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IEC 61000-4-5
Voltage dips, short
interruptions and voltage
variations on power supply
lines
IEC 61000-4-11
Power frequency
(50/60 Hz)
IEC 61000-4-8
Radiated fields in close
proximity — Immunity test
IEC 61000-4-39
Note: UT is the A.C. mains voltage prior to application of the test level.
Guidance and manufacturer's declaration — electromagnetic immunity
The Affinity is intended for use in the electromagnetic environment specified below. The customer or the user of the Affinity should assure
that it is used in such an environment,
Immunity test
Conducted RF
IEC / EN 61000-4-6
Radiated RF
IEC / EN 61000-4-3
+1 kV Line to line
+2 kV Line to earth
0% UT (100% dip in UT)
for 0.5 cycle, @ 0, 45, 90,
135, 180, 225, 270 and 315°
0% UT (100% dip in UT)
for 1 cycle
40% UT (60% dip in UT)
for 5 cycles
70% UT (30% dip in UT)
for 25 cycles
0% UT (100% dip in UT)
for 250 cycles
30 A/m
9 kHz to 13.56 MHz.
Frequency, level and
modulation defined in
AMD 1: 2020, table 11
IEC / EN 60601 test level
3 Vrms
150kHz to 80 MHz
6 Vrms
In ISM bands (and amateur
radio bands for Home
Healthcare environment.)
3 V/m
80 MHz to 2,7 GHz
10 V/m
80 MHz to 2,7 GHz
Only for Home Healthcare
environment
Not applicable
Not applicable
30 A/m
As defined in table 11
of AMD 1: 2020
Compliance level
3 Vrms
6 Vrms
3 V/m
10 V/m
(If Home Healthcare)
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Mains power quality should be that of a
typical commercial or residential environment.
Mains power quality should be that of a
typical commercial or residential environment.
If the user of the Affinity requires continued
operation during power mains interruptions, it
is recommended that the Affinity be powered
from an uninterruptable power supply or its
battery.
Power frequency magnetic fields should be at
levels characteristic of a typical location in a
typical commercial or residential environment.
If the Affinity contains magnetically sensitive
components or circuits, the proximity
magnetic fields should be no higher than the
test levels specified in Table 11
Electromagnetic environment – guidance
Portable and mobile RF communications
equipment should be used no closer to any
parts of the Affinity, including cables, than
the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Recommended separation distance:
3,5
���� =
√ ����
����������������
���� =
√ ����
3,5
����/����
80 MHz to 800
MHz
���� =
√ ����
7
����/����
800 MHz to 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
a
level in each frequency range.
b
Interference may occur in the vicinity of
equipment marked with the following symbol:
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