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Bionet FC-700 - Appendix D. Electromagnetic Emissions and Immunity; Manufacturers Declaration: Electromagnetic Emissions; Manufacturers Declaration: Electromagnetic Immunity

Bionet FC-700
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Rev.2.41 53
Fetal Monitor FC-700 Operating Manual
Appendix D Electromagnetic Emissions and
Immunity - Manufacturers declaration
Electromagnetic Emissions and Immunity
Manufacturer’s declaration - electromagnetic emission
The FC-700 system is intended for use in the electromagnetic environment specified
below. The customer or the user of FC-700 system should assure that it is used in such an
environment
Emission test
Compliance
Electromagnetic environment - guidance
RF emissions
CISPR 11
Group 1
The FC-700 system 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 FC-700 system is suitable for use in all
establishments including domestic and those
directly connected to the public low-voltage
power supplies buildings used for domestic
purposes.
Harmonics emission
IEC 61000-3-2
A
Voltage fluctuation
IEC 61000-3-3
Complies
Manufacturer’s declaration - electromagnetic immunity
The FC-700 system is intended for use in the electromagnetic environment specified
below. The customer or the user of the FC-700 system 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 %
Electrical fast
Transient / burst
IEC 61000-4-4
2kV for
power supply lines
1kV for
input/output lines
2kV for
power supply lines
1kV for
input/output lines
Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-4-5
1 kV
differential mode
2 kV common mode
1 kV
differential mode
2 kV common mode
Mains power quality
should be that of a typical
commercial or hospital
environment.