Chapter 2: Safety And Regulatory; X-Ray Protection; Indications For Use - GE Optima XR220amx Operator's Manual

DRAFT

Chapter 2: Safety and Regulatory

This chapter explains the safety considerations, general equipment and patient related precautions, 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.
FCC Statement of Conformance
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and (2) this device must accept any interference
received, including interference that may cause undesired operation.

Indications for Use

The Optima XR220amx is a self-contained, battery-operated mobile radiographic imaging system
designed to generate diagnostic radiographic images (medical x-rays) that may increase the ability to
detect disease or injury early enough for a medical problem to be managed, treated, or cured.
Optima XR220amx X-Ray System
Operator Manual
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54400222-1EN Rev 1 DRAFT 11092010
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Chapter 2: Safety and Regulatory
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