Transducer Surface Temperature Rise; Acoustic Output Measurement; Specifications; Standards - FujiFilm SonoLite M-Turbo Guia Del Usuario

Transducer surface temperature rise

Table 9-36 and Table 9-37 list the measured surface temperature rise from ambient (23°C ± 3°C) of
transducers used on the ultrasound system. The temperatures were measured in accordance with IEC
60601-2-37 with controls and settings positioned to give maximum temperatures.
For information about surface temperature rise for the TEExi transducer, refer to the TEExi Transducer User
Guide, included with the TEExi transducer.

Acoustic output measurement

Since the initial use of diagnostic ultrasound, the possible human biological effects (bioeffects) from
ultrasound exposure have been studied by various scientific and medical institutions. In October 1987, the
American Institute of Ultrasound in Medicine (AIUM) ratified a report from its Bioeffects Committee
(Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med., Sept. 1988: Vol. 7, No.
9 Supplement). The report, sometimes referred to as the Stowe Report, reviewed available data on possible
effects of ultrasound exposure. Another report, "Bioeffects and Safety of Diagnostic Ultrasound," dated
January 28, 1993, provides more current information.
The acoustic output for this ultrasound system has been measured and calculated in accordance with
"Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment" (NEMA UD2-2004), and
IEC 60601-2-37.

Specifications

Standards

Acoustic standards
NEMA UD 2-2004, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
IEC 60601-2-37:2007 Medical electrical equipment - Part 2-37: Particular requirements for the basic safety
and essential performance of ultrasonic medical diagnostic and monitoring equipment.
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