Siemens Acuson S1000 Instructions For Use Manual page 490

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: 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 @ 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
Focus (cm)
Res/Speed
Ensemble Size
Frequency (MHz)
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
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.
F - 4 8
Operating mode: Color / Power
MI
Scan
1.12 0.52
Units
(MPa) 2.21
(mW) 23.64
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.30
pi,α
(cm)
(MHz) 3.84 3.82
X (cm) 0.96
Y (cm) 0.85
(µsec) 0.97
(Hz) 13.03
(MPa) 2.99
pi
(cm)
pi
(cm) 4.00
(cm) 5.50
2
(W/cm ) 208.84
3.00 4.00
0 5
7 7
4.00 4.00
Operating mode: Pulsed Doppler
MI
Scan
1.12 -
Units
(MPa) 2.22
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.50
pi,α
(cm)
(MHz) 3.85 -
X (cm) -
Y (cm) -
(µsec) 0.93
(Hz) 100.16
(MPa) 2.96
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 196.78
4.00 -
4.00 -
0.15 -
100.16 -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
- - -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.55 - 0.88
29.34 21.12
-
-
-
1.30
0.38
3.96 - 3.95
0.96 - 0.51
0.85 - 0.85
0.35
4.01 -
5.50 -
4.00 - 4.00
4.01 - 2.01
0.15 - 0.15
11160 - 11160
TIC
0.66
23.64
3.82
0.96
0.85
4.00
5.50
4.00
5
7
4.00
TIC
0.73
15.39
3.92
0.25
0.85
1.01
5.50
4.00
1.01
0.15
11160
I n s t r u c t i o n s f o r U s e