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16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY
GUIDANCE AND MANUFACTURER'S DECLARATION
All information below is based on the normative requirements to which the manufacturers of
electro-medical devices are subject, in the sense of IEC60601-1-2.
The medical device complies with applicable electromagnetic compatibility standards,
however, the user will ensure that any electromagnetic interference does not create an
additional hazard, such as radio frequency transmitters or other electronic devices.
In this chapter you will find information necessary to ensure the installation and
commissioning of your medical device under the best conditions in terms of electromagnetic
compatibility.
The different cords/cables of the medical device must be separated from each other.
Certain types of mobile telecommunication devices such as mobile phones are likely to
interfere with the medical device. The separation distances recommended in this chapter
must therefore be strictly observed.
The medical device must not be used near or on another device. If this cannot be avoided, it
must be checked for proper operation under the conditions of use before use.
The use of accessories other than those specified or sold by MicroPort CRM as replacement
parts, may result in an increase in the emission or a decrease in the immunity of the medical
device.
GUIDANCE AND MANUFACTURER'S DECLARATION: CABLE
LENGTH
Cables and
accessories Maximum length
Test type
In compliance with
Cables/Cords < 3m
RF emission CISPR 11, Class B
Harmonic current emission IEC61000-3-2
Voltage fluctuation and
flickers
IEC61000-3-3
Electrostatic discharge immunity IEC61000-4-2
Radiated immunity –
Electromagnetic fields
IEC61000-4-3
Electrical fast transient/
burst immunity
IEC61000-4-4
Surge immunity IEC61000-4-5
Immunity to conducted
disturbances, induced by
radio-frequency fields
IEC61000-4-6
Radiated immunity -
Magnetic fields
IEC61000-4-8
Voltage dips, short
interruptions and voltage
variation immunity
IEC 61000-4-11
16.1.
16.2.
16. APPENDIX 2: ELECTROMAGNETIC COMPATIBILITY
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