Siemens Acuson S1000 Instructions For Use Manual page 489

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: 10V4
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: V5Ms
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
Focus (cm)
Frequency (MHz)
Res/Speed
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: SCW Doppler
MI
Scan
0.07 -
Units
(MPa) 0.15
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.90
pi,α
(cm)
(MHz) 4.00 -
X (cm) -
Y (cm) -
(µsec)
(Hz)
(MPa) 0.19
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 0.50
4.00 -
3.00 -
- -
- -
Operating mode: 2D-Mode
MI
Scan
0.83 0.55
Units
(MPa) 1.65
(mW) 19.99
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.90
pi,α
(cm)
(MHz) 3.84 5.92
X (cm) 0.96
Y (cm) 0.85
(µsec) 0.50
(Hz) 90.46
(MPa) 2.13
pi
(cm)
pi
(cm) 2.00
(cm) 5.50
2
(W/cm ) 125.60
2.00 2.00
4.00 6.00
0 0
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
0.62 - 2.40
32.44 32.44
-
-
-
1.90
0.18
4.00 - 4.00
0.62 - 0.62
0.50 - 0.50
0.17
4.99 -
3.00 -
4.00 - 4.00
4.99 - 4.99
- - -
- - -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
TIC
1.33
33.69
4.00
0.63
0.50
6.00
3.00
4.00
6.00
-
-
TIC
0.67
27.44
3.79
0.96
0.85
2.00
5.50
2.00
4.00
5
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