F9 Fetal & Maternal Monitor • User Manual
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A4.2 Electromagnetic Immunity – for all EQUIPMENT and
SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The F9 Monitor is intended for use in the electromagnetic environment specified below. The
customer or the user of F9 Monitor 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 floor
is covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±
2 kV for power
supply lines
±
2V for power
supply lines
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±
1 kV line to line
±
2 kV line to ground
±
1 kV line to line
±
2 kV line to ground
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency
(50Hz)
magnetic field
IEC61000-4-8
3 A/m
3 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
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