FujiFilm SonoSite Edge II User Manual page 185

The system is intended for use in the electromagnetic environment specified below.
Table 9-4: Manufacturer's Declaration - Electromagnetic Immunity
IEC 60601 Test
Immunity 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 ± 1KV line(s) to
IEC 61000-4-5 line(s)
± 2KV line(s) to earth
Voltage dips, <5% U
short
(>95% dip in U
interruptions
0.5 cycle
and voltage
40% U
variations on
(60% dip in U
power supply
cycles
input lines
70% U
IEC 61000-4-11
(30% dip in U
25 cycles
<5% U
(>95% dip in U
5s
Power 3 A/m
Frequency
Magnetic Field
IEC 61000-4-8
Safety
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
for 0.5 cycle
40% U
T
) for 5 (60% dip in U
T
5 cycles
70% U
T
) for in U
T T
cycles
<5% U
T
) for (>95% dip in U
T
for 5s
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 that of
T
a typical commercial or hospital
)
T
environment. If the user of the
FUJIFILM SonoSite ultrasound system
T
requires continued operation during
) for
T
power mains interruptions, it is
recommended that the FUJIFILM
(30% dip
T
SonoSite ultrasound system be
) for 25
powered from an uninterruptible
power supply or a battery.
T
)
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.
9-19