Electromagnetic Compatibility (Emc) - Derungs D VISIANO 10-1 P S10 Mode D'emploi

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ELECTROMAGNETIC COMPATIBILITY (EMC)

The medical device is intended for operation in an electromagnetic environment such as described below. The user must ensure
that it is operated in such an environment.
Emissions
RF emissions
(CISPR 11)
RF emissions
(CISPR 11)
Harmonic emissions
(IEC 61000-3-2)
Voltage fluctuations / flicker emissions
(IEC 61000-3-3)
The medical device is intended for operation in an electromagnetic environment such as described below. The user must ensure
that it is operated in such an environment.
Immunity against
Electrostatic discharge (ESD)
(IEC 61000-4-2)
Fast transient electrical
disturbances/bursts
(IEC 61000-4-4)
Impulse voltage/surges
(IEC 61000-4-5)
Magnetic field at the supply fre-
quency
(50/60 Hz)
(IEC 61000-4-8)
Voltage dips and short inter-
ruptions of the supply voltage
(IEC 61000-4-11)
Emitted RF disturbance
(IEC 61000-4-3)
Conducted RF interference
(IEC 61000-4-6)
d = recommended separation distance [m], P = power of transmitter [W]. The field strength of stationary radio transmitters should be for all
frequencies, in accordance with an on-site examination, less than the compliance level.
In the vicinity of equipment marked with the following symbol, disturbances are possible:
Recommended safety distances to portable and mobile RF communications equipment
Power of transmitter [W]
0.01
0.1
1
10
100
Guidelines - Electromagnetic disturbance emissions
Correspond to
Group 1
Class B
Class C
Compliant
Guidelines - Electromagnetic immunity
IEC 60601-1-2
test level
Contact discharge: ± 8 kV
Air discharge: ± 15 kV
Power cables: ± 2 kV
Longer input and output
power cables:
± 1 kV
±1 kV voltage outer conduc-
tor - outer conductor
±2 kV voltage outer conduc-
tor - earth
3 A/m
Dip > 95 %, 0.5 Per.
Dip 60 %, 5 Per.
Dip 30 %, 25 Per.
Dip > 95 %, 5 Sec.
3 V/m
80 MHz - 2.5 GHz
3 V
rms
150 kHz - 80 MHz:
150 kHz - 800 MHz
0.12 m (0.39 ft)
0.38 m (1.25 ft)
Electromagnetic environment
The medical device uses RF energy only for its internal function. Therefore, its
RF emissions are very low and it is unlikely that nearby electronic devices will
be affected.
The medical device is intended for usage in all facilities including residential
buildings and such facilities that are directly (without a transformer) connected
to the same low voltage network as the residential building.
Conformance level of the
medical device
±8 kV
± 15 kV
± 2 kV
Not applicable
±1 kV
n/a
100 A/m
Dip > 95 %, 0.5 Per.
Dip 60 %, 5 Per.
Dip 30 %, 25 Per.
Dip > 95 %, 5 Sec.
10 V/m
10 V
rms
1.2 m (3.9 ft)
3.8 m (12.5 ft)
12m (39 ft)
Electromagnetic environment
Floors are preferably made of wood, concrete
or ceramic tiles. In the case of synthetic floor
covering, the relative humidity should be at
least 30%.
The quality of the supply voltage should corre-
spond to that of a typical business or hospital
environment.
The quality of the supply voltage should corre-
spond to that of a typical business or hospital
environment.
Devices with strong line-frequency magnetic
fields (transformer stations, etc.) should not be
operated in the vicinity of the medical device.
The quality of the supply voltage should corre-
spond to that of a business or hospital environ-
ment. If the user requires continued function-
ing during interruptions in the power supply,
we recommend powering the medical device
from an uninterruptible power supply or a bat-
tery.
Recommended separation distance from port-
able and mobile RF devices in transmission
power PEIRP of the medical device including
its cords: d = 0.35√P
Recommended separation distance from port-
able and mobile RF devices in transmission
power PEIRP of the medical device including
its cords:
80 MHz – 800 MHz: d = 0.35√P
800 MHz - 2.5 GHz: d = 0.7√P
800 MHz - 2.5 GHz
0.23 m (0.76 ft)
0.73 m (2.4 ft)
2.3 m (7.6 ft)
7.3 m (23.9 ft)
23 m (76 ft)
ENG
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