GE Vivid S70, User Manual

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Acoustic output
Vivid S70 / S60
–
User Manual
2-7
BC092760-1EN 01
NOTE: The Vivid S70 / S60 does not monitor the duration of thermal
exposure.
References
• The British Medical Ultrasound Society. Guidelines for the
safe use of diagnostic ultrasound equipment.
• American Institute of Ultrasound in Medicine Consensus
Report on Potential Bioeffects of Diagnostic Ultrasound.
The maximum possible MI and Ispta on the Vivid S70 / S60 is
within the limits set in Track 3 in the FDA 510(k) guide of
September 9, 2008, MI < 1.9 and Ispta < 720 mW/cm
2
.
ALARA
Ultrasound procedures should be performed using output levels
and exposure times As Low As Reasonably Achievable
(ALARA) while acquiring clinical information.
Training
During each ultrasound examination the user is expected to
weigh the medical benefit of the diagnostic information that
would be obtained against the risk of potentially harmful effects.
Once an optimal image is achieved, the need for increasing
acoustic output or prolonging the exposure cannot be justified. It
is recommended that all users receive proper training in
applications before performing them in a clinical setting. Contact
the GE sales representative for training assistance.
Safety statement
GE safety statement
Although no harmful biological effects have been demonstrated
for ultrasound frequencies, intensities, or exposure times used
in examination with the GE system, GE recommends using the
lowest acoustic output settings which will produce diagnostically
acceptable information.