Declaration Of Conformity - OPED VADOplex Mode D'emploi

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VADOplex
Immunity test
IEC60601-1-2 test
level
Voltage dips, short
0 % U
; 0.5 cycle at
T
interruptions and
0, 45, 90, 135, 180,
voltage variations on
225, 270 and 315
power supply
degrees
input lines
IEC 61000-4-11
0 % U
; 1 cycle
T
and
70 % U
; 25/30
T
cycles
single phase: at 0
degrees
0 % U
; 250/300
T
cycles
Conducted RF
3V
RMS
IEC 61000-4-6
(0.15 – 80 MHz)
6V
RMS
Radiated RF EM fields
(ISM)
IEC 61000-4-3
3 V/m
80 MHz – 2,7 GHz
NOTE 1:
At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2:
These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones, land mobile radios,
amateur radio, AM and FM radio broadcast and TV broadcast, cannot be predicted theoretically with accuracy. To assess
the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered. If
the measured field strength in the location in which the model VADOplex is used, exceeds the applicable RF compliance
level above, the model VADOplex should be observed to verify normal operation. If abnormal performance is observed,
additional measures may be necessary, such as reorienting or relocating the device.
Over the frequency range 150 kHz to 80 MHz, field strength should be less than 3 V/m.
b
50
Compliance level
Electromagnetic environment –
guidance
0 % U
; 0.5 cycle at
Mains power quality should be
T
0, 45, 90, 135, 180,
that of a professional healthcare
225, 270 and 315
facility environment and Home
degrees
healthcare environment.
0 % U
; 1 cycle
If the user of the device requi-
T
and
res continued operation during
70 % U
; 25/30
power mains interruptions, it is
T
cycles
recommended that the device be
single phase: at 0
powered from an uninterruptible
degrees
power source.
0 % U
; 250/300
T
cycles
3V
Portable and mobile RF commu-
RMS
nications equipment should be
(0.15 – 80 MHz)
used no closer to any part of the
6V
RMS
device, including cables, than the
(ISM)
recommended separation dis-
3 V/m
tance calculated from the equati-
80 MHz – 2,7 GHz
on applicable to the frequency of
the transmitter.
Recommended separation
distance
d = 1,2√P
d = 1,2√P 80 MHz – 800 MHz
d = 2,3√P 800 MHz – 2,7 GHz
Where P is the maximum output
power rating of the transmitter
in watts (W) according to the
transmitter manufacturer and d
is the recommended separation
distance in meters (m). Field
strengths from fixed RF
transmitters, as determined by
an electromagnetic site survey
should be less than the
compliance level in each
frequency range.
b)
Interference
may occur in the vicinity of
equipment marked with the
following symbol:

Declaration of Conformity

a)
51

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