Siemens Acuson S2000, Instructions For Use Manual

Page: 513 / 518

Appendi x F Acoustic Output Reference
Instructions for Use F - 71
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:
AcuNav 10F Operating mode: 2D-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 1.38 1.31 - - - 2.77
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 3.10
W
o
P (mW) 52.45 - - 52.45
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) 0.80
d
eq
(z
sp
) d
eq
( z
b
) (cm) -
f
c
f
awf
(MHz) 5.09 5.26 - - - 5.26
Dim. of A
aprt
X (cm) 0.70 - - - 0.70
Y (cm) 0.25 - - - 0.25
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.28
PRF prr (Hz) 62.49
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 3.57
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) -
Focal Length FL x (cm) 5.00 - - 5.0
FL y (cm) 1.30 - - 1.30
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 508.27
O
per
at
or
C
ont
rol
Focus (cm)
1.00 5.00 - - - 5.00
Frequency (MHz) 5.00 5.00 - - - 5.00
Res/Speed 5 5 - - - 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.
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:
AcuNav 10F Operating mode: Color / Power
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
1.53 1.26 - - - 3.04
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 3.41
W
o
P (mW) 55.68 - - 55.68
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) 0.70
d
eq
(z
sp
) d
eq
( z
b
) (cm) -
f
c
f
awf
(MHz) 4.95 4.51 - - - 4.51
Dim. of A
aprt
X (cm) 0.70 - - 0.70
Y (cm) 0.25 - - 0.25
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.71
PRF prr (Hz) 12.07
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 3.84
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) -
Focal Length
FL
x (cm) 5.00 - - 5.00
FL y (cm) 1.30 - - 1.30
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 429.16
O
per
at
or
C
ont
rol
Focus (cm)
1.51 5.00 - - - 5.00
Res/Speed 5 5 - - - 5
Ensemble Size 7 7 - - - 7
Frequency (MHz) 5.00 4.50 - - - 4.50
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.