IVENT101

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

Revision 2 March 2010
Copyright © 2010 by VersaMed™ Medical Systems, Ltd.
0473
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 Ltd.

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.
II M1186102, Revision 1, 2009

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.
M1186102, Revision 1, 2009 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 Ltd
Kadima 60920
POB 5011
Israel
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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. Standards and Safety Requirements..........................................................11
1.6. Indicator Lights......................................................................................................13
1.7. Symbols and Labels ............................................................................................13
1.7.1. Front Panel Labeling .................................................................................................... 13
1.7.2. Back Panel Labeling – Connectors ........................................................................ 15
1.7.3. Filter Side........................................................................................................................... 16
1.7.4. Nameplate........................................................................................................................ 16
Section 2: Installation and Setup .................................................................19
2.1. Understanding the Power Sources..............................................................19
2.1.1. Integrated Battery ........................................................................................................ 20
2.1.2. Power Source .................................................................................................................. 21
2.2. Patient Circuit.........................................................................................................22
2.2.1. Circuit Accessories........................................................................................................ 25
2.3. Air Inlet Filter...........................................................................................................26
2.4. Connecting the Ventilator to an Oxygen Source ..................................26
2.5. Powering Up the Ventilator .............................................................................29
2.5.1. Shutting Down the Ventilator .................................................................................. 31
2.6. Choosing Ventilator Location .........................................................................32
M1186102, Revision 1, 2009 XI

Section 3: Theory of Operation.....................................................................33

3.1. System Operation Overview ...........................................................................33
3.2. The Pneumatic System......................................................................................33
3.2.1. Air Inlet Filter.................................................................................................................... 37
3.2.2. Pneumatic Unit Enclosure ......................................................................................... 37
3.2.3. Turbine Assembly.......................................................................................................... 38
3.2.4. Proportional Outlet Valve (POV)............................................................................... 38
3.2.5. High Pressure Box......................................................................................................... 40
3.2.6. Inspiratory Flow and Pressure Measurements ................................................ 40
3.2.7. Inspiratory One Way Valve ....................................................................................... 41
3.2.8. Patient Tubing System ................................................................................................ 41
3.2.9. Exhalation System and One Limb Accessory ................................................... 42
3.2.10. Exhalation Flow and Pressure Measurements................................................. 42
3.2.11. Exhalation Valve ............................................................................................................ 44
3.2.12. Oxygen Measurement System ................................................................................ 44
3.2.13. Oxygen Supply................................................................................................................ 45
3.3. Electronic System.................................................................................................46
3.3.1. On/Off Switch.................................................................................................................. 47
3.3.2. Power Input Components.......................................................................................... 48
3.3.3. Power Supply Assembly ............................................................................................. 48
3.3.4. External DC Power ........................................................................................................ 48
3.3.5. Integrated Battery and Gas Gauge....................................................................... 49
3.3.6. Gas Gauge Interface PCB .......................................................................................... 50
3.3.7. Backup Battery............................................................................................................... 50
3.3.8. Main PCB ........................................................................................................................... 51
3.3.9. External Interfaces........................................................................................................ 51
3.3.10. Pneumatic Unit PCB ..................................................................................................... 52
3.3.11. Interface PCB................................................................................................................... 52
3.3.12. LCD Touch Panel............................................................................................................ 52
3.3.13. Backlight Inverter PCB................................................................................................. 53
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3.3.14. Front Panel LEDs............................................................................................................ 53
3.3.15. Main Alarm Speaker..................................................................................................... 53
3.3.16. Cooling System............................................................................................................... 53
3.4. The iVent101/ ClevAir Software.....................................................................54
Section 4: Service and General Settings Screens......................................55
4.1. The Information screen .....................................................................................55
4.2. General Configuration Screen........................................................................56
4.2.1. Accessing the General Configuration Screen................................................... 56
4.2.2. Setting the Time and Date ........................................................................................ 57
4.2.3. Settings the Sound Levels ......................................................................................... 58
4.2.4. Setting the Auto Screen Lock Time ....................................................................... 59
4.2.5. Enabling the O2 Sensor ............................................................................................... 60
4.2.6. Setting the Screen Brightness ................................................................................. 60
4.3. Service Screens .....................................................................................................61
4.3.1. Accessing the Services Screen................................................................................ 63
4.3.2. Technical Info Screen .................................................................................................. 64
4.3.3. Software Update ........................................................................................................... 65
4.3.4. Patient Configuration .................................................................................................. 67
4.3.5. Technical Logbook........................................................................................................ 68
4.3.6. Settings the Language................................................................................................ 70
4.3.7. Copy Log File ................................................................................................................... 71
4.3.8. Setup Configuration ..................................................................................................... 71
4.3.9. Languages Package Update.................................................................................... 72
4.3.10. Enable TCP/IP .................................................................................................................. 74
Section 5: Testing Procedures ......................................................................75
5.1. Patient Tube Testing Procedure ....................................................................75
5.2. Ventilator Verification Test...............................................................................77
5.2.1. When to run VVT............................................................................................................ 77
5.2.2. Required Equipment: ................................................................................................... 78
5.2.3. Accessing the VVT......................................................................................................... 78
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5.2.4. Pneumatic Unit test...................................................................................................... 79

5.2.5. Power Tests...................................................................................................................... 88
5.3. Completing the VVT Procedure......................................................................94
Section 6: Calibration Procedures ...............................................................99
6.1. Calibration Overview ..........................................................................................99
6.2. Calibration Requirements ................................................................................99
6.3. Accessing Calibration.........................................................................................99
6.4. Factory Calibration Procedures.................................................................. 100
6.4.1. Factory Sensors Calibration ...................................................................................100
6.4.2. Turbine Calibration .....................................................................................................102
6.4.3. POV Factory Calibration ...........................................................................................103
6.4.4. PU Resistance Factory Calibration ......................................................................104
6.5. Service Calibration Procedures .................................................................. 105
6.5.1. When to Run Calibration..........................................................................................106
6.5.2. Sensors Calibration ....................................................................................................106
6.5.3. Circuit Compensation................................................................................................108
6.5.4. O2 Calibration................................................................................................................111
6.6. Touch Screen Calibration .............................................................................. 114
6.7. Battery Gas Gauge Update Procedure ................................................... 115
6.7.1. Charging Procedure...................................................................................................115
6.7.2. CDC (Charge- Discharge- Charge) Procedure ................................................115
6.8. Troubleshooting Calibrations ...................................................................... 118
Section 7: Performance Verification......................................................... 121
7.1. Cleaning and Inspection ................................................................................ 121
7.2. Test Equipment Set Up ................................................................................... 122
7.3. Performance Verification Tests .................................................................. 122
7.3.1. Performance Tests......................................................................................................123
7.3.2. Alarms Tests ..................................................................................................................124
Section 8: Troubleshooting ........................................................................ 127
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8.1. General Service Procedure ........................................................................... 127
8.1.1. Information Gathering ..............................................................................................127
8.1.2. Diagnostics.....................................................................................................................128
8.1.3. Preliminary Verification Procedures ...................................................................128
8.2. Service Notices................................................................................................... 128
8.2.1. Service Notice Numbers...........................................................................................130
8.3. System Alarms.................................................................................................... 133
8.4. General Errors..................................................................................................... 135
Section 9: Planned Maintenance............................................................... 137
9.1. Cleaning and Routine Planned Maintenance ...................................... 137
9.2. Planned Maintenance ..................................................................................... 138
9.2.1. Every 6 Months.............................................................................................................139
9.2.2. Every 12 Months: .........................................................................................................140
9.2.3. Every 2 years .................................................................................................................140
9.2.4. Every 3 years .................................................................................................................140
9.2.5. Every 15,000 Running Hours or 4 years............................................................141
Section 10: Service and Repair ................................................. 143
10.1. Service General Information......................................................... 143
10.1.1. Repair Safety ......................................................................................................143
10.1.2. Repair Guidelines.........................................................................................................144
10.1.3. Cleaning...........................................................................................................................145
10.1.4. Electrical Cables & Pneumatic Connections ...................................................145
10.1.5. Electro-Static Discharge (ESD) Control ..............................................................145
10.1.6. Non-conforming Parts ..............................................................................................146
10.1.7. Replacement Parts .....................................................................................................146
10.1.8. Post Repair .....................................................................................................................147
10.1.9. Repair Documentation..............................................................................................147
10.1.10. Patient System and Accessories .....................................................................147
10.1.11. Recommended Service Tooling and Materials ..................148
10.2. Service & Repair Procedures ........................................................ 148
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10.2.1. Inlet Filter Replacement ...........................................................................................149

10.2.2. Exhalation Valve/Membrane Replacement.....................................................150
10.2.3. Two limb to One Limb Accessory changeover...............................................153
10.2.4. One limb to Two limb configuration changeover .........................................153
10.2.5. O2 Sensor / Cork Installation .................................................................................154
10.2.6. Mains AC fuse replacement....................................................................................155
10.2.7. Power Pack Replacement........................................................................................156
10.2.8. Top Enclosure Replacement...................................................................................157
10.2.9. Filter Housing Replacement ...................................................................................159
10.2.10. MAIN ENCLOSURE .....................................................................................159
10.2.11. Main PCB Replacement .......................................................................................161
10.2.12. Pneumatic Unit Replacement...........................................................................164
10.2.13. Backup Battery Replacement...........................................................................166
10.2.14. Real Time Clock (RTC) Battery Replacement ..............................................168
10.2.15. Speaker Replacement..........................................................................................169
10.2.16. O2 sensor harness replacement .....................................................................170
10.2.17. Pump/Solenoid harness replacement ..........................................................171
10.2.18. Power Supply Unit Replacement.....................................................................172
10.2.19. Back Panel Assembly Replacement...............................................................174
10.2.20. Base Assembly Replacement............................................................................175
10.2.21. Verification Tests for the new parts ...............................................................177
SECTION 11: SPARE PARTS ......................................................... 179
11.1. Hardware version........................................................................................... 179
11.2. Ventilator’s Part List ...................................................................................... 179
11.2.1. Ventilator’s System.....................................................................................................179
11.2.2. Main Assemblies ..........................................................................................................180
11.2.3. Spare parts.....................................................................................................................182
11.2.4. Accessories ....................................................................................................................185
11.2.5. Maintenance Kits.........................................................................................................186
11.2.6. iVent Software ..............................................................................................................186
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Appendix A: Log Translator........................................................................ 187
A.1. Log Translator Setup ....................................................................................... 187
A.1.1. Installation Instructions:...........................................................................................187
A.2. Translating a log file......................................................................................... 188
A.2.1. The About Button ........................................................................................................192
A.2.2. The Advanced Settings Window...........................................................................192
A.3. Reading Translated Log ................................................................................. 194
Appendix B: Planned Maintenance Check list ............................. 195
Section 12: Index .......................................................................................... 199
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 21
Figure 2.2: The power cord wrapped around the handlers 22
Figure 2.3: Two limb patient circuit connected 24
Figure 2.4: One limb connection 25
Figure 2.5: Air Inlet filter 26
Figure 2.6: Low Flow O2 connector 27
Figure 2.7: Low Flow O2 connector with locking nut 27
Figure 2.8: The O2 Connector Inlet on the ventilator 27
Figure 2.9: Oxygen tubing with the connector 28
Figure 2.10: Oxygen tubing with fasten connectors 28
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 35
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Figure 3.2: Pneumatic schematic diagram of one limb configuration 36

Figure 3.3: Pneumatic module 37
Figure 3.4: Proportional Outlet Valve (POV) 39
Figure 3.5: Inspiratory flow sensor 41
Figure 3.6: Two limb configuration – exhalation Block 43
Figure 3.7: One limb configuration – exhalation block 43
Figure 3.8: Internal exhalation valve 44
Figure 3.9: Electronic system block diagram 47
Figure 3.10: Integrated battery 49
Figure 3.11Gas gauge interface PCB 50
Figure 3.12: Backup battery 50
Figure 3.13: Main PCB 51
Figure 4.1. The Information screen 55
Figure 4.2: Set date and time panel 57
Figure 4.3: Sound levels panel 58
Figure 4.4: Auto screen lock panel 59
Figure 4.5: Enable O2 Panel 60
Figure 4.6: Brightness panel 61
Figure 4.7: Services screen 61
Figure 4.8: Advanced services screen 63
Figure 4.9: Services password screen 63
Figure 4.10: Technical Info screen 64
Figure 4.11: Software update box 66
Figure 4.12: Patient configuration screen 68
Figure 4.13: Technical logbook 69
Figure 4.14: Languages configuration screen 70
Figure 4.15: Restart GUI confirmation box 70
Figure 4.16 The Language Update Box 73
Figure 5.1: Patient tube testing screen (Two limb configuration) 76
Figure 5.2, Patient tube testing screen (One limb configuration) 76
Figure 5.3: VVT screen 79
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Figure 5.4: Pressure test VVT screen (Two limb configuration) 80
Figure 5.5. Pressure test VVT screen (One limb configuration) 80
Figure 5.6: Flow test VVT screen (Two limb configuration) 82
Figure 5.7. Flow test VVT screen (one limb configuration) 82
Figure 5.8: Leak test VVT screen Two limb configuration) 83
Figure 5.9. Leak test VVT screen (one limb configuration) 84
Figure 5.10: AC connected test VVT screen 88
Figure 5.11: External connected test screen 90
Figure 5.12: External disconnect test VVT screen 91
Figure 5.13 Internal connected test 93
Figure 5.14: Charger test VVT 94
Figure 5.15: End of VVT procedure 95
Figure 6.1: Calibration Screen 100
Figure 6.2: Sensor Calibration Screen 101
Figure 6.3: Save Calibration Box 102
Figure 6.4: Turbine Factory Screen 103
Figure 6.5: Turbine Factory Screen 104
Figure 6.6: The PU Resistance Factory Calibration screen 105
Figure 6.7: Sensor Calibration Screen 107
Figure 6.8: Tube Compliance Calibration Screen (Two limb configuration) 109
Figure 6.9. Tube Compliance Calibration Screen (One limb configuration) 109
Figure 6.10: Tube Resistance Calibration Screen (Two limb configuration) 110
Figure 6.11. Tube Resistance Calibration Screen (One limb configuration) 110
Figure 6.12: O2 100% Calibration Service screen (Two Limb Configuration) 111
Figure 6.13. O2 100% Calibration Service screen (One Limb Configuration) 112
Figure 6.14: O2 21% Service Calibration screen (Two limb configuration) 113
Figure 6.15. O2 21% Service Calibration screen (One limb configuration) 113
Figure 6.16. TS Calibration screen 114
Figure 8.1: Service Notice screen 129
Figure 10.1: Inlet Filter 150
Figure 10.2: The Exhalation Cover on the lower panel 150
M1186102, Revision 1, 2009 XIX

Figure 10.3: Unlocking the exhalation valve lever 151

Figure 10.4: Releasing the exhalation valve 151
Figure 10.5: The Exhalation Valve 151
Figure 10.6: The Exhalation valve membrane 152
Figure 10.7: O2 Sensor Compartment / Cover 154
Figure 10.8. Mains AC fuse 156
Figure 10.9: Power Pack Mounting 157
Figure 10.10. Top Enclosure Screw Locations 158
Figure 10.11: Top Enclosure Components 159
Figure 10.12 Main Enclosure Mounting 160
Figure 10.13. Cooling Fans Assembly 161
Figure 10.14. Cables connection mapping 162
Figure 10.15. Tubes connection mapping 163
Figure 10.16. Pneumatic Unit Mounting 164
Figure 10.17. Pneumatic Unit tubes mapping 165
Figure 10.18. Pneumatic Unit tubing connectors 166
Figure 10.19. BACK UP BATTERY LOCATION 168
Figure 10.20 RTC Battery Location 169
Figure 10.21. Pump/Solenoid harness mapping 172
Figure 10.22. Power Supply mounting 174
Figure 11.1: Ventilator’s System 179
Figure 11.2: Main Assembly 180
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List of Tables
Table 1-1: Front panel components 5
Table 1-2: Back Panel Components 6
Table 1-3: Upper panel symbols 14
Table 1-4: Lower panel symbols 15
Table 1-5: Back panel labeling 15
Table 1-6: Filter side icons 16
Table 1-7: Nameplate icons 17
Table 2-1: Power source icons 20
Table 6-1: Calibration Troubleshooting 118
Table 8-1: Service Notices Numbers 130
Table 8-2: System Alarms 133
Table 8-3: General Error 135
Table 9-1: Cleaning and Routine Planned Maintenance (performed by the operator)
137
Table 9-2: Planned Maintenance 138
Table 10-1: Service tooling and materials 148
Table 10-2. Verification tests for new parts 177
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XXII M1186102, Revision 1, 2009

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.
M1186102, Revision 1, 2009 1

• Section 6: Calibration Procedures – Provides a summary of

calibration procedures and associated troubleshooting information.
• 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
• CPAP/PSV
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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.
M1186102, Revision 1, 2009 3

1.3. Looking at the iVent101/ ClevAir
Figure 1.1: The iVent101/ ClevAir(front view)
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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
M1186102, Revision 1, 2009 5

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
11 AC connector
12 AC cable strain relief
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Introduction
13 Power pack mounting screws

14 Power pack
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.
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
When nebulizing medications with the iVent101, use HEPA filter connected
to the Patient wye in order 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.
“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
M1186102, Revision 1, 2009 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 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.
8 M1186102, Revision 1, 2009

Introduction
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.
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.
M1186102, Revision 1, 2009 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 4.3.
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 6.5.3.
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.
10 M1186102, Revision 1, 2009

Introduction
In accordance with the important information described herein, always
comply with applicable national and local safety regulations.
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 10.2.21: Verification Tests for the new parts.
1.5. 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
M1186102, Revision 1, 2009 11

* 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
*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.
12 M1186102, Revision 1, 2009

Introduction
1.6. Indicator Lights

The indicator lights, located on the front panel of the iVent101/ ClevAir
ventilator (Figure 1.2), indicate the status of the iVent101/ ClevAir
ventilator.
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 19) indicates charging completion.
Alarm Red
1.7. Symbols and Labels

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

The labeling on the front panel of the iVent101/ ClevAir ventilator
includes the following:
• Upper Panel Symbols, refer to Table 1-3.
• Lower Panel Symbols, refer to Table 1-4.
M1186102, Revision 1, 2009 13

1.7.1.1. Upper Panel Symbols

The symbols on the upper panel of the iVent101/ ClevAir ventilator are
listed in Table 1-3:
Table 1-3: 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
Alarm Light On the right side of

the LEDs.
Battery Charge light
To Patient Below the

inspiratory port.
14 M1186102, Revision 1, 2009

Introduction
1.7.1.2. Lower Panel Symbols

The symbols in Table 1-4 appear on the lower panel of the iVent101/
ClevAir ventilator.
Table 1-4: Lower panel symbols
Expiratory Port (Only for On the plastic panel

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

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

The symbols in Table 1-5 appear on the back panel of the iVent101/
ClevAir ventilator.
Table 1-5: 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
M1186102, Revision 1, 2009 15

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
1.7.3. Filter Side

The following label appears below the filter.
Table 1-6: Filter side icons
Filter Centered, below the

filter.
1.7.4. Nameplate
The nameplate is attached underneath the ventilator and contains the
following symbols and information:
16 M1186102, Revision 1, 2009

Introduction
Table 1-7: Nameplate icons
FUNCTION ICON/ WORDING
Ventilator Name
Ivent101 or ClevAir
Manufacturer:
VersaMed or
MPV TRUMA
Date of manufacturing
Class 2 – Double
Isolation (electrical)
Type BF – Body Floating
S/N
Read this book prior to
use.
CSA/UL
Only for iVent101
Caution: Text: “Caution: US federal law restricts

this device to sale by or on order of a
physician.”
IP 31
Do Not Discard – per
WEEE directive
M1186102, Revision 1, 2009 17

18 M1186102, Revision 1, 2009

Installation and Setup
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. Refer to section 6.7: Battery Gas Gauge
Update Procedure.
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.
M1186102, Revision 1, 2009 19

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 appears in green.
connected. .
External DC is
disconnected or connected
while AC power is
connected.
Indicates end of charge for The Battery icon
battery maintenance (see appears in full green
section Battery Gas Gauge with a ‘+’ sign on it.
Update Procedure, on page
115)
Integrated battery status Full green indicates
indicating the current high battery capacity
estimated capacity of the while full gray
battery. indicates very low
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.
20 M1186102, Revision 1, 2009

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.
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 1.6:
Lights.
Note: While operating, keep the ventilator plugged in whenever
possible.
M1186102, Revision 1, 2009 21

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.
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
22 M1186102, Revision 1, 2009

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.
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.
M1186102, Revision 1, 2009 23

For Patient Circuit Compensation Test refer to section 6.5.3.

For Patient tube test refer to section 5.1.
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 4.3.4: 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 6.5.3.
For Patient tube test refer to section 5.1.
24 M1186102, Revision 1, 2009

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.
M1186102, Revision 1, 2009 25

Note: Follow the manufacturer's instructions for operating

the humidifier.
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 10.2.1: 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
26 M1186102, Revision 1, 2009

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.
For a permanent connection at a patient’s site, use ONLY the

compression nut connecter. The Low Flow O2 connector should be
used for temporary connections only (such as when making a
temporary connection in order to perform O2 calibration), and
should never be left at a patient’s site.
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
M1186102, Revision 1, 2009 27

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).
28 M1186102, Revision 1, 2009

2.5. Powering Up the Ventilator
To power up the iVent101/ ClevAir ventilator:
• 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.
M1186102, Revision 1, 2009 29

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.
30 M1186102, Revision 1, 2009

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.
M1186102, Revision 1, 2009 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:
1. Put the ventilator where it will be used most.
2. Plug the ventilator into a wall outlet.
3. Verify that the patient circuit is not connected to the iVent101/
ClevAir.
4. Turn on the ventilator and start ventilation. An alarm condition will
occur, and an audible alarm will sound.
5. 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.
6. The alarm volume can be adjusted as needed. For more information
refer to section4.2.3: Settings the Sound Levels.
32 M1186102, Revision 1, 2009

Theory of Operation
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.
M1186102, Revision 1, 2009 33

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.
34 M1186102, Revision 1, 2009

Theory of Operation
Figure 3.1: Pneumatic schematic diagram of two limb configuration
M1186102, Revision 1, 2009 35

Figure 3.2: Pneumatic schematic diagram of one limb configuration
36 M1186102, Revision 1, 2009

Theory of Operation
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.
Figure 3.3: Pneumatic module
M1186102, Revision 1, 2009 37

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.
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.
38 M1186102, Revision 1, 2009

Theory of Operation
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 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.
M1186102, Revision 1, 2009 39

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 and FiO2 measurement.
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 pressure measurement is used as a feedback to regulate
the operation of the inspiratory pneumatics.
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Theory of Operation
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 purity of the gas passing to the patient. Humidification
requirements will add items and complexity to the two system types.
M1186102, Revision 1, 2009 41

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.
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Theory of Operation
Figure 3.6: Two limb configuration – exhalation Block
Figure 3.7: One limb configuration – exhalation block
M1186102, Revision 1, 2009 43

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 high pressure box 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.
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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.
M1186102, Revision 1, 2009 45

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 – section 3.3.3.
• External DC Supply Interface – 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.
• 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.
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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
M1186102, Revision 1, 2009 47

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.
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.
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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
M1186102, Revision 1, 2009 49

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 3.11Gas 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.
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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
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.
M1186102, Revision 1, 2009 51

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.
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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, page 19) 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.
M1186102, Revision 1, 2009 53

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.
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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:
• 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.
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.
• 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. On the right side the status of the last VVT is
displayed: succeeded or failed.
M1186102, Revision 1, 2009 55

• 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.
4.2. General Configuration Screen

The General Configuration screen enables the operators and
technician to configure the following settings:
• Date and Time – Setting the time and date of the device. 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.
• Enable O2 – Enabling the O2 sensors and monitoring. Refer to
section 2.
• Set Brightness – Setting the touch screen brightness. Refer to
section 4.2.6.
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.
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4.2.2. 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 4.2: 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. Tap Accept to save the settings and close the screen.
5. 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.
M1186102, Revision 1, 2009 57

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.
Note: setting the button Volume to zero will mute the buttons sound
completely.
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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.
M1186102, Revision 1, 2009 59

4.2.5. 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 General Configuration screen tap Enable O2. The Enable O2
box is displayed on the right panel.
Figure 4.5: 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.
4.2.6. Setting the Screen Brightness

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.
60 M1186102, Revision 1, 2009

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 Set Brightness. The
Brightness slider is displayed on the right panel.
Figure 4.6: Brightness panel

2. Tap the up and down arrows to change the brightness level. The slider
displays the brightness level accordingly.
4.3. 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.
Figure 4.7: Services screen

The Services screen contains the following options:
M1186102, Revision 1, 2009 61

• 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 4.3.2.
• 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 4.3.3.
• Patient Configurations – Enables the technician to switch between
One limb or Two limbs configuration. On the right side of the Patient
Configuration button the current configuration is displayed. Refer to
Section 4.3.4.
• Technical Logbook – Enables the technician to view the technical
errors that have occurred on the device. Refer to section 4.3.5.
• Languages – Enables the technician to alter the ventilator’s current
operating language. Refer to section 4.3.6.
• Advanced– Opens the Advanced Services screen, refer to Figure 4.8
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 4.3.7.
• Setup Configuration – Enables uploading specific models
configuration to the device. Refer to section 4.3.8.
• Enable TCP/IP – Providing a connection to the ventilator through the
Ethernet connector. Refer to section 4.3.10.
• Languages Update – Enables uploading new languages packages to
the device.
62 M1186102, Revision 1, 2009

Figure 4.8: Advanced services screen
4.3.1. Accessing the Services Screen

The Services screen is password protected, preventing an
unauthorized entry to sensitive procedures such as VVT and
calibration.
To access the Services screen:
1. Ensure that the ventilator is in Clinical view or switch to it.
2. On the iVent101 Main screen tap Menu – Services. The Services
Password screen is displayed.
Figure 4.9: Services password screen

3. Type the password: 1907
4. Tap Enter. The Services screen is displayed (refer to Figure 4.7).
M1186102, Revision 1, 2009 63

Note Different SW versions may have different passwords. Consult the

Technical Notes regarding the correct password.
4.3.2. 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.
Figure 4.10: 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.
• Software Version – The current software version installed on the
device and the SW update status
Note: the update status always appears as “Not Performed.”
64 M1186102, Revision 1, 2009

• Total PU Working Hours – The total working hours of the ventilator’s
pneumatic system.
• 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. 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.
4.3.3. 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.
4.3.3.1. 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 file) to a convenient location
on your hard drive.
2. Insert a USB flash drive (memory stick) into your computer.
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.
M1186102, Revision 1, 2009 65

4.3.3.2. 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 section 4.3.1.
3. On the Services screen tap the Software Update. The SW Update box
is displayed.
Figure 4.11: 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.
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
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.
66 M1186102, Revision 1, 2009

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.
4.3.4. 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 10.2.3 and
section 10.2.4 .
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.
M1186102, Revision 1, 2009 67

Figure 4.12: 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.
4.3.5. 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:
1. On the Services screen tap Technical Logbook. The Technical Event
Log Book is displayed.
68 M1186102, Revision 1, 2009

Figure 4.13: Technical logbook
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. 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. Refer to
section 4.3.7: Copy Log File, for an explanation of the uploaded
procedure.
The logbook entries can be accessed in Performance Tests7.3.1, as
described in section 7.3.1 in order to determine the triggering
condition and corrective action.
M1186102, Revision 1, 2009 69

4.3.6. 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.
Figure 4.14: 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 4.15: Restart GUI confirmation box
70 M1186102, Revision 1, 2009

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.
4.3.7. 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 view
older events. See section 4.3.5:Technical Logbook.
To copy log files:
1. Insert USB Flash drive (Disk on Key) to the USB port (refer to Figure
1.2).
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.
4.3.8. Setup Configuration

Setup Configurations screen enables to set up different
configurations for the ventilator, enabling or disabling various options.
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.
drive contents.
4. Create a new folder on the USB flash drive called ‘Setup’.
M1186102, Revision 1, 2009 71

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.
4.3.9. 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.
72 M1186102, Revision 1, 2009

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 4.3.1.
3. In the Service screen tap Advanced… - Language Update. The
Language 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.
Figure 4.16 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.
M1186102, Revision 1, 2009 73

4.3.10. Enable TCP/IP

For factory use only.
74 M1186102, Revision 1, 2009

Testing Procedures
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,.
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 port (refer to Figure 1.1).
3. From the Main screen tap the (Patient Tube Testing) button.
The Patient Tube Testing screen is displayed.
M1186102, Revision 1, 2009 75

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.
6. The iVent closes the POV and activates the Hold solenoid.
76 M1186102, Revision 1, 2009

Testing Procedures
7. The iVent reopens the POV.
The following criteria are checked:
i. If the inspiratory flow sensor reading is less than 1000ml/s
Patient Tube the Patient Tube Testing fails.
Testing pass
Criteria ii. In Two limb configuration if the exhalation flow sensors
reading is less than 1000 ml/s the Patient Tube Testing fails.
8. When the test ends a message appears on the lower left side of the
screen: “Test passed successfully.”
9. 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.
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:
M1186102, Revision 1, 2009 77

• 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 for a list of the equipment required to perform the
performance the ventilator verification tests.
5.2.3. Accessing the VVT

The VVT procedures are accessed from the VVT screen, a sub-screen
of the 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.
4. From the Clinical view tap Menu – Services (refer to section 4.3.1:
Accessing the Services Screen).
5. In the Services screen, tap VVT.
The VVT screen is displayed, as shown in Figure 5.3 below:
78 M1186102, Revision 1, 2009

Testing Procedures
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.
5.2.4.1. Pressure Test

The VVT pressure test verifies systematically the operation of the
following ventilator components:
• Proportional Outlet Valve (POV)
M1186102, Revision 1, 2009 79

• 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..
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.
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Testing Procedures
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.
M1186102, Revision 1, 2009 81

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.
7. Tap Start when the TSI is connected.
8. The motor runs in a series of predetermined RPM settings.
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Testing Procedures
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
pass RPM 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.
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)
M1186102, Revision 1, 2009 83

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.
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.
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Testing Procedures
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
1. Patient tube is not connected Technical Config screen
properly. (1 Limb / 2 Limbs).
2. Incorrect tube type. 3. Perform sensors calibration
(section 6.5.2) and then Perform
3. Inner tubes to the pressure VVT again.
sensors are not connected
properly. 4. If the test fails, run Factory
Pressure calibration – PU Devices
test 4. Blower pressure sensor is (section 6.4.4), and perform VVT
malfunctioning. again.
5. Patient pressure sensor is 5. If the test fails open the
malfunctioning. machine and verify that all
6. POV is stuck. tubes to the pressure sensors
7. Turbine is malfunctioning. are not kinked and well
connected and in the correct
place.
6. Replace the main PCB (section
10.2.11).
7. Replace the Pneumatic unit
(section 10.2.12).
1. If pressure test fails, see above.

Inlet
Inlet port filter is blocked. 2. Replace the inlet filter.
Pressure
M1186102, Revision 1, 2009 85


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
Technical Config screen
(1 Limb / 2 Limbs).
3. If the test fails remove the
1. Patient tube is not connected exhalation vale, clean it, and
properly. place it again (section 10.2.2).
2. Incorrect tube type. 4. Perform sensors calibration
3. Occluded exhalation valve. (section 6.5.2), and then perform
4. Inner tubes to the flow sensors VVT again.
Flow are not connected properly. 5. If the test fails, run Factory
Test 5. Inhale flow sensor is calibration – PU Devices
malfunctioning. (section 6.4.4), and then perform
VVT again.
6. Exhale flow sensor is
malfunctioning. 6. If the test fails open the device
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 10.2.17).
8. Replace the main PCB (section
10.2.11).
(section 10.2.12).
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Testing Procedures
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
Technical Config screen
(1 Limb / 2 Limbs).
3. Remove the exhalation vale,
clean it, and place it again
1. Patient tube is not connected (section 10.2.2).
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
Test not connected properly. (section 6.4.4), and then
5. Leakage in the Hold pump perform VVT 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 10.2.17).
8. If the test fails replace the main
PCB (section 10.2.11).
9. If the test fails replace the
Pneumatic unit (section
10.2.12).
M1186102, Revision 1, 2009 87

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.
Figure 5.10: AC connected test VVT screen
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Testing Procedures
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.
M1186102, Revision 1, 2009 89

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:
• The 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.
The External Connected Test requires the use of external DC source. If
an external DC source is not available the test should be skipped.
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Testing Procedures
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.
M1186102, Revision 1, 2009 91

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.
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.
Test Procedure:
1. The Internal connected test VVT screen is displayed automatically
when the AC disconnected test is completed.
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Testing Procedures
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.
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.
M1186102, Revision 1, 2009 93

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.
5.3. 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.
94 M1186102, Revision 1, 2009

Testing Procedures
Figure 5.15: End of VVT procedure

If the Power VVT fails:
• AC power is not • Check the AC mains power
available at the mains • Replace mains cable
outlet • Check / replace the fuse
• AC power does not (section 10.2.6)
reach the iVent101 due • Replace rear panel
to malfunctioning mains
cable. • Replace power supply (section
10.2.18)
AC • AC power does not
reach the power supply • Replace PCB board (section
connected
due to malfunctioning 10.2.11)
test
internal 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.
M1186102, Revision 1, 2009 95


• Check DC source:
• voltage should be in the
range of 24 to 28V
• Output resistance
should be below 0.8
• External DC power is not ohm.
External connected.
connected • Visually inspect DC cable
• The External DC voltage and connector for shorts
test
is not between 19-33V. or disconnections, and
replace if needed.
• Replace the PCB board (section
10.2.11)
• Internal battery not • Check and replace internal

inserted or Internal battery battery (section 10.2.7).
malfunction • Check battery connection
External
disconnected • Battery connection wiring. wiring.
test • Input selection system • Replace the PCB board (section
(main board) malfunction 10.2.11)

AC • Battery connection wiring. wiring, and replace if needed.
disconnected • Input selection system • Replace the PCB board (section
test (main board) 10.2.11)
malfunction

Internal malfunction • Check battery connection
connected • Battery connection wiring. wiring, and replace if needed.
test
• Input selection system • Replace the PCB board (section
(main board) malfunction 10.2.11)
96 M1186102, Revision 1, 2009

Testing Procedures
Charger test • Battery connection wiring. wiring, and replace if needed.
• Input selection system or • Replace the PCB board (section
charger (main board) 10.2.11)
malfunction
M1186102, Revision 1, 2009 97

98 M1186102, Revision 1, 2009

Calibration Procedures
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 for a list of the equipment required to perform the
calibration procedure.
You can use any patient circuit during the calibration. However, the
patient circuit compensation has to be performed with the same
patient circuit type as the patient (Adult or pediatric).
6.3. Accessing Calibration

The calibration menu is accessed from the Service screen, which is
password protected. Refer to section 4.3.1 Accessing the Services
Screen.
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.
M1186102, Revision 1, 2009 99

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 includes two calibration
procedures:
• Factory Sensors calibration, refer to section 6.4.1, below.
• Turbine calibration, refer to section 6.4.2, below.
• 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
100 M1186102, Revision 1, 2009

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
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.
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.
M1186102, Revision 1, 2009 101

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.
1. From the Factory Calibration screen tap PU Devices. The first
calibration screen, the Turbine Factory Calibration screen is
displayed.
102 M1186102, Revision 1, 2009

Figure 6.4: Turbine Factory Screen

2. Connect a 22mm adapter to the expiratory port.
3. Seal the adaptor with a 22mm sealing cap.
4. When the equipment is set, tap Start to commence the calibration
procedure.
the turbine assembly.
6. On completion the POV Factory Calibration screen is displayed.
6.4.3. POV Factory Calibration

During Outlet Valve calibration the software will calibrate the device’s
proportional outlet valve (POV) assembly.
1. The POV Factory Calibration screen appears automatically when the
Turbine Factory calibration is competed. Tap Start.
M1186102, Revision 1, 2009 103

Figure 6.5: Turbine Factory Screen

2. Connect a 22mm adapter to the expiratory port.
3. Seal the adaptor with a 22mm sealing cap.
procedure.
the POV assembly.
6. On completion the PU Resistance Factory Calibration screen is
displayed.
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. Tap
Start.
104 M1186102, Revision 1, 2009

Figure 6.6: 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
6.5. Service Calibration Procedures

The service calibration procedures are part of the device
maintenance. These procedures includes:
• Sensors Calibration, refer to section 6.5.2, below.
• Circuit Compensation, refer to section 6.5.3.
• O2 Calibration, refer to section 6.5.4.
M1186102, Revision 1, 2009 105

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
106 M1186102, Revision 1, 2009

Figure 6.7: 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.
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.
M1186102, Revision 1, 2009 107


6.5.3. 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 6.8 below.
108 M1186102, Revision 1, 2009

Figure 6.8: Tube Compliance Calibration Screen (Two limb configuration)
Figure 6.9. 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 6.10below.
M1186102, Revision 1, 2009 109

Figure 6.10: Tube Resistance Calibration Screen (Two limb configuration)
Figure 6.11. 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,
110 M1186102, Revision 1, 2009

6.5.4. 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.
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 6.12: O2 100% Calibration Service screen (Two Limb Configuration)
M1186102, Revision 1, 2009 111

Figure 6.13. 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
O2 100% the device’s rear panel (see Figure 1.2).
Calibration
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.
112 M1186102, Revision 1, 2009

Figure 6.14: O2 21% Service Calibration screen (Two limb configuration)
Figure 6.15. 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
Calibration
reference.
This procedure takes 90 seconds (1.5 minutes) to complete.
On completion the Save box is displayed, as shown in Figure 6.3.
M1186102, Revision 1, 2009 113

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.
VersaMed P/N 509A0013-01.
GE P/N: M1192772
To calibrate the touch screen:
1. Extract the file TSCalibration.rar to a USB flash drive to a folder named
“iVent”.
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.
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.
114 M1186102, Revision 1, 2009

6.7. Battery Gas Gauge Update Procedure
Battery gas gauge initialization 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: 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.
6.7.1. Charging Procedure

Fully charge the battery to maximize the battery life in the following
cases:
• 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 batteryÅ.
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.
6.7.2. 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 Table 9-2: Planned
Maintenance, it is required to perform battery gas gauge update
procedure (CDC) every 6 months.
Å
Average completion time at 24C. Time may vary with environmental conditions (primarily in terms of
temperature as well as battery capacity).
M1186102, Revision 1, 2009 115

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 batteryÅ.
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 22).
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 40
alarm
High Pressure 60
Alarm
High Minute 24
Volume Alarm
Å
Average completion time at 24C. Time may vary with environmental conditions (primarily in terms of
temperature as well as battery capacity).
116 M1186102, Revision 1, 2009

Parameter Value
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 19, 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.
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 hoursÅ 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.
Å
When the ventilator is charged in a room temperature. The time may change depending on the battery
capacity and temperature.
M1186102, Revision 1, 2009 117

6.8. 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
Failed
has been applied at the wye
connector.
7. Check the patient system for leaks.
8. Replace the exhalation valve
(section 10.2.2).
9. Check the internal tubing.
10. Replace the Main PCB (section
10.2.210.2.11).
(section 10.2.12).
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.
118 M1186102, Revision 1, 2009

CALIBRATION STEP DESCRIPTION TROUBLESHOOTING
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.
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 charge-discharge-charge
Gas Gauge Insufficient Run
process (section 6.7.2).
Update Time
2. Replace the integrated battery).
M1186102, Revision 1, 2009 119

120 M1186102, Revision 1, 2009

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.
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.
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.
M1186102, Revision 1, 2009 121

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.
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.
122 M1186102, Revision 1, 2009

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)
7.3.1.3. Calibration
Performs Sensors Calibration as described in section 6.5.2, and Circuit
Compensation as described in section 6.5.3.
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)

Performs VVT test as described in section 5.2.
M1186102, Revision 1, 2009 123

7.3.1.6. O2 sensor calibration

If the O2 sensor is used performs O2 sensor calibration as described in
section 6.5.4.
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.
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.
124 M1186102, Revision 1, 2009

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.
2. 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:
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.
M1186102, Revision 1, 2009 125

Verify that PIP alarm is activated five seconds after Accept was
tapped.
default value. Verify that the alarm stops automatically after one
breath.
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.
Verify 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.
126 M1186102, Revision 1, 2009

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.
9. Verify that the physical patient circuit configuration (1-limb/2-limbs)
matches the ventilator’s settings.
M1186102, Revision 1, 2009 127

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.
128 M1186102, Revision 1, 2009

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.
M1186102, Revision 1, 2009 129

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 may be degraded, due to
sensor failure unreliable patient 2. Check and correct patient
pressure reading, and circuit configuration (1-limb/2-
basing the pressure limbs).
control on the blower 3. Check tubing connectivity.
pressure only. (Figure 10.14and Figure 10.17
Error 701 Blower Emergency backup 4. In case of error 703, replace the
pressure ventilation. Blower exhalation valve (section
sensor failure pressure is not reliable, 10.2.2).
and ventilation continues 5. Perform service calibration.
without sensors 6. If the error doesn't occur again
feedback. the ventilator can be used by
the patient.
Error 702 Inspiratory Emergency backup
flow sensor ventilation. Inspiratory 7. If calibration or VVT fails, or the
failure flow is not reliable, and error is reproduced in
ventilation continues ventilation check the internal
without sensors silicon tubing of the ventilator.
feedback. 8. If the tubing is faulty, correct
the faults, and repeat steps 3
Error 703 Exhalation flow Ventilation performance through 6.
sensor failure may be degraded, as well
as minute volume alarms 9. If the tubing is ok, replace the
performance due to PCB board (section 10.2.11). 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 10.2.11).
Error 704
3. If problem persists, send the
department.
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Troubleshooting

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
accompany service 705: duration, 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
5. Low MV. no 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
10.2.12).
7. If the problem persists, replace
the PCB board (section 10.2.11).
department.
1. Perform the preliminary verification
Error 706 Turbine Motor 1. Ventilation
test (Section 9.1.3
Error suspended.
2. Replace the pneumatic unit (section
2. Continuous buzzer 10.2.12)..
sound.
3. Replace the PCB board (section
3. Recovery attempt by 10.2.11).
the SW 4. If problem persists, send the
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. 10.2.11).
3. Recovery attempt by 3. Replace the pneumatic unit (section
the SW. 10.2.12).
department.
M1186102, Revision 1, 2009 131


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
10.2.11).
department.
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
10.2.12).
2. Unreliable exhale flow
reading.
Error 712 FPGA Failure Ventilation suspended
2. If problem persists replace the PCB
board (section 10.2.11).

Error 713 PU Board Ventilation continues.
Failure
2. If problem persists replace the
pneumatic unit (section 10.2.12)..
1. Manually shutdown and restart.

Error 714 Over Voltage 1. Ventilation
suspended. 2. If problem persists replace the PCB
2. Continuous buzzer
sound.
1. Manually shutdown and restart.

Error 715 Voltage 1. Ventilation
converter suspended. 2. If problem persists replace the PCB
failure board (section 10.2.11).
2. Continuous buzzer
sound.
132 M1186102, Revision 1, 2009

Troubleshooting
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.
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).
HIGH Block in the cooling vents 1. Verify that the cooling vents are clear
TEMPERATURE of the ventilator, high and clean.
external 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
4. If the problem occurs after 15 minutes
replace the Pneumatic unit (section
10.2.12).
INT. BATTERY IN No external power source 1. Connect the Ventilator to an External

USE is connected and the Power source
ventilator uses the 2. If the external power source is depleted
internal (Integrated) and the “Internal battery in use” alarm
battery. is repeated disconnect the external
power source or replace it with a new
one in order to avoid repeated
appearance of the alarm.
LOST LAST APNEA Internal malfunction 1. If the problem persists and appears
SETTINGS with other system alarms perform
SW update (section 4.3.3)
2. Replace the PCB board (section
10.2.11).
LOST LAST Internal malfunction 1. If the problem persists and appears
CLINICAL SETTINGS with other system alarms perform SW
update (section 4.3.3).
2. Replace the PCB board (section 10.2.11).
M1186102, Revision 1, 2009 133

ALARM PROBABLE CAUSE REMEDAY

LOST LAST Internal malfunction 1. If the problem persists and appears
TECHNICAL with other system alarms perform SW
CONFIGURATION update (section 4.3.3).
LOST LAST USER Internal malfunction 1. If the problem persists and appears
CONFIGURATION with other system alarms perform SW
update (section 4.3.3).
LOW BATTERY Ventilator operates 1. Charge the battery

without external power 2. If the problem persists replace the
source (AC or DC). integrated battery.
3. If the problem persists replace the
PCB board (section 10.2.11).
O2 CALIBRATION Calibration has not been Perform O2 calibration (section 6.5.4).
REQUIRED performed, or internal
malfunction
O2 SENSOR O2 sensor is 1. Check the O2 sensor connections.
DISCONNECT disconnected. 2. If the problem persists replace the O2
sensor (section 10.2.5)
3. Check and replace the O2 harness
(section 10.2.16).
O2 SENSOR WORN Aged O2 sensor or Replace the O2 sensor (section 10.2.5).

OUT malfunctioning.
SENSORS Calibration has not been Performed Sensor calibration (section 6.5.2)
CALIBRATION performed, or internal
REQUIRED malfunction
VVT Internal malfunction Perform VVT (section 5.2)
RECOMMENDED
134 M1186102, Revision 1, 2009

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
6.8).
fails troubleshooting
section 7.7.
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 10.2.11).
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 out or damaged. 2. Replace the Main PCB.
battery. 3. If problem persists, send the ventilator to
2. Main board
the service department.
2. Integrated battery
failure alarm is
activated.
1. Check the external DC output matches

Device is not running 1. External device
the 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
3. Check the ivnet101 with alternative
failure.
external DC source if available.
4. Refer the external DC device to service
center.
M1186102, Revision 1, 2009 135

FAILURE DESCRIPTION PROBABLE CAUSES REMEDY

1. Calibrate the touch screen section 6.6).
Touch panel will not 1. Touch screen is
respond to user not calibrated. 2. Check the Internal connections.
interaction. 3. Replace the top panel.
2. Internal cable
connections 4. Replace Main PCB (section 10.2.11).
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 10.2.8).
3. Replace Main PCB (section 10.2.11).
2. Touch panel
malfunction
3. Main board.
136 M1186102, Revision 1, 2009

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 penetrate into the ventilator.
with 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 10.2.1: Inlet
Filter Replacement.
Do not attempt to clean or
reuse the air inlet filter.
Remove and clean once
per month or more Refer to section
Exhalation frequently as necessary 10.2.2:Exhalation
Valve Replace the Exhalation Valve/Membrane
valve membrane every 6 Replacement.
months, and perform OVT.
M1186102, Revision 1, 2009 137

9.2. Planned Maintenance

Table 9-2 below describes the planned maintenance according the
time interval. For your convenient you can use the planned
maintenance checklist in Appendix B:.
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 Perform calibration if in
use.
Every 12 months Backup battery Replace the back up
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* Replace Integrated
battery
N/A Perform all the 12
months procedures.
Every 3 years RTC Battery Replace the RTC
Battery
N/A Perform all 12 months
procedures.
138 M1186102, Revision 1, 2009

Planned Maintenance
INTERVAL PART AFFECTED MAINTENANCE
Every 15,000 Pneumatic Unit Replace pneumatic

pneumatic running unit
hours, or every 4 years,
whichever come first. N/A Perform all
calibrations.
N/A Perform VVT
procedure.
N/A Perform Performance
Verification test.
* Every 2 years, or:

200 usage cycles for the standard battery, whichever comes first
600 usage cycles for the extended battery, whichever comes first
A usage cycle consists of a substantial discharge of the internal 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 10.2.1: Inlet Filter
Replacement.
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
6.5.4: O2 Calibration.
M1186102, Revision 1, 2009 139

4. Replace the Exhalation valve membrane. Refer to section 10.2.2:

Exhalation Valve/Membrane Replacement
9.2.2. Every 12 Months:

The following steps should be performed after every 12 months of use:
5. Perform the 6 months maintenance procedures as described in
section 9.2.1 above (exclude step 2).
6. Perform a charge-discharge-charge cycle on the integrated battery
Refer to section 6.7.2: CDC (Charge- Discharge- Charge) Procedure.
7. Replace the backup battery. Refer to section 10.2.13: Backup Battery
Replacement.
8. Replace the Exhalation valve and the membrane. Refer to section
10.2.2: Exhalation Valve/Membrane Replacement on.
9. Perform ALL service calibration procedures. Refer to section 7.2
Service calibration.
10. 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 10.2.7: Power
Pack Replacement.
2. Replace the O2 sensor. Refer to section 10.2.5.
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 10.2.14: Real Time Clock
(RTC) Battery Replacement.
2. Perform the 12 months procedures as describe in section 9.2.2
above.
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Planned Maintenance
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 come first:
1. Replace the pneumatic unit. Refer to section 10.2.12: 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.
M1186102, Revision 1, 2009 141

142 M1186102, Revision 1, 2009

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 10.1.11.
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 batteries and any external DC source, as applicable. If
the device must be serviced with the power on, be careful to avoid
M1186102, Revision 1, 2009 143

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.
• Replace or repair any parts that are found to be worn, missing,
damaged, cracked, or otherwise show signs of any physical
abnormalities.
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Service and Repair
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:
• 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.
M1186102, Revision 1, 2009 145

• 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.
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.
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Service and Repair
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 11.XX).
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.
M1186102, Revision 1, 2009 147

10.1.11. Recommended Service Tooling and

Materials
Table 10-1: Service tooling and materials
DESCRIPTION VERSAMED PART GE PART NUMBER

NUMBER
Ivent101 Technician Kit 910A0002-01 M1182956

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
10.2. Service & Repair Procedures

This section describes the procedures for replacing the following
components:
• Inlet Filter – section 10.2.1.
• Exhalation Valve – section 10.2.2.
• Changing from Two limb to One limb configuration – section 1. 1.
• Changing from One limb to Two limb configuration – section
10.2.4
• O2 sensor – section 10.2.5.
• Mains AC fuse replacement - section 10.2.6
• Power Pack – section 10.2.7.
• Top Enclosure – 10.2.8.
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Service and Repair
• Filter Housing – section 10.2.9.
• Main Enclosure - section 10.2.10.
• Main PCB - Section10.2.11.
• Pneumatic Unit – section 10.2.12.
• Backup Battery – section 10.2.13.
• Real Time clock Battery – section 10.2.14.
• Speaker Replacement – section 10.2.15.
• O2 sensor harness replacement – section 10.2.16.
• Pump/Solenoid harness replacement – section 10.2.17.
• Power Supply Unit Replacement – section 10.2.18.
• Back Panel Assembly Replacement – section 10.2.19.
10.2.1. 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.
M1186102, Revision 1, 2009 149

Figure 10.1: Inlet Filter
10.2.2. 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).
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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 and 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).
6. Clean the exhalation valve or put it in the
sterilization device, as instructed above.
M1186102, Revision 1, 2009 151

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.
12. Insert the exhalation valve back into the exhalation
compartment ensuring the pneumatic connectors are
properly engaged.
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Service and Repair
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.
10.2.3. Two limb to One Limb Accessory changeover

VersaMed P/N for ClevAir One limb Kit: 504HC051-01
VersaMed P/N for iVent101 One limb kit: 504BL051-01
GE P/N for One limb Kit: M1184155
To changeover Two limb to One Limb Accessory

1. Following the instructions in section 10.2.2: 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 4.3.4: Patient Configuration,
change the SW patient configuration to match that of the
hardware in use.
b. Following the instructions in section 6.5.3: Circuit Compensation,
perform the circuit calibration procedure.
c. Following the instruction in section 5.1: Patient Tube Testing
Procedure, perform the Patient Tube Testing procedure
10.2.4. 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:
M1186102, Revision 1, 2009 153

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 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 10.2.2: 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 4.3.4: Patient
Configuration, change the SW patient configuration to
match that of the hardware in use.
b) Following the instructions in section 6.5.3: Circuit
Compensation, perform the circuit calibration procedure.
c) Following the instructions in section 6.5.2: Sensors
Calibration perform the sensors calibration procedure.
d) Following the instruction in section 5.1: Patient Tube
Testing Procedure, perform the Patient Tube Testing
procedure.
10.2.5. O2 Sensor / Cork Installation
Figure 10.7: O2 Sensor Compartment / Cover
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VersaMed P/N for O2 sensor: 130B0002-03
GE P/N for O2 sensor: M1184213
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.
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.
10.2.6. 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.
M1186102, Revision 1, 2009 155

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
10.2.7. 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.
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Service and Repair
4. Set the power pack aside for disposal in an appropriate matter.
5. Remove the replacement power pack from its packaging and inspect
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.
Figure 10.9: Power Pack Mounting
10.2.8. 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.
M1186102, Revision 1, 2009 157

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 10.10 below).
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.
Figure 10.10. Top Enclosure Screw Locations
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Ground
cable Backlight
inverter
cable
LED’s
cable
Display
flat cable
Figure 10.11: Top Enclosure Components
10.2.9. 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 10.2.8.
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 10.2.8.
10.2.10. MAIN ENCLOSURE

VersaMed P/N for ClevAir Main Enclosure: 503HC100-01
M1186102, Revision 1, 2009 159

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 10.2.8.
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
Mounting screws
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.
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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.
10.2.11. 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
To replace the main PCB:
1. Remove the device’s top enclosure assembly. Refer to section 10.2.8.
2. Remove the device’s main enclosure assembly. Refer to section
10.2.10.
M1186102, Revision 1, 2009 161

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 10.14 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
Figure 10.14. 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. Refer to
Figure 10.15 below.
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Low High
Inspiration
tube
Blower
pressure tube Inlet pressure
tube
Patient
pressure tube LOW
HI
Exhalation
tube
Figure 10.15. 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.
7. Take the replacement PCB, inspecting it first the to ensure that ESD
packaging is fully intact.
8. Remove the replacement PCB from the ESD packaging and inspect
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. Refer to Figure 10.15 above.
M1186102, Revision 1, 2009 163

11. Reconnect all of the electrical harnesses to the upper side of the
PCB and the grounds cables to the left and right side of the PCB.
Refer to Figure 11.10 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
10.2.10.
13. Secure the top enclosure back in place as described in section
10.2.8.
10.2.12. Pneumatic Unit Replacement

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
Figure 10.16. Pneumatic Unit Mounting

To replace the pneumatic unit/ anti-vibration mount:
1. Remove the device’s Top enclosure assembly. Refer to section 10.2.8.
2. Remove the device’s main enclosure assembly. Refer to
section 10.2.10.
3. Remove the device’s main PCB. Refer to section 10.2.11
above.
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4. Disconnect the following tubing from the pneumatic
unit: box pressure line, O2 inlet tube, O2 sample tubes
(two tubes), exhaust line and HPB to Exhalation Valve.
Refer to Figure 10.17 below.
O2
sample HPB Pressure
tube port
Hold Solenoid O2
sample
tube
Exhaust tube
O2 inlet tube
Figure 10.17. Pneumatic Unit tubes mapping

5. Cut the strap on the side of Pneumatic Unit for detach
solenoid. Refer to Figure 10.17 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
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.
M1186102, Revision 1, 2009 165

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.
12. Tight the Main PCB mounting bracket
13. Reattach the solenoid, with strap, to the Pneumatic Unit.
Refer to Figure 10.17 above.
14. Re-establish the following tubing connections to the
pneumatic unit: box pressure line, O2 inlet tube, O2
sample tubes (two tubes), exhaust line and HPB to
Exhalation Valve. Refer to Figure 10.17 above.
HPB Pressure
port PU Ambient
O2 sample
tube O2 sample
tube
Exhaust tube
Figure 10.18. Pneumatic Unit tubing connectors

15. Place back the main PCB and reconnect its tubing as
described in section 10.2.11.
16. Secure the main enclosure back in place as described is
section10.2.10.
17. Secure the top enclosure back in place as describes in
section 10.2.83.
10.2.13. 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:
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1. Remove the device’s Top Enclosure assembly. Refer to section 10.2.8.
10.2.10.
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
10.2.10.
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Backup
Battery
Connector J19
Back-up
Battery
Figure 10.19. BACK UP BATTERY LOCATION
10.2.14. 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:
10.2.10.
3. Carefully remove the real time clock battery from its position on the
Main PCB, as shown in Figure 10.20 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.
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6. Carefully install the replacement item on the Main PCB while handling
as little as possible.
10.2.10.
8. Secure the top enclosure back in place as described in section 10.2.8,
on page 157.
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 10.20 RTC Battery Location
10.2.15. 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 10.2.8.
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10.2.10.
3. Remove the device’s main PCB. Refer to section 10.2.11.
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 10.2.11.
10.2.10.
10.2.16. 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 10.2.5.
In case that O2 sensor installed, remove it. Refer to section 10.2.5.
2. Remove the device’s Top enclosure assembly. Refer to section
10.2.8.
10.2.10.
4. Disconnect the O2 sensor harness from Main board. Refer to
Figure 10.14
5. Remove O2 sensor harness from O2 sensor compartment.
6. Set aside the old O2 sensor harness for disposal in an appropriate
manner.
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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.
9. Connect the small connector to Main board. Refer to Figure 10.14
10.2.10.
10.2.8.
12. Secure O2 sensor cover. Refer to section 10.2.5.
If needed installation of O2 sensor refer to section 10.2.5.
10.2.17. 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
To replace the Pump/Solenoid harness:
1. Remove the device’s Top enclosure assembly. Refer to section
10.2.8.
10.2.10.
3. Disconnect the Pump/Solenoid harness from Main board. Refer to
Figure 10.14
4. Pull up the pump from his place.
5. Cut the strap on the side of Pneumatic Unit for detach solenoid.
Refer to Figure 10.17.
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
packaging and inspect it for any signs of damage.
9. Place the pump, in right way, into his place.
10. Reattach the solenoid, with strap, to the Pneumatic Unit. Refer to
Figure 10.17
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11. Reconnect all silicone tubes, in right way, to pump and solenoid.
Refer to Figure 10.17
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 10.21. Pump/Solenoid harness mapping
12. Reconnect the Pump/Solenoid harness from Main board. Refer to

Figure 10.14
10.2.10.
10.2.8.
10.2.18. 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:
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10.2.10.
4. Remove the pneumatic unit Refer to section 10.2.11.
5. Remove the device’s power pack. Refer to section 10.2.6.
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 for any signs of damage.
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
10.2.1110.2.12.
13. Put back the main PCB and reconnect its tubing as described in
section 10.2.11.
10.2.10.
15. Secure the top enclosure in place as described in section 10.2.8.
16. Reinstall the power pack into place as described in section 10.2.6.
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Power Supply
Power Supply
Mounting Screws
Figure 10.22. Power Supply mounting
10.2.19. 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:
2. Remove the device’s main enclosure assembly. Refer to section 10.2.10.
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.
174 M1186102, Revision 1, 2009

Service and Repair
10. Remove the replacement Back Panel Assembly from its packaging, and
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.
16. Put back the main PCB and reconnect its tubing as described in section
10.2.11.
10.2.10.
18. Secure the top enclosure in place as described in section 10.2.8.
10.2.20. 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:
2. Remove the device’s main enclosure assembly. Refer to section 10.2.10.
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 10.2.12.
11. Remove the power pack. Refer to section 10.2.6.
12. Disconnect the Power supply harness from the base.
M1186102, Revision 1, 2009 175

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
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.
Formex box
Power Supply
Harness
Power Supply
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 10.2.19.
20. Reconnect the AC power entry harness.
21. Put back the pneumatic unit in place and assemble, Refer to section
10.2.11 on page 164.
22. Put back the main PCB and reconnect its tubing as described in section
10.2.11, on page 161.
10.2.10, on page 159.
24. Secure the top enclosure in place as described in section 10.2.8, on
page 157.
25. Reinstall the power pack into place as described in section 10.2.6, on
page 155.
176 M1186102, Revision 1, 2009

Service and Repair
10.2.21. Verification Tests for the new parts
Table 10-2 below describes the required verification tests that should
be perform to verify the integrity of the part you have replaced.
Table 10-2. 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 -- -- -- -- -- -- -- -- -- D
Replacement
One /Two Limb
changeover
-- D -- D D -- -- -- -- D
O2 Sensor
Replacement
-- -- -- -- -- -- D -- -- --
Mains AC fuse
Replacement
-- -- D -- -- -- -- -- -- --
Power Pack
Replacement
-- -- D -- -- -- -- -- -- --
Top Panel
Replacement
-- -- D -- -- -- -- D -- --
Filter Housing
Replacement
- D D -- -- -- -- -- -- --
Main
Enclosure - D D -- -- -- -- -- -- --
Replacement
Main PCB
Replacement D D D D D D D D D D
Pneumatic D
System D D D D D D D -- D
Replacement
Back-Up D
Battery - D D -- -- -- -- -- --
Replacement
RTC Battery D
Replacement D D D -- -- -- -- -- --
Speaker D
Replacement - D D -- -- -- -- -- D1
M1186102, Revision 1, 2009 177

Perfor- Patient
Service PU Power Sensor Factory O2 Touch Alarm
mance Tube OVT
Performed VVT VVT Cal Cal Cal Screen Cal Tests
Tests Comp
O2 sensor D
harness - D D -- -- -- D -- --
Replacement
Pump/Solenoid D
harness D D D -- -- -- -- -- --
Replacement
Power supply D
Replacement
D D D D D D - -- D
Back Panel D
Replacement
D D D D -- - D -- --
Base D
Replacement
D D D D D D D D D
1. Perform short alarm test according to the Operator’s Manual
178 M1186102, Revision 1, 2009

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
M1186102, Revision 1, 2009 179

11.2.2. Main Assemblies
9
10
Figure 11.2: Main Assembly
REF NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION
1 900HC003-01 M1184144 Top Enclosure

Assembly, ClevAir
- 900BL003-01 M1184143 Top Housing
Assembly, iVent101
180 M1186102, Revision 1, 2009

Spare Parts
REF NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION
2 900HC002-01 M1184142 Main PCB, ClevAir

- 900BL002-01 M1184141 Main PCB, iVent101
3 900HC001-01 M1184140 Pneumatic Unit,
ClevAir
- 900BL0001-01 M1184139 Pneumatic Unit
iVent101
4 900HC004-01 M1184146 Main Enclosure
Assembly, ClevAir
- 900BL004-01 M1184145 Main Enclosure
Assembly, iVent101
5 900HC005-01 M1184148 Base Enclosure
Assembly, ClevAir
- 900BL005-01 M1184147 Base Enclosure
Assembly, iVent101
6 900HC006-01 M1184150 Integrated Battery
Power Pack,
ClevAir
- 900BL006-01 M1184149 Integrated Battery
Power Pack,
iVent101
7 660HC001-01 M1184152 Inlet Filter, ClevAir
- 660BL001-01 M1184151 Inlet Filter, iVent101
8 900HC016-01 M1184598 Air Inlet adapter,
ClevAir
- 900BL016-01 M1185997 Air Inlet adapter,
iVent101
9 900HC007-01 M1184154 Two-limb kit,
ClevAir
- 900BL007-01 M1184153 Two-limb kit,
iVent101
10 900HC008-01 M1184158 Power supply,
ClevAir
- 900BL008-01 M1184157 Power supply,
iVent101
M1186102, Revision 1, 2009 181

11.2.3. Spare parts
NO. VERSAMED PART NUMBER GE PART NUMBER DESCRIPTION
1 130B0002-03 M1184213 O2 Sensor "MAX16"

2 504HC051-01 M1184156 One-limb kit,
ClevAir
- 504BL051-01 M1184155 One-limb kit,
iVent101
3 900HC009-01 M1184160 Back Panel
assembly, ClevAir
- 900BL009-01 M1184159 Back Panel
assembly, iVent101
4 900HC010-01 M1184162 Ground cables kit,
ClevAir
- 900BL010-01 M1184161 Ground cables kit,
iVent101
5 504HC055-01 M1184163 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 M1184169 Machine Packing
kit, ClevAir
- 900P0103-01 M1184168 Machine Packing
kit, iVent101
9 900HC011-01 M1184590 Tubing kit, ClevAir
- 900BL011-01 M1185992 Tubing kit, iVent101
182 M1186102, Revision 1, 2009

Spare Parts
10 900HC012-01 M1184591 Exhalation valve

base kit, ClevAir
- 900BL012-01 M1185993 Exhalation valve
base kit, iVent101
11 900HC013-01 M1184592 Back-up battery,
ClevAir
- 900BL013-01 M1185994 Back-up battery,

iVent101
12 900HC014-01 M1184595 Bumper + plug kit,
ClevAir
- 900BL014-01 M1185995 Bumper + plug kit,
iVent101
13 900HC015-01 M1184597 Pump & Solenoid
harness, ClevAir
- 900BL015-01 M1185996 Pump & Solenoid
harness, iVent101
14 900HC017-01 M1184599 Fans kit, ClevAir
- 900BL017-01 M1185998 Fans kit, iVent101

15 900HC018-01 M1185707 Speaker harness,
ClevAir
- 900BL018-01 M1185999 , Speaker harness,
iVent101
16 900HC019-01 M1185708 Harnesses kit,
ClevAir
- 900HC019-01 M1186000 Harnesses kit,
iVent101
17 900HC020-01 M1185710 O2 sensor Cork +
Cap kit, ClevAir
- 900BL020-01 M1185709 O2 sensor Cork +
Cap kit, iVent101
18 900HC021-01 M1185711 Gas gauge
adapter, ClevAir
- 900BL021-01 M1186001 Gas gauge
M1186102, Revision 1, 2009 183


adapter, iVent101
19 900HC022-01 M1185712 Fuse Kit, ClevAir
- 900BL022-01 M1186002 Fuse Kit, iVent101

20 900HC023-01 M1185713 Hardware kit,
ClevAir
- 900BL023-01 M1186003 Hardware kit,
iVent101
21 900HC031-01 M1185720 RTC battery, ClevAir
- 900BL031-01 M1186005 RTC battery,

iVent101
22 900P0100-01 M1187720 AC Cable 2 PIN
180CM for Europe
EN 50075:1990,
ClevAir
23 900P0104-01 M1186004 AC Cable 2 PIN
180CM for Europe
EN 50075:1990,
iVent101
24 900HC024-01 M1185714 AC Cable 2 PIN
180CM for China
GB2099.1-96,
GB1002-96
25 900HC025-01 M1185715 AC Cable 2 PIN
180CM for USA
NEMA 1-15P,
UL817, CSA C22.2
26 900HC026-01 M1185716 AC Cable 2 PIN
180CM for
Australia AS/NZS
3112:2000
27 900HC027-01 M1185717 AC Cable 2 PIN
180CM for India
IEC 60 799:1998
28 900HC028-01 M1185718 AC Cable 2 PIN
180CM for UK
184 M1186102, Revision 1, 2009

Spare Parts
BS1363
29 900HC029-01 M1185719 AC Cable 2 PIN
180CM for Brazil
NBR14136
30 900HC029-01 M1185719 AC Cable 2 PIN
180CM for Brazil
NBR14136
11.2.4. Accessories
NO. VERSAMED PART NUMBER VERSAMED PART DESCRIPTION

NUMBER
1 900HC033-01 M1184171 Extended Battery

Power Pack, ClevAir
- 900BL033-01 M1184170 Extended Battery
Power Pack,
iVent101
2 900HC030-01 M1185721 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 M1184150 Integrated Battery

Power Pack, ClevAir
- 900BL006-01 M1184149 Integrated Battery
Power Pack,
iVent101
5 900P0101-01 M1184227 Two-limb
disposable patient
circuit, ClevAir
- 900P0105-01 M1186007 Two-limb
M1186102, Revision 1, 2009 185

NO. VERSAMED PART NUMBER VERSAMED PART DESCRIPTION

NUMBER
disposable patient
circuit, iVent101
11.2.5. Maintenance Kits
1 900K0100-01 M1184173 Annual

maintenance kit:
(two-limb), ClevAir
- 900K0101-01 M1184172 Annual
maintenance kit:
(two-limb), iVent101
2 900K0102-01 M1184175 Annual
maintenance kit:
(one-limb) , ClevAir
- 900K0103-01 M1184174 Annual
maintenance kit:
(one-limb), iVent101
3 900K0104-01 M1184177 10k Maintenance kit,
ClevAir
- 900K0105-01 M1184176 10k Maintenance kit,
iVent101
11.2.6. iVent Software

1 509A0005-01 M1192231 IVent101 SW

version 1.X CD
186 M1186102, Revision 1, 2009

Spare Parts
Appendix A: Log Translator

VersaMed P/N: 809A0013-01
GE P/N: M1192772
The Log Translator application is used to read and “translate” logs
from the iVent101 device.
The logs in the Vent101 are binary, making it impossible to read them
directly. The log translator takes log files downloaded from the device
and translates them into readable text files.
The Vent101 has three types of logs:
• Technical Log (cannot be read using the GUI).
• Alarms Log (Also available using the Menu LogBook option in
GUI).
• Events Log (Also available using the Menu LogBook option in
GUI).
A.1. Log Translator Setup
Use to install the log translator application (with no additional
applications).
A.1.1. Installation Instructions:
If you already have LogTranslator of any version installed on your PC,
it is recommended to uninstall first.
1. Double click the Log Translator Setup.msi file and follow the
instructions in the application.
2. When installation is done you’ll have the following shortcuts:
• Desktop shortcut Log Translator 2.0.3
• Select Start – Programs - Versamed” to a shortcut to Log Translator
2.0.3.
3. Clicking on any of the shortcuts will execute the Log Translator
application.
M1186102, Revision 1, 2009 187

A.2. Translating a log file

To translate a Vent101/ ClevAir log file:
1. Click on one of the application shortcuts.
The following window will open:
Figure A. 1: Main application window

2. From the left panel select files from your file system.
The selected files will be added to the List of selected files or folders
panel on the right.
188 M1186102, Revision 1, 2009

Spare Parts
Figure A. 2 Several files were selected for translation
Figure A. 3. A folder was selected for translation
Note: You can select files to convert by dragging the files from the
explore window and drop it to the List of selected files or folders
panel.
3. Click on the Browse button to define the path for the translated log
file.
M1186102, Revision 1, 2009 189

Figure A. 4 Select a file to convert to
Note: If you selected a single file to convert, you can check the
“Convert to default filename”. In this case the generated file is located
in the setup folder.
4. Select the dictionary matching your installed version (it is possible
you’ll have only one dictionary available).
Figure A. 5 Select appropriate dictionary.
190 M1186102, Revision 1, 2009

Spare Parts
5. Make sure SW version changed according to the selected dictionary
version.
Figure A. 6. SW version
6. Click on the Generate button to generate the selected logs:
Figure A. 7 Generate log

A text file containing the generated log files will pop up.
M1186102, Revision 1, 2009 191

Figure A. 8. Translated log file

A.2.1. The About Button
When clicking the about button the “About” window will pop up
containing application version information.
Figure A. 9. The About window

A.2.2. The Advanced Settings Window
The Advanced Settings window allows the user to split the translated
log into sections according to a defined time interval.
To set the log into sections:
1. Click the Advanced button on the lower left side of the screen.
192 M1186102, Revision 1, 2009

Spare Parts
Figure A. 10. The Advanced settings window

2. Check the Add separator line every: box to allow editing the time
intervals.
3. Define your preferred time separator. (in Figure A.10 the time interval
was set to 2 days.)
4. Click OK to set your selection.
When log is generated there will be an empty line between logs of
each two days.
Figure A. 11Log Separator
M1186102, Revision 1, 2009 193

A.3. Reading Translated Log

The translated log file is built as a table, containing the following
information:
• Line number
• Log Type
• T = Technical
• E = Error
• A = Alarm
• Date and Time of log message
• Millisecond of message
• Description of message
• Additional parameters
Figure A. 12. Translated Log
194 M1186102, Revision 1, 2009

Spare Parts
Appendix B: Planned Maintenance Check list
Serial Number: Date: (MM/DD/YY) / /
Customer: Performed by:
1 Month 3 Month 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 1 month
Replace the air inlet filter.
Clean the Exhalation valve membrane
2. Perform the following steps every 6 months
Replace exhalation valve membrane.
Perform O2 calibration (if O2 sensor in use).
Perform CDC to the integrated battery.
M1186102, Revision 1, 2009 195

3. 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.
4. Perform the following steps every 24 months:
Replace exhalation valve.
Replace backup battery.
Replace integrated battery
Replace the O2 sensor
Perform ALL service calibrations.
196 M1186102, Revision 1, 2009

Spare Parts
5. Perform the following steps every 36 month
Replace RTC battery.
Perform all 12 months maintenance procedures.
6. Perform the following steps every 15000 hours/ 4 years of use
Replace pneumatic unit.
Perform ALL calibrations.
M1186102, Revision 1, 2009 197

198 M1186102, Revision 1, 2009

Index
Section 12: Index
A Configuration Screen
Lock screen...............................................59
AC connected test...................................... 88 Configuration screens
AC Disconnected test ............................... 92 Date .............................................................57
AC Power........................................................ 48 Time .............................................................57
AC Power Disconnect test ...................... 92 Cooling Fans .................................................53
Air Inlet Filter................................................. 37 Copy Log File.................................................71
Alarm................................................................ 58
D
Alarm Sound Levels................................... 58
Alarms Tests .............................................. 124 Date ..................................................................57
B Dual limb Patient Circuit ..........................23
E
Back Up Battery ............................. 140, 166
Backlight Inverter PCB.............................. 53 Enclosure............................................. 37, 157
Backup Battery............................................ 50 Exhalation Valve...42, 44, 137, 140, 150,
Battery 153, 154
Backup ....................................................... 50 External Dc Power ......................................48
Integrated................................................. 20 External Disconnected Test....................90
Battery Gas Gauge ................................. 115 External Test .................................................89
C F
Calibration Factory Calibrations ...............................100
factory calibrations ........................... 100 Fan.....................................................................53
FiO2........................................................... 111 Filter
Outlet valve calibration ................... 103 Air Inlet........................................................26
pneumatic resistance calibration104 Filter ................................... 26, 137, 139, 149
Sensors ................................................... 106 Filter Housing.............................................159
Service calibration ............................. 106 FiO2 ....................................................................44
Troubleshooting.................................. 118 Flow Sensor ...................................................42
Tube Compensation.......................... 108 Flow Test.........................................................81
Tube resistance................................... 108 G
Turbine calibration............................. 102
CDC Procedure ......................................... 115 Gas Gauge PCB............................................50
Charge-Discharge-Charge cycle...... 115 General Configuration............................56
Charger Test ................................................. 93 H
Circuit Compensation............................ 108
Cleaning and Routine Planned Heated Humidification .............................25
Maintenance ........................................ 137 High Pressure Box .............................. 40, 44
Configuration screen HME...................................................................25
O2 sensors................................................ 60 I
Sound Levels ........................................... 58
Indicator Lights............................................53
M1186102, Revision 1, 2009 199

Inlet Filter ................. 26, 37, 137, 139, 149 Dual limb....................................................23
Integrated Battery ..............................20, 49 One limb.....................................................24
Charge..................................................... 115 Patient Configuration................................67
Interface PCB................................................ 52 Patient Pressure Transducer .................42
L Patient Tubing Test ....................................75
PCB
Labels............................................................... 13 Interface.....................................................52
LCD Touch screen ...................................... 52 Pneumatic Unit .......................................52
Leak Test ........................................................ 83 PCB
LEDs.................................................................. 53 Backlight Inverter...................................53
Lock screen configuration...................... 59 Main .............................................................51
Log File ............................................................ 71 Planned Maintenance
Low Flow O2 connector ................................ 27 Every 12 Months..................................140
Low Flow O2 connector with locking nut Every 6 Months ....................................139
....................................................................... 28 Planned Maintenance............................141
Low Oxygen Supply................................... 26 Pneumatic Resistance Calibration ...104
M Pneumatic System .....................................33
Pneumatic Unit ...............................141, 164
Main Alarm Speaker.................................. 53 Pneumatic Unit PCB...................................52
Main Enclosure ......................................... 160 Pneumatic Unit Test ..................................79
Main PCB ..............................................51, 161 POV....................................................................38
Manifold.......................................................... 37 Power Pack .......................................140, 156
MDI.................................................................... 25 Power Sources .............................................19
Membrane.......137, 140, 150, 153, 154 Power Supply.............................................172
Memory Card................................................ 52
R
O
Real Time Clock Battery ..............140, 168
O2 Calibration ........................................... 111
O2 Connector S
Low Flow O2 connector ........................... 27 Sensors Calibration.................................106
Low Flow O2 connector with locking Service calibration...................................106
nut ........................................................... 28 Service Notice............................................128
O2 Sensor.................................................... 154 Service Notices Numbers.....................130
O2 sensors Service Screen..............................................61
Enabling..................................................... 60 Copy Log File............................................71
On Off Switch ............................................... 47 Patient Configuration...........................67
One limb ..................................................24, 67 Setup Configuration .............................71
One Limb ........................................................ 41 Software Update....................................65
One Way Valve ............................................ 41 Technical Info ..........................................64
Outlet valve calibration ........................ 103 Software Update.........................................65
OVT.................................................................... 75 Sound Levels
P Alarm...........................................................58
Button .........................................................58
Patient Circuit............................................... 22 Strut ...................................................40, 41, 42
200 M1186102, Revision 1, 2009

Index
Symbols .......................................................... 13 U
T Updating the battery gas gauge ......115
Technical Info............................................... 64 V
Technical Logbook..................................... 68 Ventilation Circuit Test..............................75
Tests VVT.....................................................................77
Alarms ..................................................... 124
AC connected test .................................88
Time.................................................................. 57
AC Disconnected test...........................92
Top Enclosure............................................ 157 AC Power Disconnect test..................92
Touch screen................................................ 52 Charger Test.............................................93
Troubleshooting....................................... 135
External battery test.............................89
Turbine ............................................................ 38 External Disconnected Test...............90
Turbine Calibration ................................. 102 Flow Test....................................................81
Turbine Pressure Transducer................ 40
Leak Test....................................................83
Two Limb.................................................41, 67
Pneumatic Unit .......................................79
M1186102, Revision 1, 2009 201

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.
202 M1186102, Revision 1, 2009

Index
GE Healthcare © VersaMed Ltd.. – All rights reserved.

P.O. Box 7550
Madison, WI 53707-7550 GE and GE Monogram are trademarks of
USA General Electric Company.
VersaMed Ltd., a General Electric

Company, doing business as GE
www.gehealthcare.com Healthcare.
The addresses listed on this cover are
current as of 2003.
Manufactured for and distributed Manufacturer: Obelis s.a.
by: VersaMed Ltd. Av. de Tervuren 34
VersaMed Ltd. Hasharon Industrial Park, Ornat Building, Bte 44 B-1040
PO Box 5011 Kadima, Israel Brussels Belgium
Kadima, Israel PO Box 5011 Tel 32 2 7325954
Tel (972) 9 891 5400 Kadima, Israel Fax 32 2 7326003
Fax (972) 9 899 7776 Tel (972) 9 891 5400 [email protected]
Fax (972) 9 899 7776
EC REP
IVent101 Technical Manual
VersMed Part Number SM-101-01
GE Part Number M1186102
Rev: 1
Revised March 2009 / 19.18.01
Copyright © 2009 by VersaMed™ Medical
Systems, Ltd.
Printed in Israel
M1186102, Revision 1, 2009 203

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iVent101 is a registered trademark of VersaMed Ltd.

II M1186102, Revision 1, 2009

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SAFETY Before attempting to service or test the iVent-101

Authorized Representative in the European Community

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

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Section 3: Theory of Operation.....................................................................33

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5.2.4. Pneumatic Unit test...................................................................................................... 79

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10.2.1. Inlet Filter Replacement ...........................................................................................149

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Figure 1.1: The iVent101/ ClevAir(front view) 4

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Figure 3.2: Pneumatic schematic diagram of one limb configuration 36

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Figure 10.3: Unlocking the exhalation valve lever 151

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1.1. Summary of Contents

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• Section 6: Calibration Procedures – Provides a summary of

1.2. General Description

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In addition, the iVent101/ ClevAir ventilator has the following

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1.3. Looking at the iVent101/ ClevAir

Figure 1.1: The iVent101/ ClevAir(front view)

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Table 1-1: Front panel components

ITEM NUMBER DESCRIPTION

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Figure 1.2: The iVent101/ ClevAir (rear view)

ITEM NUMBER DESCRIPTION

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13 Power pack mounting screws

1.4. Cautions and Warnings

The iVent101/ ClevAir ventilator is a life-sustaining device. Do not rely solely

To ensure patient safety, an appropriately trained caregiver should

Do not perform ventilation with medicinal substance without a filter

“Risks and Precautionary Measures related to Phthalates:

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

Using the iVent101/ ClevAir ventilator in combination with devices such as

Do not directly connect the iVent101/ ClevAir ventilator to a high pressure

During infant ventilation, in certain clinical conditions, Vt accuracy might