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
(
µ
sec)
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.
Содержание BF UC180F
Страница 3: ......
Страница 7: ...Contents iv ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F...
Страница 76: ...Chapter 4 Operation 69 ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F Figure 4 5 Figure 4 6...
Страница 181: ...174 Appendix D Acoustic Output Information Accordance with IEC 60601 2 37 ULTRASONIC BRONCHOFIBERVIDEOSCOPE BF UC180F...