InTENSity Twin Stim IV
Roscoe Medical
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10. ELECTROMAGNETIC COMPATIBILITY
(EMC) TABLES
Information for accompanying documents in the scope of
IEC60601-1-2:2007
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 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 for Roscoe Medical Inc. conform to this
EN60601-1-2:2007 standard for both immunity and emissions.
Nevertheless, special precautions need to be observed:
• The use of accessories and cables other than those specified by
Roscoe Medical, with the exception of cables sold by Roscoe Medical
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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