Table of Contents
Regulatory and Safety Information
This section provides information about the safe use and regulatory compliance of
this system. The system software is considered medical software. As such, it was
designed and manufactured to the appropriate medical regulations and controls.
Intended Use
The MAC 5 ECG Analysis System is intended to acquire, analyze, display, and record
electrocardiographic information from adult or pediatric populations. Basic system
delivers 3, 6, or 12 lead ECG's and interpretive analysis. Transmission and reception of
ECG data and other clinical data to and from a central clinical information system is
optional.
The MAC 5 ECG Analysis System is intended to be used under the direct supervision
of a licensed healthcare practitioner, by trained operators in a hospital, medical
professional's facility or wherever ECG testing is performed.
Indications for Use
The MAC 5 Resting ECG Analysis System is a non-invasive prescription device.
• The device is indicated for use to acquire, analyze, display and print
electrocardiograms.
• The device is indicated for use to provide interpretation of the data for
consideration by a physician.
• The device is indicated for use in a clinical setting, by a physician or by trained
personnel who are acting on the orders of a licensed physician. It is not intended
as a sole means of diagnosis.
• The interpretations of ECG offered by the device are only significant when used
in conjunction with a physician over-read as well as consideration of all other
relevant patient data.
• The device is indicated for use on adult and pediatric (birth through 21 years of
age) populations.
5864335-001-1
MAC
™
5 A4/MAC
™
5 A5/MAC
Regulatory and Safety Information
H
™
5 Lite
339
Table of Contents
