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38 Important Information Regarding Electromagnetic Compatibility(emc)
20. 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
60601-1-2:2014 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 by Shenzhen Dongdixin Technology Co., Ltd. conform to this
IEC 60601-1-2:2014 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
The use of accessories and cables other than those specified by 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.
38


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