Chapter 2: Safety and Regulatory
5495975-1EN Rev.9
2-43
© 2013-2017 General Electric Company. All rights reserved.
Regulatory Requirements
Note:
This equipment generates, uses, and can radiate radio frequency energy. The equip-
ment 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 emission limits for 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.
Note:
If this equipment is found to cause interference (which may be determined by switch-
ing the equipment on and off), you (or qualified service personnel) should attempt to
correct the problem using one or more of the following measures:
-
Reorient or relocate the affected devices.
-
Increase the space separating the equipment and the affected device.
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Power the equipment from a source different from that of the affected device.
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Consult the point of purchase or the service representative for further suggestions.
Note:
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.
Note:
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. The use of improperly shielded and grounded cables
may result in the equipment causing radio frequency interference in violation of the
European Union Medical Device directive and Federal Communications Commission
regulations.
Note:
Do not use devices which intentionally transmit radio frequency (RF) signals (cellular
phones, transceivers, or radio controlled products) in the vicinity of this equipment, as
it may cause performance outside the published specifications.
Keep the power to these type devices turned off when near the equipment.
The medical staff in charge of this equipment is required to instruct technologists, patients,
and other people who may be around this equipment, to fully comply with the above require-
ment.
This product complies with the following requirements:
Council Directive 93/42/EEC concerning medical devices when it bears the following CE mark-
ing of conformity:
Figure 2-14
CE mark label
