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Digital Color Doppler Palm Ultrasound System
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likelihood of cavitation and the related adverse effects.
MI
recognizes the importance of non-thermal processes, cavitation in particular, and the Index is an attempt
to indicate the probability that they might occur within the tissue.
2.6 Scanning Patients and Education
The Track-3 or IEC60601-2-37 output display standard allows users to share the responsibility for the safe
use of this ultrasound system. Follow these usage guidelines for safe operation:
In order to maintain proper cleanliness of the systems, always clean them between patients.
Always use a disinfected sheath on all EV/ER systems during every exam.
Continuously move the system, rather than staying in a single spot, to avoid elevated temperatures in
one part of the patient’s body.
Move system away from the patient when not actively scanning.
Understand the meaning of the TI, TIS, TIB and MI output display, as well as the relationship between
these parameters and the thermal/cavitation bioeffect to the tissue.
Expose the patient to only the very lowest practical transmit power levels for the shortest possible time
to achieve a satisfactory diagnosis (ALARA - As Low As Reasonably Achievable).
2.6.1 Safe Scanning Guidelines
Ultrasound should only be used for medical diagnosis and only by trained medical personnel.
Diagnostic ultrasound procedures should be done only by personnel fully trained in the use of the
equipment, in the interpretation of the results and images, and in the safe use of ultrasound (including
education as to potential hazards).
Operators should understand the likely influence of the machine controls, the operating mode (e.g. B-
mode, color Doppler imaging or spectral Doppler) and system frequency on thermal and cavitation
hazards.
Select a low setting for each new patient. Output should only be increased during the examination if
penetration is still required to achieve a satisfactory result, and after the Gain control has been moved
to its maximum value.
Maintain the shortest examination time necessary to produce a useful diagnostic result.
Do not hold the system in a fixed position for any longer than is necessary. It should be removed from
the patient whenever there is no need for real-time imaging or spectral Doppler acquisition. The frozen
frame and Cine loop capabilities allow images to be reviewed and discussed without exposing the
patient to continuous scanning.
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