A p p e n d i x F A c o u s t i c O u t p u t R e f e r e n c e
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: 6C1 HD
Index Label
Maximum Value
FDA
IEC
P
p
r.3
ra
W
P
o
min of [W
(z
),
Min. of [P
(z
.3
1
α
I
(z
)]
I
(z
)]
TA.3
1
ta.α
s
z
z
1
s
z
z
bp
bp
z
z
sp
b
z@PII
z @ max. I
.3max
d
(z
)
d
(z
)
eq
sp
eq
b
f
f
c
awf
Dim. of A
aprt
PD
t
d
PRF
prr
P
@ PII
@ max. I
P
r
max
r
d
@ PII
d
@ max. I
eq
max
eq
Focal Length
FLx
FLy
I
@ MI
I
@ max. MI
pa.3
max
pa,α
Frequency (MHz)
Focus (cm)
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: 6C1 HD
Index Label
Maximum Value
FDA
IEC
P
p
r.3
ra
W
P
o
min of [W
(z
),
Min. of [P
(z
.3
1
α
I
(z
)]
I
(z
)]
TA.3
1
ta.α
s
z
z
1
s
z
z
bp
bp
z
z
sp
b
z@PII
z @ max. I
.3max
d
(z
)
d
(z
)
eq
sp
eq
b
f
f
c
awf
Dim. of A
aprt
PD
t
d
PRF
prr
P
@ PII
P
@ max. I
r
max
r
d
@ PII
d
@ max. I
eq
max
eq
Focal Length
FLx
FLy
I
@ MI
I
@ max. MI
pa.3
max
pa,α
Frequency (MHz)
Focus (cm)
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.
F - 1 4
Operating mode: Pulsed Doppler
MI
Scan
1.33
-
Units
(MPa)
1.83
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
4.30
pi,α
(cm)
(MHz)
1.89
-
X (cm)
-
Y (cm)
-
2.35
(µsec)
(Hz)
100.16
(MPa)
2.33
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
100.81
2.00
-
4.00
-
0.25
-
100.16
-
Operating mode: M-Mode
MI
Scan
1.40
-
Units
(MPa)
2.67
(mW)
-
),
(mW)
s
(cm)
(cm)
(cm)
(cm)
1.70
pi,α
(cm)
(MHz)
3.63
-
X (cm)
-
Y (cm)
-
0.46
(µsec)
(Hz)
600.00
(MPa)
3.30
pi
(cm)
pi
(cm)
-
(cm)
-
2
(W/cm
)
318.16
2.50
-
2.00
-
1.00
-
600.00
-
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
-
1.36
4.21
-
240.29
146.65
4.30
3.28
7.30
0.48
-
1.95
1.94
-
2.69
2.31
-
1.40
1.40
0.43
-
11.06
-
7.00
-
2.00
2.00
-
11.06
9.58
-
0.25
0.25
-
7440
9765
TIS
TIB
Non-scan
Non-scan
A
≤1
A
>1
aprt
aprt
-
0.73
1.55
-
148.68
76.54
4.80
3.83
4.30
1.19
-
2.00
2.00
-
3.67
3.67
-
1.40
1.40
33.40
-
23.00
-
7.00
-
1.50
1.50
-
23.00
23.00
-
1.00
1.00
-
600
600
TIC
4.06
501.33
2.50
5.36
1.40
29.85
7.00
2.50
29.85
0.25
11160
TIC
1.79
183.69
3.43
3.67
1.40
23.00
7.00
2.50
23.00
1.00
600
I n s t r u c t i o n s f o r U s e