Certified Electrical Contractor Statement; Regulatory Requirements - GE Definium AMX 700 Operator's Manual

Certified Electrical Contractor Statement

All electrical installations that are preliminary to positioning of the equipment at the site prepared for the
equipment shall be performed by licensed electrical contractors. In addition, electrical feeds into the
Power Distribution Unit shall be performed by licensed electrical contractors. Other connections between
pieces of electrical equipment, calibrations, and testing shall be performed by qualified GE Medical
personnel. The products involved (and the accompanying electrical installations) are highly sophisticated,
and special engineering competence is required. In performing all electrical work on these products, GE
will use its own specially trained field engineers. All of GE's electrical work on these products will comply
with the requirements of the applicable electrical codes.
The purchaser of GE equipment shall only utilize qualified personnel (i.e., GE's field engineers, personnel
of third-party service companies with equivalent training, or licensed electricians) to perform electrical
servicing on the equipment.
CAUTION: Only trained and qualified personnel should be permitted access to the internal parts of
the Definium AMX 700 or its associated assemblies.

Regulatory Requirements

NOTE: 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, the Definium AMX
700 complies with emissions limits for a Group 1, Class A Medical Devices as stated in EN 60601-1-2.
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 switching 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):
• Reorient or relocate the affected device(s).
• Increase the separating space between the equipment and the affected device.
• Power the equipment from a source different from that of the affected device.
• Consult the point of purchase or service representative for further suggestions.
The manufacturer is not responsible for any interference caused either by the use of interconnect cables
other than those recommended, or by unauthorized changes or modifications to this equipment.
Unauthorized changes or modifications could void the user's authority to operate the equipment.
To comply with the regulations applicable to an electromagnetic interface for a Group 1, Class A Medical
Device, all interconnect cables to peripheral devices must be shielded and properly grounded. Use of
cables not properly shielded and grounded may result in the equipment causing radio frequency
interference in violation of the European Union Medical Device directive and FCC regulations.
Definium AMX 700 X-Ray System
Operator Manual
5161515-1EN Rev. 6 (10 February 2008)
© 2008 General Electric Company. All rights reserved.
Chapter 2: Safety and Regulatory
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