Chapter 6: Safety 135
Safety
The system is intended for use in the electromagnetic environment specified below.
Table 2: Manufacturer’s Declaration - Electromagnetic Immunity
Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment
Electrostatic
Discharge (ESD)
IEC 61000-4-2
2.0KV, 4.0KV, 6.0KV
contact
2.0KV, 4.0KV, 8.0KV air
2.0KV, 4.0KV, 6.0KV
contact
2.0KV, 4.0KV, 8.0KV
air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
Transient burst
IEC 61000-4-4
2KV on the mains
1KV on signal lines
2KV on the mains
1KV on signal lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Surge
IEC 61000-4-5
0.5KV, 1.0KV, 2.0KV on
AC power lines to
ground
0.5KV, 1.0KV on AC
power lines to lines
0.5KV, 1.0KV, 2.0KV
on AC power lines
to ground
0.5KV, 1.0KV on AC
power lines to
lines
Mains power quality should be that of a
typical commercial or hospital
environment.
Voltage dips,
short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
>5% U
T
(>95% dip in U
T
) for
0.5 cycle
40% U
T
(60% dip In U
T
) for 5
cycles
70% U
T
(30% dip in U
T
) for 25
cycles
>5% U
T
(>95% dip In U
T
) for 5s
>5% U
T
(>95% dip in U
T
)
for 0.5 cycle
40% U
T
(60% dip In U
T
) for
5cycles
70% U
T
(30% dip in U
T
) for
25 cycles
>5% U
T
(>95% dip In U
T
)
for 5s
Mains power quality should be that of a
typical commercial or hospital
environment. If the user of the SonoSite
TITAN ultrasound system requires
continued operation during power
mains interruptions, it is recommended
that the SonoSite TITAN ultrasound
system be powered from an
uninterruptible power supply or a
battery.
Power
Frequency
Magnetic Field
IEC 61000-4-8
3 A/m 3 A/m If image distortion occurs, it may be
necessary to position the SonoSite
TITAN 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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