Acoustic Output; Concerns With Bioeffects; Prudent Use Statement; Alara Principle (As Low As Reasonably Achievable) - Mindray DC-40 Operator's Manual

14

Acoustic Output

This section of the operator's manual applies to the overall system including the main unit,
probes, accessories and peripherals. This section contains important safety information
for operators of the device, pertaining to acoustic output and how to control patient
exposure through use of the ALARA (as low as reasonably achievable) principle. Also this
section contains information regarding the acoustic output testing and the real-time
output display.
Read this information carefully before using the system.

14.1 Concerns with Bioeffects

Diagnostic ultrasound is recognized as being safe. In fact, there have been no reports of
injuries to patients caused by diagnostic ultrasound.
It cannot be stated categorically that ultrasound is 100% safe. Studies have revealed that
ultrasound with extremely high intensity is harmful to body tissues.
Diagnostic ultrasound technology has made a great leap forward during the last several
years. This rapid advance has generated concerns about the potential risk of bioeffects
when new applications or diagnostic technologies become available.

14.2 Prudent Use Statement

Although there are no confirmed biological effects on patients caused by exposures from
present diagnostic ultrasound instruments, the possibility exists that such biological
effects may be identified in the future. Thus ultrasound should be used in a prudent
manner to provide medical benefit to the patient. High exposure levels and long exposure
times should be avoided while acquiring necessary clinical information.
14.3 ALARA Principle (As Low As
Reasonably Achievable)
It is required to practice ALARA when using ultrasound energy. Practicing ALARA
ensures that the total energy level is controlled below a low enough level at which
bioeffects are not generated while diagnostic information is being accumulated. The total
energy is controlled by output intensity and total radiation time. The output intensity
necessary for examinations differs depending on the patient and the clinical case.
Not all examinations can be performed with an extremely low level of acoustic energy.
Controlling the acoustic level at an extremely low level leads to low-quality images or
insufficient Doppler signals, adversely affecting the reliability of the diagnosis. However,
increasing the acoustic power more than necessary does not always contribute to an
increase in quality of information required for diagnosis, rather increasing the risk of
generating bioeffects.
Acoustic Output 14-1