Table 5: Manufacturer's Declaration - Electromagnetic Immunity per IEC 60601-1-2:2007
IEC 60601 Test
Immunity Test
Level
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
Conducted RF
3 Vrms
IEC 61000-4-6
150 kHz to 80 MHz
Manufacturer's declaration
Compliance
Level
± 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
) for 25
T
T
cycles
<5% U
T
) for
(>95% dip in U
T
for 5s
3 A/m
3 Vrms
Electromagnetic 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
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.
Portable and mobile RF
communications equipment should be
used no closer to any part of the
FUJIFILM SonoSite ultrasound system
including cables, than the
recommended separation distance
calculated from the equation
applicable to the frequency of the
transmitter.
Recommended Separation Distance
= 1.2 √
d
P
11