
19
EN
Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
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 level
Compliance level
Electromagnetic
environment - guidance
Electrostatic dis-
charge (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 floors are covered with
synthetic material, the
relative humidity should be
at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
power supply lines:
±2 kV
input/output lines:
±1 kV
power supply lines:
±2 kV
Mains power quality
should be
that of a typical com-
mercial or
hospital environment.
Surge
IEC61000-4-5
line(s) to line(s):
±1 kV
line(s) to earth: ±2 kV
100 kHz repetition
frequency
line(s) to line(s): ±1 kV
100 kHz repetition
frequency
Mains power quality
should be that of a typical
commercial or hospital
environment.
Voltage dips,
short interrup-
tions 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 ; 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 ;300 cycle
Mains power quality
should be
that of a typical com-
mercial or
hospital environment.
Power frequency
(50Hz/60Hz)
magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency mag-
netic fields should be at
levels characteristic of a
typical location in a typical
commercial or hospital
environment.
NOTE
UT is the a.c. mains voltage prior to application of the test level.
Table 3
Guidance and manufacturer’s declaration – electromagnetic immunity
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
level
Compliance
level
Electromagnetic
environment - guidance