Terason t3000 - Appendix F Acoustic Output Reporting for Track 3

Terason t3000 / Echo Ultrasound System User Guide 333
Appendix F Acoustic Output Reporting
for Track 3
Terason follows Track 3 of the FDA's Information for Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers. Track 3 does not require
evaluation of acoustic output on an application-specific basis, but the global maximum
derated I
SPTA
must not exceed 720 mW/cm
2
and the global maximum MI must not exceed
1.9. Ophthalmic use is an exception, and has a different requirement: the TI =
max.(TIS_as, TIC), and must not exceed 1.0. I
SPTA.3
must not exceed 50 mW/cm
2
, and
MI must not exceed 0.23.
This appendix contains tables that display the Acoustic Output Reporting for Track 3.
Tables are shown for the scanning modes for the following transducers:
t3000 Transducers (see page 334) Echo Transducers (see page 385)
4V2A
4V2A
4V2S
5C2A
5C2A 7L3V
7L3V 8EC4A
8BP4 12HL7
8EC4A 12L5V
8MC3 PDOF
8TV4
10V5S
12HL7
12L5V