Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
161
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Transducer Model: BF-UC180F Operating Mode: Mflow-mode
Index label MI
TIS TIB
TIC
Scan
Non-scan
Non-
scan
A
aprt
1cm
2
A
aprt
>1cm
2
Maximum Index Value (a) – 0.42 – 1.3 0.78
Assoc.
Acoustic
param.
p
r,
(MPa) #
W (mW) –15 13 15
min of [W
(z
1
), I
TA,
(z
1
)]
(mW)
–
z
1
(cm) –
z
bp
(cm) –
z
sp
(cm) # 1.1
d
eq
(z
sp
)
(cm)
0.14
ƒ
c
(MHz)#–6.1 –6.06.0
Dim of A
aprt
X(cm) – 0.67 – 0.67 0.67
Y(cm)
– 0.26 – 0.26 0.26
Other Info.
PD (µsec) #
PRF (Hz) #
p
r
@PII
max
(MPa) #
d
eq
@ PII
max
(cm) 0.14
Focal Length FL
x
(cm) –2.8 – 3.8
FL
y
(cm) –0.65 – 0.65
I
pa,
@.MI
max
(W/cm
2
)
#
Operator
Controls
DVA% (%) # – 73 – 92 55
Function # – – – – –
B/W Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
B/W Focus n/a n/a n/a n/a n/a n/a
B/W-Range (cm) # – 2.0 – 2.0 2.0
B/W Line Density n/a n/a n/a n/a n/a n/a
B/W Scan Area (%) n/a n/a n/a n/a n/a n/a
Doppler Image Select n/a n/a n/a n/a n/a n/a
Doppler Frequency Select (MHz) n/a n/a n/a n/a n/a n/a
Doppler Focus n/a n/a n/a n/a n/a n/a
Doppler Velocity Range (cm/sec) n/a n/a n/a n/a n/a n/a
Color Image Select # – PENET – PENET PENET
Color Doppler Frequency
Select
(MHz) # – 6 MHz – 6 MHz 6 MHz
Flow Focus # – F5 – F3 F7
Color Velocity Range (m/sec) # – 0.17 – 0.10 0.40
Color Line Density n/a n/a n/a n/a n/a n/a
Color Average n/a n/a n/a n/a n/a n/a
Flow Filter n/a n/a n/a n/a n/a n/a
Flow Scan Area (%) n/a n/a n/a n/a n/a n/a
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
Display TIS
max
0.42
Display TIB
max
1.3
Notes: (a) This index is not required for this operating mode;
see section 4.1.3.1 of the Output Display Standard (NEMA UD-3).
(b) This probe is not intended for transcranial or neonatal cephalic uses.
(c) This formulation for TIS is less than that for an alternate formulation in this mode.
# No data are reported for this operating condition since the global maximum index value is not reported for the
reason listed.