AION™ is a trademark of Artema Medical AB. D-Lite™ is a trademark of GE Medical Systems Information Technologies. DRYLINE™ is a trademark of Artema Medical AB. Gas Module II® is a U.S. registered trademark of Mindray DS USA, Inc. Gas Module SE™ is a U.S. trademark of Mindray DS USA, Inc. Nafion™ is a trademark of Perma Pure Inc. Passport® XG is a U.S. registered trademark of Mindray DS USA, Inc. Passport 2® is a U.S. registered trademark of Mindray DS USA, Inc. Spectrum® is a U.S. registered trademark of Mindray DS USA, Inc. Spectrum OR™ is a U.S. trademark of Mindray DS USA, Inc. Copyright © Mindray DS USA, Inc., 2008. All rights reserved. Contents of this publication may not be reproduced in any form without permission of Mindray DS USA, Inc. 0070-10-0522 Gas Module Service Manual Addendum Table of Contents Introduction....................................................................................................................................................v Warnings, Precautions and Notes.....................................................................................................................vi Warnings......................................................................................................................................................vi Cautions........................................................................................................................................................vii Theory Of Operation.........................................................................................................1 - 1 Gas Sampling System......................................................................................................................................1-2 Water Trap.............................................................................................................................................1-3 Zero Valve and Absorber.........................................................................................................................1-4 Nafion™ Tube.........................................................................................................................................1-4 Gas Analyzers........................................................................................................................................1-4 Sample Flow Differential Pressure Transducer..............................................................................................1-4 Working Pressure Transducer....................................................................................................................1-4 Pneumatic Unit........................................................................................................................................1-4 Connection Block.....................................................................................................................................1-4 Occlusion Valve......................................................................................................................................1-5 Sampling Pump and Damping Chamber.....................................................................................................1-5 Anesthetic Agent Sensor..................................................................................................................................1-6 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................1-6 Gas Module 3........................................................................................................................................1-8 O Sensor.....................................................................................................................................................1-11 2 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................1-11 Gas Module 3........................................................................................................................................1-12 CPU Board.....................................................................................................................................................1-14 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................1-14 Gas Module 3........................................................................................................................................1-15 O Board......................................................................................................................................................1-16 2 Communication Interface Board........................................................................................................................1-17 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................1-17 Gas Module 3........................................................................................................................................1-18 Electrical Wiring Diagram................................................................................................................................1-19 Gas Module 3 Electronics................................................................................................................................1-20 Power Supply.................................................................................................................................................1-22 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................1-22 Gas Module 3........................................................................................................................................1-23 Spirometry (Gas Module SE with Spirometry Only) Overview...............................................................................1-24 Measured Parameters..............................................................................................................................1-24 Measurement Principles............................................................................................................................1-25 PVX Measuring Unit.................................................................................................................................1-25 Specifications....................................................................................................................2 - 1 Performance Specifications..............................................................................................................................2-2 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................2-2 Gas Module 3........................................................................................................................................2-3 Gas Measurements.........................................................................................................................................2-6 Normal Conditions..................................................................................................................................2-6 Non-disturbing Gases..............................................................................................................................2-6 Disturbing Gases.....................................................................................................................................2-7 Gas Module 3 Interference Specifications...................................................................................................2-7 CO ......................................................................................................................................................2-8 2 O .........................................................................................................................................................2-9 2 N O......................................................................................................................................................2-10 2 Anesthetic Agents....................................................................................................................................2-10 Accuracy specifications at conditions exceeding normal...............................................................................2-12 Gas Module Service Manual Addendum 0070-10-0522 i Table of Contents ISO Mode Accuracy specifications for Gas Module 3..................................................................................2-13 Patient Spirometry...........................................................................................................................................2-15 Normal Conditions for Gas Module SE with Spirometry...............................................................................2-15 Accuracy specifications at conditions exceeding normal...............................................................................2-16 Power Input Ratings.........................................................................................................................................2-17 Environmental Conditions.................................................................................................................................2-17 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................2-17 Gas Module 3........................................................................................................................................2-17 Physical Characteristics...................................................................................................................................2-18 Gas Module II.........................................................................................................................................2-18 Gas Module SE.......................................................................................................................................2-18 Gas Module 3........................................................................................................................................2-18 Agency Compliance........................................................................................................................................2-18 Gas Module II.........................................................................................................................................2-18 Gas Module SE.......................................................................................................................................2-19 Gas Module 3........................................................................................................................................2-19 Repair Information...........................................................................................................3 - 1 Introduction....................................................................................................................................................3-1 Safety Precautions...........................................................................................................................................3-2 Troubleshooting..............................................................................................................................................3-2 General Troubleshooting Guidelines..........................................................................................................3-2 Gas Module Technical Troubleshooting......................................................................................................3-3 Patient Spirometry Trouble Shooting...........................................................................................................3-6 Exchange Program..................................................................................................................................3-7 Equipment and Special Tools Required..............................................................................................................3-8 Disassembly Instructions...................................................................................................................................3-9 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................3-9 Gas Module 3........................................................................................................................................3-12 Mounting Hardware and Accessories................................................................................................................3-13 Passport XG/Gas Module Mounting..........................................................................................................3-13 Expert/Gas Module Mounting...................................................................................................................3-15 Passport 2/Spectrum/Spectrum OR Gas Module Mounting..........................................................................3-17 Gas Module II/Gas Module SE Accessories.......................................................................................................3-21 Gas Module SE with Spirometry Accessories......................................................................................................3-22 Gas Module 3 Accessories..............................................................................................................................3-23 Replacement Parts............................................................................................................4 - 1 Introduction....................................................................................................................................................4-1 Available Replacement Parts and Sub-Assemblies...............................................................................................4-1 Exchange Program..........................................................................................................................................4-2 Replacement Parts Pricing Information...............................................................................................................4-2 Ordering Information......................................................................................................................................4-3 Abbreviations.................................................................................................................................................4-4 Isometric Drawing and Parts Lists......................................................................................................................4-5 Calibration.......................................................................................................................5 - 1 Introduction....................................................................................................................................................5-1 Warnings and Guidelines................................................................................................................................5-1 Test Equipment and Special Tools Required........................................................................................................5-2 Power-Up Verification......................................................................................................................................5-2 Passport XG Configuration for Gas Module................................................................................................5-2 Expert Configuration for Gas Module.........................................................................................................5-3 Passport 2/Spectrum/Spectrum OR Configuration for the GasModule..........................................................5-4 Gas Module 3 Pneumatic Leakage Test..............................................................................................................5-5 ii 0070-10-0522 Gas Module Service Manual Addendum Table of Contents Gas Module 3 Zero Reference Valve Test..........................................................................................................5-5 Calibration.....................................................................................................................................................5-6 Passport XG Gas Calibration....................................................................................................................5-6 Expert Gas Module Calibration.................................................................................................................5-8 Gas Monitor Calibration - Passport 2/Spectrum/Spectrum OR......................................................................5-10 Power Supply PC Board Calibration..........................................................................................................5-16 Patient Spirometry Calibration Measurement (Spectrum OR only)...................................................................5-18 Patient Spirometry Leak Test Verification (Spectrum OR Only)........................................................................5-20 Gas Module Leakage Current Checks................................................................................................................5-21 Preventive Maintenance....................................................................................................6 - 1 Preventive Maintenance Introduction.................................................................................................................6-1 Preventive Maintenance Schedule.....................................................................................................................6-1 Performance Verification..................................................................................................................................6-2 Perform as required, or at 6 month intervals................................................................................................6-2 Perform as required, or 1 Year intervals.....................................................................................................6-2 Patient Spirometry Leak Test Verification (Spectrum OR Only)........................................................................6-2 Mechanical / Physical / Visual Inspection.........................................................................................................6-2 Perform at 6 month intervals......................................................................................................................6-2 Consumable Item Replacement.........................................................................................................................6-2 Replace at 1 month intervals.....................................................................................................................6-2 Replace at 2 month intervals.....................................................................................................................6-2 Replace at 12 month intervals...................................................................................................................6-2 Replace at 24 month intervals...................................................................................................................6-3 Internal Adjustments/Calibration.......................................................................................................................6-3 Perform at 12 month intervals or as required...............................................................................................6-3 Patient Spirometry Calibration Measurement (Spectrum OR only)...................................................................6-3 Care and Cleaning of Gas Module...................................................................................................................6-4 Gas Module II, Gas Module SE, and Gas Module SE with Spirometry...........................................................6-4 Gas Module 3........................................................................................................................................6-5 Gas Module Service Manual Addendum 0070-10-0522 iii Table of Contents This page intentionally left blank. iv 0070-10-0522 Gas Module Service Manual Addendum Introduction Introduction Introduction The Gas Module is a companion to several Patient Monitors. It is capable of automatically identifying and measuring five anesthetic agents (Desflurane, Enflurane, Sevoflurane, Halothane and Isoflurane), as well as N O, CO and O . The unit monitors all gases via 2 2 2 sidestream sampling. The following models are referenced in this manual: Gas Module II, Gas Module SE, Gas Module SE with Spirometry, and Gas Module 3. When information is common to all models, the generic name “Gas Module” is used. Information that is unique to a specific model is identified accordingly. The system connects to the Patient Monitor via an RS232 connector. A special “Y” shaped power cord is used to supply AC voltage to both the Gas Module and the Monitor power supply. All Gas Module data displays on the monitor screen. All user commands are entered on the monitor and then electronically transmitted to the Gas Module. This addendum provides Gas Module information on theory of operation, specifications, repair, parts, calibration and preventive maintenance. For related information on the Patient Monitor, refer to the associated Service Manual and Operating Instructions. (cid:129) Passport XG Operating Instructions (cid:129) Passport 2 Operating Instructions (Domestic) (cid:129) Passport 2 Operating Instructions (International) (cid:129) Expert Operating Instructions (Domestic) (cid:129) Spectrum Operating Instructions (Worldwide) (cid:129) Spectrum OR Operating Instructions (Worldwide) NOTE: The Gas Module SE with Spirometry can only be used with the Spectrum OR monitor. NOTE: The Gas Module 3 can only be used with Passport 2, Spectrum, and Spectrum OR monitors. WARNING: Calibration gas is considered Dangerous Goods/Hazardous Materials per I.A.T.A. and D.O.T. Regulations. It is a violation of federal and international law to offer any package or over pack of dangerous goods for transportation without the package being appropriately identified, packed, marked, classified, labeled and documented according to D.O.T. and I.A.T.A. regulations. Please refer to the applicable I.A.T.A. Dangerous Goods Regulations and/or the Code of Federal Regulations 49 (Transportation, Parts 171-180) for further information. Gas Module Service Manual Addendum 0070-10-0522 v Introduction Warnings, Precautions and Notes Warnings, Precautions and Notes Please read and adhere to all warnings, precautions and notes listed here and in the appropriate areas throughout this manual. A WARNING is provided to alert the user to potential serious outcomes (death, injury, or serious adverse events) to the patient or the user. A CAUTION is provided to alert the user to use special care necessary for the safe and effective use of the device. They may include actions to be taken to avoid effects on patients or users that may not be potentially life threatening or result in serious injury, but about which the user should be aware. Cautions are also provided to alert the user to adverse effects on this device of use or misuse and the care necessary to avoid such effects. A NOTE is provided when additional general information is applicable. Warnings WARNING: Always Remove Power from the Gas Module BEFORE Disassembly. WARNING: Remove Power from the Gas Module BEFORE removing the Enclosure. WARNING: If the water trap breaks or becomes damaged during operation, there is a risk that bacteria and/or mucus may contaminate the Gas Module. WARNING: The airway adapter and sampling line are intended for single use only. WARNING: The water trap, sampling line, and airway adapter should be disposed of in accordance with local regulations for contaminated and biologically hazardous items. WARNING: To avoid high sampling flow with the Gas Module 3, do not use Adult/Pediatric water traps and/or sampling lines with neonates. WARNING: Connect only approved gas sampling lines to the water trap. WARNING: The Gas Module must not be used with flammable anesthetic agents. WARNING: The use of gas sampling accessories other than specified may cause significant measurement errors and patient risk. WARNING: With the Gas Module 3, use only Neonate sampling lines and water traps for Neonate patients. Do not use Neonate sampling lines and water traps for Adult/Pediatric patients. WARNING: Do not allow the sampling tubing to become kinked. WARNING: Do not reuse disposable devices. vi 0070-10-0522 Gas Module Service Manual Addendum Cautions Introduction WARNING: Trace Gas Hazard – When using the optional Gas Module, a health hazard exists when trace amounts of vaporized anesthetic agents are chronically inspired by operating room personnel. See Appendix A in NFPA 56A on Inhalation Anesthetics. During any procedure where such agents are employed, the Gas Module exhaust output should be connected to a medical gas-scavenging system. WARNING: When monitoring CO , connection from the exhaust port to 2 the hospital’s waste gas-scavenging system is recommended to prevent exposure of hospital personnel to the patient’s respiratory sample. WARNING: Connection of the Gas Module exhaust port to the hospital’s waste gas-scavenging system is recommended to prevent exposure of hospital personnel to the patient’s respiratory sample. Vacuum (negative pressure) should not exceed 1 mmHg at the Gas Module exhaust fitting. Excessive scavenge vacuum may result in damage to the Gas Module’s internal pump. WARNING: Equipment not suitable for use in the presence of a flammable anesthetic mixture with air or with nitrogen or nitrous oxide. WARNING: Do not connect devices that are not specified as part of the system. WARNING: Do not clean the Gas Module while it is on and/or pluggedin. WARNING: The contents of the water trap should be handled as a potential infection hazard. Cautions CAUTION: The internal sampling system of the Gas Module does not need to be cleaned or sterilized. There is no reverse flow back to the patient. If the internal sampling system is suspected to be clogged or dirty, the module should be serviced by an authorized service person only. CAUTION: If the dust filter for the fan cannot be cleaned or is damaged, replace it with part number 0378-00-0040. Use of another type of filter may decrease the cooling effectivity and cause damage to the Gas Module. CAUTION: Do not disinfect or open the water trap. Do not touch the water trap membrane. CAUTION: Dispose of the water trap in accordance with hospital policy. Gas Module Service Manual Addendum 0070-10-0522 vii Introduction Cautions This page intentionally left blank. viii 0070-10-0522 Gas Module Service Manual Addendum Theory Of Operation 1.0 Contents of this chapter....................................................................Page 1.1 Gas Sampling System ............................................................... 1-2 1.2 Anesthetic Agent Sensor ........................................................... 1-6 1.3 O2 Sensor ................................................................................ 1-11 1.4 CPU Board ................................................................................ 1-14 1.5 O2 Board ................................................................................. 1-16 1.6 Communication Interface Board ................................................ 1-17 1.7 Electrical Wiring Diagram ......................................................... 1-19 1.9 Power Supply ........................................................................... 1-22 1.10 Spirometry (Gas Module SE with Spirometry Only) Overview . 1-24 This Theory of Operation section provides block diagrams, a functional overview of the main components and the gas sampling / measurement principle for the Gas Module. The Gas Module consists of the following main components: (cid:129) Gas Sampling System (cid:129) Anesthetic Agent Sensor (cid:129) O Sensor 2 (cid:129) CPU Board (cid:129) O Board 2 (cid:129) Communications Interface Board (cid:129) Power Supply (cid:129) Spirometry Module (PVX unit) (cid:129) Water Trap (cid:129) Internal Tubing Gas Module Service Manual Addendum 0070-10-0522 1 - 1