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3.
Safety and Regulatory Information
- continued
3.
EMC (Electro Magnetic Compatibility) Declaration
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With the increased number of electronic devices such as PC's and mobiles, medical
devices in use may be susceptible to electromagnetic interference from these
devices. Which 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 with the aim to prevent unsafe product
situations, the EN60601-1-2 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 by Haag-Streit-UK Ltd conform to this EN60601-1-2
standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
The use of accessories and cables other than those specified by Haag-Streit-UK Ltd,
with the exception of cables sold by Haag-Streit-UK Ltd 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.
If adjacent or stacked use is unavoidable, the medical device should be seen to
operate normally as it should in this situation.
Further guidance regarding the EMC environment (in accordance with
EN60601-1-2) in which the device should be used is available at:
http://www.haagstreituk.com/medicalquality
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