Varex Imaging XRpad2 HWC-M Digital X-ray Manual De Usuario página 24

1.0 Scope
This document describes the design elements and respective interfaces for the
XRpad2 3025 HWC-M, XRpad2 4336 HWC-M, and XRpad2 4343 HWC-M X-ray detectors and
when applicable, unless otherwise indicated, the term XRpad2 HWC-M X-ray detector as used
in this manual applies to all models of the X-ray detectors listed above.
Varex Imaging digital X-ray Flat Panel Detectors and their accessories are components designed
to be integrated into products by X-ray system manufacturers. Manufacturers are responsible for
qualifying, validating, and certifying their products for their intended purposes and meeting all
applicable regulatory requirements.
Final application and intended purpose is 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 the safety, efficacy and compliance of the X-ray system for its intended
use, inclusive of the detector. The Digital Radiography Software referred to in this manual is
medical imaging software for radiography, which is typically supplied by the X-ray system
manufacturer or third-party provider and is not part of the XRpad2 HWC-M X-ray detector User
Manual.
2.0 Intended Purpose
The XRpad2 HWC-M detectors, when used with a radiographic imaging system, is
indicated for use in generating radiographic images of human anatomy for diagnostic X-ray
procedures, wherever conventional Screen-Film (SF), Digital Radiography (DR), or Computed
Radiography (CR) systems may be used. It is not intended for mammographic use.
3.0 Contraindication
The XRpad2 HWC-M is not intended for mammographic use.
4.0 Limitations 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 users of the X-ray detector and for X-ray system manufacturers and X-ray
system installers who are responsible for installing the X-ray detector into an X-ray system.
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