Siemens Acuson S1000 Instructions For Use Manual page 514

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 10F
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 10F
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 2
Operating mode: Pulsed Doppler
MI
Scan
1.51 -
Units
(MPa) 3.36
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.70
pi,α
(cm)
(MHz) 4.94 -
X (cm) -
Y (cm) -
(µsec) 0.55
(Hz) 100.16
(Mpa) 3.78
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 374.69
5.00 -
1.50 -
0.10 -
100.16 -
Operating mode: M-Mode
MI
Scan
1.50 -
Units
(MPa) 3.09
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 0.80
pi,α
(cm)
(MHz) 4.26 -
X (cm) -
Y (cm) -
(µsec) 0.49
(Hz) 600.00
(MPa) 3.64
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 296.16
4.00 -
3.00 -
1.00 -
600.00 -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
1.38 - 2.58
50.94 56.62
-
-
-
0.80
0.38
5.70 - 4.68
0.70 - 0.70
0.25 - 0.25
0.29
6.41 -
1.30 -
6.00 - 4.50
6.41 - 4.01
0.10 - 0.10
19531 - 13020
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.24 - 0.53
10.97 10.97
-
-
-
0.80
0.36
4.50 - 4.50
0.70 - 0.70
0.25 - 0.25
11.12
9.00 -
1.30 -
4.00 - 4.00
9.00 - 9.00
1.00 - 1.00
600 - 600
TIC
3.26
61.71
4.54
0.70
0.25
13.00
1.30
4.50
13.00
0.10
15625
TIC
0.58
10.97
4.50
0.70
0.25
9.00
1.30
4.00
9.00
1.00
600
I n s t r u c t i o n s f o r U s e