User's Manual

Acclarix AX8 Diagnostic Ultrasound System User Manual Introduction
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1 Introduction
1.1 Intended Use/ Indications for Use
For the United States of America
The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied
health professional for ultrasound evaluations. Specific clinical applications include:
 Abdominal
 Gynecology (including endovaginal)
 Obstetric
 Cardiac
 Small parts (Breast, Testes, Thyroid, etc.)
 Urology
 Musculoskeletal
 Peripheral vascular
 Intra-operative
For the EU and other non-USA regions
The Edan Acclarix AX8 Ultrasound system is intended for use by a qualified physician or allied
health professional for ultrasound evaluations. Specific clinical applications include:
 Abdominal
 Gynecology (including endovaginal)
 Obstetric
 Cardiac
 Small parts (Breast, Testes, Thyroid, etc.)
 Urology
 Musculoskeletal
 Peripheral vascular
 Intra-operative
 Pediatric
 Neonatal (including abdominal and cephalic)
 Adult Cephalic*
1.2 Contra-indications
The Edan Acclarix AX8 Ultrasound system is not intended for ophthalmic use.
1.3 Device Description
The Edan Acclarix AX8 Ultrasound system consists of a main system along with associated
transducers.
The system circuitry generates an electronic voltage pulse, which is transmitted to the
transducer. In the transducer, a piezo electric array converts the electronic pulse into an
ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body
tissues. The waves are then reflected within the body and detected by the transducer, which