed.
8.1.1. Information Gathering
1. Consult with the caregivers for the nature of the malfunction.

2. Perform visual inspection; see that the ventilator did not sustain any
external mechanical damage.
3. Check that the integrated battery is in place.
4. Check that the exhalation valve is in place.
5. Perform a visual inspection for the integrity of the AC power cable.
6. Perform a visual inspection for the integrity of the patient circuit.
7. Record the serial numbers of the ventilator, main board and PU (can be
retrieved from the technical info screen). Verify that the numbers match
the numbers of the complaint, if any were reported.
8. Record the current settings – patient type, mode, clinical settings, alarms,
apnea, and general settings.
Released
M1186102, Revision 3, 2011 133

9. Verify that the physical patient circuit configuration (1-limb/2-limbs)

matches the ventilator’s settings.
10. Download the logs to a USB flash drive using the “Copy Log Files” feature
within the “Advanced…” services dialog.
11. If a laptop PC is available, copy the logs to the laptop, and view them
using the Logs Translator tool.
8.1.2. Diagnostics
1. Read the content of the logs, focusing on the time of the reported event:
a. If no laptop PC is available, use the iVent101 internal log viewer
(Menu – Log Book).
b. If a laptop PC is available, use the Log Translator to read all the
alarms logs.
2. Record occurrences of alarms – type of alarms, timing, repetition,
frequency, and specific numbers in specific log entries that may assist you
in diagnosing the problem.
3. Refer to the following sections within this troubleshooting section to
analyze the problem.
8.1.3. Preliminary Verification Procedures

1. Restart the iVent101.
2. Perform the entire VVT procedures.
3. If VVT succeeds, start ventilation using the current ventilation
parameters for about 10 minutes, and verify that the alarm doesn’t occur
again.
8.2. Service Notices

In the event that hardware or software errors are detected by the
ventilator’s ongoing diagnostics a service notice is displayed, as shown in
Figure 8.1 below.
Released
134 M1186102, Revision 3, 2011

Troubleshooting
Figure 8.1: Service Notice screen
In response to a service notice the device initiates a high priority audible

alarm and a service notice window is displayed on the touch screen. The
service notice number and descriptive test gives an indication of the
nature of the triggering condition.
The effect of each service notices on ventilation, if in progress, varies
according to the severity of the triggering condition and its potential
impact upon safe operation. The response can range from no effect on
ventilation, to emergency backup ventilation (ventilation without
sensors feedback), or in the most severe instances to complete cessation
of ventilation.
8.2.1. Service Notice Numbers

Table 8-1 lists all of the service notices, their triggering condition, effects
on ventilation and the recommended steps to troubleshoot each error.
Table 8-1: Service Notices Numbers
ERROR REASON EFFECT REMEDY

1. Perform the preliminary
Error 700 Patient Ventilation performance
verification test (Section 8.1.3).
pressure sensor may be degraded, due to
failure unreliable patient 2. Check and correct patient circuit
pressure reading, and configuration (1-limb/2-limbs).
basing the pressure 3. Check tubing connectivity.
control on the blower (Figure 10.15 and Figure 10.21)
pressure only.
Released
M1186102, Revision 3, 2011 135


4. In case of error 703, replace the
Error 701 Blower Emergency backup
exhalation valve (section 10.3.2).
pressure sensor ventilation. Blower
failure pressure is not reliable, 5. Perform service calibration.
and ventilation continues 6. If the error doesn't occur again
without sensors feedback. the ventilator can be used by the
patient.
Error 702 Inspiratory flow Emergency backup
sensor failure ventilation. Inspiratory 7. If calibration or VVT fails, or the
flow is not reliable, and error is reproduced in ventilation
ventilation continues check the internal silicon tubing
without sensors feedback. of the ventilator.
8. If the tubing is faulty, correct the
Error 703 Exhalation flow Ventilation performance faults, and repeat steps 3
sensor failure may be degraded, as well through 6.
as minute volume alarms
9. If the tubing is ok, replace the
performance due to
PCB board (section 10.3.12). and
unreliable exhale flow
repeat steps 3 through 6.
reading.
10. If problem persists, send the
ventilator to the service
department.
A/D failure, Emergency backup
internal ventilation, due to loss of
malfunction sensors reading. 2. If the problem is persistent
during ventilation replace the
PCB board (section 10.3.12).
Error 704
department.

Error 705 Proportional Ventilation continues, but
Outlet Valve performance may
Stuck degrade. 2. If the logs contain multiple
occurrences of this error, or an
Other alarms that may occurrence with a long duration,
accompany service 705: skip to step 5.
1. Occlusion
3. Restart the ventilator.
2. Set pressure not
4. If the error doesn’t occur, start
delivered.
ventilation using the current
3. Vt not delivered settings for 10 minutes.
4. Low pressure 5. If the error doesn’t occur, and no
5. Low MV. other clinical alarms appear as
well, the ventilator may be used
by a patient.
6. If a problem was found in steps
1-4, replace the PU (section
10.3.13).
Released
136 M1186102, Revision 3, 2011

Troubleshooting

7. If the problem persists, replace
the PCB board (section 10.3.12).
department.
1. Perform the preliminary verification
Error 706 Turbine Motor 1. Ventilation suspended.
test (Section8.1.3)
Error
2. Continuous buzzer 2. Replace the pneumatic unit (section
sound. 10.3.13)..
3. Recovery attempt by 3. Replace the PCB board
the SW (section10.3.12).
ventilator to the service department.
Error 707 Not Used Not Applicable Not Applicable

Error 708 Over Current 1. Ventilation suspended
test (Section 8.1.3).
2. Continuous buzzer 2. Replace the PCB Board (section
sound. 10.3.11).
3. Recovery attempt by 3. Replace the pneumatic unit (section
the SW. 10.3.13).
Error 709 Backup Battery 1. Ventilation continues.
test (Section 8.1.3)
Failure
2. Hot swap will cause 2. Replace the Backup Battery.
device restart.
3. Replace the PCB Board (section
10.3.12).
Error 710 Not used Not applicable Not applicable

Error 711 Damaged One- 1. Ventilation
test (Section 8.1.3)
Way Valve. performance may be
degraded. 2. Replace the pneumatic unit (section
10.3.13).
2. Unreliable exhale flow
reading.
Error 712 FPGA Failure Ventilation suspended
2. If problem persists replace the PCB
board (section 10.3.12).
Released
M1186102, Revision 3, 2011 137


Error 713 PU Board Ventilation continues.
Failure
2. If problem persists replace the
pneumatic unit (section 10.3.13)
1. Manually shutdown and restart.

Error 714 Over Voltage 1. Ventilation suspended.
2. If problem persists replace the PCB
2. Continuous buzzer board (section 10.3.11).
sound.

Error 715 Voltage 1. Ventilation suspended.
converter 2. If problem persists replace the PCB
2. Continuous buzzer board (section 10.3.12).
failure
sound.

Error 716 Fans Failure 1. Ventilation continues.
2. Check Fans connection to the
2. Continuous buzzer PCB board.
sound.
Fans assembly (section 10.3.11).
PCB board (section 10.3.12).
8.3. System Alarms

Table lists the system alarms, which are not included in the General
Errors table.
The table describes the alarms their triggering condition, effects on
ventilation and the recommended steps to troubleshoot each error.
Released
138 M1186102, Revision 3, 2011

Troubleshooting
Table 8-2: System Alarms
ALARM PROBABLE CAUSE REMEDAY

FACTORY Calibration has not been 1. Perform Factory calibration (section 6.4)
CALIBRATION performed or internal 2. Save the calibration.
REQUIRED malfunction.
3. Perform VVT (section 5.2).
OVER TEMPERATURE Block in the cooling vents of 1. Verify that the cooling vents are clear and
the ventilator, high external clean.
heat, or internal 2. Shutdown the device for at least 20
malfunction. minutes.
3. Power up the device. If the problem
persists at restart replace the PCB board
(section10.3.12).
4. If the problem occurs after 15 minutes
replace the Pneumatic unit (section
10.3.13).
INT. BATTERY IN USE No external power source is 1. Connect the Ventilator to an External
connected and the Power source
ventilator uses the internal 2. If the external power source is depleted
(Integrated) battery. and the “Internal battery in use” alarm is
repeated disconnect the external power
source or replace it with a new one in
order to avoid repeated appearance of the
alarm.
INT. BATTERY Integrated Battery is not 1. Charge the battery
FAILURE connected or faulty 2. If the problem persists replace the
integrated battery.
3. If the problem persists replace the PCB
LOST LAST APNEA Internal malfunction 1. If the problem persists and appears
SETTINGS with other system alarms perform SW
update (section 4.4.5)
2. Replace the PCB board (section
10.3.12).
LOST LAST CLINICAL Internal malfunction 1. If the problem persists and appears with
SETTINGS other system alarms perform SW update
(section 4.4.5).
2. Replace the PCB board (section 10.3.12).
Released
M1186102, Revision 3, 2011 139


LOST LAST Internal malfunction 1. If the problem persists and appears with
TECHNICAL other system alarms perform SW update
CONFIGURATION (section 4.4.5).
2. Replace the PCB board (section 10.3.12).
Released
140 M1186102, Revision 3, 2011

Troubleshooting

LOST LAST USER Internal malfunction 1. If the problem persists and appears with
CONFIGURATION other system alarms perform SW update
(section 4.4.5).
2. Replace the PCB board (section 10.3.12)
AC DISC. Ventilator operates without 1. Connect the iVent to power source.

external power source (AC 2. If the problem persists replace the
or DC). mains AC fuse (section 10.3.6)
3. If the problem persists replace the
power supply (section10.3.19)
board (section 10.3.12)
LOW BATTERY Ventilator operates without 1. Charge the battery
or DC). integrated battery.
board (section 10.3.12)
EMPTY BATTERY Ventilator operates without 1. Charge the battery
or DC). integrated battery.
O2 CALIBRATION Calibration has not been Perform O2 calibration (section 6.5.3)
REQUIRED performed, or internal
malfunction
O2 SENSOR O2 sensor is disconnected. 1. Check the O2 sensor connections.
DISCONNECT 2. If the problem persists replace the O2
sensor (section 10.3.5)
3. Check and replace the O2 harness (section
10.3.17).
O2 SENSOR WORN Aged O2 sensor or Replace the O2 sensor (section 10.3.5).

OUT malfunctioning.
SENSORS Calibration has not been Performed Sensor calibration (section 6.5.2)
CALIBRATION performed, or internal
REQUIRED malfunction
VVT RECOMMENDED Internal malfunction Perform VVT (section 5.2)
OVT RECOMMENDED Tubing or Internal Perform OVT (section 5.1)
malfunction
Released
M1186102, Revision 3, 2011 141


OPEN LOOP / The ventilator is unable to 1. Performed Sensor calibration (section
EMERGENCY BACKUP obtain any readings from 6.5.2)
the sensors 2. If the problem persists replace the PCB
pneumatic unit (section 10.3.13)
NOT FOR CLINICAL Information Alarm An active alarm shall never be cleared as long
USE (DEMO UNITS as the unit is on
ONLY)
DATA STORAGE Amount of events for 1. Performed Sensor calibration (section
OVER QUOTA storage exceeds the size 6.5.2)
limit allocated for data 2. Perform OVT (section 5.1)
storage
3. Perform VVT (section 5.2)
4. Perform Performance Verification
Tests (Section 7.3)
Released
142 M1186102, Revision 3, 2011

Troubleshooting
8.4. General Errors

Table 8-3 lists general errors, their triggering condition, effect on
ventilation and the recommended steps to troubleshoot each error.
Table 8-3: General Error
FAILURE DESCRIPTION PROBABLE CAUSES REMEDY

1. Make sure that Patient tube is intact and
OVT constantly fails 1. Patient tube setup
connected properly.
is invalid.
2. Check and correct patient circuit
configuration (1-limb/2-limbs).
3. If it fails, replace the patient tube.
4. Check the exhalation valve connection, and
replace if needed.
5. Perform Calibration (section 6.5).
Refer to Calibration troubleshooting (section
Calibration constantly Refer to Calibration
6.7).
fails troubleshooting
(section6.7).
1. Confirm AC cord connected to device and
1. Device is not running 1. AC power cable
outlet.
from mains supply.
2. Burned AC fuse. 2. Replace power cable.
2. AC disconnect alarm
3. Main board 3. Check condition of AC mains fuse and
is activated.
replace if burned.
4. Power supply
4. Replace Main PCB (section 10.3.12).
5. If problem persists, send the ventilator to
the service department.
1. Replace the Integrated battery.
1. Device is not running 1. Power pack warns
from integrated battery. out or damaged. 2. Replace the Main PCB.
3. If problem persists, send the ventilator to
2. Integrated battery 2. Main board
the service department.
failure alarm is
activated.
1. Check the external DC output matches the

Device is not running 1. External device
iVent101 specification. (See iVent101
from external DC does not match the
Operator’s manual))
ivent101
specifications. 2. Check external DC device on alternative
unit if available.
2. Main board failure.
3. Check the ivnet101 with alternative
external DC source if available.
4. Refer the external DC device to service
center.
Released
M1186102, Revision 3, 2011 143


1. Calibrate the touch screen (section 6.6).
Touch panel will not 1. Touch screen is not
respond to user calibrated. 2. Check the Internal connections.
interaction. 3. Replace the top panel.
2. Internal cable
connections 4. Replace Main PCB (section 10.3.12).
3. Touch panel
malfunction
4. Main board.
1. Check the Internal connections.
Blank screen after 1. Internal cable
switch on connections 2. Replace the top panel (section 10.3.8).
2. Touch panel
malfunction
3. Main board.
1. Use the USB flash drive supplied with the

USB applications do not 1. Improper USB flash
technician kit
respond drive
2. Replace the USB flash drive
2. Main Board
Leak reading with no 1. Patient circuit 1. Check the patient’s status and well-being. If
apparent reason connections ventilation is determined to be sufficient no
further action may be required.
2. Exhalation valve
positioning 2. Check the patient circuit for leaks, and
correct if found.
3. Erroneous leak
detection affected 3. See troubleshooting for “High leak from
by O2 exhalation valve”
4. If the leak reading disappears when
ventilating for some time without O2, and
ventilation is determined to be sufficient no
further action may be required even when
ventilating with O2 again.
4. If the problem persists and you experience
degradation of ventilation, provide
alternative means of ventilation and
contact qualified service personnel
Service notice alarm Restart following a 1. Make sure power sources are operational,
with code number 713 momentary loss of have at least one of them external (AC or
appears following a power external DC)
power loss condition
2. Restart the ventilator
Released
144 M1186102, Revision 3, 2011

Troubleshooting

Inadequate battery 1. Ventilator 1. Perform battery calibration (Section 6.5.4).
performance malfunction
2. If the problem persists, replace the battery
(Late\early battery
2. Battery
alarms, short operating
malfunction
time)
3. Battery is too old
4. Battery is not
calibrated
Released
M1186102, Revision 3, 2011 145


Released
146 M1186102, Revision 3, 2011

Planned Maintenance
Section 9: Planned Maintenance

This section describes the procedures and planned maintenance which
should be performed on the iVent101/ ClevAir
9.1. Cleaning and Routine Planned Maintenance

To ensure correct ventilator operation, perform the following maintenance
procedures at the recommended intervals.
Table 9-1 list the recommended cleaning and routine maintenance schedule
for the iVent101/ ClevAir which are performed by the operator:
Table 9-1: Cleaning and Routine Planned Maintenance (performed by the operator)
PART PROCEDURE COMMENTS
Ventilator Wipe the exterior with a Do not allow liquid to

damp cloth moistened with penetrate into the ventilator.
one of the following
cleaning solutions:
 Water
 Mild detergent or
soapy water
 Medical Grade 70%
Alcohol
Patient Replace and perform Refer to section 5.1

Tubing Patient Tube Test
procedure.
Air Inlet Filter Replace every month. Refer to section 10.3.1: Inlet
Filter Replacement.
Do not attempt to clean or reuse
the air inlet filter.
Remove and clean once per
month or more frequently
Exhalation as necessary
Valve Replace the Exhalation
valve membrane every 3
months, and perform OVT.
Released
M1186102, Revision 3, 2011 147

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

Table 9-2below describes the planned maintenance according the time
interval. For your convenient you can use the planned maintenance
checklist in Appendix A:
Table 9-2: Planned Maintenance
INTERVAL PART AFFECTED MAINTENANCE
Every 6 months Air Inlet Filter Replace the air inlet

filter.
Exhalation Valve Replace the exhalation
valve membrane.
Integrated Battery Perform CDC.
O2 Sensor (1) Perform calibration if in
use.
Every 12 months Backup battery Replace the backup
battery
N/A Perform all the 6
months procedures.
N/A Perform all service

calibrations.
N/A Perform VVT Procedure.
N/A Perform Performance
Verification tests.
Every 2 years O2 Sensor Replace O2 sensor

Integrated Battery (2) Replace Integrated
battery
Released
148 M1186102, Revision 3, 2011

Planned Maintenance
INTERVAL PART AFFECTED MAINTENANCE
N/A Perform all the 12

months procedures.
Every 3 years RTC Battery Replace the RTC Battery
N/A Perform all 12 months
procedures.
Every 15,000 pneumatic Pneumatic Unit Replace pneumatic unit
running hours, or every
N/A Perform all calibrations.
4 years, whichever
comes first. N/A Perform VVT procedure.
N/A Perform Performance
Verification test.
(1) Performing O2 sensor calibration at a higher frequency interval than recommended
above will assure improved measurement accuracy.
(2) Every 2 years, or:
o 200 usage cycles for the standard battery, whichever comes first
o 600 usage cycles for the extended battery, whichever comes first
A usage cycle consists of a substantial discharge of the integrated battery followed
by recharge.
NOTE: The charge-discharge-charge procedure for the integrated

battery can be very time consuming. For this reason it may not be
practical to perform it during a field service visit.
NOTE: In addition to the items of planned maintenance listed above,

electrical safety testing should be performed as mandated by national,
local, or institutional regulations.
9.2.1. Every 6 Months

The following steps should be performed after every 6 months of use:
1. Replace the air inlet filter. Refer to section 10.3.1: Inlet Filter
Replacement.
Released
M1186102, Revision 3, 2011 149

2. Perform a charge-discharge-charge cycle on the integrated battery, as

described in the iVent101 Operator’s Manual. .
3. If the O2 sensor in use perform the O2 calibration. Refer to section 6.5.3:
O2 Calibration.
4. Replace the Exhalation valve membrane. Refer to section 10.3.2:
Exhalation Valve/Membrane Replacement
9.2.2. Every 12 Months

The following steps should be performed after every 12 months of use:
1. Perform the 6 months maintenance procedures as described in section
9.2.1 above (exclude step 2).
2. Perform a charge-discharge-charge cycle on the integrated battery Refer
to section 6.5.4: Battery Calibration
3. Replace the backup battery. Refer to section 10.3.14: Backup Battery
Replacement.
4. Replace the Exhalation valve and the membrane. Refer to section 10.3.2:
Exhalation Valve/Membrane Replacement on.
5. Perform ALL service calibration procedures. Refer to section 6.5Service
calibration procedures.
6. Perform ALL performance verification tests. Refer to section 7.3:
Performance Verification Tests.
9.2.3. Every 2 years

1. Replace the integrated battery assembly. Refer to section 10.3.7: Power
Pack Replacement.
2. Replace the O2 sensor. Refer to section 10.3.5.
3. Perform the 12 months procedures as describe in section 9.2.2 above.
9.2.4. Every 3 years

1. Replace the RTC battery. Refer to section 10.3.15: Real Time Clock (RTC)
Battery Replacement.
Released
150 M1186102, Revision 3, 2011

Planned Maintenance
2. Perform the 12 months procedures as describe in section 9.2.2 above.
9.2.5. Every 15,000 Running Hours or 4 years

The following steps should be performed after every 15,000 running
hours or 4 years whichever comes first:
1. Replace the pneumatic unit. Refer to section 10.3.13: Pneumatic Unit
Replacement.
2. Perform ALL calibration procedures. Refer to Section 6: Calibration
Procedures.
3. Perform ALL performance verification tests. Refer to Section 7:
Performance Verification.
Released
M1186102, Revision 3, 2011 151


Released
152 M1186102, Revision 3, 2011

Service and Repair
Section 10: Service and Repair
10.1. Service General Information

This section provides the following general information on service and
repairs procedures:
 Repair Safety - section 10.1.1, below.
 Repair Guidelines - section 10.1.2.
 Cleaning - section 10.1.3.
 Electrical Cables & Pneumatic Connections - section 10.1.4.
 Electro-Static Discharge (ESD) Control - section 10.1.5.
 Non-conforming Parts - section 10.1.6.
 Replacement Parts – section 10.1.7.
 Post Repair – section 10.1.8.
 Repair Documentation – section 10.1.9.
 Patient System and Accessories – section 10.1.10.
 Recommended Service Tooling and Materials – section 10.2.
10.1.1. Repair Safety

When servicing the iVent101 ventilator system, first familiarize yourself with
and adhere to all of the posted and stated safety warnings 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 (refer to
section 1.4 Cautions and Warnings).
Do not attempt to service a ventilator while it is connected to a patient
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 another person is connected to it.
To prevent electric shock hazards always ensure that all electrical power has
been removed from the device prior to commencing service. This requires
that not only mains power be removed but also the device’s internal
Released
M1186102, Revision 3, 2011 153

batteries and any external DC source, as applicable. If the device must be

serviced with the power on, be careful to avoid electrical shock. At all times
follow the accepted safety practices for electrical equipment when
performing any repairs.
To prevent possible personal injury, always ensure that the high pressure
oxygen source has been disconnected.
To prevent possible personal injury and equipment damage never attempt

to push or pull a ventilator installed on its stand with the brakes set on.
To prevent possible personal injury and equipment damage always ensure

that the brakes are set on to prevent inadvertent movement when
performing service.
10.1.2. Repair Guidelines

The following general repair guidelines should be followed at all times
when performing service to the iVent101 ventilator system.
 The majority of hardware on the ventilator system is metric sized.
Always ensure that only metric tools are used when performing
service. Use of non-metric tooling may result in damaged
hardware.
 To prevent any possible damage caused by electrostatic discharge
always ensure that the appropriate ESD guidelines are followed
when performing service to the equipment.
 Use only recommended tools, test equipment, and service
materials 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 the removed parts
to facilitate further inspection.
 Investigate and determine the cause of any detected abnormality.
Repair the unit or consult your local VersaMed technical support
location for assistance on unsolved problems.
Released
154 M1186102, Revision 3, 2011

Service and Repair

 Replace or repair any parts that are found to be worn, missing,
damaged, cracked, or otherwise show signs of any physical
abnormalities.
10.1.3. Cleaning
If required, follow the general cleaning guidelines described in this
section when cleaning the ventilator during servicing. Procedures for the
periodic cleaning and sterilization of the ventilator and its accessories
are described in the iVent101 ventilator Operator Manual. Specific
procedures for periodic cleaning and inspection done during the
ventilators preventive maintenance are provided in Section 9: Planned
Maintenance.
10.1.4. Electrical Cables & Pneumatic Connections

To ensure correct reassembly of the device make note of the label wire
or tube positions before disconnecting parts. Ensure that all of the tubes
and harnesses are correctly installed, and do not interfere with, and
cannot be damaged by, any moving parts.
10.1.5. Electro-Static Discharge (ESD) Control

It is important to follow the appropriate ESD control procedures
whenever the ventilator system is being serviced. This section describes
the minimum level of ESD precautions that should be followed to service
the iVent101 ventilator system.
10.1.5.1. General Information

ESD can permanently damage ESD-sensitive microelectronic
components or assemblies when they are handled, even when no direct
contact is made with the component or assembly. ESD damage may not
be immediately apparent, however, it 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.
10.1.5.2. Procedures & Precautions

Perform the follow minimum procedures and precautions to prevent
ESD damage to the ESD sensitive microelectronic components and the
assemblies of the Inspiration ventilator system:
Released
M1186102, Revision 3, 2011 155

 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 the 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.
10.1.6. Non-conforming Parts

When investigating reported problems, identify the cause of the failure
and repair and/ or replace the component, as necessary. Any failed, non-
conforming parts, should be retained until the subject device has been
successfully repaired. Following the completion of the repair any non-
conforming parts should be returned to the service center to allow for
failure analysis to be performed.
Any printed circuit boards (PCB’s) or similar electronic items MUST be
packaged in appropriate electrostatic discharge resistant materials. The
return authorization number provided by the manufacturer should be
clearly marked on all shipping documentation and on the exterior of the
packaging.
Released
156 M1186102, Revision 3, 2011

Service and Repair

10.1.7. Replacement Parts
To order the correct parts, identify the ventilator version and part, and
then using Section 11: SPARE PARTS , identify the manufacturer’s part
number for the item.
10.1.8. Post Repair

After successfully completing any ventilator repair, perform the
following prior to returning it to normal operation:
1. Run the appropriate portions of the calibration procedures, VVT and any
applicable functional tests before connecting the patient to the
ventilator (refer to Section 6: Calibration procedures and Section 7:
Performance verification)
2. Keep a detailed record of all maintenance performed on each device.
Ensure that service records and other documentation are completed and
maintained for the life of the product.
10.1.9. Repair Documentation

Record repairs or any work performed on the device and retained it
during the product’s life for future reference. To track product
performance and attrition it is recommended to send completed service
sheets to the manufacturer.
10.1.10. Patient System and Accessories

For maintenance of the patient system and accessory items, consult the
iVent101 ventilator Operator Manual and refer to the applicable
accessory manuals.
Released
M1186102, Revision 3, 2011 157

10.2. Recommended Service Tooling and Materials
Table 10-1: Service tooling and materials
DESCRIPTION VERSAMED PART NUMBER GE PART NUMBER
Ivent101 Technician Kit (including 910A0001-01 M1182956

TSI Test device Model 4040)
Ivent101 Technician Kit (without TSI 910A0002-01 M1182959
Test device Model 4040)
Digital Multi-tester Local Supply
TSI (model 4040) Local supply
Hexagonal Drivers, following sizes:
Local Supply
2.5mm, 3mm, 4mm
Open End Wrench -10mm Local Supply
Flat Screwdriver Local Supply
Philips Screwdriver No 1, 2 Local Supply
Torque Wrench (0-5 Nm) Local Supply
Static Dissipative Service Kit Local Supply
Cable Ties Local Supply
10.3. Service & Repair Procedures

This section describes the procedures for replacing the following
components:
 Inlet Filter – section 10.3.1.
 Exhalation Valve – section 10.3.2.
 Changing from Two limb to One limb configuration – section 10.3.3.
 Changing from One limb to Two limb configuration – section 10.3.4.
 O2 sensor – section 10.3.5.
 Mains AC fuse replacement - section 10.3.6
Released
158 M1186102, Revision 3, 2011

Service and Repair

 Power Pack – section 10.3.7.
 Top Enclosure – 10.3.8.
 Filter Housing – section 10.3.9.
 Main Enclosure - section 10.3.10.
 Fans Replacement – section 10.3.11.
 Main PCB – Section 10.3.12.
 Pneumatic Unit – section 10.3.13.
 Backup Battery – section 10.3.14.
 Real Time clock Battery – section 10.3.15.
 Speaker Replacement – section 10.3.16.
 O2 sensor harness replacement – section 10.3.17.
 Pump/Solenoid harness replacement – section 10.3.18.
 Power Supply Unit Replacement – section 10.3.19.
 Back Panel Assembly Replacement – section 10.3.20.
10.3.1. Inlet Filter Replacement

VersaMed P/N for ClevAir Air filter: 660HC001-01
VersaMed P/N for iVent101 Air filter: 660BL001-01
GE P/N for Air filter: M1184151
To replace the inlet filter:
1. Grip the filter holder and rotate it counter clockwise to disengage it from
the filter housing.
2. Verify that not foreign objects not fall into the filter.
3. Set the filter aside for disposal.
4. Remove the replacement filter/holder from its packaging and inspect it
for any signs of damage.
5. Attach the replacement filter/holder to the device by engaging with the
filter housing and turning it clockwise.
Released
M1186102, Revision 3, 2011 159

Figure 10.1: Inlet Filter
10.3.2. Exhalation Valve/Membrane Replacement

VersaMed P/N for ClevAir Two limb Kit: 900HC007-01
VersaMed P/N for iVent101 Two limb Kit: 900BL007-01
GE P/N for Two limb Kit: M1184153
To replace the exhalation valve and the membrane:

1. Carefully place the ventilator on its rear panel.
2. Remove the exhalation compartment cover. (Figure
10.2)
Figure 10.2: The Exhalation Cover on the lower panel

3. On the exhalation compartment, turn the locking
lever through 90 degrees to release the exhalation
valve (see Figure 10.3 and Figure 10.5).
Released
160 M1186102, Revision 3, 2011

Service and Repair
Lever
handle
Figure 10.3: Unlocking the exhalation valve lever
4. Carefully pull the release lever to disengage the

exhalation valve from the exhalation compartment
(see Figure 10.5).
Lever
handle
Figure 10.4: Releasing the exhalation valve
Figure 10.5: The Exhalation Valve
5. Release the latch from the cover and detach the

cover and the membrane (see Figure 10.5).
Released
M1186102, Revision 3, 2011 161

6. Clean the exhalation valve or put it in the

sterilization device, as instructed above.
7. Replace the membrane if needed.
Note: The Exhalation membrane has to be replaced every 3 months.
8. Re-assemble the exhalation membrane and cover.
Verify the exhalation membrane integrity and that
the membrane asterisk (A in Figure 10.6) is facing
the cover asterisk B in Figure 10.6). Do not have
push the membrane into its place, just to place it
inside the cover and the membrane will seat
properly when the cover is pressed on.
Figure 10.6: The Exhalation valve membrane
9. Open the cover. Verify that the membrane sits in its

place.
Note: you have to verify that the membrane is in its place before
continuing the assembly.
10. Close the cover.
11. Close the latch and verify that the cover is closed.
Released
162 M1186102, Revision 3, 2011

Service and Repair

12. Insert the exhalation valve back into the exhalation
compartment ensuring the pneumatic connectors
are properly engaged.
13. Rotate the locking lever and turn the lever back
through 90 degrees in order to lock the exhalation
valve in position.
14. Place the exhalation valve compartment cover back
in position.
10.3.3. Two limb to One Limb configuration

changeover
VersaMed P/N for ClevAir One limb Kit: 504HC051-01
GE P/N for One limb Kit: M1230871
To changeover Two limb to One Limb Accessory

1. Following the instructions in section 10.3.2: Exhalation Valve/Membrane
Replacement remove Ex. Valve from exhalation compartment
2. Set the removed item(s) aside for re-assembly or disposal.
3. Carefully place the One limb accessory into the exhalation block. Ensure
that the tubing connectors engage correctly.
4. Using a 2.5mm hex key secure the One limb accessory in its place.
5. Secure the One limb accessory cover back in place.
6. Change the patient configuration between Two and One limb
configurations as follow
a. Following the instructions in section 4.4.6: Patient
Configuration, change the SW patient configuration to match
that of the hardware in use.
b. Following the instructions in section 6.5.2: Sensors
Calibration perform the sensors calibration procedure.
c. Following the instructions in section 14.4:Error! Reference
source not found. perform the circuit calibration procedure.
Applicable for SW prior to 2.0
d. Following the instruction in section 5.1: Patient Tube Testing
Procedure, perform the Patient Tube Testing procedure
Released
M1186102, Revision 3, 2011 163

10.3.4. One limb to Two limb configuration

changeover
VersaMed part number for ClevAir Two limb kit: 900HC007-01.
VersaMed part number for iVent101 Two limb kit: 900BL007-01
GE part number for Two limb kit: M1184153
To changeover from One limb to Two limb configuration:
1. Carefully place the ventilator on its rear panel.
2. Remove the exhalation valve compartment cover.
3. Using a 2.5mm hex key remove the 4 screws holding the One limb
accessory on place.
4. Carefully pull on the release lever to disengage the one limb accessory
from the exhalation block.
5. Set the removed item(s) aside for re-assembly or disposal.
6. Follow the instruction in section 10.3.2: Exhalation Valve/Membrane
Replacement to install the exhalation valve and the compartment cover.
7. Change the patient configuration between One and Two limb
configuration as follow:
a. Following the instructions in section 4.4.6: Patient
Configuration, change the SW patient configuration to
match that of the hardware in use.
b. Following the instructions in section 6.5.2: Sensors
Calibration, perform the sensors calibration procedure.
c. Following the instructions in section 14.4: Error! Reference
source not found. perform the circuit calibration procedure.
Applicable for SW prior to 2.0
d. Following the instruction in section 5.1: Patient Tube Testing
Procedure, perform the Patient Tube Testing procedure.
Released
164 M1186102, Revision 3, 2011

Service and Repair

10.3.5. O2 Sensor / Cork Installation
Figure 10.7: O2 Sensor Compartment / Cover
VersaMed P/N for O2 sensor: 130B0002-03

GE P/N for O2 sensor: M1161179
VersaMed P/N for ClevAir O2 sensor Cork + Cap kit: 900HC020-01
VersaMed P/N for iVent101 O2 sensor Cork + Cap kit: 900BL020-01
GE P/N for O2 cork + Cap: M1185709
To replace the O2 Sensor or Cork:

1. Carefully place the ventilator onto its rear or side panel.
2. Using a 2.5mm hex key remove the 2 screws securing the O2 sensor
cover in place (refer to Figure 10.7 above).
3. To remove the O2 sensor cork unscrew the sensor blank using 5mm hex
key.
4. To remove the O2 sensor reach inside the O2 sensor cavity and carefully
disconnect the O2 sensor harness.
5. Carefully unscrew the O2 sensor using the O2 sensor removal tool, taking
care not to damage the thread in the O2 sensor compartment, and set
aside.
6. If installing the O2 sensor cork, screw in place using a 5mm hex key.
7. If installing O2 sensor, take the O2 sensor, open the carton and inspect it
for any signs of damage to the sensor or the o-ring.
Released
M1186102, Revision 3, 2011 165

8. Allow the O2 sensor to sit in room air for a minimum of 20 minutes prior
to attempting to calibrate it.
9. Install the replacement O2 sensor (or cork) taking care not to damage the
thread of the mating parts or the o-ring. Screw the replacement sensor in
place by hand tightly.
10. Carefully reconnect the O2 sensor harness (if applicable) and re-install
the O2 sensor cover piece using the hardware removed earlier.
10.3.6. Mains AC fuse replacement

VersaMed P/N for Mains AC fuse kit: 900HC022-01
VersaMed P/N for iVent101 AC fuse kit: 900BL022-01
GE P/N for Mains AC fuse: M1186002
To replace Mains AC fuse:
1. Carefully place the ventilator with its rear panel facing you.
2. Using flat screwdriver pull out fuse housing by turn screwdriver counter
clockwise.
3. Remove the fuse from fuse house and place him aside.
4. Remove the replacement fuse from its packaging and inspect it for any
signs of damage. Use digital voltmeter to check conductivity.
5. Insert the replacement fuse into fuse housing.
6. Insert the fuse housing into his place on rear panel.
7. Using flat screwdriver pull in fuse housing.
Figure 10.8. Mains AC fuse

Released
166 M1186102, Revision 3, 2011

Service and Repair

10.3.7. Power Pack Replacement
VersaMed P/N for ClevAir Power Pack: 900HC006-01
VersaMed P/N for ClevAir Extended Power Pack: 900HC033-01
VersaMed P/N for iv101 Power Pack: 900BL006-01
VersaMed P/N for iv101 Extended Power Pack: 900BL033-01
GE P/N for Power Pack: M1184149
GE P/N for Extended Power Pack: M1184170
To replace the power pack:
1. Place the ventilator on its lower enclosure.
2. Turn counterclockwise the two mounting screws (refer to Figure 10.9
below).
3. Grip the power pack and carefully remove it from the enclosure, taking
care not to damage the main electrical connectors.
4. Set the power pack aside for disposal in an appropriate matter.
5. Remove the replacement power pack from its packaging and inspect it
6. Insert the power pack into the enclosure taking care to ensure that the
electrical contacts engage properly.
7. Screw in place the two mounting screws
Charge ventilator until the appears. Refer to section 2.1:

Understanding the Power Sources.
Released
M1186102, Revision 3, 2011 167

Figure 10.9: Power Pack Mounting
10.3.8. Top Enclosure Replacement

VersaMed P/N for ClevAir Top Enclosure: 900HC003-01
VersaMed P/N for iVent101 Top Enclosure: 900BL003-01
GE P/N for Top Enclosure: M1184143
To replace the Top enclosure:
1. Carefully place the ventilator onto its rear or side panel.
2. Remove the two cap head screws that are set deep into the front of the
lower enclosure, using a 3mm hex key (refer to Figure 10.10 below).
3. Place the ventilator on to its lower enclosure.
4. Remove top two screw hole covers.
5. Remove the two cap head screws located at the upper-rear of the top
enclosure using a 3mm hex key (refer to Figure 10.10 below).
6. Lift the top enclosure up and away from the main enclosure and Main
PCB. Use ESD grounding facilities for protection.
7. Reach under the top enclosure and disconnect the display ribbon cable,
backlight inverter cable, and the LED’s cable from the Main PCB.
Disconnect the ground cable from the main board (refer to Figure
10.11below) In some version the ground cable is origin at the power
supply and need to be disconnected from the top panel side.
8. Lift the top enclosure free and set it aside into ESD safe packaging.
9. Replace the top enclosure and reconnect the display flat cable, backlight
inverter cable, and the LED’s cable to the Main PCB.
10. Secure the top enclosure back in place by screwing the caps head
screws in the lower and top enclosure, using a 3mm hex driver with a
torque of 0.7Nm.
11. Press the screw hole covers back into positions.
Released
168 M1186102, Revision 3, 2011

Service and Repair
Figure 10.10. Top Enclosure Screw Locations

Released
M1186102, Revision 3, 2011 169

Ground
cable Backlight
inverter
cable
Touch
cable
Display
flat cable
Figure 10.11: Top Enclosure Components
10.3.9. Filter Housing Replacement

VersaMed P/N for ClevAir AIR INLET ADAPTOR: 900HC016-01
VersaMed P/N for iVent101 AIR INLET ADAPTOR: 900BL016-01
GE P/N for AIR INLET ADAPTOR: M1185997
To replace the filter housing:
1. Remove the device’s top enclosure assembly and place it on a flat
surface. Refer to section 10.3.8.
2. With the device placed on its lower enclosure lift the filter housing up
and free of the pneumatic unit.
3. Inspect the replacement filter housing for any signs of damage and
ensure that the filter inside is clean.
4. Replace the filter housing taking care to ensure a good seal at its entry
point to the pneumatic unit.
5. Secure the top enclosure back in place as described in section 10.3.8.
10.3.10. Main Enclosure

VersaMed P/N for ClevAir Main Enclosure: 503HC100-01
Released
170 M1186102, Revision 3, 2011

Service and Repair

VersaMed P/N for iVent101 Main Enclosure: 503BL100-01
GE P/N for Main Enclosure: M1184146
To replace the main enclosure:
1. Remove the device’s top enclosure assembly and place it on a flat surface
and Refer to section 10.3.8.
2. Place the device on to its side panel and remove the 6 x M4 x 25 cap head
screws that are recessed into the lower enclosure, using a 3mm hex key
(refer Figure 10.12 below).
Mounting
screws
Mounting
screws
Figure 10.12 Main Enclosure Mounting
3. Place the device back onto its lower enclosure and remove the screw (M3
x 8mm) retaining the main enclosure at the exhalation housing.
4. Lift the main enclosure up and away from the device, and while doing so,
reach inside and disconnect the cooling fan harness.
Released
M1186102, Revision 3, 2011 171

Fans connector
J23
Figure 10.13. Cooling Fans Assembly
5. Remove the replacement component(s) from their packaging and inspect

them for any signs of damage.
6. Lower the main enclosure back into position taking care while connecting
the cooling fan harness to the Main PCB.
8. Start the machine by pressing On/off switch.
9. Attach piece of paper to rear panel and verify air flow from vents.
10.3.11. Fans Replacement

1. Remove the device’s top enclosure assembly. Refer to section 10.3.8.
2. Remove the device’s main enclosure assembly. Refer to section
10.3.10.
Released
172 M1186102, Revision 3, 2011

Service and Repair

3. Carefully remove the three screws securing the fans bracket in position
using a 2.5mm hex key, M3 x 6
Screws Position
Figure 10.14: Fans screws location
4. Carefully remove the fans from the bracket and connect the
replacement fans.
5. Secure the fans assembly back into position using three screws that
were removed earlier.
6. Secure the main enclosure back in place as described is section
10.3.10.
10.3.12. Main PCB Replacement

Use an appropriate ESD grounding precautions when performing this
procedure.
VersaMed P/N for ClevAir Main PCB: 900HC002-01
VersaMed P/N for iVent101 Main PCB: 900BL002-01
GE P/N for Main PCB: M1184141
Note: Every new main PCB is configured to the minimum features, new
configuration file is required with each replacement, please approach
your regional GE service provider for the file while mentioning the unit
serial number, installed SW version, required configuration and the
main PCB serial number.
Released
M1186102, Revision 3, 2011 173

To replace the main PCB:

2. Remove the device’s main enclosure assembly. Refer to section 10.3.10.
3. Carefully disconnect all electrical harnesses from the upper side of the
PCB and disconnect the ground cables from the left and right side of the
PCB. Refer to Figure 10.15 below.
Ground
Gas Gauge
cable Power Speaker
supply cable
Pump/Solenoid
cable cable
Backup battery
Motor cable
POV cable cable
O2 sensor
PU cable
Counter
cable
Ground
Not applicable
for all versions
Figure 10.15. Cables connection mapping
4. On the upper side of the Main PCB, disconnect the sensor tubing from
the inspiration differential transducer.
On the lower side of the Main PCB, disconnect the sensor tubing from
the exhalation differential transducer, blower pressure transducer,
patient pressure transducer and inlet pressure transducer (and Exhale
pressure sensor in the old PU version). Refer to Figure 10.16 below.
Released
174 M1186102, Revision 3, 2011

Service and Repair
Low
High
Blower
pressure tube
Patient Low
High
pressure tube
Figure 10.16. Tubes connection mapping
5. Carefully remove the four screws securing the Main PCB position using a
2.5mm hex key, M3 x 6
6. Carefully lift the Main PCB free of the device and set it aside into
appropriate ESD packaging.
Note: Pay special attention to the supporting bracket not to harm the
patient pressure sensor
7. Take the replacement PCB, inspecting it first to ensure that ESD
packaging is fully intact.
8. Remove the replacement PCB from the ESD packaging and inspect it for
any signs of damage.
9. Set the replacement PCB in place and fasten it using the four screws
removed earlier.
10. Reassembly the PCB by reconnecting the sensor tubing, the blower
pressure transducer, the patient pressure transducer, and the inlet
pressure transducer (and Exhale pressure sensor in the old PU version).
Refer to Figure 10.16 above.
Released
M1186102, Revision 3, 2011 175

11. Reconnect all of the electrical harnesses to the upper side of the PCB and
the grounds cables to the left (Not applicable for all HW versions) and
right side of the PCB. Refer to Figure 10.15 above.
Note: Take care not to place undue stress on the PCB when reattaching
the electrical connections.
12. Secure the main enclosure back in place as described is section 10.3.10.
10.3.13. Pneumatic Unit Replacement

Note: Two revisions of pneumatic units are available in the field they can
be distinguished according to the front tubes:
Metal barbs at the front: First revision
No Metal barbs at the front: Second revision
First Revision Second Revision

Figure 10.17. Pneumatic unit identification
Follow the appropriate instructions

Released
176 M1186102, Revision 3, 2011

Service and Repair
VersaMed P/N for ClevAir Pneumatic Unit: 900HC001-01

VersaMed P/N for iVent101 Pneumatic Unit: 900BL001-01
GE P/N for Pneumatic Unit: M1184139
GE P/N for Pneumatic Unit Ver. 2.0: M1230870
Figure 10.18. Pneumatic Unit Mounting
To replace the pneumatic unit/ anti-vibration mount:

1. Remove the device’s Top enclosure assembly. Refer to section 10.3.8.
If you have the first revision pneumatic assembly installed (otherwise
refer to paragraph 18):
3. Remove the device’s main PCB. Refer to section 10.3.12 above.
4. Disconnect the following tubing from the pneumatic unit: HPB pressure
port, O2 inlet tube, O2 sample tubes (two tubes), exhaust line and
Solenoid to Exhalation Valve. Refer to Figure 10.19 below
Released
M1186102, Revision 3, 2011 177

O2
sample HPB Pressure
tube port
Hold Solenoid O2
sample
tube
Exhaust tube
O2 inlet tube
Figure 10.19. Pneumatic rev.1 Unit tubes mapping
5. Cut the strap on the side of Pneumatic Unit for detach

solenoid. Refer to Figure 10.19 above.
6. Set the device back onto the rear of its lower enclosure.
7. Unscrew the four screws securing the pneumatic unit to
the lower enclosure, using a 10mm open-ended wrench.
8. Loosen the Main PCB mounting bracket to the left side by
slightly loose the self-tapping bolts in the base, to lift the
pneumatic unit.
9. Carefully lift the pneumatic unit up and free of the lower
enclosure taking care not to stress or damage the Main
PCB mounting lugs, and set the pneumatic unit aside.
10. Remove the replacement pneumatic unit from its
packaging and inspect it for any signs of damage.
11. Set the replacement pneumatic unit back into the lower
enclosure and screw it in position with the four screws
removed earlier with a torque of 1 Nm.
Released
178 M1186102, Revision 3, 2011

Service and Repair

12. Tight the Main PCB mounting bracket
13. Reattach the solenoid, with strap, to the Pneumatic Unit.
Refer to Figure 10.19 above.
14. Re-establish the following tubing connections to the
pneumatic unit: HPB pressure port, O2 inlet tube, O2
sample tubes (two tubes), exhaust line and solenoid to
Exhalation Valve. Refer to Figure 10.19 above and Figure
10.20 below.
HPB Pressure port

PU Ambient
O2 sample
tube O2 sample
tube
Exhaust tube
Figure 10.20. Pneumatic Unit Rev. 1 tubing connectors
15. Place back the main PCB and reconnect its tubing as
described in section 10.3.12.
16. Secure the main enclosure back in place as described is
section10.3.10.
17. Secure the top enclosure back in place as describes in
section 10.3.8.
If you have the second revision pneumatic assembly installed:
18. Disconnect the following tubing from the base enclosure:
box pressure line (circle 9), O2 inlet tube (circle 1), O2
sample tubes (two tubes, circles 6 and 7) and exhaust line
(circle 4). Refer to Figure 10.21 and Table 10-2: Pneumatic
unit rev. 2 tubing table below.
Released
M1186102, Revision 3, 2011 179

10 9 7
1
2 3 4 5
6 7 8
Figure 10.21. Pneumatic Unit rev.2 tubes mapping
Note: If additional tubing is required to support the installation refer to Section

11: Spare Parts for tubing kit P/N
Released
180 M1186102, Revision 3, 2011

Service and Repair
Item# Part description
1 O2 inlet on the back panel

2 75mm to the exhalation base
3 100mm to the exhalation base (two pieces)
4 Exhaust to the exhalation base
5 70mm from exhalation base to the solenoid
6 75mm to the O2 Sensor
7 HPB to the O2 sensor
8 60mm + 50mm (From pump to solenoid)
9 55mm + 75mm (T connector tubes)
10 T Connector
Table 10-2: Pneumatic unit rev. 2 tubing table
19. Set the device back onto the rear of its lower enclosure.
20. Unscrew the four screws securing the pneumatic unit to
the lower enclosure, using a 10mm open-ended wrench.
21. Loosen the Main PCB mounting bracket to the left side by
slightly loose the self-tapping bolts in the base, to lift the
pneumatic unit.
22. Carefully lift the pneumatic unit up and free of the lower
enclosure taking care not to stress or damage the Main
PCB mounting lugs, and set the pneumatic unit aside.
23. Remove the replacement pneumatic unit from its
24. Set the replacement pneumatic unit back into the lower
enclosure and screw it in position with the four screws
removed earlier with a torque of 1 Nm.
25. Tight the Main PCB mounting bracket
26. Re-establish the following tubing connections to the
pneumatic unit: box pressure line (circle 9), O2 inlet tube
(circle 1), O2 sample tubes (two tubes, circles 6 and 7) and
exhaust line (circle 4). Refer to Refer to Figure 10.21 and
Released
M1186102, Revision 3, 2011 181

Table 10-2: Pneumatic unit rev. 2 tubing table above.

Released
182 M1186102, Revision 3, 2011

Service and Repair
O2 Sample
HPB Pressure port tube
Exhaust tube
O2 Sample
tube
Plastic housing
Figure 10.22. Pneumatic Unit Rev.2 tubing connectors
27. Place back the main PCB and reconnect its tubing as
described in section 10.3.12.
28. Secure the main enclosure back in place as described is
section10.3.10.
29. Secure the top enclosure back in place as describes in
section 10.3.8.
Note: In case of old exhalation valve base, the solenoid will be attached to
the PU using the plastic housing.
With new exhalation valve base, use the designated location
Released
M1186102, Revision 3, 2011 183

10.3.14. Backup Battery Replacement

VersaMed P/N for ClevAir Backup Battery: 900HC013-01
VersaMed P/N for iVent101 Backup Battery: 900BL013-01
GE P/N for Backup Battery: M1185994
To replace the backup battery:
1. Remove the device’s Top Enclosure assembly. Refer to section 10.3.8.
3. Carefully disconnect the backup battery harness from the main PCB.
4. Unfasten the securing strap from the backup battery and lift it free from
the device. Set the battery aside for disposal in an appropriate manner.
5. Remove the replacement backup battery from its packaging and inspect
it for any visible damage. In addition, verify that the date/expiry codes
are still valid.
6. Set the replacement backup battery in position and fasten it in place with
the securing strap back across it.
7. Connect the backup battery harness to the main PCB.
8. Secure the main enclosure back in place as described in section 10.3.10.
Released
184 M1186102, Revision 3, 2011

Service and Repair
Backup
Battery
Connector J19
Back-up
Battery
Figure 10.23. Back Up Battery Location
10.3.15. Real Time Clock (RTC) Battery Replacement

VersaMed P/N for ClevAir Real Time Clock (RTC) Battery: 900HC031-01
VersaMed P/N for iVent101 Real Time Clock (RTC) Battery: 900BL031-01
GE P/N for Real Time Clock (RTC) Battery: M1186005
To replace the real time clock battery:
3. Carefully remove the real time clock battery from its position on the
Main PCB, as shown in Figure 10.24: below.
4. Set aside the old battery for disposal in an appropriate manner.
5. Remove the replacement battery from its packaging and inspect it for any
visible signs of damage.
Released
M1186102, Revision 3, 2011 185

6. Carefully install the replacement item on the Main PCB while handling as
little as possible.
9. Start the machine by pressing On/off switch. Wait until GUI startup.
10. Set correct date and time (refer to section 4.2.2).
11. Reboot the machine by pressing On/off switch for off and immediately,
after machine go down, press On/off switch for on the machine. Wait
until GUI startup.
12. Examine the time and date display at lower right side of the Main screen
to verify that the date and time have not changed to previous time.
Figure 10.24: RTC Battery Location
10.3.16. Speaker Replacement

VersaMed P/N for ClevAir Speaker harness: 900HC018-01
VersaMed P/N for iVent101 Speaker harness: 900BL018-01
GE P/N for Speaker: M1185999
To replace the speaker:

1. Remove the device’s Top enclosure assembly. Refer to section 10.3.8.
Released
186 M1186102, Revision 3, 2011

Service and Repair

3. Remove the device’s main PCB. Refer to section 10.3.11.
4. Using a small Philips screwdriver, remove the two screws fastening the
speaker assembly and gasket to the lower enclosure.
5. Remove the replacement speaker from its packaging and inspect it for
any signs of damage.
6. Install the replacement speaker in place and fasten using the two screws
that were removed earlier.
7. Put back the main PCB as described in section 10.3.11.
10.3.17. O2 sensor harness replacement

VersaMed P/N for ClevAir Harnesses kit: 900HC019-01(O2 sensor
harness is part of this kit)
VersaMed P/N for iVent101 Harnesses kit: 900BL019-01(O2 sensor
harness is part of this kit)
GE P/N for Harnesses kit: M1186000
To replace the O2 sensor harness:
1. Remove O2 sensor cover. Refer to section 10.3.5.
In case that O2 sensor installed, remove it. Refer to section 10.3.5.
2. Remove the device’s Top enclosure assembly. Refer to section
10.3.8.
10.3.10.
4. Disconnect the O2 sensor harness from Main board. Refer to Figure
10.15
5. Remove O2 sensor harness from O2 sensor compartment.
6. Set aside the old O2 sensor harness for disposal in an appropriate
manner.
7. Remove the replacement O2 sensor harness from its packaging and
inspect it for any signs of damage.
8. Insert the small connector into hole in O2 sensor compartment.
Released
M1186102, Revision 3, 2011 187

9. Connect the small connector to Main board. Refer to Figure 10.15

10. Secure the main enclosure back in place as described in section
10.3.10.
12. Secure O2 sensor cover. Refer to section 10.3.5.
If needed installation of O2 sensor refer to section 10.3.5.
10.3.18. Pump/Solenoid harness replacement

VersaMed P/N for ClevAir Pump/Solenoid harness kit: 900HC015-01
VersaMed P/N for iVent101 Pump/Solenoid harness kit: 900BL015-01
GE P/N for Pump/Solenoid harness kit: M1185996
NOTE: Two revisions of the pump/solenoid harness are available in the
field they can be distinguishing according to the electrical wiring
direction:
Electrical wiring facing bottom: First revision
Electrical wiring facing up: Second revision

Figure 10.25: Solenoid revisions identification
Follow the appropriate instructions
To replace the Pump/Solenoid harness:

1. Remove the device’s Top enclosure assembly. Refer to section
10.3.8.
10.3.10.
3. Disconnect the Pump/Solenoid harness from Main board. Refer to
Figure 10.15
Released
188 M1186102, Revision 3, 2011

Service and Repair

4. Pull up the pump from his place.
5. Rev. 1 Harness: Cut the strap on the side of Pneumatic Unit for
detach solenoid. Refer to Figure 10.19.
Rev. 2 Harness: Remove the solenoid from its location in the
exhalation valve base while carefully pulling the locking latch. Refer
to Figure 10.26 below.
Solenoid locking
latch
Figure 10.26: Solenoid location
6. Disconnect the all silicone tubes from solenoid and pump.

7. Set aside the old Pump/Solenoid harness for disposal in an
appropriate manner.
8. Remove the replacement Pump/Solenoid sensor harness from its
9. Place the pump, in right way, into his place.
10. Rev. 1 Harness: Reattach the solenoid, with strap, to the Pneumatic
Unit. Refer to Figure 10.21
Rev. 2 Harness: Place the solenoid back in place within the
exhalation valve base.
11. Reconnect all silicone tubes, in right way, to pump and solenoid.
Refer to Figure 10.27 Below.
Released
M1186102, Revision 3, 2011 189

Pump
Tube from pump

to right port of
solenoid. The
clear side of one-
Tube from left port of Tube from middle way valve must
solenoid to T-connector port of solenoid to be in direction of
exhalation base solenoid
Figure 10.27. Pump/Solenoid harness mapping
Rev 2. Harness: Use the tubing length as provided at section 10.3.13

paragraph 17.
12. Reconnect the Pump/Solenoid harness from Main board. Refer to
Figure 10.15
13. Secure the main enclosure back in place as described in section
10.3.10.
10.3.19. Power Supply Unit Replacement

VersaMed P/N for ClevAir Power Supply Unit: 900HC008-01
VersaMed P/N for iVent101 Power Supply Unit: 900BL008-01
GE P/N for Power Supply Unit: M1184157
To replace the power supply unit:
4. Remove the pneumatic unit Refer to section 10.3.13.
Released
190 M1186102, Revision 3, 2011

Service and Repair

5. Remove the device’s power pack. Refer to section 10.3.7.
6. Remove the 3 counter sunk screws from inside the battery enclosure
using a small Philips screwdriver.
7. Carefully disconnect the AC power entry harness and the Power supply
harness.
8. Carefully remove the power supply module from the lower enclosure.
9. Remove the replacement power supply from its packaging, and inspect it
10. Set the power supply in position and fasten it in place by screwing the
screws removed earlier.
11. Reconnect the AC power entry harness and the Power supply harness.
12. Put back the pneumatic unit in place and assemble, Refer to section
10.3.13.
13. Put back the main PCB and reconnect its tubing as described in section
10.3.12
15. Secure the top enclosure in place as described in section 10.3.8.
16. Reinstall the power pack into place as described in section 10.3.7.
Note: Power supply can also include grounding cable that will be
routed directly to the top panel
Released
M1186102, Revision 3, 2011 191

Power Supply
Power Supply
Mounting Screws
Figure 10.28. Power Supply mounting
10.3.20. Back Panel Assembly Replacement

VersaMed P/N for ClevAir Back Panel Assembly: 900HC009-01
VersaMed P/N for iVent101 Back Panel Assembly: 900BL009-01
GE P/N for Back Panel Assembly: M1184159
To replace the Back panel unit:
4. Disconnect the Power Input Cable from Power Supply.
5. Open Formex (Black cover of Power Input Cable).
6. Cut the tie that holds ferrite.
7. Disconnect O2 inlet tube from Pneumatic Unit.
8. Remove the 2 screws from base enclosure using a small 2.5mm Hex key.
9. Carefully remove the Back Panel Assembly from the base enclosure.
Released
192 M1186102, Revision 3, 2011

Service and Repair

10. Remove the replacement Back Panel Assembly from its packaging, and
inspect it for any signs of damage.
11. Set the Back Panel Assembly in position and fasten it in place by screwing
the screws removed earlier.
12. Connect O2 inlet tube to Pneumatic Unit.
13. Hold the ferrite with tie to his place.
14. Close the Formex.
15. Reconnect Power Input Cable from Power Supply.
10.3.11.
10.3.21. Base Assembly Replacement

VersaMed P/N for ClevAir Base Assembly: 900HC005-01
VersaMed P/N for iVent101 Base Assembly: 900BL005-01
GE P/N for Base Assembly: M1184147
To replace the Base unit:
4. Open Formex (Black cover of Power Input Cable).
5. Cut the tie that holds the ferrite.
6. Disconnect the AC Power Input Cable from Power Supply.
7. Disconnect O2 inlet tube from Pneumatic Unit.
8. Remove the 2 screws from base enclosure using a small 2.5mm Hex
screwdriver.
9. Carefully remove the Back Panel Assembly from the base enclosure.
10. Remove the pneumatic unit Refer to section 10.3.13.
11. Remove the power pack. Refer to section 10.3.6.
12. Disconnect the Power supply harness from the base.
Released
M1186102, Revision 3, 2011 193

13. Remove the 3 counter sunk screws from inside the battery enclosure
using a small Philips screwdriver.
14. Carefully remove the power supply module and harness from the base.
15. Remove the replacement base assembly from its packaging, and inspect it
16. Set the power supply in position in the new base and fasten it in place by
screwing the screws removed earlier.
17. Reconnect the Power supply harness the base.
Released
194 M1186102, Revision 3, 2011

Service and Repair
Formex box
Power Supply
Harness
Power Supply
Figure 10.29: Power supply location
18. Fix Formex cover box (as open sheet) in place on the base top using the
adhesive areas.
19. Reassemble the back panel assembly, Refer to section 10.3.20.
20. Reconnect the AC power entry harness.
21. Put back the pneumatic unit in place and assemble, Refer to section
10.3.11 on page 176.
10.3.11, on page 172.
23. Secure the main enclosure back in place as described in section 10.3.10,
on page 170.
24. Secure the top enclosure in place as described in section 10.3.8, on page
168.
25. Reinstall the power pack into place as described in section 10.3.6, on page
166.
Released
M1186102, Revision 3, 2011 195

10.3.22. Exhalation valve base replacement

VersaMed P/N for ClevAir Base Assembly: 900HC012-01
VersaMed P/N for iVent101 Base Assembly: 900BL012-01
GE P/N for Base Assembly: M1185993
Note: Two revisions of the exhalation valve base are available in the field they
can be distinguishing according to the physical dimensions:

Figure 10.30: Exhalation Valve base revisions
Both revisions are applicable for these instructions
To replace the exhalation valve base:

4. Disconnect the tubing from the exhalation valve base.
5. Remove the 2 screws from the exhalation valve base using a small
2.5mm Hex key.
6. Carefully remove the exhalation valve base Assembly from the base
enclosure.
7. Remove the replacement exhalation valve base assembly from its
packaging, and inspect it for any signs of damage.
8. Set the exhalation valve base assembly in position and fasten it in place
by screwing the screws removed earlier.
9. Connect the tubing according to Figure 10.21
Released
196 M1186102, Revision 3, 2011

Service and Repair
10.3.12.
8. Reinstall the power pack into place as described in section 10.3.7.
10.3.23. Verification Tests for the new parts

Table 10-3 below describes the required verification tests that should be
perform to verify the integrity of the part you have replaced.
Table 10-3: Verification tests for new parts
Perfor- Patient
Service PU Power Sensor Factory O2 Touch Alarm
mance Tube OVT
Performed VVT VVT Cal Cal Cal Screen Cal Tests
Tests Comp
Inlet Filter
- -- -- -- -- -- -- -- -- --
Replacement
Exhalation
Valve -- -- -- -- -- -- -- -- -- 
Replacement
One /Two Limb
changeover
--  --   -- -- -- -- 
O2 Sensor
Replacement
-- -- -- -- -- --  -- -- --
Mains AC fuse
Replacement
-- --  -- -- -- -- -- -- --
Power Pack
Replacement
-- --  -- -- -- -- -- -- --
Top Panel
Replacement
-- --  -- -- -- --  -- --
Filter Housing
Replacement
--   -- -- -- -- -- -- --
Main Enclosure
Replacement
--   -- -- -- -- -- -- --
Released
M1186102, Revision 3, 2011 197

Perfor- Patient
Service PU Power Sensor Factory O2 Touch Alarm
mance Tube OVT
Performed VVT VVT Cal Cal Cal Screen Cal Tests
Tests Comp
Fans
Replacement
-- --  -- -- -- -- -- -- --
Main PCB
Replacement
         
Pneumatic 
System        -- 
Replacement
Back-Up Battery
-   -- -- -- -- -- -- 
Replacement
RTC Battery
   -- -- -- -- -- -- 
Replacement
Speaker
-   -- -- -- -- -- 1 
Replacement
O2 sensor 
harness -   -- -- --  -- --
Replacement
Pump/Solenoid 
harness    -- -- -- -- -- --
Replacement
Power supply
       
Replacement
- --
Back Panel
    -- -  -- --

Replacement
Base
         
Replacement
Exhalation valve 
base   -- -- -- -- -- -- --
Replacement
1. Perform short alarm test according to the Operator’s Manual

Released
198 M1186102, Revision 3, 2011

Spare Parts
Section 11: Spare Parts

This section provides references for identifying the spare parts of the
ClevAir and iVent101. Read the information and descriptions carefully
before ordering a specific item.
11.1. Hardware version

There are two available hardware versions of the iVent101 ventilator. As
this manual is intended for both hardware versions the following
designations is to be used throughout this parts and accessories
sections:
iVent101 Serial numbers prefixed by ‘BL’, with a blue lower
enclosure. For non- European markets.
ClevAir Serial numbers prefixed by ‘HC’, with a dark gray lower
enclosure. Exclusive the European markets.
11.2. Ventilator’s Part List
11.2.1. Ventilator’s System
2 1
Figure 11.1: Ventilator’s System
REF NO. DESCRIPTION
1 Ivent101 Ventilation System

2 ClevAir Ventilation System
Table 11-1: Ventilator’s System
Released
M1186102, Revision 3, 2011 199

11.2.2. Main Assemblies
9
10
Figure 11.2: Main Assembly

Released
200 M1186102, Revision 3, 2011

Spare Parts
Table 11-2: Main Assemblies
REF NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION
1 900HC003-01 N/A Top Enclosure

Assembly,
ClevAir
- 900BL003-01 M1184143 Top Housing
Assembly,
iVent101
2 900HC002-01 N/A Main PCB,
ClevAir
- 900BL002-01 M1184141 Main PCB,
iVent101
3 900HC001-01 N/A Pneumatic
Unit, ClevAir
- 900BL0001-01 M1184139 Pneumatic
Unit iVent101
- N/A M1230870 Pneumatic
Unit iVent101
Ver. 2.0
4 900HC004-01 N/A Main
Enclosure
Assembly,
ClevAir
- 900BL004-01 M1184145 Main
Enclosure
Assembly,
iVent101
5 900HC005-01 N/A Base
Enclosure
Assembly,
ClevAir
- 900BL005-01 M1184147 Base
Enclosure
Assembly,
iVent101
6 900HC006-01 N/A Integrated
Battery Power
Released
M1186102, Revision 3, 2011 201

REF NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION

Pack, ClevAir
- 900BL006-01 M1184149 Integrated
Battery Power
Pack, iVent101
7 660HC001-01 N/A Inlet Filter,
ClevAir
- 660BL001-01 M1184151 Inlet Filter,
iVent101
8 900HC016-01 N/A Air Inlet
adapter,
ClevAir
- 900BL016-01 M1185997 Air Inlet
adapter,
iVent101
9 900HC007-01 N/A Two-limb kit,
ClevAir
- 900BL007-01 M1184153 Two-limb kit,
iVent101
10 900HC008-01 N/A Power
supply,
ClevAir
- 900BL008-01 M1184157 Power supply,
iVent101
11.2.3. Spare parts

Table 11-3: Spare Parts
NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION
1 130B0002-03 M1161179 O2 Sensor

"MAX16"
2 504HC051-01 N/A One-limb kit,
ClevAir
- N/A M1230871 One-limb kit,
iVent101
3 900HC009-01 N/A Back Panel
Released
202 M1186102, Revision 3, 2011

Spare Parts
assembly,
ClevAir
- 900BL009-01 M1184159 Back Panel
assembly,
iVent101
4 900HC010-01 N/A Ground cables
kit, ClevAir
- 900BL010-01 M1184161 Ground cables
kit, iVent101
5 504HC055-01 N/A Respiratory Kit,
ClevAir
- 504BL055-01 M1185990 Respiratory Kit,
iVent101
6 900P0106-01 M1184164 2-Liter
Breathing lung,
ClevAir
- 900P0107-01 M1185991 2-Liter
Breathing lung,
iVent101
8 900P0102-01 N/A Machine
Packing kit,
ClevAir
- 900P0103-01 M1184168 Machine
Packing kit,
iVent101
9 900HC011-01 N/A Tubing kit,
ClevAir
- 900BL011-01 M1185992 Tubing kit,
iVent101
10 900HC012-01 N/A Exhalation
valve base kit,
ClevAir
- 900BL012-01 M1185993 Exhalation
valve base kit,
iVent101
Released
M1186102, Revision 3, 2011 203

11 900HC013-01 N/A Back-up

battery, ClevAir
- 900BL013-01 M1185994 Back-up

battery,
iVent101
12 900HC014-01 N/A Bumper + plug
kit, ClevAir
- 900BL014-01 M1185995 Bumper + plug
kit, iVent101
13 900HC015-01 N/A Pump &
Solenoid
harness,
ClevAir
- 900BL015-01 M1185996 Pump &
Solenoid
harness,
iVent101
14 900HC017-01 N/A Fans kit,
ClevAir
- 900BL017-01 M1185998 Fans kit,
iVent101
15 900HC018-01 N/A Speaker
harness,
ClevAir
- 900BL018-01 M1185999 Speaker
harness,
iVent101
16 900HC019-01 N/A Harnesses kit,
ClevAir
- 900HC019-01 M1186000 Harnesses kit,
iVent101
17 900HC020-01 N/A O2 sensor Cork
+ Cap kit,
ClevAir
Released
204 M1186102, Revision 3, 2011

Spare Parts
- 900BL020-01 M1185709 O2 sensor Cork

+ Cap kit,
iVent101
18 900HC021-01 N/A Gas gauge
adapter,
ClevAir
- 900BL021-01 M1186001 Gas gauge
adapter,
iVent101
19 900HC022-01 N/A Fuse Kit,
ClevAir
- 900BL022-01 M1186002 Fuse Kit,
iVent101
20 900HC023-01 N/A Hardware kit,
ClevAir
- 900BL023-01 M1186003 Hardware kit,
iVent101
21 900HC031-01 N/A RTC battery,
ClevAir
- 900BL031-01 M1186005 RTC battery,
iVent101
22 900P0100-01 N/A AC Cable 2 PIN
180CM for
Europe EN
50075:1990,
ClevAir
- 900P0104-01 M1186004 AC Cable 2 PIN
180CM for
Europe EN
50075:1990,
iVent101
23 900HC024-01 M1185714 AC Cable 2 PIN
180CM for
China
GB2099.1-96,
GB1002-96
Released
M1186102, Revision 3, 2011 205

24 900HC025-01 M1185715 AC Cable 2 PIN

180CM for USA
NEMA 1-15P,
UL817, CSA
C22.2
25 900HC026-01 M1185716 AC Cable 2 PIN
180CM for
Australia
AS/NZS
3112:2000
26 900HC027-01 M1185717 AC Cable 2 PIN
180CM for
India IEC 60
799:1998
27 900HC028-01 M1185718 AC Cable 2 PIN
180CM for UK
BS1363
28 900HC029-01 M1185719 AC Cable 2 PIN
180CM for
Brazil
NBR14136
29 900HC029-01 M1185719 AC Cable 2 PIN
180CM for
Brazil
NBR14136
11.2.4. Accessories
Table 11-4: Accessories
NO. VERSAMED PART NUMBER VERSAMED PART DESCRIPTION

NUMBER
1 900HC033-01 N/A Extended Battery

Power Pack,
ClevAir
- 900BL033-01 M1184170 Extended Battery
Power Pack,
Released
206 M1186102, Revision 3, 2011

Spare Parts
NO. VERSAMED PART NUMBER VERSAMED PART DESCRIPTION
NUMBER
iVent101
2 900HC030-01 N/A Remote Alarm
cable, ClevAir
- 900BL030-01 M1186006 Remote Alarm
cable, iVent101
3 910A0002-01 M1182959 Technician Kit
(w/o TSI)
- 910A0001-01 M1182956 Technician Kit
4 900HC006-01 N/A Integrated

Battery Power
Pack, ClevAir
- 900BL006-01 M1184149 Integrated
Battery Power
Pack, iVent101
5 900P0101-01 N/A Two-limb
disposable
patient circuit,
ClevAir
- 900P0105-01 M1186007 Two-limb
disposable
patient circuit,
iVent101
11.2.5. Maintenance Kits

Table 11-5: Maintenance Kits
NO. VERSAMED PART GE PART NUMBER DESCRIPTION

NUMBER
1 900K0100-01 N/A Annual maintenance

kit, ClevAir
- 900K0101-01 M1184172 Annual maintenance
kit, iVent101
2 900HC001-01 N/A Pneumatic Unit, 15k

Released
M1186102, Revision 3, 2011 207


NUMBER
Maintenance, ClevAir
- 900BL0001-01 M1184139 Pneumatic Unit, 15k
Maintenance,,
iVent101
11.2.6. iVent Software

Table 11-6: iVent Software

NUMBER
1 N/A M1225601 IVent101 SW version

2.X CD
Released
208 M1186102, Revision 3, 2011

Spare Parts
Appendix A: Planned Maintenance Check list
Serial Number: Date: (MM/DD/YY) / /
Customer: Performed by:
 6 Month  12 Month 3 Years  15,000 Hours/ 4 years
 Note:
- Upon periodic maintenance, all parts should be replaced before performing

tests and calibration
- Perform OVT each time of reattaching Patient Circuit to the machine
1. Perform the following steps every 6 months
 Replace the air inlet filter.
 Replace exhalation valve membrane.
 Perform O2 calibration (if O2 sensor in use).
 Perform CDC to the integrated battery.

Released
M1186102, Revision 3, 2011 209

2. Perform the following steps every 12 months
 Replace exhalation valve.
 Replace backup battery.
 Perform CDC to the integrated battery.
 Perform ALL service calibrations.
 Perform performance verification tests.
3. Perform the following steps every 24 months:
 Replace exhalation valve.
 Replace backup battery.
 Replace integrated battery
 Replace the O2 sensor
 Perform ALL service calibrations.

Released
210 M1186102, Revision 3, 2011

Spare Parts
4. Perform the following steps every 36 month
 Replace RTC battery.
 Perform all 12 months maintenance procedures.
5. Perform the following steps every 15000 hours/ 4 years of use
 Replace pneumatic unit.
 Perform ALL calibrations.

Released
M1186102, Revision 3, 2011 211

Appendix B: Previous SW versions related procedures

This Section provides the instructions to handle procedures that were part of the
previous iVent101 SW versions.
These procedures are applicable for SW change only, for HW changes refer to section
10.3 Service & Repair Procedures
It is highly recommended to use the latest SW version release, for upgrade instruction
refer to
1. The Information screen

To open the Information Screen:
 Tap the Information ( ) button, located on the lower left side of

the screen.
Figure 11.3. Prior to SW 2.0 Information screen
The Information screen contains the following information:

device.
Note: The caption “Not Performed” will be shown always, regardless of
the software being updated).
 Total PU Working Hours – The total working hours of the
ventilator’s pneumatic unit.
Released
212 M1186102, Revision 3, 2011

Spare Parts
performed. On the right side the status of the last VVT is displayed:
succeeded or failed.
 Last OVT – The last time that OVT procedure was performed. On
the right side the status of the last OVT is displayed: succeeded or
failed.
2. Enabling the O2 Sensor

By default the Oxygen sensors, and associated FiO2 monitoring and
alarms are disabled, in order to prevent false O2 alarms. In applications
where the FiO2 monitoring is needed you can enable the oxygen
measuring sensors, which provides monitoring and associated alarms for
the delivered FiO2.
Notes:
1. Not all iVent101 models are supplied with an O2 sensor.
2. If O2 monitoring is enabled and no O2 sensor is installed the
ventilator will activate a "Missing O2 sensor" alarm.
To enable the O2 functionality:
2.1. In the General Configuration screen tap Enable O2. The Enable O2
box is displayed on the right panel.
Figure 11.4: Enable O2 Panel
2.2. Tap the box to select or clear it (works as a toggle). When the box is
selected the O2 functionality is enabled.
2.3. Tap Accept to save the settings and close the screen.
Released
M1186102, Revision 3, 2011 213

3. Technical Logbook
The Technical Logbook screen displays chronologically details on
technical events which have occurred on the ventilator. The date and
time of the event are displayed on the left side of the screen, and a
description of the event is on the right side.
To open the Technical Logbook:
3.1. On the Services screen tap Technical Logbook. The Technical Event
Log Book is displayed.
Figure 11.5: Technical logbook
3.2. Tap the fast-upward or fast-downward buttons to
browse the logbook by page. Tap the upward or downward
buttons to move between adjacent single entries.

3.3. Tap the Close button to exit from the Technical Event Log Book
screen.
The logbook has a limited capacity (198 events). Once full, events are
deleted on a first in - first out basis. The contents of the logbook may be
uploaded to USB flash drive (Disk on Key) for external view.
Released
214 M1186102, Revision 3, 2011

Spare Parts
4. Circuit Compensation
During the circuit compensation test the device will attempt to perform
calibration of the compliance (ml/cmH2O) and the resistance
(cmH2O/lpm) of the patient tubing system.
During normal operation these factors are used to correct breath
delivery and the monitoring of the tubing system, thus ensuring
ventilation at the set parameters.
In addition to intervals mentioned in section 6.5.1, the circuit
compensation calibration should be performed any time that the patient
tubing configuration is changed between Two and One limb, or any time
there is a significant change in the tubing type, for example Infant
(10mm tubing) to Adult (22mm tubing), or when the Patient Tube
Testing indicates that it may be necessary.
To perform the circuit compensation test only the desired patient tubing
and the 22mm sealing cap are required
Tube Compliance 1. Review the patient configuration setting (One or Two limb) and ensure
Calibration – Continues that the appropriate hardware configuration is in use.
2. From the Calibration screen tap Circuit Compensation. The Tube

Compliance Service Calibration screen is displayed, as shown in the
Figure 11.6Error! Reference source not found. below.
Figure 11.6: Tube Compliance Calibration Screen (Two limb configuration)

Released
M1186102, Revision 3, 2011 215

Figure 11.7. Tube Compliance Calibration Screen (One limb configuration)
3. Follow the onscreen instructions: seal the patient circuit with a 22mm
sealing cap.
4. Tap Start. The device tries to ventilate 10 times, and measures the tube
compliance.
Tube Compliance
Calibration This procedure takes approximately 10 seconds to complete.
On completion the Tube resistance Calibration screen is displayed as
shown in Figure 11.8Error! Reference source not found. below.
Figure 11.8: Tube Resistance Calibration Screen (Two limb configuration)

Released
216 M1186102, Revision 3, 2011

Spare Parts
Figure 11.9. Tube Resistance Calibration Screen (One limb configuration)
5. Follow the onscreen instructions: remove the 22mm sealing cap from the
patient circuit.
6. Tap Start.
Tube Resistance
Calibration On completion the Save box is displayed, as shown in Figure 6.3,
5. Manual Battery Gas Gauge Update Procedure

Manual battery gas gauge initialization should be performed when
Battery Calibration procedure is not applicable and periodically in order
to check the performance of the integrated battery, and to ensure
accurate monitoring of the battery’s capacity. During the procedure, the
integrated battery undergoes a complete charge-discharge-charge cycle
(CDC).
Note: When the iVent101 is not in use for a long period it is
recommended to disconnect the integrated battery and store it
separately from the ventilator.
1.1 Charging Procedure

Fully charge the battery to maximize the battery life in the following
cases:
Released
M1186102, Revision 3, 2011 217

 Prior to initial use.

 After prolonged storage (4 weeks or more).
This procedure may take 5 hours for the standard battery or 10 for the
extended battery.
1. Connect the ventilator to an external power source.

2. Power up the ventilator.
3. Verify that after a few seconds the yellow LED is lit, indicating that
the battery is charged.
4. Wait until the icon is displayed on power status area at the lower
right side of the screen.
1.2 CDC (Charge- Discharge- Charge) Procedure

The CDC (Charge-Discharge-Charge) procedure is a maintenance
procedure that ensures accurate and adequate battery’s performance.
In addition to the intervals mentioned in Error! Reference source not
found., it is required to perform battery gas gauge update procedure
(CDC) every 6 months.
Notes:
1. It is recommended to perform CDC more frequently if the battery is
not in use on daily basis.
2. Failure to perform recommended maintenance, might lead to
inaccurate indication of the remaining battery capacity, and accelerated
degradation of the battery’s performance.
This procedure may take 15 hours for the standard battery or 28 for the
extended battery.

Average completion time at 24C. Time may vary with environmental conditions (primarily in terms of
temperature as well as battery capacity).

Average completion time at 24C. Time may vary with environmental conditions (primarily in terms of
temperature as well as battery capacity).
Released
218 M1186102, Revision 3, 2011

Spare Parts
Note: It is highly recommended to run this procedure in a room
temperature of 17-25°C.
Gas Gauge Update Procedure

1. Connect the iVent101 to an AC power source and power it up.
2. Connect the ClevAir iVent101 ventilator to a patient circuit attached to
an Rp20 resistor and reservoir bag. (Refer to section 2.2: Patient Circuit,
page 23).
3. Set the ventilation to the following settings:
Parameter Value
Mode AC Pressure control
Rate 14
Sensitivity 3
Vt Limit 1000
Peep 20
Insp. Press 15
Rise Time 9
High rate alarm 40
High Pressure 60
Alarm
High Minute 24
Volume Alarm
Screen Maximum
brightness
Patient circuit Two limbs
configuration
4. Tap the Start button.
5. Disconnect the iVent101 from the charging power source and continue
to ventilate.
6. The Battery icons at the bottom of the Main screen will indicate the
remaining capacity. (Refer to section Understanding the Power Sources,
page 20, for an explanation of these icons).
7. The AC Disconnect Alarm and the Internal Battery in use Alarm are
displayed. Tap Silence to accept these alarms.
Released
M1186102, Revision 3, 2011 219

8. When the Low Battery Alarm message is displayed, tap Silence to

accept this alarm.
9. When the Empty Battery Alarm message is displayed, tap Silence to
accept this alarm.
10. Wait until a constant high tone is heard, alerting that the battery is fully
depleted. The touch screen may also become blank.
Note: Ventilation will be stopped at this stage.
11. Reconnect the charging power source to the iVent101. The charge
indicator should be yellow during charging. Wait several hours until
the icon is displayed on the Main screen.

Note: The iVent101 has to be powered up while recharging.
12. Repeat steps 1 to 11 one more time.
Note: Repeating steps 1 to 12 may improve the battery performance, effective
capacity, and lifetime.

When the ventilator is charged in a room temperature. The time may change depending on the battery
capacity and temperature.
Released
220 M1186102, Revision 3, 2011

Spare Parts
Appendix C: iVent101 Version 2.0 upgrade kit instructions
DESCRIPTION PART NUMBER

iVent101 Version 2.0 Upgrade Kit - English M1224765
iVent101 Version 2.0 Upgrade Kit – Portuguese M1230593
iVent101 Version 2.0 Upgrade Kit – Spanish M1230591
iVent101 Version 2.0 Upgrade Kit – Italian M1230589
Intended use
The ivent101 version 2.0 upgrade kit provides informative and complimentary tools that required for the new
version.
Kit Description
Please verify that the kit contains the following:

DESCRIPTION Quantity
User Reference Manual 1
iVent101 Dust cap 1
ANSI Pan Philips Screw 4-40x3/16 2
Notes:
 iVent101 SW 2.0 CD (PN: M1225601) is available for ordering through the normal channels
 It is required to perform OVT and VVT after the upgrade is done
 After upgrading SW to version 2.0 downgrade is not supported
 The upgrade process must performed by qualified Versamed iVent101 technician
 To upgrade iVent101 unit:
1. Use the dust cap as cover to the RS-232 port
2. Secure the cover in place using 2 Philips screws as described in the figure below:
Note: Each unit that has been upgraded must be return

to the customer with the dust cover installed
2 Philips
Screws
Follow instruction in the Technical reference manual (M1186102) section 4.4.5: Software update.
Released
M1186102, Revision 3, 2011 221

Appendix D: Compliance with Section 6 of IEC 60601-1-

2
a) The iVent101 needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in the accompanying documents
b) Portable and mobile RF communications equipment can affect iVent101.
c) The iVent101 was tested with the following accessories/cables to meet with the standard emission and
immunity requirements.
Port Connected Cable Indoor /

Port type Connector type Qty. Cable type
description From To Length outdoor
Power AC power EUT AC mains 2-pole 1 Unshielded 2m Indoor

Power DC power EUT Battery pack XLB2-42 1 Unshielded 2m Indoor
Signal SpO2 EUT Sensor 10214-6212VC 1 Unshielded 2.9 m Indoor
Signal Ext. alarm EUT Not connected Microphone 1 NA NA Indoor
Signal Ethernet (LAN)* EUT Not connected RJ 45 1 NA NA Indoor
Signal RS 232* EUT Not connected RJ 45 1 NA NA Indoor
Signal USB* EUT Not connected USB 1 NA NA Indoor
* Used for maintenance only.
d) The use of accessories, transducers and cables other than those specified, with the exception of transducers
and cables sold by the manufacturer of the iVent101 as replacement parts for internal components, may
result in increased emissions or decreased immunity of the iVent101
e) The iVent101 should not be used adjacent to or stacked with other equipment and that if adjacent or stacked
use is necessary, the iVent101 should be observed to verify normal operation in the configuration in which it
will be used.
d) The use of the accessory, transducer or cable with equipment and systems other than those specified may
result in increased emissions or decreased immunity of the iVent101.
e) Electro Magnetic Declaration – IVent101:
Electro-magnetic emissions
The iVent101 is designed to be used in the electro-magnetic environment specified below. The equipment’s
customer or user must ensure that it is used in such an environment.
Emission test Compliance Recommended electro-magnetic environment
RF emissions The iVent101 uses RF energy only for its internal function. Therefore
Group 1 its RF emissions are very low and are not likely to cause any interference
CISPR 11
in nearby electronic equipment.
RF emissions
CISPR 11
Class B The iVent101 is suitable for use in all establishments, including
Released
222 M1186102, Revision 3, 2011

Spare Parts
Harmonic domestic establishments and those directly connected to the public low-
emissions Class A voltage power supply network that supplies buildings used for domestic
IEC 61000-3-2 purposes.
Voltage
fluctuations/flicke
Complies
r emissions
IEC 61000-3-3
Electro-magnetic immunity
IEC 60601 test Compliance
Immunity test Recommended electro-magnetic environment
level level
Electrostatic The floors should be wood, concrete or ceramic tile. If
± 6 kV contact ± 6 kV contact
discharge (ESD) the floors are covered with synthetic material, the
± 8 kV air ± 8 kV air
IEC 61000-4-2 relative humidity should be at least 30%.
± 2 kV on
± 2 kV on power
Electrical fast power supply
supply lines Mains power quality should be that of a typical
transient/ burst lines
± 1 kV on input / commercial or hospital environment.
IEC 61000-4-4 ± 1 kV on input
output lines
/ output lines
± 1 kV
± 1 kV
differential
Surge differential Mains power quality should be that of a typical
mode
IEC 61000-4-5 mode ± 2 kV commercial or hospital environment.
± 2 kV common
common mode
mode
< 5% UT < 5% UT
(>95% dip in UT) (>95% dip in Mains power quality should be that of a typical
Voltage dips, for 0.5 cycles UT) for 0.5 commercial or hospital environment. If the user of the
short 40% UT cycles 40% UT iVent101 requires continued operation during power
interruptions and (60% dip in UT) (60% dip in UT) mains interruptions, it is recommended that the
voltage for 5 cycles for 5 cycles
variations on 70% UT 70% UT iVent101 be powered from an uninterruptible power
power supply (30% dip in UT) (30% dip in UT) supply or a battery.
input lines for 25 cycles for 25 cycles
IEC 61000-4-11 < 5% UT < 5% UT Note: Voltage reduction didn't influence the iVent101
(>95% dip in UT) (>95% dip in which is always supplied with the back up battery
for 5 s UT) for 5 s
Power frequency
Power frequency magnetic fields should be at levels
(50/60 Hz)
3 A/m 3 A/m characteristic of a typical location in a typical commercial
magnetic field
or hospital environment.
IEC 61000-4-8
NOTE: UT is the AC mains voltage prior to application of the test level.
Released
M1186102, Revision 3, 2011 223

Electro-magnetic immunity (follows)

IEC 60601 Compliance
Immunity test Recommended electro-magnetic environment
test level level
Portable and mobile RF communications equipment
should be used no closer to any part of iVent101
including cables, than the recommended separation
distance calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
d = 0.35√P from 150 kHz to 80 MHz outside ISM bands
d = 1.2√P from 150 kHz to 80 MHz within ISM bands
where P is the maximum output power rating of the
3 V rms
transmitter in watts (W) according to the transmitter
150 kHz to 80
MHz outside manufacturer and d is the recommended separation
Conducted Radio 10 V distance in metres (m) b.
ISM bandsa
frequency 150 kHz to 80
10 V rms Field strengths from fixed RF transmitters, as determined
IEC 61000-4-6 MHz
150 kHz to 80 by an electromagnetic site surveyc, should be less than the
d
MHz within compliance level in each frequency range .
ISM bandsa
Interference may occur in the vicinity of equipment
marked with the following symbol:
Recommended separation distance:

d = 1.2√P from 80 MHz to 800 MHz
d = 2.3√P from 800 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
Radiated Radio
frequency
10 V/m 10V/m distance in metres (m) b.
80 MHz to 2.5 80 MHz to 2.5
IEC 61000-4-3 Field strengths from fixed RF transmitters, as determined
GHz GHz c
by an electromagnetic site survey , should be less than the
d
compliance level in each frequency range .
Interference may occur in the vicinity of equipment
marked with the following symbol:
NOTE 1: At 80 MHz and 800 MHz, the highest frequency interval is applied NOTE 2: This guide is not applicable in
every situation. The issue of electro-magnetic waves is affected by the absorption and the reflection of structures,
objects and people.
Released
224 M1186102, Revision 3, 2011

Spare Parts
(a) The ISM bands (Industrial, Scientific and Medical) 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 to 40.70 MHz.
(b) Compliance levels in ISM frequency bands between 150 kHz and 80 MHz and between 80 MHz and 2.5 GHz are
intended to decrease the likelihood that mobile/portable communication equipment could cause interference if it is
inadvertently brought into patient areas. This is why an additional 10/3 factor is used in calculating the distance of
separation for emitters in these frequency ranges.
(c) Fields from fixed emitters, such as cordless telephone bases, mobile radios, CB radios, AM and FM radio emissions,
TV emissions may not be accurately predicted in theory. In order to evaluate the electro-magnetic environment from
fixed emitters, an electro-magnetic surveillance site must be considered. If the force field measured in the
environment where the iVent101 has to be used, exceeds the above applicable RF levels, the iVent101 must
be watched to check if it is working normally. If abnormal performance is observed, extra measures have to be taken
such as redirecting or moving the iVent101.
(d) Above the 150 kHz to 80 MHz frequency range, force fields should be less than 10 V/m.
Recommended distance between portable and mobile RF communications equipment

and iVent101
The iVent101 is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the iVent101 can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and
iVent101 as recommended below, according to the maximum output power of the communications equipment.
Distance apart in terms of the emitter’s frequency (m)
Maximum 150 kHz to 80 150 kHz to 80
power of the 80 MHz to
MHz outside the MHz within the
emitter (W) 800 MHz d 800 MHz to 2.5 GHz d = 2.3√P
ISM bands d = ISM bands d =
= 1.2√P
0.35√P 1.2√P
0.01 0.035 0.12 0.12 0.23
0.1 0.11 0.38 0.38 0.73
1 0.35 1.2 1.2 2.3
10 1.1 3.8 3.8 7.3
100 3.5 12 12 23
For checked emitters with a maximum power not listed above, the recommended separation distance « d » in
meters (m) may be determined using the equation applicable to the emitter’s frequency, where « P » is the
maximum power of the emitter in Watts (W) according to the emitter’s manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance of the highest frequency range is applied.
NOTE 2: ISM bands (Industrial, Scientific and Medical) 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 to 40.70 MHz.
NOTE 3: An additional factor of 10/3 is used in calculating the separation distance for emitters in the 150 kHz and 80
MHz ISM range as well as the frequency range between 80 MHz and 2.5 GHz in order to reduce the probability that
mobile/portable communication equipment causes interference if they are unknowingly taken near the patient.
NOTE 4: This guide is not applicable in every situation. The issue of electro-magnetic waves is affected by the
absorption and the reflection of structures, objects and people.
Released
M1186102, Revision 3, 2011 225


Released
226 M1186102, Revision 3, 2011

Index
Section 12: Index
O2 sensors......................................62
A
Sound Levels...................................56
AC connected test ..............................92 Configuration Screen
AC Disconnected test..........................96 Lock screen.....................................57
AC Power............................................47 Configuration screens
AC Power Disconnect test...................96 Date ...............................................59
Air Inlet Filter .....................................36 Time ...............................................59
Alarm .................................................56 Cooling Fans .......................................52
Alarm Sound Levels ............................56 Copy Log File ......................................75
Alarms Tests .....................................133
D
B
Date ...................................................59
Back Up Battery........................ 151, 183 Dual limb Patient Circuit.....................23
Backlight Inverter PCB ........................52
E
Backup Battery ...................................49
Battery Enclosure ................................... 36, 169
Backup............................................49 Exhalation Valve ... 41, 43, 151, 161, 164,
Integrated.......................................21 165
Battery Gas Gauge............................ 122 Expert.................................................65
Expert Services...................................63
C
External Dc Power .............................. 47
Calibration External Disconnected Test ................94
factory calibrations .......................105 External Test ......................................93
FiO2..............................................117
F
Outlet valve calibration ................109
pneumatic resistance calibration ..110 Factory Calibrations.......................... 105
Sensors.........................................112 Fan .....................................................52
Service calibration ........................112 Filter
Troubleshooting ........................... 126 Air Inlet ..........................................26
Tube Compensation......................114 Filter...................................................26
Tube resistance ............................ 114 Filter................................................. 148
Turbine calibration .......................107 Filter................................................. 151
CDC Procedure .................................123 Filter................................................. 160
Charge-Discharge-Charge cycle 120, 122 Filter Housing ................................... 171
Charger Test .......................................97 FiO2 ....................................................43
Circuit Compensation .......................114 Flow Sensor........................................41
Cleaning and Routine Planned Flow Test............................................85
Maintenance ................................ 148 G
Configuration screen
Gas Gauge PCB ...................................49
Released
M1186102, Revision 3, 2011 227

General Configuration .......................55 Enabling .........................................62

On Off Switch .....................................46
H
One limb ...................................... 24, 72
Heated Humidification........................25 One Limb............................................40
High Pressure Box...............................39 One Way Valve ...................................40
HME ...................................................25 Outlet valve calibration .................... 109
I OVT ....................................................79
Indicator Lights...................................52 P
Inlet Filter.............. 26, 36, 148, 151, 160 Patient Circuit.....................................22
Integrated Battery ........................ 21, 48 Dual limb ........................................23
Charge ..........................................123 One limb.........................................24
Interface PCB......................................51 Patient Configuration ......................... 72
L Patient Pressure Transducer...............41
Patient Tubing Test............................. 79
Labels .................................................13 PCB
LCD Touch screen ...............................51 Interface.........................................51
Leak Test ............................................87 Pneumatic Unit............................... 51
LEDs ...................................................52 PCB
Lock screen configuration...................57 Main...............................................50
Log File ...............................................75 PCB
Low Flow O2 connector ......................27 Backlight Inverter ........................... 52
Low Flow O2 connector with locking nut Planned Maintenance
.......................................................28 Every 12 Months .......................... 151
Low Oxygen Supply ............................26 Every 6 Months ............................ 151
M Planned Maintenance ...................... 152
Pneumatic Resistance Calibration..... 110
Main Alarm Speaker ...........................52
Pneumatic System.............................. 32
Main Enclosure.................................172
Pneumatic Unit......................... 152, 177
Main PCB.................................... 50, 174
Pneumatic Unit PCB............................ 51
Manifold.............................................36
Pneumatic Unit Test ........................... 83
MDI ....................................................25
POV ....................................................37
Membrane ................151, 161, 164, 165
Power Pack............................... 151, 168
Memory Card .....................................51
Power Sources....................................19
O Power Supply ................................... 190
O2 Calibration ..................................117 R
O2 Connector
Real Time Clock Battery............ 152, 185
Low Flow O2 connector ..................27
Low Flow O2 connector with locking S
nut..............................................28 Sensors Calibration........................... 112
O2 Sensor.........................................166 Service calibration ............................ 112
O2 sensors
Released
228 M1186102, Revision 3, 2011

Index
Service Notice ..................................137 Troubleshooting ............................... 146
Service Notices Numbers..................138 Turbine...............................................37
Service Screen ....................................63 Turbine Calibration........................... 107
Copy Log File ..................................75 Turbine Pressure Transducer..............39
Patient Configuration .....................72 Two Limb...................................... 40, 72
Setup Configuration........................75 U
Software Update ............................70
Technical Info .................................68 Updating the battery gas gauge........ 122
Software Update ................................70 V
Sound Levels
Alarm..............................................56 Ventilation Circuit Test .......................79
Button ............................................56 VVT ....................................................81
Strut ....................................... 39, 40, 41 AC connected test .......................... 92
Symbols..............................................13 AC Disconnected test......................96
AC Power Disconnect test...............96
T Charger Test ...................................97
Technical Info .....................................68 External battery test.......................93
Tests External Disconnected Test ............94
Alarms ..........................................133 Flow Test ........................................85
Time ...................................................59 Leak Test ........................................87
Top Enclosure...................................169 Pneumatic Unit............................... 83
Touch screen ......................................51
Released
M1186102, Revision 3, 2011 229

Warranty
This Product is sold by VersaMed under the warranties set forth in the following
paragraphs. Such warranties are extended only with respect to the purchase of this
Product directly from VersaMed or VersaMed’s Authorized Dealers as new merchandise
and are extended to the Buyer thereof, other than for the purpose of resale.
For a period of twelve (12) months from the date of original delivery to Buyer or to
Buyer’s order, but in no event for a period of more than two years from the date of
original delivery by VersaMed to a VersaMed Authorized Dealer, this Product, other
than its expendable parts, is warranted against functional defects in materials and
workmanship and to conform to the description of the Product contained in this
Technical Reference manual and accompanying labels and/or inserts, provided that the
same is properly operated under the conditions of normal use, that regular periodic
maintenance and service is performed and that replacements and repairs are made in
accordance with the instructions provided. This same warranty is made for a period of
thirty (30) days with respect to expendable parts.
The foregoing warranties shall not apply if the Product has been repaired other than by
VersaMed or in accordance with written instructions provided by VersaMed, or altered
by anyone other than VersaMed, or if the Product has been subject to abuse, misuse,
negligence, or accident.
VersaMed’s sole and exclusive obligation and Buyer’s sole and exclusive remedy under
the above warranties is limited to repairing or replacing, free of charge, at VersaMed’s
option, a Product, which is telephonically reported to the nearest VersaMed Customer
Service Center and which, if so advised by VersaMed, is thereafter returned with a
statement of the observed deficiency, not later than seven (7) days after the expiration
date of the applicable warranty, to the VersaMed Customer Service and Distribution
Center during normal business hours, transportation charges prepaid, and which, upon
VersaMed examination, is found not to conform with above warranties. VersaMed shall
not be otherwise liable for any damages including but not limited to incidental damages,
consequential damages, or special damages.
There are no express or implied warranties which extend beyond the warranties
hereinabove set forth. VersaMed makes no warranty of merchantability or fitness for a
particular purpose with respect to the product or parts thereof.
Released
230 M1186102, Revision 3, 2011

Index
GE Healthcare © VersaMed Medical Systems – All rights

P.O. Box 7550 reserved.
Madison, WI 53707-7550
USA GE and GE Monogram are trademarks of
General Electric Company.
VersaMed Medical Systems doing business

www.gehealthcare.com as GE Healthcare.
The addresses listed on this cover are
current as of 2003.
Manufactured for and distributed Obelis s.a.
by: Av. de Tervuren 34
VersaMed Medical Systems Bte 44 B-1040
P.O.B. 5011, Ornat Bldg. Brussels Belgium
Hasharon Ind. Park, Tel 32 2 7325954
Kadima 60920 Fax 32 2 7326003
Israel mail@obelis.net
EC REP
Tel (972) 9 891 5400 IVent101 Technical Manual
Fax (972) 9 899 7776 VersMed Part Number SM-101-01
GE Part Number M1186102
Rev: 3
Revised May 2011 VersaMed Medical
Systems.
Printed in Israel
Released
M1186102, Revision 3, 2011 231

Ivent 101 TRM PDF

Hochgeladen von

Dokumentinformationen

Originaltitel

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

Ivent 101 TRM PDF

Hochgeladen von

Copyright:

Verfügbare Formate

Rendered PDF File Page 1 of 256 DOC0684758, Rev:4

Electronic Signature Information

Type Controlled Document

Title iVent101 TRM

Name Reason For Change File Size (Bytes)

Route Signer Status Comments Completion Date

* Printed versions are For Reference Only *

iVent101 Technical Reference Manual Part Number SM-101-02

VersaMed iVent101 Technical Reference Manual

iVent101 is a registered trademark of VersaMed Medical Systems

ClevAir is a registered trademark of MPV TRUMA Ltd.

II M1186102, Revision 3, 2011

M1186102, Revision 3, 2011 III

VersaMed iVent101 Technical Reference Manual

SAFETY Before attempting to service or test the iVent-101 ventilator

Authorized Representative in the European Community

VersaMed, a General Electric Company, doing business as GE Healthcare.

IV M1186102, Revision 3, 2011

M1186102, Revision 3, 2011 V

VersaMed iVent101 Technical Reference Manual

VI M1186102, Revision 3, 2011

M1186102, Revision 3, 2011 VII

VersaMed iVent101 Technical Reference Manual

VIII M1186102, Revision 3, 2011

M1186102, Revision 3, 2011 IX

VersaMed iVent101 Technical Reference Manual

X M1186102, Revision 3, 2011

iVent101 / ClevAir .........................................................................................I

M1186102, Revision 3, 2011 XI

VersaMed iVent101 Technical Reference Manual

2.2. Patient Circuit...............................................................................23

XII M1186102, Revision 3, 2011

3.3.6. Gas Gauge Interface PCB ........................................................................52

M1186102, Revision 3, 2011 XIII

VersaMed iVent101 Technical Reference Manual

4.4.7. Settings the Language ............................................................................75

XIV M1186102, Revision 3, 2011

6.5.2. Sensors Calibration...............................................................................115

M1186102, Revision 3, 2011 XV

VersaMed iVent101 Technical Reference Manual

10.1. Service General Information.......................................................153

XVI M1186102, Revision 3, 2011

10.3.17. O2 sensor harness replacement .......................................................187

M1186102, Revision 3, 2011 XVII

VersaMed iVent101 Technical Reference Manual

XVIII M1186102, Revision 3, 2011

M1186102, Revision 3, 2011 XIX

VersaMed iVent101 Technical Reference Manual

Figure 4.2: Brightness panel 59

XX M1186102, Revision 3, 2011

Figure 5.13 Internal connected test 100

M1186102, Revision 3, 2011 XXI

VersaMed iVent101 Technical Reference Manual

Figure 10.7: O2 Sensor Compartment / Cover 165

XXII M1186102, Revision 3, 2011

M1186102, Revision 3, 2011 XXIII

VersaMed iVent101 Technical Reference Manual

This page is intentionally left blank

XXIV M1186102, Revision 3, 2011

1.1. Summary of Contents

M1186102, Revision 3, 2011 1

VersaMed iVent101 Technical Reference Manual

 Section 7: Performance Verification – Provides a summary of