Siemens Acuson S1000 Instructions For Use Manual page 469

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: 14L5
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: 14L5 SP
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: M-Mode
MI
Scan
1.22 -
Units
(MPa) 3.37
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.50
pi,α
(cm)
(MHz) 7.54 -
X (cm) -
Y (cm) -
(µsec) 0.24
(Hz) 600.00
(MPa) 3.79
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 456.68
6.00 -
0.75 -
1.0 -
600.00 -
Operating mode: 2D-Mode
MI
Scan
1.55 0.59
Units
(MPa) 4.30
(mW) 43.49
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.60
pi,α
(cm)
(MHz) 7.70 7.34
X (cm) 1.60
Y (cm) 0.25
(µsec) 0.25
(Hz) 43.17
(MPa) 4.70
pi
(cm)
pi
(cm) 4.00
(cm) 0.75
2
(W/cm ) 764.83
0.75 4.00
6.00 6.00
3 3
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
0.83 - 0.83
23.92 23.92
-
-
-
7.28 - 7.28
1.51 - 1.51
0.30 - 0.30
5.26 -
1.10 -
6.00 - 6.00
5.26 - 5.26
1.00 - 1.00
600 - 600
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
TIC
0.79
23.92
7.28
1.51
0.30
5.26
1.10
6.00
5.26
1.00
600
TIC
1.20
43.49
7.34
1.14
0.25
4.00
0.75
4.00
6.00
3
F - 2 7