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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: V7M
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
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.
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)
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.
F - 5 2
Operating mode: SCW Doppler
MI
Scan
0.04
-
Units
(MPa)
0.07
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.00
pi,α
(cm)
(MHz)
3.62
-
X (cm)
-
Y (cm)
-
(µsec)
(Hz)
(MPa)
0.08
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
0.15
3.75
-
1.01
-
-
-
-
-
Operating mode: 2D-Mode
MI
Scan
1.55
0.73
Units
(MPa)
3.42
(mW)
37.18
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.40
pi,α
(cm)
(MHz)
4.84
4.72
X (cm)
1.24
Y (cm)
0.50
(µsec)
0.30
(Hz)
28.76
(MPa)
4.32
pi
(cm)
pi
(cm)
9.52
(cm)
3.50
2
(W/cm
)
443.55
1.50
9.52
4.00
4.00
3
3
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
0.27
-
0.68
15.39
10.16
-
-
-
1.00
0.26
3.62
-
3.62
0.45
-
0.25
0.73
-
0.73
0.26
2.00
-
3.00
-
3.75
-
3.75
2.00
-
1.01
-
-
-
-
-
-
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
TIC
0.52
10.16
3.98
0.25
0.73
1.01
3.00
3.75
1.01
-
-
TIC
0.92
37.18
4.72
0.89
0.50
9.52
3.50
9.52
4.00
3
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