Appendi x F Acoustic Output Reference
Instructions for Use
F - 29
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 SP
Operating mode:
Pulsed Doppler
MI
TIS
TIB
TIC
Index Label
Scan
Non-scan
Non-scan
A
aprt
≤
1
A
aprt
>1
Maximum Value
1.41
-
1.84
-
1.96
2.07
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA
IEC
Units
P
r.3
p
ra
(MPa)
3.56
W
o
P
(mW)
-
59.95
46.75
46.75
min of [W
.3
(z
1
),
I
TA.3
(z
1
)]
Min. of [
P
α
(
z
s
),
I
ta.α
(
z
s
)]
(mW)
-
z
1
z
s
(cm)
-
z
bp
z
bp
(cm)
-
z
sp
z
b
(cm)
0.90
z@PII
.3max
z
@ max.
I
pi,
α
(cm)
0.70
d
eq
(z
sp
)
d
eq
(
z
b
)
(cm)
0.36
f
c
f
awf
(MHz)
6.33
-
6.45
-
6.46
6.36
Dim. of A
aprt
X (cm)
-
1.96
-
1.00
1.00
Y (cm)
-
0.25
-
0.25
0.25
O
ther
Inf
or
m
at
ion
PD
t
d
(
µ
sec)
0.63
PRF
prr
(Hz)
610.35
P
r
@ PII
max
P
r
@ max.
I
pi
(MPa)
3.77
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm)
0.21
Focal Length
FL
x
(cm)
-
5.91
-
3.00
FL
y
(cm)
-
0.75
-
0.75
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
)
452.02
O
per
at
or
C
ont
rol
Frequency (MHz)
6.25
-
6.25
-
6.25
6.25
Focus (cm)
2.00
-
5.91
-
3.00
3.00
Gate Size (cm)
0.10
-
0.10
-
0.10
0.10
Sample Rate (Hz)
610.35
-
31250
-
34722
34722
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 SP
Operating mode:
M-Mode
MI
TIS
TIB
TIC
Index Label
Scan
Non-scan
Non-scan
A
aprt
≤
1
A
aprt
>1
Maximum Value
1.31
-
0.41
-
0.46
0.43
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA
IEC
Units
P
r.3
p
ra
(MPa)
3.61
W
o
P
(mW)
-
11.89
11.89
8.91
min of [W
.3
(z
1
),
I
TA.3
(z
1
)]
Min. of [
P
α
(
z
s
),
I
ta.α
(
z
s
)]
(mW)
-
z
1
z
s
(cm)
-
z
bp
z
bp
(cm)
-
z
sp
z
b
(cm)
1.00
z@PII
.3max
z
@ max.
I
pi,
α
(cm)
0.80
d
eq
(z
sp
)
d
eq
(
z
b
)
(cm)
0.35
f
c
f
awf
(MHz)
7.45
-
7.25
-
7.45
7.48
Dim. of A
aprt
X (cm)
-
1.14
-
1.14
0.86
Y (cm)
-
0.25
-
0.25
0.25
O
ther
Inf
or
m
at
ion
PD
t
d
(
µ
sec)
0.30
PRF
prr
(Hz)
600.00
P
r
@ PII
max
P
r
@ max.
I
pi
(MPa)
4.44
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm)
11.16
Focal Length
FL
x
(cm)
-
4.00
-
3.00
FL
y
(cm)
-
0.75
-
0.75
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
)
462.29
O
per
at
or
C
ont
rol
Frequency (MHz)
6.00
-
6.00
-
6.00
6.00
Focus (cm)
1.50
-
4.00
-
4.00
3.00
Gate Size (cm)
1.00
-
1.00
-
1.00
1.00
Sample Rate (Hz)
600.00
-
600
-
600
600
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.
Summary of Contents for Acuson S2000
Page 12: ...1 Introduction 1 2 Instructions for Use ...
Page 14: ...1 Introduction 1 4 Instructions for Use System Review Example of the ultrasound system ...
Page 84: ...2 Safety and Care 2 54 Instructions for Use ...
Page 86: ...3 System Setup 3 2 Instructions for Use ...
Page 112: ...3 System Setup 3 28 Instructions for Use ...
Page 114: ...4 Examination Fundamentals 4 2 Instructions for Use ...
Page 144: ...5 Transducer Accessories and Biopsy 5 2 Instructions for Use ...
Page 196: ...7 Specialty Transducers 7 2 Instructions for Use ...
Page 200: ...7 Specialty Transducers 7 6 Instructions for Use ...
Page 202: ...8 Physiologic Function 8 2 Instructions for Use ...
Page 208: ...9 eSieFusion Imaging 9 2 Instructions for Use ...
Page 236: ...10 Virtual Touch Applications 10 2 Instructions for Use ...
Page 258: ...10 Virtual Touch Applications 10 24 Instructions for Use ...
Page 302: ...Appendix A Technical Description A 44 Instructions for Use ...
Page 326: ...Appendix B Control Panel and Touch Screen B 24 Instructions for Use ...
Page 328: ...Appendix C Control Panel C 2 Instructions for Use ...
Page 394: ...Appendix D On screen Controls D 50 Instructions for Use ...
Page 444: ...Appendix F Acoustic Output Reference F 2 Instructions for Use ...
Page 516: ...Appendix F Acoustic Output Reference F 74 Instructions for Use ...
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