2AQU7-REAL02SWSM for REAL Immersive System

1 (15) REAL ™ IMMERSIVE SYSTEM USER MANUAL Table of Contents Warning 3 Device Description 3 Indication for Use 4 Contraindications 4 Warnings 4 Precautions 4 Potential Adverse Effects/Events 4 Operating Profile 5 Operating Procedure 5 • Getting Started & Charging Components 5 • Internet Connectivity 6 • Start-Up System for Patient Use 6 • Therapy Activities 8 • System Removal 9 • Software Description 10 Technical Specifications 13 Symbol Glossary 13 Technical Information 13 WARNING! CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE. OBSERVE ALL WARNINGS AND PRECAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS. FAILURE TO DO SO MAY RESULT IN COMPLICATIONS. 2 (15) DEVICE DESCRIPTON The REAL ® Immersive System is a digital hardware and software medical device platform utilizing virtual reality technology designed for use in a clinical environment, or any other facility that may facilitate rehabilitation, setting that focuses on physical, neurorehabilitation and/or wellness needs. REAL Immersive System consists of following components: • All-In-One Headset with Software Application • Headset Controller • Large Sensor • Small Sensors • Tablet • Sensor Charger (charging station) • REAL Sensor Bands Tablet is fitted with a touch screen, a power/lock key that turns the component on or off, and a charger/accessory port. The headset contains a power button that turns the component on or off and a charger/ accessory port. The headset also provides visual feedback of virtual reality applications in concert with the REAL Immersive System tablet and small and large sensors. Large and small sensors (WTM and WSMs) are equipped with mechanical and electrical components that measure motion and direction in physical space and then translate that information into a virtual environment. The sensor charger powers the sensors. Headset controller (Only to be used in certain troubleshooting and administrative tasks. Not used during patient therapy.) At full charge, the entire system can last at a minimum of 60 minutes and it is recommended that a therapy session does not exceed 60 minutes. Please sufficiently charge all components between use for a minimum of 60 minutes. In the event of electromagnetic disturbances, the performance of the REAL Immersive System may be affected. The REAL Immersive System is a Type BF Applied Part. Frequently used features and functions: Headset • Plug headset power cord into wall outlet and headset to charge device. • Press power button to power on headset or restart headset. The power button is on top of the headset. Headset Controller • Buttons on the controller are used to control power, connect to headset, access settings, or control volume. Large Sensor and Small Sensors • Components are removed or placed back into the sensor charger (charging station) to activate or charge device. • Components are placed into the sensor bands. Tablet • Plug tablet power cord into wall outlet and tablet to charge device. • Press power button to power on tablet or restart tablet. The power button is on the edge of the device. • User Interface: - Selecting the application - Logging in - Adding or selecting patient - Initializing and syncing to sensors - Selecting, starting, modifying, or ending therapy session - Viewing data - Logging out Sensor Charger • Plug sensor charger power cord into wall outlet and sensor charger to power on device to charge sensors. Sensor Bands • Place or remove sensor bands on or from patient. There is no preventive inspection, calibration, and maintenance necessary for the REAL Immersive System besides the initial set up procedure. During the three-year product lifespan of the REAL Immersive System, the device will continue to perform safely without any routine maintenance. No parts within the REAL Immersive System will require inspection nor maintenance by a service personnel to ensure basic safety during the three-year product lifespan. Circuit diagrams and calibration instructions are not provided because service or parts repair is not necessary. At the end of the three-year product lifespan, the user should dispose of the device through an environmentally safe electronic waste recycle system. Contact the local REAL representative if the following event occurs: • The system no longer stays powered on and connected through the entire recommended duration of a therapy session. Supply mains are electrically isolated in medical equipment to maintain basic safety. 3 (15) The full expected latency of the device, including movement detection, processing, and visual representation is 35 milliseconds or less. This value is considered minimal and sufficiently low enough so that movement can be quickly detected. INDICATION FOR USE The REAL ™ Immersive System is an immersive virtual reality and display system that interactively displays and tracks upper-extremity rehabilitation exercises for adult pa- tients using a combination of virtual environments and full presence tracked avatars for visual feedback. These rehabilitation exercises are intended to be conducted in a seated position in a clinical environment or any other facility that may facilitate rehabilitation and prescribed and supervised by a medical professional trained in rehabilitation therapy. CONTRAINDICATIONS There are no known contraindications. WARNINGS If a patient complains of 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 and ensure that the patient is unlikely to trip or fall). As this device is to be used for upper body rehabilitation, we recommend that the patient remain seated to avoid a fall. Be aware of the patient’s limitations in range of motion and avoid device or program use that could lead to excessive…

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Page 1 of 29 REAL® SYSTEM 2 User Manual Table of Contents Abbreviations?? Warning 3 Device Description 3 Indication for use 4 Contraindications 4 Warnings 4 Precautions 4 Potential Adverse Effects/Events 4 Operating Profile 5 Operating Procedure 5 • Getting Started & Charging Components 5 • Internet Connectivity 6 • Start-Up System for Patient Use 6 • Therapy Activities 8 • System Removal 9 • Software Description 10 Technical Specifications 13 Symbol Glossary 13 Technical Information 13 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 2 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: Headset • 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. Headset Controller • Buttons on the controller are used to access settings. Sensor Charger • Plug sensor charger power cord into wall outlet and sensor charger to power on device to charge sensors. Page 3 of 29 Large Sensor and Small Sensors • Activate or charge sensor devices by removing or placing back into the sensor charging station. • Place sensor devices into the sensor bands. Sensor Bands • See Section 3 in Operating Procedures on instructions to put on sensor bands. User Portals • Access the User Portal through the Headset to perform the following: o Logging in o Selecting the activity o Initializing and syncing to sensors 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 Initializing and syncing to sensors o Selecting, starting, modifying, or ending therapy session o Viewing data o Logging out 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 4 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 a…

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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.

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

Label Location

Label Location

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

Penumbra Inc. RF Exposure Exhibit SCOPE OF WORK EMC TESTING – Real Immersive System, Model: Xavier 1/Xavier 2, Part Number: 18284 (WSM, Wireless Sensor Module) REPORT NUMBER 104407842MPK-026A ISSUE DATE January 08, 2021 REVISED DATE March 19, 2021 PAGES 8 DOCUMENT CONTROL NUMBER Non-Specific Radio Report Shell Rev. December 2017 MPK © 2017 INTERTEK Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 2 of 8 RF Exposure Exhibit (portable devices) Report Number: 104407842MPK-026A Project Number: G104407842 Original Issue Date: January 08, 2021 Revision Issue Date: March 19, 2021 Product Designation: Model Tested: Part Number: Real Immersive System Xavier 1/Xavier 2 18284 (WSM, Wireless Sensor Module) FCC ID: 2AQU7-REAL02S IC: 24199-REAL02S to 47CFR 2.1093 RSS-102 Issue 5 for Penumbra Inc. Tested by: Client: Intertek 1365 Adams Court Menlo Park, CA 94025 USA Penumbra Inc. One Penumbra Place Alameda, CA 94502 USA Report prepared by: Report reviewed by: Anderson Soungpanya/ Project Engineer Krishna Vemuri / EMC Manager This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 3 of 8 Report No. 104407842MPK-026A Equipment Under Test: Real Immersive System Trade Name: Penumbra Inc. Model(s) Tested: Xavier 1/Xavier 2 Applicant: Penumbra Inc. Contact: Puneet Goyal Address: Penumbra Inc. One Penumbra Place Alameda, CA 94502 Country: USA Tel. Number: 510-440-5598 Email: [email protected] Applicable Regulation: 47CFR 2.1093 RSS-102 Issue 5 REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 4 of 8 TABLE OF CONTENTS Penumbra Inc. ................................................................................................................................................. 1 1.0 RF Exposure Summary ............................................................................................................................ 5 2.0 RF Exposure Limits .................................................................................................................................. 5 3.0 Test Results (Portable Configuration) ...................................................................................................... 6 4.0 Document History ................................................................................................................................... 8 REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 5 of 8 1.0 RF Exposure Summary Test Reference FCC Reference In dustry Canada Result Radio frequency Radiation Exposure Evaluation 47 CFR§2.1093 RSS-102 Issue 5 Complies 2.0 RF Exposure Limits 2.1 FCC Limits According to FCC KDB 447498 D01 v06 Appendix A, at frequency 2479 MHz and separation distance of ≤ 5 mm SAR Exemption limit is ≤ 9.53 mW. 2.2 Industry Canada Limits According to RSS-102 sec. 2.5.1, at frequency 2479 MHz and separation distance of ≤ 5 mm SAR Exemption limit is ≤ 3.94 mW. REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 6 of 8 3.0 Test Results (Portable Configuration) 3.1 Classification For purposes of this section, a portable device is defined as a transmitting device designed to be used so that the radiating structure(s) of the device is/are within 20 centimeters of the body of the user. 3.2 EIRP calculations The Real Immersive System, Model: Xavier 1/Xavier 2 consist of one 2.4GHz radio. 3.3 Maximum RF Power Real Immersive System, Model: Xavier 1/Xavier 2: Frequency Range (MHz) Peak RF Output Antenna Gain 1 Note 2402 – 2479 7.91dBm or 6.18mW 1.3dBi Conducted power measurements were taken from 104407842MPK-026 1 As declared by the manufacturer. REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 7 of 8 3.4 RF Exposure Calculation 3.4.1 RF Exposure calculation for 2.4GHz radio, Real Immersive System, Model: Xavier 1/Xavier 2: Duty Cycle calculation based on Operational Description provided by the manufacturer: There are 244 Frames transmitted per second: 1/244 = 4096 usec => Each TDMA frame (F) length is 4096 usec Each packet sent is composed of 71 bits + payload length. (71 bits: 8bit preamble + 40bit address + 7bit length + 16bit CRC) Payload length (PNO + IMU mode 2) = 34 bytes Total payload length: 34*8 + 71 = 343 bits Total payload sent at 2Mbps: 343 / 2000000 = 171.5 usec Duty cycle: 171.5 / 4096 = 4.19% 3.4.2 RF Exposure calculation FCC Calculations for th…

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Penumbra Inc. RF Exposure Exhibit SCOPE OF WORK EMC TESTING – Real Immersive System, Model: Xavier 1/Xavier 2, Part Number: 18284 (WSM, Wireless Sensor Module) REPORT NUMBER 104407842MPK-026A ISSUE DATE January 08, 2021 REVISED DATE March 19, 2021 PAGES 8 DOCUMENT CONTROL NUMBER Non-Specific Radio Report Shell Rev. December 2017 MPK © 2017 INTERTEK Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 2 of 8 RF Exposure Exhibit (portable devices) Report Number: 104407842MPK-026A Project Number: G104407842 Original Issue Date: January 08, 2021 Revision Issue Date: March 19, 2021 Product Designation: Model Tested: Part Number: Real Immersive System Xavier 1/Xavier 2 18284 (WSM, Wireless Sensor Module) FCC ID: 2AQU7-REAL02S IC: 24199-REAL02S to 47CFR 2.1093 RSS-102 Issue 5 for Penumbra Inc. Tested by: Client: Intertek 1365 Adams Court Menlo Park, CA 94025 USA Penumbra Inc. One Penumbra Place Alameda, CA 94502 USA Report prepared by: Report reviewed by: Anderson Soungpanya/ Project Engineer Krishna Vemuri / EMC Manager This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 3 of 8 Report No. 104407842MPK-026A Equipment Under Test: Real Immersive System Trade Name: Penumbra Inc. Model(s) Tested: Xavier 1/Xavier 2 Applicant: Penumbra Inc. Contact: Puneet Goyal Address: Penumbra Inc. One Penumbra Place Alameda, CA 94502 Country: USA Tel. Number: 510-440-5598 Email: [email protected] Applicable Regulation: 47CFR 2.1093 RSS-102 Issue 5 REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 4 of 8 TABLE OF CONTENTS Penumbra Inc. ................................................................................................................................................. 1 1.0 RF Exposure Summary ............................................................................................................................ 5 2.0 RF Exposure Limits .................................................................................................................................. 5 3.0 Test Results (Portable Configuration) ...................................................................................................... 6 4.0 Document History ................................................................................................................................... 8 REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 5 of 8 1.0 RF Exposure Summary Test Reference FCC Reference In dustry Canada Result Radio frequency Radiation Exposure Evaluation 47 CFR§2.1093 RSS-102 Issue 5 Complies 2.0 RF Exposure Limits 2.1 FCC Limits According to FCC KDB 447498 D01 v06 Appendix A, at frequency 2479 MHz and separation distance of ≤ 5 mm SAR Exemption limit is ≤ 9.53 mW. 2.2 Industry Canada Limits According to RSS-102 sec. 2.5.1, at frequency 2479 MHz and separation distance of ≤ 5 mm SAR Exemption limit is ≤ 3.94 mW. REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 6 of 8 3.0 Test Results (Portable Configuration) 3.1 Classification For purposes of this section, a portable device is defined as a transmitting device designed to be used so that the radiating structure(s) of the device is/are within 20 centimeters of the body of the user. 3.2 EIRP calculations The Real Immersive System, Model: Xavier 1/Xavier 2 consist of one 2.4GHz radio. 3.3 Maximum RF Power Real Immersive System, Model: Xavier 1/Xavier 2: Frequency Range (MHz) Peak RF Output Antenna Gain 1 Note 2402 – 2479 7.91dBm or 6.18mW 1.3dBi Conducted power measurements were taken from 104407842MPK-026 1 As declared by the manufacturer. REPORT NUMBER: 104407842MPK-026A Issued: January 08, 2021 Non-Specific Radio Report Shell Rev. December 2017 MPK EMC Report for Penumbra, Inc. on the Wireless Sensor Module (Part Number: 18284) Page 7 of 8 3.4 RF Exposure Calculation 3.4.1 RF Exposure calculation for 2.4GHz radio, Real Immersive System, Model: Xavier 1/Xavier 2: Duty Cycle calculation based on Operational Description provided by the manufacturer: There are 244 Frames transmitted per second: 1/244 = 4096 usec => Each TDMA frame (F) length is 4096 usec Each packet sent is composed of 71 bits + payload length. (71 bits: 8bit preamble + 40bit address + 7bit length + 16bit CRC) Payload length (PNO + IMU mode 2) = 34 bytes Total payload length: 34*8 + 71 = 343 bits Total payload sent at 2Mbps: 343 / 2000000 = 171.5 usec Duty cycle: 171.5 / 4096 = 4.19% 3.4.2 RF Exposure calculation FCC Calculations for th…

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Part Number: 18284 (WSM, Wireless Sensor Module)