Siemens Acuson S2000, Instructions For Use Manual

Page: 479 / 518

Appendi x F Acoustic Output Reference
Instructions for Use F - 37
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:
4V1 Operating mode: Color / Power
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 1.18 0.88 - - - 3.27
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 1.68
W
o
P (mW) 114.10 - - 281.64
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) -
z@PII
.3max
z @ max. I
pi, α
(cm) 3.70
d
eq
(z
sp
) d
eq
( z
b
) (cm) -
f
c
f
awf
(MHz) 2.03 2.04 - - - 2.04
Dim. of A
aprt
X (cm) 1.01 - - - 2.82
Y (cm) 1.35 - - - 1.35
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 2.06
PRF prr (Hz) 8.07
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 2.04
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) -
Focal Length FL x (cm) 4.02 - - 29.41
FL y (cm) 7.00 - - 7.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 102.39
O
per
at
or
C
ont
rol
Focus (cm)
4.02 4.02 - - - 29.41
Res/Speed 5 5 - - - 5
Ensemble Size 12 12 - - - 12
Frequency (MHz) 2.00 2.75 - - - 2.00
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:
4V1 Operating mode: Pulsed Doppler
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
1.29 - - 1.44 3.76 3.65
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 1.85
W
o
P (mW) - - 297.14 320.88
min of [W
.3
(z
1
),
I
TA.3
(z
1
)]
Min. of [ P
α
( z
s
),
I
ta.α
( z
s
)]
(mW)
146.73
z
1
z
s
(cm) 4.6
z
bp
z
bp
(cm) 3.11
z
sp
z
b
(cm) 7.90
z@PII
.3max
z @ max. I
pi, α
(cm) 4.20
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.58
f
c
f
awf
(MHz) 2.05 - - 2.05 2.05 2.05
Dim. of A
aprt
X (cm) - - 2.51 2.51 2.82
Y (cm) - - 1.35 1.35 1.35
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 2.64
PRF prr (Hz) 610.35
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 2.44
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm) 0.54
Focal Length FL x (cm) - - 10.03 12.03
FL y (cm) - - 7.00 7.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 130.54
O
per
at
or
C
ont
rol
Frequency (MHz)
2.00 - - 2.00 2.00 2.00
Focus (cm) 5.01 - - 10.03 10.03 12.03
Gate Size (cm) 0.40 - - 0.40 0.40 0.40
Sample Rate (Hz) 610.35 - - 26042 26042 22321
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.