FujiFilm SonoSite Edge II User Manual page 169

The system is intended for use in the electromagnetic environment specified below.
Table 9-4: Manufacturer's Declaration - Electromagnetic Immunity
Immunity Test IEC 60601 Test Level
Electrostatic ± 2.0KV, ± 4.0KV, ±
Discharge (ESD) 6.0KV contact
IEC 61000-4-2 ± 2.0KV, ± 4.0KV, ±
8.0KV air
Electrical fast ± 2KV on the mains
Transient burst ± 1KV on signal lines
IEC 61000-4-4
Surge IEC 61000- ± 1KV line(s) to line(s)
4-5 ± 2KV line(s) to earth
Voltage dips, <5% U
short
(>95% dip in U
interruptions and
0.5 cycle
voltage
40% U
variations on
(60% dip in U
power supply
cycles
input lines
70% U
IEC 61000-4-11
(30% dip in U
cycles
<5% U
(>95% dip in U
Power Frequency 3 A/m
Magnetic Field
IEC 61000-4-8
Electromagnetic compatibility
Compliance Level
± 2.0KV, ± 4.0KV, ±
6.0KV contact
± 2.0KV, ± 4.0KV, ±
8.0KV air
± 2KV on the mains
± 1KV on signal lines
± 1KV line(s) to line(s)
± 2KV line(s) to earth
<5% U
T
) for (>95% dip in U
T
0.5 cycle
40% U
T
) for 5 (60% dip in U
T
cycles
70% U
T
) for 25 U ) for 25 cycles
T T
<5% U
(>95% dip in U
T
) for 5s
T
3 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.
Mains power quality should be
T
that of a typical commercial or
) for
T
hospital environment. If the user
of the FUJIFILM SonoSite
T
ultrasound system requires
) for 5
T
continued operation during
power mains interruptions, it is
(30% dip in
T
recommended that the FUJIFILM
SonoSite ultrasound system be
powered from an uninterruptible
T
power supply or a battery.
) for 5s
T
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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