Chapter 2. Safety 2 - 33
factory defaults vary with probe, application and mode. Defaults that are below the FDA
limits have been chosen for intended use.
Depth
An increase in the 2D-mode depth will automatically decrease the 2D-mode frame
rate. This would decrease the TI. The system may also automatically choose a
deeper 2D-mode focal depth. A change of focal depth may change the MI. The MI
displayed is that of the zone with the largest peak intensity.
Application
Acoustic output defaults are set when you select an application. Samsung Medison's
factory defaults vary with probe, application, and mode. Defaults that are below the
FDA limits have been chosen for intended use.
▌ Related Guidance Documents
For more information about ultrasonic bioeffects and related topics, refer to the following;
- AIUM Report, January 28, 1993, “Bioeffects and Safety of Diagnostic Ultrasound”
- Bioeffects Considerations for the Safety of Diagnostic Ultrasound, J Ultrasound Med.,
Sept. 1998: Vol. 7, No. 9 Supplement
- Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment. (AIUM,
NEMA. 1998)
- Acoustic Output Labeling Standard for Diagnostic Ultrasound Equipment (AIUM, 1998)
- Second Edition of the AIUM Output Display Standard Brochure, Dated March 10, 1994.
(A copy of this document is shipped with each system.)
- Information for Manufacturer Seeking Marketing Clearance of Diagnostic Ultrasound
Systems and Transducers. FDA. September 1997. FDA.
- Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on
Diagnostic Ultrasound Equipment. (Revision 1, AIUM, NEMA. 1998)
- 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, Supplement1.
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