Omnilux CLEAR User manual

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User Guide

CIFU-EN-0622 Page 1 of 15
Users of this device can obtain benefit from using it only if they read
and comprehend all information in the User Guide.
You must follow all of the instructions in the User Guide.
Please feel free to contact us if you have any comments about the Omnilux
CLEAR™ device or this User Guide.
GlobalMed Technologies Co.
163 Camino Dorado Suite B
Napa, CA 94558
Tel: [phone]
www.omniluxled.com
The information in this document is proprietary to iSMART Development
Ltd, and supplied on the understanding that it shall be kept confidential to
recipients and that it shall not be reproduced and/or used for commercial
purposes without the written consent of iSMART Developments Ltd

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1. Introduction
Thank you for choosing Omnilux CLEAR™.
The Omnilux CLEAR LED device emits light in the red and blue region of
the light spectrum and is indicated for the treatment of mild to moderate
acne vulgaris on the face.
(See “Who should use Omnilux CLEAR” section 2 - page 4, for more
information about how to tell if you have mild to moderate acne and if
Omnilux CLEAR is right for you).
Users of this device can obtain benefit from using it only if they read and
comprehend all information in the User Guide.
You must follow all the instructions in the User Guide.
Please feel free to contact us if you have any comments about Omnilux
CLEAR or this User Guide.
Before using the Omnilux CLEAR device, you must carry out a sensitization
test and wait 6 hours. (see section 6.3 - page 9).
Contents
Page Number
Section Header
1. Introduction
2. Who should use Omnilux CLEAR™?
3. Device description
3.1 Intended use
4. When should Omnilux CLEAR NOT be used? 4.1
Contraindications, warning, and precautions
5. Risks and benefits
5.1 Potential risks
5.2 Potential benefits
6. First time setup
6.1 Unpacking and charging your Omnilux CLEAR
6.2 Connecting Omnilux CLEAR to the controller
6.3 Sensitization test
7. Using the Omnilux CLEAR device
7.1 Treatment recommendations
7.2 Wearing the Omnilux CLEAR device
7.3 Carrying out a treatment
8. Care and maintenance
8.1 Cleaning the Omnilux CLEAR device
8.2 Disposal
8.3 Troubleshooting
9. Labeling
10. Recycling
11. Technical specifications
12. Explanation of symbols
13. Warranty
3
4
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3. Device description
1. Flexible silicone CLEAR device with integrated eye-wear
2. Controller (containing a lithium battery) & power supply
3. Country specific adapters
4. 2x adjustable straps
5. Carry bag
No pimples or spots or
yellow pus-filled spots.
No whiteheads or
blackheads
Clear Skin NO
Omnilux CLEAR is NOT
indicated for clear skin.
Omnilux CLEAR should
NOT be used to prevent
pimples or spots forming.
2. Who should use Omnilux CLEAR?
The typical appearance of acne is a mixture of the following: greasy
skin, red pimples or spots, yellow pus-filled spots and scars. Use
this chart to determine whether Omnilux CLEAR is suitable for you.
Acne Type Description Suitable for
Omnilux CLEAR
A few pimples or spots, a
few pus-filled spots,
some whiteheads or
blackheads
Mild Acne YES
Mild acne is suitable for
treatment with Omnilux
CLEAR
Some pimples or spots,
some pus-filled spots, only
a few small nodules. Some
whiteheads or blackheads
Moderate
Acne
YES
Moderate acne is suitable
for treatment with
Omnilux CLEAR
Many pimples or spots,
many pus-filled spots.
many nodules
Severe
Acne
NO
Omnilux CLEAR is NOT
indicated for severe acne.
Please consult your
doctor for a more
appropriate treatment.
Many whiteheads or
blackheads. No pimples
or spots. No pus-filled
spots
Whiteheads
or
Blackheads
or
Comedonal
Acne
NO
Omnilux CLEAR is NOT
indicated for whiteheads or
blackheads. Please consult
your doctor for a more
appropriate treatment.
To find out if Omnilux CLEAR is right for you and to
find a full list of who can and who can’t use the
Omnilux CLEAR, scan the QR code.
Omnilux CLEAR is a home-use wearable LED light therapy device. It produces
a cool, narrow band of light which reduces mild to moderate acne vulgaris on
the face. It consists of a flexible silicone device that contains light emitting
diodes (LEDs) and a controller. The LEDs generate the light. The device is
worn on the face and is held in place by adjustable Velcro straps. The
controller turns the LEDs ON/OFF and controls power to the mask. The
controller contains a rechargeable lithium-ion polymer battery and uses a
visible display comprising of 3 micro LEDs to show the user the battery charge
status of the device. The power supply is used to charge the lithium battery
and is connected to a suitable mains outlet via a 2 or 3 pin input socket and
wall plug. The power cable is connected to the controller by a standard micro
USB A-C connector.
Omnilux CLEAR cannot be operated while charging.
The device is not used to make measurements of any sort, or to draw any
conclusions regarding the indication to treat. The device does not require
checks on the light output as the LEDs do not dim with age to any practical
extent.
3.1. Intended use
Omnilux CLEAR is an over-the-counter LED device that emits energy in the
red and blue region of the light spectrum, and is specifically indicated to
treat mild to moderate acne vulgaris on the face through a non-thermal
mechanism called endogenous Photodynamic Therapy.

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Photosensitivity is a common side effect of various medications. These
can include certain antibiotics, chemotherapy drugs, and diuretics.
If you are unsure about any medication you may be taking consult
your healthcare provider.
Other substances not listed above can also cause photosensitivity.
Warnings
4. When should Omnilux CLEAR NOT be used?
4.1 Contraindications, warnings and precautions
Contraindications
DO NOT share Omnilux CLEAR with any other person. The Omnilux CLEAR
device is for single person use only.
DO NOT use Omnilux CLEAR to treat any other conditions apart from those
listed in the indications for use (mild to moderate acne vulgaris). The
Omnilux CLEAR device has not been tested for any other conditions than
those listed, and the risk is unknown.
Do NOT use Omnilux CLEAR if you are pregnant, planning on becoming
pregnant, or breastfeeding. The Omnilux CLEAR device has NOT been
tested on pregnant or breastfeeding women and therefore the risk to the
fetus, neonate, or pregnant woman is unknown.
DO NOT use Omnilux CLEAR if you are a child under 14 years of age. The
safety of the device for children younger than 14 years of age has NOT
been tested and the risk is unknown.
DO NOT use Omnilux CLEAR if you suffer from light-induced
headaches.
DO NOT use Omnilux CLEAR if you suffer from any genetic conditions of the
eyes. The Omnilux CLEAR device has NOT been tested on subjects who
suffer with genetic conditions of the eyes and therefore the risks are
unknown. If you are unsure about any related eye condition and using
Omnilux CLEAR, contact your ophthalmologist or doctor.
DO NOT use Omnilux CLEAR if you suffer from any photosensitive
disorder (sensitization to light) of the eye. The Omnilux CLEAR device has
NOT been tested on subjects who suffer with photosensitive disorders of the
eye and therefore the risks are unknown. If you are unsure about any
related eye condition, contact your ophthalmologist or doctor.
DO NOT use Omnilux CLEAR if you suffer from Lupus erythematosus,
photosensitive eczema, or albinism. If you use the Omnilux CLEAR device to
treat lupus erythematosus, photosensitive eczema, or albinism you may cause
a severe skin reaction.
DO NOT use Omnilux CLEAR if you suffer from any photosensitive
disorder (sensitization to light) of the skin. If you use the Omnilux CLEAR
device and you suffer from a photosensitive disorder, you may cause a
severe reaction.
DO NOT use Omnilux CLEAR if you are taking any medication that can
cause photosensitivity. If you use the Omnilux CLEAR device and you are
taking any medication that can cause photosensitivity, you may cause a
severe skin reaction.
For a full list of drugs that can cause photosensitivity, please visit:
www.omniluxled.com
Common examples of these substances are:
St John's Wort, coal tar, deodorants, antibacterial soaps, artificial
sweeteners, naphthalene (mothballs), petroleum products, brightening
agents found in laundry detergent, and cadmium sulphide (a chemical
injected into the skin during tattooing).
Before using Omnilux CLEAR, you must carry out a sensitization test
(see section 6.3 - page 9).
DO NOT use Omnilux CLEAR in any way that is not exactly as
specified in these instructions for use. Use of Omnilux CLEAR other
than exactly as specified in these instructions for use has not been tested
and the risk is unknown.
TURN OFF and REMOVE Omnilux CLEAR immediately if it feels hot or
your skin feels uncomfortably warm.
STOP using Omnilux CLEAR if you experience headaches, changes in
vision or pain in your eyes.
DO NOT use Omnilux CLEAR without first removing creams, serums,
lotions, and make-up BEFORE treatment.
Some ingredients in these products may cause light sensitization or
may reduce the effect of the treatment.
DO NOT use Omnilux CLEAR near water or anywhere water can spill
onto the equipment.
DO NOT use Omnilux CLEAR if you think it may have come into contact
with water.
Keep Omnilux CLEAR away from HOT surfaces.
DO NOT attempt to modify Omnilux CLEAR in any way. Modifying the
Omnilux CLEAR device will void your warranty. Modifying the Omnilux
CLEAR device could cause an electric shock when the device is used
again. The device contains no serviceable parts.
DO NOT use Omnilux CLEAR if the device, battery, or charging plug
are damaged in any way.

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General safety
The Omnilux CLEAR device is an electrical device, which under certain
circumstances could present an electrical shock hazard to the user. Please
read the accompanying User Guide thoroughly and follow directions
stated in the manual to assure maximum safety during operation.
Precautions
The Omnilux CLEAR straps contains a mixture of polyester, nylon and
lycra. If you are allergic to any of these materials, you may not be able to
use the head straps provided.
The Omnilux CLEAR device cannot be used in charging mode.
Before each use, with the device off, clean the device. All surfaces of
the Omnilux CLEAR device may be cleaned by following the cleaning
instructions in Section 8.1 - page 11.
Do NOT use any other cleaning products other than those stated in the
cleaning instructions. Use of other cleansing products may damage
Omnilux CLEAR.
Store Omnilux CLEAR flat and at room temperature in dry
conditions, away from direct sunlight.
Immediately after treatment skin may appear red. Skin should return to
normal within 1-2 hours.
Some users have reported pigmentation, skin flaking or peeling,
associated pruritis and dryness. This is transient and clears within a few
days.
Temporary headaches immediately following the light treatment.
Headaches can be treated with an appropriate over the counter analgesic
and rehydration.
This list although not exhaustive lists the most commonly reported side
effects.
5. Risks and benefits
5.1 Potential risks
6. First time setup
6.1 Unpacking and charging your Omnilux CLEAR
The Omnilux CLEAR device uses a controller which contains a lithium-ion
polymer battery. Omnilux CLEAR cannot be used in charging mode.
The lifetime of the lithium battery can be maximized by allowing it
to fully charge and then fully discharge during regular use.
Unpack Omnilux CLEAR and check off the parts described in Section 3
page 5.
Before use, fully charge the battery.
To charge the Omnilux CLEAR battery, insert the USB-C cable into the
controller. Insert the power supply into a suitable electrical outlet and press
ON/OFF button on controller.
The 3 LEDs in the controller will start to flash to indicate charging. The
Omnilux CLEAR battery is fully charged when the three indicator LEDs on
the controller stay illuminated.
6.2 Connecting Omnilux CLEAR to the controller
Connect the Omnilux CLEAR mask by inserting the USB A connector of the
mask into the USB port of the controller.
6.3 Sensitization test
People who have undergone a course of 4 weekly treatments for 6
weeks using the Omnilux CLEAR device report a reduction of mild to
moderate acne vulgaris.
5.2 Potential benefits
Before carrying out your first treatment, you must carry out a
sensitization test. Follow the step by step guide below:
1. Place the Omnilux CLEAR device over your inner arm.
2.Press the ON/OFF button on the controller until lights are illuminated and
allow device to run for its full 10-minute treatment program.
3. At any time if your skin feels HOT or uncomfortable,
immediately turn OFF your device and remove from skin.
4. After the treatment, wait at least 6 hours. If your skin on
your inner arm is red or itchy then Omnilux CLEAR is not
suitable for you.

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The lifetime of the lithium battery can be maximized by allowing it to fully
charge and then fully discharge during regular use.
Store the Omnilux CLEAR device flat and at room temperature in dry
conditions. Use the carry bag provided to store your device.
Avoid storing the Omnilux CLEAR device in dusty conditions, in direct
sunlight or in damp and humid conditions.
The Omnilux CLEAR device contains no serviceable parts.
Before each use, with the device turned off, clean the device following
the cleaning instructions below.
If you follow the care and maintenance for your Omnilux CLEAR, then
Omnilux CLEAR has a minimum lifetime of 2 years.
7. Using the Omnilux CLEAR device 8. Care and maintenance
8.1 Cleaning the Omnilux CLEAR device
DO NOT use any other cleansing products as these
may damage the plastics.
People who have undergone a course of 4 weekly treatments for 6
weeks using the Omnilux CLEAR device report a reduction of mild
to moderate acne vulgaris.
Clean the front and back of the device with a water-based wipe or
damp, clean cloth. Stubborn stains can be removed by wiping gently
with 70% alcohol.
Regarding electromagnetic compatibility (EMC) and
electromagnetic fields (EMF), in and around the home
environment the Omnilux CLEAR device should be kept away
from radio frequency (RF) equipment to avoid interference.
7.1 Treatment recommendations
Omnilux CLEAR comes with two adjustable Velcro straps that allow you to
comfortably wear the mask.
To fit the mask, thread the straps through the inlet holes on either side of
the mask.
Loop the straps around your head and secure firmly.
Adjust if necessary.
7.2 Wearing the Omnilux CLEAR device
1. Cleanse and exfoliate skin to remove any traces of skincare.
2. Place Omnilux CLEAR on the face, secure with the adjustable straps.
3. Connect the Omnilux CLEAR device to the controller and press the
ON/OFF button on controller. The device turns off after its 10-minute
treatment. You may stop the treatment at any time by pressing the ON/OFF
button on the controller.
4. Remove the device, apply your normal skincare.
5. Clean the device using a water-based wipe or a damp, clean cloth.
Ensure that the device is NOT being charged when cleaning.
6. For best results, treat for 4 days a week for 6 weeks.
7.3 Carrying out a treatment
8.2 Disposal
DO NOT dispose of any part of the device at a domestic waste
facility.
The Omnilux CLEAR controller contains a lithium-ion polymer
battery. For protection of the environment, please package and
return this unit to the manufacturer or their representative at the end
of its working life or safely dispose of the device following your local
guidelines.

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8.3 Troubleshooting
Problem
No blue or red light
from Omnilux CLEAR
Possible Cause Action
Date of manufacture
Catalogue number and batch code
Operating environment
If the actions suggested fail to fix the problem, or the problem reoccurs, and
your device is within the warranty period please return to your provider.
9. Labeling
The labeling supplied with the device contains the following information
This symbol indicates: this product shall not be disposed of with normal
household waste (2012/19/EU).
This symbol indicates: this product contains a built-in rechargeable
battery which shall not be disposed of with normal household waste
(2006/66/EC). We advise you to take your product to an official
collection point to have a professional remove the rechargeable
battery. Follow your country’s rules for the separate collection of
electrical and electronic products and rechargeable batteries. Correct
disposal helps prevent damage to the environment and human health.
10. Recycling
Not charged Plug in the controller to
the charger making sure
that the connections are
attached and leave
charging until the three
indicator LEDs on the
controller remain lit and
do NOT flash
No blue or red light
from Omnilux CLEAR
Device connected to an
electrical outlet
Unplug USB connector
from controller
LEDs do NOT turn OFF
after 10 minutes
Device is faulty Return to your supplier
LEDs flicker continuously
during treatment
Omnilux CLEAR is not fully
inserted into controller
Ensure the controller and
Omnilux CLEAR device
are connected correctly
Do NOT attempt to investigate any further.
Do NOT attempt to modify the device in any way. Omnilux
CLEAR has NO parts you can repair yourself.
This symbol indicates: A warning to read the enclosed documents
before use and take all safety precautions required.
This symbol indicates: Read the User Guide before you start using
the device.
This symbol indicates: Omnilux CLEAR is specified as applied part
type BF. B indicates that it is used on the Body and F indicates that
it is not connected to the mains voltage.
This symbol indicates: Conformity to UK Directives on health,
safety, and environmental protection standards. UKCA stands for
UK Conformity
This symbol indicates: “Manufactured by” and provides the name
and address of the legal manufacturer.
This symbol indicates: Input for the power supply. This symbol
means that the device may only be charged with the adapter that is
supplied in the package. Usage of other adapters may not be safe
and could lead to electrical shock. The adapter has the following
electrical specification: 100-240Vac, 50/60Hz. 0.25A. Electrical
Output; 5V.
11. Technical specification
Program time: 10 minutes fixed
Controller: 102.8mm max (L) x 46.3mm (W) x 34.9mm max (H)
Operating temperature: 0°C to 40°C
Storage and transport temperature: -5°C to 55°C
Operating humidity: 30% to 95% without condensation
Storage and transport humidity: 20% to 85% without condensation
Electrical input from power adapter: 100-240Vac, 50/60Hz. 0.25A
Electrical output: 5V
12. Explanation of symbols

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Under normal use this product is guaranteed for 2 years after its original
purchase date against manufacturing defects in materials or workmanship.
13.1 Standard warranty:
The lithium battery is guaranteed for 1 year after its original purchase date
against manufacturing defects in materials or workmanship.
This warranty extends only to the original purchaser.
This warranty does not cover damage caused by the following:
13.2 Warranty exceptions:
13.3 What to do if your product is faulty
13. Warranty
Please register your warranty at
https://omniluxled.com/pages/product-registration
This symbol indicates: Keep dry.
This symbol indicates: The serial number of the device.
This symbol indicates: The catalogue number for the Omnilux
CLEAR device.
This symbol indicates: The batch code for the Omnilux CLEAR
device.
This symbol indicates: The USB connector.
This symbol indicates: The device uses a lithium ion polymer
battery.
This symbol indicates: Made in China.
This symbol indicates: Keep the device away from direct sunlight.
This symbol indicates: The upper and lower operating
temperatures that the Omnilux CLEAR device can be safely used
at.
This symbol indicates: The upper and lower operating humidity
that the Omnilux CLEAR device can be safely used at.
This symbol indicates: The cardboard packaging that Omnilux
CLEAR came in can be recycled.
This symbol indicates: The device is protected against a solid
object greater than 12.5mm such as a finger and against
vertically falling drops of water at up to 15 degrees from vertical.
Accident, misuse, abuse or alteration
Servicing by unauthorized persons
Connection to incorrect power sources
Use with unauthorized accessories
GlobalMed Technologies Co. or its authorized distributor shall not
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If the product is defective within the warranty period, please contact your
provider.