Mindray Eagus TEX21 - Indications for Use

Operator’s Manual K - 1
K 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
Power
Doppler
Combine
d
(specify
)
Other (Specify)
Ophthalmic Ophthalmic P P P P P Note 1
Fetal Imaging &
Other
Fetal PPPPPPPNote 1, 2,3,5
Abdominal PPPPPPPNote 1, 2,3,5,8
Intra-operative (Specify*) P P P P P P Note 1, 2,3,5
Intra-operative (Neuro)
Laparoscopic PPP PPPNote 1
Pediatric PPPPPPPNote 1, 2,3,5
Small Organ (Specify**)PPPPPPPNote 1, 2,3,5,6
Neonatal Cephalic PPPPPPPNote 1, 2,3,5
Adult Cephalic PPPPPPPNote 1, 2,3,5
Trans-rectal PPP PPPNote 1, 2,3,5,6
Trans-vaginal PPP PPPNote 1, 2,3,5,6
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
PPPPPPPNote 1, 2,3,5,6
Musculo-skeletal
(Superficial)
PPPPPPPNote 1, 2,3,5,6
Intravascular
Thoracic/Pleural
(Specify***)
PPP PPPNote 1, 2,3,5
Urology P P P P P P Note 1, 2,3,5,6
Cardiac
Cardiac Adult PPPPPPPNote 1,
2,3,4,5,7
Cardiac Pediatric PPPPPPPNote 1, 2,3,4,5
Intravascular (Cardiac)
Trans-esoph. (Cardiac)PPPPPPPNote 1,4,5
Intra-cardiac
Peripheral vessel Peripheral vessel P P P P P P 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.
***Thoracic/Pleural - For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging.
Note 2: Smart 3D
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)