Siemens Acuson S1000 Instructions For Use Manual page 501

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: MC9-4
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 @ max. MI
pa.3 max pa,α
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: MC9-4
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 @ max. MI
pa.3 max pa,α
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.
I n s t r u c t i o n s f o r U s e
Operating mode: Pulsed Doppler
MI
Scan
1.36 -
Units
(MPa) 3.01
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.59
pi,α
(cm)
(MHz) 4.93 -
X (cm) -
Y (cm) -
0.66
(µsec)
(Hz) 100.16
(MPa) 3.95
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 449.4
5 -
2.01 -
0.1 -
100.16 -
Operating mode: M-Mode
MI
Scan
1.4 -
Units
(MPa) 2.85
(mW) -
), (mW)
s
(cm)
(cm)
(cm)
(cm) 1.71
pi,α
(cm)
(MHz) 4.14 -
X (cm) -
Y (cm) -
0.57
(µsec)
(Hz) 600
(MPa) 3.64
pi
(cm)
pi
(cm) -
(cm) -
2
(W/cm ) 321.65
4 -
2 -
1 -
600 -
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
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.96 - 1.81
47.08 22.84
-
-
-
0.71
0.22
5.05 - 5.03
1.18 - 0.23
0.6 - 0.6
0.14
9 -
2 -
5 - 5
9 - 1
0.15 - 0.15
1085 - 28409
TIS TIB
Non-scan Non-scan
A ≤1 A >1
aprt aprt
0.41 - 0.82
27.6 27.6
-
-
-
1.59
0.48
4.21 - 4.21
1.34 - 1.34
0.6 - 0.6
15.41
9.5 -
2 -
4 - 4
9.5 - 9.5
1 - 1
600 - 600
TIC
2.16
25.7
5.06
0.12
0.6
0.51
2
5
0.51
0.25
28409
TIC
0.99
40.13
5.06
1.34
0.6
9.5
2
8
9.5
1
1200
F - 5 9