PadScan HD 2
Caresono Technology Co., Ltd
30
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.
Users must take responsibility for the safety of patients and utilize ultrasound deliberately.
Deliberate use of ultrasound means that output power of ultrasound must be selected based on ALARA.
Additional information regarding the concept of ALARA and the possible bioeffects of Ultrasound
is available in a document from the AIUM (American Institute of Ultrasound Medicine) title “Medical
Ultrasound Safety”.
Users can not adjust the acoustic output energy of the PadScan HD2 Bladder Scanner. And the
output level is below than the levels which were referred in AIUM remarks in 1992 and there were no
reported biological effects under the level. However, to minimize exposure, measurements should be
kept as short as possible. Refer to the acoustic output section for more information.
10.4 Acoustic Output
10.4.1 Derated Ultrasonic Output Parameters
The ‘derated’ intensity calculations are based on the measured center frequency of the acoustic
signal (fc, MHz) and the current hydrophone to the tested transducer(d, cm) using the derating factor
e‐.069×fc×d
10.4.2 Limits of Acoustic Output
In accordance with the FDA Track 1 requirements, the derating (or attenuated) approach was
incorporated into the FDA Acoustic Output Limits, as listed below. The maximum acoustic output level
from any transducer in any operating mode is expected to fall below these limits.
