Olympus BF-UC180F Instructions Manual page 163

Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: "Information for Manufacturers
Acoustic output table
Global maximum derated I
Acoustic measurement precision and uncertainty
156
 Acoustic output table
Transducer
I
SPTA.3
model
BF-UC180F 50
The following values represent worst-case values of the I
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
Transducer model
BF-UC180F
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.
Quantity
Pr
Pr
.3
Wo
Fc
Pll
Pll
.3
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
TI type TI value
TIc
and MI values
SPTA
SPTA
Imaging mode
2D
Color power
doppler
Precision
(% of standard deviation)
5.4%
5.4%
6.2%
< 1%
3.2%
3.2%
MI
0.3 0.58
and MI for each
SPTA.3
and MI values
I
SPTA.3
14
50
Uncertainty
(95% confidence)
15%
15%
19%
4.5%
+21% to
+21% to
I @MImax
pa.3
76.38
MI
0.58
0.56

24%

24%