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Appendix A:
EMC Information
Fetal Doppler needs special precautions regarding EMC and needs to be installed and put
into service according to the EMC information provided for in the ACCOMPANYING
OCUMENTS.
The Fetal Doppler is intended for use in the electromagnetic environment specified below.
The customer or the user of the Fetal heart monitor should assure that it is used in such an
environment.
Emissions test Compliance
RF
emissions
CISPR 11
Group
1 The Fetal Doppler 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.
RF
emissions
CISPR 11
Class B The Fetal Doppler 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.
The Fetal Doppler is intended for use in the electromagnetic environment specified below.
The customer or the user of the Fetal Doppler should assure that it is used in such an
environment.
Immunity test IEC
60601
test level
Compliance
level Electromagnetic environment guidance
Electrostatic
discharge
(ESD)
IEC 61000-4-2
±6 kV
contact
±8 kV air
±6 kV
contact
±8 kV air
Floors should be wood, concrete or ceramic
tile. If floors are covered with synthetic
material, the relative humidity should be at
least 30 %.
The Fetal Doppler is intended for use in the electromagnetic environment specified below.
The customer or the user of the Fetal Doppler should assure that it is used in such an
environment.
Immunity
test IEC
60601
Compliance
level
Electromagnetic environment – guidance
CAUTION