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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: 18L6 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
@ max. I
P
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
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.
F - 3 2
Operating mode: M-Mode
MI
Scan
1.50
-
Units
(MPa)
3.97
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.20
pi,α
(cm)
(MHz)
6.97
-
X (cm)
-
Y (cm)
-
0.27
(µsec)
(Hz)
600.00
(MPa)
4.78
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
603.46
8.00
-
1.50
-
1.00
-
600.00
-
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
0.14
-
0.26
4.68
2.87
-
-
-
1.60
0.12
6.48
-
6.78
1.38
-
1.08
0.40
-
0.40
3.70
3.00
-
1.80
-
8.00
-
8.00
3.00
-
2.00
1.00
-
1.00
600
-
600
TIC
0.14
4.68
6.48
1.38
0.40
3.00
1.80
8.00
3.00
1.00
600
I n s t r u c t i o n s f o r U s e
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