160
Appendix C: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF-UC180F
Transducer Model:
BF-UC180F
Operating Mode:
PWD-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)
–
14
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
–
6.0
6.0
Dim of
A
aprt
X
(cm)
–
0.67
–
0.67
0.67
Y
(cm)
–
0.26
–
0.26
0.26
Other Info.
PD
(
µ
sec)
#
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)
n/a
n/a
n/a
n/a
n/a
n/a
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
#
–
PENET
–
PENET
PENET
Doppler Frequency Select
(MHz)
#
–
6 MHz
–
6 MHz
6 MHz
Doppler Focus
#
–
F5
–
F3
F7
Doppler Velocity Range
(cm/sec)
#
–
16.6
–
10.0
39.8
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
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.