Chapter 12 - System Safety and Maintenance
Indications For Use
Terason t3000 / Echo Ultrasound System User Guide
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Indications for Use - 8TV4 Transducer
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).
f
Includes ultrasound guidance for placement of needles, catheters, cryosurgery, and brachytherapy.
g
Includes ultrasound guidance of transvaginal biopsy.
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: 8TV4
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
X
X
X
X
X
Abdominal
Intra-operative (Specify)
Intra-operative (Neuro)
Laparoscopic
Pediatric
Small Organ (Thyroid, Breast, Testes,
etc.)
Neonatal Cephalic
Adult Cephalic
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)
Musculo-skel. (Superficial)
Intra-luminal
Other (Specify)
Cardiac
Cardiac Adult
Cardiac Pediatric
Trans-esoph. (Cardiac)
Other (Specify)
Peripheral
Vessel
Peripheral vessel
Other (Specify)