MAC 5000 Resting ECG Analysis System ... - Jaken Medical...

Introduction: Safety Information
General Information
Intended Use
The intended use of this device is to record ECG signals
from surface ECG electrodes. This device can analyze,
record, and store electrocardiographic information from
adult and pediatric populations. 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
before 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.
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 substitute
for, the physician’s decision process. It should 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.
To ensure accuracy, only use computer-generated tracings
and not the display for physician interpretation.
This equipment will not cause abnormal operation of a
patient’s pacemaker or other electronic stimulator.
1-8 MAC 5000 System — 2000657-033, Revision A