Safety Biological Safety
46 Lumify Ultrasound System
Philips Healthcare 4535 618 58571_A/795 * MAY 2016
• Transducer: Each transducer type has unique specifications for contact area, beam shape,
and center frequency. Defaults are initialized when you select a transducer. Factory defaults
vary with transducer, application, and selected mode. Defaults have been chosen below the
FDA limits for intended use.
Related Guidance Documents
For more information about ultrasonic bioeffects and related topics, see the following:
• "Bioeffects and Safety of Diagnostic Ultrasound." AIUM Report, January 28, 1993.
• "American Institute of Ultrasound in Medicine Bioeffects Consensus Report." Journal of
Ultrasound in Medicine, Vol. 27, Issue 4, April 2008.
• Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM,
NEMA, 2004)
• Third Edition of the AIUM Medical Ultrasound Safety brochure, 2014. (A copy of this
document is provided with each system.)
• Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers. FDA, September 2008.
• Standard for Real‑Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment. (AIUM, NEMA, 2004)
• WFUMB. "Symposium on Safety of Ultrasound in Medicine: Conclusions and
Recommendations on Thermal and Non‑Thermal Mechanisms for Biological Effects of
Ultrasound." Ultrasound in Medicine and Biology, 1998: Vol. 24, Supplement 1.
Acoustic Output and Measurement
Since the initial use of diagnostic ultrasound, the possible human 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." Journal of
Ultrasound in Medicine, Vol. 7, No. 9 Supplement, September 1988), sometimes referred to as
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