iVent201 Service Manual Rev 4 revised Aug 2005

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 iVent201 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: +32-2-732-60.03

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 ... 18 1.1 Intended Use... 18 1.2 General Description ... 19 1.3 Safety Information... 20 1.3.1 Safety Regulations ...21 1.3.2 Technician Safety ...21 1.3.2.1 Hazard Notices...21 1.3.2.2 Calibration and Verification Test ...21 1.3.2.3 Handling PC Boards...22 1.3.3 Important Safety Considerations ...22 1.4 Labels and Symbols... 23 1.4.1 Symbols ...23 1.4.2 Labels...24

Section 2 System Specifications ... 27 2.1 Specifications ... 27 2.1.1 Ventilation Modes ...27 2.1.2 Ventilation Performance and Controlled Parameters ...27 2.1.3 Power Supply ...28 2.1.4 Oxygen Supply...28 2.1.5 Size and Weight ...28 2.1.6 Environmental Specifications ...29 2.2 Standards and Safety Requirements... 29 2.3 Monitoring and Displayed Parameters ... 30 2.4 Adjustable Non-Displayed Parameters ... 31

2.5 User Adjustable Alarms ... 31 2.6 Additional Alarms and Indicators... 31 2.6.1 Alarms... 31 2.6.2 Indicators and Icons... 32

Section 3 Installation and Setup ...33 3.1 External Electrical Supply... 33 3.2 Internal Battery ... 34 3.2.1 Battery Charging ... 34 3.2.2 Internal Battery Charge Level Indicator ... 35 3.3 Oxygen Supply... 35 3.3.1 High Pressure Supply... 35 3.3.2 Low Pressure Oxygen Supply... 36 3.4 Patient Circuit ... 37 3.4.1 Patient Circuit Connection... 39 3.5 Filters... 40 3.5.1 Air Inlet Filter ... 41 3.5.1.1 Low Pressure Oxygen Adapter and Filter... 41 3.5.1.2 CBRN Filter ... 41 3.5.1.3 Bacterial Filter ... 41 3.6 Ventilator Controls ... 44 3.6.1 Rotational Control Knob (Encoder)... 44 3.6.2 Keypad... 44 3.6.3 LED Indicators... 45 3.7 Ventilator Operation ... 45

Section 4 Theory of Operation ...46 4.1 Pneumatic Unit... 46

4.1.1 Blower Assembly (Turbine) ...49 4.1.2 Oxygen Blending System ...49 4.1.2.1 O2 Pressure Switch...50 4.1.2.2 Demand Valve...50 4.1.2.3 Proportioning Valve ...50 4.1.2.4 Valve Controller...51 4.1.2.5 Valve Limit Switch (O2 Microswitch) ...51 4.1.2.6 Oxygen Sensor...52 4.1.3 Solenoid Valve System...53 4.1.4 Filters and Mufflers ...54 4.1.5 Cooling Fan...54 4.1.6 Patient Circuit ...54 4.1.6.1 Wye and Flow Sensor...54 4.1.6.2 Exhalation Valve ...55 4.1.6.3 One-way Valve...55 4.2 Electronic Module ... 56 4.2.1 Computer ...59 4.2.1.1 System Memory ...59 4.2.1.2 BIOS ...59 4.2.1.3 DiskOnChip® ...59 4.2.1.4 RS-232 ...60 4.2.1.5 VGA Display...60 4.2.1.6 Keyboard...61 4.2.1.7 Ethernet ...61 4.2.1.8 PC Watchdog...61 4.2.1.9 Operating System (OS)...61 4.2.2 Main Board ...61 4.2.2.1 Sensors Interface ...62 4.2.2.1.1 Flow Sensor...62 4.2.2.1.2 Pressure Sensors...63 4.2.2.1.3 Oxygen Sensor...63 4.2.2.1.4 Temperature Sensor...63

4.2.2.1.5 Battery Voltage... 63 4.2.2.2 Digital/Analog Interface... 63 4.2.2.3 Control and Status... 64 4.2.2.4 Motor Interface ... 64 4.2.2.5 Bus Interface... 64 4.2.2.6 Solenoids Interface ... 65 4.2.2.7 Stepper Interface... 65 4.2.2.8 Watchdog Timer... 65 4.2.2.9 Remote Alarm... 65 4.2.2.10 SpO2 ... 66 4.2.3 Zeroing/Purge Board ... 66 4.2.4 Switching Board ... 67 4.2.4.1 Switching Block ... 68 4.2.4.2 RF Filter Block... 68 4.2.4.3 Protective Devices ... 68 4.2.4.4 Battery Charger Block... 69 4.2.4.5 5V Output DC/DC Converter... 69 4.2.4.6 Power On/ Off Switching ... 69 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 ... 70 4.2.4.10 Auxiliary Power Supplies ... 70 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 ... 72

Section 5 Maintenance and Calibration...74 5.1.1 Cleaning and Routine Maintenance ... 74 5.2 Preventive Maintenance... 75

5.2.1 500 Hour PM ...76 5.2.2 1500 Hour PM ...76 5.2.3 Annual PM...77 5.2.4 15000 Hour PM ...78 5.3 Storage... 78 5.4 Calibration Procedure... 78 5.4.1 Purpose...79 5.4.2 Scope...79 5.4.3 Tools & Equipment...79 5.4.4 Initialization...79 5.4.5 Procedure...79 5.4.5.1 Initialization...80 5.4.5.2 Zero Sensors...81 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 ... 88 6.1 Operational Verification Test ... 88 6.1.1 Purpose...88 6.1.2 Scope...88 6.1.3 Tools & Equipment...88 6.1.4 Initialization...88 6.1.5 Procedure...88 6.2 Ventilator Verification Test (VVT) Procedure ... 90 6.2.1 Purpose...90

6.2.2 Scope ... 90 6.2.3 Tools & Equipment ... 90 6.2.4 Initialization ... 90 6.2.5 Procedure ... 90 6.2.5.1 Alarm Sound Tests ... 91 6.2.5.2 Pressure Tests... 93 6.2.5.3 Flow Tests... 94 6.2.5.4 O2 Tests ... 94 6.2.5.5 Battery Test... 95 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 ... 98 6.3.5 Procedure ... 99 6.3.5.1 O2 Delivery and Linearity ... 99 6.3.5.2 100% O2 (Suction) Test... 100 6.3.5.3 Safety Alarms Test ... 102 6.3.5.3.1 High Pressure Alarm ... 102 6.3.5.3.2 Apnea Alarm... 102 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 ...106 7.1 Software Upgrade Procedure ... 106 7.1.1 Purpose ... 106 7.1.2 Scope ... 106 7.1.3 Tools & Equipment ... 106

7.1.4 Procedure...107 7.2 Technical Logs Download ... 109 7.2.1 Purpose...110 7.2.2 Scope...110 7.2.3 Tools & Equipment...110 7.2.4 Procedure...110 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 ...114 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 ...119 7.4.4.3 Electronic Module Installation...120 7.4.5 Pneumatic Unit Removal and Installation...121 7.4.5.1 Tools & Equipment...121 7.4.5.2 Pneumatic Unit Removal...121 7.4.5.3 Pneumatic Unit Installation...123 7.4.6 LCD Assembly Removal and Installation...126 7.4.6.1 Tools and Equipment ...126 7.4.6.2 LCD Assembly Removal...126

7.4.6.3 LCD Assembly Installation... 127 7.4.7 Interface Board Removal and Installation ... 128 7.4.7.1 Tools & Equipment ... 128 7.4.7.2 Interface Board Removal... 128 7.4.7.3 Interface Board Installation... 129 7.4.8 Electronic Module Cover Removal and Installation... 130 7.4.8.1 Tools & Equipment ... 130 7.4.8.2 Electronic Module Cover Removal... 131 7.4.8.3 Electronic Module Cover Installation... 132 7.4.9 Power Pack Disassembly and Assembly ... 133 7.4.9.1 Tools & Equipment ... 133 7.4.9.2 Power Pack Disassembly... 133 7.4.9.3 Power Pack Assembly ... 134 7.4.10 O2 Sensor Removal and Installation... 135 7.4.10.1 Tools & Equipment ... 135 7.4.10.2 O2 Sensor Removal... 135 7.4.10.3 O2 Sensor Installation... 135 7.5 Battery Gas Gauge Initialization Procedure ... 136 7.5.1 Purpose ... 136 7.5.2 Scope ... 136 7.5.3 Tools & Equipment ... 136 7.5.4 Procedure ... 136

Section 8 Troubleshooting ...138 8.1 Troubleshooting Guide ... 138 8.2 Diagnostics and Repairs ... 143 8.2.1 Power Switch ... 143 8.2.2 Demand Valve ... 145 8.2.3 Pressure Switch ... 146 8.2.4 Valve Limit Switch (O2 Microswitch)... 147

8.2.5 Flow Sensor Leak ...149 8.2.5.1 Root Cause - Pneumatic vs. Electronic ...151 8.2.5.2 Isolation of Internal Tube Leak ...151 8.2.5.3 Blower Pressure & Exhalation Valve Control...152 8.2.5.4 Negative (-) Flow Port vs. Positive (+) Flow Port ...153 8.2.5.5 Negative (-) Flow Port & Patient Pressure ...153 8.2.5.6 Positive (+) Flow Port...157 8.3 Exhale VT Accuracy ... 157 8.3.1 Inhale VT Accuracy ...158 8.3.2 Exhale VT Accuracy Interferences ...158 8.3.3 Leakage ...158 8.3.4 Velocity...159 8.3.5 MAQUET (Siemens 190) Test lung ...160 8.4 Miscellaneous Issues... 161 8.4.1 Black Screen ...161 8.4.2 Fails Calibrate Flow Sensor ...161 8.4.3 Erratic O2 Control ...161 8.4.4 Erratic Exhale Tidal Volumes ...162 8.4.5 Low Pressure During Calibration or VVT ...162 8.5 Setting Up the Ventilator for Static Pressure... 162

Appendix A: Parts and Accessories ... 164 Appendix B: Service Report Form... 166 Index ... 169

Illustrations Figure 1-1: The iVent201 (front view)... 19 Figure 1-2:The iVent201 (rear view) ... 20 Figure 3-1: External AC and DC Power ... 34 Figure 3-2: Oxygen Inlet Connector ... 36 Figure 3-3: Low Pressure Oxygen Supply System... 37 Figure 3-4: Patient Circuit... 38 Figure 3-5: Patient Circuit Connection ... 40 Figure 3-6: Filters ... 43 Figure 3-7: Ventilator Controls ... 44 Figure 4-1: Pneumatic Unit... 47 Figure 4-2: Pneumatic Unit Overview ... 48 Figure 4-3: Electronic Module... 57 Figure 4-4: Ventilator Overview ... 58 Figure 5-1: Cooling Vent (left) and Cooling Air Inlet Filter (right) ... 76 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 O2 System ... 86 Figure 5-10: Save Calibration ... 87 Figure 6-1: OVT #1 ... 89 Figure 6-2: OVT #2 ... 89 Figure 6-3: Entering the Maintenance Window ... 92 Figure 6-4: Entering VVT... 92 Figure 6-5: Pressure Tests ... 93 Figure 6-6: Pressure Test Results ... 94 Figure 6-7: Flow Tests ... 94 Figure 6-8: O2 Tests (21%)... 95 Figure 6-9: O2 Tests (100%)... 95 Figure 6-10: Battery Test ... 96 Figure 6-11: Reconnect AC Power... 96 Figure 6-12: Watchdog Timer Tests ... 97 Figure 6-13: VVT Test Results... 97 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 iVent201... 107 Figure 7-2: Upgrade iVent201 Software Screen ... 108 Figure 7-3: Upgrade iVent201 PC Application Screens ... 108 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... 120 Figure 7-10: Rear Enclosure (Inside View) #2 ... 120 Figure 7-11: Rear Enclosure (Inside View) #3 ... 123 Figure 7-12: O2 Mixer Cam to Mid Point Position... 124 Figure 7-13: PU Ground Point Locations ... 125 Figure 7-14: Front Enclosure (Inside View #2) ... 127 Figure 7-15: Front Enclosure (Inside View) #3 ... 129 Figure 7-16: EM Cover Screw Locations ... 132 Figure 7-17: Power Pack (Rear View) ... 133 Figure 7-18: Power Pack (Removed) ... 134 Figure 8-1: Power Switch Assembly ... 144 Figure 8-2: O2 Inlet Pipe and Demand Valve ... 146 Figure 8-3: PU Main Connector (Front View) - Pressure Switch Pinout... 147 Figure 8-4: O2 Mixer (Top View)... 148 Figure 8-5: Main Connector (Front View) - Microswitch Pinout ... 149 Figure 8-6: Pneumatic Sensors Connections ... 150 Figure 8-7: Test Setup (Unit Operating Disassembled) ... 156 Figure 8-8: Flow Graphs (Occluding the Negative Flow Sensor Port) ... 156 Figure 8-9: Flow Graphs (Occluding the Positive Flow Sensor Port) ... 157 Figure 8-10: Flow Graphs (High Velocity Exhale)... 160 Figure 8-11: Test Lung 190 and iVent201 Waveforms ... 161

Tables Table 2-1: Displayed Parameters and Indicators During Ventilation ... 30 Table 3-1: Internal Battery Charge Level Indicator... 35 Table 5-1: Cleaning and Routine Maintenance... 74 Table 5-2: Preventive Maintenance Schedule ... 75 Table 8-1: Troubleshooting Guide... 139

Section 1 Introduction 1.1 Intended Use This Service Manual describes the service, maintenance and test procedures for the iVent201 (hardware version 1.4). It is intended to ensure optimal 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.

IMPORTANT

Issued: 15-Aug-05

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 iVent201 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.

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1.2 General Description The iVent201 is a portable, computer controlled, electrically powered ventilator providing continuous or intermittent ventilatory support to patients requiring mechanical ventilation, as prescribed by an attending physician. The iVent201 features advanced software, electronic and mechanical technologies which, along with easy operation, provide effective and reliable ventilation.

Air Inlet Filter

LCD Display

LED Indicators

Keypad

Ventilator Outlet

Rotational Control

Sensor Lines Connectors

Speaker Exhalation Valve Control Line Connector

Patient Circuit

Figure 1-1: The iVent201 (front view)

Issued: 15-Aug-05

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Keyboard Connector

Carrying Handle Cooling Fan Outlet Vents

Remote Alarm Connector

Ground Post External Display Connector

DC Power Cord Connector

SpO2 Probe Connector (Optional)

DC Fuse AC Fuses (2)

High Pressure O2 Connector

AC Power Cord Connector

Power Switch Internal Battery Power Pack

RS-232 Connector

Power Pack Handle AC Power Cord

Figure 1-2: The iVent201 (rear view)

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.

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VersaMed iVent201 Service Manual

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 iVent201 ventilator, perform a Calibration and Verification Test according to the instructions in Section 5 and Section 6.

Issued: 15-Aug-05

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1.3.2.3 Handling PC Boards •

The PC boards contain components that are highly sensitive to static electricity.

•

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

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•

Specially trained personnel must service the iVent201 at the specified 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 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 iVent201 beyond the scope of the service and maintenance instructions or by anyone other than an

VersaMed iVent201 Service Manual