Related Documentation; Intended Audience; Indications For Use; Usability - Carestream DRX-Revolution Hardware Manual

Related Documentation

•
DRX-Revolution Nano Mobile X-ray System Safety and Regulatory Information
•
DirectView Online Help Topics and DirectView Software User Release Notes
•
DRX-Revolution Nano Mobile X-ray System User Release Notes
•
DRX-Revolution Nano Mobile X-ray System Installation Guide
•
DRX-Revolution Nano Mobile X-ray System Preventative Maintenance Guide
•
DRX-Revolution Nano Mobile X-ray System Site Specification Guide
•
User Guide for Remote Exposure Switches for Mobile X-ray Systems

Intended Audience

The audience for this guide includes technologists, radiologists, service engineers, and
quality assurance technicians.

Indications for Use

The device is designed to perform radiographic X-ray examinations on pediatric and
adult patients, in all treatment areas. Mammography examinations are excluded.

Usability

The design and development of this diagnostic X-ray system incorporated a usability
engineering process in accordance with IEC 60601-1-6: Medical Electrical
Equipment, Part 1-6: General requirements for safety. Collateral Standard:
Usability

Training

This equipment is intended for use by appropriately educated and skilled radiological
health care professionals who have received specific training on the operation and use
of this equipment.
Caution
Only qualified, trained X-ray personnel should operate the System. Operation of the equipment
by persons who have not been trained or who are unfamiliar with the functions and controls of
the System may cause serious injury to the patient, serious injury to the operator, or equipment
damage.
Caution
Federal law restricts this device to sale by or on the order of a physician.
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Overview
AF0118 | 2018-03-27