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
Electrostatic discharge
(ESD) IEC 61000-4-2
Electrical fast
transients/bursts IEC
61000-4-4
Surge
IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
magnetic field IEC
61000-4-8
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ENGLISH
IEC 60601 test level
± 8 kV contact
discharge ±2 kV, ±4
kV, ±8 kV,
±15 kV air discharge
± 2 kV for
AC power port, 100kHz
repetition frequency
±0.5kV, ±1kV
(line-to-line)
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
30 A/m; 50Hz or 60Hz
Compliance level
± 8 kV contact
discharge ±2 kV, ±4
kV, ±8 kV,
±15 kV air discharge
± 2 kV for
AC power port, 100kHz
repetition frequency
±0.5kV, ±1kV
(line-to-line)
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
30 A/m; 50Hz or 60Hz
Electromagnetic environment -
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Mains power quality should be that
of a typical commercial or hospital
environment.
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial or hospital
environment. It may be necessary
to position the pump further from
the sources of power frequency
magnetic fields. The power
frequency magnetic field should be
measured in the location to assure
that it is sufficiently low.
ART-70295-01-AA