Siemens Acuson S2000, Instructions For Use Manual

Page: 494 / 518

Appendi x F Acoustic Output Reference
F - 52 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:
V7M Operating mode: SCW Doppler
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 0.04 - 0.27 - 0.68 0.52
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 0.07
W
o
P (mW) - 15.39 10.16 10.16
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) 1.00
z@PII
.3max
z @ max. I
pi, α
(cm) 1.00
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.26
f
c
f
awf
(MHz) 3.62 - 3.62 - 3.62 3.98
Dim. of A
aprt
X (cm) - 0.45 - 0.25 0.25
Y (cm) - 0.73 - 0.73 0.73
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) 0.08
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) 0.26
Focal Length FL x (cm) - 2.00 - 1.01
FL y (cm) - 3.00 - 3.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 0.15
O
per
at
or
C
ont
rol
Frequency (MHz)
3.75 - 3.75 - 3.75 3.75
Focus (cm) 1.01 - 2.00 - 1.01 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.
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:
EV-8C4 Operating mode: 2D-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
1.55 0.73 - - - 0.92
Asso
ci
at
ed
A
co
ust
ic
Par
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 3.42
W
o
P (mW) 37.18 - - 37.18
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
sp
z @ max. I
pi, α
(cm) 1.40
d
eq
(z
sp
) d
eq
( z
b
) (cm) -
f
c
f
awf
(MHz) 4.84 4.72 - - - 4.72
Dim. of A
aprt
X (cm) 1.24 - - - 0.89
Y (cm) 0.50 - - - 0.50
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.30
PRF prr (Hz) 28.76
P
r
@ PII max P
r
@ max. I
pi
(MPa) 4.32
d
eq
@ PII max
d
eq
@ max.
I
pi
(cm) -
Focal Length FL x (cm) 9.52 - - 9.52
FL y (cm) 3.50 - - 3.50
I
pa.3
@ MI max I
pa.3
@ MI max (W/cm
2
) 443.55
O
per
at
or
C
ont
rol
Focus (cm)
1.50 9.52 - - - 9.52
Frequency (MHz) 4.00 4.00 - - - 4.00
Res/Speed 3 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.