Service Manual
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GE Healthcare
MAC™ 1600 ECG Analysis System - Product Code SDE Service Manual Software Version 1.0.4 2028451-183 Revision E
MAC™ 1600 ECG Analysis System English © 2008-2012 General Electric Company. All Rights Reserved.
Publication Information The information in this manual applies only to MAC™ 1600 with product code SDE. Due to continuing product innovation, specifications in this manual are subject to change without notice. Marquette, Archivist, CardioSoft, CASE, Hookup Advisor, MAC, MARS, Mactrode, Multi-Link, MUSE, SilverTRACE, 12SL and BabyMAC are trademarks owned by GE Medical Systems Information Technologies, Inc., a General Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners. ©2008–2011 General Electric Company. All rights reserved. The document part number and revision appear at the bottom of each page. The revision identifies the document’s update level. The revision history of this document is summarized in the following table. Revision History, PN 2028451-183 Revision
Date
A
10 April 2008
B
14 July 2009
Comment Initial release of document.
• Expanded battery replacement procedure.
• Removed unnecessary steps from printhead replacement procedure.
• Modified Parts List for version 1.0.2. C
14 November 2010
Revised to include services disclaimer addendum
D
14 June 2011
Revised to include new software part number.
E
14 February 2012
Revised for v1.0.4. Changed SD card part number
To access other GE Healthcare manuals, go to the Common Documentation Library (CDL), located at http://www.gehealthcare.com/usen/ service/biomed_tech_selfservice/services_user_doc/products/support.html and click Cardiology. To access Original Equipment Manufacturer (OEM) manuals, go to the device manufacturer's Web site.
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Contents
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Introduction Intended User... 7 Indications for Use ... 7 Contraindications ... 7 Prescription Device Statement ... 7 Regulatory and Safety Information... 8 Safety Conventions... 8 Safety Hazards... 8 Parts and Accessories Information... 9 Responsibility of the Manufacturer... 9 Responsibility of the Purchaser/Customer... 9 Symbols... 10
Training ... 13 Equipment Identification... 13 Product Label... 13 Serial Number Format... 14 Product Codes... 14
Service Information... 15 Service Requirements... 15 Additional Assistance... 15
Manual Information ... 15 Intended Audience... 15 Manual Purpose... 15 Document Conventions... 15
Related Documents... 17
2
Equipment Overview Front View ... 19 Side View ... 20 Rear View ... 21 Keyboard ... 22 Keyboard (Stress Option)... 24
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Block Diagram... 26 Hardware/Firmware Architecture... 27
3
Troubleshooting General Fault Isolation... 29 Power Up Self-Test... 29 Poor Quality ECGs... 30 Visual Inspection... 30
Event Logging ... 31 Setting Up Event Logging... 31 Exporting the Event Log... 33
Performing Diagnostic Tests... 33 Accessing the System Diagnostics Function... 33 Testing the Display... 35 Testing the Speaker... 36 Testing the Keyboard... 37 Testing the Acquisition Module... 38 Checking Battery Status... 38 Testing the Writer... 39 Testing the RS232 Port... 42 Testing the LAN Option... 43 Testing the Modem... 44 Testing the USB Port... 45 Testing the Patient Lead Wires... 46
Equipment Problems: ECG Data Noise ... 46 Error Codes ... 47 Acquisition Error Codes... 47 Printer Error Codes... 49
Frequently Asked Questions ... 50 Maintenance... 50 System Setup... 53 Clinical... 55 Navigating the User Interface... 55
4
Maintenance Recommended Maintenance ... 59 Required Tools and Supplies ... 59 FRU Replacement Procedures ... 60 High Level FRU Identification... 60 Preparing System for FRU Replacement... 61 Replacing the Patient Cable... 61 Replacing Barcode Reader or Barcode Reader Cable... 62 Replacing the Paper Tray Assembly... 64 Replacing the Battery... 64 Replacing the Keyboard... 67 Replacing the Display Assembly... 71 Replacing the Internal Modem (Option)... 71 Replacing the Power Supply Assembly... 72 Replacing the Acquisition Board Assembly... 75 Replacing the KISS Pump Assembly (Option)... 77
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Replacing the Printer Assembly... 80 Replacing the Printer Board... 86 Replacing the Printhead... 88 Replacing the Optical Sensors... 92 Replacing the Mainboard/ETE Module Assembly... 94
Functional Checkout ... 99 Visual Inspection... 100 Functional Checkout Procedures... 101
Electrical Safety Checks ... 102 Updating Software... 104 Conditioning The Battery Pack... 106
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Parts Lists Ordering Parts... 109 General Information... 109
Field Replaceable Units (FRUs) ... 110 MAC 1600 Upper Level Assembly, PN 2032093... 110 Power Supply FRU Kit, PN 2035703-001... 117 Mainboard ETE Assembly FRU Kit, PN 2035704-001... 117 Acquisition Assembly FRU Kit, PN 2035705-001... 117 Cable Harness FRU Kit, PN 2035707-001... 117 Display Cover Assembly FRU Kit, PN 2035706-001... 118 Printer Assembly FRU Kit, PN 2035702-001... 118 Paper Tray And Printer Door FRU Kit, PN 2035711-001... 118 Display Assembly FRU Kit, PN 2035700-001... 118 Printer Board Assembly FRU Kit, PN 2036813-001... 119 KISS Pump Assembly FRU Kit, PN 2036814-001... 119 KISS Pump Hardware FRU Kit, PN 2036815-001... 119 Internal Modem FRU Kit, PN 2036816-001... 119 Printhead FRU Kit, PN 2036817-001... 120 Optical Sensor And Bracket FRU Kit, PN 2036818-001... 120 Fastener Hardware FRU Kit, PN 2035708-001... 121 Middle And Base Plastic FRU Kit, PN 2036812-001... 122 Plastics Kit, PN 2035709-001... 122 Keyboards, Non-Stress... 123 Keyboards, Stress... 124 Data Matrix Barcode Scanner Kits... 125 Power Cords... 126
A
Technical Specifications
B
Electromagnetic Compatibility Electromagnetic Compatibility (EMC)... 133 Guidance And Manufacturer’s Declaration - Electromagnetic Emissions... 133 Guidance And Manufacturer’s Declaration - Electromagnetic Immunity... 134 Guidance And Manufacturer's Declaration - Electromagnetic Immunity... 136 Recommended Separation Distances... 137 EMC Exceptions Disclosure... 139
C
EMC-Compliant Supplies & Accessories Introduction ... 141 Standard Accessories... 141
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Value Accessories ... 142 Thermal Papers ... 142 Country-Specific Power Cords... 143 Optional Accessories... 143
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Introduction
This chapter provides general information required for the proper use of the product and the manual. Familiarize yourself with this information before using the product.
Intended User The intended user of this technical information is service representatives and technical personnel so they can maintain the equipment to the assembly level.
Indications for Use The intended use of this device is to record ECG signals from surface ECG electrodes. This device can analyze, record, and store electrocardiographic information from adult and pediatric populations. This data can then be computer analyzed with various algorithms such as interpretive ECG and signal averaging for presentation to the user. This device is intended for use under the direct supervision of a licensed health care practitioner.
Contraindications The MAC 1600 device is NOT intended: • to be used during patient transport, • to be used for intra-cardiac applications, • to be used as a vital signs physiological monitor, or • to provide alarms for Arrhythmia detection. The Arrhythmia detection mode is provided for the convenience of automatic documentation.
Prescription Device Statement CAUTION: United States federal law restricts this device to sale by or on the order of a physician.
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Regulatory and Safety Information This section provides information about the safe use and regulatory compliance of this device. Familiarize yourself with this information and read and understand all instructions before attempting to use this device. The system software is considered medical software. As such, it was designed and manufactured to the appropriate medical regulations and controls. Any exceptions are noted in the Compliance Information - Exceptions section. NOTE: Disregarding the safety information provided is considered abnormal use of this device and could result in injury, loss of data, and void any existing product warranties.
Safety Conventions A Hazard is a source of potential injury to a person, property, or the product. This manual uses the terms DANGER, WARNING, and CAUTION to point out hazards and to designate a degree or level of seriousness. Familiarize yourself with the following definitions and their significance. Definitions of Safety Conventions Safety Convention
Definition
DANGER
Indicates an imminent hazard, which, if not avoided, will result in death or serious injury.
WARNING
Indicates a potential hazard or unsafe practice, which, if not avoided, could result in death or serious injury.
CAUTION
Indicates a potential hazard or unsafe practice, which, if not avoided, could result in minor personal injury or product/property damage.
Safety Hazards The following messages apply to the product as a whole. Specific messages may also appear elsewhere in the manual. DANGER: Do not use in the presence of flammable anesthetics. WARNING: CONNECTION TO MAINS. This is class I equipment. The mains plug must be connected to an appropriately grounded power supply. WARNING: BATTERY OPERATION. If the integrity of the protective earth conductor is in doubt, operate the unit from its battery.
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CAUTION: This equipment contains no user serviceable parts. Refer servicing to qualified service personnel. U.S. Federal law restricts this device to the sale by or on the order of a physician.
Parts and Accessories Information WARNING: PATIENT SAFETY - To ensure patient safety, use only parts and accessories manufactured or recommended by GE Healthcare. Contact GE Healthcare for information before connecting any devices to this equipment that are not recommended in this manual. If the installation of this equipment in the U.S.A. uses 240V rather than 120V, the source must be a center-tapped, 240V, single-phase circuit. Parts and accessories must meet the requirements of the applicable 60601 safety standards, and/or the system configuration must meet the requirements of the 60601-1-1 Medical Electrical Systems standard. Using accessory equipment that does not comply with the equivalent safety requirements of this equipment may lead to a reduced level of safety of the resulting system. Consideration relating to the choice shall include: • Use of the accessory in the Patient Vicinity. Patient vicinity is defined as a space, within a location intended for the examination and treatment of patients, extending 6 ft. (1.83 m) beyond the normal location of the bed, chair, table, treadmill, or other device(s) supporting the patient during examination and treatment, and extending vertically to 8 ft. 2.4 in. (2.5 m) above the floor. • Evidence that the safety certification of the accessory was performed in accordance with the appropriate 60601-1 and/or 60601-1-1 standard(s).
Responsibility of the Manufacturer GE Healthcare is responsible for the effects of safety, reliability, and performance on GE-supplied hardware only if the following conditions are met: • Assembly operations, extensions, readjustments, modifications, or repairs are carried out by persons authorized by GE Healthcare. • The electrical installation of the relevant room complies with the requirements of the appropriate local, state, and other government regulations. • The equipment is used in accordance with the instructions for use.
Responsibility of the Purchaser/Customer The customer is responsible for providing appropriate desks, chairs, electrical wall outlets, network connections, analog phone lines, and for locating any of the system components described in this manual in compliance with all local, state, and national codes.
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Introduction
Symbols The following symbols may appear on the device or its packaging. Familiarity with these symbols assists in the safe use and disposal of the equipment. For equipment symbols not shown, refer to the original equipment manufacturers (OEM) manuals. Defibrillation-proof type BF equipment.
Equipotential ground point
Protective earth terminal
Attention, see instructions for use
Consult instructions for use.
Catalogue (part) number.
Serial number.
For use by or on the order of a physician or persons licensed by state law. (US Only) Date of manufacture.
Manufacturer address.
Environment-friendly Use Period per Chinese standard SJ/T11363-2006 (China specific).
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This way up.
Recyclable.
Atmospheric limits.
Temperature limits.
Humidity limits.
Keep dry.
Fragile.
Do not throw or dispose of in fire.
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Introduction
Indicates the device is classified as type 20 for solid and liquid ingress per IEC/EN 60529. • X = Ingress of solid objects:
•
•
0
non-protected
•
1
>= 50 mm dia
•
2
>=12.5 mm dia
•
3
>=2.5 mm dia
•
4
>=1.0 mm dia
•
5
dustprotected
•
6
dusttight
Y = ingress of liquid
•
0
nonprotected
•
1 vertical dripping
•
2 dripping (15 deg tilted)
•
3 spraying
•
4
splashing
•
5
jetting
•
6
powerful jetting
•
7 temporary immersion
•
8 continuous immersion
Secure Digital (SD) Card.
Batch or lot number. Authorized representative in a European country CCC Mark - China Compulsory Certification mark North American Product Safety Certification. Symbolizes compliance with both Canadian and U.S. applicable requirements. CE marking symbolizing conformity with applicable European Community directives. PCT. GOST marking symbolizing conformity with applicable Russian Gosstandart technical and safety standards.
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Introduction
Training This manual is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the use of the device, you should request training assistance from GE Healthcare. To see available training, go to the GE Healthcare training website (http://www.gehealthcare.com/usen/education/index.html) and select Diagnostic Cardiology under the Technical Service Education section. For more self-paced course offerings, tools, and reference guides you may find useful, please visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.
Equipment Identification Every GE Healthcare device has a product label that identifies the product name, part number, manufacturing information, and unique serial number. This information is required when contacting GE Healthcare for support.
Product Label The product label is laid out in the following format. Depending on the product, the label may vary slightly in format, but it contains the same information.
Product Label Format
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Item
Description
1
Product description
2
Product part number
3
Date of manufacture in YYYY-MM format
4
Device serial number (Refer to “Serial Number Format” on page 14 for more information.
5
Manufacturer name and address
6
Product bar code
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Introduction
Serial Number Format Each device has a serial number that uniquely identifies the device and provides important information about the device. The serial number format is shown in the following illustration:
Serial Number Format Item
Name
Description
1
Product Code
Three-letter code that uniquely identifies the product line. Refer to “Product Codes” on page 14 for more information.
2
Year Manufactured
Two-digit code identifying the year the device was manufactured. Values range from 00 to 99 For example: 00 = 2000, 04 = 2004, 05 = 2005 (and so on).
3
Fiscal Week Manufactured
Two-digit code identifying the week the device was manufactured. Values range from 01 to 52. GE Healthcare's fiscal weeks correspond to the calendar week. For example, 01 = first week in January.
4
Product Sequence
Four-digit number identifying the order in which this device was manufactured. Values range from 000 to 9999.
5
Manufacturing Site
One-letter code identifying the site where the device was manufactured. For example, F = Milwaukee, N = Freiburg, P = Bangalore
6
Miscellaneous Characteristic
For example, P = unit is a prototype, R = unit was refurbished, U = unit was upgraded to meet the specifications of another product code.
Product Codes The product code identifies specific system platforms. You need the product code before servicing or requesting support for your device. You can identify the product code using the serial number listed on the product label located in one of the following places: • On the product label attached to the base the system. • On the product label provided with the application CD. • In the application: • On IT systems: Launch the system application and click Help > About to view the serial number. 14
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For information on launching the application, refer to the product's service or operator's manual. • On MAC systems: On the Service Only Setup window, select System Setup, press Shift+F2, and enter the service password to view the serial number. Contact GE Healthcare support if you do not know the service password.
Service Information This section provides information pertaining to the maintenance and servicing of the device. Familiarize yourself with this information before requesting service from GE Healthcare or its authorized representatives.
Service Requirements Failure on the part of the responsible individual, hospital, or institution using this equipment to implement a satisfactory maintenance schedule may cause undue equipment failure and possible safety hazards. Regular maintenance, irrespective of usage, is essential to ensure that the components of this system are always functional when required.
Additional Assistance GE Healthcare maintains a trained staff of application and technical experts to answer questions and respond to issues and problems that may arise during the installation, maintenance, and use of this product. Contact your local GE Healthcare representative to request additional assistance.
Manual Information This section provides information for the correct use of this manual. Keep this manual with the equipment at all times and periodically review it. You should request training assistance from GE Healthcare, if needed.
Intended Audience This manual is intended for the person who uses, maintains, or troubleshoots this equipment.
Manual Purpose This manual supplies technical information for service representatives and technical personnel so they can maintain the equipment to the assembly level. Use it as a guide for maintenance and electrical repairs considered field repairable. Where necessary the manual identifies additional sources of relevant information and/or technical assistance.
Document Conventions This manual uses the following conventions. 2028451-183E
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Typographical Conventions Convention
Description
Bold Text
Indicates keys on the keyboard, text to enter, or hardware items such as buttons or switches on the equipment.
Italicized-Bold Indicates software terms that identify menu items, buttons or options in Text various windows. CTRL+ESC
Indicates a keyboard operation. A plus (+) sign between the names of two keys indicates that while holding the first key, you should press and release the second key. For example, Press CTRL+ESC means to press and hold the CTRL key and then press and release the ESC key.
<space>
Indicates that you must press the spacebar. When instructions are given for typing a precise text string with one or more spaces, the point where you must press the spacebar is indicated as: <space>. This ensures that the correct number of spaces are inserted in the correct positions within the literal text string. The purpose of the < > brackets is to distinguish the command from the literal text within the string.
Enter
Indicates that you must press the Enter or Return key on the keyboard. Do not type Enter.
>
The greater than symbol, or right angle bracket, is a concise method to indicate a sequence of menu selections. For example, the statement “From the main menu, select System > Setup > Options to open the Option Activation window” replaces the following: 1.
From the main menu, select System to open the System menu.
2.
From the System menu, select Setup to open the Setup menu.
3.
From the Setup menu, select Options to open the Option Activation window.
Illustrations All illustrations in the manual are provided as examples only. Depending on system configuration, screens that appear in the manual may differ from the screens as they appear on your system. All patient names and data are fictitious. Any similarity to actual persons is coincidental.
Notes Notes provide application tips or additional information that, while useful, are not essential to the correct operation of the product. They are called out from the body text through a flag word and indentation, as follows: NOTE: The tip or additional information appears indented below the NOTE flag word.
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Related Documents You can find additional information in the following documents: Documents Related to this manual
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Part Number
Document Title
2028451-182
MAC™ 1600 ECG Analysis System Operator’s Manual
MAC™ 1600
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Introduction
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Equipment Overview
The MAC™ ECG Analysis System is a 12–lead, 12–channel system with a 6.5 inch (165 mm) diagonal display, active patient cable, and battery operation. There are also options for communication capabilities.
Front View
Front View of the System Item
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Name
Description
1
Display
Presents waveform and text data.
2
Power LED
Indicates the unit is plugged in and receiving power.
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Equipment Overview
Front View of the System (cont'd.) Item 3
Name
Description
Battery LED
Indicates various battery states: • Solid amber light indicates the battery is charging. • Flashing amber light indicates the battery is low. • No light indicates the battery is neither charging nor low.
4
Keyboard
Input device for controlling the system or entering data. See “Keyboard” on page 22 for more information.
5
Writer
Prints reports.
Side View
Side View of the System
20
Item
Name
1
ECG signal input connector
D-sub 15-pin female connector for the acquisition cable.
2
KISS connector
Connection port for the optional KISS lead system.
3
Carrying handle
Handle for carrying the device.
MAC™ 1600
Description
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