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The Bavigilant Aura Fusion System is a tool for assessing oral cancer risk. It is meant to be used by healthcare providers on adult patients with visible oral abnormalities. The test combines biomarkers and clinical risk factors to provide a result. It is only for patients with visible lesions and not for those with active cancer or fungal infections. To use the system, follow the instructions provided and power up the reader. The test must be done on a flat surface. Congratulations, and welcome to the Bavigilant Aura Fusion System. The Aura Fusion System is a point-of-care, semi-quantitative, oral cancer risk assessment tool intended to be used by qualified healthcare providers on symptomatic adult patients, specifically those with oral mucosal abnormalities visible to the healthcare provider during the oral cancer exam. The test provides a result based upon the fusion of multiple biomarkers and the patient's clinical risk factors. This test is indicated only for patients with a visible lesion in the oral cavity. The test is not indicated for use in patients with an active cancer diagnosis or an infection of fungus in the mouth. To get started, open the Bavigilant reader box and remove the components. The components include the Bavigilant reader, the instructions for use, and the power supply, including the electrical outlet adapters for your particular region of the world. Prior to powering up the Bavigilant reader, be sure to carefully read the instructions for use, which contains information about the safe and effective operation of the reader. After you've thoroughly read the instructions for use, it's time to power up the reader and set your account. Press the power button located on the back of the reader and hold for one second. It will take the unit up to 30 seconds to fully power up and display the Home or Log In screen. The unit must remain on a flat surface for the duration of the test.