iVent201 Technical Reference Manual Rev 5 revised March 2009

Owner’s Record The model number and serial number of your iVent201 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:

Ivnet201 is a registered trademark of VersaMed Ltd Other brand names or product names used in this manual are trademarks or registered trademarks of their respective holders.

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.

Table of Contents Section 1: Introduction...1 1.1 Intended Use...1 1.2 General Description ...2 1.2.1 Looking At The iVent 201 ...3 1.2.2 Product Versions...5 1.2.3 Safety Information ...6 1.2.4 Safety Regulations ...7 1.2.4.1 Handling PC Boards ...8 1.3 Labels and Symbols...9 1.3.1 Symbols...9 1.3.2 Labels...10

Section 2: System Specifications ...13 2.1.1 Ventilation Modes ...13 2.1.2 Ventilation Performance and Controlled Parameters...13 2.1.3 Monitored Data ...14 2.2 Monitoring and Displayed Parameters ...17 2.3 Adjustable Non-Displayed Parameters...18 2.4 User Adjustable Alarms ...19 2.5 Additional Alarms...19 2.5.1 Size and Weight ...20 2.5.2 Power Supply ...20 2.5.3 Oxygen Supply...20 2.5.4 Environmental Specifications...21

2.6 Standards and Safety Requirements ... 21 2.6.1 Indicators and Icons ...22

Section 3: Installation and Setup ... 23 3.1 Introduction ... 23 3.2 Unpacking The Ventilator... 23 3.3 Connection Of Power Sources ... 23 3.3.1 External Power Sources ...23 3.3.2 Internal Power Pack ...25 3.3.2.1 Internal Power Pack Charging...25 3.3.2.2 Internal Battery Power Level Indicator...25 3.3.3 Electrical Safety Testing...26 3.4 Connecting Alternate Power Sources ... 26 3.4.1 High Pressure Oxygen...26 3.4.2 Low Pressure Oxygen...27 3.5 Patient Circuit and Accessory Connection... 29 3.6 Patient Circuit... 29 3.6.1 Disposable Patient Circuit...30 3.6.2 Reusable Patient Circuit ...31 3.6.3 Dual Limb Patient Circuit ...31 3.6.4 Circuit Resistance...33 3.7 Pre Use Testing... 33 3.8 Filters ... 34 3.8.1 Air Inlet Filter ...34 3.8.1.1 Low Pressure Oxygen Adapter and Filter...34 3.8.1.2 CBRN Filter ...34 3.8.1.3 Bacterial Filter...34 3.9 Ventilator Controls... 37

3.9.1 Rotational Control Knob (Encoder) ...37 3.9.2 Keypad ...37 3.9.3 LED Indicators...38 3.10 Ventilator Operation ...38

Section 4: Theory of Operation ...39 4.1 Overview Of System Operation...39 4.2 Pneumatic System...40 4.2.1 Inlet Filter and Manifold ...45 4.2.2 Oxygen Blending System – PSV Units (iV15000>) ...45 4.2.2.1 O2 Regulator...45 4.2.2.2 O2 Pressure Switch...46 4.2.2.3 O2 Proportional Solenoid Valve...46 4.2.2.4 O2 Flow Sensor ...46 4.2.3 Oxygen Blending System - Stepper Units (<iV14999) ...47 4.2.3.1 Demand Valve...47 4.2.3.2 Proportioning Valve...48 4.2.3.3 Valve Controller...48 4.2.3.4 Valve Limit Switch (O2 Microswitch)...48 4.2.4 Turbine System...49 4.2.5 Solenoid Valve System ...49 4.2.6 O2 Sensor...50 4.2.7 Patient Connector & Outlet Muffler ...51 4.2.8 Cooling Fan ...52 4.2.9 Patient Circuit...52 4.2.9.1 Wye and Flow Sensor ...52 4.2.9.2 Exhalation Valve...52 4.2.9.3 One Way Valve ...53 4.2.9.4 Inspiratory & Expiratory Hold ...53 4.2.9.5 Nebulizer System...54

4.3 Electronic System... 55 4.3.1 Power Entry Module...58 4.3.2 Power Supply PCB ...58 4.3.3 Integrated Power Pack...58 4.3.3.1 Gas Gauge PCB ...58 4.3.4 External DC Supply...59 4.3.5 Switching PCB ...59 4.3.5.1 Switching Block...60 4.3.5.2 RFI Filter Block ...60 4.3.5.3 Protective Devices...61 4.3.5.4 Battery Charger Block...61 4.3.5.5 5V Output DC/DC Converter ...61 4.3.5.6 Power On/ Off Switching...61 4.3.5.7 Status Block ...61 4.3.5.8 Motor Driver...62 4.3.5.9 External DC/DC Converter and External DC Source ...62 4.3.5.10 Auxiliary Power Supplies ...62 4.3.6 CPU PCB...62 4.3.6.1 System Memory ...63 4.3.6.2 BIOS ...63 4.3.6.3 DiskOnChip® ...63 4.3.6.4 RS-232...63 4.3.6.5 Display Driver ...64 4.3.6.6 Keyboard ...64 4.3.6.7 Ethernet...64 4.3.6.8 PC Watchdog ...64 4.3.6.9 Operating System (OS)...64 4.3.7 Main Board...65 4.3.7.1 Sensors Interface ...65 4.3.7.1.1 Flow Sensor...65 4.3.7.1.2 Pressure Sensors ...66 4.3.7.1.3 Oxygen Sensor...66

4.3.7.1.4 Temperature Sensor ...66 4.3.7.1.5 Battery Voltage...66 4.3.7.2 Digital/Analog Interface...66 4.3.7.3 Control and Status...67 4.3.7.4 Motor Interface...67 4.3.7.5 Bus Interface ...67 4.3.7.6 Solenoids Interface ...67 4.3.7.7 Stepper Interface ...68 4.3.7.8 Watchdog Timer ...68 4.3.7.9 Remote Alarm ...68 4.3.8 Zeroing/Purge Board ...69 4.3.9 Hold/Nebulizer Controller PCB ...69 4.3.10 Mounting PCB...69 4.3.11 Switching Board...70 4.3.11.1 Switching Block...71 4.3.11.2 RF Filter Block ...71 4.3.11.3 Protective Devices ...71 4.3.11.4 Battery Charger Block...71 4.3.11.5 5V Output DC/DC Converter ...72 4.3.11.6 Power On/ Off Switching...72 4.3.11.7 Status Block...72 4.3.11.8 Motor Driver...72 4.3.11.9 External DC/DC Converter and External DC Source ...72 4.3.11.10 Auxiliary Power Supplies...73 4.3.12 Power Supply (AC/DC Converter)...73 4.3.12.1 Cooling Fan...73 4.4 LCD Display ...73 4.5 Interface Board ...74

Section 5: Maintenance Menu ...75 5.1 Introduction ...75 5.2 Accessing the Maintenance Menu ...75

5.3 Maintenance Menu... 76 5.4 Calibration Screen ... 76 5.5 Ventilator Verification Test... 76 5.6 Configuration Screen ... 77 5.6.1 Software Version...77 5.6.2 Default Start Screen ...77 5.6.3 Default Start Weight...78 5.6.4 Default FIO2 Setting...78 5.6.5 Serial Number...78 5.6.6 Card Number...79 5.6.7 Sensor Type...79 5.6.8 Package Type ...79 5.7 Service Screen ... 80 5.7.1 Communication Port...80 5.7.2 Communication Rate ...80 5.7.3 Update Software Version ...81 5.7.4 Update Package Key ...81 5.7.5 Reset Battery LMD...82 5.8 Technical Log Book... 83 5.9 Localization ... 84 5.9.1 Language ...85 5.9.2 Date / Interfield Format...85 5.10 Total Operation Hours ... 86

Section 6: Self Tests ... 87 6.1 Introduction ... 87 6.2 Operator Verification Test... 87

6.2.1 O.V.T. Requirements...87 6.2.2 Accessing O.V.T. ...87 6.2.3 O.V.T. Procedure:...87 6.2.4 O.V.T. Technical Description ...89 6.3 Ventilator Verification Test ...91 6.3.1 V.V.T. Requirements ...92 6.3.2 Accessing V.V.T. ...92 6.4 V.V.T. Procedure:...92 6.4.1 V.V.T. Technical Description...98 6.4.1.1 Audible Alarm Tests ...98 6.4.1.2 Pressure Tests ...98 6.4.1.3 Solenoid System Tests...99 6.4.1.4 Flow Tests...100 6.4.1.5 Oxygen Tests at 21% ...100 6.4.1.6 Oxygen Tests at 100% ...101 6.4.1.7 Battery Test ...101 6.4.1.8 Watchdog Tests ...102 6.5 Troubleshooting Self Tests ...102 6.5.1 OVT Tests ...102 6.5.2 VVT Tests...103

Section 7: Calibrations ...107 7.1 Introduction ...107 7.2 Calibration Overview...107 7.3 When To Run Calibration...108 7.4 Calibration Requirements...108 7.5 Accessing Calibration...109 7.6 Calibration Procedures ...109 7.6.1 Zero Sensors Calibration...109

7.6.2 Pressure Sensor Calibration...110 7.6.3 PEEP-RPM Calibration ...112 7.6.4 Flow Sensor Calibration ...114 7.6.5 Volume Calibration ...115 7.6.6 O2 System Calibration ...117 7.6.6.1 Oxygen Calibration on Stepper Units ...117 7.6.6.2 Oxygen Calibration on Proportional Solenoid Units...118 7.6.7 Saving Calibration Data ...120 7.7 Battery Gas Gauge Initialization Procedure ... 121 7.8 Troubleshooting Calibrations ... 122 7.8.1 Calibration Tests ...122 THIS PAGE INTENTIONALL LEFT BLANK ... 124

Section 8: Functional Test Procedure ... 125 8.1 Introduction ... 125 8.2 Notes... 125 8.3 When To Run Tests ... 125 8.4 Test Equipment & Materials ... 126 8.5 Cleaning and Inspection... 126 8.6 Performance Testing ... 127 8.6.1 Electrical Safety Test...127 8.6.1.1 Procedure...128 8.6.2 Oxygen Performance Tests ...129 8.6.2.1 Procedure...129 8.6.2.2 100% O2 (Suction) Test...130 8.6.3 Alarm Tests ...131 8.6.3.1 High Pressure Alarm Test...132 8.6.3.2 Apnea Alarm Test...132 8.6.3.3 Tube Disconnect Alarm...133

8.6.3.4 Patient Disconnect Alarm ...134 8.6.3.5 Sensor Disconnect Alarm...135

Section 9: Planned Maintenance...137 9.1 Introduction ...137 9.2 Cleaning and Routine Planned Maintenance ...137 9.2.1 Cleaning the Ventilator...138 9.3 Planned Maintenance...138 9.3.1 500 Hour PM Procedure...140 9.3.2 1500 Hour PM Procedure...140 9.3.3 Annual PM Procedure ...141 9.3.4 15000 Hour PM Procedure...142 9.4 Storage ...143

Section 10: Software Applications ...145 10.1 Introduction ...145 10.2 Hardware Requirements ...145 10.3 Software Utilities Set Up ...145 10.4 Software Utility Availability ...146 10.5 Technical Error / Event Log Download Utility ...146 10.6 Ventilator Software Upgrade Utility ...149 10.6.1 Installation of Software Update Application...150 10.6.2 Software Update Procedure ...150 10.7 Troubleshooting Communication Problems ...152

Section 11: Service & Repair Procedures...153 11.1 Introduction ...153 11.2 Repair Safety ...153 11.3 Repair Guidelines ...154

11.4 Cleaning... 155 11.5 Electrical Cables and Pneumatic Connections ... 155 11.6 Electro-Static Discharge (E.S.D) Control ... 155 11.6.1 General Information...155 11.6.2 Procedures and Precautions ...156 11.7 Non-Conforming Parts... 156 11.8 Replacement Parts... 157 11.9 Post Repair ... 157 11.10 Repair Documentation... 158 11.11 Patient System and Accessory Devices ... 158 11.12 Recommended Service Tooling and Materials... 158 11.13 Service and Repair Procedures ... 159 11.13.1 Enclosure Disassembly...159 11.13.1.1 Enclosure Assembly...162 11.13.2 Electronic Module Removal and Installation ...163 11.13.2.1 Tools & Equipment ...163 11.13.2.2 Electronic Module Removal...163 11.13.2.3 Electronic Module Installation...165 11.13.3 Pneumatic Unit Removal and Installation ...166 11.13.3.1 Tools & Equipment ...166 11.13.3.2 Pneumatic Unit Removal ...166 11.13.3.3 Pneumatic Unit Installation...168 11.13.4 Power Pack Disassembly and Assembly ...170 11.13.4.1 Tools & Equipment ...170 11.13.4.2 Power Pack Disassembly ...170 11.13.4.3 Power Pack Assembly ...171 11.13.5 O2 Sensor Removal and Installation ...171 11.13.5.1 Tools & Equipment ...172 11.13.5.2 O2 Sensor Removal...172 11.13.5.3 O2 Sensor Installation...173

Section 12: Troubleshooting ...175 12.1 Troubleshooting Guide ...175 12.2 Diagnostics and Repairs...179 12.2.1 Demand Valve...179 12.2.2 Pressure Switch ...181 12.2.3 Root Cause - Pneumatic vs. Electronic...182 12.2.3.1 Isolation of Internal Tube Leak...183 12.2.3.2 Blower Pressure & Exhalation Valve Control ...183 12.2.3.3 Negative (-) Flow Port vs. Positive (+) Flow Port...184 12.2.3.4 Positive (+) Flow Port ...184 12.3 Exhale VT Accuracy ...185 12.3.1 Inhale VT Accuracy...185 12.3.2 Exhale VT Accuracy Interferences ...186 12.3.3 Leakage ...186 12.3.4 Velocity ...186 12.3.5 MAQUET (Siemens 190) Test lung ...187 12.4 Miscellaneous Issues...188 12.4.1 Black Screen ...188 12.4.2 Fails Calibrate Flow Sensor ...188 12.4.3 Erratic O2 Control ...188 12.4.4 Erratic Exhale Tidal Volumes...188 12.4.5 Low Pressure During Calibration or VVT...189 12.5 Setting Up the Ventilator for Static Pressure ...189

Section 13: Spare Parts and Accessories ...191 13.1 Introduction ...191 13.2 Hardware Versions ...191 13.3 Parts Lists ...192

13.3.1 Ventilator Systems and Options...192 13.3.2 Ventilator Accessories...193 13.3.3 Sub-Assemblies ...195 13.3.4 Rear Panel Components ...197 13.3.5 Integrated Battery Components ...198

Appendix A: Ventilator Wiring Diagram ... 201 Appendix B: Installation Check list... 203 Appendix C: Planned Maintenance Check List ... 204 Index... 206

Illustrations Figure 1.1 Front View of the iVent201 ... 3 Figure 3.1 Power connections to iVent201 ... 24 Figure 3.2 The oxygen DISS inlet connector... 27 Figure 3.3Low pressure oxygen connector... 28 Figure 3.4: Patient Circuit Connection... 30 Figure 3.6. Patient Circuit Connections (Breathing Circuit) ... 30 Figure 3.8: iVent201 Filters ... 36 Figure 3.10: Ventilator Controls ... 37 Figure 4.1: Pneumatic Unit – PSV Based System... 41 Figure 4.3: Pneumatic Unit – Stepper Based System ... 42 Figure 4.5 Pneumatic System – PSV Based Units ... 43 Figure 4.6 Pneumatic System – Stepper Based Units ... 44 Figure 4.7 Hold/Nebulizer Mounting... 54 Figure 4.8: Electronic Module... 56 Figure 4.9: Ventilator Overview... 57 Figure 5.1 Main Menu and Confirmation Screens ... 75 Figure 5.2 Maintenance Menu Screen... 76 Figure 5.3, Configuration Screen ... 77 Figure 5.4 Service Screen ... 80 Figure 5.5, Package Key Update Screen ... 82 Figure 5.6 Battery type selection ... 83 Figure 5.7 Confirmation window ... 83 Figure 5.8, Technical Error Log Screen... 84 Figure 5.9, Localization Screen... 85 Figure 6.1, O.V.T. part one ... 88 Figure 6.2 O.V.T part two... 88 Figure 6.3: Initiating V.V.T... 92

Figure 6.4, Pressure Tests ...93 Figure 6.5, Pressure Test Results...94 Figure 6.6: Flow Tests...94 Figure 6.7 O2 Tests (21%) ...95 Figure 6.8, O2 Tests (100%)...95 Figure 6.9, Disconnect AC Power ...96 Figure 6.10, AC Reconnect / Watchdog Test ...97 Figure 6.11, VVT Test Results...97 Figure 7.1, Entering the Calibration Menu ...109 Figure 7.2, Zero Sensors...110 Figure 7.3 Calibrate Pressure Sensors...111 Figure 7.4, Calibrate PEEP-RPM ...113 Figure 7.5: Calibrate Flow Sensor ...114 Figure 7.6 Calibrate Volume ...116 Figure 7.7, O2 system calibration screens (Stepper Units) ...117 Figure 7.8 O2 Calibration Cover...119 Figure 7.9, O2 System Calibration Screens (Proportional Valve Units) ...119 Figure 7.10: Save Calibration ...121 Figure 8.1, Electrical Safety Test Set Up ...128 Figure 8.2, Oxygen performance test setup...129 Figure 8.3: Internal O2 Measurement...130 Figure 8.4: 100% O2 (Suction) Mode...131 Figure 8.5: High Pressure Alarm...132 Figure 8.6: Apnea Alarm...133 Figure 8.7: Tube Disconnect Alarm...134 Figure 8.8: Patient Disconnect Alarm ...135 Figure 9.1: Cooling Vent (left) and Cooling Air Inlet Filter (right) ...141 Figure 10.1, Software utilities cabling setup...146 Figure 10.2, iVDownload Application Window...148 Figure 10.3, Event Log...148 Figure 10.4, Error Log...149

Figure 10.5, Upgrade software version window ...151 Figure 10.6, Upgrade iVent application screens ...151 Figure 11.1 Enclosure (Rear View) # 1...160 Figure 11.2Front Enclosure (Inside View) # 1...161 Figure 11.3 Rear Enclosure (Inside View) # 1 ...161 Figure 11.5 Enclosure (Rear View) # 2...164 Figure 11.8: Rear Enclosure (Inside View) # 2 ...165 Figure 11.10: Rear Enclosure (Inside View) # 3 ...167 Figure 11.12: O2 Mixer Cam to Mid Point Position...168 Figure 11.14: PU Ground Point Locations ...169 Figure 11.16: Power Pack (Rear View)...171 Figure 11.18: Power Pack (Removed) ...171 Figure 11.20 The O2 sensor location on the pneumatic unit...172 Figure 11.21 The Shield holder 3 legs ...173 Figure 12.1: O2 Inlet Pipe and Demand Valve ...181 Figure 12.3: PU Main Connector (Front View) - Pressure Switch Pinout...182 Figure 12.5: Flow Graphs (Occluding the Positive Flow Sensor Port)...185 Figure 12.7: Flow Graphs (High Velocity Exhale)...187 Figure 12.9: Test Lung 190 and iVent201 Waveforms ...187

Tables Table 1-1 Front View of the iVent201 ... 3 Table 1-3 Rear View of the iVent201 ... 5 Table 2-1: Displayed Parameters and Indicators During Ventilation... 17 Table 3-1 The battery indicator ... 26 Table 9-1: Cleaning and Routine Maintenance...137 Table 9-2: Planned Maintenance Schedule ...138 Table 12-1: Troubleshooting Guide...176

Section 1: Introduction 1.1 Intended Use The information within this Manual describes the service, maintenance and test procedures for the iVent201 ventilator system. It is intended to assist in maintaining the optimal functional operation and safety of the device. This Service Manual should only be used by authorized, VersaMed certified, technicians. Should you require further information on becoming a VersaMed certified technician pleased contact your local VersaMed representative. The information within this manual is not intended as a sole source of reference and has been intended for use in conjunction with the iVent 201 Operators Manual (OM-01-04). 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.

IMPORTANT:

THE TECHNICAL INFORMATION WHICH IS SUPPLIED IN THIS MANUAL 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.

M1162065, 2009

1

Introduction

1.2 General Description The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and costlier ventilators. A turbine-powered air source and a rechargeable internal battery provide freedom from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alarm settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of graphical and numerical modes. The iVent201 supports many modes: •

•

Assist/Control •

Volume Controlled A/C

•

Pressure Controlled A/C

Synchronized Intermittent Mandatory Ventilation (SIMV) •

Volume Controlled SIMV (Vctrl SIMV)

•

Pressure Controlled SIMV (Pctrl SIMV)

•

Continuous Positive Airway Pressure (CPAP)

•

Pressure Support Ventilation (PSV)

(Note: Certain modes are optional features and may not be operational in some iVent201 models.) In addition, the iVent201 has these advanced features:

2

• •

Rise time is adjustable Preset Parameters by Patient Weight enables quick setup

•

Adaptive Peak Flow can determine and deliver Inspiratory Peak Flow Rate according to a target mandatory tidal volume, maintaining a 1:2 I:E ratio

•

Adaptive I-Time allows the ventilator to determine and deliver a respiratory cycle time to sustain a 1:2 I:E ratio

•

The iVent201's Adaptive Bi-Level feature enables leaktolerance for facemask ventilation or other specialized high-leak tube ventilation

•

Easy Exhale is an advanced PEEP mode designed to reduce expiratory work of breathing

•

Firmware is upgradeable via a PC connection

M1162065, 2009