Brivo OEC 715/785/865 Mobile C-Arm X-Ray Product
Page 1-17
1.10. Electromagnetic Compatibility Statement
This product conforms with IEC60601-1-2 Ed3.0 and Ed4.0 EMC standard for medical devices.
This equipment generates, uses, and can radiate radio frequency energy. The equipment
may cause or be subject to radio frequency interference with other medical and
non–medical devices and radio communications. There may be RISKS of reciprocal
interference posed by this equipment during specific investigations and treatments. To
provide reasonable protection against such interference, the Brivo OEC 715/785/865
Mobile C-arm X-ray Product system complies with emissions limits for a Group 1, Class A
Medical Devices and has applicable immunity level as stated in IEC60601-1-2.
However, there is no guarantee that interference will not occur in a particular installation.
The system needs special precautions regarding EMC and needs to be installed and put into
service according to the EMC information provided in the Operator Manual.
Portable and mobile RF communication equipment can affect system. Keep the power to
these RF sources turned off when near this equipment. Recommended separation distances
and information regarding compatibility with other equipment are located in the EMC
Declaration Table as below.
If this equipment is found to cause interference (which may be determined by switching the
equipment on and off), the operator (or qualified service personnel) should attempt to
correct the problem by one or more of the following measure(s):
1. Reorient or relocate the affected device(s).
2. Increase the separating space between the equipment and the affected device.
3. Power the equipment from a source different from that of the affected device.
4. Consult the point of purchase or service representative for further suggestions.
Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
The manufacturer is not responsible for any interference caused either by the use of cables
other than those recommended, or unauthorized changes or modifications to this
equipment. Unauthorized changes or modifications could void the operator’s authority to
operate the equipment.
Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and
the other equipment should be observed to verify that they are operating normally.
This equipment may be interfered with by other equipment, even if that equipment
complies with CISPR EMISSON requirements.
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