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.
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.
• 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.
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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.
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• 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.
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.
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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.
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...
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.
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.
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.
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.
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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.
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.
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.
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 &...
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.
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.
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.
• 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/...
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...
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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.
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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/...
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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.
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...
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.
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.
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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 –...
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.
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...
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...
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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.
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**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...
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...
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.
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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.
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.
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.
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.
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