Siemens Acuson S1000 Instructions For Use Manual page 508

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: 9EVF4
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
Focus (cm)
Res/Speed
Ensemble Size
Frequency (MHz)
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: 9EVF4
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 - 6 6
Operating mode: Color / Power
MI
Scan
1.34 0.70
Units
(MPa) 3.07
(mW) 32.84
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.40
pi,α
(cm)
(MHz) 5.24 5.15
X (cm) 1.13
Y (cm) 0.60
(µsec) 0.70
(Hz) 7.97
(MPa) 3.84
pi
(cm)
pi
(cm) 10.03
(cm) 3.00
2
(W/cm ) 368.49
2.00 10.03
5 5
12 12
5.50 5.50
Operating mode: Pulsed Doppler
MI
Scan
1.34 -
Units
(MPa) 3.07
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.40
pi,α
(cm)
(MHz) 5.24 -
X (cm) -
Y (cm) -
(µsec) 0.70
(Hz) 976.56
(MPa) 3.84
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 367.95
5.50 -
2.00 -
0.15 -
976.56 -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
- - -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.85 - 1.01
33.66 31.70
-
-
-
1.60
0.39
5.31 - 5.30
1.12 - 1.00
0.60 - 0.6
0.26
9.02 -
3.00 -
5.50 - 5.50
9.02 - 4.03
0.15 - 0.15
20833 - 24083
TIC
0.79
32.84
5.15
1.13
0.60
10.03
3.00
10.03
5
12
5.50
TIC
0.91
33.66
5.31
1.12
0.60
9.02
3.00
5.50
9.02
0.15
20833
I n s t r u c t i o n s f o r U s e