MAC 7 Service Manual Rev 2 Sept 2021

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. 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

1

23 February 2021

Initial Release

2

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. 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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MAC™ 7 Resting ECG Analysis System

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Table of Contents Publication Information... 2

1: Product Overview... 14 Serial Number Label... 14 Serial Number Format... 15 Front View... 16 Side and Rear View... 17

2: Architecture... 19 Hardware and Firmware Architecture... 19 Product Interfaces External Connections...20 Harness Diagram... 21

3: Equipment Setup... 22

Insert the Battery... 22 Connect the AC Power...23 Connect the External Barcode Reader... 25 Lock and Unlock the Trolley Wheels...26 Attach the Device to the Trolley... 27 Adjust the Paper Tray for Paper Size...28 Insert the Paper... 30

4: Login and Security... 33

User Menu Options Description... 33 Power On the ECG Device... 35 Power Off the ECG Device... 36 User Authentication... 36 Log On to the Device... 38 Log Out of the Device...39 Lock the Device...40 Unlock the Device... 40 Change the User Password...40 Enable and Configure Service User...41 Disable Service User Profile... 44 Configure Service User Role... 46 Access the Service Screen...49 Perform System Reset... 50

5: Service Tasks...52

Service Screen Overview... 52 Enter Chinese Characters... 53 Display Device Information... 53 Configure Device Information... 53 Restore Configuration Data from PSoC...54 Restore to Factory Defaults... 55 Enable the Options... 57 Disable the Options...58

Display Battery Metrics... 59 Format Log Data Partition...62 Format User Data Partition...63 Erase all Device Data... 64 Configure Lead Fail Test Mode...65 Configure Wireless Country of Operation... 66 Print a Service Report... 67

6: Software Upgrade... 69

Upgrade or Downgrade Production Software... 69 Download and Install Manufacturer Software...71

7: Diagnostics... 74 Diagnostics Screen Overview...74 Perform Touchscreen Diagnostics... 74 Perform Battery Charging Diagnostics...76 Perform Battery Discharging Diagnostics...78 Perform Quick Battery Charge and Discharge Test... 80 Perform Barcode Reader Diagnostics...81 Perform Display Diagnostics...83 Perform Audio Diagnostics...85 Perform Writer Diagnostics...86 Perform LAN Diagnostics... 92 Perform WLAN Diagnostics...94 Perform Brightness Diagnostics...97 Perform USB Port Diagnostics... 97 Perform KISS Pump Diagnostics...98 Perform Keyboard LED Diagnostics... 99 View Diagnostic Test Results... 100 Export Diagnostic Test Results to a USB Flash Drive... 101

8: Working with Logs... 103

Audit Logs...103 View the Audit Logs... 103 Export an Audit Log File to a USB Flash Drive... 104 Event Log... 105 View the Event Log...105 Export an Event Log File to a USB Flash Drive...106 Clear the Event Logs...107 View the Transmission Log... 108 Generate the Service Snapshot...109 Export Logs to a USB Flash Drive...109

9: Parts List... 112

Part Identification... 112 Prepare the System for FRU Replacement... 113 Tools... 113 Top Subsystem: Field Replaceable Parts List... 114 Printer Subsystem: Field Replaceable Parts List...115 Base Subsystem: Field Replaceable Parts List... 116 FRU Lists...117 Top FRU List... 117 Printer FRU List... 119 Base FRU List...121 Miscellaneous FRU List... 124

10: FRU Replacement: Top Subsystem... 126

Top Cover Assembly FRU Replacement...126 Remove the Top Cover Assembly...126 Replace the Top Cover Assembly... 128 Keyboard PWA FRU Replacement...130 Remove the Keyboard PWA... 130 Replace the Keyboard PWA... 130 Display Module Cable FRU Replacement...132 Remove the Display Module Cable...132 Replace the Display Module Cable... 134 Display Unit FRU Replacement... 136 Remove the Display Unit... 136 Replace the Display Unit...136

11: FRU Replacement: Printer Subsystem...139

Printer Roller FRU Replacement... 139 Remove the Printer Roller... 139 Replace the Printer Roller...140 Paper Spacer FRU Replacement... 141 Remove the Paper Spacer... 141 Replace the Paper Spacer...142 Paper Tray FRU Replacement... 143 Remove the Paper Tray...144 Replace the Paper Tray... 144

12: FRU Replacement: Base Subsystem... 147

Antenna FRU Replacement...147 Remove the Antenna...147 Replace the Antenna... 148 WLAN Module FRU Replacement... 149 Remove the WLAN Module...150 Replace the WLAN Module...150 Heatsink FRU Replacement... 151 Remove the CPU Thermal Plate Assembly...152 Replace the CPU Thermal Plate Assembly... 152 Remove the Battery Charge Heatsink...153 Replace the Battery Charge Heatsink... 154 CPU Module FRU Replacement...155 Remove the CPU Module...156 Replace the CPU Module... 156 ACDC Module FRU Replacement...159 Remove the ACDC Module...160 Replace the ACDC Module... 160 Cable Kit FRU Replacement...161 Remove the AC Inlet Cable...161 Replace the AC Inlet Cable... 163 Remove the DC Power Cable... 165 Replace the DC Power Cable...166 Remove the Printer Cable... 166 Replace the Printer Cable...167 Printer Head FRU Replacement...167 Remove the Printer Head...167 Replace the Printer Head... 169 Printer Brush FRU Replacement...171 Remove the Printer Brush... 171

Replace the Printer Brush... 173 Carrier Board FRU Replacement... 175 Remove the Carrier Board PWA...175 Replace the Carrier Board PWA... 177 Ground Metal FRU Replacement...181 Remove the Ground Metal...181 Replace the Ground Metal... 182 Battery Spring FRU Replacement... 183 Remove the Battery String...183 Replace the Battery String...184 Battery Door FRU Replacement... 186 Remove the Battery Door...186 Replace the Battery Door...187 Base Frame FRU Replacement... 188 Remove the Base Frame... 188 Replace the Base Frame...190

13: Functional Checkout...193

Recommended Maintenance...193 Functional Checkout Workflow...193 FRU Repairs... 194 Non-FRU Repairs...195 Visual Inspection [as per IEC62353:2014(subsection 5.2) requirement]... 195 Electrical Safety Checks... 197 Functional Checkout Procedures... 199 Operational Checks... 200 Diagnostic Checks...200

14: Troubleshooting...202 ECG Data Noise... 202 Software Upgrade Errors... 203 Troubleshooting USB Port Failures...205 Troubleshooting LAN Communication Failures...207 Troubleshooting Wireless Communication Failures...209 Troubleshooting Touchscreen Failures... 211 Troubleshooting Printer Door Failures...212 Device Disaster Recovery... 214

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.

Serial Number Label The serial number label is in the format as follows:

Table 1: Serial Number Label Format

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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

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Product Overview

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 2: 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.

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.

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Product Overview

Front View

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.

3

Power on LED

Shows if the device is on or off.

4

16

Battery 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.

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Product Overview

Item

Name

Description

5

AC Power LED

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

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.

•

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.

3

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USB Slot A

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.

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Product Overview

18

Item

Name

Description

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 3: 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 4: 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

20

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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Equipment Setup

Table 5: Power Cord Parts Item

Description

1

Female end of the device power cord connected to the back of the device.

2

Male end of the device power cord connected to an AC outlet.

NOTE: Before you connect the device to the power line, check that the voltage and frequency ratings of the power line are the same as those indicated on the unit label. If this is not the case, do not connect the system to the power line until you adjust the power source to match the unit power requirements. 1.

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Connect the female end of the power cord (1) to the AC power connector on the back of the device.

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Equipment Setup

2.

Plug the male end of the power cord (2) into an AC outlet. NOTE: It is recommended that you connect the device into an uninterruptible power supply (UPS) or a surge suppressor.

3.

Check the AC Power LED. If the AC Power LED is green, the device is receiving power from the AC outlet.

Connect the External Barcode Reader If you purchase the optional barcode reader with the device, connect it to the USB port on the device. NOTE: The BRCD - External Barcode Reader option is activated at the factory when you purchase the barcode reader with the device. Configure the barcode settings for your site before you use the barcode reader.

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Equipment Setup

Table 6: Barcode Reader Parts Item

Description

1

Barcode reader

2

Barcode reader holder

3

Barcode reader cable connected to the USB slot

1.

Insert the barcode reader cable connector (3) into the USB slot of the device. Make sure that the cable is seated securely.

2.

If you have a trolley, place the barcode reader (1) in the barcode reader holder (2) attached to the trolley. Refer to the Compact Trolley Reference Manual.

Lock and Unlock the Trolley Wheels 1.

To lock each trolley wheel, press the wheel brake down. Lock the wheels before each use for safety purposes.

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Equipment Setup

2.

To unlock the trolley wheel, push the wheel brake up.

Attach the Device to the Trolley

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1.

Apply a pair of dual locks onto the rectangular groove (1) of the trolley top plate.

2.

Apply a pair of dual locks onto the rectangular groove (2) at the bottom of the MAC 7 device.

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