Siemens Acuson S1000 Instructions For Use Manual page 504

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: 7CF1
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
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 2
Operating mode: M-Mode
MI
Scan
1.27 -
Units
(MPa) 2.22
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.4
pi,α
(cm)
(MHz) 3.04 -
X (cm) -
Y (cm) -
(µsec) 0.73
(Hz) 600
(MPa) 2.57
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 191.69
3 -
2 -
1 -
600 -
Operating mode: 2D-Mode
MI
Scan
1.27 0.18
Units
(MPa) 2.19
(mW) 19.19
), (mW)
s
(cm)
(cm)
(cm)
(cm) 3.40
pi,α
(cm)
(MHz) 3.00 4.40
X (cm) 1.32
Y (cm) 1.10
(µsec) 0.76
(Hz) 29.13
(MPa) 3.06
pi
(cm)
pi
(cm) 4.00
(cm) 6.00
2
(W/cm ) 205.50
4.00 4.00
3.00 4.50
0 3
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- 0.59 0.99
- 51.38
42.56
2.98
2.88
3.25
0.61
- 2.89 2.92
- 2.63 1.44
- 1.1 1.1
16.27
- 20
- 5
- 3 3
- 20 6
- 1 1
- 600 600
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
- - -
- -
-
-
-
-
-
- - -
- - -
- - -
-
- -
- -
- - -
- - -
- - -
TIC
1
77.09
2.89
2.63
1.1
20
5
3
20
1
600
TIC
0.86
87.52
2.97
2.58
1.10
20.00
6.00
20.00
3.00
3
I n s t r u c t i o n s f o r U s e