Table of Contents
Advertisement
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: 14L5
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: 14L5
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.
F - 2 6
Operating mode: Color / Power
MI
Scan
1.45
2.27
Units
(MPa)
3.66
(mW)
30.66
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
0.70
pi,α
(cm)
(MHz)
6.35
6.36
X (cm)
0.12
Y (cm)
0.3
(µsec)
0.61
(Hz)
7.57
(MPa)
4.26
pi
(cm)
pi
(cm)
0.51
(cm)
1.10
2
(W/cm
)
556.62
1.00
0.51
5
3
12
12
6.25
6.25
Operating mode: Pulsed Doppler
MI
Scan
1.22
-
Units
(MPa)
3.09
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.10
pi,α
(cm)
(MHz)
6.32
-
X (cm)
-
Y (cm)
-
(µsec)
0.62
(Hz)
100.16
(MPa)
3.93
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
435.76
6.25
-
1.50
-
0.10
-
100.16
-
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
2.91
-
2.91
82.07
82.07
-
-
-
7.43
-
7.43
2.63
-
2.63
0.30
-
0.30
7.93
-
1.10
-
7.50
-
7.50
7.93
-
7.93
0.10
-
0.10
24083
-
24083
TIC
2.34
30.83
6.36
0.12
0.30
0.51
1.10
0.51
3
12
6.25
TIC
2.22
89.11
6.34
2.63
0.30
7.93
1.10
6.25
7.93
0.10
24083
I n s t r u c t i o n s f o r U s e
Hide quick links:
Advertisement
Chapters
Table of Contents
Troubleshooting
