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
Regulatory Information
1
Regulatory Information
Familiarize yourself with this information before attempting to use this system.
Keep this manual with your Operator Manual and equipment at all times, and
periodically review it.
This section provides information about the 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 system is intended to acquire, analyze, display, and record electrocardiographic
information from adult, pediatric or neonatal 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 system is intended to be used under the direct supervision of a licensed
healthcare practitioner, by trained operators in a hospital or medical professional’s
facility.
Indications for Use
This device is a non-invasive prescription device.
The device is indicated for use:
• To acquire, analyze, display and print electrocardiograms.
• To provide interpretation of the data for consideration by a physician.
• 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.
• On adult and pediatric (birth through 21 years of age) populations.
4 MAC
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7 Resting ECG Analysis System 2109599-003 A