REVIAN RED 101 User manual

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Model: REVIAN 101
Part Number: 10000-10001
Instructions for Use
Product Overview ............................................................... 1
Product Contents ...............................................................2
Adjusting the Cap ……………………….………………………….……. 2
Connecting to the Cap ...................................................3
Cap Firmware……………………………………………………………………3
Performing a Treatment ................................................. 4
User Control ........................................................................ 4
Charging the Cap ..............................................................5
Menu Tour...............................................................................5
Cleaning and Travel..........................................................7
Troubleshooting ..................................................................7
Learn More ...........................................................................10
Appendices………………………………………………………………………14+
Product Overview
2.
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
.
Indications for Use:
REVIAN RED is indicated to treat
androgenetic alopec
ia and promote hair growth in males
who have Norwood
-Hamilton Classifications of IIa to V
patterns of hair loss; and
to treat androgenetic alopecia
and promote hair growth in females who have Ludwig
-
Savin Scale I
-1 to I-4, II-1, II-2, or frontal patterns of hair
loss, both with Fitzpatrick Skin Types I
- IV.
Contraindications for Use:
REVIAN RED has no known
contraindicat
ions.

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Product Contents
3.
4.
CAUTION: DO NOT cut through the protective
storage box to avoid any damage to the device.
1. Carefully cut the tape covering the shipping box to not
damage the storage box inside.
2. Remove the storage box from the shipping box.
•Cut the tape dots located on the sides of the
storage box.
3. Open the one seal on the storage box to reveal the
Cap
and support base.
4. Lift the support base to reveal the accessory kit.
5. Remove the accessory kit and carefully read the Quick
Start Guide on the box lid or in the app manual.
6. Remove the accessories contained inside the accessory
kit:
•USB-to-Magnetic Micro-USB cable
•Travel Bag
•AC Adaptor
•Adjustment Headliners
7. Charge the Cap for at least one hour prior to use with
the AC adaptor and magnetic micro-USB cable.
5.
Adjusting the Cap
The Cap comes with front standard and back 10mm headliners
installed as illustrated below. The Cap should not be loose
enough that it falls off the head with ease, nor should it fit too
tightly. A proper fitting Cap is an important step for a reliable
treatment.
NOTE
: Light emitting area (emission aperture) shown above. Applied Part.
To Adjust Headliners:
1. A sensor detects when the Cap is on the head and
close to your forehead. If the Cap needs adjustment,
remove the 10mm back headliner from the headliner
dots. If loose, replace with the optional 20 or 30mm
back headliner. If tight, replace with the optional
standard back headliner.
2. Fit test: press the Cap against your forehead. If a
pinky finger can still fit between the Cap and the
back of your head, then the Cap is too loose.
NOTE:
To ensure proper sensor connection, the thick headliners
should only be used in the back of the 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.

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Connecting to the Cap
The Cap must be connected via
Bluetooth ®to its controller,
the
REVIAN mobile app, for a treatment to begin.
1. Download the REVIAN
mobile app on a mobile
device from the App Store ®
or Google Play ®store.
2. For a first-time use, click
the
REGISTER
button and
follow the registration
process and email verification
to obtain your login
credentials or login through
the
Log In
link with your
established credentials.
3. Upon initial login, you will
be taken to a Connect Your
Cap screen. See below for
the next steps.
4. Set the Bluetooth setting
to “ON” in the mobile device.
Disconnect from any
previously connected
devices, like a smart watch,
prior to performing a treatment, if applicable.
Your device
may ask for permission to use your
Bluetooth. Respond with
Accept or OK so that the
Cap can communicate with the app.
5. A sensor detects when the Cap is properly placed on
your head. Place the Cap on your head to activate the
sensor or put your finger over the sensor located in the
forehead area of the cap. Press the CONNECT YOUR CAP
button once the cap is activated.
If the REVIAN app does not locate a Cap, try restarting the
app or charging the cap for a few seconds to reset it then
place it on your head and try again.
Cap Firmware
New firmware will be
released as new versions are available. If
the
device shows a “Cap Firmware Update” pop-up, allow the
mobile app to
initiate a Cap update. Do not leave the mobile
app while firmware is updating, this should only take about
two minutes.
Once the firmware has successfully updated, the Cap will
turn off and reset. Reconnect the Cap as described
previously.
NOTE: When connecting to the Cap, BT pairing can only occur
within the mobile app, NOT within the general settings menu on
a mobile device.
NOTE: If the device shows an “Failed” pop-up when updating
firmware, the firmware will resolve the problem and attempt to
download again immediately after or on your next login.

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User Control
The
REVIAN mobile app makes hair regrowth simple by
enabling personal control. This tour highlights the key
functions within the mobile app.
•The
User
button in the bottom tray is where you can keep
up with your treatment history, compliance and set
reminders. Completed treatments are circled on the
calendar and the compliance is automatically listed in the
red bar at the bottom. In the reminders tab you can set or
toggle a weekly reminder to pop up on your device.
Performing a Treatment
To begin a treatment, place the Cap on the head and press
the “Treatment” icon at the bottom of the screen. Press the
“Connect Your Cap” button and connect via Bluetooth (see
page 2
). A tone will be heard once the Cap has been properly
connected.
Press the center play button within the round
dial on the treatment page to start.
The treatment can be paused by pressing the pause icon
or removing the Cap.
For immediate shutdown, remove the Cap
from
the head.
To res
ume the treatment paused by removing the Cap, just
place the Cap again on your head and it will automatically
pick up where it left off.
Only a single 10-minute treatment can
be initiated daily. Time remaining will be displayed on the
mobile app screen. Another treatment cannot be initiated
on a
later day until the full 10
minutes of the prior
treatment (once started) has
been completed.
NOTE:
Once treatment is
complete, the Cap will emit an
auditory tone. Place Cap back
on support base for optimal
protection. The Cap will perform
at least two treatments before
needing to be recharged and
for optimal battery life should
be charged after the second
treatment and not daily.
Taking Progress Photos
S
eeing is believing! It is important to document progress while
using the Cap with before and after photos. To take advantage of
this benefit, choose the “Journal” icon at the bottom of the screen.
The first time you use this feature it will ask for permiss
ion to access
your photos. You can limit access to just select photos or all.
We
take your privacy seriously and will never share your photos unless
we get permission from you. See our privacy policy for more details.
You can add images or utilize your pho
ne’s camera to take new
ones. Once the photo is added you can also touch on the photo
thumbnail to enlarge it or delete it.

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For Best Results:
•Maintain consistency in
position, lighting, and angle
for all photos.
•Avoid fluorescent lighting
and using flash.
•Style hair in same condition
for each photo.
•Hold the camera at an
arm’s length away from the
top of head or get another
person to help.
Charging the Cap
Attach the micro-USB cable to the AC adaptor. The Cap
should be left on the support base. Plug the AC adaptor in
either orientation into an indoor outlet and then insert the
magnetic cable connector into the port located on top of
the Cap. The charging port in the Cap will illuminate when
successfully charging. Once fully charged, the light will softly
alternate on/off every 4 seconds. The magnetic cable also
has a small blue light that will stay illuminated as long as it
has power. To disconnect, unplug the AC adaptor from the
indoor outlet and the magnetic cable connector from the
Cap.
Charging Light Indications:
•When the Cap is charging
the charging port will
illuminate blue.
•When the battery is fully
charged the charging port
light will softly flash every 4
seconds.
•When the cap is charging, the app is not connected and will
not provide a battery level. To determine the battery level,
disconnect the charging cable from the cap and connect the
cap to the app ( see page 3) . The battery level will be
dispayed on the treatment page.
NOTE: While charging, the Cap will disconnect from the mobile app
and will NOT allow a treatment to be delivered.
The magnetic charging cable connects to a magnetic insert in the
port. Best practice for unplugging the cable from the port is tilting to
one side to break the magnetic hold. Sudden pulling from directly
above could remove the insert in the port. If accidently removed, re-
insert straight in and follow best practice above.
DO NOT CLEAN THE CAP WHILE CHARGING
.
When the battery is too low to perform a treatment, and needs to be
charged, a battery icon and indicator message will appear. While
connected, this can occur prior to or during a treatment. If during a
treatment go ahead and remove the cap and connect to the charging
system. Once charged, the treatment will resume when the Cap is
worn.
WARNING: DO NOT connect this equipment with any other
equipment not provided in the accessory kit.
WARNING:
The micro-USB cable may be a
strangulation hazard.

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Menu Tour
•
The
MENU
can always be accessed in the upper-
left corner of the screen.
This presents a set of
options to find content
and information for
interacting within the
application in various
ways.
•
The
SUPPORT
page
includes Troubleshooting
and FAQs linked to our
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.
•
SETTINGS
allow you to edit your user profile, Add a 2nd
User or Log out of the application.
•
Under
LEGAL
you will find information about our Terms
of Service, Warranty, Privacy Policy, Patents, or
disclosures about Open-Source features.
•
REVIAN Referral Program
is an offer to allow you to
share with friends and family and get rewards!
•
User ID and App Versions
details are also shared at
the bottom of this menu slider. Use these when looking
for the latest revision of the app or during support
tickets to help
troubleshoot any issues
you may be having with
the app.
SUPPORT >
•
In the
Troubleshooting
section you can find
answers to commonly
asked questions and
troubleshoot issues. If you
are unable to find the
answer to your question,
there is a link button to
create a support ticket
with the REVIAN team.
•
INSTRUCTIONS FOR USE are the latest downloadable
instructions for the use of the REVIAN Cap and control
application. This convenient, included set of mobile
instructions are available anytime or place you need
them.
SETTINGS >
•
Edit User Profile
– Edit your
personal settings including
your name, email, and
password.
•
Add a 2nd User
–
REVIAN
allows a second
user to connect to a Cap
with a one-time licensing
fee. Follow the link in the
app to find out more.
•
Log Out
– log completely
out of the application.
LEGAL >
•
Terms of Service –
Provisions and terms for use
of REVIAN services.
•
Warranty –
Limited
warranty listed (see page 11
of this document for full
text).
•
Privacy Policy –
discloses
the privacy practices for the
REVIAN website, user
dashboards, applications,
and admin portals.
•
Patents-
This page is to
satisfy the marking
requirements of 35 U.S.C §
287. All patents for this
product are listed here.
•
Open Source
– Definition
requirements for open-
source software.

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Cleaning and Travel
.
8.
WARNING: DO NOT wash or submerge Cap at any time.
DO NOT use cleaning agents or solvents to clean Cap as
this may discolor or degrade the fabric or damage internal
electronics.
9.
WARNING: Travel bag may be a suffocation hazard if
placed over nose and mouth. DO NOT place bag over the
head.
.
•Visually inspect interior of the Cap for film, debris, or
possible damage. A damaged cap should not be used.
Email [e-mail] for help.
•Clean the Cap monthly by wiping with a soft cloth
lightly moistened with water. Allow to air dry before
storage. DO NOT CLEAN THE CAP WHILE CHARGING.
•Store the Cap on the support base in either the storage
box or travel bag when not in use.
•As a reminder, it is recommended to charge the Cap
every 2-3 treatments to reduce charging cycles on the
battery.
•For easy travel and added support, store the Cap on
support base when in the travel bag.
•Replacement headliners are recommended to maintain
proper fit and cleanliness. Contact [e-mail]
if you would like to purchase additional headliners for
your Cap.
1
Troubleshooting Messages
The Cap will halt a treatment if the
internal temperature exceeds the
maximum allowable operating
temperature. Allow the Cap to cool
down before continuing a
treatment.
The mobile app must be in
use and the mobile device
connected to the internet to
continue
treatments.
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.
Messages and sound signals during use:
The
mobile app will display messages on occasion. These will appear as
direct messages or icons
in the mobile app.
App Messages
“Check Bluetooth”
This message appears when Bluetooth
needs to be turned on, connected, or is
scanning.
“Scanning for
Devices”
This message appears when Bluetooth is
scanning to find the Cap.
“Please put Your
Cap Back On”
This message appears when the Cap has
been removed or is not detected by the
biosensor during a treatment.
“Connect to the
Internet for
treatment”
This message appears when the users
phone or device is not connected to the
internet.
“New Firmware
Available”
This message appears when new firmware
is available and ready to install.
“Firmware Needs to
be Updated”
This message appears if the update was
deferred the first time and the mobile app
will now automatically update the firmware.
“Firmware Update
Successful”
This message appears if the update was
successfully transmitted to the Cap.
There are spec
ific messages that will appear as an alert if the
mobile app
is not performing properly.
Error Messages
“The Cap needs to
cool down”
This message appears, with a
temperature warning icon, when the
temperature exceeds the maximum
allowable operating temperature.
“Battery Low.
Treatment not
possible.”
This message appears, with a battery
icon, when the battery is too low to
perform a treatment and needs to be
charged. This can occur prior to or
during a treatment.
“Firmware Update
Failed”
This message appears when there is a
problem updating the firmware. The
firmware will automatically resolve the
problem and attempt to update again.
There are
five different audible tones that will be heard when certain
actions take place.
Cap Audible Tones
1.
Bluetooth Connected / Treatment Complete
2.
Treatment Started
3. Treatment Stop/Pause
4. Treatment Resume
5. Treatment Temperature Abort

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Troubleshooting continued
PROBLEM
POSSIBLE CAUSE
SOLUTION
The mobile app is being nonresponsive
to commands
The mobile app was left open or in an
unknown state from the previous time it
was used
iOS or A
ndroid device needs to be
updated
Swipe up and force close out of the mobile
app and relaunch it
Update your mobile device with latest
software.
Delete and reinstall the app
The Cap has successfully paired and
has been properly placed on the head,
but a treatment will not start
The Cap sensor doesn’t detect the Cap
as being positioned correctly on the head
(A “Place Cap on Head” pop-up message
is shown)
Reposition the Cap or place your finger over the
forehead sensor. If your finger activates the
cap, it is likely a fit issue.
Your forehead is
needed to be against this sensor to operate.
The Cap may not be fitting appropriately. Try
increasing the thickness of the back headliner
size only.
The mobile device is not connected to the
internet
Connect the mobile device to the internet while
the mobile app is in use
The Cap is not pairing with the mobile
device
Bluetooth is not enabled on your mobile
device Enable Bluetooth on mobile device
The mobile device has connected to
another Bluetooth device, and not the
Cap
Check mobile device settings and ensure
device isn’t already paired with another device
The mobile app is not scanning for the
Cap
Force the mobile app to scan for the Cap by
tapping “Connect your Cap” on the treatment
page .
Plug the Cap into the AC Charger for a few
seconds to reset it then try again.
The mobile app is showing a high
temperature pop-up message
The internal temperature of the Cap may
have reached a higher-than-normal
operating setting
The Cap may need to cool before continuing
treatment, remove the Cap for a brief period
and allow to cool
The mobile app is showing a low
battery pop-up message
The battery may not be in a fully charged
state
Place the Cap on the support base and charge
for at least 30 minutes or until the solid light
starts to softly
blink every 4 seconds (full
charge).
The mobile app is unable to start a
treatment
The iOS or Android mobile device’s
internal software was updated prior to
the REVIAN app updating
Make sure the cap is on your head, charged and
not plugged in.
Restart the REVIAN app or check for updates to
the REVIAN app in the app store.
The mobile app will not open The mobile device is an outdated version
and is not compatible with the mobile app
Try to delete and reinstall the app from the app
store on your device.
Your iOS device must have a software version of
10.X+ to work properly
Your Android device must have a software
version of 6.X+ to work properly.

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NOTE: If there is a connectivity issue or the mobile app is non-functional, force close and then restart the REVIAN app. If that
does not fix the problem, delete the app and reinstall from the app store on your mobile device. Contact customer support
if this does not resolve the issue at [e-mail] or on the website at revian.com/support/.
PROBLEM
POSSIBLE CAUSE
SOLUTION
The mobile app will not download
firmware or software updates
The cloud server is unavailable
The device software is incompatible with
the REVIAN app
Check mobile device for Wi-Fi connection
and/or verify Internet connection
Ensure your mobile device is updated to the
latest version
The Cap is allowing multiple treatments
within a 24-hour period Software and/or firmware error
Force close and re-launch the REVIAN app
Contact revian.com/support/

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Learn More
*Please read all instructions in manual before using REVIAN RED Cap.*
3.
This warning symbol appears next to information
about possible safety and product risks. Please be
sure to follow all warning and safety information.
4.
Table of Contents:
1. Storage and Operation
2. Operational Modes
3. Recommended Usage
4. Warnings and Cautions
5. Warranty
6. Glossary
7. FAQs
8. Customer Support
1.
STORAGE AND OPERATION
•
Storage Temperature:
5-35˚C (41-95˚F)
•
Relative Storage Humidity:
Up to 90%, non-condensing
•
Operating (Use / Charging) Temperature:
15-35˚C (59-95˚F)
•
Relative Operating Humidity:
Up to 90%, non-condensing
•
Atmospheric Pressure:
700 hPa to 1060 hPa
•
Cap Dimensions and Weight:
Height: 15.87 cm (6.25 in) x Width: 20 cm (7.87 in) x
Length: 22.86 cm (9 in), Weight: 155 g (0.34 lbs)
•
Head Circumference Size Range:
54 cm (21.26 in) – 64 cm (25.20 in)
•
AC Charger:
Input 100-240V, 50Hz/60 Hz
•
Battery:
Lithium Polymer – Lithium polymer batteries are classified by the
US federal government as non-hazardous waste. Refer to local
requirements for disposal or recycling instructions.
•
Optical Characteristics:
1.67 mW/cm2, 620-660 nm +/- 10 nm, per IEC 60601-2-57 (1st
edition): 2011.
•
Temperature Limiting Requirement:
A temperature sensor is embedded into the device to prevent the
inside surface of Cap from exceeding 46˚C (108˚F). The device will
go into a reduced power mode until the internal temperature is
lowered to the appropriate range.
•
Bluetooth Low Energy Module:
ISM Band 2.402 to 2.480 GHz operation.
• It is recommended to keep the support base and product box for
storage to protect against product damage.
•
REVIAN app compatibility:
Most Android based devices 6.X+ operating system and
manufactured within last three years
iOS device 10.X+ operating system
2.OPERATIONAL MODES
•
CHARGING MODE:
When the Cap is plugged in it is in
CHARGING mode. An LED indicator located inside the Cap
near the micro-USB charging port will illuminate blue. The
charging cable connector will illuminate blue always when
connected to AC power. The battery should be charged
from a depleted state to a full charge within 4 hours. The
battery will have enough charge to run multiple treatments.
NOTE
: While charging, the Cap will NOT allow a treatment
to be delivered. For best results when charging, place
the Cap on the support base and then insert the cable
end into the top port. When the Cap is fully charged, the
charging port light will blink every 4 seconds. Leave the
Cap on the support base and then remove the charging
cable. Class II medical equipment.
•
SLEEP/STANDBY MODE:
When the Cap is removed from
AC Power but not activated, it will be in its lowest power
consumption state and is in a SLEEP/STANDBY mode. The
battery indicator, treatment LEDs, and Bluetooth module
will not be active. To bring the Cap out of SLEEP/STANDBY
mode it should be placed on the head or hold the copper-
colored forehead sensor.
•
ACTIVE MODE:
When the Cap is placed on the head it is in
ACTIVE mode. This mode will turn on the Bluetooth module,
allowing for pairing with the mobile app. The Cap will stay
in this ACTIVE mode for 60 seconds after placement while
attempting to pair with the mobile app. Failure to pair or if
removed from the head will cause the Cap to go into
SLEEP/STANDBY mode to save battery.
•
TREATMENT MODE:
When the Cap
is activated,
successfully paired with the mobile app, and placed in
position for treatment, it is in TREATMENT mode. Treatment
begins once the play icon is pressed on the treatment
screen of the mobile app. An audible tone will be heard,
and the treatment countdown clock begins. Upon
completion of the 10-minute treatment an audible tone will
be heard, then the Cap will switch back to SLEEP/STANDBY
mode. Only a single treatment can be initiated within a
given calendar day.
•
PAUSE MODE:
When the Cap is removed or when the
pause icon is pressed on the mobile app during a
treatment session, the Cap is in PAUSE mode. LEDs will turn
off until the cap is placed back on the head. Treatment
time remaining is stored in the Cap until completion of the
paused treatment.

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Learn More
3.
RECOMMENDED USAGE
•Use the Cap daily, for 10 minutes at any convenient time.
•Use indoors or in a cool, dry area. This product is not
intended for exposed use outdoors.
•Use only on dry or towel dried hair.
•If REVIAN RED treatments are stopped for several weeks or
more, natural hair loss may resume.
•Commit to disciplined daily use and be patient, as it may
take a full hair cycle of 16-26 weeks to achieve initial results.
•Patient is the intended operator of this device.
•REVIAN RED is not a defibrillation proof device.
4.
WARNINGS AND CAUTIONS
5.
WARNINGS
•DO NOT use the USB-to-micro-USB 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 support base in or
near water. If exposed to water unplug the
device immediately from the power outlet.
•DO NOT reach into water to retrieve the
device while plugged into an outlet.
•DO NOT use the Cap while in the bathtub or
the shower.
•DO NOT use the Cap if you are taking
photosensitizing medications, shampoos,
lotions, or other therapies that sensitize the
skin to light. Consult your physician
regarding use in these conditions.
•DO NOT use with wet hair.
•DO NOT insert foreign objects into micro-
USB receptacle on top of the Cap (Water
resistant to IP22 standards).
•DO NOT use any cables, adaptors, or
products that are not provided or approved
for the device as this may result in non-
compliance.
•DO NOT use any cables, adaptors, or
products that are not provided or approved
for the device, as they may negatively
interfere with the EMC performance.
•Interference may occur with other electrical
equipment near the REVIAN RED Cap due to
the use of mobile Radio Frequency (RF)
communications.
•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.
16.
7.
8.
CAUTIONS
•If the REVIAN RED Cap meets water,
humidity, or excessive perspiration, allow to
dry before use, charging or storage.
•Use of cleaning agents or solvents are not
recommended and may damage the REVIAN
RED Cap.
•The battery is rechargeable but not
intended as a user-replaceable part.
•Use the Cap only as intended and described
in the application instructions. Any attempt
to bypass the approved mobile app or
hardware will void the warranty.
•If pregnant or nursing, consult your primary
care physician regarding use of the Cap in
these conditions.
•Keep the Cap out of reach of children and
pets.
•The Cap is to be operated at a temperature
of at least 15˚C (59˚F).
•Use of the Cap is intended for a single
registered user.
•Keep the micro-USB port cover located on
top of the Cap closed when not charging.
•BATTERY: Risk of Fire and Burns. Do Not
Open, Crush, Heat Above 100˚C or
Incinerate. Follow Manufacturer's
Instructions.
•Do not look directly into LED lights.
5. LIMITED WARRANTY
The Company warrants that this Device will be free from manufacturing
defects in material and workmanship for a period of twelve (12) months from
the date of delivery. The Company does not warrant that the operation of
the Device will be error-free or uninterrupted. The user is responsible for the
proper maintenance and handling of the Device. No warranty is extended
to any Device that has been altered, physically damaged, or modified in
any way. The limited warranty does not cover problems caused by user acts
(or failures to act), the acts of others or event(s) beyond the reasonable
control of the Company.
If Device fails to meet the warranty set forth above, then the Company will,
at its option, either (i) repair the defective Device, (ii) provide a free
replacement Device or (iii) replacement parts. Any replacement Device or
part will be comparable in function but may not be identical to the original.
The replacement or repaired Device is warranted for the remainder of the
original warranty period.
If the Device or any component thereof is defective or otherwise does not
function properly within the Limited Warranty period (as defined above),
contact the Company at www.revian.com/support/ to submit a Warranty
claim. All returns must be authorized by the Company prior to receipt. Once
a return is authorized, the Company will issue a Return Merchandise
Authorization (RMA) number and provide instructions on how to return the
Device.

1200-000002 r04 12 UPDATED 10/25/2022
IP22
Learn More
19.
6.
GLOSSARY
Cap:
The external, Bluetooth device that the user will wear on their
head, connected to the REVIAN mobile app controller, to facilitate
hair growth.
Mobile Device:
The personal device that has the REVIAN mobile app
installed on it and can connect and control the Cap (NOT included
unless specified).
Successful Treatment:
Completing a 10-minute treatment session
for
day initiated.
Unsuccessful Treatment:
Not initiating a new treatment on a specific
one calendar day before 12:00 a.m. of the following day.
User:
The authorized person who can log into the mobile app and
perform a treatment.
MLTTM:Modulated Light Therapy enhances natural healing mechanisms by
targeting specific biochemical processes with precise intensity, dose and
wavelengths of light.
REVIAN MOBILE APP – this symbol represents the mobile app
controller
BLUETOOTH – this symbol appears when Bluetooth is connected
or scanning or waiting for connection.
CHARGE BATTERY – this symbol may appear prior to treatment or
during treatment
MENU – this symbol reveals the mobile app menu when clicked
TEMPERATURE WARNING – this symbol appears when the Cap
needs to cool down
CAPS BATTERY LEVEL – this symbol appears during an active
connection of the cap with the app there is a % battery level
listed at the bottom of the treatment screen.
POSITION CAP ON HEAD – this symbol appears when the Cap
has been removed or is not placed properly on the head
USB 2.0 – this symbol represents USB 2.0 to micro-USB cable the
Cap uses to recharge
CATALOG NUMBER – this symbol represents any number used to
identify an item in a catalog
LOT CODE – this symbol is accompanied by a batch code
MANUFACTURER – this symbol is accompanied by the name and
address of the product manufacturer
SEE INSTRUCTIONS FOR USE – this symbol refers to the
Instructions for Use for further definition
MANUFACTURED DATE – this symbol is accompanied by a date
TEMPERATURE LIMITATION – this symbol indicates the upper or
lower limit of temperature
PACKAGE DAMAGE – this symbol appears as a warning to not use
the device if the package is damaged
KEEP DRY – this symbol appears if a device is required to be kept
dry
LED – this symbol represents the use of LEDs
NON-IONIZING – this symbol represents non-ionizing
electromagnetic radiation
INTERNET CONNECTION – this symbol appears when the mobile
app has not connected to the internet in seven days to allow data
transfer
7.
FREQUENTLY ASKED QUESTIONS
•
What is the REVIAN RED Cap?
A wearable medical device that
is worn on the head to reverse hair loss. The approximate size of
the Cap is: Height: 15.87 cm (6.25 in) x Width: 20 cm (7.87 in) x
Length: 22.86 cm (9 in), Weight: 155 g (0.34lbs)
•
How is the REVIAN RED Cap shipped?
After order completion,
the Cap will be shipped via the method you selected when you
placed your order. If free shipping was selected the REVIAN RED
cap will be shipped to the address, you provided via FedEx
Ground/Home Delivery or United States Postal Service (USPS)
Priority Mail.
•
How is the REVIAN RED Cap controlled?
The Cap is controlled
by the user and links to an application on a portable device
(iPhone, iPad, Android device) via Bluetooth communications.
•
How does it work?
The Cap uses Modulated Light Therapy
(MLT)TM that stimulates hair follicles to promote growth and
restoration. To learn more about MLT, visit and refer to the
technology section at revian.com.
•
Is the REVIAN RED Cap Safe?
Yes, it is safe to use. The LEDs
utilized by the REVIAN RED Cap are specifically programmed to
deliver a specific dose of light that is strong enough to be
effective while still safe. While some light sources (like lasers) can
cause damage to the eyes, the LEDs used in the REVIAN RED
Cap do not harm the eyes or retina.
•
Are there any potential side effects?
No side-effects have
been observed.
•
Can I use the REVIAN RED Cap while taking photosensitizing
medications, shampoos, lotions, or other therapies?
No, you
should not use REVIAN RED while taking these therapies. Consult
your physician regarding use of these products with REVIAN
RED.
•
Can I use the REVIAN RED Cap while pregnant and/or
nursing
? Consult your physician regarding use in these
conditions.
•
Can I share my Cap?
The Cap treatment is to only be used by
a single user on one account for 10 minutes a day. If you would
like to share the cap with your spouse or partner click the “Add
a 2nd User” link under the Settings tab in the Menu.
•
What is the progress wheel and why has it appeared?
The
progress wheel will appear when there is an indication of a
loss or slow server connection while trying to upload data.
IP 22 – this symbol represents water spray protection of the
Cap
QUANTITY – this symbol represents the number of devices
HUMIDITY LIMITATION – this symbol indicates the upper or
lower limit of humidity
ATMOSPHERIC PRESSURE LIMITATION – this symbol indicates
the environmental limitation for the device
TYPE BF APPLIED PART – this symbol indicates this is a “Body
Floating” applied part in concern with electrical contact
CAUTION – this symbol appears next to information about
possible safety and product risks
### NUMBER – this symbol represents a current version number
INSTRUCTIONS MANUAL – this symbol references the manual
for charging instructions
USE BY – this symbol is accompanied by the useful product
life service date

1200-000002 r04 13 UPDATED 10/25/2022
FAQ - Continued
•
How can I track my treatments?
A unique feature of the REVIAN RED
Cap is the ability to automatically track your treatments and progress.
The Cap must be connected via Bluetooth for a treatment to start. A
treatment does not need Bluetooth connection to continue after the
treatment has started. At the end of a treatment the Cap will
download the treatment data to the mobile device. However, if
Bluetooth connection was severed or lost during a treatment the data
will be sent the next time the Cap connects to the mobile app.
•
How will I know to charge my Cap?
An interrupt message will appear
on the mobile app, “REVIAN RED Cap battery needs charge” if
conditions are not met during each initial pairing with the mobile app.
The battery should be charged from a depleted state to a full charge
within 4 hours. The battery will have enough charge to run at least two
treatments. There are also visual indicators that show the state of the
Cap’s charge when connected to the app. When the Cap is charging
the port will appear illuminated blue and once the charge is complete
the light will lightly flash every 4 seconds.
•
Do I need to use Bluetooth to connect to the Cap?
The REVIAN RED
Cap must be connected via Bluetooth for a treatment to start.
However, once a treatment has started, the Bluetooth connection can
be severed, and the Cap will continue until the 10-minute treatment is
completed.
•
Do I need to connect to Wi-Fi or Cellular to start a treatment?
Yes,
an authorization for a treatment can only be started while connected.
•
When will I see results?
The Cap is recommended to be used once a
day for 10 minutes. Every individual is different, but visible hair growth
should be observed during the initial six months of treatment
(introductory treatment phase). REVIAN RED can be used indefinitely.
However, once treatments are stopped then hair loss may resume.
•
How do I clean my Cap?
You can clean the Cap by simply wiping it
down with a lightly moistened cloth. Visit the MANUAL section of the
mobile app for more information.
•
How do I purchase additional items?
Visit the REVIAN website for
additional items or email us at [email protected]om.
•
How should I style my hair when performing a treatment?
For best
coverage of the scalp when using the Cap, part your hair to maximize
exposure to MLT to reach thinning areas.
•
Why should I attach headliners?
The recommended headliners not
only ensure proper fit of the Cap, but they also provide additional
comfort and help maintain cleanliness.
•
Is this a “use it or lose it” treatment plan?
Yes. We recommend that
you initiate and complete a treatment every day. If you do not initiate
a treatment on any given day, then it will be lost for that day.
•
Do I need to disconnect from other BT connected devices?
Yes. IF
you experience connection issues, disconnect from any previously
connected devices like a smart watch prior to performing a treatment.
Once a treatment has been initiated you may resume the use of other
BT devices.
•
Can I switch to other apps during my treatment?
Yes, once a
treatment has been initiated you can use your device as you normally
would.
•
Where can I find my login information?
Emails sent to you by REVIAN
will contain the login email address you provided. If you forgot your
password, go to the “forgot password” area on the mobile app or
members.revian.com to reset.
•
What is the useful service life of the Cap?
The Cap and
accessories* are warrantied for 12 months. They have been life
tested to be safe and useful for at least two years under daily
use. If the Cap is well maintained and undamaged, it may last up
to 3-4 years based on estimated battery life. *
Headliners are
suggested to be replaced every three months for consistent fit
and sanitary reasons
•
How do I dispose of my Cap properly after it’s useful service
life?
This Cap contains a lithium polymer battery that is classified
by the U.S. government as non-hazardous waste. Refer to your
local requirements for disposal and recycling.
•
Is REVIAN RED suited for everyone?
REVIAN RED is FDA-cleared
for males who have Norwood-Hamilton classifications of IIa to V
patterns of hair loss and in females who have Ludwig-Savin scale
classifications of I-1 to I-4, II-1, II-2, or frontal patterns of hair loss,
both with Fitzpatrick Skin Types I-IV. Compare yourself to the
chart below:
**If you cannot find the answer to your question, refer to the
REVIAN
website at
revian.com/support/ to search our Knowledge Base for
additional answers and the latest information about our product.
8. CUSTOMER SUPPORT
If the REVIAN RED System is not functioning as outlined in these
instructions for use, please refer to Revian.com/support/ for
additional troubleshooting details.
© 2022 Revian, Inc. All Rights Reserved.
REVIAN and REVIAN Logo are all trademarks of Revian, Inc.
Registered in the U.S.
Revian ®, Inc. Durham, NC
4222 Emperor Blvd. Suite 470
For further assistance, please contact us at:
Email: [e-mail]

1200-000002 r04 14 UPDATED 10/25/2022
Table 1. Guidance and manufacturer’s declaration – electromagnetic emissions – for all ME EQUIPMENT
and ME SYSTEMS (see 5.2.2.1 c).
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
RF emissions
CISPR 11
Group 1
REVIAN RED 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.
RF emissions
CISPR 11
Class B
REVIAN RED is suitable for use in all establishments other than
domestic and those directly connected to the public low-
voltage power supply network that supplies buildings used for
domestic purposes.
Harmonic emissions
IEC 61000-3-2
Not applicable
Voltage fluctuations /
flicker emissions
IEC 61000-3-3
Not applicable
APPENDIX A – ELECTROMAGNETIC EMISSIONS

1200-000002 r04 15 UPDATED 10/25/2022
APPENDIX B – ELECTROMAGNETIC IMMUNITY
Table 2. Guidance and manufacturer’s declaration -electromagnetic immunity - for all ME EQUIPMENT
and ME SYSTEMS (see 5.2.2.1 f).
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.
Immunity Test
IEC 60601
Test Level
Compliance Level
Electromagnetic Environment -
Guidance
Electromagnetic
discharge (ESD)
IEC 61000-4-2
+8 kV contact
+15 kV air PASS
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
+2 kV for power supply
lines
+1 kV for input/output
lines
PASS
Mains power quality should be that of a
typical commercial, hospital or home
healthcare environment.
Surge
IEC 61000-4-5
+1 kV line(s) to line(s)
+2 kV line(s) to earth
PASS
Mains power quality should be that of a
typical, hospital or home healthcare
environment.
Voltage dips, short
interruptions, and
voltage variations on
power supply input lines
IEC 61000-4-11
<5 % UT
(>95 % dip in UT)
for 0.5 cycle
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 sec
PASS
Mains power quality should be that of a
typical commercial or hospital or home
healthcare environment. If the user of
REVIAN RED requires continued
operation during power mains
interruptions, it is recommended that
REVIAN RED be powered from an
uninterruptible power supply or a
battery.
Power frequency (50/60
Hz) magnetic field
IEC 61000-4-8
30 A/m
PASS
Power frequency magnetic fields should
be at levels characteristic of a typical
location in a typical commercial or
hospital or home healthcare
environment.
NOTE:UTis the a.c. mains voltage prior to application of the test level.

1200-000002 r04 16 UPDATED 10/25/2022
APPENDIX C – Electromagnetic Immunity
Table 3. Guidance and manufacturer’s declaration – electromagnetic immunity For ME EQUIPMENT
and ME SYSTEMS that are not LIFE-SUPPORTING (see 5.2.2.2).
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 user
should assure that it is used in such an environment.
Immunity Test
IEC 60601
Test Level
Compliance
Level
Electromagnetic Environment - Guidance
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2700 MHz
3 V
10 V/m
Portable and mobile RF communications equipment
should be used no closer to any part of the REVIAN RED
101, including cables, than the recommended
separation distance calculated from the equation
applicable to the frequency of the transmitter.
Recommended separation distance
d = [3.5/ V1 ] √ P
d
= [3.5/ E1 ] √ P 80 MHz to 800 MHz
d = [7/ E1 ] √ P 800 MHz to 2.5 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 surveyashould
be less than the compliance level in each frequency
rangeb
Interference may occur in the vicinity of equipment
marked with the following symbol:
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 strength 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 the REVIAN RED 101 is used exceeds the applicable RF compliance level above, the REVIAN
RED 101 should be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the REVIAN RED 101.
b
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

1200-000002 r04 17 UPDATED 10/25/2022
APPENDIX D – PORTABLE AND MOBILE RF COMMUNICATIONS
Table 4. Recommended separation distances between portable and mobile RF communications equipment
and the ME Equipment or ME System – for ME Equipment and ME Systems that are not Life-Supporting.
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.
Rated maximum output
power
of transmitter
W
Separation distance according to frequency of transmitter
m
150 kHz to 80 MHz
P
v
d





=
1
5.3
80 MHz to 800 MHz
P
E
d





=
1
5.3
800 MHz to 2.5 GHz
P
E
d





=
1
7
0.01
0.12
0.12
0.23
0.1
0.379
0.379
0.727
1
1.2
1.2
2.3
10
3.79
3.79
7.27
100
12
12
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 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.

1200-000002 r04 18 UPDATED 10/25/2022
Wi-Fi/Cellular
CLOUD
SERVICES
REVIAN Cap
Bluetooth (BT) Connection
APPENDIX E – 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.
Information flows between the REVIAN mobile
application running on an iOS or Android operating
system and REVIAN cloud services as well as
between the REVIAN app and the REVIAN RED Cap
(Figure E1). Communications of treatment is
transmitted once Cap is activated. No known
hazards exist from the REVIAN RED device
connecting to an IT network. Connection to IT
networks including other equipment could result in
previously unidentified risks to patients, operators,
or third parties. REVIAN will continually monitor any
associated risks with using the REVIAN RED System,
including any new risks, associated with changes to
IT network.

1200-000002 r04 19 UPDATED 10/25/2022
APPENDIX F – FCC COMPLIANCE
The REVIAN RED Cap contains transmitter Module RN4020 FCC ID: T9JRN4020
This module is used to connect via Bluetooth the Cap to a mobile device running the REVIAN mobile app
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. The
REVIAN RED device generates, uses and can radiate radio frequency energy, and if not used in accordance with the instructions,
may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a
particular installation. If the Cap does cause harmful interference to radio or television reception, which can be determined by
turning the Cap off and on by removing it from head, disconnecting from the mobile device running the REVIAN mobile app, and
charging the Cap; the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the Cap and/or mobile device running the REVIAN mobile app.
• Increase the separation between the Cap and mobile device running the REVIAN mobile app.
• Visit REVIAN.com for additional assistance.