F15 Series Fetal & Maternal Monitor User Manual EMC Information
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A7.2 Electromagnetic Immunity
Guidance and manufacture’s declaration – electromagnetic immunity
The F15 Series Fetal & Maternal Monitors are intended for use in the electromagnetic environment
specified below. The customer or the user of F15 Series Fetal & Maternal Monitors should assure that
it is used in such an environment.
Immunity test
IEC 60601 test
level
Electromagnetic
environment -
guidance
Electromagnetic environment
- guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
15 kV air
8 kV contact
15 kV air
Floors should be wood,
concrete or ceramic tile. If floor
are 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
1 kV for
input/output lines
2kV for power
supply lines
Not applicable
Mains power quality should be
that of a typical commercial or
hospital environment.
1 kV line(s) to
line(s)
2 kV line(s) to
ground
1 kV line(s) to
line(s)
2 kV line(s) to
ground
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency
(50Hz/60Hz)
magnetic field
IEC61000-4-8
Power frequency magnetic
fields should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
Traditional 510(k) of Fetal & Maternal Monitor
014_14.1_F15_Series_User_Manual
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