Siemens Acuson S1000 Instructions For Use Manual page 464

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: 9L4
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: 12L4
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 @ max. MI
pa.3 max pa,α
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 - 2 2
Operating mode: M-Mode
MI
Scan
1.21 -
Units
(MPa) 2.52
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.60
pi,α
(cm)
(MHz) 4.32 -
X (cm) -
Y (cm) -
(µsec) 0.43
(Hz) 600.00
(MPa) 3.20
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 415.59
4.00 -
2.00 -
1.00 -
600.00 -
Operating mode: 2D-Mode
MI
Scan
1.36 0.58
Units
(MPa) 3.08
(mW) 83.73
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.50
pi,α
(cm)
(MHz) 5.13 5.27
X (cm) 3.34
Y (cm) 0.70
0.32
(µsec)
(Hz) 29.96
(MPa) 4.48
pi
(cm)
pi
(cm) 10.00
(cm) 2.50
2
(W/cm ) 300.48
3.50 10.00
0.00 0.00
0 3
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.47 - 0.71
58.74 30.59
-
-
-
3.70
0.33
4.16 - 4.26
2.76 - 1.44
0.90 - 0.90
10.14
9.00 -
2.0 -
4.00 - 4.00
9.00 - 4.00
1.00 - 1.00
600 - 600
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
TIC
0.83
58.74
4.21
2.76
0.90
9.00
2.00
4.00
9.00
1.00
600
TIC
1.30
111.07
5.27
2.39
0.70
10.00
2.50
10.00
6.15
3
I n s t r u c t i o n s f o r U s e