Chapter 6: Safety 155
Safety
Global Maximum Derated I
SPTA
and MI Values
The following values represent worst-case values of the I
SPTA.3
and MI for each 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 14: C8/8-5 Transducer
Transducer Model Imaging Mode
Derated I
SPTA
MI
C8/8-5 MHz 2D 10 0.8
CPD 362 0.9
MMode 78 0.8
PW Doppler 474 0.9
Table 15: C11/8-5 Transducer
Transducer Model Imaging Mode
Derated I
SPTA
MI
C11/8-5 MHz 2D 3 0.4
CPD/Color 58 0.5
MMode 21 0.4
PW Doppler 340 0.5
CW Doppler 73 <0.1
Table 16: C15/4-2 Transducer
Transducer Model Imaging Mode
Derated I
SPTA
MI
C15/4-2 MHz 2D 12 0.7
CPD/Color 137 0.7
MMode 73 0.7
PW Doppler 423 0.7
CW Doppler 289 0.1