Table 5: Manufacturer's Declaration - Electromagnetic Immunity per IEC 60601-1-2:2007
IEC 60601 Test
Immunity Test
Level
Radiated RF
3 V/m
IEC 61000-4-3
80 MHz to 2.5 GHz
Note
U
At 80 MHz and 800 MHz, the higher frequency range applies.
These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
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.
12
Compliance
Level
3 V/m
80 MHz to 2.5 GHz
is the AC mains voltage prior to application of the test level.
T
Electromagnetic Environment
= 1.2 √
80 MHz to 800 MHz
d
P
= 2.3 √
800 MHz to 2.5 GHz
d
P
Where
is the maximum output
P
power rating of the transmitter in
watts (10) according to the
transmitter manufacturer and it is the
recommended separation distance in
meters (m).
Field strengths from fixed RF
transmitters, as determined by an
electromagnetic site survey
be less than the compliance level in
b
each frequency range
Interference may occur in the vicinity
of equipment marked with the
following symbol:
(IEC 60417 No. 417-IEC-5140:
"Source of non-ionizing radiation")
Manufacturer's declaration
a
, should
.