Safety Manual
Table Of Contents
- Table of Contents
- Publication Information
- Regulatory Information
- Intended Use
- Indications for Use
- Contraindications
- Prescription Device Statement
- Classification of Medical Device
- Recording ECGs during Defibrillation
- Modulating Effects in Digital Systems
- Biocompatibility
- Legal Notice
- Responsibility of the Manufacturer
- Responsibility of the Purchaser/Customer
- Warranty Information
- Safety Information
- Product and Packaging Information
- Equipment Identification
- Electromagnetic Compatibility (EMC)
- Wireless Regulations
Publication Information
This document describes version 1.00 of MAC
™
7 Resting ECG Analysis System, also referred to as the “product” or "system" or "device".
It does not apply to earlier product versions. Due to continuing product innovation, specifications in this document are subject to change
without notice.
MUSE, MAC, MARS, CASE, CardioSoft, and 12SL are trademarks owned by GE Medical Systems Information Technologies, Inc., a General
Electric Company going to market as GE Healthcare. All other trademarks contained herein are the property of their respective owners.
The MAC
™
7 Resting ECG Analysis System is intended to be used, under the direct supervision of a licensed healthcare practitioner by
trained operators in a hospital or facility providing patient care.
This document provides information required for the proper use of the system. Familiarize yourself with this information and read and
understand all instructions before attempting to use this system.
NOTE:
Illustrations in this document are provided as examples only. Depending on system configuration, screens in the document may differ
from the screens on your system. Patient names and data are fictitious. Any similarity to actual persons is coincidental.
The document part number and revision are on each page of the document. The revision identifies the document’s update level. The
revision history of this document is summarized in the following table.
Revision Date Comment
A 15 August 2018 Initial Release
To access other GE Healthcare Diagnostic Cardiology documents, go to the Common Documentation Library (CDL), located at http://
apps.gehealthcare.com/servlet/ClientServlet?REQ=Enter+Documentation+Library, and click Cardiology.
To access Original Equipment Manufacturer (OEM) documents, go to the device manufacturer's website.
Support
GE Healthcare maintains a trained staff of application and technical experts to answer questions and to respond to issues and problems
that may arise during the installation, maintenance, and use of this product.
If you require additional assistance, contact your GE Healthcare representative or GE Healthcare support at one of the following numbers:
• North America: 1-800-558-7044
• Europe: +49 761 45 43 -0
• Asia: +86 21 3877 7888
Training
This document is intended as a supplement to, not a substitute for, thorough product training. If you have not received training on the use
of the product, you should request training assistance from GE Healthcare.
To see available training, go to the GE Healthcare training website (www.gehealthcare.com/training). Select Education> Product
Education-Technical> Diagnostic Cardiology. For more self-paced course offerings, tools, and reference guides you may find useful,
please visit the GE Healthcare Education Store at www.gehealthcare.com/educationstore.
2 MAC
™
7 Resting ECG Analysis System 2109599-003 A