User's Manual

Table Of Contents
InnoSight Ultrasound System
Biological Safety 
2 enin
20
P6992-4, EN, 16/12/6
Take particular care to reduce output and minimize exposure time of an embryo or fetus when
the temperature of the mother is already elevated
Take particular care to reduce the risk of thermal hazard during diagnostic ultrasound when
exposing an embryo less than eight weeks after gestation, or the head, brain or spine of any
fetus or neonate
Although applicable to any transducer, take particular care during trans-vaginal exams during
the first eight weeks of gestation
During continuous operation, the system temperature may become too high If the following system
message displays during a real-time scan, touch OK and the system displays frozen imaging screen To
resume scanning, wait until the system engine cools down
System temperature is high. Please cease
the current scan for a few minutes.
OK
Operators should continually monitor the on-screen thermal index (TI) and mechanical index (MI) values
and use control settings that keep these settings as low as possible while still achieving diagnostically
useful results In obstetric examinations, TIS (soft tissue thermal index) should be monitored during
scans carried out in the first eight weeks after gestation, and TIB (bone thermal index) thereafter
MI 3 Minor damage is likely to happen to neonatal lung or intestine If such exposure is
necessary, reduce the exposure time as much as possible
MI  Risk of cavitation exists if an ultrasound contrast agent containing gas microspheres is
being used There is a theoretical risk of cavitation without the presence of ultrasound
contrast agents The risk increases with MI values above this threshold
TI  The overall exposure time of an embryo or fetus should be restricted in accordance with
the following table as a reference
TI Maximum exposure time (minutes)
 60
1 3
1 1
2 4
2 1
Tale 2Maximum exposure time recommended for an embryo or fetus
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 should be performed only by those with sufficient training and education
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
 and the MI should always be less than 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