ECO 3 EXPERT Ultrasound Diagnostic System
Page 14 / 191
Maximum recommended exposure times for an embryo or fetus
Non-diagnostic use of ultrasound equipment is not generally recommended. Examples of
non-diagnostic uses of ultrasound equipment include repeated scans for operator training,
equipment demonstration using normal subjects, and the production of souvenir pictures or videos
of a fetus. For equipment of which the safety indices are displayed over their full range of values,
the TI should always be less than 0.5 and the MI should always be less than 0.3. Avoid frequent
repeated exposure of any subject. Scans in the first trimester of pregnancy should not be carried
out for the sole purpose of producing souvenir videos or photographs, nor should their production
involve increasing the exposure levels or extending the scan times beyond those needed for
clinical purposes.
Diagnostic ultrasound has the potential for both false positive and false negative results.
Misdiagnosis is far more dangerous than any effect that might result from the ultrasound exposure.
Therefore, diagnostic ultrasound system should be performed only by those with sufficient training
and education.
2.6.2 Understanding the MI/TI Display
Track-3 follows the Output Display Standard for systems that include fetal Doppler applications.
The acoustic output will not be evaluated on an application-specific basis, but the global maximum
de-rated Ispta must be ≤ 720 mW/ cm
2
and either the global maximum MI must be ≤ 1.9 or the
global maximum de-rated Isppa must be ≤ 190 W/cm
2
. An exception is for ophthalmic use, in
which case the TI = max (TIS_as, TIC) is not to exceed 1.0; Ispta.3 ≤50mW/cm
2
, and MI ≤ 0.23.
Track-3 gives the user the freedom to increase the output acoustic power for a specific exam, and
still limit output acoustic power within the global maximum de-rated Ispta ≤ 720 mW/cm
2
under an
Output Display Standard.
For any diagnostic ultrasonic systems, Track-3 provides an Output Indices Display Standard. The
diagnostic ultrasound systems and its operation manual contain the information regarding an
ALARA (As Low As Reasonably Achievable) education program for the clinical end-user and the
To Next Page
Loading...
