REAL™ IMMERSIVE SYSTEM OPERATION, MAINTENANCE, AND SERVICE MANUAL
Table of Contents Warning 1 Device Description 1 Indication for Use 2 Contraindications 2 Warnings 2 Precautions 2 Potential Adverse Effects/Events 2 Operating Profile 3 Operating Procedure 3 • Getting Started & Charging Components 3 • Internet Connectivity 4 • Start-Up System for Patient Use 4 • Therapy Experience 6 • System Removal 7 • Software Description 8 Technical Specifications 11 Symbol Glossary 11 Technical Information 11
WARNING! CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS. DEVICE DESCRIPTON The REAL™ Immersive System is a digital hardware and software medical device platform using a combination of virtual environments and full presence tracked avatars for visual feedback. It is designed for use in healthcare and focusing on physical and neuro rehabilitation.
INDICATION FOR USE The REAL Immersive System is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult patients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.
OPERATOR PROFILE Operators of the REAL Immersive System should be trained in rehabilitation therapy. 3. Ensure sensors with white sides facing forward are in their corresponding size slots on the sensor charger. LED lights on sensors will show flashing red, flashing green, or solid green to display charging status. Note: These rehabilitation exercises are intended to be conducted in a clinical environment and prescribed and supervised by a medical professional trained in rehabilitation therapy.
SECTION 2: INTERNET CONNECTIVITY 1. Turn on tablet by pressing power button for approximately 5 seconds. (May take up to 30 seconds if tablet was fully drained of battery). 3. Turn on headset by pressing and holding power button for approximately 5 seconds. 4. Ensure the patient is in a seated position away from metal components and remains seated at all times for the duration of the therapy session. 5. Place headset on patient’s head in the sequence numbered below.
8. Place small sensors onto bands by sliding them into elasticized loops. For the hand sensor bands, tighten elasticized loop using the buckle. Place large sensor into pocket of shoulder band. 9. Once sensors are placed in the bands, put each band onto its corresponding body part (see image below). Connect hook and loop fasteners of shoulder band if desired. Make sure the elbow sensor is sitting behind the patient’s elbow. Adjust bands for comfortable fit, if necessary. 10. Log in on the tablet.
Front View Back View 6
11. Once a patient is selected or created, the healthcare provider (HCP) may initiate the session by pressing “Start Session” from the header. Each session begins in the Hide and Seek game by default. See figure below 12. Orient the patient in a neutral seated position, facing forward. Press the Go button on the tablet. 13. The HCP may navigate to additional therapy experiences by selecting the corresponding icon from the display.
5. Always remain with the patient throughout therapy session to provide direct supervision. 6. Monitor patient view on tablet; select and change activities as desired. Note: If sensors lose synchronization or headset loses tracking, turn off entire system then back on to reset. Headset is turned off and on using the power button. Sensors are turned off and on by placing them in the powered charging station and removing them again. 7.
Section 6: SOFTWARE DESCRIPTION The REAL Immersive System contains a variety of experiences that incorporate clinically recognized, existing therapeutic and functional exercises to facilitate motor and cognitive rehabilitation. Settings for each experience will involve parameters such as turning on and off avatar features and environmental factors as well as switching between activities.
stage. Wind driven clouds bump into the balloon and move the balloon arbitrarily which the patient has to counteract with trunk movements. Sub-Activity 2: Harvest Therapy Game 3: Sunrise This experience is based on simple shoulder flexion. The patient holds their arms out straight in front of them and raises their arms up and over their head in a motion that ideally, is pure shoulder flexion with a maximum, healthy ROM of 180 degrees.
The Ice Cave sub-activity involves freeing a variety of Cave Penguins from ice blocks by raising and lowering ones arms a number of times in order to trigger the appearance of day-night cycles. Different numbers of cycles necessary to fully free a penguin can be controlled by the HCP through difficulty settings. Upon each Cave Penguin’s release, the patient receives an award that is saved in their game record.
can also serve as targets. The HCP can control how fast the ball travels towards the patient, the distance the patient must reach to block the ball, and the number of balls to be kicked at the patients. Sub-Activity 3: Flying Fish Flying fish is similar to Chuckleball where the patient must deflect a fish being pitched at them with the hand or the head. This may elicit a defensive response movement from the patient in VR.
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REAL™ Immersive System is intended for use in the electromagnetic environment specified below. The customer or the user of REAL Immersive System should assure that it is used in such an environment. Emissions Test RF emissions CISPR 11 Compliance Immunity test REAL Immersive System uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Immunity to RF Wireless Communications Equipment Test Frequency (MHz Band a) 385 380-390 Service a) Modulation b) Maximum Power (W) Distance (m) IMMUNITY TEST LEVEL (V/m) Pulse modulation b) 18 Hz 1.8 0.3 27 (MHz) TETRA 400 450 430-470 GMRS 460, FRS 460 FM c) ±5 kHz deviation 1 kHz sine 2 0.3 28 710 704 – 787 LTE Band 13, 17 Pulse modulation b) 217 Hz 0.2 0.
