Intended Use

ImPACT Version 4 is a medical device intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT Version 4 is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.

Warnings and Cautions#

ImPACT Version 4 is not intended to provide a diagnosis or decision about the test taker. The results should be interpreted only by qualified healthcare professionals.

ImPACT Version 4 does not identify the presence or absence of a clinical diagnosis.

ImPACT Version 4 cannot be used as a stand-alone diagnostic for concussion.

The device is not intended to be used as a stand-alone assessment for making determinations regarding return to activity.

Caution should be exercised when using this test to assess individuals that have been diagnosed with or are currently experiencing other confounding conditions including but not limited to the following: insomnia, post-traumatic stress disorder (PTSD), depression, attention deficit hyperactivity disorder (ADHD), memory impairment, vision impairment corrected outside normal limits, dementia, delirium, prescription and non-prescription medication, some nutritional supplements, as well as other neurological and psychiatric disorders in which impaired cognitive function may be present and a variety of other psychological states (e.g., fatigue and stress).

The safety and effectiveness of ImPACT Version 4 for individuals under the age of 12 years and over the age of 80 years has not been established.

The reliability and validity of the ImPACT Version 4 results in individuals with color blindness has not been established.

The reliability and validity of the ImPACT Version 4 results in individuals with a reading level below the sixth grade has not been established.

Baseline testing performed in an unsupervised manner may include a higher possibility for distraction than baseline testing performed in a supervised manner, which requires clinical judgment when interpreting results.

ImPACT Version 4 is intended to be used by medical professionals qualified to interpret the results of a concussion assessment examination and aid in the management of concussion.

Caution: US Federal Law restricts this device to use by, or on the order of a licensed healthcare professional.

Contact the ImPACT Applications Support Team for product or training support, to submit a complaint or report if the use of the device contributed to a serious injury, or to obtain a free printed copy of this manual.

Web: www.impacttest.com/contact

Tel: 1-877-646-7991

Email: support@impacttest.com