Siemens Acuson S2000, Instructions For Use Manual

Page: 464 / 518

Appendi x F Acoustic Output Reference
F - 22 Instructions for Use
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:
9L4 Operating mode: M-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 1.21 - 0.47 - 0.71 0.83
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 2.52
W
o
P (mW) - 58.74 30.59 58.74
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) 3.70
z@PII
.3max
z @ max. I
pi, α
(cm) 1.60
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.33
f
c
f
awf
(MHz) 4.32 - 4.16 - 4.26 4.21
Dim. of A
aprt
X (cm) - 2.76 - 1.44 2.76
Y (cm) - 0.90 - 0.90 0.90
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.43
PRF prr (Hz) 600.00
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 3.20
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) 10.14
Focal Length FL x (cm) - 9.00 - 9.00
FL y (cm) - 2.0 - 2.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 415.59
O
per
at
or
C
ont
rol
Frequency (MHz) 4.00 - 4.00 - 4.00 4.00
Focus (cm) 2.00 - 9.00 - 4.00 9.00
Gate Size (cm) 1.00 - 1.00 - 1.00 1.00
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.
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:
12L4 Operating mode: 2D-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
1.36 0.58 - - - 1.30
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 3.08
W
o
P (mW) 83.73 - - 111.07
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) 2.50
d
eq
(z
sp
) d
eq
( z
b
) (cm) -
f
c
f
awf
(MHz) 5.13 5.27 - - - 5.27
Dim. of A
aprt
X (cm) 3.34 - - - 2.39
Y (cm) 0.70 - - - 0.70
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.32
PRF prr (Hz) 29.96
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 4.48
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm) -
Focal Length FLx (cm) 10.00 - - 10.00
FLy (cm) 2.50 - - 2.50
I
pa.3
@ MI
max
I
pa,α
@ max. MI (W/cm
2
) 300.48
O
per
at
or
C
ont
rol
Focus (cm)
3.50 10.00 10.00
Frequency (MHz) 0.00 0.00 6.15
Res/Speed 0 3 3
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.