SonoSite titan, User Manual Supplement

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4 Chapter 6: 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
5 cycles
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
ultrasound system requires continued
operation during power mains
interruptions, it is recommended that
the SonoSite 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
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.