Prudent Use Statement; References For Acoustic Output And Safety; Transducer Acoustic Output Data - EDAN Acclarix AX3 User Manual

Acclarix AX3 Series Diagnostic Ultrasound System User Manual
 Indirect Controls
The acoustic output of the system can be controlled indirectly through many imaging parameters,
including imaging modes, field of view, line density, probe frequency, focus number/position, depth
and pulse repetition frequency (PRF).
The imaging mode determines whether the ultrasound beam is scanning or non-scanning. Thermal
bioeffect is closely associated with M, PW and Color mode.
Acoustic attenuation of tissue is directly connected to probe frequency.
The focus number/position is related to active aperture of probe and beam width.
The higher PRF (pulse repetition frequency), the more output pulses occur over a period of time.
 Receiver Controls
The receiver controls (such as gain, TGC, dynamic range and image processing), which are used to
improve image quality, have no effect on acoustic output. Thus these controls should be optimized
before increasing acoustic output.
B.6 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.
B.7 References for Acoustic Output and Safety
"Bioeffects and Safety of Diagnostic Ultrasound" issued by AIUM in 1993
1.
"Medical Ultrasound Safety" issued by AIUM in 1994
2.
3. "Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment, Revision 3"
issued by AIUM/NEMA in 2004
4. "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems
and Transducers" issued in 2008.
5. .IEC60601-2-37, Medical electrical equipment - Part 2-37:2007+AMD1:2015 Particular
requirements for the basic safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment, International Electro technical Commission.
6. Roy C. Preston, David R. Bacon, and Robert A. Smith, Calibration of Medical Ultrasonic
Equipment - Procedures and Accuracy Assessment, IEEE Transactions on Ultrasonics,
Ferroelectrics, and Frequency Control, Vol. 35, No. 2, page110, March 1988.
B.8 Transducer Acoustic Output Data
Please refer to the User Manual Advanced Volume(P/N: 01.54.458118) for details acoustic output
data of each transducer.
- 135 -
Ultrasound Intensity and Safety