Service Manual
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GE Healthcare
MAC™ 7 Resting ECG Analysis System Service Manual Version 1
2109599-002D
MAC™ 7 Resting ECG Analysis System Service Manual English © 2020-2021 General Electric Company All Rights Reserved.
Publication Information
Publication Information This document describes version 1.00 of MAC™ 7 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. 12SL, CASE, CardioSoft, InSite ExC, MAC, MACCRA, MARS, MUSE, Marquette, MobileLink, and MULTI-LINK 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 - 2020. For more information about compliance, refer to the Regulatory and Safety Manual for this product. 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
A
15 April 2020
Initial Release
B
3 July 2020
Update legal manufacturer and registration information
C
8 September 2020
Add product left side view image
D
12 September 2021
Update according to Service team's comments
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. This document describes the MAC™ 7 Resting ECG Analysis System, also referred to as the” product”, “system”, or “device”. This document is intended to be used by an operator of the MAC™ 7 Resting ECG Analysis system. The MAC™ 7 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. 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. 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.
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MAC™ 7 Resting ECG Analysis System
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Publication Information
To see available training, go to the GE Healthcare training website www.gehealthcare.com/training. For more self-paced course offerings, tools, and reference guides you may find useful, visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.
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Table of Contents Publication Information... 2
1: Product Overview... 15 Hardware Label Locations...15 Serial Number Label... 18 Serial Number Format... 19 Front View... 20 Side and Rear View... 21
2: Architecture... 23 Hardware and Firmware Architecture... 23 Product Interfaces External Connections...24 Harness Diagram... 25
3: Equipment Setup... 26
Insert the Battery... 26 Connect the AC Power...27 Connect the External Barcode Reader... 29 Lock and Unlock the Trolley Wheels...30 Attach the Device to the Trolley... 31 Adjust the Paper Tray for Paper Size...32 Insert the Paper... 34
4: Login and Security... 37
User Menu Options Description... 37 Power On the ECG Device... 39 Power Off the ECG Device... 40 User Authentication... 40 Log On to the Device... 42 Log Out of the Device...43 Lock the Device...44 Unlock the Device... 44 Change the User Password...44 Enable and Configure Service User...45 Disable Service User Profile... 48 Configure Service User Role... 50 Access the Service Screen...53 Perform System Reset... 54
5: Service Tasks...56
Service Screen Overview... 56 Enter Chinese Characters... 57 Display Device Information... 57 Configure Device Information... 58 Restore Configuration Data from PSoC...59 Restore to Factory Defaults... 60 Enable the Options... 61
Disable the Options...63 Display Battery Metrics... 64 Format Log Data Partition...66 Format User Data Partition...67 Erase all Device Data... 68 Configure Lead Fail Test Mode...70 Configure Wireless Country of Operation... 71 Print a Service Report... 72
6: Software Upgrade... 74
Upgrade or Downgrade Production Software... 74 Download and Install Manufacturer Software...76
7: Diagnostics... 79 Diagnostics Screen Overview...79 Perform Touchscreen Diagnostics... 79 Perform Battery Charging Diagnostics...81 Perform Battery Discharging Diagnostics...83 Perform Quick Battery Charge and Discharge Test... 85 Perform Barcode Reader Diagnostics...86 Perform Display Diagnostics...88 Perform Audio Diagnostics...90 Perform Writer Diagnostics...91 Perform LAN Diagnostics... 97 Perform WLAN Diagnostics...99 Perform Brightness Diagnostics...102 Perform USB Port Diagnostics... 102 Perform KISS Pump Diagnostics... 103 Perform Keyboard LED Diagnostics... 104 View Diagnostic Test Results... 105 Export Diagnostic Test Results to a USB Flash Drive... 106
8: Working with Logs... 108
Audit Logs...108 View the Audit Logs... 108 Export an Audit Log File to a USB Flash Drive... 109 Event Log... 110 View the Event Log...110 Export an Event Log File to a USB Flash Drive...111 Clear the Event Logs...112 View the Transmission Log... 113 Generate the Service Snapshot...114 Export Logs to a USB Flash Drive...114
9: Parts List... 117
Part Identification... 117 Prepare the System for FRU Replacement... 118 Tools... 118 Top Subsystem: Field Replaceable Parts List... 119 Printer Subsystem: Field Replaceable Parts List...120 Base Subsystem: Field Replaceable Parts List... 121 FRU Lists...122 Top FRU List... 122 Printer FRU List... 124 Base FRU List...126
Miscellaneous FRU List... 129
10: FRU Replacement: Top Subsystem... 131
Top Cover Assembly FRU Replacement...131 Remove the Top Cover Assembly...131 Replace the Top Cover Assembly... 133 Keyboard PWA FRU Replacement...135 Remove the Keyboard PWA... 135 Replace the Keyboard PWA... 135 Display Module Cable FRU Replacement...137 Remove the Display Module Cable...137 Replace the Display Module Cable... 139 Display Unit FRU Replacement... 141 Remove the Display Unit... 141 Replace the Display Unit...141
11: FRU Replacement: Printer Subsystem...144
Printer Roller FRU Replacement... 144 Remove the Printer Roller... 144 Replace the Printer Roller...145 Paper Spacer FRU Replacement... 146 Remove the Paper Spacer... 146 Replace the Paper Spacer...147 Paper Tray FRU Replacement... 148 Remove the Paper Tray...149 Replace the Paper Tray... 149
12: FRU Replacement: Base Subsystem... 152
Antenna FRU Replacement...152 Remove the Antenna...152 Replace the Antenna... 153 WLAN Module FRU Replacement... 154 Remove the WLAN Module...155 Replace the WLAN Module...155 Heatsink FRU Replacement... 156 Remove the CPU Thermal Plate Assembly...157 Replace the CPU Thermal Plate Assembly... 157 Remove the Battery Charge Heatsink...158 Replace the Battery Charge Heatsink... 159 CPU Module FRU Replacement...160 Remove the CPU Module...161 Replace the CPU Module... 161 ACDC Module FRU Replacement...164 Remove the ACDC Module...165 Replace the ACDC Module... 165 Cable Kit FRU Replacement...166 Remove the AC Inlet Cable...166 Replace the AC Inlet Cable... 168 Remove the DC Power Cable... 170 Replace the DC Power Cable...171 Remove the Printer Cable... 171 Replace the Printer Cable...172 Printer Head FRU Replacement...172 Remove the Printer Head...172 Replace the Printer Head... 174 Printer Brush FRU Replacement...176
Remove the Printer Brush... 176 Replace the Printer Brush... 178 Carrier Board FRU Replacement... 180 Remove the Carrier Board PWA...180 Replace the Carrier Board PWA... 182 Ground Metal FRU Replacement...186 Remove the Ground Metal...186 Replace the Ground Metal... 187 Battery Spring FRU Replacement... 188 Remove the Battery String...188 Replace the Battery String...189 Battery Door FRU Replacement... 191 Remove the Battery Door...191 Replace the Battery Door...192 Base Frame FRU Replacement... 193 Remove the Base Frame... 193 Replace the Base Frame...195
13: Functional Checkout...198
Recommended Maintenance...198 Functional Checkout Workflow...198 FRU Repairs... 199 Non-FRU Repairs...200 Visual Inspection [as per IEC62353:2014(subsection 5.2) requirement]... 200 Electrical Safety Checks... 202 Functional Checkout Procedures... 204 Operational Checks... 205 Diagnostic Checks...205
14: Troubleshooting...207 ECG Data Noise... 207 Software Upgrade Errors... 208 Troubleshooting USB Port Failures...210 Troubleshooting LAN Communication Failures...212 Troubleshooting Wireless Communication Failures...214 Troubleshooting Touchscreen Failures... 216 Troubleshooting Printer Door Failures...217 Device Disaster Recovery... 219
Product Overview
1 Product Overview The MAC 7 Resting ECG Analysis System, (referred to as "the device" throughout this document), 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.
Hardware Label Locations The illustrations and tables in this section describe the labels and their location on your device and its packaging.
Table 1: Label Descriptions on the Device and Packaging
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Item
Label
Location
Description
1
Product and Rating Label
Back of the device
Regulatory and cautionary information. See Device Address Label and Rating Plate for an explanation of the label.
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Product Overview
Table 2: Label Descriptions on the Device and Packaging
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Item
Label
Location
Description
2
Country-specific Label
Right side of the Country registration information. device
3
Serial Number Label
Right side of the Device identification. See Serial Number Label on page device 18 for a description of the label contents.
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Product Overview
Table 3: Label Descriptions on the Device and Packaging
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Item
Label
Location
Description
4
MAC device Address Label
Bottom of the device
The MAC device address of the device.
5
Option Code Label
Bottom of the device
Use the option codes to set up the purchased options in your system.
6
Wireless Label
Bottom of the device
The wireless registration information.
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Product Overview
Table 4: Label Descriptions on the Device and Packaging Item
Label
Location
Description
7
Radio Equipment Directive (RED) Label
On the shipping package
The Radio Equipment Directive registration information.
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Shipping Label
On the shipping package
Regulatory and safety shipping information.
9
Battery Shipping On the shipping Label package
FRAGILE-Lithium Ion batteries can cause fire if damaged.
10
Environmental Symbols
Safety indicators required for shipping. For a full description of symbols, see Symbol Descriptions.
On the shipping package
Serial Number Label The serial number label is in the format as follows:
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Product Overview
Table 5: Serial Number Label Format Item
Description
1
Product Part Number
2
Product Model
3
Date of Manufacture in YYYY-MM-DD Format
4
Country of Origin
5
Device Serial Number
6
UDI Barcode
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 illustration below:
Table 6: Serial Number Format
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Item
Name
Description
1
Product Code
A three-character code that uniquely identifies the product line.
2
Year Manufactured
A two-digit code identifying the year the device was manufactured. Values range from 00 to 99. For example: 00 = 2000, 04 = 2004, 17 = 2017 (and so on).
3
Fiscal Week Manufactured
A 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 = the first week in January. MAC™ 7 Resting ECG Analysis System
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Product Overview
Item
Name
Description
4
Product Sequence
A four-digit number identifying the order in which this device was manufactured. Values range from 0001 to 9999.
5
Manufacturing Site
A one-letter code identifying the site where the device was manufactured. For example, F = Milwaukee, N = Freiburg, P = Bangalore, W = Wuxi, H = Helsinki, S = Mexico
6
Miscellaneous Characteristic
A one-letter code identifying manufacturing status. For example, P = the device is a prototype, R = the device was refurbished, U = the device was upgraded to meet the specifications of another product code, A = device is in production.
Item
Name
Description
1
Display and Touchscreen
Displays waveform and text data. The touchscreen enables you to interact directly with the device through touch gestures.
2
Power button
Turns the device on or off.
Front View
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Product Overview
Item
Name
Description
3
Power on LED
Shows if the device is on or off.
4
5
Battery LED
AC Power LED
•
Green light - on.
•
No light - off.
•
Flashing green light - standby mode.
Battery status: •
Flashing amber light at two-second intervals - battery is charging.
•
Flashing amber light at a one-second interval - battery is critically low.
•
Flashing amber light at a half-second interval - battery has a communication failure.
•
No light - battery is fully charged, not installed, or discharging.
AC power status: •
Green light - the device is plugged in and receiving power.
•
No light - the device is not plugged into AC power.
Side and Rear View
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Item
Name
Description
1
ECG Patient Cable Connector
D-sub 15–pin female connector for the acquisition cable.
2
USB Slot B
•
Used to connect a USB flash drive or USB cable. You can connect a USB flash drive for a software update, backup/restore or export operations, or a barcode reader USB cable.
•
Standard USB connector for USB devices, for example, the external barcode reader, USB memory stick, USB keyboard and USB mouse.
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Product Overview
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Item
Name
Description
3
USB Slot A
•
Used to connect a USB flash drive or USB cable. You can connect a USB flash drive for a software update, backup/restore or export operations, or a barcode reader USB cable.
•
Standard USB connector for USB devices, for example, the external barcode reader, USB memory stick, USB keyboard and USB mouse.
4
KISS Pump Connector
Used to connect a KISS pump cable.
5
Ethernet/LAN Port
Used to connect an Ethernet cable.
6
Battery Compartment
Used to insert the battery.
7
Equipotential Grounding Plug
Used to connect non-grounded peripheral devices.
8
Label
Product label.
9
AC Power Inlet
Used to connect the AC power cord.
Item
Name
Description
10
Printer Door
Used to pull out the paper tray.
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Architecture
2 Architecture Hardware and Firmware Architecture The diagram below illustrates the system architecture of the device:
Table 7: Subsystem Components
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Component
Description
CPU Board
The software application, settings and data run on the main CPU Board located on the Module ROM07420 Qseven. The CPU interfaces with all peripherals through the Carrier Board.
Carrier board
All the peripherals, such as the display, touchscreen, LAN, Wireless, USB ports, Printer, Battery and KISS Pump are interfaced and controlled by the CPU through the Carrier board. MAC™ 7 Resting ECG Analysis System
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Architecture
Component
Description
Display Module
The display is a 10.1–inch diagonal graphics LED backlight display with P-CAP multipoint touch input, 1024 x 800 resolution, and interfaced to the Carrier Board through the LVDS interface cable. The Display module also contains: - the system on/off button - the LED indicators used for battery status - AC mains
Power Supply
The power inlet connector interfaces with the AD/DC module. The AC/DC is a 100 Watt power supply accepting a wide input AC voltage and delivering 24 DC to the Carrier Board.
Thermal Printer
The printer has an A4/Letter thermal printhead, motor, paper sensors, and door sensor.
KISS Pump
A KISS pump is powered by the Carrier Board. The suction connector is next to the patient connector in the assembly.
Product Interfaces External Connections Table 8: Product Interfaces External Connections Type of Port
Number Description of Ports
RJ45 port
1
Connects to an ethernet network using a 10/100/1000Base-T Ethernet connector.
USB connector
2
Connects to USB-capable devices, for example, the barcode reader, the wireless dongle, or external USB storage devices. The external USB storage device is used for:
DIN connector
24
1
•
Storing ECGs
•
Flashing the device with software updates
•
Connecting memory or future I/O extensions
Connects to a KISS Pump system.
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Architecture
Harness Diagram
Callout
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Description
1
AC Inlet to AC/DC Module Cable
2
AC/DC Module to Carrier Board Cable
3
Thermal Printer to Carrier Board Cable
4
Carrier Board to Display Module Cable
Parts Included In FRU Description
FRU Part Number
MAC 7 FRU Internal Cables
2105959-001-S
MAC 7 FRU Display Module Cable
2105951-001-S
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Equipment Setup
3 Equipment Setup Insert the Battery The device is shipped with one lithium ion battery with minimum charge. Fully charge the battery before you use the device for the first time. Use the device on AC power while the battery is charging.
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1.
Place your thumb on the door release tab of the battery compartment door and gently pull it open.
2.
Slide the battery into the battery compartment slots in the correct orientation and direction indicated by the arrow.
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Equipment Setup
3.
Lift the battery compartment door to close it.
Connect the AC Power This device can run with AC or battery power. When the device is plugged into an AC outlet, it uses AC power and charges the installed battery. NOTE: If the integrity of the protective earth conductor is in doubt, operate the unit from its battery.
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