Siemens Acuson S1000 Instructions For Use Manual page 493

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: V7M
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: V7M
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: Pulsed Doppler
MI
Scan
1.48 -
Units
(MPa) 2.94
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.80
pi,α
(cm)
(MHz) 3.92 -
X (cm) -
Y (cm) -
(µsec) 1.00
(Hz) 100.16
(MPa) 3.67
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 405.85
4.00 -
3.01 -
0.15 -
100.16 -
Operating mode: M-Mode
MI
Scan
1.16 -
Units
(MPa) 2.30
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.20
pi,α
(cm)
(MHz) 3.92 -
X (cm) -
Y (cm) -
(µsec) 0.47
(Hz) 600.00
(MPa) 3.05
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 232.41
4.00 -
3.00 -
1.00 -
600.00 -
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
0.45 - 1.48
23.57 23.57
-
-
-
1.90
0.21
4.00 - 4.00
0.75 - 0.75
0.73 - 0.73
0.21
3.00 -
3.00 -
4.00 - 4.00
3.00 - 3.00
0.15 - 0.15
15625 - 15625
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.34 - 0.72
17.84 17.24
-
-
-
2.10
0.30
3.98 - 4.00
1.02 - 1.02
0.73 - 0.73
9.58
11.00 -
3.00 -
4.00 - 4.00
11.00 - 7.00
1.00 - 1.00
600 - 600
TIC
0.71
23.57
3.98
0.75
0.73
3.00
3.00
4.00
3.00
0.15
15625
TIC
0.46
17.84
4.00
1.02
0.73
11.00
3.00
4.00
11.00
1.00
600
F - 5 1