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TABLE 2:
DECLARATION - ELECTROMAGNETIC IMMUNITY
The device is intended for use in the electromagnetic environment specified below. The customer 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, concrete or ceramic tie. 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 commercial
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 commercial
or hospital environment. If the user of the device requires
continued operation during power mains interruptions,
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
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.
