Siemens Acuson S1000 Instructions For Use Manual page 480

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: 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
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: 4V1c
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.
F - 3 8
Operating mode: M-Mode
MI
Scan
1.56 -
Units
(MPa) 2.63
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.70
pi,α
(cm)
(MHz) 2.83 -
X (cm) -
Y (cm) -
(µsec) 0.64
(Hz) 600.00
(MPa) 3.05
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 384.55
3.00 -
2.00 -
1.00 -
600.00 -
Operating mode: 2D-Mode
MI
Scan
1.40 0.70
Units
(MPa) 2.03
(mW) 73.44
), (mW)
s
(cm)
(cm)
(cm)
(cm) 4.10
pi,α
(cm)
(MHz) 2.02 3.05
X (cm) 1.63
Y (cm) 1.31
(µsec) 0.90
(Hz) 15.61
(MPa) 2.60
pi
(cm)
pi
(cm) 4.30
(cm) 7.00
2
(W/cm ) 177.87
4.30 4.30
2.00 3.00
5 5
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- 0.99 1.65
- 150.52
79.05
3.50
2.79
3.90
1.02
- 2.62 2.62
- 2.01 2.01
- 1.35 1.35
30.34
- 10.00
- 7.00
- 3.00 3.00
- 10.00 10.00
- 1.00 1.00
- 600 600
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
TIC
2.02
150.52
2.62
2.01
1.35
10.00
7.00
3.00
10.00
1.00
600
TIC
1.85
103.52
1.99
1.17
1.31
10.00
7.00
10.00
2.00
5
I n s t r u c t i o n s f o r U s e