158
Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Acoustic output table for default settings when combined
with SSD-5
Transducer Model: BF-UC180F
Acoustic Output
MI
TIS TIB
TIC
Maximum Value 0.65 0.31 0.37 0.67
Operating mode B B/Bflow PWD B/Bflow
Operator
Controls
DVA% (%)70547054
Function ––––
B/W Frequency Select (MHz) 12 MHz 12 MHz 12 MHz 12 MHz
B/W Focus F4+F7 F6 F6 F6
B/W-Range (cm) 12.0 12.0 12.0 12.0
B/W Line Density HIGH HIGH HIGH HIGH
B/W Scan Area (%) 100 100 100 100
Doppler Image Select n/a n/a PENET n/a
Doppler Frequency Select (MHz) n/a n/a 5 MHz n/a
Doppler Focus n/a n/a F7 n/a
Doppler Velocity Range (cm/sec) n/a n/a 24.9 n/a
Color Image Select n/a STD n/a STD
Color Doppler Frequency Select (MHz) n/a 5 MHz n/a 5 MHZ
Flow Focus n/a F7 n/a F7
Color Velocity Range (m/sec) n/a 0.17 n/a 0.17
Color Line Density n/a LOW n/a LOW
Color Average n/a HIGH n/a HIGH
Flow Filter n/a #5 n/a #5
Flow Scan Area (%) n/a 50 n/a 50
Triplex Velocity Range n/a n/a n/a n/a
I
SPTA.3
(mW/cm
2
)
8.7 19 67 19