Siemens Acuson S2000, Instructions For Use Manual

Page: 489 / 518

Appendi x F Acoustic Output Reference
Instructions for Use F - 47
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:
10V4 Operating mode: SCW Doppler
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 0.07 - 0.62 - 2.40 1.33
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 0.15
W
o
P (mW) - 32.44 32.44 33.69
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) 1.90
z@PII
.3max
z @ max. I
pi, α
(cm) 1.90
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.18
f
c
f
awf
(MHz) 4.00 - 4.00 - 4.00 4.00
Dim. of A
aprt
X (cm) - 0.62 - 0.62 0.63
Y (cm) - 0.50 - 0.50 0.50
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec)
PRF prr (Hz)
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 0.19
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) 0.17
Focal Length FL x (cm) - 4.99 - 6.00
FL y (cm) - 3.00 - 3.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 0.50
O
per
at
or
C
ont
rol
Frequency (MHz)
4.00 - 4.00 - 4.00 4.00
Focus (cm) 3.00 - 4.99 - 4.99 6.00
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:
V5Ms Operating mode: 2D-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
0.83 0.55 - - - 0.67
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 1.65
W
o
P (mW) 19.99 - - 27.44
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) 1.90
d
eq
(z
sp
) d
eq
( z
b
) (cm) -
f
c
f
awf
(MHz) 3.84 5.92 - - - 3.79
Dim. of A
aprt
X (cm) 0.96 - - - 0.96
Y (cm) 0.85 - - - 0.85
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.50
PRF prr (Hz) 90.46
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 2.13
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm) -
Focal Length FL x (cm) 2.00 - - 2.00
FL y (cm) 5.50 - - 5.50
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 125.60
O
per
at
or
C
ont
rol
Focus (cm)
2.00 2.00 - - - 2.00
Frequency (MHz) 4.00 6.00 - - - 4.00
Res/Speed 0 0 - - - 5
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.