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Table 2
Declaration - electromagnetic immunity
The device is intended for use in the electromagnetic environment specified below.
Thecustomer or the user of device should assure that it is used in such an environment.
Immunity test IEC 60601test level 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, con-
crete 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
± 2 kV for power
supply lines
± 1 kV for input/
output lines
Not applicable Mains power quality
should be that of a typical
commercial or hospital
environment.
Surge
IEC 61000-
4-5
± 0.5kV, ± 1 kV
line(s) to lines
± 0.5kV, ± 1 kV, ± 2
kV line(s) to earth
Not applicable Mains power quality should
be that of a typical commer-
cial 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
cycles
Not applicable Mains power quality should
be that of a typical commer-
cial or hospital environment.
If the user of the device
requires continued operation
during power mains inter-
ruptions, it is recommended
that the device be powered
from an uninterruptible power
supply or a battery.
Power
frequency
(50/60 Hz)
magnetic
field
IEC 61000-
4-8
30 A/m 30 A/m Power frequency magnetic
fields should be at levels cha-
racteristic of a typical loca-
tion in a typical commercial
or hospital environment.
NOTE: UT is the a.c. mains voltage prior to application of the test level.
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