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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: 9EVF4
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: 9EVF4
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)
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.
I n s t r u c t i o n s f o r U s e
Operating mode: 2D-Mode
MI
Scan
1.47
0.42
Units
(MPa)
3.28
(mW)
18.49
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.30
pi,α
(cm)
(MHz)
5.01
4.85
X (cm)
0.97
Y (cm)
0.60
(µsec)
0.46
(Hz)
18.79
(MPa)
3.95
pi
(cm)
pi
(cm)
10.53
(cm)
3.00
2
(W/cm
)
455.61
1.50
10.53
4.00
4.00
3
3
Operating mode: 2D-Mode (THI)
MI
Scan
1.28
0.33
Units
(MPa)
2.74
(mW)
15.51
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.40
pi,α
(cm)
(MHz)
4.66
4.57
X (cm)
0.87
Y (cm)
0.60
(µsec)
0.40
(Hz)
4.70
(MPa)
3.18
pi
(cm)
pi
(cm)
4.56
(cm)
3.00
2
(W/cm
)
306.87
1.50
4.56
9.00
9.00
3
3
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
0.52
18.49
4.85
0.69
0.60
10.53
3.00
10.53
4.00
3
TIC
0.45
15.51
4.57
0.63
0.60
4.56
3.00
4.56
9.00
3
F - 6 5
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