MAC® 5000
Resting ECG Analysis System
Operator’s Manual
Software Version 008B
2020300-016 Revision A
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© GE Medical Systems Information Technologies, 2004. All rights reserved.
T-2 MAC 5000 System Revision A
2020300-016 24 May 2004
Contents
CE Marking Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CE-1
Compliance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CE-1
Recommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . CE-1
1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Manual Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Purpose . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Intended Audience . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Revision History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-3
Conventions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-4
Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-6
Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-6
Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Underwriters Laboratories, Inc. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-18
Legal Notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
Responsibility of the Manufacturer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-19
General Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-20
Equipment Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-24
Service Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-27
Service Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27
Equipment Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1-27
2 Equipment Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Equipment Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Front View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-3
Back View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Internal View . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-4
Connectors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-5
Keyboard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-6
Keyboard–Exercise Test Keys (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-8
Acquisition Module . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-9
Getting Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-12
Prepare the Equipment for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-12
Software Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-14
Selecting Menu Functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-18
Entering Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .2-20
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3 Preparing the Patient . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Prepare the Patient’s Skin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Apply the Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-5
Resting Electrodes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-5
Exercise Electrodes (with Exercise–Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3-9
4 Entering Patient Information . . . . . . . . . . . . . . . . . . . . . . 4-1
Enter Patient Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Enter the Information . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-3
Using a Patient Card Reader (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Connect and Configure the Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Slide Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-4
Using a Bar Code Reader (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-5
Connect and Configure the Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Scan the Bar Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-5
Receive Orders from a MUSE CV System (Option) . . . . . . . . . . . . . . . . . . . . . . . . 4-6
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-6
Load the Orders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Select the Orders to Receive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Select an Order to Complete . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Complete the Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-7
Enter Orders Manually (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-8
Manually Create an Order . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-8
Selecting and Completing Manually Created Orders. . . . . . . . . . . . . . . . . . . . . . .4-8
5 Recording an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Hookup Advisor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Record a Resting, Pediatric, Vector Loops, or 15 Lead ECG . . . . . . . . . . . . . . . . 5-5
Record the ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-5
Record a Signal Averaged ECG (Options) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-6
Record a Master’s Step Test (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-7
Run the Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5-7
Using ACI-TIPI (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-9
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6 Exercise Stress Test (Option) . . . . . . . . . . . . . . . . . . . . . 6-1
Start an Exercise Stress Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
Exercise Test Keys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-3
Test Phases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Pretest Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-5
Exercise Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-7
Recovery Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9
Test End Phase . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-9
7 Editing Protocols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Operating Steps . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-3
Advance to Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-7
Advance to Recovery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-8
Advance to Test End . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-9
Save Current Protocol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-10
8 Printing an ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Print Stored ECG Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Print Another Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
9 Transmitting an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-1
Transmit Stored ECGs by Modem (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-3
Transmit Stored ECGs Locally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-5
Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .9-5
Transmit Stored ECGs by Wireless (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9-7
Transmit Stored ECGs to the Serial Port in XML Format . . . . . . . . . . . . . . . . . . . . 9-8
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10 Receiving an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-1
Receive ECGs by Modem (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-3
Receive ECGs Locally . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10-4
Retrieve Confirmed ECGs from a MUSE CV System via Modem (Option) . . . . . 10-5
Select an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6
Display or Print the ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-6
Retrieve Confirmed ECGs from a MUSE CV System via Wireless (Option) . . . . 10-7
Display or Print the ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .10-8
11 Editing an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-1
Edit Demographic and Interpretive Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11-3
Store the Edited ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .11-5
12 Deleting an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-1
Delete Stored ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-3
Delete Stored ECG Orders (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12-4
13 Completing Other Tasks . . . . . . . . . . . . . . . . . . . . . . . . . 13-1
Prepare a Disk for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-3
Lock and Unlock . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-3
Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-3
Eject a Disk From the Drive Slot . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-4
Display Stored ECGs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13-5
Print the ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-5
Display Medians or Rhythm Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-5
Display Measurement and Analysis Statements . . . . . . . . . . . . . . . . . . . . . . . . .13-5
Display the Next Selected ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-5
Return to the Main Menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-6
Display ECGs From a Different Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .13-6
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14 System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-1
Using the System Setup Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-3
Select the System Setup Function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-3
Define the System Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-3
Save Your Changes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-3
Program the System to Automatically Do a Task 14-4
Power Up the System into a Specific Resting Function . . . . . . . . . . . . . . . . . . . .14-4
Preview ECG Data Before Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-4
To Print a Resting ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-4
Print a Signal Averaged ECG Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-5
Store an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-5
Transmit an ECG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-5
Enable or Disable the ACI-TIPI Option . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-5
Define the Basic System Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-7
Miscellaneous Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-7
Patient Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-8
Screen Colors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-10
Transmission . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-11
Date and Time . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-12
Language . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-13
Power Up Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-13
Order Manager Interface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-13
PS/2 Port . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-14
Define the ECG Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-15
ECG Acquisition . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-15
ECG Analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-16
Patient Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-18
Writer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-18
Resting, Pediatric, 15 Lead, and Vector Loops ECG Reports . . . . . . . . . . . .14-19
Analog Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-22
Define the Exercise Test Setup (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-23
Miscellaneous Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-23
Patient Data/Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-23
Writer Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-24
12 and 15 Lead Exercise Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-25
Final Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-27
Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-27
Inputs / Outputs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-28
Define the Signal Averaged ECG Setup (Option) . . . . . . . . . . . . . . . . . . . . . . . . 14-30
Card Reader Option Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-31
Automatic Configuration of Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-31
Manual Configuration of Card Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-32
Revision A MAC 5000 System v
2020300-016
Bar Code Reader Option Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-33
Automatic Configuration of Bar Code . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-33
Manual Configuration of Bar Code Reader . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-34
Creating Bar Codes and Magnetic Cards . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-34
Master’s Step Setup (Option) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-37
Miscellaneous Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14-38
Print Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-38
Save Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-38
Restore Setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .14-38
Appendix A –Maintenance . . . . . . . . . . . . . . . . . . . . . . . .A-1
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-3
Inspecting and Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-4
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-4
Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-6
Changing the Paper Tray Size . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-6
Replacing Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-7
Storing Paper . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-7
Maintaining the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-10
Battery Gauge Icon . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10
Charging the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-10
Periodic Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-12
Replacing the Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .A-12
Replacing Acquisition Module Leadwire Adapters . . . . . . . . . . . . . . . . . . . . . . . A-14
Handling a Disk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-15
Appendix B – Troubleshooting . . . . . . . . . . . . . . . . . . . . .B-1
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-3
First Things to Ask . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3
Visual Inspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-3
Equipment Problems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-4
Reducing ECG Data Noise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-4
There is No ACI-TIPI Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-4
No BP Readings from External Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-4
Treadmill / Ergometer Does Not Move . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .B-5
System Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-6
vi MAC 5000 System Revision A
2020300-016
Appendix C – Editing Acronyms . . . . . . . . . . . . . . . . . . . .C-1
Resting ECG Acronyms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . C-3
Appendix D – Report Formats . . . . . . . . . . . . . . . . . . . . . .D-1
Format Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . D-3
4 by 2.5s + 1 Rhythm Lead Format . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-3
Key to Bottom of Exercise Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4
Additional Report Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-4
In-Test Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-5
Exercise Final Report Names . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .D-6
Appendix E – Master’s Step Data . . . . . . . . . . . . . . . . . . .E-1
Master’s Step Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-3
ST-T Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . E-5
Positive . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-5
Borderline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-5
Negative . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-5
Calculation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .E-5
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Index-1
Revision A MAC 5000 System vii
2020300-016
For your notes
viii MAC 5000 System Revision A
2020300-016
CE Marking Information
CE Marking Information
Compliance
The MAC 5000 system bears the CE mark “CE-0459”, notified body
GMED, indicating its conformity with the provisions of the Council
Directive 93/42/EEC, concerning medical devices and fulfills the
essential requirements of Annex I of this directive.
Any other directive(s) and all the standards the product complies to are
listed in the general information of the operator manual for the product
following this page.
The country of manufacture can be found on the equipment labeling.
The safety and effecti veness of this device has been verified against
previously distributed devices. Although all standards applicable to
presently marketed devices may not be appropriate for prior devices (i.e.
electromagnetic compatibility stand ards), this device will not impair the
safe and effective use of those previously distributed devices.
Recommendations
Users should be a ware of k nown RF sources , such as rad io or TV stat ions
and hand-held or mobile two-way radios, and consider them when
installing a medical device or system.
Be aware that adding accessories or components, or modifying the
medical device or system may degrade the EMI performance. Consult
with qualified personnel regarding changes to the system configuration.
Operating the MAC 5000 system near radio frequency (RF)
electromagnetic interference (EMI) above the conditions defined in the
EMC Standard EN60601-1-2 for Radiated Immunity (field strengths
above 3 volts per meter) may cause waveform distortions.
Medical Electrical Equipment needs special precautions regarding EMC
and needs to be installed and put into service according to the EMC
information provided in the accompanying service manual.
Portable and mobile RF communications equipment can affect medical
electrical equipment.
Revision A MAC 5000 System CE-1
2020300-016
CE Marking Information
The use of accessories, transducers and cables other than those specified,
with the exception of transducers and cables sold by the manufacturer of
the MAC 5000 system as replacement parts for internal components,
may result in increased emissions or decreased immunity of theMAC
5000 system.
The MAC 5000 system should not be used adjacent to or stacked with
other equipment and that if adjacent to or stacked use is necessary, the
MAC 5000 system should be observed to verify normal operation in the
configuration in which it will be used.
Review the AAMI Committee Technical Information Report (TIR) 18,
“Guidance on Electromagnetic Compatibility of Medical Devices for
Clinical/Biomedical Engineers”. This guidance document provides a
means to evaluate and manage the EMI environment in the hospital.
The following actions can be taken to reduce the risk of medical device
EMI and achieve EMC:
Assess the EMC environment of the healthcare facility (e.g., identify
radio transmitters in around the facility) and identify areas where
critical medical devices are used (e.g., ER, ICU, CCU, NICU).
Increase the distance between sources of EMI and susceptible
devices.
Remove the devices that are highly susceptible to EMI.
Lower power transmitted from electrical and electronic equipment
(EMI sources) under hospital control (i.e. paging systems).
Label devices susceptible to EMI.
Educate healthcare facility staff (nurses and doctors) to be aware of,
and to recognize, potential EMI related problems.
CE-2 MAC 5000 System Revision A
2020300-016
1 Introduction
Revision A MAC 5000 System 1-1
2020300-016
For your notes
1-2 MAC 5000 System Revision A
2020300-016
Manual Informatio n
Purpose
This manual contains the instructions necessary to operate the MAC
5000 system in accordance with its function and intended use.
Intended Audience
This manual is intended for the person who uses, maintains, or
troubleshoots this equipment.
Revision History
Each page of the document has the document part number and revision
letter at the bottom of the page. The revision letter identifies the
document’s update level.
Introduction: Manual Information
Conventions
Styles
Table 1. Revision History, PN 2020300-016
Revision Date Comment
A 24 May 2004 Initial release of manual.
127(
Provides additional user information.
Bold text Indicates keys on the keyboard, text to be entered, or hardware
items such as buttons or switches on the equipment.
Italicized text Indicates software terms that identify menu items, buttons, or
options in various windows.
Revision A MAC 5000 System 1-3
2020300-016
Introduction: Manual Information
Ctrl+esc Indicates a keyboard operation. A (+) sign between the names of
two 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.
<Space> Indicates you must press the spacebar. When instructions are
given for typing a precise text string with one or more spaces, the
point where the spacebar must be pressed is indicated as:
<Space>. The purpose of the < > brackets is to ensure you press
the spacebar when required.
Enter Indicates you must press the “Enter” or “Return” key on the
keyboard. Do not type “enter”.
1-4 MAC 5000 System Revision A
2020300-016
Safety Information
Definitions
The terms danger, warning, and caution are used throughout this
manual to point out hazards and to designate a degree or l evel of
seriousness. Familiarize yourself with their definitions and significance.
Hazard is defined as a source of potential injury to a person.
DANGER indicates an imminent hazard whi ch, 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 uns afe practice which, if not
avoided, could result in minor personal injury or product/property
damage.
Introduction: Safety Information
NOTE provides application tips or other useful information to assure
that you get the most from your equipment.
The safety information given in this manual is classified as follows.
:$51,1*
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.
:$51,1*
Battery Operation — If the integrity of the protective
earth conductor is in doubt, operate the unit from its
battery.
Revision A MAC 5000 System 1-5
2020300-016
Introduction: Safety Information
:$51,1*
Cables — To avoid possible strangulation, route all
cables away from patient's throat.
:$51,1*
Connection To Mains — This is class I equipment.
The mains plug must be connected to an appropriate
power supply.
:$51,1*
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.
:$51,1*
Electrodes — Polarizing electrod e s (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 nonpolarizing (silver/silver chloride construction) electrode s
for ECG monitoring.
1-6 MAC 5000 System Revision A
2020300-016
Introduction: Safety Information
:$51,1*
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.
:$51,1*
Explosion Hazard — Do NOT use in the presence of
flammable anesthetics vapors or liquids.
:$51,1*
Interpretation Hazard — Computerized interpretation is
only significant when used in conjunction with clinical
findings.
A qualified physician must overread all computergenerated tracings.
:$51,1*
Operator — Medical technical equipment such as the
MAC 5000 System must only be used by qualified and
trained personnel.
:$51,1*
Shock Hazard — Improper use of this device presents a
shock hazard. Strictly observe the following warnings.
Revision A MAC 5000 System 1-7
2020300-016
Introduction: Safety Information
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/EN 606 01- 1-1 must be
complied with in all cases.
:$51,1*
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, adeq uate
precautions must be taken to prevent them from
dropping on the patient.
:$51,1*
Treadmills — Avoid rapid changes in treadmill speed
and/or grade during a stress test.
&$87,21
Accessories (Supplies) — To ensure patient sa fety, use
only parts and accessories manufactured or
1-8 MAC 5000 System Revision A
2020300-016
Introduction: Safety Information
recommended by GE Medical Systems Information
Technologies.
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.
&$87,21
Proper Leadwire Connection — Improper connection will
cause inaccuracies in the ECG.
Trace each individual leadwire from its ac quisition
module label to the colored connector and then to the
proper electrode to ensure that it is matched to the
correct label location.
&$87,21
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 harmoni zed na tion al
standard.
&$87,21
Battery Power — If a device equipped with an optional
battery pack will not be used or not be connected to the
power line for a period of over six months, remove the
battery.
Revision A MAC 5000 System 1-9
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Introduction: Safety Information
&$87,21
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.
&$87,21
Disposables — Disposable devices are intended for single
use only. They should not be reus ed as performance may
degrade or contamination could occur.
&$87,21
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 Medical Systems Information
Technologies or its representatives.
&$87,21
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.
1-10 MAC 5000 System Revision A
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Introduction: Safety Information
&$87,21
Electric Shock — To reduce the risk of electric shock, do
NOT remove cover (or back).
Refer servicing to qualified personnel.
&$87,21
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.
&$87,21
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 centertapped, 240V, single-phase circuit.
This equipment is suitable for connection to public mains
as defined in CISPR 11.
&$87,21
Restricted Sale — U.S. federal law restricts this device to
sale by or on the order of a physician.
Revision A MAC 5000 System 1-11
2020300-016
Classification
Introduction: Safety Information
&$87,21
Serviceable Parts — This equipment contains no user
serviceable parts. Refer servicing to qualified service
personnel.
&$87,21
Supervised Use — This equipment is intended for use
under the direct supervision of a licensed health care
practitioner.
The unit is classified, according to IEC 60601-1, as:
Type of protection against electrical shock Class I internally powered equipment
Degree of protection against electrical
shock
Degree of protection against harmful
ingress of water
Degree of safety of application 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
Mode of operation Continuous operation
Type CF defibrillation-proof applied part
Ordinary Equipment (enclosed equipment without protection against ingress of water)
Equipment not suitable for use in the presence of a flammable anesthetic mixture with
air or with oxygen or nitrous oxide
Not applicable
1-12 MAC 5000 System Revision A
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Introduction: Safety Information
4P41
Underwriters Laboratories, Inc.
Legal Notice
Our equipment contains several fields which can be filled in before
performing an ECG. Some of these fields must be filled in before
performing an exam, some are optional and therefore 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 revealin g 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.
Medical Equipment
With respect to electric shock, fire and mechanical hazards
only in accordance with UL 2601-1, and CAN/CSA C22.2
NO. 601.1.
Responsibility of the Manuf acturer
GE Medical Systems Information Technologies is responsible for the
effects of safety, reliability, and performance only if:
Assembly operations, extensions, readju stments, modifications, or
repairs are carrie d out by persons aut horized b y GE Medica l Systems
Information Technologies.
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
Intended Use
The intended use of this device is to record ECG signals from surface
ECG electrodes. This device can record, analyze, print, and store
electrocardiographic information from adult and pediatric populations.
Revision A MAC 5000 System 1-13
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Introduction: Safety Information
This data can then be computer analyzed with various algorithms such
as interpretive ECG and signal averaging for presentation to the user.
This device is intended for use under the direct supervision of a licensed
health care practitioner.
This device is not intended for use with high frequency surgical units.
Disconnect the patient from the device b efore using the high frequency
surgical unit.
This equipment uses a computerized ECG analysis program which can
be used as a tool in ECG tracing interpretation. It is recommended that
all ECGs are confirmed by a qualified physician or cardiologist.
To ensure accuracy, only use printed tracings and not the display for
physician interpretation .
This equipment will not cause abnormal operation of a patient’s
pacemaker or other electronic stimulator.
The Acute Cardiac Ischemia–Time Insensitive Predictive Instrument
(ACI-TIPI) Option is intended to be used in a hospital or clinical
environment by competent health professionals. ACI-TIPI uses recorded
ECG data to produce a numerical score which is the predicted probability
of acute cardiac ischemia. Like any computer-assisted ECG
interpretation program, the GE Medical Systems Information
Technologies ACI-TIPI evaluation and probability score is intended to
supplement, not subst itute for, t he physician ’s decision pro cess. It sho uld
be used in conjunction with knowledge of the patient’s history, the
results of a physical examination, the ECG tracing, and other clinical
findings.
ACI-TIPI is intended for adult patient populations.
This system is not intended to be used as a vital signs physiological
monitor.
Recording ECGs During Defibrillation
This equipment is protected a gainst the effects of cardiac defibrill ator
discharge to ensure recovery, as required by test standards.
The patient signal input of the acquisition module is defibrillation-proof.
Therefore, it is not necessary to remove the ECG electrodes pri or to
defibrillation.
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Introduction: Safety Information
When using stainless steel or silver electrodes a defibrillator discharge
current may cause the electrodes to retain a residual charge causing a
polarization or dc offset voltage. This electrode polarization will block
acquisition of the ECG signal. To avoid t his conditio n, use non-pol arizing
electrodes (which will not form a dc offset voltage when subjected to a dc
current) such as silver/silver-chloride types if there is a situation where
there is a likelihood that a defibrillation procedure will b e necessary.
If polarizing electrodes are used, we recommend disconnecting the
leadwires from the patient before delivering the shock.
Electrode defibrillation recovery is the ability of the electrode to allow
the ECG trace to return after defibrillation. We recommend using nonpolarizing disposable electrodes with defibrillation recovery ratings as
specified in AAMI EC12 3.2.2.4. (MMS P/N 9623-105 Silver MacTrodes,
MMS spec. TP9623-003). AAMI EC12 requires that the polarization
potential of an electrode pair does not exceed 100mV, 5 seconds after a
defibrillation discharge.
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 sam pling techniques that may produc e some
variation in amplitudes of Q, R, and/or S waves from one heart be at 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.
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Parts and Accessories
Introduction: Safety Information
Contact GE Medical Systems Information Technologies for information
before connecting any devices to this equi pment not recommended in this
manual.
To ensure patient safety, use only parts and access ories manufactured or
recommended by GE Medical Systems Information Technologies.
Parts and accessories used must meet t he requireme nts of t he appli cable
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.
Equipment Symbols
Type BF equipment. The acquisition module is protected from defibrillation
shocks.
Alternating current.
Equipotential.
Charge the battery. The flashing amber LED next to this symbol indicates
you must connect the system to AC power to re-charge the battery.
Do NOT throw the battery into the garbage.
Recycle the battery.
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Introduction: Safety Information
Consult accompanying documents.
This position of the switch removes battery power from the equipment.
I
S
F
S
I
E
A
L
C
R
C
MEDICAL EQUIPMENT
UL 2601-1 CAN/CSA 601.1
4P41
Classified with respect to electric shock, fire, mechanical, and other
D
US
specified hazards only in accordance with UL 2601-1, CAN/CSA C22.2 No.
601-1, CAN/CSA C22.2 No. 601-2-25, EN 60601-2-25, EN 60601-1-1, IEC
60601-1-2: 2001.
To reduce the risk of electric shock, do NOT remove cover (or back). Refer
servicing to qualified personnel.
098A, 096A, 108A, 101A, 102A, 103A, 100A, 181A, 099A
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Service Information
Service Requirements
Refer equipment servicing to GE Medical Systems Information
Technologies authorized service personnel only. Any unauthorized
attempt to repair equipment under warranty voi ds that warranty.
It is the user’s responsibility to report the need for service to GE Medical
Systems Information Technologies or to one of their authorized agents.
Equipment Identification
Every GE Medical Systems Information Technologies device has a
unique serial number for identification. The serial number appears on
the device label
Introduction: Service Information
### ## ## #### # #
ABCDEF
A
B Year Manufactured (00-99)
C Fiscal Week Manufactured
D Production Sequence Number
1
Product Code
00 = 2000
01 = 2001
02 = 2002
(and so on)
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