Chapter 2: Safety and Regulatory
Definium 5000 X-Ray System 5197809-1EN Rev. 4 (13 February 2008) 2-12
Operator Manual © 2008 General Electric Company. All rights reserved.
Emergency Procedures
It is not always possible to determine when some components, such as the X-ray tubes, are nearing the
end of their operating lives. These components could stop operating during a patient examination.
WARNING: WARNING: The facility must establish procedures for handling the patient in case of the
loss of radiographic imaging or other system functions during an exam.
Radio Frequency Interference
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 to radio
communications. To provide reasonable protection against such interference, the Definium 5000
complies with emissions limits for Group 1, Class A Medical Devices as stated in EN 60601-1-2.
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 following
measures:
• 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 of FCC Regulations.
FOR TRAINING PURPOSES ONLY!
NOTE: Once downloaded, this document is UNCONTROLLED, and therefore may not be the latest revision. Always confirm revision status against a validated source (ie CDL).
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