Electromagnetic Compatibility
Efficia CM Series Service Guide B-1
B
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:
• Is the interference due to misplaced or poorly applied electrodes or sensors? If so,
re-apply electrodes and sensors correctly according to directions in the product’s
Instructions for Use.
• Is the interference intermittent or constant?
• Does the interference occur only in certain locations?
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