MEDA MD-6000P - Annex B. Acoustic Output Reporting Table; According to Ud2-2004 and Fda Guide for Track 1

Annex B. Acoustic Output Reporting Table
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Annex B. Acoustic Output Reporting Table
According to IEC 60601-2-37
System Model:
RZ17060020
Transducer Model:
MD-6000P
Operating Mode:
B
Index Label
MI
TIS
TIB
TIC
At
surface
Below
surface
At
surface
Below
surface
Maximum Index Value
0.148
0.00052
0.00106
0.00106
Index Component Value
0.00052
0.00052
0.00106
0.00052
Associated
acoustic
parameters
p
r,α
at z
MI
(Mpa)
0.216
P
(mW)
0.068
0.068
0.068
P
1x1
(mW)
0.051
0.051
z
s
(cm)
#
z
b
(cm)
#
z
MI
(cm)
3.2
z
pii,α
(cm)
3.2
f
awf
(MHz)
2.136
2.136
2.136
2.136
Other
information
prr
(Hz)
250
srr
(Hz)
3.1
n
pps
1
I
pa,α
at z
pii,α
(W/cm
2
)
1.187
I
spta,α
at z
pii,α
or z
sii,α
(mW/cm
2
)
0.010
I
spta
at z
pii
or z
sii
(mW/cm
2
)
0.015
p
r
at z
pii
(Mpa)
0.291
Operating
control
conditions
Freq
(MHz)
2.5
Mode
Pre & 3D scan
Others
Default
(a) Intended use does not include cephalic so TIC is not computed
# No data reported
According to UD2-2004 and FDA Guide for Track 1
Probe
MD-6000P
Operation Mode:
B Mode
Working Frequency:
2.5MHz.
Acoustic Output
MI
(unitless)
I
SPAT.3
( mW/cm
2
)
I
SPPA.3
( W/cm
2
)
Sample Size
3
3
3
K ( P=0.90, gamma=0.9 )
4.258
4.258
4.258
Mean ( x )
0.225
1.08
2.493
StdDev ( Sx )
0.008
0.0436
0.410
Limit ( X )
0.259
1.266
4.24