Siemens Acuson S2000, Instructions For Use Manual

Page: 491 / 518

Appendi x F Acoustic Output Reference
Instructions for Use F - 49
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: M-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 1.16 - 0.41 - 0.55 0.55
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 2.29
W
o
P (mW) - 22.50 13.63 22.50
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) 1.30
z@PII
.3max
z @ max. I
pi, α
(cm) 2.40
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.40
f
c
f
awf
(MHz) 3.83 - 3.87 - 3.93 3.77
Dim. of A
aprt
X (cm) - 0.96 - 0.66 0.96
Y (cm) - 0.85 - 0.85 0.85
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) 3.07
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) 11.80
Focal Length FL x (cm) - 9.00 - 9.00
FL y (cm) - 5.50 - 5.50
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 258.25
O
per
at
or
C
ont
rol
Frequency (MHz)
4.00 - 4.00 - 4.00 4.00
Focus (cm) 3.00 - 9.00 - 1.00 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:
V5Ms Operating mode: SCW Doppler
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
0.05 - 0.39 - 1.25 0.94
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 0.08
W
o
P (mW) - 24.80 24.80 19.83
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) 1.10
z@PII
.3max
z @ max. I
pi, α
(cm) 1.10
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.35
f
c
f
awf
(MHz) 3.31 - 3.31 - 3.31 3.82
Dim. of A
aprt
X (cm) - 0.42 - 0.42 0.25
Y (cm) - 0.85 - 0.85 0.85
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) 0.09
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm) 0.35
Focal Length FL x (cm) - 2.01 - 1.01
FL y (cm) - 5.50 - 5.50
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 0.22
O
per
at
or
C
ont
rol
Frequency (MHz)
3.50 - 3.50 - 3.50 3.50
Focus (cm) 2.01 - 2.01 - 2.01 1.01
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.