SonoSite titan - Acoustic Output Measurement

140 Chapter 6: Safety
Safety
The thermal index consists of three user selectable indices, and only one of these is displayed at any
one time. In order to display properly and meet the ALARA principle, the user selects an
appropriate TI based on the specific exam being performed. SonoSite provides the AIUM Medical
Ultrasound Safety reference which contains guidance on how to determine which TI is appropriate
(see second reference listed in “Related Guidance Documents” below).
Related Guidance Documents
• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems
and Transducers, FDA, 1997.
• Medical Ultrasound Safety, American Institute of Ultrasound in Medicine (AIUM), 1994. (A
copy is included with each system.)
• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, NEMA
UD2-1998.
• Acoustic Output Measurement and Labeling Standard for Diagnostic Ultrasound Equipment,
American Institute of Ultrasound in Medicine, 1993.
• Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment, American Institute of Ultrasound in Medicine, 1998.
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 prepared by its
Bioeffects Committee (Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J
Ultrasound Med., Sept. 1988: Vol. 7, No. 9 Supplement), sometimes referred to as the Stowe Report,
which 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 the “Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment” (NEMA
UD 2-1998), and the “Standard for Real-Time Display of Thermal and Mechanical Acoustic Output
Indices on Diagnostic Ultrasound Equipment” (AIUM and NEMA 1998).