Acoustic Output; Applying Alara - FujiFilm SonoLite M-Turbo Guia Del Usuario

Table 6: Manufacturer's Declaration - Electromagnetic Immunity per IEC 60601-1-2:2014
IEC 60601 Test
Immunity Test
Level
Note U
T
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.
FCC Caution: This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a commercial environment. This equipment
generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with
the instruction manual, may cause harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful interference in which case the user will be required
to correct the interference at his own expense.

Acoustic output

Applying ALARA

The system imaging mode selected by the qualified ultrasound user is determined by the diagnostic
information required. 2D imaging provides anatomical information; CPD imaging provides information about
the energy or amplitude strength of the Doppler signal over time at a given anatomical location and is used
for detecting the presence of blood flow; Color imaging provides information about the energy or amplitude
strength of the Doppler signal over time at a given anatomical location and is used for detecting the
presence, velocity, and direction of blood flow; tissue harmonic imaging uses higher received frequencies to
reduce clutter, artifact, and improve resolution on the 2D image. Understanding the nature of the imaging
mode used allows the qualified ultrasound user to apply the ALARA principle.
Applying ALARA
Compliance
Level
is the AC mains voltage prior to application of the test level.
Electromagnetic Environment
15