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Table 2
Guidance and manufacturer’s declaration-electromagnetic emission
The Patient Monitor is intended for use in the electromagnetic environment specified below. The customer or the user
of the Patient Monitor should assure that it is used in such an environment.
Immunity test
IEC60601 test level
Compliance level
Electromagnetic environment
-guidance
Electrostatic
discharge (ESD)
IEC61000-4-2
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ± 15 kV
air
±8 kV contact
±2 kV, ±4 kV, ±8 kV, ± 15 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
IEC61000-4-4
±2kV for power
Supply lines
±1kV for Input a.c. Power
Ports
±2kV for power
Supply lines
±1kV for Input a.c. Power
Ports
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±0.5 kV, 1kV line (s) to line(s)
±0.5 kV, ± 1 kV, ±2kV line(s)
to earth
±0.5 kV, 1kV line (s) to line(s)
±0.5 kV, ± 1 kV, ±2kV line(s)
to earth
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage dips, short
interruptions and
voltage variations on
power supply input
lines
IEC61000-4-11
<5% UT (>95% dip in UT) for
0.5 cycle
<40% UT (60% dip in UT) for
5 cycles
<70% UT (30% dip in UT) for
25 cycles
<5% UT (>95% dip in UT) for
5 s
<5% UT (>95% dip in UT) for
0.5 cycle
<40% UT (60% dip in UT) for
5 cycles
<70% UT (30% dip in UT) for
25 cycles
<5% UT (>95% dip in UT) for
5 s
Mains power quality should be
that of a typical commercial or
hospital Environment .If the user
of the patient monitor requires
continued operation during
power mains interruptions, it is
recommended that the patient
monitor should be powered from
an uninterruptible power supply or
a battery
Power frequency
(50Hz/60Hz) magnetic
field
IEC61000-4-8
30A/m
30A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical location
in a typical commercial or hospital
environment.
