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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: 7CF1
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: 7CF1
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
1.37
0.89
Units
(MPa)
2.21
(mW)
92.24
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
3.53
pi,α
(cm)
(MHz)
2.6
3.04
X (cm)
1.44
Y (cm)
1.1
(µsec)
1.53
(Hz)
5.8
(MPa)
3.02
pi
(cm)
pi
(cm)
6
(cm)
5
2
(W/cm
)
258.76
5
6
2
2
12
12
2.5
3.25
Operating mode: Pulsed Doppler
MI
Scan
1.37
-
Units
(MPa)
2.39
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
4.13
pi,α
(cm)
(MHz)
3.04
-
X (cm)
-
Y (cm)
-
(µsec)
1.27
(Hz)
100.16
(MPa)
3.37
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
240.07
3.25
-
6
-
0.20
-
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
-
1.2
2.3
-
67.67
81.33
3.62
3.02
3.59
0.31
-
3.1
3.14
-
2.91
1.02
-
1.1
1.1
0.43
-
12
-
5
-
3.08
3.25
-
12
4.25
-
0.4
0.4
-
3125
24083
TIC
1.84
160.85
3.1
2.91
1.1
12
5
12
2
12
3.25
TIC
2.18
176.46
3.1
2.91
1.1
12
5
3.25
12
0.4
3125
F - 6 1
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