Olympus EVIS EXERA II - Page 245

Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
239
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
 Acoustic output table for track3 when combined with
SSD-α10
Transducer Model:
GF-UCT180
Operating Mode:
PWD-mode
Index label MI
TIS TIB
TIC
TIS
scan
TIS
non-scan
Non-
scan
A
aprt
<=1 A
aprt
>1
Maximum Index Value 0.88 – 0.71 – 1.7 0.96
Assoc.
Acoustic
Param.
p
r. 3
(MPa) 2.0
W
0
(mW) –20 24 26
min of [W
.3
(z
1
), I
TA.3
(z
1
)]
(mW)
–
z
1
(cm) –
z
bp
(cm) –
z
sp
(cm) 1.4
z@PII.
3max
(cm) 1.4
d
eq
(z
sp
)
(cm)
0.19
ƒ
c
(MHz) 5.3 – 7.4 – 5.3 5.3
Dim of A
aprt
X(cm) – 0.74 – 0.74 0.74
Y(cm)
– 0.50 – 0.50 0.50
Other Info.
PD (µsec) 0.47
PRF (Hz) 5210
p
r
@PII
max
(MPa) 2.5
d
eq
@ PII
max
(cm) 0.18
Focal Length FL
x
(cm) –4.3 – 4.3
FL
y
(cm) –1.0 – 1.0
I
pa.3
@MI
max
(W/cm
2
)
209
Operator
Controls
DVA% (%) 100 – 89 – 97 100
Function CHE B –
eF ExPHD
–
eF ExPHD eF ExPHD
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 PENET
Doppler Frequency Select (MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Doppler Focus F5–F15 –F11F16
Doppler Velocity Range (cm/sec) 19.9 – 36.2 – 76.0 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
0.71
Display TIB
max
1.7