REVIAN Red System Instructions For Use Manual

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Model: REVIAN 101 | Part Number: 10000-10001
Read all instructions before using the REVIAN Red System.
Instructions for Use

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Summary of Contents for REVIAN Red System

  • Page 1 Model: REVIAN 101 | Part Number: 10000-10001 Read all instructions before using the REVIAN Red System. Instructions for Use...
  • Page 2: Table Of Contents

    User ....Network for the REVIAN Red Mobile App Menu ....
  • Page 3: Product Overview

    PRODUCT OVERVIEW The REVIAN Red System is to be used in male and female patients with androgenetic alopecia in ages 18 and above. It is a non-invasive, hands-free, over-the-counter medical device operated via mobile app to promote hair growth. REVIAN Red is intended for a daily 10-minute treatment. A treatment can be paused after it is initiated, the remaining treatment time must be used prior to the initiation of another treatment.
  • Page 4: Device & Accessories

    2. Remove the sleeve holding the top and the bottom of the box together. Open the box. 3. The contents of your package will contain the following: • REVIAN Red Cap • Clear Charging Base • Accessory Kit Lift up the Clear Charging Base and remove the Accessory Kit.
  • Page 5: Warnings & Cautions

    • DO NOT use the Charging Cable or AC Adaptor if either are damaged. • DO NOT use the Cap or AC Adaptor if either has been exposed to water. Visit revian.com/support for additional information. • DO NOT place the Cap or Clear Charging Base in or near water. If exposed to water, unplug the device immediately from the power outlet.
  • Page 6 WARNINGS & CAUTIONS WARNINGS • Interference may occur with other electrical equipment near the REVIAN Red Cap due to the use of mobile Radio Frequency (RF) communications. • DO NOT attempt to remove internal components of the device. The Cap has NO user-serviceable parts and any attempt to remove internal components will void the warranty and may cause harm to the user.
  • Page 7 • Do not look directly into LED lights. • If the REVIAN Red Cap meets water, humidity, or excessive perspiration, allow to dry before use, charging or storage. • The battery is rechargeable but not intended as a user-replaceable part.
  • Page 8: Charging The Cap

    PORT COVER WARNING: DO NOT connect this equipment with any other equipment not provided in the Accessory Kit. Contact Customer Support or email support@revian.com for replacement charging components. WARNING: The Charging Cable may be a strangulation hazard. IMPORTANT: DO NOT operate (use or charge) the Cap near a heat source.
  • Page 9 NOT allow a treatment to be delivered. • To determine the battery level, disconnect the Charging Cable from the Cap and connect the Cap to the REVIAN Mobile App. The battery level will be displayed on the treatment screen.
  • Page 10: Adjusting The Cap Fit

    Cap. The front headliner is only to be replaced for sanitary purposes. For consistent fit and wear, it is suggested to replace headliners every three months. Replacement headliners can be ordered at REVIAN.com...
  • Page 11: Cap Audible Tones

    CAP AUDIBLE TONES The REVIAN Red Cap is programmed to deliver audible tones that represent a specific status. The table below shows the meaning of each specific tone. Tone Tone Meaning Occurs When . . . Bluetooth The Cap and the Mobile App have successfully connected.
  • Page 12: Registering Your Account

    Appendix VI. To continue, you must acknowledge that the REVIAN Red System is to be used only once per day per user. NOTE: The REVIAN Mobile App must be in use and the mobile device connected to the internet to start a treatment.
  • Page 13: Connecting To The Cap

    Cap once successfully connected. NOTE: When connecting to the Cap, If the REVIAN App does not locate a Cap, try the following: Bluetooth pairing can only occur within the • On your mobile device, confirm Bluetooth is turned on.
  • Page 14: Performing A Treatment

    PERFORMING A TREATMENT IMPORTANT: DO NOT operate (use or charge) the Cap near a heat source. To begin a treatment, place the Cap on your head and tap the CONNECT YOUR CAP button in the Mobile App. Once connected, a 10-minute timer will display. Tap the PLAY button in the round dial to start your treatment.
  • Page 15 A temperature sensor is embedded into the device to prevent the inside surface of Cap from exceeding 46 ˚C (108 ˚F). The REVIAN Mobile App will display a message and the device will go into a reduced power mode until the internal temperature is lowered to the appropriate range.
  • Page 16: User Calendar & Reminders

    USER CALENDAR & REMINDERS The REVIAN Mobile App allows you to track your treatment history and set reminder notifications for future treatments. To access, tap USER in the bottom footer of the Mobile App. Treatment Calendar • Completed treatments are circled in green on your calendar and missed treatments are circled in grey.
  • Page 17: Taking Progress Photos

    We take your privacy seriously and we will never share your photos unless we receive written permission from you. See the Revian Privacy Policy for more details. You can add photos from your phone’s library or utilize your phone’s camera to take new ones. Once the photo is added, you can tap on the photo thumbnail to view in slideshow mode.
  • Page 18: Light & Dark Mode

    LIGHT & DARK MODE The REVIAN Mobile App allows users to choose a visually comfortable interface depending on whether they are in a bright or low-light environment. Light Mode The Mobile App is defaulted to Light Mode, however, you may switch between Dark Mode Light &...
  • Page 19: Adding A 2 Nd User

    Tap SEND INVITE. The 2 user will receive an email with subject line “Revian: You’ve been added as a 2 user.” Check spam folder if email is not received within a few minutes. Follow steps in the email to complete registration process for the 2 user.
  • Page 20: Mobile App Menu

    Knowledge Base. There is also a link to the latest Instructions for Use document. • NOTIFICATIONS are messages from the Revian Team to keep you updated on the latest news and offers that are available. A red number icon may be present to let you know how many unread messages are present.
  • Page 21: Cap Firmware

    Do not leave the REVIAN Mobile App while firmware is updating, this should only take about two minutes. The progress of the update will be shown in the REVIAN Mobile App. Once the firmware has successfully updated, the Cap will turn off and reset.
  • Page 22: Cleaning & Travel

    • For easy travel and added support, store the Cap on the Clear Charging Base when in the Travel Bag. • Replacement Headliners are recommended to maintain proper fit and cleanliness. Headliners can be purchased on the Revian website: https://revian.com/product/revian-headliner-universal-kit/...
  • Page 23: Troubleshooting

    TROUBLESHOOTING This section summarizes the most common problems users could potentially encounter with the REVIAN RED System. If you are unable to solve the problem with the information provided below, please visit revian.com/support for more information. MOBILE APP MESSAGES: The REVIAN Mobile App will display ERROR MESSAGES: There are specific messages that...
  • Page 24 TROUBLESHOOTING PROBLEM POSSIBLE CAUSE POTENTIAL SOLUTION The Mobile App was left open or in • Swipe and force close out of the mobile app and relaunch it. an unknown state from the The mobile app is • previous time it was used. being nonresponsive to Update your mobile device with latest software.
  • Page 25 REVIAN Mobile app. Ensure your mobile device is updated to the latest version. The Cap is allowing multiple • Force close and re-launch the REVIAN Mobile App treatments within a 24-hour Software and/or firmware error. • Contact revian.com/support/...
  • Page 26 NOTE: If there is a connectivity issue or the REVIAN Mobile App is non-functional, force close and then restart the REVIAN Mobile App. If that does not fix the problem, delete and reinstall the Mobile App on your mobile device.
  • Page 27: Appendix I: Product Specifications

    Bluetooth Low Energy Module 1.67 mW/cm ISM Band 2.402 to 2.480 GHz operation 620-660 nm +/- 10 nm REVIAN Mobile App Compatibility per IEC 60601-2-57 (1 edition): 2011 Android Devices: Most Android based devices running operating systems 9.X+ and manufactured...
  • Page 28: Appendix Ii: Storage & Operating Conditions

    APPENDIX III: DISPOSAL REVIAN Red is powered by a Lithium Polymer battery. Lithium polymer batteries are classified by the US federal government as hazardous waste. Refer to local requirements on how to dispose or recycle devices containing lithium polymer batteries.
  • Page 29: Appendix Iv: Definitions & Symbols

    Mobile App installed on it and can connect and control the controller, to facilitate hair growth. Cap (NOT included). User: The authorized person who can log into the REVIAN Successful Treatment: Completing a 10-minute treatment Mobile App and perform a treatment.
  • Page 30 APPENDIX IV: DEFINITIONS & SYMBOLS NON-IONIZING – this symbol represents non- USB Trident Logo – this symbol represents the USB ionizing electromagnetic radiation Connection the Cap uses to recharge CAUTION – this symbol appears next to information INSTRUCTIONS MANUAL – this symbol references the about possible safety and product risks manual for charging instructions CATALOG NUMBER –...
  • Page 31: Appendix V: Operational Modes

    APPENDIX V: OPERATIONAL MODES CHARGING MODE: When the Cap is plugged in it is in TREATMENT MODE: When the Cap is activated, CHARGING mode. An LED indicator located inside the successfully paired with the Mobile App, and placed Cap near the Charging Port will illuminate blue. The in position for treatment, it is in TREATMENT mode.
  • Page 32: Appendix Vi: Mobile App Onboarding Screens

    APPENDIX VI: MOBILE APP ONBOARDING SCREENS The first time the REVIAN Mobile App is downloaded, the user will be navigated through five (5) educational onboarding screens. Those screens are referenced below. Onboard Screen 1 Onboard Screen 2 Onboard Screen 3...
  • Page 33: Appendix Vii: Frequently Asked Questions

    Consult your physician regarding use in these conditions. Is the REVIAN Red Cap Safe? Yes, it is safe to use. The LEDs utilized by the REVIAN Red Cap are specifically Can I share my Cap? If you would like to share the programmed to deliver a specific dose of light that is...
  • Page 34 Do I need to use Bluetooth to connect to the Cap? The REVIAN Red Cap must be connected via of the REVIAN Red Cap is the ability to automatically Bluetooth for a treatment to start. However, once a track your treatments and progress. The Cap must treatment has started, the Bluetooth connection can be connected via Bluetooth for a treatment to start.
  • Page 35 **If you cannot find the answer to your question, refer to resume the use of other BlueTooth devices. the Revian website at revian.com/support/ to search our Where can I find my login information? Send an Knowledge Base for additional answers and the latest email to support@revian.com along with your Order...
  • Page 36: Appendix Viii: Electromagnetic Emissions

    Guidance and Manufacturer’s Declaration – Electromagnetic Emissions The REVIAN RED 101 is intended for use in the electromagnetic environment specified below. The Customer or the user of the REVIAN RED 101 should assure that it is used in such an environment. Emissions Test Compliance Electromagnetic Environment—Guidance...
  • Page 37: Appendix Ix: Electromagnetic Immunity

    Table 2. Guidance and manufacturer’s declaration—electromagnetic immunity—for all ME EQUIPMENT and ME SYSYTEMS. Guidance and Manufacturer’s Declaration – Electromagnetic Immunity The REVIAN RED 101 is intended for use in the electromagnetic environment specified below. The Customer or the end user should assure that it is used in such an environment.
  • Page 38 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 the REVIAN RED 101 is used exceeds the applicable RF compliance level above, the REVIAN RED 101 should be observed to verify normal operation.
  • Page 39: Appendix X: Portable And Mobile Rf Communications

    Recommended separation distance between portable and mobile RF communications equipment and the REVIAN RED 101 The REVIAN RED 101 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the REVIAN RED 101 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the REVIAN RED 101 as recommended below, according to the maximum output power of the communications equipment.
  • Page 40: Appendix Xi: Characteristics Of The It-Network For The Revian Red System

    APPENDIX XI: CHARACTERISTICS OF THE IT-NETWORK FOR THE REVIAN RED SYSTEM The REVIAN RED System connects to a cloud service on the internet via user defined Wi-Fi or Cellular connections. There are no specific technical specifications or security requirements for this connection.
  • Page 41: Appendix Xii: Fcc Compliance

    This module is used to connect the Cap to a mobile device running the REVIAN Mobile App via Bluetooth. The REVIAN Red Cap 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 in a residential installation.
  • Page 42: Appendix Xiii: Product Labels

    APPENDIX XIII: PRODUCT LABELS REVIAN Red REVIAN Red See Instruction Device ID Label Device Symbol Label Manual Label REVIAN Red Package Label...
  • Page 43 Revian, Inc. © 2025 REVIAN, Inc 615 Davis Drive, Suite 800 All Rights Reserved. REVIAN and REVIAN Logo are Morrisville, NC 27560 all trademarks of Revian, Inc. Registered in the US. 1240-000002 r11 | Eff: 18-FEB-2025...

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