Manufacturer's Declaration - FujiFilm SonoLite M-Turbo Guia Del Usuario

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Manufacturer's declaration

The tables in this section document the intended use environment and EMC compliance levels of the system.
For maximum performance, ensure that the system is used in the environments described in this table.
The system is intended for use in the electromagnetic environment specified below.
Table 4: Manufacturer's Declaration - Electromagnetic Emissions per IEC 60601-1-2:2007 and
IEC 60601-1-2:2014
Emissions Test
RF emissions
ClSPR 11
RF emissions
ClSPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
The system is intended for use in the electromagnetic environment specified below.
Table 5: Manufacturer's Declaration - Electromagnetic Immunity per IEC 60601-1-2:2007
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
10
Compliance
Group 1
Class A
Class A
Complies
Compliance
Level
± 2.0KV, ± 4.0KV,
± 6.0KV contact
± 2.0KV, ± 4.0KV,
± 8.0KV air
± 2KV on the
mains
± 1KV on signal
lines
Electromagnetic Environment
The SonoSite M-Turbo ultrasound
system uses RF energy only for its
internal function. Therefore, its RF
emission is very low and is not
likely to cause any interference in
nearby electronic equipment.
The SonoSite M-Turbo ultrasound
system is suitable for use in all
establishments other than
domestic and those directly
connected to the public low-
voltage power supply network
which supplies buildings used for
domestic purposes.
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.
Manufacturer's declaration

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