Appendix Vemc - Fazzini FM5000C User Manual

Maternal/fetal monitor
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Attention
The monitor meets the requirement of electromagnetic compatibility in IEC60601-1-2.
The user needs to install
information which is attached with it.
Portable and mobile RF communicationdevices may influence the monitor performance, so the
monitor should be kept away from them during using.
Guidance and manufacturer's declaration stated in the appendix.
Warning
The monitor should not be used adjacent to or stacked with other equipment and that if
adjacent or stacked use is necessary, the monitor should be observed to verify normal operation
in the configuration in which it will be used.
Class A equipment is intended for use in an industrial environment. The monitor may be
potential difficulties in ensuring electromagnetic compatibility in other environments, due to
conducted as well as radiated disturbances.
Guidance and manufacturer's declaration –electromagnetic emissions
The monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitor should assure that it is used in such an environment.
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Guidance and manufacturer's declaration – electromagnetic immunity
The monitor is intended for use in the electromagnetic environment specified below. The customer or the
user of the monitor should assure that it is used in such an environment.
IEC 60601 test
Immunity test
Electrostatic
discharge (ESD)
IEC 61000-4-2
and use
Compliance
The monitor uses RF energy only for its internal function.
Group 1
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
The monitor is suitable for use in all establishments other
Class A
than domestic and those directly connected to the public
low-voltage power supply network that supplies buildings
Class A
used for domestic purposes.
Complies
Compliance level
level
±6 kV contact
± 6 kV contact
±8 kV air
± 8 kV air
FM5000C - FM5000PLUS
Maternal/Fetal Monitor
according to electromagnetism compatibility
Electromagnetic environment - guidance
Electromagnetic environment –
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic
humidity should be at least 30 %.
V-1
User Manual
Appendix V EMC
guidance
material,
the
relative

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