2. Statement of Intended Use
Statement of intended use
The Varex Nexus DR Digital X-Ray Imaging System is a high-resolution digital imaging system
intended to replace conventional film techniques, or existing digital systems, in multipurpose or
dedicated applications specified below.
The Varex Nexus DR Digital X-Ray Imaging System enables an operator to acquire, display,
process, export images to portable media, send images over a network for long-term storage,
and distribute hard-copy images with a laser printer. Image processing algorithms enable the
operator to bring out diagnostic details difficult to see using conventional imaging techniques.
Images can be stored locally for temporary storage. The major system components include an
image receptor, computer, monitor and imaging software.
For the DR application, the Varex Nexus DR Digital X-ray Imaging System is intended for use
in general radiographic examinations and applications (excluding fluoroscopy, angiography,
and mammography).
Note:
For the purposes of clarity, the imaging system is also referenced as Nexus DR
throughout this manual and other product-related documentation.
Warning:
Do not modify this equipment without authorization from
Nexus DR.
Intended patient population
Because Nexus DR relies on ionizing radiation to generate images, it is not recommended
for use on patients who are or may be pregnant. Nexus DR is approved for use on all other
patients.
When imaging pediatric patients, Varex provides the following recommendations:
• Measure patient thickness and set appropriate child size technique.
• Avoid using anti-scatter grids for patient thickness less than 10-12cm.
• Radiate only the necessary anatomy, employing appropriate collimation and shielding.
Intended anatomy
Nexus DR may be used to image any part or area of human anatomy that can be imaged with
X-ray radiation, with or without a contrast agent.
Intended user profile
Nexus DR is designed and approved for use by trained Radiological Technologists, or by any
certified medical professional who is (a) under the supervision of a physician, (b) trained in the
use of X-ray equipment, and (c) trained in the use of Nexus DR by Varex.
6 | Nexus DR Regulatory and Safety Manual, 736-226-G1, Rev. J
Summary of Contents for nexus DR
Page 1: ...Regulatory and Safety Manual 736 226 G1 Rev J...
Page 2: ...Regulatory and Safety Manual 2 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...
Page 13: ...1 Regulatory Information 4 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...
Page 17: ...2 Statement of Intended Use 8 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...
Page 21: ...3 Cleaning Practices 12 Nexus DR Regulatory and Safety Manual 736 226 G1 Rev J...
Page 44: ...Index 35...
Page 45: ......
