Intended Use And Functional Description - GE Medical Systems MAC 1200 Operator's Manual

Intended Use and Functional Description

Revision B
The Basics: MAC 1200 Resting ECG Analysis System Option Codes
The MAC 1200 is an ECG acquisition and recording system designed and
manufactured by GE Medical Systems Information Technologies.
It is intended to be used for resting ECG recording and realtime ECG
recording with or without arrhythmia detection.
It is not intended for use as a vital signs physiological monitor.
The arrhythmia detection portion of the MAC 1200 is provided to the
customer for the convenience of automatic documentation. It is not
designed to provide alarms for arrhythmia detection.
The MAC 1200 offers no diagnostic opinion to the user. Instead it
provides analytical statements when configured with the appropriate
options.
It is intended to be used by trained operators under direct physician
supervision when ECG records are required.
It is not suitable for intracardiac application.
It is designed for continuous operation.
It is not intended for home use.
The MAC 1200 is designed as a portable device and can easily be
moved from one patient to another or to different locations. It is not
intended to be used during patient transport.
Equipped with the standard software, the MAC 1200 supports the
following operating modes.
12 Lead Mode (acquisition of 12 leads of ECG for a period of 10
seconds),
6 Lead Mode (realtime recording of 6 ECG leads), and
Arrhythmia Mode (continuous ECG analysis for arrhythmias).
The graphics display shows 3 leads at a time.
Resting ECGs can be transferred to the CardioSys/CardioSoft or MUSE
CV Information System via the RS232 interface.
The device operates from both AC and DC (rechargeable batteries) power
sources.
MAC 1200
2012250-022
1-5