156
Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Acoustic output table
Acoustic output table
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, and over-all operating conditions for that mode.
These tables fulfill the requirements of Appendix G, Section C2, of the
September 30, 1997 FDA document, “Information for Manufacturers Seeking
Marketing Clearance of Diagnostic Ultrasound Systems and Transducers”.
Global maximum derated I
SPTA
and MI values
Acoustic measurement precision and uncertainty
All table entries have been obtained at the same operating conditions that give
rise to the maximum index value in the first column of the table. Measurement
precision and uncertainty for power, pressure, intensity, and other quantities that
are used to derive the values in the acoustic output table are shown in the table
below. In accordance with Section 6.4 of the output display standard, the
following measurement precision and uncertainty values are determined by
making repeat measurements and stating the standard deviation as a
percentage.
Transducer
model
I
SPTA.3
TI type TI value MI
I
pa.3
@MImax
BF-UC180F 50 TIc 0.3 0.58 76.38
Transducer model Imaging mode
I
SPTA.3
MI
BF-UC180F 2D 14 0.58
Color power
doppler
50 0.56
Quantity
Precision
(% of standard deviation)
Uncertainty
(95% confidence)
Pr 5.4% 15%
Pr
.3
5.4% 15%
Wo 6.2% 19%
Fc < 1% 4.5%
Pll 3.2%
+21% to
24%
Pll
.3
3.2%
+21% to 24%
To Next Page
Loading...
