Siemens Acuson S1000 Instructions For Use Manual page 488

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: 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 @ 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
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 6
Operating mode: Pulsed Doppler
MI
Scan
1.05 -
Units
(MPa) 2.24
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.70
pi,α
(cm)
(MHz) 4.49 -
X (cm) -
Y (cm) -
(µsec) 0.75
(Hz) 100.16
(MPa) 2.84
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 232.32
4.50 -
2.50 -
0.15 -
100.16 -
Operating mode: M-Mode
MI
Scan
1.50 -
Units
(MPa) 3.32
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.80
pi,α
(cm)
(MHz) 4.82 -
X (cm) -
Y (cm) -
(µsec) 0.46
(Hz) 600.00
(MPa) 3.79
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 419.57
4.00 -
1.00 -
1.00 -
600.00 -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
1.75 - 2.52
63.73 60.76
-
-
-
2.90
0.21
5.78 - 4.64
1.32 - 0.92
0.50 - 0.50
0.21
7.01 -
3.00 -
6.00 - 4.50
7.01 - 3.67
0.15 - 0.15
17361 - 14204
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.48 - 0.48
21.96 21.96
-
-
-
4.61 - 4.61
0.94 - 0.94
0.50 - 0.50
9.52 -
3.00 -
4.00 - 4.00
9.52 - 9.52
1.00 - 1.00
600 - 600
TIC
2.02
73.90
4.66
1.32
0.50
7.01
3.00
4.50
7.01
0.15
17361
TIC
0.71
21.96
4.61
0.94
0.50
9.52
3.00
4.00
9.52
1.00
600
I n s t r u c t i o n s f o r U s e