PadScan HD 2
Caresono Technology Co., Ltd
29
Chapter Ten Acoustic Output
This section of the User ’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.
Read this information carefully before using the PadScan HD2 Bladder Scanner.
10.1 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.
10.2 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.
10.3 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
