Siemens Acuson S1000 Instructions For Use Manual page 512

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: AcuNav 8F
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: AcuNav 8F
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 - 7 0
Operating mode: M-Mode
MI
Scan
1.29 -
Units
(MPa) 2.62
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.40
pi,α
(cm)
(MHz) 4.13 -
X (cm)
Y (cm)
(µsec) 0.47
(Hz) 600.00
(MPa) 3.13
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 243.93
4.00 -
2.00 -
1.00 -
600.00 -
Operating mode: SCW Doppler
MI
Scan
0.06 -
Units
(MPa) 0.12
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.40
pi,α
(cm)
(MHz) 4.44 -
X (cm) -
Y (cm) -
(µsec)
(Hz)
(MPa) 0.13
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 0.24
4.50 -
3.00 -
- -
- -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.23 - 0.59
11.28 11.28
-
-
-
0.70
0.35
4.23 - 4.23
0.70 - 0.70
0.19 - 0.19
11.27
7.00 -
1.30 -
4.00 - 4.00
7.00 - 7.00
1.00 - 1.00
600 - 600
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.08 - 0.59
3.94 3.94
-
-
-
0.40
0.13
4.44 - 4.44
0.15 - 0.15
0.19 - 0.19
0.13
3.00 -
1.30 -
4.50 - 4.50
3.00 - 3.00
- - -
- - -
TIC
0.68
11.28
4.18
0.70
0.19
7.00
1.30
4.00
7.00
1.00
600
TIC
0.51
3.94
4.44
0.15
0.19
3.00
1.30
4.50
3.00
-
-
I n s t r u c t i o n s f o r U s e