VersaMed i Vent201 Service Manual
i Vent
201
Service Manual
Part No. SM-01-04 Rev. 5 Revised February 2006
0473
© 2006 VersaMed
All Rights Reserved. No part of this document may be photocopied,
reproduced, stored in a retrieval system, or transmitted, in any form
or by any means, electronic, mechanical, or otherwise without the
prior written permission of VersaMed.
No warranty of accuracy is given concerning the contents of the
information contained in this publication. To the extent permitted
by law no liability (including liability to any person by reason of
negligence) will be accepted by VersaMed, its subsidiaries or
employees for any direct or indirect loss or damage caused by
omissions from or inaccuracies in this document.
VersaMed reserves the right to change details in this publication
without notice.
Adaptive Flow® and Adaptive Time® are registered trademarks of
VersaMed.
SAFETY: Before attempting to service or test the iVent
read this manual and the Operator's Manual in their entirety to
familiarize yourself with all Cautions and Warnings.
Manufacturer’s Address
VersaMed Medical Systems Inc.
2 Blue Hill Plaza Bldg. 2
Pearl River, NY 10965
845-770-2840
Authorized Representative in the European Community
Obelis S.A.
Avenue de Tervuren 34, Bte 44
B-1040 Brussels
Belgium
+32-2-732-59.54
Fax: +32-2-732-60.03
ventilator please
201
Calling For Help
If you have a ventilator problem that you cannot solve and you purchased
your ventilator directly from VersaMed, call:
800-475-9239 Customer Care and Service Assistance Line
or
866-483-6820 (866-iVent201)
If you have a ventilator problem that you cannot solve and you purchased
your ventilator from an authorized VersaMed distributor, please contact
your distributor directly to report the problem.
NOTE:
If this ventilator has not been purchased directly from VersaMed, please
ensure that it has been purchased from an authorized distributor of
VersaMed. To obtain a list of authorized distributors contact VersaMed at
sales@versamed.com.
visit our website: www.versamed.com
Table of Contents
Section 1: Introduction.................................................
1.1 Intended Use .................................................................................... 21
1.2 General Description......................................................................... 22
1.3 Safety Information ........................................................................... 23
1.3.1 Safety Regulations................................................................................24
1.3.2 Technician Safety.................................................................................. 24
1.3.2.1 Hazard Notices .............................................................................24
1.3.2.2 Calibration and Verification Test ...............................................24
1.3.2.3 Handling PC Boards ....................................................................24
1.3.3 Important Safety Considerations .......................................................25
1.4 Labels and Symbols ........................................................................ 26
1.4.1 Symbols..................................................................................................26
1.4.2 Labels .....................................................................................................27
21
Section 2: System Specifications................................
2.1 Specifications................................................................................... 31
2.1.1 Ventilation Modes ................................................................................31
2.1.2 Ventilation Performance and Controlled Parameters.....................31
2.1.3 Power Supply........................................................................................ 32
2.1.4 Oxygen Supply .....................................................................................32
2.1.5 Size and Weight....................................................................................32
2.1.6 Environmental Specifications ............................................................. 33
2.2 Standards and Safety Requirements ............................................. 33
2.3 Monitoring and Displayed Parameters........................................... 34
2.4 Adjustable Non-Displayed Parameters .......................................... 35
31
2.5 User Adjustable Alarms ...................................................................35
2.6 Additional Alarms and Indicators ...................................................36
2.6.1 Alarms ................................................................................................... 36
2.6.2 Indicators and Icons ............................................................................ 36
Section 3: Installation and Setup.................................
3.1 External Electrical Supply ...............................................................37
3.2 Internal Battery .................................................................................38
3.2.1 Battery Charging.................................................................................. 38
3.2.2 Internal Battery Charge Level Indicator........................................... 39
3.3 Oxygen Supply .................................................................................39
3.3.1 High Pressure Supply ......................................................................... 39
3.3.2 Low Pressure Oxygen Supply ........................................................... 40
3.4 Patient Circuit ...................................................................................41
3.4.1 Patient Circuit Connection ................................................................. 43
3.5 Filters ................................................................................................44
3.5.1 Air Inlet Filter....................................................................................... 44
37
3.5.1.1 Low Pressure Oxygen Adapter and Filter................................ 45
3.5.1.2 CBRN Filter................................................................................... 45
3.5.1.3 Bacterial Filter............................................................................... 45
3.6 Ventilator Controls ...........................................................................47
3.6.1 Rotational Control Knob (Encoder) .................................................. 47
3.6.2 Keypad .................................................................................................. 47
3.6.3 LED Indicators ..................................................................................... 48
3.7 Ventilator Operation.........................................................................48
Section 4: Theory of Operation....................................
4.1 Pneumatic Unit .................................................................................49
49
4.1.1 Blower Assembly (Turbine)................................................................52
4.1.2 Oxygen Blending System ....................................................................52
4.1.2.1 O2 Pressure Switch .......................................................................53
4.1.2.2 Demand Valve ..............................................................................53
4.1.2.3 Proportioning Valve.....................................................................53
4.1.2.4 Valve Controller............................................................................54
4.1.2.5 Valve Limit Switch (O2 Microswitch)........................................54
4.1.2.6 Oxygen Sensor ..............................................................................54
4.1.3 Solenoid Valve System ........................................................................55
4.1.4 Filters and Mufflers..............................................................................56
4.1.5 Cooling Fan ...........................................................................................57
4.1.6 Patient Circuit .......................................................................................57
4.1.6.1 Wye and Flow Sensor ..................................................................57
4.1.6.2 Exhalation Valve...........................................................................57
4.1.6.3 One-way Valve..............................................................................58
4.2 Electronic Module ............................................................................ 59
4.2.1 Computer............................................................................................... 61
4.2.1.1 System Memory ............................................................................ 61
4.2.1.2 BIOS................................................................................................61
4.2.1.3 DiskOnChip®................................................................................61
4.2.1.4 RS-232.............................................................................................62
4.2.1.5 VGA Display .................................................................................62
4.2.1.6 Keyboard........................................................................................62
4.2.1.7 Ethernet..........................................................................................62
4.2.1.8 PC Watchdog.................................................................................63
4.2.1.9 Operating System (OS) ................................................................63
4.2.2 Main Board............................................................................................63
4.2.2.1 Sensors Interface ...........................................................................64
4.2.2.1.1 Flow Sensor............................................................................64
4.2.2.1.2 Pressure Sensors....................................................................64
4.2.2.1.3 Oxygen Sensor.......................................................................64
4.2.2.1.4 Temperature Sensor .............................................................65
4.2.2.1.5 Battery Voltage ..................................................................... 65
4.2.2.2 Digital/Analog Interface ............................................................ 65
4.2.2.3 Control and Status ....................................................................... 65
4.2.2.4 Motor Interface............................................................................. 65
4.2.2.5 Bus Interface ................................................................................. 66
4.2.2.6 Solenoids Interface....................................................................... 66
4.2.2.7 Stepper Interface .......................................................................... 66
4.2.2.8 Watchdog Timer........................................................................... 66
4.2.2.9 Remote Alarm............................................................................... 67
4.2.2.10 SpO2............................................................................................. 67
4.2.3 Zeroing/Purge Board.......................................................................... 67
4.2.4 Switching Board................................................................................... 68
4.2.4.1 Switching Block............................................................................ 69
4.2.4.2 RF Filter Block .............................................................................. 69
4.2.4.3 Protective Devices........................................................................ 69
4.2.4.4 Battery Charger Block ................................................................. 70
4.2.4.5 5V Output DC/DC Converter ................................................... 70
4.2.4.6 Power On/ Off Switching........................................................... 70
4.2.4.7 Status Block................................................................................... 70
4.2.4.8 Motor Driver................................................................................. 70
4.2.4.9 External DC/DC Converter and External DC Source ............ 71
4.2.4.10 Auxiliary Power Supplies......................................................... 71
4.2.5 Power Supply (AC/DC Converter) .................................................. 71
4.2.5.1 Cooling Fan................................................................................... 71
4.3 LCD Display ......................................................................................71
4.4 Interface Board .................................................................................72
4.5 Power Pack .......................................................................................72
4.5.1 Gas Gauge............................................................................................. 73
Section 5: Maintenance and Calibration .....................
75
5.1 Cleaning and Routine Maintenance................................................75
5.2 Preventive Maintenance...................................................................76
5.2.1 500 Hour PM .........................................................................................76
5.2.2 1500 Hour PM .......................................................................................77
5.2.3 Annual PM ............................................................................................78
5.2.4 15000 Hour PM .....................................................................................78
5.3 Storage ............................................................................................. 79
5.4 Calibration Procedure ..................................................................... 79
5.4.1 Purpose ..................................................................................................79
5.4.2 Scope ......................................................................................................80
5.4.3 Tools & Equipment ..............................................................................80
5.4.4 Initialization .......................................................................................... 80
5.4.5 Procedure...............................................................................................80
5.4.5.1 Enter Calibration Menu ...............................................................81
5.4.5.2 Zero Sensors ..................................................................................82
5.4.5.3 Pressure Sensors ...........................................................................82
5.4.5.4 PEEP-RPM .....................................................................................83
5.4.5.5 Flow Sensor ...................................................................................84
5.4.5.6 Volume...........................................................................................85
5.4.5.7 O2 System.......................................................................................85
5.4.5.8 Save New Calibration ..................................................................86
Section 6: Ventilator Test Procedures ........................
6.1 Operational Verification Test .......................................................... 89
6.1.1 Purpose ..................................................................................................89
6.1.2 Scope ......................................................................................................89
6.1.3 Tools & Equipment ..............................................................................89
6.1.4 Initialization .......................................................................................... 89
6.1.5 Procedure...............................................................................................89
89
6.2 Ventilator Verification Test (VVT) Procedure................................. 91
6.2.1 Purpose ..................................................................................................91
6.2.2 Scope...................................................................................................... 91
6.2.3 Tools & Equipment.............................................................................. 91
6.2.4 Initialization.......................................................................................... 91
6.2.5 Procedure .............................................................................................. 91
6.2.5.1 Alarm Sound Tests....................................................................... 92
6.2.5.2 Pressure Tests ............................................................................... 94
6.2.5.3 Flow Tests ..................................................................................... 95
6.2.5.4 O2 Tests.......................................................................................... 95
6.2.5.5 Battery Test ................................................................................... 96
6.2.5.6 Watchdog Timer Tests................................................................. 96
6.3 Functional Verification Test Procedure..........................................98
6.3.1 Purpose.................................................................................................. 98
6.3.2 Scope...................................................................................................... 98
6.3.3 Tools & Equipment.............................................................................. 98
6.3.4 Initialization.......................................................................................... 99
6.3.5 Procedure .............................................................................................. 100
6.3.5.1 O2 Delivery and Linearity........................................................... 100
6.3.5.2 100% O2 (Suction) Test ................................................................ 101
6.3.5.3 Safety Alarms Test ....................................................................... 102
6.3.5.3.1 High Pressure Alarm ........................................................... 102
6.3.5.3.2 Apnea Alarm......................................................................... 103
6.3.5.3.3 Tube Disconnect Alarm....................................................... 103
6.3.5.3.4 Patient Disconnect Alarm ................................................... 104
6.3.5.3.5 Sensor Disconnect Alarm.................................................... 105
Section 7: Service Procedures.....................................
7.1 Software Upgrade Procedure ..........................................................107
7.1.1 Purpose.................................................................................................. 107
7.1.2 Scope...................................................................................................... 107
107
7.1.3 Tools & Equipment.............................................................................. 107
7.1.4 Procedure...............................................................................................107
7.2 Technical Logs Download............................................................... 110
7.2.1 Purpose ..................................................................................................110
7.2.2 Scope ......................................................................................................110
7.2.3 Tools & Equipment ..............................................................................110
7.2.4 Procedure...............................................................................................111
7.3 Option Package Update................................................................... 112
7.3.1 Purpose ..................................................................................................112
7.3.2 Scope ......................................................................................................112
7.3.3 Tools & Equipment ..............................................................................112
7.3.4 Procedure...............................................................................................112
7.4 Ventilator Disassembly and Assembly .......................................... 114
7.4.1 Purpose ..................................................................................................114
7.4.2 Scope ......................................................................................................114
7.4.3 Enclosure Disassembly & Assembly ................................................. 114
7.4.3.1 Tools & Equipment ......................................................................114
7.4.3.2 Enclosure Disassembly ................................................................115
7.4.3.3 Enclosure Assembly.....................................................................117
7.4.4 Electronic Module Removal and Installation...................................118
7.4.4.1 Tools & Equipment ......................................................................118
7.4.4.2 Electronic Module Removal........................................................118
7.4.4.3 Electronic Module Installation....................................................120
7.4.5 Electronic Module Disassembly and Assembly...............................121
7.4.5.1 Electronic Module Cover Removal and Installation ...............121
7.4.5.1.1 Tools & Equipment...............................................................121
7.4.5.1.2 Electronic Module Cover Removal ....................................121
7.4.5.1.3 Electronic Module Cover Installation................................122
7.4.5.2 Zeroing/ Purge Board Removal and Installation....................123
7.4.5.2.1 Tools & Equipment...............................................................123
7.4.5.2.2 Zeroing/ Purge Board Removal ........................................ 123
7.4.5.2.3 Zeroing/ Purge Board Installation .................................... 124
7.4.5.3 Main Board Removal and Installation ...................................... 125
7.4.5.3.1 Tools & Equipment .............................................................. 125
7.4.5.3.2 Main Board Removal........................................................... 125
7.4.5.3.3 Main Board Installation....................................................... 128
7.4.5.4 CPU Board Removal and Installation....................................... 128
7.4.5.4.1 Tools & Equipment .............................................................. 128
7.4.5.4.2 CPU Board Removal............................................................ 129
7.4.5.4.3 CPU Board Installation........................................................ 131
7.4.5.5 Power Supply Board Removal and Installation ...................... 131
7.4.5.5.1 Tools & Equipment .............................................................. 131
7.4.5.5.2 Power Supply Board Removal ........................................... 131
7.4.5.5.3 Power Supply Board Installation....................................... 133
7.4.5.6 Switching Board Removal and Installation.............................. 133
7.4.5.6.1 Tools & Equipment .............................................................. 133
7.4.5.6.2 Switching Board Removal................................................... 133
7.4.5.6.3 Switching Board Installation .............................................. 135
7.4.6 Pneumatic Unit Removal and Installation ....................................... 136
7.4.6.1 Tools & Equipment...................................................................... 136
7.4.6.2 Pneumatic Unit Removal............................................................ 136
7.4.6.3 Pneumatic Unit Installation........................................................ 137
7.4.7 LCD Assembly Removal and Installation........................................ 140
7.4.7.1 Tools and Equipment .................................................................. 140
7.4.7.2 LCD Assembly Removal............................................................. 140
7.4.7.3 LCD Assembly Installation......................................................... 141
7.4.8 Interface Board Removal and Installation........................................ 142
7.4.8.1 Tools & Equipment...................................................................... 142
7.4.8.2 Interface Board Removal............................................................. 142
7.4.8.3 Interface Board Installation ........................................................ 143
7.4.9 Power Pack Disassembly and Assembly.......................................... 144
7.4.9.1 Tools & Equipment...................................................................... 144
7.4.9.2 Power Pack Disassembly ............................................................ 144
7.4.9.3 Power Pack Assembly..................................................................145
7.4.10 O2 Sensor Removal and Installation ................................................146
7.4.10.1 Tools & Equipment ....................................................................146
7.4.10.2 O2 Sensor Removal .....................................................................146
7.4.10.3 O2 Sensor Installation.................................................................146
7.5 Battery Gas Gauge Initialization Procedure .................................. 147
7.5.1 Purpose ..................................................................................................147
7.5.2 Scope ......................................................................................................147
7.5.3 Tools & Equipment ..............................................................................147
7.5.4 Procedure...............................................................................................147
Section 8: Troubleshooting..........................................
8.1 Troubleshooting Guide ................................................................... 149
8.2 Diagnostics and Repairs ................................................................. 154
8.2.1 Power Switch ........................................................................................154
8.2.2 Demand Valve ......................................................................................156
8.2.3 Pressure Switch.....................................................................................157
8.2.4 Valve Limit Switch (O2 Microswitch)................................................158
8.2.5 Flow Sensor Leak..................................................................................160
8.2.5.1 Root Cause - Pneumatic vs. Electronic ...................................... 162
8.2.5.2 Isolation of Internal Tube Leak...................................................162
8.2.5.3 Blower Pressure & Exhalation Valve Control ..........................163
8.2.5.4 Negative (-) Flow Port vs. Positive (+) Flow Port....................163
8.2.5.5 Negative (-) Flow Port & Patient Pressure................................164
149
8.2.5.6 Positive (+) Flow Port ..................................................................167
8.3 Exhale VT Accuracy......................................................................... 168
8.3.1 Inhale VT Accuracy..............................................................................168
8.3.2 Exhale VT Accuracy Interferences..................................................... 168
8.3.3 Leakage ..................................................................................................169
8.3.4 Velocity.................................................................................................. 169
8.3.5 MAQUET (Siemens 190) Test lung ................................................... 170
8.4 Miscellaneous Issues.......................................................................171
8.4.1 Black Screen .......................................................................................... 171
8.4.2 Fails Calibrate Flow Sensor ................................................................ 171
8.4.3 Erratic O2 Control ................................................................................ 171
8.4.4 Erratic Exhale Tidal Volumes ............................................................ 172
8.4.5 Low Pressure During Calibration or VVT ....................................... 172
8.5 Setting Up the Ventilator for Static Pressure................................. 172
Appendix A: Parts and Accessories............................
Appendix B: Service Report Form...............................
Appendix C: Technician Tool Utility Software............
C.1 Purpose ............................................................................................181
C.2 Scope................................................................................................181
C.3 Tools & Equipment ..........................................................................181
C.4 Procedure.........................................................................................181
C.4.1 Software Installation........................................................................... 181
C.4.2 Initial Setup.......................................................................................... 182
C.4.3 Overview.............................................................................................. 184
C.4.4 Read All Parameters ........................................................................... 184
175
177
181
C.4.5 Card Number....................................................................................... 185
C.4.6 Read O2 Raw Value............................................................................ 185
C.4.7 Read Battery LMD .............................................................................. 186
C.4.8 Reset Battery Gas Gauge.................................................................... 187
C.4.9 Set Machine Serial Number............................................................... 188
C.4.10 SetUp Button ......................................................................................189
Appendix D: Wiring and Cables...................................
Index...............................................................................
191
195
Illustrations
Figure 1-1: The iVent
Figure 1-2: The iVent
(front view) .............................................................................. 22
201
(rear view)................................................................................ 23
201
Figure 3-1: External AC and DC Power ......................................................................... 38
Figure 3-2: Oxygen Inlet Connector................................................................................ 40
Figure 3-3: Low Pressure Oxygen Supply System ....................................................... 41
Figure 3-4: Patient Circuit ................................................................................................ 42
Figure 3-5: Patient Circuit Connection ........................................................................... 44
Figure 3-6: iVent
Filters................................................................................................ 46
201
Figure 3-7: Ventilator Controls........................................................................................ 47
Figure 4-1: Pneumatic Unit .............................................................................................. 50
Figure 4-2: Pneumatic Unit Overview............................................................................ 51
Figure 4-3: Electronic Module ......................................................................................... 59
Figure 4-4: Ventilator Overview...................................................................................... 60
Figure 5-1: Cooling Vent (left) and Cooling Air Inlet Filter (right)............................ 77
Figure 5-2: Entering the Maintenance Menu................................................................. 81
Figure 5-3: Entering the Calibration Menu.................................................................... 81
Figure 5-4: Zero Sensors ................................................................................................... 82
Figure 5-5: Calibrate Pressure Sensors ........................................................................... 83
Figure 5-6: Calibrate PEEP-RPM..................................................................................... 84
Figure 5-7: Calibrate Flow Sensor ................................................................................... 84
Figure 5-8: Calibrate Volume........................................................................................... 85
Figure 5-9: Calibrate O
System....................................................................................... 86
2
Figure 5-10: Save Calibration........................................................................................... 87
Figure 6-1: OVT #1 ............................................................................................................ 90
Figure 6-2: OVT #2 ............................................................................................................ 90
Figure 6-3: Entering the Maintenance Window............................................................ 93
Figure 6-4: Entering VVT ................................................................................................. 93
Figure 6-5: Pressure Tests .................................................................................................94
Figure 6-6: Pressure Test Results .....................................................................................94
Figure 6-7: Flow Tests........................................................................................................95
Figure 6-8: O2 Tests (21%).................................................................................................95
Figure 6-9: O2 Tests (100%)...............................................................................................96
Figure 6-10: Battery Test ...................................................................................................96
Figure 6-11: Reconnect AC Power...................................................................................97
Figure 6-12: Watchdog Timer Tests.................................................................................97
Figure 6-13: VVT Test Results ..........................................................................................98
Figure 6-14: External O2 Analyzer Test Setup ...............................................................99
Figure 6-15: Internal O2 Measurement..........................................................................100
Figure 6-16: 100% O2 (Suction) Mode ...........................................................................101
Figure 6-17: High Pressure Alarm.................................................................................102
Figure 6-18: Apnea Alarm ..............................................................................................103
Figure 6-19: Tube Disconnect Alarm.............................................................................104
Figure 6-20: Patient Disconnect Alarm .........................................................................104
Figure 6-21: Sensor Disconnect Alarm..........................................................................105
Figure 7-1: RS-232 Cable to iVent
Figure 7-2: Upgrade iVent
Figure 7-3: Upgrade iVent
Software Screen.............................................................108
201
PC Application Screens................................................109
201
..............................................................................108
201
Figure 7-4: ivDownload PC Application Screens........................................................111
Figure 7-5: Update Package Key....................................................................................113
Figure 7-6: Enclosure (Rear View) #1............................................................................116
Figure 7-7: Front Enclosure (Inside View) #1 ..............................................................116
Figure 7-8: Rear Enclosure (Inside View) #1................................................................117
Figure 7-9: Enclosure (Rear View) #2............................................................................119
Figure 7-10: Rear Enclosure (Inside View) #2..............................................................120
Figure 7-11: EM Cover Screw Locations.......................................................................122
Figure 7-12: EM Sensor Tubing Cover Screw Locations ............................................122
Figure 7-13: EM with Cover Removed to Show Zeroing/ Purge PCB ....................124
Figure 7-14: Electronic Module (Rear View) – Remote Alarm Area ........................125
Figure 7-15: Main Board ................................................................................................. 127
Figure 7-16: CPU Board.................................................................................................. 130
Figure 7-17: EM with Side Cover Lowered to Show Power Supply........................ 132
Figure 7-18: EM with Side Cover Lowered to Show Switching Board.................... 134
Figure 7-19: Switching Board Screw Locations........................................................... 135
Figure 7-20: Rear Enclosure (Inside View) #3 ............................................................. 137
Figure 7-21: O2 Mixer Cam to Mid Point Position...................................................... 138
Figure 7-22: PU Ground Point Locations ..................................................................... 139
Figure 7-23: Front Enclosure (Inside View #2)............................................................ 141
Figure 7-24: Front Enclosure (Inside View) #3............................................................ 143
Figure 7-25: Power Pack (Rear View) ........................................................................... 145
Figure 7-26: Power Pack (Removed)............................................................................. 145
Figure 8-1: Power Switch Assembly............................................................................. 155
Figure 8-2: O2 Inlet Pipe and Demand Valve .............................................................. 157
Figure 8-3: PU Main Connector (Front View) - Pressure Switch Pinout................. 158
Figure 8-4: O2 Mixer (Top View) ................................................................................... 159
Figure 8-5: Main Connector (Front View) - Microswitch Pinout ............................ 160
Figure 8-6: Pneumatic Sensors Connections................................................................ 161
Figure 8-7: Test Setup (Unit Operating Disassembled) ............................................. 166
Figure 8-8: Flow Graphs (Occluding the Negative Flow Sensor Port) .................... 167
Figure 8-9: Flow Graphs (Occluding the Positive Flow Sensor Port) ...................... 167
Figure 8-10: Flow Graphs (High Velocity Exhale)...................................................... 170
Figure 8-11: Test Lung 190 and iVent
Waveforms ................................................. 171
201
Figure C-1: Password Entry Box ................................................................................... 182
Figure C-2: Creating File Message Box ........................................................................ 183
Figure C-3: Select Communication Port....................................................................... 183
Figure C-4: Main Screen ................................................................................................. 184
Figure C-5: O2 Raw Value Too Low Pop-Up.............................................................. 186
Figure C-6: LMD Value Too Low Pop-Up................................................................... 187
Figure C-7: LMD Reset Verification Pop-Up............................................................... 188
Figure C-8: Set Machine Serial Number....................................................................... 189
Figure D-1: iVent
Wiring Diagram (Page 1).............................................................193
201
Figure D-2: iVent
Wiring Diagram (Page 2).............................................................194
201
Tables
Table 2-1: Displayed Parameters and Indicators During Ventilation........................ 34
Table 3-1: Internal Battery Charge Level Indicator ...................................................... 39
Table 5-1: Cleaning and Routine Maintenance ............................................................. 75
Table 5-2: Preventive Maintenance Schedule................................................................ 76
Table 8-1: Troubleshooting Guide ............................................................................... 150
Section 1: Introduction
1.1 Intended Use
This Service Manual describes the service, maintenance and test procedures
for the iVent
functional operation and safety of the device.
This Service Manual should only be used by authorized VersaMed trained
technicians.
This Service Manual must be used in conjunction with the Operator's
Manual (OM-01-04) and is complementary to it.
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.
VersaMed reserves the right to modify the product without amending this
document or advising the user.
(hardware version 1.4). It is intended to ensure optimal
201
IMPORTANT: Technical information is supplied in this manual that is
intended to facilitate a complete understanding of the
ventilator's structure and function. Not every
component or subsystem discussed in this manual is
accessible or repairable in the field. The iVent
201
was
designed to provide easy access to serviceable areas
of the ventilator. Whenever possible, this manual
describes the practical (hands-on) aspect of a
component or system.
Issued: 23-Feb-06
21
1.2 General Description
A
r
t
t
The iVent
is a portable, computer controlled, electrically powered
201
ventilator providing continuous or intermittent ventilatory support to
patients requiring mechanical ventilation, as prescribed by an attending
physician.
The iVent
features advanced software, electronic and mechanical
201
technologies which, along with easy operation, provide effective and
reliable ventilation.
ir Inlet Filte
LED Indicators
Ventilator Outle
LCD Display
Keypad
Rotational
Control
Sensor Lines
Connectors
Patient Circui
Figure 1-1: The iVent
(front view)
201
Speaker
Exhalation Valve
Control Line
Connector
22
VersaMed iVent
Service Manual
201
Carrying Handle
r
y
r
Cooling Fan
Outlet Vents
Ground Post
DC Power Cord
Conne cto
DC Fuse
AC Fuses (2)
AC Power Cord
Conne cto
Keyboard
Conne ctor
Remote Alarm
Conne ctor
External Display
Conne ctor
SpO
Probe
2
Conne ctor
(Optional)
High Pressure
Conne ctor
O
2
Power Switch
Internal Batter
Power Pack
Power Pack Handle
Figure 1-2: The iVent
1.3 Safety Information
In accord with the important information herein, always comply with
applicable national and local safety regulations.
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.
(rear view)
201
RS-232
Conne ctor
AC Power Cord
Issued: 23-Feb-06
23
1.3.1 Safety Regulations
The following medical electrical equipment safety standards have been
met:
IEC 60601-1-1 Medical Electrical Equipment - Part 1: General requirements
for safety 1: Collateral standard: Safety requirements for
medical electrical systems
IEC 60601-1-2 Medical Electrical Equipment - Part 1: General requirements
for safety 2: Collateral standard: Electromagnetic
Compatibility (EMC)
IEC 60601-1-4 Medical Electrical Equipment - Part 1: General requirements
for safety 4: Collateral standard: Programmable Electrical
Systems
IEC 60601-2-12 Medical Electrical Equipment - Part 2-12: Particular
requirements for the safety of lung ventilators – Critical care
ventilators
UL 94 HB Flammability
1.3.2 Technician Safety
1.3.2.1 Hazard Notices
Before disassembling or assembling the ventilator ensure that:
• The O2 gas supply is disconnected
The AC or DC power cords are disconnected
•
• The power switch is set to OFF
WARNING: If the power switch is set to ON, the internal battery will
continue to supply power to the PC Boards!
1.3.2.2 Calibration and Verification Test
After any servicing of the iVent
Verification Test according to the instructions in Section 5: and Section 6:
ventilator, perform a Calibration and
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1.3.2.3 Handling PC Boards
• The PC boards contain components that are highly sensitive to static
electricity.
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VersaMed iVent
Service Manual
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• When coming into contact with circuit boards containing sensitive
components, you must take precautions to avoid damaging the
components (ESD protection).
Always use a grounded wristband and grounded work surface when
•
working with ESD sensitive components. Adequate service tools must
also be used.
•
PC boards (spare or exchanged parts) must always be kept in protective
packaging for ESD sensitive devices.
• Remove and insert the PC boards very carefully to avoid damage to the
connectors.
1.3.3 Important Safety Considerations
• Specially trained personnel must service the iVent
at the specified
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periodic intervals described in Section 5:. Any service or maintenance
must be noted in a log book provided for that purpose in accordance
with legal and civic regulations. It is recommended that service be
performed as part of a service contract with VersaMed.
• The internal battery must be replaced every year according to the
instructions in this Service Manual. The stated battery backup time,
approximately 60 minutes, can be guaranteed only if it is used
according to the instructions provided in the Operator's Manual.
• Old or used non-functioning batteries and oxygen sensors must be
returned to the place of purchase or to a place where they can be
properly disposed of. Batteries and oxygen sensors must not be
discarded with ordinary waste.
A high voltage of 1800 Vrms exists on the DC-AC inverter unit. Do not
•
touch this unit for at least 5 minutes after the ventilator is powered off.
• Only genuine VersaMed replacement parts should be used. Failure to
comply may seriously impair the ventilator's performance, safety or
reliability.
• Alteration or repair of the iVent
maintenance instructions or by anyone other than an authorized
VersaMed service person could result in the product's failure to perform
as designed.
• During reassembly of the iVent
care to inspect and reconnect all electrical grounds that have been
previously disconnected.
Issued: 23-Feb-06
beyond the scope of the service and
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or any of it’s subcomponents take
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1.4 Labels and Symbols
1.4.1 Symbols
The following IEC 601-1 symbols appear on the ventilator:
Symbol Definition
Refer to documentation for further information
Potential equalization (Ground Point)
Direct Current ( DC) and Alternating Current (AC)
Dangerous voltage
Type BF equipment
Defibrillation proof, Type BF applied part
IP54 – Degree of protection provided by the enclosure (dust
protected and splash proof)
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VersaMed iVent
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1.4.2 Labels
Location
Label
AC Connector
AC IN 100-240V
50-60Hz 1.6A
AC Fuses
2xT3.15AL (250V)
Air Inlet
INLET AIR
FILTER
DO NOT
OBSTRUCT
Cooling Fan Vent
COOLING
FAN
Connector
DC Fuse
Device ID
Device Product
DO NOT
OBSTRUCT
DC IN
12-15V
8.5A
T15A (250V)
S/N: IV1813
Model:
iVent
201
IC
Issued: 23-Feb-06
27
Location
Label
Ethernet
Connector (not on
all units}
External Display
Connector
High Pressure
Oxygen Inlet
EXT. SCREEN
OXYGEN
INLET
40-60 psi
2.8-4.2 bar
Use 50 psi
(3.5 bar)
DISCONNECT
WHEN NOT IN
USE
OR
Keyboard
Connector
Power Pack Fuse
Power Switch
Remote Alarm
Connector
Serial
Communication
Connector
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KEYBOARD
T15A (250V)
ON
OFF
REMOTE
ALARM
RS-232
OR
OR
VersaMed iVent
I 0 I 0 I
Service Manual
201
Location
Label
Power Pack
Product (inside)
POWER PACK
P/N : 503A0012
This Power Pack contains a sealed Lead -
2
Pulse Oximetry
Probe connector
Caution:
Acid Batte ry . Dispos al of this unit s ho uld be
according to Environmental Safety Requirements for
Lead-Acid batteries.
SpO
(optional; not on
all units)
VersaMed
Issued: 23-Feb-06
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