Siemens Acuson S1000 Instructions For Use Manual page 485

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: 8V3
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
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: 8V3
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.
I n s t r u c t i o n s f o r U s e
Operating mode: Pulsed Doppler
MI
Scan
1.49 -
Units
(MPa) 2.40
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.60
pi,α
(cm)
(MHz) 2.60 -
X (cm) -
Y (cm) -
(µsec) 1.72
(Hz) 1775.57
(MPa) 2.94
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 138.31
2.50 -
3.00 -
0.30 -
1775.57 -
Operating mode: M-Mode
MI
Scan
1.56 -
Units
(MPa) 3.03
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.80
pi,α
(cm)
(MHz) 3.80 -
X (cm) -
Y (cm) -
(µsec) 0.49
(Hz) 600.00
(MPa) 4.11
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 454.07
4.00 -
3.00 -
1.02 -
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
- 1.17 3.96
- 131.27
93.31
2.30
2.22
5.30
0.28
- 2.68 2.68
- 1.92 1.75
- 0.90 0.90
0.29
- 8.01
- 4.00
- 2.50 2.50
- 8.01 7.01
- 0.30 0.30
- 15625 17361
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.40 - 0.69
27.90 27.90
-
-
-
3.10
0.42
3.70 - 3.61
1.37 - 1.37
0.90 - 0.90
11.67
10.50 -
4.00 -
4.00 - 4.00
10.50 - 4.50
1.02 - 1.02
600 - 600
TIC
2.36
139.73
2.57
1.92
0.90
8.01
4.00
2.50
8.01
0.30
15625
TIC
0.56
27.90
3.76
1.37
0.90
10.50
4.00
4.00
10.50
1.02
600
F - 4 3