Electromagnetic Compatibility
Efficia CM Series Rack and Modules Instructions for Use A-1
A4
Electromagnetic
Compatibility
This appendix lists the tests and compliance levels that make the Efficia CM patient
monitors suitable for use in the specified electromagnetic environment according to
IEC 60601-1-2:2014, 4th Edition Standard.
Instructions for Use
Medical electrical equipment can either generate or receive electromagnetic interference.
This product has been evaluated for electromagnetic compatibility (EMC) with the
appropriate accessories according to IEC 60601-1-2:2014, the international standard for
EMC for medical electrical equipment. This IEC standard has been adopted in the
European Union as the European Norm, EN 60601-1-2:2015.
Radio frequency (RF) interference from nearby transmitting devices can degrade
performance of the product. Electromagnetic compatibility with surrounding devices
should be assessed prior to using the product.
Fixed, portable, and mobile radio frequency communications equipment can also affect
the performance of medical equipment. See your service provider for assistance with the
minimum recommended separation distance between RF communications equipment
and the product.
The cables, sensors/transducers, and other accessories for which compliance is claimed
are listed in this manual.
Warnings • Use of accessories, transducers and cables other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment and result in
improper operation.
• The Efficia CM patient monitors should not be used adjacent to or stacked with
other equipment. This should be avoided because it could result in improper
operation. If adjacent or stacked use is necessary, the monitor should be observed
to verify normal operation in the configuration in which it is used.
Reducing Electromagnetic Interference
The Efficia CM patient monitors and associated accessories can be susceptible to
interference from other RF energy sources and continuous, repetitive, power line bursts.
Examples of other sources of RF interference are other medical electrical devices, cellular
products, information technology equipment, and radio/television transmission. If
interference is encountered, as demonstrated by artifact on the ECG or dramatic
variations in physiological parameter measurement values, attempt to locate the source.
Assess the following:
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