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Immunity test
Electrostatic discharge
(ESD)
IEC 61000-4-2
Electrical fast
transient/burst
IEC 61000-4-4
Surge
IEC61000-4-5
Voltage dips, short
interruptions and voltage
variations on power
supply input lines
IEC 61000-4-11
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
1. is the a.c. mains voltage prior to application of the test level.
2. Mammo Tomosynthesis doesn't contain susceptible components to magnetic fields
K5902035 MAMMO TOMOSYNTHESIS 07/12/2017
IEC 60601
Test levels
± 6kV contact
± 8kV air
± 2kV for power supply
lines
± 1kV for input/ output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
1
< 5% U
(> 95% dip in
T
U
) for 0.5 cycle
T
40% U
(60% dip in U
T
for 5 cycles
70% U
(30% dip in U
T
for 25 cycles
< 5% U
(>95% dip in
T
U
) for 5s
T
3 A/m
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Compliance level
± 6kV contact
± 8kV air
± 2kV for power supply
lines
± 1kV for input/ output
lines
± 1 kV line(s) to line(s)
± 2 kV line(s) to earth
< 5% U
(> 95% dip in
T
U
) for 0.5 cycle
T
)
40% U
(60% dip in U
T
T
for 5 cycles
)
70% U
(30% dip in U
T
T
for 25 cycles
< 5% U
(>95% dip in
T
U
) for 5s
T
2
Not applicable
3 V
3 V/m
7. Important information
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%
Mains power quality
should be that of a typical
commercial or hospital
environment
Mains power quality
should be that of a typical
commercial or hospital
environment
Mains power quality
should by that of a
typical commercial or
)
T
hospital environment. If
the user of the Mammo
)
Tomosynthesis requires
T
continued operation
during power mains
interruptions, it is
recommended that the
Mammo Tomosynthesis
be powered from an
uninterruptible power
supply or a battery.
Power frequency
magnetic fields should
be at levels characteristic
of a typical location in
a typical commercial or
hospital environment.
Portable and mobile
RF communications
equipment should
be used no closer
to any part of the
Mammo Tomosynthesis,
including cables, than
the recommended
separation distance
calculated from the
equation applicable
to the frequency
of the transmitter.
Recommended
separation distance
d = 1.2√P
d = 1.2√P 80 MHz to 800
MHz
45
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