FCC ID: 2AQU7-REAL01S REAL Immersive System

REAL IMMERSIVE SYSTEM OPERATION, MAINTENANCE, AND SERVICE 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 Experience System Removal Software Description Technical Specifications Symbol Glossary Technical Information 1 1 2 2 2 2 2 3 3 3 4 4 6 7 8 11 11 11 WARNING! CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS. DEVICE DESCRIPTON The REAL Immersive System is a digital hardware and software medical device platform using a combination of virtual environments and full presence tracked avatars for visual feedback. It is designed for use in healthcare and focusing on physical and neuro rehabilitation. The use of the REAL Immersive System is intended to be in a clinical environment, supervised by a medical professional trained in rehabilitation therapy. The REAL Immersive System consists of a clinician tablet, head-mounted display

(HMD or headset), small sensors, large sensor, sensor charger, router, router battery, headset controller, power cords, and USB cables. Note: Sensor bands are required for use and are sold separately. Tablet is fitted with a touch screen, a power/lock button 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 the small and large sensors. The large and small sensors are equipped with mechanical and electrical compo-

nents that measure position and orientation in physical space and then translate that information to construct a virtual environment. The sensor charger acts as a dock to store and charge the sensors. The headset controller is used to access system settings. It should only be used in certain troubleshooting and administrative tasks and not during patient therapy. At full charge, the entire system can be operated for roughly 2 hours. However, 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. Please sufficiently charge all the 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 B Applied Part. Type B is the least stringent classification, and is used for applied parts that are generally not conductive and can be immediately released from the patient. Frequently used features and functions:

Headset Plug headset power cord into wall outlet to charge device. Press power button to turn on headset or restart headset. The power button is on top of the headset. Headset Controller Buttons on the controller are used to control power, connect to headset, access settings, or control volume. Large Sensor and Small Sensors Sensors are turned off and charging when placed in the charging station. Sensors turn on and attempt to sync when removed from the charging station. Sensors are placed into the sensor bands, which are sold separately. Tablet Press the power button to power on tablet or restart tablet. The power button is on the edge of the device. User Interface:

- Logging in

- Adding or selecting patient

- Initializing and syncing to sensors

- Selecting, starting, modifying, or ending therapy session

- Viewing data

- Logging out 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 one-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 one-year product lifespan. Circuit diagrams and calibration instructions are not provided because service or parts repair is not necessary. At the end of the one-year product lifespan, the user should dispose of the device through an environmentally safe electronic waste recycle system if the following event occurs:

The system no longer stays powered on and connected through the entire recommended duration of a therapy session when initially fully charged. Supply mains are electrically isolated in medical equipment to maintain basic safety. 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. 1 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 and prescribed and supervised by a medical professional trained in rehabilitation therapy. CONTRAINDICATIONS There are no known contraindications. WARNINGS If a patient experiences motion sickness, dizziness, headache, eye strain, or fatigue when using the device, stop use of device immediately. 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 to prevent injury). As this device is to be used for upper body rehabilitation, the patient must 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. Device should not be dropped. Device is not intended for continued use if dropped from higher than 1 meter (3 feet). Damage (mechanical and electrical) may result if the tablet, headset, sensors, router, router battery, and/or sensor charger are dropped or struck against another object. Do not touch the router and patient at the same time. Patients using the device should not be allowed to touch the router at any time. During use and while charging, the surface of the equipment will not exceed 41C. Sensors will transmit inaccurate position data if used near metal including, but not limited to, wheelchairs, walkers, and utility carts. Headset tracking may be lost or compromised if close or low-contrast objects or surfaces obscure the tracking cameras on the front of the headset. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 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 centimeters (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. 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 the manufacturer. Any changes or replacements of accessories could impact FCC compliance of REAL Immersive System. 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 provok-

ing an epileptic seizure. Should this occur, stop using the device immediately. Other possible complications include, but are not limited to, the following:

discomfort or pain in the head or eyes dizziness drowsiness eye strain headache light-headedness migraine motion sickness nausea pain vertigo vision problems Should any of the above occur, stop using the device immediately. 2 OPERATOR PROFILE Operators of the REAL Immersive System should be trained in rehabilitation therapy. 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, router must be configured and connected to the local internet. Note: These rehabilitation exercises are intended to be conducted in a seated posi-

tion. 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 flashing red, flashing green, or solid green to display charging status. Solid Green: Full battery 4. Ensure the headset is connected to its power cords (AC adapter power cord and USB-C cord). LED lights on top of headset will show blinking green or solid green to indicate charging status. 5. Ensure the tablet is connected to its power cord (USB-C cord). 2. Connect the REAL Immersive System Case to its power cord (AC adapter power cord). Plug the power cord into a grounded electrical outlet. Ensure the power receptacle is connected to a supply mains with protective earth. 3 SECTION 2: INTERNET CONNECTIVITY 1. Turn on tablet by pressing power button for approximately 5 seconds.

(May take up to 30 seconds if tablet was fully drained of battery). 2. Open the TherapyView app if it is not already open. 3. On the log in page, click on the Network Setup button. Network Setup 4. Enter the username and password below to login into the router:

a. Username: realadmin b. Password: realsystem 5. Connect using your wireless network name and password OR Connect by whitelisting the device MAC address. c. To connect using a network name and password:

i. Select Wireless 5 GHz from the menu. If the desired network is a not a 5 GHz network, select Wireless 2.4 GHz. Wireless 5 GHz is preferred to Wireless 2.4 GHz. ii. Select Scan to search for local networks. iii. Select Connect next to the desired network. iv. Enter the password into the corresponding field. v. Select Save and exit the control panel. vi. The REAL Immersive System should now be connected. d. To connect by whitelisting the device MAC address:

i. Select Status from the menu. ii. The device MAC address is listed under WAN. iii. Whitelist the MAC address on the local network. See your IT Administrator for network support. iv. Select Wireless 5 GHz from the menu. If the network is a not a 5 GHz network, select Wireless 2.4 GHz. v. Select Scan to search for local networks. vi. Locate the desired network from the list. vii. Select Connect next to the desired network. viii. Select Save and exit the control panel. ix. The REAL Immersive System should now be connected. Continue to Section 3 when the components are sufficiently charged, and the system has secure internet connectivity. SECTION 3: START-UP SYSTEM FOR PATIENT USE 1. Unplug power cords from tablet and headset when charged and ready for use, the LED lights on the headset should be solid green when fully charged. 2. If tablet is not turned on, turn on. 3. Turn on headset by pressing and holding power button for approximately 5 seconds. 4. Ensure the patient is in a seated position away from metal components and remains seated at all times for the duration of the therapy session. 5. Place headset on patients head in the sequence numbered below. Patient can immediately begin visually interacting with the environment. 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 may keep eyeglasses on. 6. Remove sensor bands from reusable packaging (sold separately). 7. Remove all sensors from sensor charger. 4 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. 10. Log in on the tablet. Add new patient or select patient from directory; edit patient information as needed. 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 fit, if necessary. 5 Front View Back View 6 11. Once a patient is selected or created, the healthcare provider (HCP) may initiate the session by pressing Start Session from the header. Each session begins in the Hide and Seek game by default. See figure below 13. The HCP may navigate to additional therapy experiences by selecting the corresponding icon from the display. Once the activity has loaded, the HCP can press the Start Activity button to start the activity. See Section 4 for more information. 12. Orient the patient in a neutral seated position, facing forward. Press the Go button on the tablet. Section 4: THERAPY EXPERIENCE 1. Confirm patients avatar in VR space corresponds to actual patients physical movement. 2. Confirm patients view in the VR space corresponds with patients head movement. 3. Confirm application audio can be heard but doesnt block out HCPs communication; adjust volume on headset as needed. 4. Conduct rehabilitation session as planned. (See Section 6 which includes a software description for details of therapeutic experiences). 7 5. Always remain with the patient throughout therapy session to provide direct supervision. 6. Monitor patient view on tablet; select and change activities as desired. Note: If sensors lose synchronization or headset loses tracking, turn off entire system then back on to reset. Headset is turned off and on using the power button. Sensors are turned off and on by placing them in the powered charging station and removing them again. 7. When planned therapy experiences are complete, press End Session on tablet. Patient will be returned to the Hide and Seek experience without a tracked avatar. Gaze interactions will still function. 8. 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 and power off tablet. 5. Clean headset and sensors with institutional approved sanitizing wipes*. 6. Connect tablet and headset to their respective power cords. 7. Return all sensors to sensor charger. Green LEDs should be noted on sensors when placed correctly in the charging station. 8. Store and label bands for future individual patient use. 9. Ensure REAL Immersive System Case is plugged in and component LED lights indicate charging. 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. Therefore, it may be necessary to power cycle the headset and/or restart the application on the tablet in between therapy sessions.

*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 com-

ponents of headset with institutional approved sanitizing wipe. Do not use petro-

leum-based compounds, acids, caustics, or chlorinated solvents to clean or lubricate any parts. Use only water-based solvents for cleaning. 8 Section 6: SOFTWARE DESCRIPTION The REAL Immersive System contains a variety of experiences that incorporate clinically recognized, existing therapeutic and functional exercises to facilitate motor and cognitive rehabilitation. Settings for each experience will involve parameters such as turning on and off avatar features and environmental factors as well as switching between activities. 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 Game 1: Hide and Seek Hide and Seek can be used with or without a displayed avatar tracking the patients upper body because it primarily relies on head movement and visual scanning ability. Once the sensors have synced, the avatar should appear. Hide and Seek puts the pa-

tient in a pastoral setting with a number of animated animals that react to the patients acknowledgement of them. This is the experience the patient first starts with, giving a chance for the HCP to place sensors on the patients body and then activate visu-

alization of the avatar. Its also the last experience prior to ending the patients session which provides the ability for the HCP to remove the sensors and for the patient to 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. The penguin will then disappear and reappear in a dif-

ferent location. The pointer is positioned to represent the patients upper body vertical midline, 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 as to their true body midline helping them relearn to position themselves in relation to it. 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 will have control over the range of locations that animals appear and wait to be found through difficulty settings on the tablet. Hide and Seek locations in the world will change and evolve over a number of sessions to provide an experience of logical progression and achievement as the patient continues their course of rehabilitation. Therapy Game 2: Hot Air Balloon 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, such as knocking apples off a tree and contacting other balloons or clouds. 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. Sub-Activity 1: Balloon Pilot This sub-activity takes place near the ground. The patient-controlled balloon is teth-

ered to the ground to limit balloon travel and encourage simple torso centering. 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. Objects, such as bridge components, can also be picked up and carried over to the mountain to help hikers cross gaps. 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, over to the house 9 stage. Wind driven clouds bump into the balloon and move the balloon arbitrarily which the patient has to counteract with trunk movements. Sub-Activity 2: Harvest Therapy Game 3: Sunrise This experience is based on simple shoulder flexion. The patient holds their arms out straight in front of them and raises their arms up and over their head in a motion that ideally, is pure shoulder flexion with a maximum, healthy ROM of 180 degrees. This exercise may be done passively with HCP assistance or actively by the patient themselves. 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 experience will be stored as a session output for the HCPs record. 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 experience and feedback of a simple coordi-

nated arm raise. The Bumper Crop 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. Different numbers of cycles necessary to fully grow a vegetable can be controlled by the HCP through difficulty settings. Upon full growth of each veg-

etable, the patient receives an award that is saved in their game record. 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 10 The Ice Cave sub-activity involves freeing a variety of Cave Penguins from ice blocks by raising and lowering ones arms a number of times in order to trigger the appearance of day-night cycles. Different numbers of cycles necessary to fully free a penguin can be controlled by the HCP through difficulty settings. Upon each Cave Penguins release, the patient receives an award that is saved in their game record. This activity creates an incentive for the patient to do multiple repetitions of this exercise if called for by the patients rehabilitation plan. Therapy Game 4: Bird Forest The Bird Forest experience incorporates standard functional exercises into a virtual reality experience by requiring the patient to reach out with one or both hands to allow a bird in their immediate vicinity to jump into their hand. Patients have opportunities to reach from low to high, high to low, from left to right crossing their midline, etc. 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. Adjustable settings include the number of nests and their placement around the pa-

tient, whether the hand must properly pronate and supinate in order to pick up and deposit a bird, the smoothness and/or speed of movement required to get a bird to a nest before they fly away, the color of target nests and the patterns applicable to the cognitive exercises. 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 of the game so it can be played again. Sub-Activity 2: Nest Hop 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 our 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 dropped off to colored target nests in a spe-

cific order. Only one target nest will be active at a time. The bird will be placed in a sequence of non-repeating colored target nests. When all nests have been filled, the exercise will reset. Therapy Game 5: Penguin Sports Park In this activity, the patient must move their upper extremities to intersect with 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. Sub-Activity 1: ChuckleBall The patient fends off approaching Chuckleballs by deflecting them with his head or hands. There are no additional difficulty levels. The Chuckleballs will be kicked con-

tinually until a new activity is started. Sub-Activity 2: Chuckleball Arena Chuckleball requires the patient to protect their goal from kicked Chuckleballs com-

ing 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 Chuckle-

ball will deflect in specific directions and advanced patients can learn to deflect the chuckle back into the opposing goal. Other objects and animals in the environment 11 TECHNICAL INFORMATION REAL Immersive System Case Instructions:

The case resembles a suitcase and includes a TSA approved zipper lock. How to reset the combination lock:

1. Set all combination dials to the following: 0-0-0. 2. Find the hole located to the right of the dials. Use a paper clip or similar device 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. Turn the dials to the correct combination, and push the slide button on the left of the dial towards the direction of the arrow to unlock. 2. Put in the loop portion of the zipper into the slots of the lock, then turn the dials randomly to conceal the personal combination to lock. 3. Repeat step 1 to unlock case. WARNING: TSA key lock must be turned to the red dot position at all times. If the TSA key lock is turned away from the red dot, it must be turned to the red dot position. Any tool which can be inserted in the TSA key lock is acceptable to use. can also serve as targets. The HCP can control how fast the ball travels towards the patient, the distance the patient must reach to block the ball, and the number of balls to be kicked at the patients. Sub-Activity 3: Flying Fish Flying fish is similar to Chuckleball where the patient must deflect a fish being pitched at them with the hand or the head. This may elicit a defensive response movement from the patient in VR. 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 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*): 1 mW (0 dBm) typical Frequency Band: ISM (Industrial, Scientific, and Medical) Typical Center frequency: 2.44 GHz Channel: 40 channels Bandwidth: 2 MHz per channel Modulation: GFSK (Gaussian frequency-shift keying) Data flow: Bi-directional

*EIRP = Equivalent isotropically radiated power

*REAL Immersive System is calibrated appropriately to detect movement in virtual reality space in relation to real space accu-

rately 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 exam-

ple, if the patient is in a metal wheelchair and cannot move to a non-metal chair, reduction in accuracy and precision may occur. SYMBOL GLOSSARY RX Only IP00 REAL Immersive System is a Type B Applied Part. 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 B Applied Part WEEE Manufacturer Catalog Number Lot Number Serial Number Date of Manufacture No protection against ingress of solid and liquid Both Direct and Alternating Current Class II Equipment 11 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. 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 Voltage Fluctuations/

Flicker emissions Group 1 Class A Class A 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 interfer-

ence in nearby electronic equipment. REAL Immersive System is suitable for use in all establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. 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

(50/60 Hz) magnetic field IEC 61000-4-8 Voltage Dips 30% reduction, 25/30 periods At 0 Voltage Dips 30% reduction, 25/30 periods At 0 Voltage Dips > 95% reduc-

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

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

tion, 1 period At 0 Voltage Dips > 95% reduc-

tion, 1 period At 0 Voltage Interruptions > 95%

reduction, 250/300 periods Voltage Interruptions > 95%

reduction, 250/300 periods 30 A/m 30 A/m 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. Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commer-

cial or hospital environment. Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance 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 3 V/m 80 MHz to 2.7 GHz 3 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 appli-

cable 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 reflec-

tion from structures, objects and people. a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radi-

os, 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 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. portable and mobile RF communications equipment and REAL Immersive System Recommended separation distances between REAL Immersive System is intended for use in an electromagnetic environment in which radiated RF disturbances are con-

trolled. 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 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 d = 1.2P d = 2.3P 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 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 reflec-

tion from structures, objects and people. 12 Test Band a) Service a) Modulation b) Maximum Distance Immunity to RF Wireless Communications Equipment Frequency

(MHz 385

(MHz) 380-390 TETRA 400 450 430-470 GMRS 460, FRS 460 Power

(W) 1.8

(m) 0.3 2 0.3 Pulse modulation b) 18 Hz FM c) 5 kHz deviation 1 kHz sine 704 787 LTE Band 13, 17 Pulse 0.2 0.3 IMMUNITY TEST LEVEL

(V/m) 27 28 9 and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Mode of Operation:

Charging mode and battery mode Highest Clock Frequency:

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

2402 MHz 2480 MHz Transmitting Frequency and Modulation:

Frequency-shift Keying (FSK) modulation. 2Mbps modulation for all transmitter frequencies. 0.3 28 Antenna Make, Model, and Gain:

1700-1990 0.3 28 2 2 710 745 780 810 870 930 1720 1845 1970 800-960 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 2450 2400-2570 5100-5800 WLAN 802.11 a/n 5240 5500 5785 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 0.3 28 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. This device may not cause interference. 2. 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 :

1. Lappareil ne doit pas produire de brouillage;

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 users 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 A 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 commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed Device WSM WTM HMD Antenna Make Antenna Model Antenna Gain Johanson P/N 2450AT43B100E Peak Gain Average Gain -0.5 dBi 1.3 dBi Penumbra Inc. P/N 14536 Min: -1 dBi Max: 2.4 dBi Power Output and Data Rate:

Device WSM WTM HMD Power Output Transmitter with programmable output power of +4 dBm to -20 dBm, in 4 dB steps. Programmed by the firmware to +0dBm. Data Rate GFSK modulation, 2 Mbps data rate. Product availability varies by country. Please contact your local REAL representative for more information. Copyright 2019 Penumbra, Inc. All rights reserved. The REAL logo, TherapyView, and Chuckleball 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 13661 Rev.02 2019-02 13

WSM Internal Photos View In-Chassis Front Photo In-Chassis Back In-Chassis Left In-Chassis Right In-Chassis Top In-Chassis Bottom PCBA Front PCBA Back WTM Internal Photos View In-

Housing Front Photo PCBA Front PCBA Back Open

WSM External Photos View Front Photo Back Left/Right Top Bottom WTM External Photos View Front Photo Back Left/Right Top Bottom

ID Label Location NOTE: Label locations are indicated in red rectangular box. Lables shown may not represent the final label design and content. HMD:

WSM:

WTM:

OMFARO PANN KS Penumobra Attention: Application Examiner Ne Request for Confidentiality Applicant: Penumbra Inc. FCC 1D: 2AQU7-REALO1S To Whom it May Concern:

Permanent Confidentiality 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 ae hie 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. Nye e 1h Royal Wang R&D Manager Penumbra Inc. Penumbra 07/10/2019 Attention: Application Examiner RE: Request for Confidentiality Applicant: Penumbra Inc. FCC ID: 2AQU7-REALO1 To Whom It May Concern:

eee ese 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 Parts list 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. SNR) A Royal Wang CCAD E VEL Penumbra Inc.

Penumora 07/22/2019 Innovation, Science and Economic Development Canada Certification and Engineering Bureau 3701 Carling Avenue Bldg. 94 P.O. Box 11490, Station H Ottawa, Ontario K2H 8S2 Attention: Reviewing Engineering Subject: Limited Agency Agreement mallet een tes To Whom It May Concern:

We, Penumbra Inc., hereby authorized Intertek Testing Services to act as our Agent on our behalf in front of Industry Canada Certification and Engineering Bureau with respect to all matters relating to certification of equipment. The effective date of this Limited Agency Agreement is 07/22/19. The Limited Agency Agreement expires on 07/22/20, unless sooner terminated or extended by written notice to Intertek Testing Services and Industry Canada Certification and Engineering Bureau. If you have any questions or comments, please do not hesitate to contact the undersigned. Royal Wang tT PME Tary<cie Penumbra Inc. TTA e sl A

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.