EDAN F6 User manual - A4.4 Prudent Use Statement

F Series Fetal & Maternal Monitor User Manual                   Ultrasound Intensity and Safety 

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pressure values and ± 14.52 percent for the Mechanical Index. 

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.