44
K01/03/23.12.2021
Guidance and manufacturer’s declaration – electromagnetic emissions
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
discharges
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 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
100 kHz repetition
frequency
Power supply
lines: ±2 kV
Input/output lines: ±1
kV
100 kHz repetition
frequency
Mains power quality should be that of a typical
commercial or hospital environment.
Surges
Line-to-line
IEC 61000-4-5
± 0,5 kV, ± 1 kV
± 0,5 kV, ± 1 kV
Mains power quality should be that of a typical
commercial or hospital environment.
Surges
Line-to-ground
IEC 61000-4-5
± 0,5 kV, ± 1 kV,
± 2 kV
± 0,5 kV, ± 1 kV,
± 2 kV
Voltage dips
IEC 61000-4-11
0 %
U
T
; 0,5 cycle
At 0°, 45°, 90°,
135°, 180°, 225°,
270° and 315°
0 % UT; 0,5 cycle
At 0°, 45°, 90°, 135°,
180°, 225°, 270° and
315° °
Mains power quality should be that of a typical
commercial or hospital environment.
0%
U
T
; 1 cycle and
70%
U
T
;25/30 cycle
Single phase: 0º
0%
U
T
;1 cycle and
70%
U
T
;25/30 cycle
Single phase: 0º
Voltage
interruptions
IEC 61000-4-11
0%
U
T
;250/300
cycle
0%
U
T
;250/300 cycle
Power frequency
(50/60Hz)
magnetic field
IEC 61000-4-8
30 A/m
50Hz/60Hz
30 A/m
50Hz/60Hz
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or hospital environment.
Not:
U
T
is the a.c. mains voltage prior to application of the test level.
