Output Display; Related Guidance Documents; Transducer Surface Temperature Rise; Acoustic Output Measurement - FujiFilm SonoSite Edge II Manual De Instrucciones

Output display

Related guidance documents

Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and
Transducers, FDA, 2008.
Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 2014. (A copy is included
with each system.)
Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA UD2-2004.
IEC 60601-2-37: 2015, Particular requirements for the basic safety and essential performance of ultrasonic
diagnostic and monitoring equipment.

Transducer surface temperature rise

Table 10-4 and Table 10-5 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.

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: 2015, Particular requirements for the basic safety and essential performance of ultrasonic
diagnostic and monitoring equipment.

Acoustic output tables

The format of the acoustic output tables has been updated.
Transducer model: C8x Operating mode: 2D .......................................................................................... 36
Transducer model: C8x Operating mode: M mode ................................................................................. 37
Transducer model: C8x Operating mode: Color/CPD ............................................................................. 38
Transducer model: C8x Operating mode: PW Doppler .......................................................................... 39
Output display 33