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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: 9L4
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)
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.
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: 9L4
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
Frequency (MHz)
Focus (cm)
Gate Size (cm)
Sample Rate (Hz)
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: Color / Power
MI
Scan
1.27
2.19
Units
(MPa)
2.83
(mW)
105.79
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.40
pi,α
(cm)
(MHz)
4.98
5.01
X (cm)
0.48
Y (cm)
0.90
(µsec)
0.74
(Hz)
6.13
(MPa)
3.57
pi
(cm)
pi
(cm)
2.00
(cm)
2.00
2
(W/cm
)
309.25
2.01
2.00
0
5
14
14
5.00
5.00
Operating mode: Pulsed Doppler
MI
Scan
1.20
-
Units
(MPa)
2.70
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.60
pi,α
(cm)
(MHz)
4.99
-
X (cm)
-
Y (cm)
-
(µsec)
0.73
(Hz)
100.16
(MPa)
3.55
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
357.12
5.00
-
2.00
-
0.15
-
100.16
-
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
2.19
-
2.19
176.82
176.82
-
-
-
5.08
-
5.08
2.17
-
2.17
0.90
-
0.90
6.49
-
2.00
-
5.00
-
5.00
6.49
-
6.49
0.15
-
0.15
28409
-
28409
TIC
2.50
207.85
5.01
3.28
0.90
13.75
2.00
13.75
5
14
5.00
TIC
2.80
176.82
5.08
2.17
0.90
6.49
2.00
5.00
6.49
0.15
28409
F - 2 1
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