Table 6: Manufacturer's Declaration - Electromagnetic Immunity per IEC 60601-1-2:2014
IEC 60601 Test
Immunity Test
Level
Electrostatic
± 8.0KV, contact
Discharge (ESD)
± 2.0KV, ± 4.0KV, ±
IEC 61000-4-2
8.0KV air, ± 15KV
Electrical fast
± 2KV on the mains
Transient burst
± 1KV on signal lines
IEC 61000-4-4
Surge
± 1KV line(s) to
IEC 61000-4-5
line(s)
± 2KV line(s) to earth
Voltage dips,
0% U
short
0% U
interruptions
70% U
and voltage
(30% dip in U
variations on
500 msec
power supply
<5% U
input lines
(>95% dip in U
IEC 61000-4-11
5s
Power
30 A/m
Frequency
Magnetic Field
IEC 61000-4-8
Manufacturer's declaration
Compliance
Level
± 8.0KV, ± 4.0KV,
± 8.0KV air,
± 15KV
± 2KV on the
mains
± 1KV on signal
lines
± 1KV line(s) to
line(s)
± 2KV line(s) to
earth
for 0.5 cycle
0% U
T
for 5 cycles
0.5 cycle
T
0% U
T
70% U
) for
T
in U
T
500 msec
T
<5% U
) for
T
(>95% dip in U
for 5s
30 A/m
Electromagnetic Environment
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.
for
Mains power quality should be that of
T
a typical commercial or hospital
environment. If the user of the
for 5 cycles
T
FUJIFILM SonoSite ultrasound system
(30% dip
T
requires continued operation during
) for
power mains interruptions, it is
recommended that the FUJIFILM
T
SonoSite ultrasound system be
)
powered from an uninterruptible
T
power supply or a battery.
If image distortion occurs, it may be
necessary to position the FUJIFILM
SonoSite ultrasound system further
from sources of power frequency
magnetic fields or to install magnetic
shielding. The power frequency
magnetic field should be measured in
the Intended installation location to
assure that it is sufficiently low.
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