INDICATIONS, SAFETY, AND WARNINGS O-arm Surgical Imaging System

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 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.


Caution - Laser Radiation. Do not view directly with optical instruments. Class 1M Laser Product.