Siemens Acuson S2000, Instructions For Use Manual

Page: 512 / 518

Appendi x F Acoustic Output Reference
F - 70 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:
AcuNav 8F Operating mode: M-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 1.29 - 0.23 - 0.59 0.68
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 2.62
W
o
P (mW) - 11.28 11.28 11.28
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) 0.70
z@PII
.3max
z @ max. I
pi, α
(cm) 1.40
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.35
f
c
f
awf
(MHz) 4.13 - 4.23 - 4.23 4.18
Dim. of A
aprt
X (cm) 0.70 - 0.70 0.70
Y (cm) 0.19 - 0.19 0.19
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.47
PRF prr (Hz) 600.00
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 3.13
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) 11.27
Focal Length FL x (cm) - 7.00 - 7.00
FL y (cm) - 1.30 - 1.30
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 243.93
O
per
at
or
C
ont
rol
Frequency (MHz)
4.00 - 4.00 - 4.00 4.00
Focus (cm) 2.00 - 7.00 - 7.00 7.00
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:
AcuNav 8F Operating mode: SCW Doppler
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
0.06 - 0.08 - 0.59 0.51
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 0.12
W
o
P (mW) - 3.94 3.94 3.94
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) 0.40
z@PII
.3max
z @ max. I
pi, α
(cm) 0.40
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.13
f
c
f
awf
(MHz) 4.44 - 4.44 - 4.44 4.44
Dim. of A
aprt
X (cm) - 0.15 - 0.15 0.15
Y (cm) - 0.19 - 0.19 0.19
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) 0.13
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm) 0.13
Focal Length FL x (cm) - 3.00 - 3.00
FL y (cm) - 1.30 - 1.30
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 0.24
O
per
at
or
C
ont
rol
Frequency (MHz)
4.50 - 4.50 - 4.50 4.50
Focus (cm) 3.00 - 3.00 - 3.00 3.00
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.