Siemens Acuson S1000 Instructions For Use Manual page 476

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: 4P1
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: 4P1
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 - 3 4
Operating mode: Color / Power
MI
Scan
1.34 1.16
Units
(MPa) 1.91
(mW) 142.99
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.70
pi,α
(cm)
(MHz) 2.01 2.48
X (cm) 0.94
Y (cm) 1.60
(µsec) 2.06
(Hz) 13.57
(MPa) 2.23
pi
(cm)
pi
(cm) 4.00
(cm) 5.00
2
(W/cm ) 146.54
4.00 4.00
5 5
7 7
2.00 2.50
Operating mode: Pulsed Doppler
MI
Scan
1.34 -
Units
(MPa) 1.91
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.70
pi,α
(cm)
(MHz) 2.01 -
X (cm) -
Y (cm) -
(µsec) 2.06
(Hz) 1220.70
(MPa) 2.23
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 146.54
2.00 -
4.00 -
0.30 -
1220.7 -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
- - -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- 1.12 2.77
- 164.91
69.98
3.70
2.87
6.30
0.31
- 3.36 3.36
- 1.80 1.80
- 1.60 1.60
0.28
- 7.65
- 5.00
- 3.50 3.50
- 7.65 7.65
- 0.30 0.30
- 8223 8223
TIC
2.73
142.99
2.48
0.94
1.60
4.00
5.00
4.00
5
7
2.50
TIC
2.15
164.91
3.36
1.80
1.60
7.65
5.00
3.50
7.65
0.30
8223
I n s t r u c t i o n s f o r U s e