Safety
92 KOSMOS User Guide
• TIS: Soft tissue thermal index. The main TI category. Used for applications that
do not image bone.
• TIB: Bone thermal index (bone located in a focal region).
M
ECHANICAL INDEX
MI is the estimated likelihood of tissue damage due to cavitation. The absolute
maximum limits of the MI is 1.9 as set by the Guidance for Industry and FDA
Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
(2019).
I
SPTA
The Ispta is the Spatial Peak Temporal Average Intensity. The absolute maximum
limit of Ispta is 720 mW/cm2 as set by the Guidance for Industry and FDA
Staff - Marketing Clearance of Diagnostic Ultrasound Systems and Transducers
(2019).
O
UTPUT DISPLAY ACCURACY
Output display accuracy of the bioeffect indices, MI and TI, is dependent on the
uncertainty and precision of the measurement system, engineering assumptions
within the acoustic model used to calculate the parameters, and variability in the
acoustic output of the systems. EchoNous also compares both internal and third-
party acoustic measurements and confirms that both measurements are within
recommended display quantization of 0.2 as outlined by the standards.
The accuracy of the MI and TI indices are as follows:
• MI: accurate to within ±25% or +0.2, whichever value is larger
• TI: accurate to within ±30% or +0.2, whichever value is larger
See acoustic output tables, TABLE 9-1 through TABLE 9-6.
Acoustic output tables
All MI and TI values displayed on KOSMOS will not exceed the
maximum global values (listed in the Track 3 acoustic output
tables) by more than 0.2.
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