Chapter 2: Safety and Regulatory
Optima XR220amx X-Ray System
54400222-1EN
Rev 1 DRAFT 11092010
2-2
Operator Manual
© 2010 General Electric Company. All rights reserved.
The Optima XR220amx is indicated for use on adult and pediatric patients for general-purpose diagnos-
tic radiographic examinations and procedures. Its mobility enables generating radiographic images of
human anatomy in all general-purpose x-ray diagnostic procedures within radiology departments,
emergency rooms, intensive care units, operating rooms, pediatrics, orthopedics and clinical environ-
ments. This may include patients that may not be able to be moved, or in cases where it is unsafe or
impractical to move them to a traditional RAD room.
The Optima XR220amx is intended to take exposures utilizing film or CR, however the Optima XR220amx
utilizes the GE Universal Radiographic Detector, which is intended to replace radiographic film screen
systems in all general purpose diagnostic procedures, for digital radiography (DR). The flat panel detector
provides increased functionality to enable images of patients of all sizes, and can produce comparable
quality images with as little as half the dose of traditional CR cassettes and other flat panel detectors
with lower DQE.
The system is indicated for taking radiographic exposures of the skull, spinal column, chest, abdomen,
extremities, and other body parts with the patient sitting, standing, or lying in the prone or supine posi-
tion. The system has medical applications ranging from but not limited to gastrointestinal examinations,
cranial, skeletal, thoracic, and lung exposures as well as examination of the urogenital tract.
WARNING
United States Federal law restricts this device to sale by or on the order of a physi-
cian.
Contraindications
This device is not intended for mammographic applications.
Users
The targeted clinical users include qualified trained doctors, radiographers, or radiologic technologists
(RTs) working in various locations. Locations may include orthopedic clinics, radiology imaging centers,
hospital radiology departments, or hospital orthopedic departments.
Safety
The electrical wiring of the relevant rooms complies with all national and local codes, as well as the Reg-
ulations for the electrical equipment of buildings published by the Institution of Electrical Engineers. All
assembly operations, extensions, re-adjustments, or repairs must be carried out by qualified service rep-
resentatives. Any modifications must be carried out by GE Healthcare Technologies authorized service
representatives. The equipment must be used in accordance with the instructions for use.
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