Siemens Acuson S3000 - Page 515

Appendix F Acoustic Output Reference
Instructions for Use F - 73
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: AcuNav 10F Operating mode: SCW Doppler
MI
TIS
TIB
TIC
Index Label
Scan
Non-scan
Non-scan
A
aprt
≤1
A
aprt
>1
Maximum Value
0.05
-
0.04
-
0.40
0.22
Associated Acoustic Parameters
FDA
IEC
Units
P
r.3
p
ra
(MPa)
0.10
W
o
P
(mW)
1.99
1.99
1.99
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)
0.40
z@PII
.3max
z @ max. I
pi,α
(cm)
0.40
d
eq
(z
sp
)
d
eq
(z
b
)
(cm)
0.10
f
c
f
awf
(MHz)
4.00
-
4.00
-
4.00
4.00
Dim. of A
aprt
X (cm)
-
0.15
-
0.15
0.15
Y (cm)
-
0.25
-
0.25
0.25
Other Information
PD t
d
(µsec)
PRF
prr
(Hz)
P
r
@ PII
max
P
r
@ max. I
pi
(MPa)
0.11
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm)
0.10
Focal Length
FLx
(cm)
-
2.01
-
2.01
FL
y
(cm)
-
1.30
-
1.30
I
pa.3
@ MI
max
I
pa.3
@ MI max
(W/cm
2
)
0.28
Operator
Control
Frequency (MHz)
4.00
-
4.00
-
4.00
4.00
Focus (cm)
2.01
-
2.01
-
2.01
2.01
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.