Patient Indication For Use
The REAL® Immersive System is a virtual reality device that enables you to experience, in an interactive way, your upper body movements as you perform rehabilitation exercises in a variety of virtual environments through an avatar that is displayed as though you are in the virtual environment on display. These rehabilitation exercises must always be performed in a healthcare setting, such as hospitals, outpatient centers, mobile gyms or other facilities that are equipped for rehabilitation therapy.
A healthcare professional must be present at all times to provide direct supervision of the use of the product. Federal (USA) law restricts this device to sale by or on the order of a healthcare provider.
There are no known contraindications.
- If you experience motion sickness, dizziness, headache, eye strain, or fatigue when using the device, stop using the device immediately.
- Use caution when using this device if you have a history of inner ear issues that might cause vertigo, or motion sickness.
- Make sure to perform the activities with the REAL System device in a safe environment, without any objects you could bump into within arms’ reach. Be aware of any limitations you may have with your range of motion and avoid over-extending yourself to prevent injuries. Ensure a medical professional is with you at all times to prevent any injury.
- Using the headset for longer than your healthcare professional recommends might result in discomfort or eye strain.
- Your avatar may not appear correctly or may become distorted if the sensors are not placed on your body correctly.
- If the components of the device are dropped or struck against another object, mechanical or electrical damage may result.
- Dropping the device from higher than 1 meter could damage the device. Do not use the device if damaged.
- Do not touch the router at any time during use of the device.
- Do not continue to use the device if components start to overheat or are hot to the touch. Their temperature should not exceed 105.8 °F (41 °C).
- The sensors will transmit inaccurate position data if the device is used near metal including, but not limited to, wheelchairs, walkers, utility carts, smart watches and mobile devices.
- Your avatar won’t appear correctly if you use the device within 4-5 feet of any large objects, such as concrete walls, metal objects with lead or magnetic surfaces, or near white or glass walls.
- To avoid risk of electric shock, only plug the device into a grounded outlet.
- Do not use the device near any liquids.
- Do not make any changes to the REAL System.
- Use of accessories other than those specified or provided by the manufacturer of the device could cause it to malfunction.
- Do not use portable RF communications equipment (such as antenna cables, external antennas, mobile devices, and smart watches) closer than 12 inches of any part of the REAL System, including cables specified by the manufacturer. Otherwise, the device may not perform as it is intended to perform.
- Do not use the device near or stacked with other equipment because it may not work properly. If such use is necessary, the device and the other equipment should be watched to ensure they are working normally.
- Accessories such as power adapters and cords should only be replaced by Penumbra.
- Make sure the device with online access is used on a secure network to ensure the security of any data processed by the device.
Potential Adverse Effects/Events
Visual stimulation through the headset may have a small possibility of provoking an epileptic seizure. Should this occur, stop using the device immediately.
Other possible complications include but are not limited to: claustrophobia, discomfort or pain in the head or eyes, disorientation/vertigo/dizziness, drowsiness, eye strain, falls or fractures, headache/migraine, insomnia, light-headedness, motion sickness, nausea, pain, seizure, repetitive strain injury, vision problems, skin irritation.
Should any of the above occur, stop using the device immediately.