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Table 2
Guidance and declaration of manufacturer-electromagnetic immunity
(For home healthcare environment)
The device is intended for use in the electromagnetic environment specified below.
The customer or the user of the device should assure that it is used in such an environment.
IMMUNITY test
IEC 60601
test leve
Compliance
level
Electromagnetic environment
-guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
± 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 cov-
ered with synthetic material, the
relative humidity should be at least
30%.
Electrostatic
transient/burst
IEC 61000-4-4
± 2 kV , 100kHz,
for AC power
port
± 2 kV ,
100kHz, for AC
power port
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
±0.5kV, ±1kV
(differential
mode)
±0.5kV, ±1kV
(differential
mode)
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
IEC 61000-4-11
0% UT;
0,5 cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270°
and 315°
0% UT;
1 cycle
and 70% UT;
25/30 cycles
Single phase:
at 0° 0% UT;
250/300 cycle
0% UT;
0,5 cycle
At 0°, 45°, 90°,
135°, 180°,
225°, 270°
and 315°
0% UT;
1 cycle
and 70% UT;
25/30 cycles
Single phase:
at 0° 0% UT;
250/300 cycle
Mains power quality should be
that of a typical commercial or
hospital environment.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m; 50Hz
or 60Hz
30 A/m; 50Hz
or 60Hz
Power frequency magnetic fields
should be at levels characteristic
of a typical location in a typical
commercial or hospital environ-
ment.
ENGLISH
