FCC ID: 2AQU7-REAL02T WTM for REAL Immersive System

REAL IMMERSIVE SYSTEM USER MANUAL Table of Contents Warning Device Description Indication for Use Contraindications Warnings Precautions Potential Adverse Effects/Events Operating Profile Operating Procedure Getting Started & Charging Components Internet Connectivity Start-Up System for Patient Use Therapy Activities System Removal Software Description Technical Specifications Symbol Glossary Technical Information 3 3 4 4 4 4 4 5 5 5 6 6 8 9 10 13 13 13 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. 1 (27) DEVICE DESCRIPTON The REAL Immersive System is a digital hardware and software medical device platform utilizing virtual reality technology designed for use in a clinical environment, or any other facility that may facilitate rehabilitation, setting that focuses on physical, neurorehabilitation and/or wellness needs. Headset Plug headset power cord into wall outlet and headset to charge device. Press power button to power on headset or restart headset. The power button is on top of the headset. REAL Immersive System consists of following components:

Buttons on the controller are used to control power, connect to headset, access Headset Controller All-In-One Headset with Software Application Headset Controller Large Sensor Small Sensors Tablet Sensor Charger (charging station) REAL Sensor Bands Tablet is fitted with a touch screen, a power/lock key that turns the component on or off, and a charger/accessory port. The headset contains a power button that turns the component on or off and a charger/

accessory port. The headset also provides visual feedback of virtual reality applications in concert with the REAL Immersive System tablet and small and large sensors. Large and small sensors (WTM and WSMs) are equipped with mechanical and electrical components that measure motion and direction in physical space and then translate that information into a virtual environment. The sensor charger powers the sensors. Headset controller (Only to be used in certain troubleshooting and administrative tasks. Not used during patient therapy.) At full charge, the entire system can last at a minimum of 60 minutes and it is recommended that a therapy session does not exceed 60 minutes. Please sufficiently charge all components between use for a minimum of 60 minutes. In the event of electromagnetic disturbances, the performance of the REAL Immersive System may be affected. The REAL Immersive System is a Type BF Applied Part. Frequently used features and functions:

settings, or control volume. Large Sensor and Small Sensors Components are removed or placed back into the sensor charger (charging station) to activate or charge device. Components are placed into the sensor bands. Tablet Plug tablet power cord into wall outlet and tablet to charge device. Press power button to power on tablet or restart tablet. The power button is on the edge of the device. User Interface:

- Selecting the application

- Logging in

- Adding or selecting patient

- Initializing and syncing to sensors

- Selecting, starting, modifying, or ending therapy session

- Viewing data

- Logging out Sensor Charger Plug sensor charger power cord into wall outlet and sensor charger to power on device to charge sensors. Sensor Bands Place or remove sensor bands on or from patient. There is no preventive inspection, calibration, and maintenance necessary for the REAL Immersive System besides the initial set up procedure. During the three-year product lifespan of the REAL Immersive System, the device will continue to perform safely without any routine maintenance. No parts within the REAL Immersive System will require inspection nor maintenance by a service personnel to ensure basic safety during the three-year product lifespan. Circuit diagrams and calibration instructions are not provided because service or parts repair is not necessary. At the end of the three-year product lifespan, the user should dispose of the device through an environmentally safe electronic waste recycle system. Contact the local REAL representative if the following event occurs:

The system no longer stays powered on and connected through the entire recommended duration of a therapy session. Supply mains are electrically isolated in medical equipment to maintain basic safety. 2 (27) The full expected latency of the device, including movement detection, processing, and visual representation is 35 milliseconds or less. This value is considered minimal and sufficiently low enough so that movement can be quickly detected. 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 pa-

tients 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 or any other facility that may facilitate rehabilitation and prescribed and supervised by a medical professional trained in rehabilitation therapy. CONTRAINDICATIONS There are no known contraindications. Headset tracking can be lost or compromised if large objects obscure the headset. At no time should liquid products be allowed near any device component. No modification of this equipment is allowed. Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the REAL Immersive System, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. WARNINGS If a patient complains of motion sickness, dizziness, headache, eye strain, or fatigue when using the device, stop use of device immediately. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Use caution when using this device if a patient has a history of vestibular issues or motion sickness. PRECAUTIONS Ensure a safe environment for the patient while performing activities with the device

(e.g. remove any surrounding obstacles and ensure that the patient is unlikely to trip or fall). As this device is to be used for upper body rehabilitation, we recommend that the patient remain seated to avoid a fall. Be aware of the patients limitations in range of motion and avoid device or program use that could lead to excessive gestures that could injure a patient. Extended use of the headset can cause discomfort or eye strain. Incorrect placement of the sensors on the patient may result in the avatar appearing incorrectly or distorted on the headset and tablet. Damage (mechanical and electrical) may result if the tablet, headset, sensors, and/or sensor charger are dropped or struck against another object. Device is not intended for continued use if dropped from higher than 1 meter. Surface temperature around the headset exhaust may reach 46C if operating above nominal room temperature. 3rd conductor of the AC cord is only a functional earth. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. Sensors will transmit inaccurate position data if used near metal including, but not limited to, wheelchairs, walkers, and utility carts. Accessories such as power adapters and cords should not be replaced by the end user and should only be replaced by Penumbra. Any changes or replacements of accessories will likely impact compliance of REAL Immersive System. Use of this device should be in a secure information technology environment. Outbound https communication channels must be open. AC power cord must not exceed 6 feet in length. POTENTIAL ADVERSE EFFECTS/EVENTS Visual stimulation through head-mounted displays 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, the following:

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 3 (27) Should any of the above occur, stop using the device immediately. OPERATOR PROFILE Operators of the REAL Immersive System should be trained in rehabilitation therapy. Follow hospital guidelines for use and access to account login credentials. The same account login credentials shall not be used by more than one REAL System at any given time. 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. Rehabilitation therapy treatment and technique decisions will vary based on the clinical judgement of the treating medical professional. A medical professional must be present at all times to provide direct supervision throughout course of therapy. OPERATING PROCEDURE Note: Prior to first time use, HMD and Tablet must be configured and connected to the local internet. Note: Over-the-air software updates may occur throughout the lifespan of the REAL System. User may be prompted/required to complete software updates to continue using the product. Note: These rehabilitation exercises are intended to be conducted in a seated position. The patient must be seated at all times when the system is in use. SECTION 1: GETTING STARTED AND CHARGING COMPONENTS 1. Remove REAL Immersive System case from the shipping container. 3. Ensure sensors with white sides facing forward are in their corresponding size slots on the sensor charger. LED lights on sensors will show the following:

4 (27) 4. Ensure the headset is connected to its power cord (USB-C cord). LED lightson top of 3. Turn on headset by pressing and holding power button for approximately 5 headset will only show blinking green or solid green to indicate charging status. seconds. 5. Ensure the tablet is connected to its power cord (USB-C cord). 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 patients head in the sequence numbered below. Patient can immediately begin visually interacting with the environment. SECTION 2: INTERNET CONNECTIVITY Connecting via WiFi 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). 2. Open the TherapyView app if it is not already open. 3. On the log in page, click on the Network Setup button. 4. Connect using the desired wireless network name and password. 5. 6. Click the button at the top left of the screen to return to the TherapyView home screen. Continue to Section 3 when the components are sufficiently charged, and the system has secure internet connectivity. Note: Size of headset strap and interpupillary distance can be adjusted for fit. Top of head pad may be removed temporarily for better fit on larger heads. Note: Patient can keep eyeglasses on. 6. Remove sensor bands from reusable packaging (sold separately). Each patient should have their own sensor bands and bands should not be shared between patients. SECTION 3: START-UP SYSTEM FOR PATIENT USE 1. Unplug power cords from tablet and headset when ready to use. 7. Remove all sensors from sensor charger. 2. If tablet is not turned on, turn on. 5 (27) 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 patients elbow. Adjust bands for comfortable fi t, if necessary. 12. Have the patient sit in a neutral position, facing forward with hands on knees or thighs. Press the button on the tablet screen to calibrate the sensors. 10. Log in on the tablet. Add new patient or select patient from directory; edit patient information as needed. 11. Once a patient is selected or created, the healthcare provider (HCP) may initiate the session by pressing Start Session. 13. Confirm patients avatar in VR space corresponds to actual patients physical movement. Edit the default avatar settings to match your patient. If the avatar looks correct, press Continue. If not, HCP can recalibrate the sensors by selecting the Remap Sensors button. 14. The HCP may navigate to additional therapy activities by selecting the corre-

sponding icon from the display. Once the activity has loaded, the HCP can press the Start Activity Session button to begin the activity. See Section 6 for more information. 6 (27) Section 4: THERAPY ACTIVITIES 1. Confirm patients avatar in VR space corresponds to actual patients physical movement. 2. Confirm application audio can be heard but doesnt block out HCPs communication; adjust volume on headset as needed. 3. Conduct rehabilitation session as planned. (See Section 6 which includes a software description for details of therapeutic activities). 4. Always remain with the patient throughout therapy session to provide direct supervision. 5. Monitor patient view on tablet; select and begin new 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. App should be relaunched on the tablet. Sensors are turned off and on by placing them in the powered charging station (while the REAL Immersive System is plugged in) and removing them again. 6. When planned therapy activities are complete, press End Session on tablet. Patient will be returned to the Hide and Seek activity. 7. View patient results on tablet. You may also switch to the Notes tab for a summary of session and activity times. Section 5: SYSTEM REMOVAL 1. Remove sensors and bands. 2. Remove headset from patients head. 3. Power off headset by pressing and holding onto the power button for approximately 5 seconds. 4. Log out of tablet. 5. Clean headset and sensors with institutional approved sanitizing wipes*. 6. Ensure REAL Immersive System Case is plugged in. 7. Connect tablet and headset to their respective power cords. 7 (27) 8. Return all sensors to sensor charger. Red or green LEDs should be noted on Section 6: SOFTWARE DESCRIPTION sensors when placed correctly in the charging station. 9. Store and label bands for future individual patient use. 10. Sufficiently charge all components after each use and prior to next use for 60 minutes. Note: Standard operation is to power cycle and relaunch application between therapy sessions to reestablish system connections.

*Handle the lenses on the headset carefully to avoid smears or scratches. Wipe lenses with a soft cloth for cleaning as needed. Clean outer and inner plastic components of headset with institutional approved sanitizing wipe. Do not use petroleum-based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Use only water-based solvents for cleaning. REAL Immersive System Case Instructions:

The REAL Immersive System is housed in a travel case that may be locked with the attached combination lock that secures the zipper. The combination lock should be turned to the red dot position at all times. If the combination lock is turned away from the red dot, turn it to the red dot position. How to reset the combination lock:

1. Set all combination dials to the following: (0-0-0 default) 2. Find the hole located to the right of the dials. Use a paper clip or similar tool to press down on the reset button until an audible click is heard. 3. Set personal combination by turning the dials to display the desired set of numbers, e.g. 2-8-7. 4. Push the slide button located on the left of the dials towards the direction of the arrow and the reset button will push back up. An audible click will be heard. 5. Remember the personal combination and repeat the steps above to reset the personal combination, if necessary. How to use the combination lock:

1. button on the left of the dial towards the direction of the arrow to unlock. To unlock: Turn the dials to the correct combination. Push the slide 2. then turn the dials randomly to conceal the personal combination to lock. To lock: Put the loop portion of the zipper into the slots of the lock, REAL y-Series contains a variety of experiences with a multitude of activities that incorporate clinically recognized, existing therapeutic, functional, and wellness exercises to facilitate motor learning, cognitive function, memory, and relaxation. Settings for each experience and their activities will involve parameters such as turning on and off avatar features and environmental factors. While using the REAL y-Series, the HCP remains responsible for the patients safety and the appropriateness of individual exercises including range of motion (ROM) attempted and any other limb or joint limitations unique to that patient. REAL Home REAL Home is a peaceful, serene lakeside experience to acclimate patients to VR. The REAL Home experience moves at its own pace and provides a secure space for patients to spend as much or as little time as they wish here before, in-between, and after activities. Patients can listen to music, birds chirping, lapping water, and wind chimes as they enjoy the tranquil lakeside and grow comfortable in this virtual space. 8 (27) Happy Valley Hide and Seek Activity Happy Valley is designed to support physical rehabilitation, cognitive function, and wellness immersing the patient in a delightful world of penguins. Happy Valley includes a total of 18 therapeutic and wellness activities. Hide and Seek can be used with or without a displayed avatar tracking the patients body as it primarily relies on cervical proprioception and range of motion (ROM). Hide and Seek puts the patient in a pastoral setting with a number of animated animals that react to the patients acknowledgement of them. Visually scanning the environment, patients are tasked with finding a small penguin by hovering a blue gaze pointer on the penguin by turning and rotating their head to exercise their cervical range of motion. The penguin will then disappear and reappear in a different location. The pointer is positioned to represent the patients vertical midline and is itself a useful tool as some patients in neurorehabilitation have lost their sense of body position resulting in midline shift. The blue pointer provides a visual, external cue to their true body midline helping them relearn centering themselves. Hide and Seek encourages visual scanning of the patients environment, an important functional ability, and cognitive recognition of nameable animals, objects, and environmental locations in their immediate surroundings. At the end of the patients session, the patient can visualize overall progress they made during the session in the form of virtual rewards. HCPs may adjust various activity parameters using the TherapyView application. 9 (27) Catch & Glow Activity Catch & Glow is designed to help the patient exercise cervical proprioception and ROM. This activity takes place in a low-stimulation, nighttime environment, where the patient is tasked to focus on and control a small penguin with their head movement to catch fireflies that appear in a specific pattern. This activity provides a range of challenges to help focus on the patients gaze stability, oculomotor and visual control, and postural and cervical control. The HCP can control the complexity of the activity by adjusting various activity parameters. Hot Air Balloon Activities Hot Air Balloon is a family of activities designed to help the patient work on trunk and core control, Base of Support, strength, centering, and postural proprioception. By leaning their torso in a certain direction, and holding it there against gravity, they fly a hot air balloon in that same direction. To fly the balloon away and towards them, the patient uses thoracolumbar flexion and extension, and to fly from left to right involves thoracolumbar flexion to the left or right. This set of activities provides a range of challenges focusing on enhancement of trunk control, postural stability, and dynamic balance, all of which are foundational to body function. HCPs may adjust various activity parameters. Balloon Pilot Activity Balloon Pilot takes place near the ground. The patient-controlled balloon is tethered to the ground to limit balloon travel and encourage simple torso centering, trunk mobility, and dynamic weight shifting. The patient can pilot the balloon on-tether to nearby interactive objects, such as the trees and the bell. Bumper Band Activity Bumper Band takes place halfway up the mountainside. The patient uses trunk extension, flexion, as well as lateral flexion to steer an untethered balloon to bump other balloons with band members in them, back to the performance stage. Summit Rescue Activity Summit Rescue takes place at the peak of the mountain where the patient steers the balloon to rescue hikers and bring them back to the safety of the chalet. The patient is asked to counteract different obstacles using cognitive planning, problem solving, and trunk control movements. 10 (27) Sunrise Activities Harvest Activity Harvest involves growing a variety of vegetables by raising and lowering ones arms a number of times in order to trigger the appearance of day- night cycles. This activity creates an incentive for the patient to do multiple repetitions of this exercise if called for by the patients rehabilitation or wellness plan. Optional mirror therapy setting available. Ice Cave Activity Ice Cave 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. This activity creates an incentive for the patient to do multiple repetitions of this exercise if called for by the patients rehabilitation or wellness plan. Optional mirror therapy setting available. Bird Forest Activities The Sunrise family of activities focuses 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. This exercise may be done passively with HCP assistance or actively by the patient themselves. This exercise encourages postural alignment and symmetrical shoulder flexion. When this motion is initiated, a Sun rises up from beyond the horizon in proportion to the patients shoulder flexion ROM. The Sun also rotates in the sky and translates side to side, depending on the patients postural symmetry. When the patients arms are horizontally and vertically symmetric, and their torso is in vertical alignment with their pelvis and head, the Sun will be smiling broadly and high in the sky straight ahead of the patient. If the patients posture exhibits asymmetry or other compensating characteristics, the Suns position and the expression on its face will alter from the ideal state, thereby providing the patient an external visual cue as to their posture, and allowing them to learn via alternative references, what is proper, non-compensating posture. Maximum shoulder flexion ROM achieved during this activity will be stored as a session output for the HCPs record. HCPs may adjust various activity parameters through the tablet. Sunrise Activity As the patient fully lowers and fully raises their arms to the best of their ability, the lighting in the virtual world will exhibit night-time or daytime according to the suns position, thus greatly accentuating the activity and feedback of a simple coordinated arm raise. There is a rep counter on the tree to count the number of reps the patient completes. Optional mirror therapy setting available. The Bird Forest family of activities incorporates standard functional exercises including dynamic reaching and pronation/supination requiring the patient to reach out with one or both hands to pick up birds and place them into nests. Patients have opportunities to reach from low to high, high to low, from left to right and vice versa to practice functional reach. These exercises mimic standard functional exercises that would be practiced during rehabilitation to help the patient regain skills necessary to live at home with a degree of functional independence, and perform activities of daily living (ADL) such as unpacking groceries, cooking, unloading a dishwasher, self-care, etc. HCPs may adjust various activity parameters Free Birds Activity In Free Birds, the patient uses functional movements to pick up and place birds into nests. Optional setting to include pronation and supination therapy by instructing patients to pick up and place birds into their nests. 11 (27) Nest Hop Activity In Nest Hop, the patient uses functional movements to pick up a single bird and place it into a series of nests, under an optional time limit. When a target nest has been filled, a new target nest will appear, and the patient will have to move the bird from the previous nest to the new target nest. Optional setting to include pronation and supination therapy by instructing patients to pick up and place the bird into nests. Bird Match Activity In Bird Match, the patient uses functional movement to pick up a bird and place it into a nest with its matching-colored ribbon. Optional setting to include pronation and supination therapy by instructing patients to pick up and place the birds into their nests. Sports Park Activities Using cognitive skills, the patient must predict the trajectory and reach for a certain location to block and hit the Chuckleball into the opposing goal or into other characters within the environment to collect points. The HCP can control how fast the ball travels towards the patient, the direction and distance the patient must reach to block the ball, and the number of balls to be kicked at the patients. Flying Fish Activity Designed to facilitate trunk stability and functional reach, patients will test their reactive movement by blocking blue fish with their hands or head or dodging red spiky fish. Fish may turn from blue fish, which should be deflected, to red spiky fish, which need to be avoided. This requires extra cognitive processing to decide, under time pressure, which fish should be contacted, and which should be avoided, in addition to predicting where the fish are coming and integrating proper movement to accomplish the task. Creative Canvas Activities The Creative Canvas family of activities is table-top based, designed to support functional reach, fine motor control, and cognitive abilities. These activities incorporate simple cognitive and creative elements through selecting colors, painting pictures, and stamping images, while providing a therapeutic experience. For patients who cannot benefit from more advanced functional reach activities, the activities in Creative Canvas allow patients to focus on rehabilitation of their cervical range of motion. The activities also include a canvas angle setting that allows the HCP to adjust for more able patients to experience more advanced arm reach and fine motor control. HCPs may adjust therapy settings and difficulty through various activity parameters. Paint by Numbers Activity In the Sports Park family of activities, the patient must move their upper extremities to intercept a Chuckleball coming at them, in a time dependent manner. These activities require quick cognitive processing and visual-motor integration to succeed, and thus are more advanced activities for a neurorehabilitation patient. Other primary skills being challenged are reflective movements, dynamic postural control, visual recognition, and motor control. HCPs may adjust various activity parameters. Chuckleball Activity The patient fends off approaching Chuckleballs by deflecting them with their hands or head. This activity is designed to challenge reflexive movements, dynamic control, visual recognition, and motor control. Chuckleball Arena Activity Designed to exercise trunk control and functional reach, the patient must defend their goal using their hands or head as a penguin tries to score with a Chuckleball. In Paint By Numbers, the patient will fill in empty cells of an image with the required matching color and number by selecting the color and filling in the image with 14 (26) various brush strokes. Besides using the left or right hand to select colors and paint on the canvas, the patient can utilize Gaze Painting Mode. This mode allows the patient to select paint colors from a palette and paint on the canvas using only the gaze pointer, providing a cervical motion exercise variation. The patient also has the ability to access a hand palette in the non-painting hand, to help promote two handed interaction within the activity. The HCP can control the level of complexity by choosing the number of color selections available. Free Paint Activity Free Stamp Activity Free Paint allows the patient to express their own artistic creativity, without restrictions. This activity has two modes: Blank Canvas and Coloring Book. There are no rules, goals or tasks that need to be completed; the patient can paint whatever they would like on a canvas. Using the paintbrush, the patient chooses a color from the color palette or paint swatches to paint the canvas. The patient also has the ability to access a hand palette in the non-painting hand, to help promote two handed interaction within the activity. Free Stamp allows the patient to express their creativity by selecting and stamping down images onto a provided canvas background to create their own artistic compositions. There are no rules, goals or tasks that need to be completed. This activity helps provide a free form cognitive exercise encouraging the patient to combine stamps together creatively to construct their own scene and story. Three sets of stamp collections are available to the patient: Happy Farm, Happy Trails, and Happy Geometry. The patient also has the ability to access a hand palette in the non-

stamping hand, to help promote bimanual coordination within the activity. 15 Mad Tavern Activity they get to be a celebrated hero tasked to help island citizens using multi-directional movements to complete tasks. Island Antics includes 4 activities that support therapeutic motions to exercise trunk control, functional reach, reaction time, fluid movements, postural control, coordination, and cross-body movements. Island Antics promotes big and dynamic movements to improve postural stability, coordination, encourage full upper-body movement, to help address impairments like resting tremor, postural instability, bradykinesia, hypokinesia, depressed moods, and loss of cognitive function (sustained attention, difficulty changing strategies quickly). Functional deficits that can result from such symptoms can include a sense of weakness during functional activities, and impaired balance and posture. High intensity exercises require high effort, increased amplitude, increased repetitions, and accuracy. Make island improvements with big movements!

Save the Seagulls Activity Mad Tavern is a pain distraction activity using distraction techniques where the patient is surrounded by animated characters in a cozy tavern setting. Visually scanning the environment, the patient interacts with each character by using the blue gaze pointer by turning and rotating their head to exercise their cervical range of motion. The patients pointer is positioned to represent the patients upper body vertical midline and triggers a series of short stories within the tavern. This activity is designed for practicing visual processing skills and cognitive aspects for focus and attention. Island Antics Island Antics experience is designed for patients who need to work on upper body reconditioning and motor functions. It transports patients to a city of antics where Using trunk control, functional reach, and cross body motions, patients are tasked with fending off UFO drones poaching seagulls by tossing them back like frisbees. A UFO Mothership has descended upon Island Antics and is planning to abduct the island seagulls. A swarm of mini-UFOs will approach the seagulls on top of the building in front of the patient. When a UFO reaches their selected seagull, the UFO tractor beam will turn on and begin to abduct the seagull. The patient will need to reach out utilizing trunk control, functional reach, and cross body motions to fend off UFOs by touching and tossing them back like frisbees. Each successful UFO toss will knock a piece of equipment off the UFO Mothership causing damage. Once all the pieces of equipment on the UFO Mothership are destroyed, all UFOs in the scene will return to the UFO Mothership and all together they will blast off back into Space. 16 Citizen Crossing Activity Leaks and Levers Activity Using trunk control, functional reach, and dynamic balance, patients are asked to help citizens cross a street being blocked by a giant beached whale. A giant whale is beached in the middle of Island Avenue after crashing through civilian pathway bridges and preventing the citizens from crossing safely. The citizens need the patients help to cross the road and continue their way to work. Using trunk control, functional reach, and dynamic balance, the patient must reach out to pick up the citizen and follow the path visualization to place the citizen on the other side of the street. Once the patient has successfully helped the island citizens cross the road, the patient is asked to free the whale by launching her back to the ocean in one swift upwards movement. Leaks and Levers concentrates on shoulder flexion and extension to turn various valves and pull different levers. Patients use these therapeutic motions to fix the citys plumbing system by turning valves to unblock pipes. Too many sea creatures are getting flushed and blocking the islands pipes. Seated in front of a control panel of pipes and valves, the patient is tasked with fixing the citys plumbing system by turning valves to unblock pipes. Using shoulder active range of motion (ROM), strength, and multi-directional arm movement patterns, the patient turns the valves and pulls the levers. Upon successfully turning the valves and pulling the levers, the sea creatures will be sent back to the sea. 17 Coconut Chuck Activity Using a giant slingshot, patients send coconuts over the ocean and onto floating cargo ships by exercising functional reach and trunk movement. A coconut will be knocked off the palm tree and slide down the path to a giant slingshot. Using functional reach and trunk movement, the patient must reach out to pull the slingshot and send the coconuts through the air onto the floating cargo ships. Once the coconut is resting in the giant slingshot, the patient should reach forward and lean back while pulling arms back as far as possible. Upon completing that movement, the coconut will launch out in the sky, over the ocean, and onto the cargo ship. After all coconuts have been launched to the cargo ship, the patient must pull down on a chain to activate the work whistle, which causes the cargo ship to depart towards the main island. Utilize one or two hands to activate the slingshot. Slingshot paths can be created to be longer or shorter based on patient needs. Mindful Market 18 Welcome to Mindful Market, where patients can emphasize high-level cognitive skills, performing instrumental ADLs (Activities of Daily Living), and stimuli tolerance, in an engaging, lively marketplace. Recover executive functions, working memory, sequencing and sorting abilities, and resilience to stimulation by volunteering at multiple small businesses in the charming market square. Make savory sandwiches, feed the markets animals, and flex your monetary skills as you volunteer your unique skills for the benefit of the townspeoples enthusiastic entrepreneurs. Designed to rebuild confidence in cognitive skills, this virtual space offers differing stimulation levels and challenge settings that can help support community re-

entry. These therapeutic and wellness activities can be utilized to help patients ease back into the workplace. All activities take place in environments with adjustable settings tailored to patient needs. Mindful Market contains three visual stimulation levels, so therapists can determine what level of visual detail is most suitable for the patient. Sandwich Shop Activity Take on the role of a chef in Sandwich Shop, fulfilling sandwich orders for customers to help build sequencing and working memory skills. The patient is in front of a sandwich making station, like a real kitchen environment, where they can utilize different countertops to the left, right, and in front of them to access sandwich ingredients. Customers arrive one at a time to request their orders, which are listed in steps on large tickets for the patient to see. Sandwich sequences are communicated to the patient through images of ingredients listed from bottom to top. Once the order is complete, lift the order and present it to the customer at the window. Customers will respond with facial expressions and actions to convey their sandwich satisfaction. If an incorrect order is made, a customer may show confusion or mild disappointment. 19 Harvest Helper Activity Stamp Stand Activity Help a local farmer sort her delivery of animal feed while the animals clamor for their food. Catch items as theyre thrown to improve ability to concentrate in a distracting environment. The farmer unloads her delivery of animal feed by tossing each item to the patient. The farmer picks up an item from the tractor trailer and tosses the item when the patient indicates they are ready to catch by placing their hands up to match the outline shown in the activity. As the patient catches each item the farmer throws, they can increase resilience and ability to concentrate around audio stimulation as they sort each item in its place. Sort each item using object recognition and place each item on the correct pallet in front of the patient. The farmer will provide reactions when the patient places the animal feed on the correct pallet. There are three pallets to choose from and each pallet will have an example of the item that the farmer throws. Designed to improve memory and money management skills, patients will sell postage stamps and help customers stay within their designated budget. Use mental math and working memory to get as close to the customers budget as the patient can. The customer will have a certain amount of money shown to the left of the patient. Patients will use the stamp sheets on the right side to provide the customer with the correct number of stamps equal or close to the value. Each small stamp square equals the price at the top of the stamp sheet. Add up the small squares to determine the entire cost of the sheet. Use the calculator for additional assistance. Music in Motion Engage in musically driven exercises by using therapeutic motions like visual scanning, core control, and shoulder flexion in reactive environments in a fantastical 20 Lean into the Music Activity virtual world. Music in Motion is an entertaining music-themed VR rehabilitation experience designed for upper extremity and cognitive rehabilitation. Clinicians can utilize this experience to deliver engaging and effective rehabilitation exercises to support patients who suffer from neurological disorders. Encouraging movement early during the rehabilitation process is key to regaining function in affected extremities. Rhythm relies on varying parts of the brain (frontal and parietal cortices, as well as the cerebellum) to stimulate motor pathways and encourage neural reorganization. Patients may utilize rhythm combined with music therapy to promote recovery of lost function. Music in Motion has four activities in two environments that can be customized by the clinician to fit each patients rehabilitation needs by modifying range of motion and speed of each activity. Combining rehab with rhythm, patients are asked to move their body to the music and hit notes while gathering prizes as a reward for their hard work. This allows them to keep track and visualize their progress session by session. Song Safari Activity Use cervical range of motion, trunk control, and core stabilization to steer and elevate the flying bird toward various targets. Steer and control the bird by leaning the body lean back to raise the bird, lean forward to lower the bird, or lean left and right to guide the bird in those directions. The bird will spin if it is lined up with the targets. Reach for the Rhythm Activity Utilize cervical ROM and visual scanning to spot various candy critters hiding within the sweet or beach environment. To spot each candy critter, hold the gaze-pointer on the critter hiding in the environment. Each critter will peek out from behind or above various objects and then hide again. After successfully spotting each critter, they will jump out and perform a celebratory animation before hiding again. Utilize trunk control, dynamic balance, and functional reach to touch colored targets with the appropriate hand (right or left) as they fly by. Red targets are hit with the 21 left hand while blue targets are hit with the right hand. The virtual avatar will have colored wrist bands to help the patient with color coordination. Turn with the Tempo Activity recovering cognitive skills while providing options for the therapist to address rehabilitation goals through more directed, stress-relieving experiences. Pleasant Cove includes a relaxing mix of activities set in a low-intensity, tranquil vacation destination to help improve quality of life, confidence, and engagement though relaxation and procedural memory-inspired tasks. Pleasant Cove is an intuitive and flexible experience with multiple activities that can incorporate structure or be used for relaxation. Bountiful Birdseed Activity Reach out and utilize wrist/forearm pronation and supination to match the flying music notes color and rotation. Reach out to hold the music note and turn the right or left wrist to match the notes rotation. The virtual avatar will be holding red and blue music notes to help support the patients proper alignment to the incoming music notes. Pleasant Cove Working on sustained attention, patients use wrist ROM to interact with birds by picking up and shaking seeds out of the can. The patient can experience a friendly interaction with birds happy to eat seeds off the ground or even from their right or left hand. If the patient is up for a challenge, they can try to coax the shy blue bird into their hand. If the patient is gentle, theyll be rewarded with a dance. Pleasant Cove focuses on the mental wellness component of therapy for patients 22 Playful Percussion Activity Grow flowers in mere moments! The patient can personalize their garden by decorating and arranging by size, color, or shape for added difficulty. Following visual cues, use the shovel to place dirt, pour a packet of one of three seed types, water the newly planted seeds, and pick the flowers for final placement once the flowers have finished blossoming. Practice sequencing skills by matching the instruction card placed in front of the floral foam. ADL Cards Activity Focusing on sequencing, psychomotor skills, and working memory, patients participate in a playful percussion interaction with a xylophone and mallets. Patients can create their own melodies or for more of a challenge, follow the arrows to play the correct notes of a song from the jukebox-style songbook. The songbook will both play and be used to guide the patient through eight simple songs of varying difficulty levels including Ode to Joy, Pop Goes the Weasel, Mary Had a Little Lamb, Jingle Bells, and Twinkle, Twinkle Little Star. Green Thumb Gardening Activity ADL (Activities of Daily Living) Cards includes three mini activities Sequencing, Sorting, and Item Find! Cards will feature ADLs; specifically, bathing, dressing, grooming, and eating. Interact with the cards by picking them up and placing them in the correct order based on the specific exercise. Upon placing the cards in the correct order, the green bird will celebrate. o Sequencing: The patient will have either 3 or 5 cards where they will put the process of the specific ADL in order from start to finish. o Sorting: The patient will pick out the appropriate ADL and place those cards in order from start to finish. o Item Find: Using the cards in front of the patient, verbally cue the patient to pick up a card using their object identification skills. 23 REAL Pinball Hit all 6-star targets to win additional points and see the elephant ride across the stage. Note: Once a star target has been hit, it will turn blue. Hit the pinball into each of the clown bumpers to win additional points and see the clowns pop up from behind the bumpers. Hit the pinball along the roller coaster track to win additional points and see the giraffe pop up. Alien Arrival Activity Aim for your highest scores in this fast-paced, vintage pinball experience that supports range of motion, processing speeds, muscle tone & endurance, control of voluntary movement functions, neuromusculoskeletal skills, and psychomotor skills. Patients can engage in three themed pinball tables where the primary objective is to score as many points as possible before losing a total of three pinballs. Various control methods can be used to launch and hit the ball including a kayak paddle, pong, and rackets. Customize settings to promote bimanual coordination or utilize gaze-only control designed for patients who have upper body impairments. Carnival Blast Activity Using ROM, the patient can engage in a friendly battle against an alien boss across three pinball challenges. First Challenge: Hit all 12-star targets Second Challenge: Defeat Robots*

Third Challenge: Defeat UFO and Robots*

Step right up and join the circus, testing the patients ROM and endurance as they try to score as many points as possible before losing all their pinballs. The patient will use their gaze to aim each ball launch. After a short countdown, the pinball will launch out and put the activity in play. As the patient successfully hits targets in the activity, the alien boss will express anger and frustration. Likewise, the alien boss will laugh at the patient when it initiates a new challenge from the robots and UFO.

*For the second challenge, the patient will defeat 25 waves of robots in a variety of patterns. Some robots might be carrying an extra pinball above their head, when these robots are struck the patient will have a multi-ball experience. For the third challenge, upon defeating the UFO and robots successfully, the patient will receive an extra ball reward and extra bonus points. 24 Magical Garden Activity Missions include:

- Mushroom House: Multi-ball mode, unlocked once three balls are locked.

Branch Path with Acorns: Collect the golden acorns by hitting the pinball up the branch path and into the mushroom house.

- Gnomes: Hit the gnomes to wake them up and they will start to run a lap on the track.

- Moles Mound: Hit the front door of the mole mound three times to initiate whack-a-mole.

- Whack-a-Mole: Once the mole has awakened from its mound, play whack-a-

mole. Once the mole has been hit 5 times, the patient is rewarded with extra points. Flowerpots: Hit the pinball into each of the 4 flowerpots until the flowers are completely grown to win additional points. Turtle: Hit the pinball into the turtle to watch the turtle spin. Lanterns: Hit the ball past the spinners on the right and left side of the table to see each lantern light fill up. Once the two lanterns are fully lit, the patient will receive bonus points.

Using ROM, the patient can discover their magical abilities and complete various pinball challenges and missions in an enchanted miniature garden. The patient will have a mission objective map in front of them on the table. There will be 3 missions that need to be achieved at each time. Once all 3 missions are lit and completed, the mission map is reshuffled with new missions and the patient is rewarded bonus points. 25 TECHNICAL SPECIFICATIONS TECHNICAL INFORMATION Sensor Accuracy*

Sensor Precision*

Latency Operating Temperature Operating Pressure Operating Relative Humidity Operating Elevation Radio Module 2 cm at a max distance of 75 cm 2 cm or less 35 milliseconds 15C to 30C 102 kPa or less 30% to 90%

2,500 meters or less Output power (EIRP*): 6.31 mW (8 dBm) max Frequency Band: ISM (Industrial, Scientific, and Medical) Typical Center frequency: 2.44 GHz Channel: 77 channels Bandwidth: 2 MHz per channel Modulation: GFSK (Gaussian frequency-shift keying) Data flow: Bi-directional

*EIRP = Equivalent Isotropic Radiated Power 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 Compliance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Group 1 Class B Class A Voltage Fluctuations/

Flicker emissions Complies 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. REAL Immersive System is suitable for use in all establishments other than domestic and those directly connected to the public mains. 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 8 kV contact 15 kV air 8 kV contact 15 kV air 2 kV for power supply lines 1 kV for input/output lines 2 kV for power supply lines 1 kV for input/output lines Surge IEC 61000-4-5 1 kV differential mode 2 kV common mode 1 kV differential mode 2 kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 Voltage Dips 30% reduction, 25/30 periods At 0 Voltage Dips 30% reduction, 25/30 periods At 0 Voltage Dips > 95%

reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%

reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%

reduction, 1 period At 0 Voltage Dips > 95%

reduction, 1 period At 0 Voltage Interruptions > 95%

reduction, 250/300 periods Voltage Interruptions > 95%

reduction, 250/300 periods Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the EQUIPMENT requires continued operation during power mains interruptions, it is recommended that REAL Immersive System be powered from an uninterruptible power supply or a battery. 26

*REAL Immersive System is calibrated appropriately to detect movement in virtual reality space in relation to real space accurately and precisely. Sensors will compute and display position at an accuracy of a 2 cm radius with respect to real space at a max distance of 75 cm relative to the headset. Sensors will also reproducibly compute position at a maximum deviation of a 2 cm radius for repeated movements at a max distance of 75 cm relative to the headset. Please note that accuracy and precision specifications contain limitations and are dependent on certain factors such as the amount of metal near the system. For example, if the patient is in a metal wheelchair and cannot move to a non-metal chair, reduction in accuracy and precision may occur.

(50/60 Hz) magnetic fi eld IEC 61000-4-8 30 A/m 30 A/m Power frequency magnetic fi elds should be at levels characteristic of a typical location in a typical commercial or hospital environment. SYMBOL GLOSSARY Refer to User Guide (Instruction Manual) Prescription only US Federal Law restricts this device to use by or on the order of a physician Type BF Applied Part WEEE Manufacturer Catalog Number Lot Number Date of Manufacture Both Direct and Alternating Current Class II Equipment Serial Number US and Canada Certification Medical Device 27 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. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Immunity to RF Wireless Communications Equipment Test Frequency

(MHz) Band a)

(MHz) Service a) Modulation b) Maximum Power

(W) Conducted RF IEC 61000-4-6 3 Vrms 150 kHz to 80 MHz

(6 Vrms in ISM radio Bands within 150kHz 80MHz) 3 Vrms Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz 10 V/m Portable and mobile RF communications equipment should be used no closer to any part of REAL Immersive System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2P d = 1.2P 80 MHz to 800 MHz d = 2.3P 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters

(m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey a, should be less than the compliance level in b. each frequency range NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which REAL Immersive System is used exceeds the applicable RF compliance level above, REAL Immersive System should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating REAL Immersive System. b range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Over the frequency Recommended separation distances between portable and mobile RF communications equipment and REAL Immersive System REAL Immersive System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of REAL Immersive System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and REAL Immersive System as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d = 1.2P 80 MHz to 800 MHz d = 1.2P 800 MHz to 2.7 GHz d = 2.3P 385 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 704 787 LTE Band 13, 17 710 745 780 810 870 930 1720 1845 1970 800-960 1700-1990 2450 2400-2570 5100-5800 5240 5500 5785 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;

CDMA 1900;

GSM 1900;

DECT;

LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 WLAN 802.11 a/n Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine Pulse modulation b) 217 Hz Pulse modulation b) 18 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz Distance

(m) 0.3 0.3 0.3 IMMUNITY TEST LEVEL

(V/m) 27 28 9 0.3 28 0.3 28 0.3 28 1.8 2 0.2 2 2 2 0.2 0.3 9 a) b) c) represent actual modulation, it would be worst case. For some services, only the uplink frequencies are included. The carrier shall be modulated using a 50 % duty cycle square wave signal. As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not 0.01 0.1 1 10 100 0.12 0.38 1.2 3.8 12 0.12 0.38 1.2 3.8 12 0.23 0.73 2.3 7.3 23 This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas license-exempt RSS(s). Operation is subject to the following two conditions:

1. 2. This device may not cause interference. This device must accept any interference, including interference that may cause undesired operation of the device. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Lappareil ne doit pas produire de brouillage;

Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre 1. 2. fonctionnement. le Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the equipment. 28 Les changements ou les modifications qui nont pas t expressment approuvs par la partie responsable de la conformit peuvent faire perdre lutilisateur son droit dutiliser lappareil. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential setting. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Mode of Operation:

Charging mode and battery mode Highest Clock Frequency:

HMD: 32 MHz WSM: 32 MHz WTM: 24.576 MHz Frequency Range:

GFSK: 2402 MHz 2479 MHz Transmitting Frequency and Modulation:

Gaussian Frequency-shift Keying (GFSK) modulation. 2 Mbps modulation for all transmitter frequencies. BLE Antenna Make, Model, and Gain:

Device Antenna Make Antenna Model Antenna Gain WSM WTM HMD Johanson P/N 2450AT43B100E Penumbra, Inc. P/N 17107 Peak Gain 1.3 dBi Average Gain -0.5 dBi Peak Gain 0.7 dBi Average Gain -2.6 dBi Power Output and Data Rate:

Device WSM WTM HMD Power Output Programmed by the firmware to +8dBm. Programmed by the firmware to +4dBm. Programmed by the firmware to +8dBm. Data Rate GFSK modulation, 2 Mbps data rate. Product availability varies by country. Please see www.realsystem.com for more information. Copyright 2020 Penumbra, Inc. All rights reserved. The REAL Hero logo, REAL, Chuckleball, and TherapyView are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are the property of their respective owners. Manufacturer:

Penumbra Inc. One Penumbra Place Alameda, CA 94502 USA Tel: 1.855.REAL-SYS 1.855.732.5759 21417.D E 2019-12 2023-3 29

REAL SYSTEM 2 User Manual Table of Contents Abbreviations??

Warning Device Description Indication for use Contraindications Warnings Precautions Potential Adverse Effects/Events Operating Profile Operating Procedure Internet Connectivity Getting Started & Charging Components Start-Up System for Patient Use Therapy Activities System Removal Software Description 3 3 4 4 4 4 4 5 5 5 6 6 8 9 10 13 13 13 Technical Specifications Symbol Glossary Technical Information Troubleshooting Guide 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 System 2 is a digital hardware and software medical device platform utilizing virtual reality technology designed for use in residential or rehabilitation setting that focuses on physical, neurorehabilitation and/or wellness needs. REAL System 2 consists of following components:

Page 1 of 29 All-In-One Headset with Software Application Headset Controller Large Sensor Small Sensors Sensor Charger (charging station) REAL Sensor Bands The headset contains a power button that turns the component on or off and a charger/accessory port. The headset also provides visual feedback of virtual reality applications in concert with the REAL System 2 small and large sensors. Large and small sensors are equipped with mechanical and electrical components that measure motion and direction in physical space and then translate that information into a virtual environment. The sensor charger powers the sensors. Headset controller can be used to perform administrative tasks such as connect to network, select therapy activity, access settings, etc. At full charge, the entire system can last at a minimum of 60 minutes and it is recommended that a therapy session does not exceed 60 minutes. The expected amount of time to charge the system to last the recommended therapy session time is 60 minutes. In the event of Electromagnetic disturbances, the performance of the REAL System 2 may be affected. The REAL System 2 is a Type BF Applied Part. Frequently used features and functions:

Plug the headset power cord into wall outlet and the headset to charge device. Press power button to power on or off headset. The power button is on top of the Headset Controller Buttons on the controller are used to access settings. Plug sensor charger power cord into wall outlet and sensor charger to power on device Headset headset. Sensor Charger to charge sensors. Page 2 of 29 Large Sensor and Small Sensors Activate or charge sensor devices by removing or placing back into the sensor charging Place sensor devices into the sensor bands. See Section 3 in Operating Procedures on instructions to put on sensor bands. station. Sensor Bands User Portals Access the User Portal through the Headset to perform the following:

Initializing and syncing to sensors o Logging in o Selecting the activity o o Starting, modifying, or ending therapy session o Viewing data o Logging out HCP Portal o Selecting the application o Logging in o Adding or selecting patient o o Selecting, starting, modifying, or ending therapy session o Viewing data o Logging out Initializing and syncing to sensors There is no preventive inspection, calibration, and maintenance necessary for the REAL System 2 besides the initial set up procedure. During the three-year product lifespan of the REAL System 2, the device will continue to perform safely without any routine maintenance. No parts within the REAL System 2 will require inspection nor maintenance by a service personnel to ensure basic safety during the three-year product lifespan. Circuit diagrams and calibration instructions are not provided because service in parts repair is not necessary. If the system no longer stays powered on and connected through the entire recommended duration of a therapy session, dispose of the device through an environmentally safe electronic waste recycle system. If the sensor bands no longer adequately hold the sensors nor stay strapped to your body, dispose of the sensor bands and reorder through the REAL website. Supply mains are electrically isolated in medical equipment to maintain basic safety. Page 3 of 29 The full expected latency of the device, including movement detection, processing, and visual representation is 35 milliseconds or less. This value is considered minimal and sufficiently low enough so that movement can be quickly detected. INDICATION FOR USE The REAL System 2 is an immersive virtual reality and display system that interactively displays and tracks rehabilitation exercises 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 residential environment, or any other facility that may facilitate rehabilitation. CONTRAINDICATIONS There are no known contraindications. WARNINGS If motion sickness, dizziness, headache, eye strain, or fatigue is experienced when using the device, stop use of device immediately. Use caution when using this device if you have a history of vestibular issues or motion sickness. Precautions Ensure a safe environment while performing activities with the device (e.g. remove any surrounding obstacles that may lead to injuries caused by trips and falls). As this device is to be used for upper body rehabilitation, it is required to remain seated to avoid a fall. Be aware of the limitations in range of motion and avoid device or program use that could lead to excessive gestures that could result in injuries. Extended use of the headset can cause discomfort or eye strain. Incorrect placement of the sensors may result in the avatar appearing incorrectly or distorted on the headset. Damage (mechanical and electrical) may result if the headset, sensors, and/or sensor charger are dropped or struck against another object. Device is not intended for continued use if dropped from higher than 1 meter. Surface temperature around the headset exhaust may reach 46C if operating above nominal room temperature. Sensors will transmit inaccurate position data if used near metal including, but not limited to, wheelchairs, walkers, and utility carts. Headset tracking can be lost or compromised if large objects obscure the headset. Page 4 of 29 At no time should liquid products be allowed near any device component. No modification of this equipment is allowed. Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the REAL System 2, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Accessories such as power adapters and cords should not be replaced by the end user and should only be replaced by Penumbra. Any changes or replacements of accessories will likely impact compliance of REAL System 2. Use of this device should be in a secure information technology environment. Outbound https communication channels must be open. POTENTIAL ADVERSE EFFECTS/EVENTS Visual stimulation through head-mounted displays 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, the following:

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 repetitive strain injury seizure skin irritation vision problems Should any of the above occur, stop using the device immediately. OPERATOR PROFILE Intended users for this device are those with physical, neurorehabilitation and/or wellness needs. A caregiver may be optionally present to help operate the system. Healthcare provider (HCP) of the REALTM System 2 prescribing rehabilitation activities should be trained in rehabilitation therapy. Page 5 of 29 OPERATING PROCEDURE Note: These rehabilitation exercises are intended to be conducted in a seated position. Be seated at all times when the system is in use. SECTION 1: GETTING STARTED AND CHARGING COMPONENTS 1. Remove REAL System 2 components from the product box. Commented [PG1]: Images in this section will be changed to reflect REAL2 (Xavier 2) configuration. 2. Connect sensor charger base to its power cable supplied in the Accessories box. The wire will go through the grommet hole supplied in the box. Plug into a wall outlet. Ensure sensors with white sides facing forward are in their corresponding size slots on the sensor charger. LED lights on sensors will show the following. Page 6 of 29 3. Connect the headset to its power cord supplied in the Accessories box and plug into a wall outlet. LED lights on top of headset will show either blinking green or solid green to indicate charging status. SECTION 2: Internet Connectivity User:

Page 7 of 29 1. Unplug power cords from headset when ready for use. 2. Turn on headset by pressing and holding power button for approximately 2 seconds. 3. Turn on the headset controller by pressing the small circular button. The controller will vibrate once it has been turned on. Note: If the headset controller does not vibrate, press and hold both the headset controllers small circular button and the headsets Volume Down button the singular dot on the left underside of the headset. Hold both buttons down at the same time until the controller vibrates. 4. Once the headset and headset controller are on, hold the controllers Volume Down button on the right side and the headset controllers trigger at the top of the backside. This will decrease the headsets volume as well as switch the headset to the HTC Vive environment. In the Vive environment, an Android Settings (AS) menu will be viewable. If the AS menu is not visible, slowly turn your body around until the menu appears in the headset viewer. 5. 6. The headset controller is used to navigate the menu. i. Pressing the small circular button will cause the controller to vibrate and bring the pointer into view. ii. Using the controller, point the pointer at the desired menu item, then press the circular trackpad at the top of the headset controller to select it. Note: If the pointer disappears, repeat the process until the pointer reappears. iii. If the trackpad button causes the menu to scroll undesirably, use the controllers trigger to open the menu instead. Hold down the trigger, then press and move trigger to select. Make sure the controller pointer is pointed at the desired text in the menu. 7. Using the headset controllers pointer and trackpad, select Wi-Fi in the headsets Android Menu. 8. Connect your headset to your desired wireless home network. You may be prompted to enter your password. Page 8 of 29 9. Once connected, the headset will display your home Wi-Fi at the top of the WLAN list and the status will read Connected. 10. To exit, power off the headset before starting a session. 11. Ensure patients personal device such as computer, tablet or smartphone is connected to 12. Reset password to log into patient portal using the login information provided in the welcome desired Wi-Fi email HCP:

1. Ensure your personal device is connected to the internet to access the portal and assign 2. Reset password to log into HCP portal using the log in information provided in the welcome activities to patients email Continue to Section 3 when the components are sufficiently charged, and the system has secure internet connectivity. SECTION 3: START UP USER:

1. Using a personal device, log into the user portal using your username and password. 2. Select the activity assigned by your therapist within the user portal 3. Remove sensor bands from the Real Sensor Bands box. 4. Remove all sensors from sensor charger. 5. Place the 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 the torso band. Page 9 of 29 4. Once sensors are placed in the bands, put each band onto its corresponding body part (see image below). Connect hook and loop fasteners of the torso band if desired. Adjust bands for comfortable fit, if necessary. 5. Be in a seated position away from metal components and remain seated at all times for the duration of the therapy session. Initiate the session by pressing Start Session. 6. 7. Put on the headset per in the sequence numbered below and begin visually interacting with the environment. Page 10 of 29 Note: Size of headset strap and interpupillary distance can be adjusted for fit. Top of head pad may be removed temporarily for better fit on larger heads. Note: Eyeglasses may be worn during device use. 8. Sit in a neutral position, farcing forward with hands on knees or thighs. Press the button on the screen to calibrate the sensors. After the sensors are calibrated, begin the activity. Page 11 of 29 HCP:

Patient Rehabilitation Activities:

1. 2. Log into the HCP Portal and locate the patient profile. Select the designated activity and click Start Session. Patient Wellness Activities:

1. Log into the HCP Portal and locate the patient profile. 2. Review patients session results. See Section 4 and 6 for more information. Section 4: ACTIVITY NAVIGATION User 1. Conduct rehabilitation session as planned. (See Section 6 which includes a software description for details of therapeutic activities). Note: If sensors lose synchronization or headset loses tracking, turn off headset then turn 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 (while the REAL System 2 is plugged in) and then removing them again. HCP 1. Conduct rehabilitation session as planned. (See Section 6 which includes a software description for details of therapeutic activities). 2. Navigate to additional therapy activities by selecting the corresponding icon from the HCP Portal. Once the activity is loaded, the HCP can press the Start Activity button to begin the activity. 3. Always remain with the patient throughout therapy session to provide direct supervision. 4. Monitor patient view on the HCP portal; select and change activities as desired. Page 12 of 29 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. App should be relaunched on the tablet. Sensors are turned off and on by placing them in the powered charging station (while the REAL System 2 is plugged in) and then removing them again. 5. When planned therapy activities are complete, press End session. Patient will be returned to the Hide and Seek activity. 6. View patient results. You may also switch to the Notes tab for a summary of session activity times. Section 5: SYSTEM REMOVAL 1. Remove sensors and bands. 2. Remove headset. Page 13 of 29 3. Power off headset by pressing and holding onto the power button for approximately 2 seconds. 4. Clean headset and sensors with institutional approved sanitizing wipes*. 5. Connect headset to the power cord. 6. Ensure REAL System 2 sensor charger is plugged in. 7. Return all sensors to sensor charger. Red or green LEDs should be noted on sensors when placed correctly in the charging station. 8. 9. Store and label bands for future use. Sufficiently charge all components after each use and prior to next use for 60 minutes. NOTE: Standard operation is to power cycle and relaunch application between therapy sessions to reestablish system connections.

*Handle the lenses on the headset carefully to avoid smears or scratches. Wipe lenses with a soft cloth for cleaning as needed. Clean outer and inner plastic components of headset with institutionally approved sanitizing wipe. Do not use petroleum-based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Use only water-based solvents for cleaning. Section 6: THERAPY EXPERIENCE The REAL Immersive System contains a variety of activities that incorporate clinically recognized, existing therapeutic and functional exercises to facilitate motor and cognitive rehabilitation. Settings for each activity will involve parameters such as turning on and off avatar features and environmental factors. While using the REAL Immersive System, the HCP remains responsible for the patients safety and the appropriateness of individual exercises including range of motion (ROM) attempted and any other limb or joint limitations unique to that patient. Therapy Activity 1: Hide and Seek Page 14 of 29 Hide and Seek can be used with or without a displayed avatar tracking the patients upper body as it primarily relies on head movement and visual scanning ability. Hide and Seek puts the patient in a pastoral setting with a number of animated animals that react to the patients acknowledgement of them. This is both the first and last experience for the patient. At the end of the patients session, the patient can visualize overall progress they made during the session in the form of virtual rewards. Patients find a little penguin by hovering a blue gaze pointer on the penguin by turning and rotating their head to exercise their cervical range of motion. The penguin will then disappear and reappear in a different location. The pointer is positioned to represent the patients upper body vertical midline and is itself a useful tool as some patients in neurorehabilitation have lost their sense of body position resulting in midline shift. The blue pointer provides a visual, external cue to their true body midline helping them relearn centering themselves. The Hide and Seek exercise encourages visual scanning of their environment, an important functional ability, and cognitive recognition of nameable animals, objects, and environmental locations in their immediate surrounding. HCPs may adjust various activity parameters through the tablet. Therapy Activity 2: Hot Air Balloon Page 15 of 29 Hot Air Balloon is an introductory activity to help the patient work on core control and strength as well as centering and postural proprioception. By leaning their torso from a sitting position in a certain direction, and holding it there against gravity, they fly a hot air balloon in that same direction. There are a number of objectives the patient can achieve by flying the balloon around. To fly the balloon away and towards them, the patient uses thoracolumbar flexion and extension, and to fly from left to right involves thoracolumbar flexion to the left or right. This set of activities provide a range of challenges focusing on enhancement of trunk control, postural stability, and dynamic balance, all of which are foundational to upper extremity function. HCPs may adjust various activity parameters through the tablet. Sub-Activity 1: Balloon Pilot This sub-activity takes place near the ground. The patient-controlled balloon is tethered to the ground to limit balloon travel and encourage simple torso centering, trunk mobility, and dynamic weight shifting. The patient can pilot the balloon on-tether to nearby interactive objects. Sub-Activity 2: Bumper Band This sub-activity takes place halfway up the mountainside. The patient uses trunk extension, flexion, as well as lateral flexion to drive the balloon in an untethered mode to bump other balloons with characters in them, back to the performance stage. Sub-Activity 3: Summit Rescue This sub-activity takes place at the peak of the mountain where the player has to steer the balloon to bring hikers which made it to the summit. The patient has to counteract different obstacles using cognitive planning, problem solving, and trunk control movements. Page 16 of 29 Therapy Activity 3: Sunrise This activity 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. This exercise may be done passively with HCP assistance or actively by the patient themselves. This exercise encourages postural alignment and symmetrical seated shoulder flexion. When this motion is initiated, a Sun character rises up from beyond the horizon in proportion to the patients shoulder flexion ROM. The sun also rotates in the sky and translates side to side, depending on the patients postural symmetry. When the patients arms are horizontally and vertically symmetric, and their torso is in vertical alignment with their pelvis and head, the sun will be smiling broadly and high in the sky straight ahead of the patient. If the patients posture exhibits asymmetry or other compensating characteristics, the suns position and the expression on its face will alter from the ideal state, thereby providing the patient an external visual cue as to their posture, and allowing them to learn via alternative references, what is proper, non-

compensating posture. Maximum shoulder flexion ROM achieved during this activity will be stored as a session output for the HCPs record. HCPs may adjust various activity parameters through the tablet. Sub-Activity 1: Sunrise As the patient fully lowers and fully raises their arms to the best of their ability, the lighting in the virtual world will exhibit night-time or daytime according to the suns position, thus greatly accentuating the activity and feedback of a simple coordinated arm raise. Sub-Activity 2: Harvest Page 17 of 29 The Harvest sub-activity involves growing a variety of vegetables by raising and lowering ones arms a number of times in order to trigger the appearance of day-night cycles. This activity creates an incentive for the patient to do multiple repetitions of this exercise if called for by the patients rehabilitation plan. Sub-Activity 3: Ice Cave 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. This activity creates an incentive for the patient to do multiple repetitions of this exercise if called for by the patients rehabilitation plan. Therapy Activity 4: Bird Forest The Bird Forest activity incorporates standard functional exercises including dynamic reaching and pronation/supination into a virtual reality activity by requiring the patient to reach out with one or both hands to allow a bird to jump into their hand. Patients have opportunities to reach from low to high, high to low, from left to right and vice versa to practice functional reach. These exercises mimic standard functional exercises that would be practiced during rehabilitation to help the patient regain skills necessary to live at home with a degree of functional independence, and perform activities such as unpacking groceries, cooking, unloading a dishwasher, self-care, etc. HCPs may adjust various activity parameters through the tablet. Sub-Activity 1: Free Birds The patient must use their hand(s) to pick up a bird and then move their hand(s) to a nest, also within arms reach, and maintain that position in order to deposit the bird into the nest. Filling all nests with a bird will reset the activity so it can be played again. Sub-Activity 2: Nest Hop Page 18 of 29 The patient should use their hand(s) to pick up a bird and move it to a colored target nest in a specific order under time pressure. This sub-activity will exercise both the patients functional and cognitive ability. When a target nest has been filled, a new target nest will appear, and the patient will have to move the bird from the previous nest to the new target. Sub-Activity 3: Bird Match A bird will need to be picked up and matched to the corresponding colored nest. When all nests have been filled, the exercise will reset. Therapy Activity 5: Penguin Sports Park In these activities, the patient must move their upper extremities to intercept an object coming at them, in a time dependent manner. These activities require quick cognitive processing and visual-motor integration to succeed, and thus are more advanced activities for a neurorehabilitation patient. Other primary skills being challenged are reflective movements, dynamic postural control, visual recognition, and motor control. HCPs may adjust various activity parameters through the tablet. Sub-Activity 1: Chuckleball The patient fends off approaching Chuckleballs by deflecting them with their head or hands. The Chuckleballs will be kicked continually until a new activity is started. Sub-Activity 2: Chuckleball Arena Chuckleball Arena requires the patient to protect the goal from kicked Chuckleballs coming from the penguin in front of them. Chuckleballs can be deflected by either hand or the head. Depending on the plane of contact of the hand or head, the Chuckleball will deflect in specific directions and advance patients can learn to deflect the Chuckleball into the opposing goal. Other objects and animals in the Page 19 of 29 environment 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 their head or hands. This may elicit a defensive response movement from the patient in VR. Fish may turn from good blue fish which are supposed to be deflected to bad red spiky fish, which need to be avoided. This requires extra cognitive processing to decide, under time pressure, which fish should be contacted, and which should be avoided, in addition to predicting where the fish are coming and integrating proper movement to accomplish the task. TECHNICAL SPECIFICATIONS Sensor Accuracy*

Sensor Precision*

Latency Operating Temperature Operating Pressure Operating Relative Humidity Operating Elevation Transportation and Storage Temperature Transportation and Storage Pressure Transportation and Storage Relative Humidity Radio Module 2 cm at a max distance of 75 cm 2 cm or less 35 milliseconds 15 C to 30 C 102 kPa or less 15% to 90%

2,500 meters or less 0C to 30 C 102 kPa or less 15% to 90%

Output power (EIRP**): 6.31 mW (8 dBm) max Frequency Band: ISM (Industrial, Scientific, and Medical) Typical Center frequency: 2.44 GHz Channel: 77 channels Bandwidth: 2 MHz per channel Modulation: GFSK (Gaussian frequency-shift keying) Data flow: Bi-directional

**EIRP = Equivalent Isotropic Radiated Power

*REAL System 2 is calibrated appropriately to detect movement in virtual reality space in relation to real space accurately and precisely. Sensors will compute and display position at an accuracy of a 2 cm radius with respect to real space at a max distance of 75 cm relative to the headset. Sensors will also reproducibly compute position at a maximum deviation of a 2 cm radius for repeated movements at a max distance of 75 cm relative to the headset. Please note that accuracy and precision specifications contain limitations and are dependent on certain factors such as the amount of metal near the system. For example, if the patient is in a metal wheelchair and cannot move to a non-metal chair, reduction in accuracy and precision may occur. Page 20 of 29 SYMBOL GLOSSARY Refer to User Guide (Instruction manual) Manufacturer Type BF Applied Part WEEE Catalog Number Lot Number Date of Manufacture Class II Equipment Serial Number Both Direct and Alternating Current US and Canada Certification Medical Device Keep Dry Protection against ingress of solid foreign objects level 2 and water level 1 Protection against ingress of solid foreign objects level 2 and water level 2 TECHNICAL INFORMATION REALTM System 2 is intended for use in the electromagnetic environment specified below. The customer or the user of REAL System 2 should assure that it is used in such an environment. Page 21 of 29 Emissions Test Compliance RF emissions CISPR 11 Group 1 REAL System 2 is intended for use in the electromagnetic environment specified below. The customer or the user of REAL System 2 should assure that it is used in such an environment. REAL System 2 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. REAL Immersive System is suitable for use in all establishments other than domestic and those directly connected to the public mains. Class B Class A Complies IEC 60601 test level 8 kV contact 15 kV air 2 kV for power supply lines 1 kV for input/output lines 1 kV differential mode 2 kV common mode Voltage Dips 30%

reduction, 25/30 periods At 0 Voltage Dips > 95%

reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%

reduction, 1 period At 0 Compliance level 8 kV contact 15 kV air 2 kV for power supply lines 1 kV for input/output lines 1 kV differential mode 2 kV common mode Voltage Dips 30%

reduction, 25/30 periods At 0 Voltage Dips > 95%

reduction, 0.5 period At 0, 45, 90, 135, 180, 225, 270 and 315 Voltage Dips > 95%

reduction, 1 period At 0 Electromagnetic environment guidance Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %. Mains power quality should be that of a typical residential or rehabilitation environment. Mains power quality should be that of a typical residential or rehabilitation environment. Mains power quality should be that of a typical residential or rehabilitation environment. If the user of the EQUIPMENT requires continued operation during power mains interruptions, it is recommended that REAL System 2 be powered from an uninterruptible power supply or a battery. Page 22 of 29 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Voltage Fluctuations/

Flicker emissions Immunity test Electrostatic discharge (ESD) IEC 61000-4-2 Electrical fast transient/burst IEC 61000-4-4 Surge IEC 61000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 REALTM System 2 is intended for use in the electromagnetic environment specified below. The customer or the user of REAL System 2 should assure that it is used in such an environment. Immunity test Compliance level Voltage Interruptions

> 95% reduction, 250/300 periods 30 A/m Voltage Interruptions >

95% reduction, 250/300 periods 30 A/m IEC 60601 test level 3 Vrms 150 kHz to 80 MHz

(6 Vrms in ISM and amateur radio Bands within 150kHz 80MHz) 10 V/m 80 MHz to 2.7 GHz 3 Vrms 10 V/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical residential or rehabilitation environment. Electromagnetic environment guidance Portable and mobile RF communications equipment should be used no closer to any part of REAL System 2, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1.2P d = 1.2P 80 MHz to 800 MHz d = 2.3P 800 MHz to 2.7 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site surveya, should be less than the compliance level in each frequency range.b NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which REAL System 2 is used exceeds the applicable RF compliance level above, REAL System 2 should be observed to verify normal Page 23 of 29

(50/60 Hz) magnetic field IEC 61000-4-8 Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating REAL System 2. b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. Recommended separation distances between portable and mobile RF communications equipment and REAL System 2 REAL System 2 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of REAL System 2 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and REAL System 2 as recommended below, according to the maximum output power of the communications equipment. Rated maximum output power of transmitter W 0.01 0.1 1 10 100 Separation distance according to frequency of transmitter m 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.7 GHz d = 1.2P 0.12 0.38 1.2 3.8 12 d = 1.2P 0.12 0.38 1.2 3.8 12 d = 2.3P 0.23 0.73 2.3 7.3 23 For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Immunity to RF Wireless Communications Equipment Test Frequency

(MHz) Band a)

(MHz) Service a) Modulation b) Maximum Power

(W) Distance

(m) IMMUNITY TEST LEVEL

(V/m) 385 380 390 TETRA 400 450 710 430 470 GMRS 460, FRS 460 704 787 LTE Band 13, 17 Pulse 1.8 2 0.2 0.3 0.3 0.3 27 28 9 Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine Page 24 of 29 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 800 960 1700 1990 2400 2570 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;

CDMA 1900;

GSM 1900;

DECT;

LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 modulation b) 217 Hz Pulse modulation b) 18 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz Pulse modulation b) 217 Hz 2 2 2 0.3 28 0.3 28 0.3 28 5100 5800 WLAN 802.11 a/n 0.2 0.3 9 a) For some services, only the uplink frequencies are included. b) The carrier shall be modulated using a 50 % duty cycle square wave signal. c) As an alternative to FM modulation, 50 % pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This device contains license-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canadas license-exempt RSS(s). Operation is subject to the following two conditions:

1. 2. operation of the device. Lmetteur/rcepteur exempt de licence contenu dans le prsent appareil est conforme aux CNR dInnovation, Sciences et Dveloppement conomique Canada applicables aux appareils radio exempts de licence. Lexploitation est autorise aux deux conditions suivantes :

1. This device may not cause interference. This device must accept any interference, including interference that may cause undesired Lappareil ne doit pas produire de brouillage;

Page 25 of 29 2. Lappareil doit accepter tout brouillage radiolectrique subi, mme si le brouillage est susceptible den compromettre le fonctionnement. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Les changements ou les modifications qui nont pas t expressment approuvs par la partie responsable de la conformit peuvent faire perdre lutilisateur son droit dutiliser lappareil. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a residential setting. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving antenna. Increase the separation between the equipment and receiver. Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. Consult the dealer or an experienced radio/TV technician for help. Mode of Operation:

Charging mode and battery mode Mode of Transportation:

Devices should be transported in provided packaging. Highest Clock Frequency:

HMD: 32 MHz WSM: 32 MHz WTM: 24.576 MHz Frequency Range:

2402MHz - 2479MHz Transmitting Frequency and Modulation:

Gaussian Frequency-shift Keying (GFSK) modulation. 2 Mbps modulation for all transmitter frequencies. Antenna Make, Model, and Gain:

Page 26 of 29 Device WSM WTM HMD Antenna Make Johanson Antenna Model P/N 2450AT43B100E Penumbra, Inc. P/N 17107 Antenna Gain Peak Gain 1.3 dBi Average Gain -0.5 dBi Peak Gain 0.7 dBi Average Gain -2.6 dBi Power Output and Data Rate:

Device WSM WTM HMD Power Output Programmed by the firmware to +8dBm. Programmed by the firmware to +4dBm. Programmed by the firmware to +8dBm. Data Rate GFSK modulation, 2 Mbps data rate. Product availability varies by country. Please see www.realsystem.com for more information. Copyright 2020 Penumbra, Inc. All rights reserved. The REAL Hero logo, REAL, Chuckleball, and TherapyView are registered trademarks or trademarks of Penumbra, Inc. in the USA and other countries. All other trademarks are the property of their respective owners. TROUBLESHOOTING GUIDE

*Refer to help line if troubleshooting solutions are unable to resolve the issue 1. Sensors are not charging:

2. Headset is not charging:

3. Headset is not turning on:

Make sure charging cable is properly plugged into the sensor charge base and the wall outlet. Make sure charging cable is properly plugged into the headset and the wall adaptor. Charge the headset for 30 minutes and try again. Make sure the LED light on the headset blinking/solid green. If sensor(s) does not have an illuminating LED:

4. Charge the sensor(s) for 30 minutes and try again. 5. Sensor(s) does not switch to blinking blue when taken out of the charger:

Put sensor(s) back in the charging station and take them out again. 6. Sensor(s) does not switch from blinking red to blinking green when charging for prolonged time:

Take the sensor(s) out of the charging station and dock it back in. 7. Cannot connect Headset to the WiFi:

Try again and make sure the correct password was entered. 8. Damage to equipment:

Do not use the device and call the REAL help line. 9. Equipment was exposed to liquid:

Page 27 of 29 Remove the exposed equipment from the body. Power down the headset if possible and do not put the sensors back in the charging station. Do not use the equipment. Pat dry the wet equipment. Call the REAL help line. 10. Web application does not launch on the computing device:

Make sure the computing device is connected to internet and the URL is correct (list URL HERE). 11. Cannot log in to the web application:

Make sure the username and/or password is correct. 12. Component(s) is missing or damaged out of the box:

Call the REAL help line. Page 28 of 29 18951.01 2019-12 Page 29 of 29

) R E A | FCC ID: 2AQU7-REALO2T 1C:24199-REALO2T

. i HVIN WTM2 :

Large Sensor (ol | P22 Penumbra, Inc. One Penumbra Place REAL2 Alameda, CA 94502, USA Tel: 1.855.REAL-SYS [sn] aa12345 1.855.732.5797 Pat. www.penumbrainc.com/patents aa 2000-05-31 18774.01 LE00-LS90T Label Here

Attention: Application Examiner Re: Covered List, located at https://www.fcc.gov/supplychain/coveredlist and 47 CFR parts 2.903 and 2.911(d)(5)(ii) of the FCC rules Applicant: Penumbra Inc. FCC ID: 2AQU7-REAL02S To whom it may concern, Penumbra Inc. (Applicant) certifies that the equipment for which authorization is sought is not covered equipment prohibited from receiving an equipment authorization pursuant to 47 CFR part 2.903 of the FCC rules and does not originate directly or indirectly from any company named on the covered list located in the link above or any subsidiary or affiliate thereof. Applicant further certifies that, as of the date of the filing of the application, the Applicant is not identified on the Covered List as an entity producing covered equipment and is not a subsidiary or affiliate of any such entity pursuant to 47 CFR part 1.50002 and required by 47 CFR part 2.911(d)(5)(ii) of the FCC rules. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant and agree to immediately notify Intertek if there is any change in the status identified above. Puneet Goyal Senior R&D Engineer Penumbra Inc. 02/23/2023 Form: RFT-AMER-TCB-OP-19n Date: 1/25/2023 Revision: 1 Page 1 of 1

Penumbra Sincerely, Royal Wang R&D Manager Penumbra Inc. OECTA ES Intertek Testing Services NA Ltd. rA0M Orolo leat la ma llimacer-\) Boxborough, MA 01719 Attention: Reviewing Engineering Subject: Authorization Letter Penumbra Inc. To Whom It May Concern:

We, Penumbra Inc., hereby authorized Puneet Goyal to correspond or communicate and sign any form with TCB starting 06/01/2019 If you have any questions or comments, please do not hesitate to contact the undersigned.

Attention: Application Examiner Re: Certification designating a U.S. agent for service of process pursuant to 47 CFR part 2.911(d)(7) of the FCC rules To whom it may concern, This letter is to certify that Penumbra Inc. (Applicant) accepts responsibilities to act as its own agent pursuant to 47 CFR part 2.911(d)(7) of the FCC rules for service of process. I consent to the obligation to accept service of process on behalf of the Applicant for all certification applications to the FCC. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant. I further acknowledge the requirement to maintain an agent extends for no less than one year after the termination of all marketing and importation or the conclusion of and commission-related proceeding involving the equipment and agree to immediately notify the FCC and Intertek if there is any change in the status identified above. Applicant Company Name Contact Name Address Telephone No Email Applicant FRN

: Penumbra Inc.

: Puneet Goyal

: 1351 Harbor Bay Pkwy, Alameda, CA 94502

: 510-748-3200

: pgoyal@penumbrainc.com

: 0027759653 Signature: ____________________________________ Date: ____________________________________ Form: RFT-AMER-TCB-OP-19o Date: 1/25/2023 Revision: 1 Page 1 of 1 02/22/2023

Penumbra 9 12/10/2020 Attention: Application Examiner Subject: Limited Agency Agreement Applicant: Penumbra Inc. To Whom It May Concern:

We, Penumbra Inc., hereby authorized Intertek Testing Services to act as our Agent on our behalf in front of FCC with respect to all matters relating to certification of equipment. The effective date of this Limited Agency Agreement is 07/22/20. The Limited Agency Agreement expires on 07/22/21, unless sooner terminated or extended by written notice to Intertek Testing Services and FCC. If you have any questions or comments, please do not hesitate to contact the undersigned. Sincerely,

Puneet Goyal R&D Engineer Ill Penumbra Inc.

4/20/2021 Attention: Application Examiner RE:

Family Certification Information Applicant: Penumbra Inc. FCC: 2AQU7-REAL02T To Whom It May Concern:

REAL is a digital hardware and software medical device platform utilizing virtual reality technology designed for use in healthcare and focusing on physical, neurorehabilitation and/or wellness needs. REAL is offered in two configurations: REAL System and REAL System 2. REAL System is intended to be used in a clinical environment, or any other facility that may facilitate rehabilitation by healthcare providers who have received appropriate training in rehabilitation therapy. REAL System 2 is intended to be used in a residential environment, or any other facility that may facilitate rehabilitation individuals with physical, neurorehabilitation and/or wellness needs. A caregiver may be optionally present to help the user operate the system. Both configurations use the same sensor modules listed under FCC: 2AQU7-REAL02T (HVIN:

WTM2). Headset plastic, Sensor Charger, User Manual, and Label content differences between the two configurations is for home healthcare compliance purposes and does not alter the functionality between REAL System and REAL System 2. Sincerely, Puneet Goyal R&D Engineer III Penumbra Inc.

Penumbra Attention: Application Examiner RE: Request for Confidentiality Applicant: Penumbra Inc. FCC ID: 2AQU7-REALO2T To Whom It May Concern:

eR SCL sd Request is hereby submitted by Penumbra Inc. to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential:

Schematics Detailed Block Diagrams Detailed Operational/Functional Description eee iis Rationale for request for confidentiality:

Penumbra Inc. has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. TTT RIA Puneet Goyal ta De al aUnoee am LT Penumbra Inc. 11/16/2020