SonoSite iLook - Acoustic Output Tables; Global Maximum Derated ISPTA and MI Values

52 Chapter 5: Safety
Safety
Acoustic Output Tables
Table 2 indicates the acoustic output for the system and the C15 and L25 transducers.
Global Maximum Derated I
SPTA
and MI Values
The following values represent worst-case values of the I
SPTA.3
and MI for the transducer and each
mode, over all operating conditions for that mode. These tables fulfill the requirements of Appendix
G, Section C2, of the September 30, 1997 issue of the FDA document, “Information for
Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.”
Table 2: Acoustic Output
Transducer Model
I
SPTA.3
TI Type TI Value MI
I
pa.3
@MI
max
C15/4-2 MHz 27 TIC 0.6 0.6 25.73
L25/10-5 MHz 29 TIC 0.2 0.7 41.51
Table 3: C15/4-2 Transducer
Transducer Model Imaging Mode
Derated I
SPTA
MI
C15/4-2 MHz 2D 6 0.5
CPD 17 0.6
DCPD 27 0.6
Table 4: L25/10-5 Transducer
Transducer Model Imaging Mode
Derated I
SPTA
MI
L25/10-5 MHz 2D 9 0.7
CPD 29 0.7