23-1
23 Acoustic Output
This section of the operator’s manual applies to the overall system including the main unit,
transducers, 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.
23.1 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.
23.2 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.
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