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Traditional 510(k) of Fetal & Maternal Monitor
F15 Series Fetal & Maternal Monitor User Manual
FL
I
at max MI
pi.α
A
aprt
MI
TIS
TIB
TIC
TRACK1 parameter
I
I
014_14.1_F15_Series_User_Manual
y
parameter specified in TRACK1 of FDA Guidance
p
r.3
W
0
z
sp
f
c
x
-6
y
-6
PD
PRF
MI
SPTA.3
SPPA.3
Az.
Ele.
EDS
EBD
Attenuated Pulse-average Intensity at the point of
Maximum MI
-12dB Output Beam Area
Mechanical Index
Soft Tissue Thermal Index
Bone Thermal Index
Cranial-bone Thermal Index
Derated Peak-rare-factional Acoustic Pressure
Output Power
z
=z
, Depth for Bone Thermal Index
sp
B.3
Center Frequency, Acoustic
-6dB Beamwidth
Pulse Duration
Pulse Repetition Frequency
Mechanical Index
Derated Spatial-peak Temporal-average Intensity
Derated Spatial-peak Pulse-average Intensity
Aperture X width
Entrance Dimensions Of The Scan
Entrance Beam Dimensions
- 155 -
Ultrasound Intensity and Safety
NOTE
Y Dimeter
171／202
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