52
Chapter 5: Safety
Sa
fe
ty
Acoustic Output Tables
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
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