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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: 6C2
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: 8C3 HD
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
@ max. MI
pa.3
max
pa,α
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: M-Mode
MI
Scan
1.20
-
Units
(MPa)
1.99
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
4.00
pi,α
(cm)
(MHz)
2.78
-
X (cm)
-
Y (cm)
-
(µsec)
0.78
(Hz)
600.00
(MPa)
2.87
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
277.59
2.50
-
4.00
-
3.00
-
600.00
-
Operating mode: 2D-Mode
MI
Scan
1.18
0.76
Units
(MPa)
2.60
(mW)
45.13
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.20
pi,α
(cm)
(MHz)
4.83
4.25
X (cm)
3.03
Y (cm)
1.20
0.37
(µsec)
(Hz)
13.91
(MPa)
3.17
pi
(cm)
pi
(cm)
16.00
(cm)
6.90
2
(W/cm
)
259.76
2.00
16.00
0.00
0.00
3
3
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
-
0.95
1.59
-
182.79
73.68
4.20
3.14
3.90
1.25
-
2.71
2.71
-
2.87
2.87
-
1.20
1.20
37.54
-
20.00
-
6.90
-
2.50
2.50
-
20.00
20.00
-
3.00
3.00
-
600
600
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
TIC
2.18
182.79
2.71
2.87
1.20
20.00
6.90
2.50
20.00
3.00
600
TIC
1.14
78.66
3.44
1.93
1.20
8.00
6.90
8.00
0.00
3
F - 1 7
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