Chapter 2: Safety and Regulatory
5495975-1EN Rev.9 2-1
© 2013-2017 General Electric Company. All rights reserved.
Chapter 2: Safety and Regulatory
This chapter explains the safety considerations, general equipment and patient related pre-
cautions, and the symbols used for the safe operation of your equipment. This chapter also
includes information about the emergency procedures.
This chapter presents the concepts necessary to successfully operate your system safely.
X-Ray Protection
X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein
contained should be thoroughly read and understood by everyone who will use the
equipment before you attempt to place this equipment in operation. GE Healthcare, will be
glad to assist and cooperate in placing this equipment in use.
Although this apparatus incorporates a high degree of protection against x-radiation other
than the useful beam, no practical design of equipment can provide complete protection. Nor
can any practical design compel the operator to take adequate precautions to prevent the
possibility of any persons carelessly exposing themselves or others to radiation.
It is important that everyone having anything to do with x-radiation be properly trained and
fully acquainted with the recommendations of the National Council on Radiation Protection
and Measurements as published in NCRP Reports available from NCRP Publications, 7910
Woodmont Avenue, Room 1016, Bethesda, Maryland 20814, and of the International
Commission on Radiation Protection, and take adequate steps to protect against injury.
The equipment is sold with the understanding that GE Healthcare, its agents, and
representatives have no responsibility for injury or damage which may result from improper
use of the equipment.
Various protective material and devices are available. It is urged that such materials or
devices be used.
Indications for Use
The Optima XR646 is intended to generate digital radiographic images of the skull, spinal col-
umn, chest, abdomen, extremities, and other body parts in patients of all ages. Applications
can be performed with the patient sitting, standing, or lying in the prone or supine position
and the system is intended for use in all routine radiography exams.
The device is not intended for mammographic applications.
CAUTION Federal law restricts this device to sale by or on the order of a physician.
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