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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: P8-4
Associated Acoustic Parameters
Index Label
Maximum Value
FDA
IEC
Units
P
p
(MPa)
r.3
ra
W
P
(mW)
o
min of [W
(z
),
Min. of [P
(z
),
(mW)
.3
1
α
s
I
(z
)]
I
(z
)]
TA.3
1
ta.α
s
z
z
(cm)
1
s
z
z
(cm)
bp
bp
z
z
(cm)
sp
b
z
z @ max. I
(cm)
sp
pi,α
d
(z
)
d
(z
)
(cm)
eq
sp
eq
b
f
f
(MHz)
c
awf
Dim. of A
X (cm)
aprt
Y (cm)
Other information
FDA
IEC
Units
PD
t
(μsec)
d
PRF
prr
(Hz)
P
@ PII max
P
@ max. I
(MPa)
r
r
pi
d
@ PII max
d
@ max. I
(cm)
eq
eq
pi
Focal Length
FLx
(cm)
FLy
(cm)
I
@ MI max
I
@ max. MI
(W/cm
pa.3
pa.α
Operator Control
TX-Level
(dB)
Focus
(mm)
PRF(prr)
(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 C I O N E S
D E
Operating mode: M-mode
MI
TIS
Scan
A
aprt
(a)
1.02
#
37.78
#
#
5.67
0.96
0.8
#
#
#
2.0
5.0
2
)
#
#
#
U T I L I Z A C I Ó N
A p é n d i c e D R e f e r e n c i a d e s a l i d a a c ú s t i c a
TIB
Non-scan
Non-scan
A
>1
≤1
aprt
-
-
<1
-
#
-
-
-
#
#
-
-
#
-
-
#
-
-
#
#
-
-
-
-
-
#
-
#
TIC
<1
#
#
#
#
#
#
#
#
#
D - 5 5
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