Safety
pr at Pllmax: 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).
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 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
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