Siemens Acuson S2000, Инструкция по эксплуатации

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Appendi x F Acoustic Output Reference
Instructions for Use F - 35
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:
4P1 Operating mode: M-Mode
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value 1.24 - - 0.46 0.93 1.03
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 1.86
W
o
P (mW) - - 61.56 69.13
min of [W
.3
(z
1
),
I
TA.3
(z
1
)]
Min. of [ P
α
( z
s
),
I
ta.α
( z
s
)]
(mW)
43.89
z
1
z
s
(cm) 3.00
z
bp
z
bp
(cm) 2.50
z
sp
z
b
(cm) 4.50
z@PII
.3max
z @ max. I
pi, α
(cm) 2.30
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.78
f
c
f
awf
(MHz) 2.20 - - 2.19 2.11 3.05
Dim. of A
aprt
X (cm) - - 1.37 1.37 1.37
Y (cm) - - 1.60 1.60 1.60
O
ther
Inf
or
m
at
ion
PD t
d
( µ sec) 0.88
PRF prr (Hz) 600.00
P
r
@ PII
max
P
r
@ max. I
pi
(MPa) 2.21
d
eq
@ PII
max
d
eq
@ max. I
pi
(cm) 22.68
Focal Length FL x (cm) - - 16.00 16.00
FL y (cm) - - 5.00 5.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 164.06
O
per
at
or
C
ont
rol
Frequency (MHz)
2.00 - - 3.00 2.00 3.00
Focus (cm) 2.80 - - 16.00 16.00 16.00
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:
4P1 Operating mode: SCW Doppler
MI TIS TIB TIC
Index Label Scan Non-scan Non-scan
A
aprt
≤ 1 A
aprt
>1
Maximum Value
0.09 - 1.25 - 2.67 2.77
As
soc
iat
ed A
cous
tic
P
ar
am
et
er
s
FDA IEC Units
P
r.3
p
ra
(MPa) 0.13
W
o
P (mW) - 148.23 111.80 148.23
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) 4.20
z@PII
.3max
z @ max. I
pi, α
(cm) 3.80
d
eq
(z
sp
) d
eq
( z
b
) (cm) 0.53
f
c
f
awf
(MHz) 2.00 - 2.50 - 2.00 2.50
Dim. of A
aprt
X (cm) - 0.88 - 0.88 0.88
Y (cm) - 1.60 - 1.60 1.60
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) 0.16
d
eq
@ PII
max
d
eq
@ max.
I
pi
(cm) 0.52
Focal Length FL x (cm) - 14.56 - 14.56
FL y (cm) - 5.00 - 5.00
I
pa.3
@ MI
max
I
pa.3
@ MI max (W/cm
2
) 0.45
O
per
at
or
C
ont
rol
Frequency (MHz)
2.00 - 2.50 - 2.00 2.50
Focus (cm) 6.02 - 14.56 - 14.56 14.56
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.