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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: AcuNav 8F
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: AcuNav 8F
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
1.62
0.88
Units
(MPa)
4.02
(mW)
40.61
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
0.40
pi,α
(cm)
(MHz)
6.16
4.44
X (cm)
0.70
Y (cm)
0.19
(µsec)
0.57
(Hz)
132.63
(MPa)
4.37
pi
(cm)
pi
(cm)
5.00
(cm)
1.30
2
(W/cm
)
568.27
1.00
5.00
0
5
7
7
6.50
4.50
Operating mode: Pulsed Doppler
MI
Scan
1.55
-
Units
(MPa)
3.46
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
0.40
pi,α
(cm)
(MHz)
5.00
-
X (cm)
-
Y (cm)
-
(µsec)
0.52
(Hz)
390.63
(MPa)
3.71
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
429.52
5.00
-
1.02
-
0.15
-
390.63
-
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
0.97
-
2.79
44.66
41.81
-
-
-
1.30
0.23
4.54
-
4.54
0.70
-
0.63
0.19
-
0.19
0.22
7.01
-
1.30
-
4.50
-
4.50
7.01
-
2.51
0.15
-
0.15
17361
-
15625
TIC
2.50
40.81
4.42
0.70
0.19
3.00
1.30
3.00
5
7
4.50
TIC
2.71
44.66
4.63
0.70
0.19
7.01
1.30
4.50
7.01
0.15
17361
F - 6 9
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