Siemens Acuson S1000 Instructions For Use Manual page 479

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: 4V1
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: 4V1
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.
I n s t r u c t i o n s f o r U s e
Operating mode: Color / Power
MI
Scan
1.18 0.88
Units
(MPa) 1.68
(mW) 114.10
), (mW)
s
(cm)
(cm)
(cm)
(cm) 3.70
pi,α
(cm)
(MHz) 2.03 2.04
X (cm) 1.01
Y (cm) 1.35
(µsec) 2.06
(Hz) 8.07
(MPa) 2.04
pi
(cm)
pi
(cm) 4.02
(cm) 7.00
2
(W/cm ) 102.39
4.02 4.02
5 5
12 12
2.00 2.75
Operating mode: Pulsed Doppler
MI
Scan
1.29 -
Units
(MPa) 1.85
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 4.20
pi,α
(cm)
(MHz) 2.05 -
X (cm) -
Y (cm) -
(µsec) 2.64
(Hz) 610.35
(MPa) 2.44
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 130.54
2.00 -
5.01 -
0.40 -
610.35 -
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
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
- - -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- 1.44 3.76
- 297.14
146.73
4.6
3.11
7.90
0.58
- 2.05 2.05
- 2.51 2.51
- 1.35 1.35
0.54
- 10.03
- 7.00
- 2.00 2.00
- 10.03 10.03
- 0.40 0.40
- 26042 26042
TIC
3.27
281.64
2.04
2.82
1.35
29.41
7.00
29.41
5
12
2.00
TIC
3.65
320.88
2.05
2.82
1.35
12.03
7.00
2.00
12.03
0.40
22321
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