Important Safety Information (ISI)
Skylar’s Run is a novel personalized digital therapeutic for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children.
Skylar’s Run is a biopsychosocial treatment for ADHD in children.
Skylar’s Run is not a substitute for your child’s ADHD medication or other treatments
Skylar’s Run has NOT been cleared by the U.S. Food and Drug Administration (FDA).
During the COVID-19 public health emergency, Skylar’s Run is being made available without a prescription for the treatment of ADHD in children.
Contact your child’s healthcare provider before using Skylar’s Run.
Do not drop, sit on, step on, or otherwise damage the AV™ Headset device.
As with any wearable electronics, in the event of a short circuit or the appearance of smoke or fire, remove the headset immediately. Similarly, if you are in or near a fire, remove the headset immediately.
Do not use the AV™ Headset if the skull of the patient is not intact, or the patient has a sensitive dermatological condition on the scalp, or if even very light electrode contact forces cannot be tolerated.
Do not use the AV™ Headset in case of open wounds or infections on the scalp to avoid exacerbation of those conditions.-To keep the AV™ Headset safe, do not:
- Immerse into any liquid, other than light moistening of dry sensors to promote rapid contact.
- Sterilize. other than the use of disinfecting wipes.
- Expose the product to direct sunlight or heat source or thermal radiation, moisture, vibration, mechanical shock, excessive dust, or humidity.
- Use when damaged.
- Use caustic or abrasive cleaning agents to clean the device or electrodes.
- Charge while being worn by the patient.
A very small percentage of individuals may experience epileptic seizures or blackouts when exposed to certain light patterns or flashing lights. Playing video games may trigger epileptic seizures or blackouts in these individuals. These conditions may also trigger previously undetected epilepsy or seizures in persons who have no prior history of epilepsy or seizures. If your child, or anyone in your family, has an epileptic condition or has had seizures of any kind, please talk with your child’s physician about the history before playing Skylar’s Run.
Skylar’s Run may not be appropriate for children with color blindness or physical limitations that restrict use of a mobile device. If your child has any of these conditions, please consult with your child’s physician before using Skylar’s Run.
If your child experiences health problems while playing Skylar’s Run (such as dizziness, lightheadedness, nausea, altered vision, eye or muscle twitches, eye discomfort or pain, joint discomfort or pain, loss of awareness, disorientation, seizures, convulsions or any involuntary movements), stop use and contact your child’s physician before resuming Skylar’s Run.
If your child experiences any side effects related to playing Skylar’s Run (such as frustration, headache, dizziness, emotional reaction, nausea, or aggression), stop use immediately and contact your child’s physician before resuming Skylar’s Run.
Please follow all mobile device manufacturer’s instructions for the safe operation of a mobile device.
For example, this may include appropriate volume settings, proper battery charging, and not operating the device if damaged. Contact your mobile device manufacturer for any questions or concerns that pertain to your device.
