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12 Electromagnetic compatibility (EMC)
12.1 General EMC information
Medical Electrical Equipment needs to be installed and used according to the EMC information in this manual.
This product has been tested and found to comply with EMC limits specified by IEC/EN 60601-1-2 for Class B equipment.
Portable and mobile RF communications equipment can affect the operation of this product.
Other devices may experience interference from even the low levels of electromagnetic emissions permitted by the above
standard. To determine if the emission from this product is causing the interference, run and stop running this product. If
the interference with the other device operation stops, then this product is causing the interference. In such rare cases,
interference may be reduced or corrected by the following:
•
Reposition, relocate, or increase the separation between the devices.
12.2 Electromagnetic emission
Guidance and manufacturer´s declaration
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this
product should assure that it is used in such an environment.
Emissions test
Compliance
RF emissions
Group I
CISPR 11
RF emissions
Class B
CISPR 11
Harmonic
emissions
Class A
IEC 61000-3-2
Voltage fluctuations
/flicker emissions
Complies
IEC 61000-3-3
12.3 Electromagnetic Immunity
Guidance and manufacturer´s declaration
This product is intended for use in the electromagnetic environment specified below. The customer or the user of this
product should assure that it is used in such an environment.
Immunity test
Test / Compliance level
Electrostatic
± 8 kV contact
discharge (ESD)
± 2 kV, ± 4 kV, ± 8 kV, ±
IEC 61000-4-2
15 kV air
± 2 kV for power supply
lines; 100 kHz repetition
Electrostatic
frequency
transient / burst
± 1 kV for input / output
IEC 61000-4-4
lines; 100 kHz repetition
frequency
Surge
± 1 kV line to line
IEC 61000-4-5
± 2 kV line to earth
60127405-A
Electromagnetic environment - guidance
This product uses RF energy only for its internal function. Therefore, its RF
emissions are very low and are not likely to cause any interference in nearby
electronic equipment.
This product is suitable for use in all establishments including domestic
establishments and those directly connected to the public low-voltage power
supply network that supplies buildings used for domestic purposes.
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile. If floors are covered with
synthetic material, the relative humidity should be at least 30 %.
Mains power quality should be that of a typical commercial or hospital
environment.
Mains power quality should be that of a typical commercial or hospital
environment.
Electromagnetic compatibility (EMC)
31
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