Siemens Acuson S1000 Instructions For Use Manual page 510

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: CW5
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
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 - 6 8
Operating mode: CW Doppler
MI
Scan
0.05 -
Units
(MPa) 0.12
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.90
pi,α
(cm)
(MHz) 5.00 -
X (cm) -
Y (cm) -
(µsec)
(Hz)
(MPa) 0.16
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 0.39
5.00 -
9.10 -
- -
- -
Operating mode: 2D-Mode
MI
Scan
1.35 0.86
Units
(MPa) 2.78
(mW) 43.65
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.70
pi,α
(cm)
(MHz) 4.23 4.12
X (cm) 0.70
Y (cm) 0.19
(µsec) 0.45
(Hz) 47.83
(MPa) 2.99
pi
(cm)
pi
(cm) 2.00
(cm) 1.30
2
(W/cm ) 234.00
1.00 2.00
4.00 4.00
5 5
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
1.64 - 1.64
68.94 68.94
-
-
-
5.00 - 5.00
0.44 - 0.44
1.13 - 1.13
9.10 -
4.50 -
5.00 - 5.00
9.10 - 9.10
- - -
- - -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
TIC
2.16
68.94
5.00
0.44
1.13
9.10
4.50
5.00
9.10
-
-
TIC
2.64
43.65
4.12
0.70
0.19
2.00
1.30
2.00
4.00
5
I n s t r u c t i o n s f o r U s e