Overview
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AF0118 | 2018-03-27
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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.