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Simpli Series System Instructions for Use
33
01-5034-00 R1
Appendix E
–
Summary of the Acoustic Quantities
The acoustic output data is shown for each probe in each operating mode.
Summary of the acoustic quantities: GP-C01 Probe Mode: B-Mode
Index
MI
TIS
TIB
TIC
At Surface Below
Surface
At Surface Below
Surface
Maximum index value
1.02
0.115
0.322
(3)
Index Component Value
0.115
0.115
0.322
0.115
-
IEC
FDA
Units
Associated
acoustic
parameter
p
r.a
at z
MI
p
r.3
(MPa)
1.96
P
W
0
(mW)
32.9
32.9
-
P
1x1
(mW)
6.62
6.62
-
z
s
z
1
(cm)
1.63
z
b
z
sp
(cm)
-
1.63
Z
MI
Z
MI
(cm)
1.63
Z
pi,α
Z
pi,α
(cm)
1.63
-
f
awf
F
c
(MHz)
3.65
3.65
3.65
-
Other
Information
prr
(Hz)
5120
srr
(Hz)
40
n
pps
1
I
pa,α
at z
pii,α
(W/cm
2
)
180
-
I
spta,α
at z
pii,α
or z
sii,α
(mW/cm
2
) 10.3
I
spta
at z
pii
or z
sii
(mW/cm
2
) 15.5
p
r
at z
pii
(MPa)
2.4
Operating
Control
Conditions
Scan rate
40 Hz
Lines per scan
128
Scan angle
60°
Transmit focus
2.0 cm
Note 1: Information need not be provided for any formulation of TIS not yielding the maximum value of TIS for that
mode.
Note 2: Information need not be provided regarding TIC for any Transducer Assembly not intended for transcranial or
neonatal cephalic uses.
Note 3: Information on MI and TI need not be provided if the equipment meets both the exemption clauses given in
51.2 aa) and 51.2 dd).
(a)
Intended use does not include cephalic so TIC is not computed.