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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: EV-8C4
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: EV-8C4
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
z @ max. I
sp
d
(z
)
d
(z
)
eq
sp
eq
b
f
f
c
awf
Dim. of A
aprt
PD
t
d
PRF
prr
P
@ PII max
P
@ max. I
r
r
d
@ PII max
d
@ max. I
eq
eq
Focal Length
FLx
FLy
I
@ MI max
I
@ MI max
pa.3
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.
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
1.47
0.80
Units
(MPa)
3.17
(mW)
38.89
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.80
pi,α
(cm)
(MHz)
4.61
4.32
X (cm)
1.96
Y (cm)
0.50
(µsec)
0.28
(Hz)
19.24
(MPa)
4.11
pi
(cm)
pi
(cm)
4.41
(cm)
3.50
2
(W/cm
)
406.64
2.00
4.41
9.00
9.00
3
3
Operating mode: Color / Power
MI
Scan
1.48
0.96
Units
(MPa)
3.02
(mW)
47.57
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.30
pi,α
(cm)
(MHz)
4.20
4.78
X (cm)
1.17
Y (cm)
0.50
(µsec)
0.83
(Hz)
8.00
(MPa)
3.65
pi
(cm)
pi
(cm)
6.50
(cm)
3.50
2
(W/cm
)
361.82
2.01
6.50
5
5
12
12
4.20
5.00
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
1.03
38.89
4.32
1.40
0.50
4.41
3.50
4.41
9.00
3
TIC
1.32
50.76
4.76
1.29
0.50
13.50
3.50
13.50
5
12
5.00
F - 5 3
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