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
Safety Information
WARNING:
EQUIPMENT FAILURE AND HEALTH HAZARDS - Failure on the part of all responsible
individuals, hospitals or institutions, employing the use of this system, to
implement the recommended maintenance schedule, may cause equipment
failure and possible health hazards. The sole responsibility rests with the
individuals, hospitals, or institutions utilizing the system. The manufacturer does
not, in any manner, assume the responsibility for performing the recommended
maintenance schedule, unless an Equipment Maintenance Agreement exists.
CAUTION:
DISPOSAL HAZARD
Disposable devices are intended for single use only. They should not be reused as
performance may degrade or contamination could occur.
CAUTION:
DISPOSAL HAZARD - At the end of its service life, the product described in this
manual, as well as its accessories, must be disposed of in compliance with local,
state, or federal guidelines regulating the disposal of such products.
If you have questions concerning disposal of the product, please contact GE or its
representatives.
CAUTION:
INTERCONNECTED DEVICES - When several items of medical equipment are
interconnected, summation of leakage current must meet the leakage current as
per IEC 60601-1.
Connect the device only to the GE approved supplies and accessories.
CAUTION:
ISOLATION FROM SUPPLY MAINS
Do not position the device so that it is difficult to operate the disconnection of the
AC power supply of the device.
Supplies and Accessories
This section is in regard to the supplies and accessories you may purchase for your
product.
You should use only supplies and accessories recommended by GE Healthcare. For a
list of recommendations, refer to the supplies and accessories guide for this system.
Contact GE Healthcare before using anything that is not recommended for this
system.
12 MAC
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7 Resting ECG Analysis System 2109599-003 A