Operator’s Manual
I - 1
I
Indications for use
Intended Use:
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Clinical Application
Mode of Operation
General(Track 1
Only)
Specific (Track 1 & 3) B
M
PWD
CWD
Color
Doppler
Amplitude
Doppler
Combined
(specify)
Other (Specify)
Ophthalmic
Ophthalmic
N
N
N
N
N
Note 1
Fetal Imaging &
Other
Fetal
N
N
N
N
N
N
N
Note 1, 2,3,5
Abdominal
N
N
N
N
N
N
N
Note 1, 2,3,5,8
Intra-operative
(Specify*)
N
N
N
N
N
N
Note 1, 2,3,5
Intra-operative (Neuro)
Laparoscopic
N
N
N
N
N
N
Note 1
Pediatric
N
N
N
N
N
N
N
Note 1, 2,3,5
Small Organ
(Specify**)
N
N
N
N
N
N
N
Note 1, 2,3,5,6
Neonatal Cephalic
N
N
N
N
N
N
N
Note 1, 2,3,5
Adult Cephalic
N
N
N
N
N
N
N
Note 1, 2,3,5
Trans-rectal
N
N
N
N
N
N
Note 1, 2,3,5,6
Trans-vaginal
N
N
N
N
N
N
Note 1, 2,3,5,6
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skeletal
(Conventional)
N
N
N
N
N
N
N
Note 1, 2,3,5,6
Musculo-skeletal
(Superficial)
N
N
N
N
N
N
N
Note 1, 2,3,5,6
Intravascular
Thoracic/Pleural
(Specify****)
N
N
N
N
N
N
Note 1, 2,3,5
Cardiac
Cardiac Adult
N
N
N
N
N
N
N
Note 1, 2,3,4,5,7
Cardiac Pediatric
N
N
N
N
N
N
N
Note 1, 2,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac) N
N
N
N
N
N
N
Note 1,4,5
Intra-cardiac
Peripheral vessel
Peripheral vessel
N
N
N
N
N
N
N
Note 1, 2,3,5
Other (Specify***)
N
N
N
N
N
N
Note 1, 2,3,5,6
N=new indication, P=previously cleared by FDA
Additional comments, Combined modes--B+M, PW+B, Color + B, Power + B, PW +Color+ B, Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart3D
Note 3: iScape View
Note 4: TDI
Note 5: Color M
Note 6: Strain Elastography
Note 7: Contrast imaging (Contrast agent for LVO)
Note 8: Contrast imaging (Contrast agent for Liver)
Summary of Contents for TE X
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