Chapter 12 - System Safety and Maintenance Indications For Use
Terason t3000 / Echo Ultrasound System User Guide 255
Indications for use - Diagnostic Ultrasound System
a
Includes Color Doppler (CD), Directional Power Doppler (DPD), and (non-directional) Power Doppler (PD).
b
B+M; B+PWD; B+CD; B+DPD; B+PD; B+CD+PWD.
c
Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI).
d
Includes ultrasound guidance for placement of needles, catheters.
e
Abdominal organs and peripheral vessels.
f
Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy.
g
Includes ultrasound guidance of transvaginal biopsy.
h
Includes ultrasound guidance of amniocentesis, infertility monitoring of follicle development.
j
Includes ultrasound guidance for placement of needles.
k
Abdominal includes GYN/Pelvic.
l
Other use includes Urology/Prostate.
Includes uses in military field settings in addition to hospital/clinic settings.
DIAGNOSTIC ULTRASOUND INDICATIONS FOR USE FORM
System: Terason Ultrasound System
Transducer: See Comments
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 (Tracks 1 and 3) B M PWD CWD
Color
Dopp
a
Comb.
Modes
b
Other
c
Ophthalmic
Ophthalmic
Fetal Imaging
and Other
Fetal
X
h
X
h
X
h
X
h
X
h
X
h
Abdominal
k
X
d
X
d
X
d
X
d
X
d
X
d
X
d
Intra-operative
e
XXX X X X
Intra-operative (Neuro) X X X X X X
Laparoscopic X X X X X X
Pediatric
X
d
X
d
X
d
X
d
X
d
X
d
X
d
Small Organ (Thyroid, Breast,
Testes, etc.)
X
d
X
d
X
d
X
d
X
d
X
d
Neonatal Cephalic X X X X X X X
Adult Cephalic X X X X X X X
Trans-rectal
X
f
X
f
X
f
X
f
X
f
X
f
Trans-vaginal
X
g
X
g
X
g
X
g
X
g
X
g
Trans-urethral
Trans-esoph. (non-Cardiac)
Musculo-skel. (Conventional)
X
d
X
d
X
d
X
d
X
d
X
d
Musculo-skel. (Superficial)
X
d
X
d
X
d
X
d
X
d
X
d
Intra-luminal
Other (Specify)
Cardiac
Cardiac Adult X X X X X X X
Cardiac Pediatric X X X X X X X
Trans-esoph. (Cardiac)
Other (specify)
Peripheral
Vessel
Peripheral vessel
X
d
X
d
X
d
X
d
X
d
X
d
Other (specify)
To Next Page
Loading...