Diagnostic ultrasound has been in use for over 25 years with no confirmed adverse effects on patients or instrument operators at the intensities typical of present diagnostic instruments. Although the total absence of adverse effects to human subjects after such extensive use at diagnostic power levels is gratifying, available data are not conclusive and the possibility that biological effects may be identified in the future remains. It is therefore deemed desirable by medical and other scientific authorities in this field that exposure to ultrasound should be limited to the duration and intensity appropriate for the clinical objective. Because fetal tissue could be more sensitive to biological effects, exposure to pregnant subjects should be kept to a minimum.
At present, there is a clear consensus that the benefits to patients of prudent use of diagnostic ultrasound outweigh the risks, if any that may be present.
AngelSounds is a portable battery operated detector designed for the detection of fetal life and confirmation of continued life during pregnancy.
Minimizing patient exposure
Acoustic output of the AngelSounds is internally controlled and cannot be changed by the operator in the course of the examination. The duration of which is, however, fully under the control of the operator. Mastery of the techniques described in the operating instructions will facilitate the maximum amount of diagnostic information with the minimum of exposure.
ULTRASOUND SAFETY CONSIDERATIONS AND DATA
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2 April 2009
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