IMPORTANT PRODUCT INFORMATION

Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician.

Indication: The NGENUITY^® 3D Visualization System consists of a 3D stereoscopic, high-definition digital video camera and workstation to provide magnified stereoscopic images of objects during micro-surgery. It acts as an adjunct to the surgical microscope during surgery displaying real-time images or images from recordings.

Warnings: The system is not suitable for use in the presence of flammable anesthetics mixture with air or oxygen. There are no known contraindications for use of this device.

Precautions: Do not touch any system component and the patient at the same time during a procedure to prevent electric shock. When operating in 3D, to ensure optimal image quality, use only approved passive-polarized glasses. Use of polarized prescription glasses will cause the 3D effect to be distorted. In case of emergency, keep the microscope oculars and mounting accessories in the cart top drawer. If there are any concerns regarding the continued safe use of the NGENUITY^® 3D Visualization System, consider returning to using the microscope oculars.

Attention: Refer to the user manual for a complete list of appropriate uses, warnings and precautions.