Kaixin BVT01 - Appendix B: Acoustic Output Data Disclosure

Bladder Volume Tester User’s Manual V1.02
- 34 -
Appendix B: Acoustic Output Data Disclosure
Pursuant to the provisions of EN 60601-2-37 “Medical electrical equipment - Part 2-37: Particular
requirements for the basic safety and essential performance of ultrasonic medical diagnostic and
monitoring equipment”, acoustic output data disclosure as follows:
In the acoustic output measurement data, the MI uncertainty is 12%, TI uncertainty is 23%.
Manufacturer: Xuzhou Kaixin Electronic Instrument Co.,Ltd.
Product Name: Bladder Volume Tester
Test Mode: B-Mode Probe Type: 2.5S120M1 Probe No.: 1503008
Index Label
MI
TIS TIB
TIC
Scan
Non-scan
Non-scan
A
aprt
≤1cm
2
A
aprt
>1cm
2
Maximum Index Value
0.37 0.017
- - - -
Associated
Acoustic
Parameters
p
ra
(MPa)
0.61
P (mW)
1.3 - - -
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)
5.4
d
eq
(z
b
) (cm)
-
f
awf
(MHz)
2.78 2.78
- - - -
Dim of A
aprt
X
(cm)
0.82
- - - -
Y
(cm)
1.02
- - - -
Other
Information
t
d
(µsec)
0.724
prr (Hz)
760
p
r
at max. I
pi
(MPa)
1.03
d
eq
at max. I
pi
(cm)
-
I
p
i,
α
at max. MI (µJ/cm
2
)
9.06
Focal Length
FLx
(cm)
- - - - - -
FLy
(cm)
- - - - - -
Operating
Control
Conditions
Frequency (MHz) 2.5 2.5 - - - -
Default setting
 
- - - -