Appendix E: Acoustic Output Information Accordance with IEC 60601-2-37
245
ULTRASOUND GASTROVIDEOSCOPE GF-UCT180
Acoustic output table when combined with SSD-α10
Transducer Model:
GF-UCT180
Operating Mode:
B-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 0.84 0.69 – – – 0.76
Associated
acoustic
parameters
p
r, α
(MPa) 2.0
P (mW) 27 – –20
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) 1.2
d
eq
(z
b
)
(cm)
–
ƒ
awf
(MHz) 5.4 5.3 – – – 4.4
Dim of A
aprt
X(cm) 1.2 – – – 0.72
Y(cm)
0.50 – – – 0.50
Other
information
t
d
(µsec) 0.29
prr (Hz) 6940
p
r
at max. I
pi
(MPa) 2.3
d
eq
at max. I
pi
(cm) –
I
pa,α
at max.MI
(W/cm
2
)
313
Focal Length FL
x
(cm) 2.8 – – 0.56
FL
y
(cm) 1.0 – – 1.2
Operating
control
conditions
DVA% (%) 100 100 – – – 100
Function
CHE A Penet CHE B
–––
CHE A Penet
B/W Frequency Select (MHz) 5.4 MHz 5.4 MHz – – – 4.3 MHz
B/W Focus F4 F9 – – – F2
B/W-Range (cm) 8.0 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 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
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.