Mindray TE9 - J Indications for use

Operator’s Manual J - 1
J Indications for use
Transducer: C11-3s
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) BM PWD CWD Color
Doppler
Amplitude
Doppler
Combined
(specify)
Other
(specify)
Ophthalmic Ophthalmic
Fetal Imaging
& Other
Fetal
Abdominal NNN N N N Note 1,4
Intra-operative (Specify*)
Intra-operative (Neuro)
Laparoscopic
Pediatric NNN N N N Note 1,4
Small Organ (Specify**)
Neonatal Cephalic NNN N N N Note 1,4
Adult Cephalic
Trans-rectal
Trans-vaginal
Trans-urethral
Trans-esoph. (non-Card.)
Musculo-skeletal
(Conventional)
Musculo-skeletal
(Superficial)
Intravascular
Thoracic/Pleural
(Specify****)
NNN N N N Note 1,4
Cardiac
Cardiac Adult
Cardiac Pediatric
NNN N N N Note 1,4
Intravascular (Cardiac)
Trans-esoph. (Cardiac)
Intra-cardiac
Peripheral
vessel
Peripheral vessel NNN N N N Note 1,4
Other (Specify***)
N=new indication ； P=previously cleared by FDA ； E=added under Appendix E
Additional comments：Combined modes--B+M、 PW+B、 Color + B、 Power + B、 PW +Color+ B、 Power + PW +B.
*Intraoperative includes abdominal, thoracic, and vascular etc.
**Small organ-breast, thyroid, testes.
***Other use includes Urology.
****For detection of fluid and pleural motion/sliding.
Note 1: Tissue Harmonic Imaging. The feature does not use contrast agents.
Note 2: Contrast imaging (Contrast agent for LVO)
Note 3: TDI
Note 4: Color M
Note 5: Smart 3D
Note 6: Contrast imaging (Contrast agent for Liver)
Note 7: iScape View