Service Manual
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GE Healthcare
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite Resting ECG Analysis System Service Manual 5864335-002-2
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite Resting ECG Analysis System English © 2021-2022 General Electric Company All Rights Reserved.
Publication Information
Publication Information This document describes version 1.00 of MAC™ 5 Resting ECG Analysis System, also referred to as the “product” or "system" or "device". It does not apply to earlier product versions. Due to continuing product innovation, specifications in this document are subject to change without notice. MUSE, MAC, MARS, CASE, CardioSoft and 12SL 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. This product complies with the requirements concerning medical devices from the following regulatory bodies.
Date of first CE mark - 2022. The MAC™ 5 Resting ECG Analysis System is intended to be used, under the direct supervision of a licensed healthcare practitioner by trained operators in a hospital or facility providing patient care. This document provides information required for the proper use of the system. Familiarize yourself with this information and read and understand all instructions before attempting to use this system. Keep this document with the Regulatory and Safety manual, and with the equipment at all times, and periodically review it. NOTE: Illustrations in this document are provided as examples only. Depending on system configuration, screens in the document may differ from the screens on your system. Patient names and data are fictitious. Any similarity to actual persons is coincidental. The document part number and revision are on each page of the document. The revision identifies the document’s update level. The revision history of this document is summarized in the following table.
Revision
Date
Comment
1
20 September 2021
Initial Release
2
20 January 2022
Update according to the service validation
Access other GE Healthcare Diagnostic Cardiology documents at the Customer Documentation Portal. Go to https:// www.gehealthcare.com/en/support/support-documentation-library and scroll to the bottom of the page. To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website. Support GE Healthcare maintains a trained staff of application and technical experts to answer questions and to respond to issues and problems that may arise during the installation, maintenance, and use of this product. If you require additional assistance, contact your GE Healthcare representative or GE Healthcare support at one of the following numbers: •
North America: 1-800-558-7044
•
Europe: +49 761 45 43 -0
•
Asia: +86 21 3877 7888
Training This document is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the use of the product, you should request training assistance from GE Healthcare. To see available training, go to the GE Healthcare training website (www.gehealthcare.com/training). Select Education > Product Education-Technical > Diagnostic Cardiology. 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.
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MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Table of Contents Publication Information... 2
1: Product Overview... 14 MAC 5 A4 Hardware Label Locations...14 MAC 5 A5 Hardware Label Locations...18 MAC 5 Lite Hardware Label Locations...23 Certification Information...27 Serial Number Label... 28 Device Address Label and Rating Plate... 29 Symbol Descriptions... 30 Serial Number Format... 34 Front View... 35 Side and Rear View... 36 Bottom View...37
2: Architecture... 39 Hardware and Firmware Architecture... 39 Product Interfaces External Connections...40 Harness Diagram... 41
3: Equipment Setup... 42
Insert the Battery... 42 Connect the AC Power...43 Connect the External Barcode Reader... 44 Adjust the Device for Paper Size... 45 Insert the Paper... 49 Lock and Unlock the Trolley Wheels...52 Attach the Device to the Trolley... 53 Connect the LAN Cable...55 Configure the Device... 55 Test the Device...56
4: Login and Security... 57
User Menu Options Description... 57 Power On the ECG Device... 58 Power Off the ECG Device... 59 User Authentication... 59 Log On to the Device... 61 Log On the Device as a STAT User... 63 Access the Device using a Technician ID...63 Log Out of the Device...63 Change the User Password...64 Activate or Deactivate Privacy Mode... 64 Lock the Device...65 Unlock the Device... 65 Enable and Configure Service User...66 Disable Service User Profile... 67 Configure Service User Role... 68
Access the Service Screen...70 Perform System Reset... 71 Put the Device on Standby...71
5: Service Tasks...73
Service Screen Overview... 73 Enter Chinese Characters... 74 Display Device Information... 74 Configure Device Information... 75 Restore Configuration Data from PSoC...76 Restore to Factory Defaults... 77 Enable the Options... 78 Disable the Options...80 Display Battery Metrics... 81 Format Log Data Partition...84 Format User Data Partition...85 Erase all Device Data... 86 Configure Lead Fail Test Mode...87 Configure Wireless Country of Operation... 88 Print a Service Report... 89
6: Software Upgrade... 91
Upgrade or Downgrade Production Software... 91 Download and Install Manufacturer Software...93
7: Diagnostics... 96 Diagnostics Screen Overview...96 Perform Touchscreen Diagnostics... 96 Perform Battery Charging Diagnostics...98 Perform Battery Discharging Diagnostics... 100 Perform Quick Battery Charge and Discharge Test...102 Perform Barcode Reader Diagnostics... 103 Perform Display Diagnostics...105 Perform Audio Diagnostics... 107 Perform Writer Diagnostics... 108 Perform LAN Diagnostics...114 Perform WLAN Diagnostics... 116 Perform Brightness Diagnostics...119 Perform USB Port Diagnostics... 120 Perform KISS Pump Diagnostics... 122 Perform Keyboard LED Diagnostics... 123 Perform Network Printer Diagnostics...124 View Diagnostic Test Results... 126 Export Diagnostic Test Results to a USB Flash Drive... 127
8: Working with Logs... 129
Audit Logs...129 View the Audit Logs... 129 Export an Audit Log File to a USB Flash Drive... 130 Event Log... 131 View the Event Log...131 Export an Event Log File to a USB Flash Drive...132 Clear the Event Logs...133 View the Transmission Log... 134 Generate the Service Snapshot...135
Export Logs to a USB Flash Drive...135
9: Parts List... 138
Part Identification... 138 Prepare the System for FRU Replacement... 139 Tools... 139 MAC 5 A4: Field Replaceable Parts List...140 MAC 5 A5: Field Replaceable Parts List...143 MAC 5 Lite: Field Replaceable Parts List...146 FRU Lists...148 Top FRU List... 148 Bottom FRU List...151 Miscellaneous FRU List... 155
10: FRU Replacement: Top Subsystem... 158
Battery Door FRU Replacement... 158 Remove the Battery Door...158 Replace the Battery Door...160 KISS Adapter Plug FRU Replacement... 163 Remove the KISS Adapter Plug...163 Replace the KISS Adapter Plug...163 Base Frame FRU Replacement... 164 Remove the Base Frame... 164 Replace the Base Frame...166 Keyboard PWA FRU Replacement...168 Remove the Keyboard PWA... 168 Replace the Keyboard PWA... 169 Display Module Cable FRU Replacement...170 Remove the Display Module Cable...170 Replace the Display Module Cable... 172 Display Unit FRU Replacement... 175 Remove the Display Unit... 175 Replace the Display Unit...176
11: FRU Replacement: Bottom Subsystem...177
Printer Door Button FRU Replacement... 177 Remove the Printer Door Button... 177 Replace the Printer Door Button...178 Printer Door FRU Replacement...179 Remove the Printer Door Shaft Sleeve...179 Replace the Print Door Shaft Sleeve... 180 Remove the Printer Door...181 Replace the Printer Door... 182 Printer Roller FRU Replacement... 183 Remove the Printer Roller... 183 Replace the Printer Roller...183 Printer Sheet Metal FRU Replacement...184 Remove the Printer Sheet Metal... 184 Replace the Printer Sheet Metal... 184 Printer Head FRU Replacement...186 Remove the Printer Head...186 Replacing the Printer Head... 187 Printer Cable FRU Replacement... 187 Remove the Printer Cable... 187 Replace the Printer Cable...188 Main Board FRU Replacement... 188
Remove the Main Board... 188 Replace the Main Board...190 KISS Board with Cable FRU Replacement... 193 Remove the KISS Cable... 194 Replace the KISS Cable... 194 Remove the KISS Board... 195 Replace the KISS Board...196 Ground Metal FRU Replacement...197 Remove the Ground Metal...197 Replace the Ground Metal... 199 Handle FRU Replacement... 201 Remove the Handle...201 Replace the Handle... 204 Paper Spacer FRU Replacement... 207 Remove the Paper Spacer... 207 Replace the Paper Spacer...209 Paper Pull Tab FRU Replacement...210 Remove the Paper Pull Tab... 210 Replace the Paper Pull Tab...212 Bottom FRU Replacement...214 Remove the Bottom... 214 Replace the Bottom...215
12: Functional Checkout...218
Recommended Maintenance...218 Functional Checkout Workflow...218 FRU Repairs... 219 Non-FRU Repairs...220 Visual Inspection [as per IEC62353:2014(subsection 5.2) requirement]... 220 Electrical Safety Checks... 222 Functional Checkout Procedures... 224 Operational Checks... 224 Diagnostic Checks...225
13: Troubleshooting...226 ECG Data Noise... 226 Software Upgrade Errors... 227 Troubleshooting USB Port Failures...229 Troubleshooting LAN Communication Failures...232 Troubleshooting Wireless Communication Failures...233 Troubleshooting Touchscreen Failures... 234 Troubleshooting Printer Door Failures...235 Device Disaster Recovery... 236
Product Overview
1 Product Overview The MAC 5 Resting ECG Analysis System has three modes: • MAC 5 A4 - This mode includes an A4/Letter paper size thermal printer. • MAC 5 A5 - This mode includes an A5 paper size thermal printer. • MAC 5 Lite - This mode does not include a thermal printer. The MAC 5 Resting ECG Analysis System, (referred to as "the device"), supplies 12-lead ECG measurement and interpretative analysis, prints 12-leads of ECG, and transmits ECG data to and from a central ECG cardiovascular information system.
MAC 5 A4 Hardware Label Locations
Table 1: Label Descriptions on the Right Side of the Device
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Item
Label
Description
1
General Warning Symbol
See Symbol Descriptions on page 30 for an explanation of the label.
2
Country-specific Label
Country registration information.
3
Serial Number Label
Device identification. See Serial Number Label on page 28 for a description of the label contents.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Product Overview
Table 2: Label Descriptions on the Back Side of the Device
5864335-002-2
Item
Label
Description
4
TUV and IFU Symbol Label
See Certification Information on page 27 and Symbol Descriptions on page 30 for a description of the label contents.
5
Product and Rating Label
Regulatory and cautionary information. See Device Address Label and Rating Plate on page 29 for an explanation of the label.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
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Product Overview
Table 3: Label Descriptions on the Bottom of the Device Item
Label
Description
6
Option Code and MAC Address Label
The MAC address of the wired network card.
Wireless Label
The wireless registration information.
7
16
Use the option codes to set up the purchased options in your system.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Product Overview
Table 4: Label Descriptions on the Shipping Package of the Device
5864335-002-2
Item
Label
Description
8
Battery Shipping Label
Lithium Ion battery damaged caution label.
9
Shipping Label
Regulatory and safety shipping information.
10
Radio Equipment Directive (RED) Label
The Radio Equipment Directive registration information.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
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Product Overview
Item
Label
Description
11
Battery The battery transportation information. Transportation Label
12
Radio Equipment Directive (RED) European Union Declaration of Conformity Guidance
The Radio Equipment Directive (RED) European Union Declaration of Conformity Guidance.
13
Environmental Symbols
Safety indicators required for shipping. For a full description of symbols, see Symbol Descriptions on page 30.
MAC 5 A5 Hardware Label Locations
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MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Product Overview
Table 5: Label Descriptions on the Right Side of the Device Item
Label
Description
1
General Warning Symbol
See Symbol Descriptions on page 30 for an explanation of the label.
2
Product and Rating Label
Regulatory and cautionary information. See Device Address Label and Rating Plate on page 29 for an explanation of the label.
3
Serial Number Label
Device identification. See Serial Number Label on page 28 for a description of the label contents.
Table 6: Label Descriptions on the Back Side of the Device
5864335-002-2
Item
Label
Description
4
TUV and IFU Symbol Label
See Certification Information on page 27 and Symbol Descriptions on page 30 for a description of the label contents.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
19
Product Overview
Table 7: Label Descriptions on the Bottom of the Device Item
Label
Description
5
Option Code and MAC Address Label
The MAC device address of the device.
Country Specific Label
Country registration information.
6
20
Use the option codes to set up the purchased options in your system.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Product Overview
Item
Label
Description
7
Wireless Label
The wireless registration information.
Table 8: Label Descriptions on the Shipping Package of the Device
5864335-002-2
Item
Label
Description
8
Battery Shipping Label
FRAGILE-Lithium Ion batteries can cause fire if damaged.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
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Product Overview
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Item
Label
Description
9
Shipping Label
Regulatory and safety shipping information.
10
Radio Equipment Directive (RED) Label
The Radio Equipment Directive registration information.
11
Battery The battery transportation information. Transportation Label
12
Radio Equipment Directive (RED) European Union Declaration of Conformity Guidance
Radio Equipment Directive (RED) European Union Declaration of Conformity Guidance.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Product Overview
Item
Label
Description
13
Environmental Symbols
Safety indicators required for shipping. For a full description of symbols, see Symbol Descriptions on page 30.
MAC 5 Lite Hardware Label Locations
Table 9: Label Descriptions on the Right Side of the Device Item
Label
Description
1
General Warning Symbol
See Symbol Descriptions on page 30 for an explanation of the label.
2
Product and Rating Label
Regulatory and cautionary information. See Device Address Label and Rating Plate on page 29 for an explanation of the label.
3
Serial Number Label
Device identification. See Serial Number Label on page 28 for a description of the label contents.
Table 10: Label Descriptions on the Back Side of the Device
5864335-002-2
Item
Label
Description
4
TUV and IFU Symbol Label
See Certification Information on page 27 and Symbol Descriptions on page 30 for a description of the label contents. MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
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Product Overview
Table 11: Label Descriptions on the Left Side of the Device
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Item
Label
Description
5
Country Specific Label
Country registration information.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Product Overview
Table 12: Label Descriptions on the Bottom of the Device Item
Label
Description
6
Option Code and MAC Address Label
The MAC device address of the device.
Wireless Label
The wireless registration information.
7
5864335-002-2
Use the option codes to set up the purchased options in your system.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
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Product Overview
Table 13: Label Descriptions on the Shipping Package of the Device
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Item
Label
Description
8
Battery Shipping Label
FRAGILE-Lithium Ion batteries can cause fire if damaged.
9
Shipping Label
Regulatory and safety shipping information.
10
Radio Equipment Directive (RED) Label
The Radio Equipment Directive registration information.
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
5864335-002-2
Product Overview
Item
Label
Description
11
Battery The battery transportation information. Transportation Label
12
Radio Equipment Directive (RED) European Union Declaration of Conformity Guidance
Radio Equipment Directive (RED) European Union Declaration of Conformity Guidance.
13
Environmental Symbols
Safety indicators required for shipping. For a full description of symbols, see Symbol Descriptions on page 30.
Certification Information Table 14: Certification Information This system bears CE mark 0197 indicating it conforms with the provisions of Council Regulation EU 2017/745 concerning medical devices, and it fulfills the requirements of Annex I of this regulation. The system is in radio-interference protection class B in accordance with EN 55011. The country of manufacture is indicated on the equipment labeling. The product complies with the requirements of standard EN 60601-1-2 “Electromagnetic Compatibility – Medical Electrical Equipment”. The medical device has a lifetime of 7 years with respect to the Council Regulation EU 2017/745 Annex I, Requirement 6. Medical Equipment With respect to electric shock, fire, and mechanical hazards only in accordance with IEC 60601-1, and CAN/CSA C22.2 NO. 601.1.
5864335-002-2
MAC™ 5 A4/MAC™ 5 A5/MAC™ 5 Lite
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