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Acoustic Output Reporting Table — Track 3, FDA 510(k) and IEC 60601-2-37
(Per transducer/mode that exceeds MI or TI value of 1.0)
Transducer model: 12L4
Index Label
Maximum Value
FDA
IEC
P
p
r.3
ra
W
P
o
min of [W
(z
),
Min. of [P
(z
.3
1
α
I
(z
)]
I
(z
)]
TA.3
1
ta.α
s
z
z
1
s
z
z
bp
bp
z
z
sp
b
z@PII
z @ max. I
.3max
d
(z
)
d
(z
)
eq
sp
eq
b
f
f
c
awf
Dim. of A
aprt
PD
t
d
PRF
prr
P
@ PII
@ max. I
P
r
max
r
d
@ PII
d
@ max. I
eq
max
eq
Focal Length
FLx
FLy
I
@ MI
I
@ max. MI
pa.3
max
pa,α
Focus (cm)
Frequency (MHz)
Res/Speed
a
This Index is not relevant to this operating mode.
b
This transducer is not intended for transcranial or neonatal cephalic uses.
c
This formulation for TIS is less than that for an alternate formulation in this mode.
#
No data is provided for this operation condition since the maximum index value is not reported for the reason listed.
Acoustic Output Reporting Table — Track 3, FDA 510(k) and IEC 60601-2-37
(Per transducer/mode that exceeds MI or TI value of 1.0)
Transducer model: 12L4
Index Label
Maximum Value
FDA
IEC
P
p
r.3
ra
W
P
o
min of [W
(z
),
Min. of [P
(z
.3
1
α
I
(z
)]
I
(z
)]
TA.3
1
ta.α
s
z
z
1
s
z
z
bp
bp
z
z
sp
b
z@PII
z @ max. I
.3max
d
(z
)
d
(z
)
eq
sp
eq
b
f
f
c
awf
Dim. of A
aprt
PD
t
d
PRF
prr
P
@ PII
P
@ max. I
r
max
r
d
@ PII
d
@ max. I
eq
max
eq
Focal Length
FLx
FLy
I
@ MI
I
@ max. MI
pa.3
max
pa,α
Focus (cm)
Res/Speed
Ensemble Size
Frequency (MHz)
a
This Index is not relevant to this operating mode.
b
This transducer is not intended for transcranial or neonatal cephalic uses.
c
This formulation for TIS is less than that for an alternate formulation in this mode.
#
No data is provided for this operation condition since the maximum index value is not reported for the reason listed.
I n s t r u c t i o n s f o r U s e
Operating mode: 2D-Mode (THI)
MI
Scan
1.50
0.50
Units
(MPa)
3.22
(mW)
68.66
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
2.67
pi,α
(cm)
(MHz)
4.60
6.07
X (cm)
4.01
Y (cm)
0.70
0.30
(µsec)
(Hz)
18.36
(MPa)
4.81
pi
(cm)
pi
(cm)
10.00
(cm)
2.50
2
(W/cm
)
410.05
3.50
10.00
0.00
0.00
0
1
Operating mode: Color / Power
MI
Scan
1.21
1.01
Units
(MPa)
2.75
(mW)
109.30
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
2.09
pi,α
(cm)
(MHz)
5.19
5.17
X (cm)
2.67
Y (cm)
0.70
(µsec)
0.69
(Hz)
5.54
(MPa)
4.02
pi
(cm)
pi
(cm)
8.00
(cm)
2.50
2
(W/cm
)
344.11
2.50
8.00
5
0
14
14
5.50
5.50
A p p e n d i x F A c o u s t i c O u t p u t R e f e r e n c e
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
TIS
TIB
Non-scan
Non-scan
A
>1
A
≤1
aprt
aprt
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
TIC
1.12
96.14
4.95
2.86
0.70
10.00
2.50
10.00
4.00
3
TIC
1.45
109.30
5.17
2.67
0.70
8.00
2.50
8.00
0
14
5.50
F - 2 3
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