Siemens Acuson S2000 - Page 453

Appendix F Acoustic Output Reference
Instructions for Use F - 11
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: 4C1 Operating mode: Color / Power
MI
TIS
TIB
TIC
Index Label
Scan
Non-scan
Non-scan
A
aprt
≤1
A
aprt
>1
Maximum Value
1.31
0.67
-
-
-
2.75
Associated Acoustic Parameters
FDA
IEC
Units
P
r.3
p
ra
(MPa)
1.80
W
o
P
(mW)
73.73
-
-
356.62
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)
-
z@PII
.3max
z @ max. I
pi,α
(cm)
4.20
d
eq
(z
sp
)
d
eq
(z
b
)
(cm)
-
f
c
f
awf
(MHz)
1.89
3.33
-
-
-
1.88
Dim. of A
aprt
X (cm)
1.19
-
-
-
5.34
Y (cm)
1.40
-
-
-
1.40
Other Information
PD t
d
(µsec)
2.28
PRF
prr
(Hz)
8.02
P
r
@ PII
max
P
r
@ max. I
pi
(MPa)
2.34
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm)
-
Focal Length
FLx
(cm)
5.01
-
-
28.59
FL
y
(cm)
4.88
-
-
4.88
I
pa.3
@ MI
max
I
pa.3
@ MI max
(W/cm
2
)
157.55
Operator
Control
Focus (cm)
5.02
5.01
-
-
-
28.59
Res/Speed
5
5
-
-
-
5
Ensemble Size
12
12
-
-
-
12
Frequency (MHz)
2.00
3.50
-
-
-
2.00
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: 4C1 Operating mode: Pulsed Doppler
MI
TIS
TIB
TIC
Index Label
Scan
Non-scan
Non-scan
A
aprt
≤1
A
aprt
>1
Maximum Value
1.31
-
-
1.42
3.56
3.25
Associated Acoustic Parameters
FDA
IEC
Units
P
r.3
p
ra
(MPa)
1.80
W
o
P
(mW)
-
-
185.50
397.25
min of [W
.3
(z
1
),
I
TA.3
(z
1
)]
Min. of [P
α
(z
s
),
I
ta.α
(z
s
)]
(mW)
156.22
z
1
z
s
(cm)
4.50
z
bp
z
bp
(cm)
3.68
z
sp
z
b
(cm)
6.40
z@PII
.3max
z @ max. I
pi,α
(cm)
4.2
d
eq
(z
sp
)
d
eq
(z
b
)
(cm)
0.51
f
c
f
awf
(MHz)
1.89
-
-
1.91
1.90
1.88
Dim. of A
aprt
X (cm)
-
-
3.39
2.00
5.25
Y (cm)
-
-
1.40
1.40
1.40
Other Information
PD
t
d
(
µ
sec)
2.28
PRF
prr
(Hz)
610.35
P
r
@ PII
max
P
r
@ max. I
pi
(MPa)
2.34
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm)
0.48
Focal Length
FLx
(cm)
-
-
14.04
26.39
FLy
(cm)
-
-
4.88
4.88
I
pa.3
@ MI
max
I
pa.3
@ MI max
(W/cm
2
)
157.60
Operator
Control
Frequency (MHz)
2.00
-
-
2.00
2.00
2.0
Focus (cm)
5.01
-
-
14.04
8.36
26.39
Gate Size (cm)
0.3
-
-
0.30
0.30
0.30
Sample Rate (Hz)
610.35
-
-
24083
22321
24083
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.