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USER MANUAL | Users Manual | 1.06 MiB | April 21 2021 | |||
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INTERNAL PHOTOS | Internal Photos | 886.28 KiB | April 17 2023 | |||
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EXTERNAL PHOTOS | External Photos | 124.34 KiB | April 17 2023 | |||
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LABEL | ID Label/Location Info | 161.81 KiB | April 21 2021 | |||
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COVERED LIST ATTESTATION | Attestation Statements | 217.95 KiB | April 17 2023 | |||
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GRANTEE SIGNATURE AUTHORIZATION | Cover Letter(s) | 22.86 KiB | April 17 2023 | |||
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RF EXPOSURE EXHIBIT | RF Exposure Info | 345.93 KiB | April 17 2023 | |||
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TEST REPORT | Test Report | 4.55 MiB | April 17 2023 | |||
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TEST SETUP PHOTOS | Test Setup Photos | 2.44 MiB | April 17 2023 | |||
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US AGENT | Attestation Statements | 266.04 KiB | April 17 2023 | |||
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AGENT AUTHORIZATION | Cover Letter(s) | 306.44 KiB | April 21 2021 | |||
1 2 | BLOCK DIAGRAM | Block Diagram | April 21 2021 | confidential | ||||
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MODEL DIFFERENCES | Cover Letter(s) | 192.72 KiB | April 21 2021 | |||
1 2 | OPERATIONAL DESCRIPTION | Operational Description | April 21 2021 | confidential | ||||
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REQUEST FOR CONFIDENTIALITY | Cover Letter(s) | 33.89 KiB | April 21 2021 | |||
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RF EXPOSURE | RF Exposure Info | 257.53 KiB | April 21 2021 | |||
1 2 | SCHEMATICS | Schematics | April 21 2021 | confidential |
1 2 | USER MANUAL | Users Manual | 1.06 MiB | April 21 2021 |
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
1 2 | LABEL | ID Label/Location Info | 161.81 KiB | April 21 2021 |
HVIN WSM2 R E A L Small Sensor
Penumbra, Inc. One Penumbra Place Alameda, CA 94502, USA Tel: 1.855.REAL-SYS 1.855.732.5797 FCC ID: 2AQU7-REAL02S IC: 24199-REAL02S
(] 2000-05-31 Pat. www.penumbrainc.com/patents 18775.01
1 2 | COVERED LIST ATTESTATION | Attestation Statements | 217.95 KiB | April 17 2023 |
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
1 2 | GRANTEE SIGNATURE AUTHORIZATION | Cover Letter(s) | 22.86 KiB | April 17 2023 |
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.
1 2 | US AGENT | Attestation Statements | 266.04 KiB | April 17 2023 |
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
1 2 | AGENT AUTHORIZATION | Cover Letter(s) | 306.44 KiB | April 21 2021 |
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.
1 2 | MODEL DIFFERENCES | Cover Letter(s) | 192.72 KiB | April 21 2021 |
4/20/2021 Attention: Application Examiner RE:
Family Certification Information Applicant: Penumbra Inc. FCC: 2AQU7-REAL02S 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-REAL02S (HVIN:
WSM2). 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.
1 2 | REQUEST FOR CONFIDENTIALITY | Cover Letter(s) | 33.89 KiB | April 21 2021 |
Penumbra Attention: Application Examiner RE: Request for Confidentiality Applicant: Penumbra Inc. FCC ID: 2AQU7-REALO2S AM semi MC Aes ia 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 Ta eas 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. Sincerely, Puneet Goyal R&D Engineer Ill Penumbra Inc. 11/16/2020
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2023-04-17 | 2402 ~ 2479 | DTS - Digital Transmission System | Class II permissive change or modification of presently authorized equipment |
2 | 2021-04-21 | 2402 ~ 2479 | DTS - Digital Transmission System | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 2 | Effective |
2023-04-17
|
||||
1 2 |
2021-04-21
|
|||||
1 2 | Applicant's complete, legal business name |
Penumbra Inc
|
||||
1 2 | FCC Registration Number (FRN) |
0027759653
|
||||
1 2 | Physical Address |
One Penumbra Place
|
||||
1 2 |
Alameda, California 94502
|
|||||
1 2 |
Alameda, CA
|
|||||
1 2 |
United States
|
|||||
app s | TCB Information | |||||
1 2 | TCB Application Email Address |
t******@intertek.com
|
||||
1 2 | TCB Scope |
A4: UNII devices & low power transmitters using spread spectrum techniques
|
||||
app s | FCC ID | |||||
1 2 | Grantee Code |
2AQU7
|
||||
1 2 | Equipment Product Code |
REAL02S
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 2 | Name |
R**** W****
|
||||
1 2 | Title |
R&D Manager
|
||||
1 2 | Telephone Number |
51099********
|
||||
1 2 | Fax Number |
51081********
|
||||
1 2 |
r******@penumbrainc.com
|
|||||
app s | Technical Contact | |||||
1 2 | Firm Name |
Penumbra
|
||||
1 2 | Name |
P****** G******
|
||||
1 2 | Physical Address |
1 Penumbra Place
|
||||
1 2 |
Alameda, California 94502
|
|||||
1 2 |
United States
|
|||||
1 2 | Telephone Number |
70724********
|
||||
1 2 |
p******@penumbrainc.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 2 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
1 2 | Yes | |||||
1 2 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 2 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 2 | Equipment Class | DTS - Digital Transmission System | ||||
1 2 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | WSM for REAL Immersive System | ||||
1 2 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 2 | Modular Equipment Type | Does not apply | ||||
1 2 | Purpose / Application is for | Class II permissive change or modification of presently authorized equipment | ||||
1 2 | Original Equipment | |||||
1 2 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 2 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
1 2 | Grant Comments | Power output is listed as conducted | ||||
1 2 | Power output listed is conducted. | |||||
1 2 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 2 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 2 | Firm Name |
IntertekTesting Services NA Inc.
|
||||
1 2 | Name |
C****** P******
|
||||
1 2 | Telephone Number |
650-4********
|
||||
1 2 | Fax Number |
650 4********
|
||||
1 2 |
c******@intertek.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402 | 2479 | 0.00618 | ||||||||||||||||||||||||||||||||||||
1 | 2 | 15C | 2402 | 2479 | 0.0059 | ||||||||||||||||||||||||||||||||||||
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
2 | 1 | 15C | 2402.00000000 | 2479.00000000 | 0.0061800 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC