Siemens Acuson S1000 Instructions For Use Manual page 506

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: 7CF2
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: 7CF2
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 4
Operating mode: Pulsed Doppler
MI
Scan
1.16 -
Units
(MPa) 1.86
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 4.00
pi,α
(cm)
(MHz) 2.62 -
X (cm) -
Y (cm) -
(µsec) 1.75
(Hz) 100.16
(MPa) 2.63
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 176.99
2.50 -
5.00 -
0.20 -
100.16 -
Operating mode: M-Mode
MI
Scan
1.34 -
Units
(MPa) 2.30
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 3.40
pi,α
(cm)
(MHz) 3.01 -
X (cm) -
Y (cm) -
(µsec) 0.77
(Hz) 600.00
(MPa) 3.21
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 225.96
3.00 -
4.00 -
1.00 -
600.00 -
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- 0.86 2.35
- 81.64
69.30
4.40
2.98
3.60
0.41
- 2.61 2.62
- 2.83 1.16
- 1.10 1.10
0.38
- 11.96
- 6.00
- 2.50 2.50
- 11.96 5.02
- 0.20 0.20
- 20833 22321
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- 0.55 0.96
- 55.13
39.54
3.50
2.85
3.30
0.66
- 2.94 2.92
- 2.58 1.41
- 1.10 1.10
18.17
- 20.00
- 6.00
- 3.00 3.00
- 20.00 6.00
- 1.00 1.00
- 600 600
TIC
2.04
194.73
2.58
4.08
1.10
16.95
6.00
2.50
16.95
0.20
19531
TIC
1.07
81.49
2.97
2.58
1.10
20.00
6.00
3.00
20.00
1.00
600
I n s t r u c t i o n s f o r U s e