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43
IMPORTANT INFORMATION REGARDING ELECTRO MAGNETIC 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
IEC60601-1-2 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.
Medical devices manufactured for OMRON Healthcare conform to this
IEC60601-1-2:2014 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
•The use of accessories and cables other than those specified by
OMRON, with the exception of cables sold by OMRON 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.
•Do not use mobile (cellular) telephones and other devices, which
generate strong electrical or electromagnetic fields, near the medical
device. This may result in incorrect operation of the unit and create a
potentially unsafe situation. Recommendation is to keep a minimum
distance of 30 cm (12 inches). Verify correct operation of the device in
case the distance is shorter.
During the immunity tests described below the device operated
normally.
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