Olympus EVIS EXERA II - Page 246

240
Appendix D: Acoustic Output Information in Accordance with the FDA Guidance: “Information for Manufacturers
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Transducer Model:
GF-UCT180
Operating Mode:
Mflow-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 – 0.76 – 1.7 0.89
Assoc.
Acoustic
param.
p
r. 3
(MPa) 2.0
W (mW) –22 22 24
min of [W
.3
(z
1
), I
TA.3
(z
1
)]
(mW)
–
z
1
(cm) –
z
bp
(cm) –
z
sp
(cm) 1.2
z@PII.
3max
(cm) 1.4
d
eq
(z
sp
)
(cm)
0.19
ƒ
c
(MHz) 5.3 – 7.4 – 5.1 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) –4.6 – 4.3
FL
y
(cm) –1.0 – 1.0
I
pa.3
@MI
max
(W/cm
2
)
209
Operator
Controls
DVA% (%) 100 – 100 – 100 100
Function CHE B –
eF ExPHD –OffeF 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) 4.0 – 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 PENET
Color Doppler Frequency
Select
(MHz) 5 MHz – 7.5 MHz – 5 MHz 5 MHz
Flow Focus F5 – F16 – F9 F16
Color Velocity Range (m/sec) 0.20 – 0.80 – 0.61 0.94
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
0.76
Display TIB
max
1.7