252
Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Transducer Model:
GF-UCT180
Operating Mode:
Power flow-mode
Table 201.103 – Acoustic output reporting table
Index label MI
TIS TIB
TIC
Scan
Non-scan
Non-
scan
A
aprt
≤1cm
2
A
aprt
>1cm
2
Maximum Index Value 0.88 0.91 – – – 0.82
Associated
acoustic
parameters
p
r, α
(MPa) 2.0
P (mW) 26 – –27
Min of [P
α
(z
s
), I
ta,α
(z
s
)]
(mW)
–
z
s
(cm) –
z
bp
(cm) –
z
b
(cm) –
z at max. I
pi,α
(cm) 1.4
d
eq
(z
b
)
(cm)
–
ƒ
awf
(MHz) 5.3 5.5, 7.5 – – – 5.1, 5.5
Dim of A
aprt
X(cm) 1.1 – – – 1.1
Y(cm)
0.50 – – – 0.50
Other
information
t
d
(µsec) 0.47
prr (Hz) 8730
p
r
at max. I
pi
(MPa) 2.5
d
eq
at max. I
pi
(cm) –
I
pa,α
at max.MI
(W/cm
2
)
209
Focal Length FL x(cm) 2.7 – – 3.8
FL
y
(cm) 1.0 – – 0.84
Operating
control
conditions
DVA% (%) 100 100 – – – 100
Function
CHE B
Off – – – Off
B/W Frequency Select (MHz) 4.7 MHz 5 MHz – – – 5 MHz
B/W Focus F5 F15 – – – F14
B/W-Range (cm) 4.0 4.0 – – – 4.0
B/W Line Density HIGH HIGH – – – HIGH
B/W Scan Area (%) 25 25 – – – 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 PENET PENET – – – PENET
Color Doppler Frequency Select (MHz) 5 MHz 7.5 MHz – – – 5 MHz
Flow Focus F5 F8 – – – F16
Color Velocity Range (m/sec) 0.76 0.50 – – – 0.61
Color Line Density LOW LOW – – – LOW
Color Average HIGH HIGH – – – HIGH
Flow Filter #4 #4 – – – #4
Flow Scan Area (%) 20 20 – – – 20
Triplex Velocity Range n/a n/a n/a n/a n/a n/a
NOTE1 Data should only be entered in one of the columns related to TIS.
NOTE2 Information need not be provided regarding TIC for any TRANSDUCER ASSEMBLY not intended for transcranial or
neonatal cephalic uses.
NOTE3 If the requirements of 201.12.4.2a are met, it is not required to enter any data in the columns related to TIS, TIB or TIC.
NOTE4 If the requirements of 201.12.4.2b are met, it is not required to enter any data in the columns related to MI.
NOTE5 Focal Length is a NOMINAL value.