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Azure 3131Z - 4131Z Reference Manual
1.0
Scope
This document describes design elements and respective interfaces for the Varex Imaging Azure
3131Z and 4131Z Ethernet X-ray detectors. All applicable mechanical, electronic, and software
interfaces are described.
2.0
Intended Purpose
Varex Imaging Azure X-ray detectors and their accessories are designed to be integrated into
systems by X-ray system manufacturers. The Azure 3131Z and 4131Z Ethernet X-ray detectors
are specifically designed to meet the imaging needs of cardiovascular and angiography imaging
applications.
The Varex Image Viewing and Acquisition Pro (Viva Pro) application referred to in this manual
is intended to be used for development, testing, and maintenance purposes only.
Final application and intended use are determined by the X-ray system manufacturer and is
based on the completed X-ray system design. It is the responsibility of the X-ray system
manufacturer to confirm safety, efficacy and compliance of the X-ray system intended for use,
inclusive of the X-ray detector. Manufacturers are responsible for qualifying, validating, and
certifying their products for their intended uses and meeting all applicable regulatory
requirements.
The system integrator is responsible for obtaining regulatory clearance for
Note
medical use.
3.0
Contraindication
No part of the X-ray detector is intended to be attached to and/or contact the patient.
4.0
Limitation of Use/Intended Users
The X-ray detector is intended for use by trained and qualified Radiologists, X-ray technicians, or
radiological personnel who are knowledgeable with the use of X-ray detectors, X-ray systems,
and electrical equipment. Installation requires a qualified technician to install and integrate the
detector into the X-ray system.
When used in medical applications, the X-ray detector is for prescription use by a trained
professional.
For USA: Rx
5.0
Audience
This document is for professionally trained users of the X-ray detector, X-ray System
Manufacturers, and X-ray System Installers who are responsible for installing the X-ray detector
into an X-ray System.
www.vareximaging.com
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