Siemens Acuson S2000, Instructions For Use Manual

Page: 485 / 518

Appendi x F Acoustic Output Reference
Instructions for Use F - 43
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:
8V3 Operating mode: Pulsed Doppler
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 1.49 - - 1.17 3.96 2.36
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 2.40
W
o
P (mW) - - 131.27 139.73
min of [W
.3
(z
1
),
I
TA.3
(z
1
)]
Min. of [ P
α
( z
s
),
I
ta.α
( z
s
)]
(mW)
93.31
z
1
z
s
(cm) 2.30
z
bp
z
bp
(cm) 2.22
z
sp
z
b
(cm) 5.30
z@PII
.3max
z @ max. I
pi, α
(cm) 2.60
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.28
f
c
f
awf
(MHz) 2.60 - - 2.68 2.68 2.57
Dim. of A
aprt
X (cm) - - 1.92 1.75 1.92
Y (cm) - - 0.90 0.90 0.90
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 1.72
PRF prr (Hz) 1775.57
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 2.94
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) 0.29
Focal Length FL x (cm) - - 8.01 8.01
FL y (cm) - - 4.00 4.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 138.31
O
per
at
or
C
ont
rol
Frequency (MHz)
2.50 - - 2.50 2.50 2.50
Focus (cm) 3.00 - - 8.01 7.01 8.01
Gate Size (cm) 0.30 - - 0.30 0.30 0.30
Sample Rate (Hz) 1775.57 - - 15625 17361 15625
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:
8V3 Operating mode: M-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
1.56 - 0.40 - 0.69 0.56
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 3.03
W
o
P (mW) - 27.90 27.90 27.90
min of [W
.3
(z
1
),
I
TA.3
(z
1
)]
Min. of [ P
α
( z
s
),
I
ta.α
( z
s
)]
(mW)
-
z
1
z
s
(cm) -
z
bp
z
bp
(cm) -
z
sp
z
b
(cm) 3.10
z@PII
.3max
z @ max. I
pi, α
(cm) 2.80
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.42
f
c
f
awf
(MHz) 3.80 - 3.70 - 3.61 3.76
Dim. of A
aprt
X (cm) - 1.37 - 1.37 1.37
Y (cm) - 0.90 - 0.90 0.90
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.49
PRF prr (Hz) 600.00
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 4.11
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm) 11.67
Focal Length FL x (cm) - 10.50 - 10.50
FL y (cm) - 4.00 - 4.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 454.07
O
per
at
or
C
ont
rol
Frequency (MHz)
4.00 - 4.00 - 4.00 4.00
Focus (cm) 3.00 - 10.50 - 4.50 10.50
Gate Size (cm) 1.02 - 1.02 - 1.02 1.02
Sample Rate (Hz) 600.00 - 600 - 600 600
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.