O-ARM SURGICAL IMAGING SYSTEM
For full details, please refer to your System Manual.
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 27kg 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.
BRIEF STATEMENT
See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu