I - 2 Operator’s Manual
I Indications for use
Transducer: C5-1s
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
Fetal Imaging &
Other
Fetal N N N N N N Note 1, 2,3,5
Abdominal N N N N N N Note 1,
2,3,5,8
Intra-operative
(Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric N N N N N N Note 1, 2,3,5
Small Organ
(Specify**)
Neonatal Cephalic
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-
Card.)
Musculo-skeletal
(Conventional)
N N N N N N Note 1, 2,3,5
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
N N N N N N Note 1, 2,3,5
Cardiac
Cardiac Adult
Cardiac Pediatric
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral
vessel
Peripheral vessel N N N N N N Note 1, 2,3,5
Other (Specify***) N N N N N N Note 1, 2,3,5
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)