FujiFilm SonoSite Edge II Manual De Instrucciones página 21

Table 1-4: Manufacturer's Declaration - Electromagnetic Immunity per IEC 60601-1-2:2007
IEC 60601 Test
Immunity Test
Level
a. Field strengths from fixed transmitters such as base stations for radio (cellular/cordless) telephones
and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be
predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF
transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the FUJIFILM SonoSite ultrasound system is used exceeds the applicable RF
compliance level above, the FUJIFILM SonoSite ultrasound system should be observed to verify normal
operation. If abnormal performance is observed, additional measures may be necessary, such as re-
orienting or relocating the FUJIFILM SonoSite ultrasound system.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 1-5: Manufacturer's Declaration - Electromagnetic Immunity per IEC 60601-1-2:2014
IEC 60601 Test
Immunity Test
Level
Electrostatic ± 8.0KV, contact
Discharge (ESD) ± 2.0KV, ± 4.0KV, ±
IEC 61000-4-2 8.0KV air, ± 15KV
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, 0% U
short
0% U
interruptions
70% U
and voltage
(30% dip in U
variations on
500 msec
power supply
<5% U
input lines
(>95% dip in U
IEC 61000-4-11
5s
Manufacturer's declaration
Compliance
Level
Compliance
Level
± 8.0KV, ± 4.0KV,
± 8.0KV air, ±
15KV
± 2KV on the
mains
± 1KV on signal
lines
± 1KV line(s) to
line(s)
± 2KV line(s) to
earth
for 0.5 cycle 0% U
T
for 5 cycles cycle
T
0% U
T
70% U
) for
T
in U
T
msec
T
<5% U
) for
T
(>95% dip in U
for 5s
Electromagnetic Environment
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.
for 0.5 Mains power quality should be that of
T
a typical commercial or hospital
environment. If the user of the
for 5 cycles
T
FUJIFILM SonoSite ultrasound system
(30% dip
T
requires continued operation during
) for 500
power mains interruptions, it is
recommended that the FUJIFILM
T SonoSite ultrasound system be
)
powered from an uninterruptible
T
power supply or a battery.
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