Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
159
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Acoustic output table for track3 when combined with
SSD-5
Transducer Model:
BF-UC180F
Operating Mode:
B-mode
Index label MI
TIS TIB
TIC
Scan
Non-scan
Non-
scan
A
aprt
1cm
2
A
aprt
>1cm
2
Maximum Index Value 1.5 (a) – – – (a)
Assoc.
Acoustic
Param.
p
r,
(MPa) 4.0
W (mW) #– –#
min of [W
(z
1
), I
TA,
(z
1
)]
(mW)
–
z
1
(cm) –
z
bp
(cm) –
z
sp
(cm) 0.36 –
d
eq
(z
sp
)
(cm)
–
ƒ
c
(MHz) 6.7 # – – – #
Dim of A
aprt
X(cm) #– ––#
Y(cm)
#– ––#
Other Info.
PD (µsec) 0.12
PRF (Hz) 8680
p
r
@PII
max
(MPa) 4.1
d
eq
@ PII
max
(cm) –
Focal Length FL
x
(cm) #– – #
FL
y
(cm) #– – #
I
pa,
@.MI
max
(W/cm
2
)
970
Operator
Controls
DVA% (%) 100 # – – – #
Function – # – – – #
B/W Frequency Select (MHz) 7.5MHz # – – – #
B/W Focus F1 # – – – #
B/W-Range (cm) 2.0 # – – – #
B/W Line Density HIGH # – – – #
B/W Scan Area (%) 25 # – – – #
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 n/a n/a n/a n/a n/a n/a
Color Doppler Frequency
Select
(MHz) n/a n/a n/a n/a n/a n/a
Flow Focus n/a n/a n/a n/a n/a n/a
Color Velocity Range (m/sec) n/a n/a n/a n/a n/a n/a
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
#
Display TIB
max
#
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.