FujiFilm SonoSite M-Turbo User Manual page 125

FCC Caution: Changes or modifications not expressly approved by the party responsible for
compliance could void the user's authority to operate the equipment.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two
conditions:
• This device may not cause harmful interference.
This device must accept any interference received, including interference that may cause undesired
operation.
Immunity testing requirements
The M-Turbo ultrasound system complies with the essential performance requirements specified in
IEC 60601-1-2 and IEC 60601-2-37. Results of immunity testing show that the M-Turbo ultrasound
system meets these requirements and is free from the following:
• Noise on a waveform or artifacts or distortion in an image or error of a displayed numerical value
that cannot be attributed to a physiological effect and that may alter the diagnosis
• Display of incorrect numerical values associated with the diagnosis to be performed
• Display of incorrect safety related indications
• Production of unintended or excessive ultrasound output
• Production of unintended or excessive transducer assembly surface temperature
Production of unintended or uncontrolled motion of transducer assemblies intended for
intracorporeal use ALARA principle
ALARA is the guiding principle for the use of diagnostic ultrasound. Sonographers and other
qualified ultrasound users, using good judgment and insight, determine the exposure that is
"as low as reasonably achievable." There are no set rules to determine the correct exposure for
every situation. The qualified ultrasound user determines the most appropriate way to keep
exposure low and bioeffects to a minimum, while obtaining a diagnostic examination.
A thorough knowledge of the imaging modes, transducer capability, system setup and
scanning technique is necessary. The imaging mode determines the nature of the ultrasound
beam. A stationary beam results in a more concentrated exposure than a scanned beam, which
spreads that exposure over that area. The transducer capability depends upon the frequency,
penetration, resolution, and field of view. The default system presets are reset at the start of
each new patient. It is the scanning technique of the qualified ultrasound user along with
patient variability that determines the system settings throughout the exam.
The variables which affect the way the qualified ultrasound user implements the ALARA
principle include: patient body size, location of the bone relative to the focal point, attenuation
in the body, and ultrasound exposure time. Exposure time is an especially useful variable,
because the qualified ultrasound user can control it. The ability to limit the exposure over time
supports the ALARA principle.
Chapter 6: Safety 113