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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: 4P1
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: 4P1
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
1.18
0.74
Units
(MPa)
1.75
(mW)
221.13
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
2.40
pi,α
(cm)
(MHz)
2.19
2.16
X (cm)
1.92
Y (cm)
1.60
(µsec)
0.89
(Hz)
84.69
(MPa)
1.96
pi
(cm)
pi
(cm)
10.00
(cm)
5.00
2
(W/cm
)
146.06
4.30
10.00
2.00
2.25
4
4
Operating mode: 2D-Mode (THI)
MI
Scan
1.38
0.96
Units
(MPa)
2.00
(mW)
155.95
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
2.40
pi,α
(cm)
(MHz)
2.06
2.06
X (cm)
0.74
Y (cm)
1.60
(µsec)
1.22
(Hz)
61.24
(MPa)
2.33
pi
(cm)
pi
(cm)
3.00
(cm)
5.00
2
(W/cm
)
157.13
3.00
3.00
4.00
4.00
5
5
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
2.80
221.13
2.16
1.92
1.60
10.00
5.00
10.00
2.25
4
TIC
3.14
155.95
2.06
0.74
1.60
3.00
5.00
3.00
4.00
5
F - 3 3
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