VersaMed iVent201 User manual

iVent201
Service Manual
Part No. SM-01-04 Rev. 5 Revised February 2006
© 2006 VersaMed
0473

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
201
ventilator please
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: [phone]

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
[email protected].
visit our website: www.versamed.com

Table of Contents
Section 1: Introduction................................................. 21
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
Section 2: System Specifications................................ 31
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

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................................. 37
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
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.................................... 49
4.1 Pneumatic Unit .................................................................................49

4.1.1 Blower Assembly (Turbine)................................................................52
4.1.2 Oxygen Blending System ....................................................................52
4.1.2.1 O
2
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 (O
2
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 O
2
System.......................................................................................85
5.4.5.8 Save New Calibration ..................................................................86
Section 6: Ventilator Test Procedures ........................ 89
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
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 O
2
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 O
2
Delivery and Linearity........................................................... 100
6.3.5.2 100% O
2
(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..................................... 107
7.1 Software Upgrade Procedure ..........................................................107
7.1.1 Purpose.................................................................................................. 107
7.1.2 Scope...................................................................................................... 107
7.1.3 Tools & Equipment.............................................................................. 107