Siemens Acuson S1000 Instructions For Use Manual page 461

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: 8C3 HD
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 @ max. MI
pa.3 max pa,α
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.
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: 8C3 HD
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 @ max. MI
pa.3 max pa,α
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.
I n s t r u c t i o n s f o r U s e
Operating mode: Pulsed Doppler
MI
Scan
1.41
Units
(MPa) 2.41
(mW)
), (mW)
s
(cm)
(cm)
(cm)
(cm) 3.50
pi,α
(cm)
(MHz) 2.93
X (cm)
Y (cm)
1.43
(µsec)
(Hz) 100.16
(MPa) 3.46
pi
(cm)
pi
(cm)
(cm)
2
(W/cm ) 230.88
2.85
4.50
0.15
100.06
Operating mode: M-Mode
MI
Scan
0.92 -
Units
(MPa) 1.83
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.20
pi,α
(cm)
(MHz) 3.93 -
X (cm) -
Y (cm) -
0.58
(µsec)
(Hz) 600.00
(MPa) 2.12
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 135.56
3.00 -
2.00 -
1.00 -
600.00 -
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
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.81 - 2.23
45.44 45.44
-
-
-
1.00
0.36
3.72 - 3.72
0.24 - 0.24
1.20 - 1.20
0.34
1.00 -
6.90 -
3.75 3.75
1.00 1.00
0.10 0.10
24083 24083
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- 0.20 0.39
- 15.83
11.66
2.80
2.73
2.50
0.52
- 3.68 3.41
- 2.17 1.45
- 1.20 1.20
13.07
- 20.00
- 6.90
- 3.00 3.00
- 20.00 6.00
- 1.00 1.00
- 600 600
TIC
1.89
45.44
3.72
0.24
1.20
1.00
6.90
3.75
1.00
0.10
24083
TIC
0.33
23.75
3.68
2.17
1.20
20.00
6.90
3.00
20.00
1.00
600
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