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37
With the increased number of electronic
devices such as computers 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
(Electromagnetic Compatibility) with the aim to
prevent unsafe product situations, the IEC60601-
1-2 standard has been implemented. This standard
denes the levels of immunity to electromagnetic
interferences as well as maximum levels of
electromagnetic emissions for medical devices.
Medical devices manufactured for Compass
Health Brands conform to this IEC60601-1-2:2007
standard for both immunity and emissions.
Nevertheless, special precautions need to be
observed:
• The use of accessories and cables other than
those specied by Compass Health Brands,
with the exception of cables sold by Compass
Health Brands as replacement parts, 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 conguration in which it will
be used.
• Refer to further guidance below regarding the
EMC environment in which the device should
be used.
IMPORTANT INFORMATION REGARDING ELECTROMAGNETIC COMPATIBILITY (EMC)
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