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41
Anhang
The device is intended for use in the electromagnetic environment specified below.
The user of the device should make sure that it is used in such an environment.
Immunity tests
EN/IEC 60601 test level
Electrostatic discharge (ESD)
± 8 kV Contact discharge
acc. to IEC 61000-4-2
± 15 kV Air discharge
Rapid transient electrical
± 2 kV for power lines
Interferences/bursts acc. to
± 1 kV for input and output lines
IEC 61000-4-4
100 kHz repetition
Surges
± 1 kV line(s) to line(s)
acc. to IEC 61000-4-5
± 2 kV line(s) to earth
Voltage dips, short
Voltage Dip:
interruptions and fluctuations
Dip to 0 % for 1 cycle
of the supply voltage
@ 0° phase angle
acc. to IEC 61000-4-11
Dip to 70 % for 25/30 cycles
@ 0° phase angle
Dropout to 0 % for 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°,
225°, 270° & 315° phase angles
Voltage interruption:
100 % for 250/300 cycles
Magnetic field at the supply
30 A/m at 50 Hz/60 Hz
frequency (50/60 Hz)
acc. to IEC 61000-4-8
Radiated, radio-frequency,
3 V/m 80 MHz to 2.7 GHz
electromagnetic field immunity
*Refer table 2 for wireless Proximity
test acc. to IEC 61000-4-3
RF field test levels
Immunity to conducted
3 V
on 150 kHz to 80 MHz
rms
disturbances, induced
1 kHz 80% AM modulation
by radio-frequency fields
6 V
in ISM bands
rms
acc. to IEC 61000-4-6
Appendix
Table 1 – Compliance level for Immunity tests
Guidance and manufacturer's declaration – electromagnetic immunity
Compliance level
± 8 kV Contact discharge
± 15 kV Air discharge
± 2 kV/1 kV
± 1 kV for input and output lines
100 kHz repetition
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
Voltage Dip:
Dip to 0 % for 1 cycle
@ 0° phase angle
Dip to 70 % for 25/30 cycles
@ 0° phase angle
Dropout to 0 % for 0.5 cycle
@ 0°, 45°, 90°, 135°, 180°, 225°,
270° & 315° phase angles
Voltage interruption:
100 % for 250/300 cycles
30 A/m at 50 Hz/60 Hz
3 V/m 80 MHz to 2.7 GHz
3 V
on 150 kHz to 80 MHz
rms
1 kHz 80 % AM modulation
6 V
in ISM bands
rms
Anexo
Electromagnetic environment – guidance
Floors should be wood, concrete or ceramic tile.
If floors are covered with synthetic material, the
relative humidity should be at least 30%.
The power supply quality should be that of a typical
commercial or hospital environment.
The power supply quality should be that of a typical
commercial or hospital environment.
The power supply 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.
If image distortion occurs, it may be necessary
to position the device further from sources of
electromagnetic fields or to install magnetic shielding.
Before installing the device, the electromagnetic field
should be measured to ensure that it is sufficiently
low.
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