F9, F9 Express Fetal & Maternal Monitor User Manual Ultrasound Intensity and Safety
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A4.4 Prudent Use Statement
Although no confirmed bioeffects on patients caused by exposure from present diagnostic
ultrasound equipment have ever been reported, the potential exists that such bioeffects may be
identified in the future. Therefore, the ultrasound should be used prudently. High levels of
acoustic output and long exposure time should be avoided while acquiring necessary clinical
information.
A4.5 References for Acoustic Output and Safety
1. “Bioeffects and Safety of Diagnostic Ultrasound” issued by AIUM in 1993
2. “Medical Ultrasound Safety” issued by AIUM in 1994
3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment,
Revision 3" issued by AIUM/NEMA in 2004
4. "Standard for real-time display of thermal and mechanical acoustic output indices on
diagnostic ultrasound equipment, Revision 2" issued by AIUM/NEMA in 2004
5. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic
Ultrasound Systems and Transducers" issued in 2008.
6. “Medical electrical equipment—Part 2-37: Particular requirements for the basic safety and
essential performance of ultrasonic medical diagnostic and monitoring equipment" issued by
IEC in 2007.
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