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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
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: 14L5 SP
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
@ MI max
pa.3
max
pa.3
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: 14L5 SP
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
@ MI max
pa.3
max
pa.3
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.
F - 2 8
Operating mode: 2D-Mode (THI)
MI
Scan
1.16
0.48
Units
(MPa)
3.14
(mW)
36.75
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
0.70
pi,α
(cm)
(MHz)
7.31
7.07
X (cm)
1.20
Y (cm)
0.25
(µsec)
0.19
(Hz)
21.58
(MPa)
3.51
pi
(cm)
pi
(cm)
3.00
(cm)
0.75
2
(W/cm
)
415.81
1.50
3.00
14.00
14.00
3
3
Operating mode: Color / Power
MI
Scan
1.45
1.15
Units
(MPa)
3.94
(mW)
40.15
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
0.60
pi,α
(cm)
(MHz)
7.34
7.35
X (cm)
0.72
Y (cm)
0.25
(µsec)
0.49
(Hz)
6.43
(MPa)
4.58
pi
(cm)
pi
(cm)
3.00
(cm)
0.75
2
(W/cm
)
672.67
1.00
3.00
5
5
14
14
7.50
7.50
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
1.02
36.75
7.07
0.86
0.25
3.00
0.75
3.00
14.00
3
TIC
1.51
44.62
6.38
0.72
0.25
3.00
0.75
3.00
5
14
6.25
I n s t r u c t i o n s f o r U s e
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