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IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)
With the increased number of electronic devices such as
PC’s and mobile (cellular) telephones, medical devices in
use may be susceptible to electromagnetic interference
from other devices. Electromagnetic interference may result
in incorrect operation of the medical device and create a
potentially unsafe situation. Medical devices should also not
interfere with other devices.
In order to regulate the requirements for EMC (Electro
Magnetic Compatibility) with the aim to prevent unsafe
product situations, the IEC 60601-1-2 standard has been
implemented. This standard defines the levels of immunity
to electromagnetic interferences as well as maximum levels
of electromagnetic emissions for medical devices.
The device conforms to this IEC 60601-1-2 standard for
both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those
specified by manufacturer with the exception of cables
sold by manufacturer as replacement parts for internal
components, may result in increased emission or
decreased immunity of the device.
• The medical devices should not be used adjacent to or
stacked with other equipment. In case adjacent or stacked
use is necessary, the medical device should be observed
to verify normal operation in the configuration in which it
will be used.
• Refer to further guidance below regarding the EMC
environment in which the device should be used.
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