GE MAC 800 User manual

Operator's Manual
2031504-182 Revision F
GE Healthcare
MAC™ 800
Resting ECG Analysis System
Software Version 1

T-2 MAC™ 800 Resting ECG Analysis System 2031504-182F
24 July 2009
© 2008-2009 General Electric Company. All rights reserved.
Archivist, CardioSoft, CASE, Hookup Advisor, MAC, Mactrode, Multi-Link, MUSESilverTRACE, and 12SL
are trademarks owned by GE Medical Systems Information Technologies, a division of General Electric Company going
to market as GE Healthcare. All other marks are not owned by GE and are instead owned by their respective
owners.
NOTE
This manual applies to the MAC™ 800 Resting ECG Analysis System, software version 1. Due to
continuing product innovation, specifications in this manual are subject to change without notice.
This product complies with regulatory requirements of the following European Directive 93/42/EEC
concerning medical devices.

2031504-182F MAC™ 800 Resting ECG Analysis System i
Contents
1 Introduction
Manual Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Product References . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Illustrations and Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Safety Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
NRTL Certification Mark . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Legal Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-11
Recording ECGs During Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-11
Accuracy Of the Input Signal Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
Modulating Effects in Digital Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
Installation and Connection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
Parts and Accessories . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-12
Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-13
Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Product Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-16
2 Equipment Overview
Equipment Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Bottom View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Keyboard Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Acquisition Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Leadwire Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Carrying Handle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Setting Up the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-8
Inserting the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Connecting the AC Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Connecting Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10

ii MAC™ 800 Resting ECG Analysis System 2031504-182F
Inserting Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Connecting a Magnetic Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Connecting the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Connecting the Optional Internal Modem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Connecting to a LAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Connecting an External Laser Printer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Turning on the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Configuring the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Testing the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
System Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
Start Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-13
Using the MAC 800 Keyboard. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-13
3 Preparing the Patient
Prepare the Patient’s Skin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Applying Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Standard 12 Lead Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
NEHB Lead Placement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
4 Entering Patient Information
Entering Patient Information Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Entering Patient Information with a Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . 4-3
Entering Patient Information with a Magnetic Card Reader . . . . . . . . . . . . . . . . . . 4-4
5 Recording a Resting ECG
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-2
Resting ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Recording a Resting ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-3
ECG Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-4
Post-Acquisition Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-6
Generating a Rhythm Report (Manual recording) . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
ECG Reanalysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
Reanalyzing an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Reanalysis Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
Reanalysis Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-11
Hookup Advisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Special Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-13

2031504-182F MAC™ 800 Resting ECG Analysis System iii
Recording ECGs of Pacemaker Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13
Recording ECGs during Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-14
6 Arrhythmia Mode Recording
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Arrhythmia Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Printing an Arrhythmia Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-2
Arrhythmia Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
Printing Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
Arrhythmia Codes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . 6-5
7 RR Analysis
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
RR Analysis Mode. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Printing an RR Analysis Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-2
RR Analysis Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Waveform Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Output Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-5
RR Analysis Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-5
8 Managing Internal Storage
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-2
Importing Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Printing the File Manager Directory . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Finding Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Editing Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-5
Deleting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-6
Printing Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Transmitting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-7
Exporting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-8
Setting Up Export Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9
Exporting Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-9
PDF File Naming Convention . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-11

iv MAC™ 800 Resting ECG Analysis System 2031504-182F
9 System Configuration
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Setup Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Basic Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2
Resting ECG Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Arrhythmia Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-12
Communication Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-13
Country Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-17
Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-18
User Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-21
Options Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-23
Service Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-24
Date/Time Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-24
Setup Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-25
Print Setup Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-25
Select Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-26
Export Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-27
Import Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-27
Exporting Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-28
10 Maintenance
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
MAC 800 Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
Inspecting the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-3
Cleaning the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Cable and Leadwire Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Sanitizing Cables and Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Storing Cables and Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
Replacing Leadwire Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-7
Paper Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-8
Replacing Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
Storing Thermal Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-9
Battery Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-9
Battery Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
Conditioning the MAC 800 Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-11
Supplies and accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-12
A Troubleshooting
General Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2

2031504-182F MAC™ 800 Resting ECG Analysis System v
Equipment Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
System Will Not Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
ECG Data Contains Noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
ACI-TIPI Statement is Not Included on Report . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Paper Jams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
SD Card Not Present . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Cannot Import or Transmit Records Via Modem . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Cannot Export to Shared Directories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
System Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
B Creating Barcodes
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Setting up the Patient Data Scheme . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-2
Configuring the Barcode Reader. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
Configuring the Barcode Reader Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
Configuring the Barcode Reader Automatically . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
C Magnetic Card Reader Configuration
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Understanding the Data Header . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-2
Configuring the Magnetic Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
Index

vi MAC™ 800 Resting ECG Analysis System 2031504-182F

2031504-182F MAC™ 800 Resting ECG Analysis System 1-1
1Introduction

1-2 MAC™ 800 Resting ECG Analysis System 2031504-182F
Introduction
Manual Information
Purpose
This manual describes the safe and effective operation of the MAC™ 800
Resting ECG Analysis System.
Intended Audience
This manual is written for clinical professionals who use, maintain, and/
or troubleshoot the MAC™ 800 Resting ECG Analysis System. Clinical
professionals are expected to have a working knowledge of appropriate
medical procedures, practices, and terminology used in the treatment of
patients.
Revision History
The document part number and revision appear at the bottom of each
page. The revision identifies the document’s update level.
Revision History, PN 2031504-182
Revision Date Comment
A 11 July 2008 Initial release of document.
B 15 August 2008 Revised document assembly instructions.
C 10 October 2008 Various changes per validation results.
D 5 December 2008 Various changes per pilot site feedback.
E 12 January 2009 Add High-Frequency Device warning.
F 24 July 2009 Updated SD Card information
Corrected part number for LAN Option
Installation and Troubleshooting Guide
Updated European address on back
cover
Updated Equipment Symbols

Introduction
2031504-182F MAC™ 800 Resting ECG Analysis System 1-3
Conventions
The following conventions are used throughout this manual.
Product References
The name of the product described in this manual is MAC 800 ECG
Analysis System. It will be referred to as “the system” or “the device”
throughout this document.
Illustrations and Names
All illustrations in this manual are provided as examples only. They may
not necessarily reflect your system’s setup or the data on your system.
In this manual, all names appearing in examples and illustrations are
fictitious. The use of any real person’s name is purely coincidental.
Safety Information
Safety Messages
The terms danger, warning, and caution are used throughout this
manual to point out hazards and to designate a degree or level of
seriousness.
Definitions
Familiarize yourself with the safety message definitions and
significance.
Hazard is defined as a source of potential injury to a person.
Bold Indicates keys on the keyboard, text to be entered, or hardware items
such as buttons or switches on the equipment.
Italics Indicates software terms that identify menu items, buttons, or
options in various windows.
[Key1] + [Key2] Indicates a keyboard operation. A (+) sign between the names of two
keysindicatesthatyoumustpressandholdthefirstkey while pressing
the second key once.
For example, “Press Ctrl +Esc” means to press and hold down the
Ctrl key while pressing the Esc key.
Enter Indicates you must press the “Enter”or “Return” key on the keyboard.
Do not type “enter”.

1-4 MAC™ 800 Resting ECG Analysis System 2031504-182F
Introduction
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.
NOTE provides application tips or other useful information to assure
that you get the most from your equipment.
Applicable Messages
The following safety information applies to the MAC 800 ECG Analysis
System.
WARNING
ACCIDENTAL SPILLS — If liquids have entered a
device, take it out of service and have it checked by a
service technician before it is used again.
To avoid electric shock or device malfunction liquids must
not be allowed to enter the device.
WARNING
BATTERY OPERATION — If the integrity of the
protective earth conductor is in doubt, operate the unit
from its battery.
WARNING
STRANGULATION — To avoid possible strangulation,
route all cables away from patient's throat.
WARNING
CONNECTION TO MAINS — This is class I equipment.
The mains plug must be connected to an appropriately
grounded power supply.
WARNING
RF INTERFERENCE — Known RF sources, such as cell
phones, radio or TV stations, and two-way radios, may
cause unexpected or adverse operation of this device
Consult qualified personnel regarding system installation.

Introduction
2031504-182F MAC™ 800 Resting ECG Analysis System 1-5
WARNING
DEFIBRILLATOR PRECAUTIONS — Do not come into
contact with patients during defibrillation. Otherwise,
serious injury or death could result.
Patient signal inputs labeled with the CF symbol with
paddles are protected against damage resulting from
defibrillation voltages.
To ensure proper defibrillator protection, use only
GE-recommended cables and leadwires.
Proper placement of defibrillator paddles in relation to the
electrodes is required to ensure successful defibrillation.
WARNING
ELECTRODES — Polarizing electrodes (stainless steel
or silver constructed) may cause the electrodes to retain a
residual charge after defibrillation. A residual charge will
block acquisition of the ECG signal.
Whenever patient defibrillation is a possibility, use non-
polarizing (silver/silver chloride construction) electrodes
for ECG monitoring.
WARNING
MAGNETIC AND ELECTRICAL INTERFERENCE —
Magnetic and electrical fields are capable of interfering
with the proper performance of the device.
For this reason make sure that all external devices
operated in the vicinity of the device comply with the
relevant EMC requirements. X-ray equipment or MRI
devices are possible sources of interference as they may
emit higher levels of electromagnetic radiation.
WARNING
EXPLOSION HAZARD — Do NOT use in the presence
of flammable anesthetics vapors or liquids.
WARNING
INTERPRETATION HAZARD — Computerized
interpretation is only significant when used in conjunction
with clinical findings.
A qualified physician must overread all computer-
generated tracings.

1-6 MAC™ 800 Resting ECG Analysis System 2031504-182F
Introduction
WARNING
OPERATOR — Medical technical equipment such as this
system must only be used by qualified and trained
personnel.
WARNING
SHOCK HAZARD — Improper use of this device
presents a shock hazard. Strictly observe the following
warnings. Failure to do so may endanger the lives of the
patient, the user, and bystanders.
When disconnecting the device from the power line,
remove the plug from the wall outlet first, before
disconnecting the cable from the device; otherwise, there
is a risk of coming in contact with line voltage by
inadvertently introducing metal parts in the sockets of the
power cord.
Devices may be connected to other devices or to parts of
systems only after making certain that there is no danger
to the patient, the operators, or the environment as a
result. Standards IEC 60601-1-1/EN60601-1-1 must be
complied with in all cases.
WARNING
DROPPING HAZARD — For devices installed above the
patient, adequate precautions must be taken to prevent
them from dropping on the patient.
WARNING
PACKAGING DISPOSAL — Dispose of all packaging
material, observing all applicable waste control
regulations and keeping out of children’s reach.
WARNING
ELECTRIC SHOCK — To reduce the risk of electric
shock, do NOT remove cover (or back).
Refer servicing to qualified personnel.

Introduction
2031504-182F MAC™ 800 Resting ECG Analysis System 1-7
WARNING
BURN PROTECTION — To ensure defibrillator
protection and protection against high-frequency burns,
use only GE-recommended cables and leadwires.
Otherwise, serious injury could result.
WARNING
HIGH-FREQUENCY PRECAUTIONS — Do not use the
device with high-frequency surgical units.
CAUTION
ACCESSORIES (SUPPLIES) — To ensure patient
safety, use only parts and accessories manufactured or
recommended by GE.
Parts and accessories used must meet the requirements of
the applicable IEC 60601 series safety standards and
essential performance standards, and/or the system
configuration must meet the requirements of the IEC
60601-1-1 medical electrical systems standard.
CAUTION
PROPER LEADWIRE CONNECTION — Improper
connection will cause inaccuracies in the ECG.
Trace each individual leadwire from its acquisition
module label to the colored connector and then to the
proper electrode to ensure that it is matched to the correct
label location.
CAUTION
TRIPPING HAZARD — To avoid tripping injuries, keep
patient cables off the floor and route them away from
patient legs and the healthcare provider’s work area.

1-8 MAC™ 800 Resting ECG Analysis System 2031504-182F
Introduction
CAUTION
ACCESSORIES (EQUIPMENT) — The use of accessory
equipment not complying 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; and
Evidence that the safety certification of the accessory has
been performed in accordance to the appropriate IEC
60601-1 and/or IEC 60601-1-1 harmonized national
standard.
CAUTION
BEFORE INSTALLATION — Compatibility is critical to
safe and effective use of this device. Please contact your
local sales or service representative prior to installation to
verify equipment compatibility.
CAUTION
DISPOSABLES — Disposable devices are intended for
single use only. They should not be reused as performance
may degrade or contamination could occur.
CAUTION
PRODUCT DISPOSAL — At the end of its service life,
the product described in this manual, as well as its
accessories, must be disposed of in compliance with local,
state, or federal guidelines regulating the disposal of such
products.
If you have questions concerning disposal of the product,
please contact GE or its representatives.
CAUTION
EQUIPMENT DAMAGE — Devices intended for
emergency application must not be exposed to low
temperatures during storage and transport to avoid
moisture condensation at the application site.
Wait until all moisture has vaporized before using the
device.

Introduction
2031504-182F MAC™ 800 Resting ECG Analysis System 1-9
CAUTION
OPERATOR — Medical technical equipment such as
this electrocardiograph system must only be used by
persons who have received adequate training in the use of
such equipment and who are capable of applying it
properly.
CAUTION
POWER REQUIREMENTS — Before connecting 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's label. If this is not the case, do not
connect the system to the power line until you adjust the
unit to match the power source.
In the U.S.A., if the installation of this equipment will use
240V rather than 120V, the source must be a center-
tapped, 240V, single-phase circuit.
This equipment is suitable for connection to public mains
as defined in CISPR 11.
CAUTION
RESTRICTED SALE — U.S. federal law restricts this
device to sale by or on the order of a physician.
CAUTION
SERVICEABLE PARTS — This equipment contains no
user serviceable parts. Refer servicing to qualified service
personnel.
CAUTION
SUPERVISED USE — This equipment is intended for
use under the direct supervision of a licensed health care
practitioner.
CAUTION
EQUIPMENT CONFIGURATION — The equipment or
system should not be used adjacent to, or stacked with
other equipment.
If adjacent or stacked use is necessary, test the equipment
or system to verify normal operation.

1-10 MAC™ 800 Resting ECG Analysis System 2031504-182F
Introduction
Classification
The unit is classified, according to IEC 60601-1, as follows:
NRTL Certification Mark
Biocompatibility
The parts of the product described in this operator’s manual, including
all accessories, that come in contact with the patient during the intended
use, fulfill the biocompatibility requirements of the applicable standards.
If you have questions in this matter, please contact GE or its
representatives.
Legal Notice
Our equipment contains several fields which can be filled in before
performing an ECG. While some of these fields are required, some are
optional and left to the user to assess whether they are needed to
perform the exam. A field RACE is one of these optional fields. It has
been acknowledged by the medical profession as useful to analyze some
Type of protection against
electrical shock Class I, internally powered equipment
Degree of protection
against electrical shock Type CF defibrillation-proof applied part
Degree of protection
against harmful ingress of
water
Ordinary Equipment (enclosed equipment without
protection against ingress of water).
Degree of safety of
application in the presence
of a flammable anesthetic
mixture with air or with
oxygen or nitrous oxide
Equipment not suitable for use in the presence of a
flammable anesthetic mixture with air or with oxygen or
nitrous oxide
Method(s) of sterilization or
disinfection recommended
by the manufacturer
Not applicable
Mode of operation Continuous operation
Medical Equipment
With respect to electric shock, fire and mechanical
hazards only in accordance with UL 60601-1, and
CAN/CSA C22.2 NO. 601.1.

Introduction
2031504-182F MAC™ 800 Resting ECG Analysis System 1-11
pathologies. You should be aware that, in some jurisdictions, the
processing of data revealing an individual’s racial origin is subject to
legal requirements, such as obtaining the patient’s prior consent. If you
elect to collect this type of data, it is your responsibility to ensure that
you comply with all applicable legal requirements.
Responsibility of the Manufacturer
GE is responsible for the effects of safety, reliability, and performance
only if:
Assembly operations, extensions, readjustments, modifications, or
repairs are carried out by persons authorized by GE.
The electrical installation of the relevant room complies with the
requirements of the appropriate regulations.
The equipment is used in accordance with the instructions for use.
General Information
Recording ECGs During Defibrillation
It is not necessary to remove the ECG electrodes prior to defibrillation;
the patient signal is defibrilation-proof.
Use silver-silver chloride electrodes. A defibrillator discharge may cause
stainless steel or silver electrodes to retain a residual charge, which
could cause a polarization that will block the acquisition of the ECG
signal for several minutes.
We recommend using non-polarizing disposable electrodes with
defibrillation recovery ratings as specified in AAMI EC 12.3.2.2.4
(SilverTRACE family of electrodes). AAMI EC12 requires that the
polarization potential of an electrode pair does not exceed 100 mV
5 seconds after a defibrillation discharge.
If other electrodes are used, disconnect the patient cable from the system
before delivering the defibrillation shock.
NOTE
If excessive DC voltages are present at the electrode, then a message
will appear indicating a Lead Off condition.
ADS (cubic spline correction) can cause a signal delay of approximately 2
seconds; therefore they should be disabled if the patient has to be
defibrillated while the ECG is being recorded.

1-12 MAC™ 800 Resting ECG Analysis System 2031504-182F
Introduction
Accuracy Of the Input Signal Reproduction
Overall System Error is tested using the method described in
AAMI EC11 3.2.7.1. Overall System Error is less than +/-5%.
Frequency Response is tested using the method described in
AAMI EC11 3.2.7.2 methods A and D.
Modulating Effects in Digital Systems
This device uses digital sampling techniques that may produce some
variation in amplitudes of Q, R, and/or S waves from one heart beat to
the next, which may be particularly noticeable in pediatric recordings. If
this phenomenon is observed, the clinician should be aware that the
origin of amplitude variations is not entirely physiologic. For measuring
voltages of Q, R, and S waves, it is advisable to use the QRS complexes
with the largest deflection of the particular waves.
Installation and Connection
If the installation of this equipment, in the USA, will use 240 V rather
than 120 V, the source must be a center-tapped, 240 V, single-phase
circuit.
Contact GE for information before connecting any devices to this
equipment not recommended in this manual.
Parts and Accessories
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE. Browse to www.gehealthcare.com to obtain
information about GE-recommended supplies and accessories.
Parts and accessories used must meet the requirements of the applicable
IEC 601 series safety standards, and/or the system configuration must
meet the requirements of the IEC 60601-1-1 medical electrical systems
standard.
The use of ACCESSORY equipment not complying 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; and
evidence that the safety certification of the ACCESSORY has been
performed in accordance to the appropriate IEC 60601-1 and/or IEC
60601-1-1 harmonized national standard.