INTENDED USE
The O-arm® O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighing 60 lbs or greater and having an abdominal thickness greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm® O2 Imaging System is compatible with certain image guided surgery systems.
United States law restricts this device to sale, distribution, and use by or on the order of a physician.
USE OF VIDEO GRAPHICS PRINTER
Printouts from the optional Video Graphics Printer are not intended to be used for diagnostic purposes. The printer's primary use is for physician reference and documentation.
USE OF THE DVD/CD RW DRIVE
Information stored on DVDs is not intended to be used for diagnostic purposes. The primary use of such information is for physician reference and documentation.
EQUIPMENT USERS
Users of the O-arm Imaging System should be trained, licensed, and/or certified in the proper use of medical x-ray equipment and its medical applications. Users should read this user manual and the labels on the Image Acquisition System (IAS) and the Mobile View Station (MVS).
SAFETY OVERVIEW
Potential hazards exist in the use of medical electronic devices and X-ray systems such as the O-arm Imaging System. Personnel using the equipment should understand the safety issues, emergency procedures, and the operating instructions provided in the User Manual.
It is important that you discuss the potential risks, complications, and benefits of spinal surgery with your doctor prior to receiving treatment, and that you rely on your doctor’s judgment. Only your doctor can determine whether you are a suitable candidate for this treatment.
The materials on this website are for general educational purposes only. Information you read on this website cannot replace the relationship that you have with your healthcare professional. We do not practice medicine or provide medical services or advice as a part of this website. You should always talk to your healthcare professional for diagnosis and treatment.
Information on this site should not be used as a substitute for talking with your doctor. Always talk with your doctor about diagnosis and treatment information.
