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 MALFUNCTION/INTERFERENCE - Use of portable phones or other radio
frequency (RF) emitting equipment near the system may cause unexpected or
adverse operation.
Do not use portable phones or other electronic equipment that may emit radio
frequency (RF) near this system.
WARNING:
EQUIPMENT MALFUNCTION/INTERFERENCE - Do not use the equipment or system
adjacent to, or stacked with, other equipment.
If adjacent or stacked use is necessary, test the equipment or system to verify
normal operation in the configuration in which you are using it.
WARNING:
ACCESSORIES/COMPONENTS - Adding accessories or components, or modifying
the medical device or system, may result in increased EMISSIONS or decreased
IMMUNITY of the device or system.
CAUTION:
ACCESSORIES/COMPONENTS - Ensure that all cables are less than 3 meters long.
Cable lengths greater than 3 meters may result in decreased IMMUNITY of the
device or system.
CAUTION:
ACCESSORIES (SUPPLIES)
To ensure patient safety, use only parts and accessories manufactured or
recommended by GE Medical Systems Information Technologies. Parts and
accessories used must meet the requirements of the applicable IEC 60601 series
safety standards and essential performance standards, and/or the system
configuration must meet the requirements of the IEC 60601-1-1 medical electrical
systems standard.
CAUTION:
ACCESSORIES (EQUIPMENT)
The use of ACCESSORY equipment not complying with the equivalent safety
requirements of this equipment may lead to a reduced level of safety of the
resulting system. Consideration relating to the choice shall include: Use of the
accessory in the PATIENT VICINITY; and Evidence that the safety certification of the
ACCESSORY has been performed in accordance to the appropriate IEC 60601-1
and/or IEC 60601-1-1 harmonized national standard.
WARNING:
DATA LOSS - Formatting the device’s internal flash drive erases all the data in
memory and returns the device to its factory settings.
If possible, back up or record any data that you do not want to lose before
performing the following procedure.
2109599-003 A MAC
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7 Resting ECG Analysis System 11