Regarding Setup of Cognivue

Cognivue is delivered fully assembled. Once unpackaged and plugged into a grounded, standard wall socket, Cognivue is ready to use.

Learning to use the Cognivue system is easy. The Cognivue system includes all the necessary manuals for operation and for the physician to interpret the results. An on-site technician will be available to set up the system and answer any questions. In addition, there are video tutorials, Continuing Medical Education (CME) presentations, and information on the company’s website.

Updates to the software are prompted automatically when available. Additional information can be found on the website.

No. Cognivue is a Class 2, single-function medical device.

Please refer to the Cognivue Operator’s Manual.

About Reporting and Scoring

At the end of each session, test scores are entered into a one-page report, containing a mix of graphical and textual results, that includes subject identifying information and final performance level scores.

6-7-16 HQ test report

Cognivue provides a single average cumulative score for the eight perception and memory sub-tests scores, and average perception and memory scores for each of their respective four sub-tests.

Average scores greater than 75 suggest the patient is doing well, and is not impaired. Average scores below 50 suggest that they may be having some trouble that should be addressed with the patient and family as appropriate. Scores between 50-75 may indicate that the patient’s brain health may be under stress and that the patient, doctor, and the family should discuss.

This information is archived on Cognivue and entered into the established database.

About the Test Battery

Unlike other cerebral assessment tools, Cognivue is rooted in cognitive psychophysics—which involves engaging individuals in continuous stimulus-response paradigms that demand an intervening cognitive process. This approach enables the measurement of cortical function to be compared to individual and group performance standards—and assists clinicians in the detection and monitoring of cognitive function.

Studies addressing impairments in various cortical functional domains led to the selection of Cognivue’s battery of tests for the analysis of the functional integrity of localized and integrative cortical function.

Cognivue’s test battery consists of 10 one-minute, separately scored sub-tests. These sub-tests measure tracking movement, vision, and the perception and memory of letters, words, shapes and motion.

Cognivue uses the initial two sub-tests (movement and vision) to automatically adjust the speed and brightness of testing to match the motor control and visual sensitivity of each individual patient. These sub-tests do not contribute to the overall score.

Cognivue is self-administered. It is highly recommended that the operator does not offer assistance or allow distractions during testing, as this could alter scoring. A training manual is provided that outlines how to interact with a patient during testing. If the individual being tested cannot perform a sub-test, Cognivue will terminate that test and move on to the next sub-test in the sequence.

Once testing is completed, Cognivue will immediately generate a test report. The operator can then decide to print a report, or exit the session. The patient’s test report will automatically be saved to the computer, even if the operator inadvertently closes the application.

By Patients

If you are age 55 or older and experiencing symptoms such as forgetfulness—or have a family history of dementia—you can discuss your concerns with your physician and determine if a baseline Cognivue test is right for you.

Cognivue is a medical device that can only be used by, or on the order of, a licensed practitioner. Call your physician and ask if he/she has a Cognivue system for cognitive assessment testing. If not, encourage your doctor to call (585) 203-1969 and request a demonstration from Cerebral Assessment Systems (CAS).

You don’t have to know how to use a computer to take the Cognivue test. It simply involves watching a computer screen for 10 minutes and turning a small wheel (called the CogniWheel™) to follow prompts that you see on the screen.

Test results are immediately available to the physician. Your physician can review the results with you before you leave the office, and provide you with a simple one-page report that you can share with your family.

In general, it is thought that repeat testing up to two times a year might be appropriate. Of course, your physician will make exceptions where appropriate to an individual patient’s circumstances.

Cognivue uses the initial two sub-tests (movement and vision) to automatically adjust the speed and brightness of testing to match the motor control and visual sensitivity of each individual patient. Glasses may be worn during the test.

By Physicians

The FDA classifies Cognivue as a Computerized Cognitive Assessment Aid: Prescription Device that uses an individual’s score(s) on a battery of cognitive tasks to provide an interpretation of the current level of ‘cognitive function.’” Source?

Cognivue testing is FDA approved for patients from age 55 to 95 years who express concern about their cognitive health, or whose caregiver or practitioner has such concerns.

Cognivue is the first of its kind: an objective, computer-based solution to rapidly assess, measure, and monitor brain function to detect early signs of dementia in the primary care setting.

Cognivue was designed to be used specifically in primary care with four key attributes: 1) 10 tests in 10 minutes; 2) a one-page report with one average score representing the performance on all tests; 3) patient administered; and 4) the physician can be reimbursed.

Pivotal FDA Studies demonstrated equal or superior accuracy and repeatability as compared to the standard paper-and-pencil tests.

Common causes of reversible impairment include sleep disorders, infection, systemic illness, and mood disorders.

Cognivue is based on psychophysics directly linked to cortical neurophysiology.

Yes. All testing, reporting, and recordkeeping are conducted in a manner consistent with relevant regulatory guidance for the protection of individual patient confidentiality.

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