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VERION® IMAGE GUIDED SYSTEM IMPORTANT PRODUCT INFORMATION
Verion® Reference Unit and Verion® Digital Marker
CAUTION: Federal (USA) law restricts this device to sale by, or on the order of, a physician.
INTENDED USES: The Verion® Reference Unit is a preoperative measurement device that captures and utilizes a high-resolution reference image of a patient's eye. In addition, the Verion® Reference Unit provides pre-operative surgical planning functions to assist the surgeon with planning cataract surgical procedures. The Verion® Reference Unit also supports the export of the reference image, preoperative measurement data, and surgical plans for use with the Verion ® Digital Marker and other compatible devices through the use of a USB memory stick. The Verion® Digital Marker links to compatible surgical microscopes to display concurrently the reference and microscope images, allowing the surgeon to account for lateral and rotational eye movements. In addition, details from the Verion® Reference Unit surgical plan can be overlaid on a computer screen or the physician's microscope view.
CONTRAINDICATIONS: The following conditions may affect the accuracy of surgical plans prepared with the Verion® Reference Unit: a pseudophakic eye, eye fixation problems, a non-intact cornea, or an irregular cornea. In addition, patients should refrain from wearing contact lenses during the reference measurement as this may interfere with the accuracy of the measurements. The following conditions may affect the proper functioning of the Verion® Digital Marker: changes in a patient's eye between preoperative measurement and surgery, an irregular elliptic limbus (e.g., due to eye fixation during surgery, and bleeding or bloated conjunctiva due to anesthesia). In addition, the use of eye drops that constrict sclera vessels before or during surgery should be avoided.
WARNINGS: Only properly trained personnel should operate the Verion ® Reference Unit and Verion® Digital Marker. Use only the provided medical power supplies and data communication cable. Power supplies for the Verion ® Reference Unit and the Verion® Digital Marker must be uninterruptible. Do not use these devices in combination with an extension cord. Do not cover any of the component devices while turned on. The Verion ® Reference Unit uses infrared light. Unless necessary, medical personnel and patients should avoid direct eye exposure to the emitted or reflected beam.
PRECAUTIONS: To ensure the accuracy of Verion® Reference Unit measurements, device calibration and the reference measurement should be conducted in dimmed ambient light conditions. Only use the Verion® Digital Marker in conjunction with compatible surgical microscopes.
ATTENTION: Refer to the user manuals for the Verion® Reference Unit and the Verion® Digital Marker for a complete description of proper use and maintenance of these devices, as well as a complete list of contraindications, warnings and precautions.