Safety
pr at Pllmax:
is the peak rare factional pressure at the point where the free-field, spatial peak pulse
intensity integral is a maximum (megapascals). (See section 6 of the Standard for
Real-Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound
Equipment, entitled "Measurement Methodology for Mechanical and Thermal
Indices", § 6.2.6.1.)
FL:
is the focal length, or azimuthal and elevational lengths, if different (millimeters).
ROC:
is the radius of curvature (millimeters).
deq at Pllmax: is the equivalent beam diameter at the point where the free-field, spatial-peak pulse
intensity integral is a maximum (millimeters). (See Section 6 of the Standard for
Real-Time Display of Thermal and Mechanical Indices on Diagnostic Ultrasound
Equipment, entitled "Measurement Methodology for Mechanical and Thermal
Indices", § 6.2.6.1.).
Reference:
Revised 510(k) Diagnostic Ultrasound Guidance for 1993; CDRH, FDA; Feb. 17, 1993
2.13.9 Acoustic
Measurement
Uncertainties
ISPTA:
±
16% MI: ± 10%
ISPPA:
±
17% TIB: ± 35%
Pr:
±
10% TIS: ± 19%
Fc:
±
1% TIC ± 21%
W:
±
19%
2.13.10 Acoustic Output Tables
Acoustic Output Tables (acc. to Track 3 as demanded in the Revised 510(k). Diagnostic Ultrasound
Guidance for 1993; CDRH, FDA; Feb. 17, 1993), respectively guidance
Information for
Manufacturers Seeking Marketing
Clearance of Diagnostic Ultrasound Systems and Transducers
issued on September 30, 1997:
Please read the safety section for the complete explanation of the acoustic output in the User’s Manual
of the respective probes.
Voluson
®
730 - Instruction Manual
2-18
105838 Rev. 3
