Siemens Acuson S1000 Instructions For Use Manual page 466

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: 12L4
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 @ max. MI
pa.3 max pa,α
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: 12L4
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 @ max. MI
pa.3 max pa,α
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 - 2 4
Operating mode: Pulsed Doppler
MI
Scan
1.55 -
Units
(MPa) 3.52
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.25
pi,α
(cm)
(MHz) 5.18 -
X (cm) -
Y (cm) -
0.73
(µsec)
(Hz) 100.16
(MPa) 5.00
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 465.98
5.50 -
2.75 -
0.15 -
100.16 -
Operating mode: M-Mode
MI
Scan
1.38 -
Units
(MPa) 3.10
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 2.60
pi,α
(cm)
(MHz) 5.05 -
X (cm) -
Y (cm) -
0.33
(µsec)
(Hz) 600.00
(MPa) 4.61
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 278.75
6.00 -
3.50 -
1.00 -
600.00 -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
1.21 - 2.00
70.10 35.06
-
-
-
1.11
0.26
5.44 - 5.39
1.50 - 0.51
0.70 - 0.70
0.21
4.50 -
2.50 -
5.50 - 5.50
4.50 - 1.50
0.15 - 0.15
24083 - 26042
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.29 - 0.40
19.16 19.16
-
-
-
1.76
0.60
4.88 - 4.88
1.55 - 1.55
0.70 - 0.70
17.75
6.50 -
2.50 -
6.00 - 6.00
6.50 - 6.50
1.00 - 1.00
600 - 600
TIC
1.52
70.10
5.44
1.50
0.70
4.50
2.50
5.50
4.50
0.15
24083
TIC
0.41
19.16
4.88
1.55
0.70
6.50
2.50
6.00
6.50
1.00
600
I n s t r u c t i o n s f o r U s e