Appendix F Acoustic Output Reference
Instructions for Use F - 11
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: 4C1 Operating mode: Color / Power
A
aprt
>1
Associated Acoustic Parameters
.3
1
I
(z
)]
α
s
I
(z
)]
(mW)
-
aprt
Other Information
PD t
d
(µsec)
2.28
FL
Operator
Control
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: 4C1 Operating mode: Pulsed Doppler
Associated Acoustic Parameters
min of [W
.3
(z
1
),
I
(z
)]
Min. of [P
α
(z
s
),
I
(z
)]
(mW)
156.22
z
aprt
Other Information
t
µ
Operator
Control
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.