GE Centricity RA600, Service Manual

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Regulatory Requirements
This product complies with the regulatory requirements of the following:
u
Medical Device Quality Systems Regulation, FDA (Food and Drug Administration, Department of
Health and Human Services, USA).
u Underwriters’ Laboratories, Inc. (UL), an independent testing laboratory.
u Canadian Standards Association (CSA).
u International Electrotechnical Commission (IEC), international standards organization, when
applicable.
u
General Electric Medical Systems is ISO 9001 and EN 46001 certified.
u
The original document was written in English.
This equipment generates, uses, and can radiate radio frequency energy. The equipment may cause
radio frequency interference to other medical and non-medical devices and radio communications.
To provide reasonable protection against such interference, this product complies with emissions
limits for a Group 1, Class A Medical Devices Directive as stated in EN60601–1–2. However, there is
no guarantee that interference will not occur in a particular installation.
If this equipment is found to cause interference (which may be determined by turning the equipment
on and off), the user (or qualified service personnel) should attempt to correct the problem by one or
more of the following measure(s):
u
reorient or relocate the affected device(s)