GE Voluson 730Pro - Acoustic Measurement Uncertainties; Acoustic Output Tables

Safety
p
r
at Pll
max
: is the peak rarefactional 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).
d
eq
at Pll
max
: 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
I
SPTA
: ± 16% MI: ± 10%
I
SPPA
: ± 17% TIB: ± 35%
Pr: ± 10% TIS: ± 19%
F
c
: ± 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 refer to Probes and Biopsy
(chapter 20) as well as to the Advanced Reference Manual of
Voluson
®
730Pro for the complete explanation of the acoustic output of the respective probes.
Voluson
®
730Pro - Basic User Manual
2-18 105831 Rev. 0