Siemens Acuson S1000 Instructions For Use Manual page 498

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: EC9-4
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: EC9-4
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 - 5 6
Operating mode: Color / Power
MI
Scan
1.26 0.59
Units
(MPa) 2.81
(mW) 29.12
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.60
pi,α
(cm)
(MHz) 4.85 4.81
X (cm) 0.99
Y (cm) 0.60
(µsec) 0.72
(Hz) 7.91
(MPa) 3.67
pi
(cm)
pi
(cm) 4.00
(cm) 3.00
2
(W/cm ) 299.39
2.00 4.00
3 5
12 12
5.00 5.00
Operating mode: Pulsed Doppler
MI
Scan
0.98 -
Units
(MPa) 2.19
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.00
pi,α
(cm)
(MHz) 5.05 -
X (cm) -
Y (cm) -
(µsec) 0.74
(Hz) 100.16
(MPa) 3.07
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 238.97
5.00 -
2.00 -
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
1.14 - 1.20
47.23 27.78
-
-
-
1.90
0.27
5.06 - 5.05
1.17 - 0.48
0.60 - 0.60
0.29
10.02 -
3.00 -
5.00 - 5.00
10.02 - 2.00
0.15 - 0.15
17361 - 20833
TIC
0.68
29.12
4.81
0.99
0.60
4.00
3.00
4.00
5
12
5.00
TIC
1.25
47.23
4.85
1.17
0.60
10.02
3.00
5.00
10.02
0.15
17361
I n s t r u c t i o n s f o r U s e