Siemens Acuson S1000 Instructions For Use Manual page 486

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
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: 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 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.
F - 4 4
Operating mode: SCW Doppler
MI
Scan
0.09 -
Units
(MPa) 0.15
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.80
pi,α
(cm)
(MHz) 2.50 -
X (cm) -
Y (cm) -
(µsec)
(Hz)
(MPa) 0.16
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 0.34
2.50 -
2.01 -
- -
- -
Operating mode: 2D-Mode
MI
Scan
1.16 0.83
Units
(MPa) 2.87
(mW) 32.44
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.00
pi,α
(cm)
(MHz) 5.81 5.82
X (cm) 1.32
Y (cm) 0.50
(µsec) 0.24
(Hz) 24.92
(MPa) 4.29
pi
(cm)
pi
(cm) 3.00
(cm) 3.00
2
(W/cm ) 308.11
2.00 3.00
6.00 6.00
5 5
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.49 - 2.21
41.54 41.54
-
-
-
0.80
0.37
2.50 - 2.50
0.24 - 0.24
0.90 - 0.90
0.37
2.01 -
4.00 -
2.50 - 2.50
2.01 - 2.01
- - -
- - -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
TIC
1.98
41.54
2.50
0.24
0.90
2.01
4.00
2.50
2.01
-
-
TIC
1.05
32.44
5.82
0.94
0.50
3.00
3.00
3.00
6.00
5
I n s t r u c t i o n s f o r U s e