GE MAC 1600 User manual

Operator's Manual
2028451-182 Revision B
GE Healthcare
MAC™ 1600
ECG Analysis System
Software Version 1.0

T-2 MAC™1600 2028451-182B
25 April 2008
NOTE
This manual applies MAC™ 1600 software version 1.0.
This product complies with regulatory requirements of the following European Directive 93/42/EEC
concerning medical devices.
Archivist, CardioSoft, CASE, Hookup Advisor, MAC, Mactrode, Multi-Link, MUSE, SilverTRACE, and 12SL
are trademarks owned by General Electric Company. All other marks are not owned by GE and are instead
owned by their respective owners.
©2008 General Electric Company. All rights reserved.

2028451-182B MAC™1600 i
Contents
1 Introduction
Manual Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-2
Product References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Illustrations and Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Safety Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Safety Messages. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
Underwriters Laboratories, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-9
Biocompatibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Legal Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-10
Indications of Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-10
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .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 Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-15
Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
Equipment Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-15
2 Equipment Overview
Equipment Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-2
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-2
Side View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Keyboard Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Acquisition Modules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Leadwire Adapters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-7
Setting Up the Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-7
Inserting the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Connecting the AC Power Adapter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Connecting Leadwires . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9

ii MAC™1600 2028451-182B
Inserting Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Connecting the Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Connecting the Optional Internal Modem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Connecting to an External Modem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Connecting to a LAN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Connecting External Devices (Stress Option) . . . . . . . . . . . . . . . . . . . . . . . . . . .2-10
Turning on the System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Configuring the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
Testing the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-11
System Description. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Start Up Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Using the MAC 1600 Keyboard. . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
3 Preparing the Patient
Prepare the Patient’s Skin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2
Applying the Electrodes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Resting ECG Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-4
Stress ECG Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-6
4 Entering Patient Information
Entering Patient Information Manually . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Entering Patient Information with a Barcode Reader . . . . . . . . . . . . . . . . . . . . . . . 4-3
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) . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
ECG Reanalysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-8
Reanalyzing an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-8
Reanalysis Layout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-9
Reanalysis Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-10
Hookup Advisor Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Special Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-12
Recording ECGs of Pacemaker Patients . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13
Recording ECGs during Defibrillation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-13

2028451-182B MAC™1600 iii
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 Stress Testing
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Stress Mode Interface. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Stress Test Information Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-3
Stress Test Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-5
Stress Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .7-6
Conducting Stress Tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Conducting a Stress Test with a Treadmill or Ergometer . . . . . . . . . . . . . . . . . . . .7-8
Conducting a Stress Test with a Master’s Step Device . . . . . . . . . . . . . . . . . . . .7-11
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
9 System Configuration
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2
Setup Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-2

iv MAC™1600 2028451-182B
Basic Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-2
Resting ECG Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-6
Arrhythmia Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-12
Stress ECG Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-13
Communication Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-19
Country Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-23
Patient Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-24
User Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-27
Options Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-29
Service Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-30
Date/Time Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-31
Setup Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-31
Print Setup Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-31
Select Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-32
Export Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-33
Import Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-34
Exporting Audit Trail . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-34
10 Maintenance
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-2
MAC 1600 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
Adjusting the Paper Tray for Paper Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-9
Storing Thermal Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-10
Battery Maintenance. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-11
Battery Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-12
Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-12
Conditioning the MAC 1600 Battery Pack . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-13
Supplies and Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-14
A Troubleshooting
General Troubleshooting Tips . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
Equipment Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-2
System Will Not Power Up . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3

2028451-182B MAC™1600 v
ECG Data Contains Noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
ACI-TIPI Statement is Not Included on Report . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
No BP Readings from Ergoline 900 Ergometer . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
External Device Does Not Move . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Paper Jams . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
SD Card Not Present . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-5
Cannot Import or Transmit Records Via Modem . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Cannot Export to Shared Directories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
System Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-7
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
Index

vi MAC™1600 2028451-182B

2028451-182B MAC™1600 1-1
1Introduction

1-2 MAC™1600 2028451-182B
Introduction
Manual Information
Purpose
This manual describes the safe and effective operation of the MAC™
1600 .
Intended Audience
This manual is written for clinical professionals who use, maintain, and/
or troubleshoot the MAC™ 1600 . 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.
Conventions
The following conventions are used throughout this manual.
Revision History, PN 2028451-182
Revision Date Comment
A 29 February 2008 Initial release of document.
B 25 April 2008 Corrected the duration of the battery’s
normal operation from 4 hours to 3.
Bold Indicateskeysonthekeyboard,text tobeentered,or hardware itemssuch
as buttons or switches on the equipment.
Italics Indicates software terms that identify menu items, buttons, or options in
various windows.
Ctrl + Esc Indicatesakeyboard operation. A(+) sign betweenthe names oftwo keys
indicates that you must press and hold the first key 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”.

Introduction
2028451-182B MAC™1600 1-3
Product References
The name of the product described in this manual is MAC 1600 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.
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 1600 ECG Analysis
System.

1-4 MAC™1600 2028451-182B
Introduction
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
CABLES — 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.
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 and BF
symbols with paddles are protected against damage
resulting from defibrillation voltages.
To ensure proper defibrillator protection, use only the
recommended cables and leadwires.
Proper placement of defibrillator paddles in relation to the
electrodes is required to ensure successful defibrillation.

Introduction
2028451-182B MAC™1600 1-5
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.
WARNING
OPERATOR — Medical technical equipment such as this
system must only be used by qualified and trained
personnel.

1-6 MAC™1600 2028451-182B
Introduction
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
SITE REQUIREMENTS — Do not route cables in a way
that they may present a stumbling hazard.
For safety reasons, all connectors for patient cables and
leadwires are designed to prevent inadvertent
disconnection, should someone pull on them.
For devices installed above the patient, adequate
precautions must be taken to prevent them from dropping
on the patient.
WARNING
TREADMILLS — Avoid rapid changes in treadmill
speed and/or grade during a stress test.
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.

Introduction
2028451-182B MAC™1600 1-7
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
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.

1-8 MAC™1600 2028451-182B
Introduction
WARNING
PACKAGING DISPOSAL — Dispose of all packaging
material, observing all applicable waste control
regulations and keeping out of children’s reach.
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.
WARNING
ELECTRIC SHOCK — To reduce the risk of electric
shock, do NOT remove cover (or back).
Refer servicing to qualified personnel.
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.

Introduction
2028451-182B MAC™1600 1-9
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.
Classification
The unit is classified, according to IEC 60601-1, as:
Underwriters Laboratories, Inc.
Medical Equipment
With respect to electric shock, fire and mechanical
hazards only in accordance with UL 60601-1,
IEC 60601-2-25, and CAN/CSA C22.2 NO. 601.1.
Type of protection against electrical shock Class I internally powered equipment
Degree of protection against electrical
shock Type BF 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
presenceofaflammableanestheticmixture
with air or with oxygen or nitrous oxide
Equipment not suitable for use in the presence of a flammable anestheticmixture 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

1-10 MAC™1600 2028451-182B
Introduction
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
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
Indications of Use
The MAC 1600 ECG Analysis System is a portable ECG acquisition,
analysis, and recording system. It is intended:
to acquire, analyze, display, and record information from adult and
pediatric populations,
to be used under the direct supervision of a licensed health care
practitioner,
to be used by trained operators in a hospital or medical professional’s
facility environment to record ECG signals from surface electrodes,
to offer two basic modes of operation: (1) resting ECG mode and
(2) arrhythmia mode
to print 6 or 12 leads of ECGs,

Introduction
2028451-182B MAC™1600 1-11
to be upgradable to provide software options such as 12-lead ECG
measurement and interpretive analysis,
to be upgradable with a third mode of operation: (3) Exercise mode
for exercise stress testing, and
to provide for the optional transmission and reception of ECG data to
and from a central ECG cardiovascular information system.
NOTE
Pediatric population is defined as patients between the ages of 0 and
15 years of age.
Arrhythmia detection is provided for the convenience or automatic
documentation.
Contraindications
The MAC 1600 device is NOT intended:
to be used during patient transport,
to be used for intra-cardiac applications,
to be used as a vital signs physiological monitor, or
to provide alarms for Arrhythmia detection.
The Arrhythmia detection mode is provided for the convenience of
automatic documentation.
Recording ECGs During Defibrillation
It is not necessary to remove the ECG electrodes prior to defibrillation;
the patient signal is defibrillation-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) and the FRF algorithm 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™1600 2028451-182B
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 +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.