ECO 2 Ultrasound Diagnostic System
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necessary, reduce the exposure time as much as possible.
MI> 0.7 there is a risk of cavitations if an ultrasound contrast agent containing gas micro-spheres
is being used. There is a theoretical risk of cavitations without the presence of ultrasound contrast
agents. The risk increases with MI values above this threshold.
TI> 0.7 the overall exposure time of an embryo or fetus should be restricted in accordance with
table below as a reference:
Maximum exposure
time (minutes)
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
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