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)
OphthalmicOphthalmic N N NNNNote 1
Fetal Imaging &
Other
Fetal NNNNNNNNote 1, 2,3,5
Abdominal NNNNNNNNote 1, 2,3,5,8
Intra-operative
(Specify*)
NNN NNNNote 1, 2,3,5
Intra-operative (Neuro)
Laparoscopic NNN NNNNote 1
Pediatric NNNNNNNNote 1, 2,3,5
Small Organ
(Specify**)
NNNNNNNNote 1, 2,3,5,6
Neonatal CephalicNNNNNNNNote 1, 2,3,5
Adult CephalicNNNNNNNNote 1, 2,3,5
Trans-rectal NNN NNNNote 1, 2,3,5,6
Trans-vaginal NNN NNNNote 1, 2,3,5,6
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skeletal
(Conventional)
NNNNNNNNote 1, 2,3,5,6
Musculo-skeletal
(Superficial)
NNNNNNNNote 1, 2,3,5,6
Intravascular
Thoracic/Pleural
(Specify****)
NNN NNNNote 1, 2,3,5
Cardiac
Cardiac AdultNNNNNNNNote 1, 2,3,4,5,7
Cardiac PediatricNNNNNNNNote 1, 2,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac)NNNNNNNNote 1,4,5
Intra-cardiac
Peripheral vessel
Peripheral vesselNNNNNNNNote 1, 2,3,5
Other (Specify***) N N N NNNNote 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)