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Guidance and Manufacturer's Declaration - Electromagnetic Immunity: This device is
intended for use in the electromagnetic environment specifi ed below. The user of this
device should make sure that it is used in such an environment.
IMMUNITY TEST
Electrostatic
Discharge (ESD)
IEC 61000-4-2
Electrical Fast
Transient/Burst
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
fi eld IEC 61000-4-8
Note: UT is the A.C. mains voltage prior to application of the test level.
IEC 60601 TEST
LEVEL
±8kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
±2kV for power
supply cords
±1kV for input-output
lines
± 0,5 kV,
± 1 kV diff erential
mode
± 0,5 kV, ± 1 kV,
± 2 kV common
mode
0 % UT;
1 cycle at 0° 70 % UT;
25 cycles at 0°
0% UT ;250 cycles
30 A/m
13/199
COMPLIANCE
LEVEL
±8kV contact
± 2 kV, ± 4 kV, ± 8 kV,
± 15 kV air
±2 kV for power
supply cords
Not applicable
± 0,5 kV,
± 1 kV diff erential
mode
Not applicable
0 % UT;
1 cycle at 0° 70 % UT;
25 cycles at 0°
0% UT ;250 cycles
30 A/m
ELECTROMAGNETIC
ENVIRONMENT-
GUIDANCE
Floors should be
wood, concrete or ce-
ramic tile. If fl oors are
covered with synthetic
material, the relative
humidity should be at
least 30%.
Mains power quality
should be that of a ty-
pical home or hospital
environment.
Mains power quality
should be that of a ty-
pical home or hospital
environment.
Mains power quality
should be that of a ty-
pical home or hospital
environment.
Power frequency ma-
gnetic fi elds should be
at levels characteristic
of a typical location in
a typical hospital or
home environment.
EN
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