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EMC Conformance Statement
Compliance Statement
This equipment complies with IEC 60601-1-2 Edition 2.1 (2004-11) EMC standards for medical
devices.
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 the
radiated emission standard limits as per CISPR11 Group1 Class A standard limits. 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):
•
Reorient or relocate the affected device(s)
•
Increase the separation between the equipment and the affected device (see
recommended separation distances)
•
Power the equipment from a source different from that of the affected device
•
Consult the point of purchase or service representative for further suggestions
Use of accessories, transducers, cables and other parts other than those specified by the
manufacturer of this equipment may result in increased emissions or decreased immunity of
the equipment.
The manufacturer is not responsible for any interference caused by using other than
recommended interconnect cables or by unauthorized changes or modifications to this
equipment. Unauthorized changes or modifications could void the users' authority to operate
the equipment.
All interconnect cables to peripheral devices must be shielded and properly grounded, except
when technologically prohibited. Use of cables not properly shielded and grounded may
result in the equipment causing radio frequency interference.
The Optima XR646 systems are predominantly intended for use in non-domestic
environments, and not directly connected to the Public Mains Network that supplies buildings
used for domestic purposes.
The compatible accessories must be used within the recommended operating conditions
outlined in the operation manuals. In addition to calibration and warm-up, other devices must
be reset before and after use to ensure accurate dose measurements. Sustained exposure to
electromagnetic fields (exceeding the test conditions) may cause false measurements. Failure
to follow the recommended use may cause false measurements.
The magnetic field environment from a MRI device located nearby is a risk of interference.
5495975-1EN Rev.9
© 2013-2017 General Electric Company. All rights reserved.
Chapter 2: Safety and Regulatory
2-10
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