Omnilux CLEAR TN2112 User manual

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User Guide

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English
Users of this device can obtain benet 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 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 I-SMART Development Ltd,
and supplied on the understanding that it shall be kept condential to recipients
and that it shall not be altered, reproduced and/or used for commercial purposes
without the written consent of I-SMART Developments Ltd.
Med-Di-Dia Limited Galway Technology Centre Mervue
Business Park, Galway, Ireland
Emergo Australia, Level 20 Tower II, Darling Park
201 Sussex Street, Sydney, NSW 2000, Australia
Contents
Section Header Section number
Introduction 1.0
Who should use Omnilux Clear? 2.0
Device description 3.0
Intended Purpose 3.1
When should Omnilux Clear NOT be used? 4.0
Contraindications, Warning and Precautions
Known Side Effects and Benets 5.0
First time Setup 6.0
Unpacking and Charging your Omnilux Clear 6.1
Connecting the Omnilux Clear to the Controller 6.2
Sensitization Test 6.3
Using Omnilux Clear 7.0
Treatment Recommendations 7.1
Wearing the Omnilux Clear 7.2
Carrying out a Treatment 7.3
Care and Maintenance 8.0
Cleaning the Omnilux Clear Device 8.1
Disposal 8.2
Troubleshooting 8.3
Labelling 9.0
Recycling 10.0
Technical specications 11.0
Explanation of symbols 12.0
Warranty 13.0
1.0. Introduction
Thank you for choosing Omnilux Clear.
The Omnilux Clear LED mask is intended to emit light in the blue and red region.
of the light spectrum and is indicated for the treatment of mild to moderate acne
vulgaris of the face.
(See “Who should use Omnilux Clear” section 2 on page 4, for more information
about how to tell if you have mild to moderate acne and if the Omnilux Clear is
right for you).
Users of this device can obtain benet 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 commented about Omnilux Clear
or this User Guide.
Before using the Omnilux Clear you must carry out a sensitization test
and wait 6 hours. (See section 6.3).
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2.0. Who should use Omnilux Clear?
The typical appearance of acne is a mixture of the following: a greasy skin, red pimples
or spots, yellow pus-lled spots, and scars. Use this chart to determine whether Omnilux
Clear™ is suitable for you.
Acne type Description Suitable for Omnilux Clear
Clear Skin No pimples or
spots or yellow
pus-lled spots.
No whiteheads or
blackheads
NO
Omnilux Clear is NOT
indicated for Clear
skin. Omnilux Clear
should NOT be used to
prevent pimples or spots
forming.
Mild acne A few pimples
or spots, a few
pus-lled spots,
some whiteheads,
or blackheads
YES
Mild acne is suitable for
treatment with Omnilux
Clear
Moderate
acne
Some pimples or
spots, some pus-
lled spots, only a
few small nodules
Many whiteheads
or blackheads
YES
Moderate acne is
suitable for treatment
with Omnilux Clear
Severe acne Many pimples
or spots, many
pus-lled spots.
Some nodules.
Many whiteheads
or blackheads
NO
Omnilux Clear is NOT
indicated for severe
acne.
Please consult your
doctor for a more
appropriate treatment
Whiteheads
or Blackheads
– Comedonal
acne
Many whiteheads
or blackheads.
No pimples or
spots. No pus-
lled spots
NO
Omnilux Clear is
NOT indicated
for whiteheads or
blackheads.
Please consult your
doctor for a more
appropriate treatment.
 TondoutiftheOmniluxClearisrightforyouandtondafull
list of who can and who can’t use the Omnilux Clear scan the QR
If Omnilux Clear is not suitable for you, return the device to the retailer.
3.0. Device Description
1. Flexible silicone CLEAR device with integrated eye-wear
2. Controller (containing a lithium battery) & power supply.
3. Country Specic adapters
4. 2x adjustable Straps
5. Carry Bag
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 exible silicone device that contains light emitting diodes (LED’s)
and a controller. The LEDs generate the light. The device is worn on the face and
is help 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 whilst 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.

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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 specically indicated to treat mild
to moderate acne vulgaris on the face through a non-thermal mechanism
called endogenous Photodynamic Therapy.
The device is intended to be used in the home by people ≥14 years of age.
4.0. When should Omnilux Clear NOT be used?
4.1. Contraindications, Warnings and Precautions
Contraindications
• DO NOT share the Omnilux ClearDevice with any other person. The
Omnilux Clear Device is for single person use only.
• DO NOT use the Omnilux Clear Device to treat any other conditions apart
from those listed in the intended 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 Device if you are pregnant, trying to
conceive, or breastfeeding. The Omnilux Clear Device has NOT been
tested on pregnant or breast-feeding women and therefore the risk to the
foetus, neonate or pregnant woman is unknown
• DO NOT use the Omnilux Clear if you are a child under 14 years of age.
The safety of the device for children younger than 14 years of ages has
NOT been tested and the risk is unknown.
• DO NOT use the Omnilux Clear Device if you suffer from light induced
headaches.
• DO NOT use the Omnilux Clear Device 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 the Omnilux Clear contact a health care professional.
• DO NOT use Omnilux Clear Device 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 and using the Omnilux Clear contact a health care
professional.
• DO NOT use Omnilux Clear Device 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 Device 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 Device 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 and other substances that can cause photosensitivity,
please visit: www.omniluxled.com
• 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.
Common examples of these substances are: St John’s Wort, coal tar,
deodorants, antibacterial soaps, articial sweeteners, naphthalene
(mothballs), petroleum products, brightening agents found in laundry
detergent, and cadmium sulphide (a chemical injected into the skin
during tattooing).
Warnings
• Before using the Omnilux Clear you must carry out a sensitization test
(see section 6.3).
• DO NOT use the Omnilux Clear Device in any way that is not exactly as
specied in these instructions for use. Use of the Omnilux Clear other than
exactly as specied in these instructions for use has not been tested and
the risk is unknown.
• DO NOT use the Omnilux Clear if your acne pustules are oozing or
bleeding. Stop treatment and resume when your pustules have formed a
plug or scab.
• DO NOT use the Omnilux Clear in an environment that is NOT specied
by the manufacturer, use of the Omnilux Clear in an environment NOT
specied by the manufacturer may cause damage to the device or harm to
the user.
• TURN OFF and REMOVE the Omnilux Clear immediately if it feels hot or
your skin feels uncomfortably warm. STOP using the device and contact
your supplier.
• STOP using the Omnilux Clear during a treatment if you experience
severe headache, changes in vision or pain in your eyes. Should this occur,
contact a healthcare professional.
• DO NOT use the Omnilux Clear without rst removing sunscreens, topical
creams, lotions, or make-up BEFORE treatment. Some ingredients in these
products may cause light sensitization or may reduce the effect of the
treatment. If you use the Omnilux Clear without removing these products,
you may cause a skin reaction, or may reduce the effect of the treatment.
• NEVER use the Omnilux Clear near water or where water can be spilt onto
the equipment.
• DO NOT use the Omnilux Clear if you think it has come into contact
with water.
• Keep the Omnilux Clear away from hot surfaces or direct sunlight.
• The Omnilux Clear contains cables that could have the potential to cause
strangulation – Keep out of the reach of infants.
• DO NOT attempt to modify the Omnilux Clear in any way. Modifying
the Omnilux Clear will void your warranty. Modifying the Omnilux Clear
could cause an electric shock when the system is used again. The system
contains no serviceable parts.
• DO NOT use the Omnilux Clear if the mask, controller, charging plug or
cord 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 this User Guide thoroughly and follow directions stated in the manual
to assure maximum safety during operation.
Omnilux Clear may only be charged with the power supply that is supplied
with the device. Use of other power supplies may not be safe and could lead
to electric shock.
Precautions
• DO NOT pick or rub acne pustules that have scabbed or blocked. Picking
acne pustules may lead to acne scarring or worsening.
• The Omnilux Clear straps contain 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 strap provided.
• The Facemask is made from Medical Grade Silicone, if you have an Allergy
to Silicone, you will not be able to use the Omnilux Clear device.
• The Omnilux Clear Device cannot be used in charging mode.
• Before each use, with the device switched off, clean the face mask. All
surfaces of the Omnilux Clear device may be cleaned by following the
cleaning instructions in Section 8.1.
• DO NOT use any other cleaning products other than those stated in the
cleaning instructions. Use of other cleansing products may damage the
Omnilux Clear
• Store the Omnilux Clear at room temperature in dry conditions, away from
direct sunlight.
5.0.SideEffectsandClinicalBenets
5.1. Potential Side Effects
• Immediately after treatment skin may appear red. Skin should return to
normal within 1-2 hours.
• Some users have reported pigmentation, skin aking 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.
If you experience a side effect that is greater than that described above
or a serious side effect not listed, STOP using the device and seek advice
from a healthcare provider and report such an incident rstly to the
manufacturer Globalmed Technologies, [email protected], who will
contact the Competent Authorities if deemed applicable. Country specic
contact numbers for Globalmed Technologies can be found
at www.omniluxled.com
 5.2.ClinicalBenet
People who have undergone a course of 4 weekly treatments for 6 weeks
using the Omnilux Clear report a reduction of mild to moderate
acne vulgaris.
6.0. 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 maximised by allowing it to fully
charge and then fully discharge during regular use.
• Unpack the Omnilux Clear and check off the parts described in Section 3.
• Visually inspect the parts and connections. Return the device to your
supplier if you think the device or connecting parts or components are
damaged, missing, or have been previously used.
• 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 the ON/OFF button on the controller.
• The 3 LEDs in the controller will start to ash to indicate charging. The
Omnilux Clear battery is fully charged when the three indicator LEDs on
the controller stay illuminated.
6.2. Connecting the Omnilux Clear to the Controller
• Ensure the controller is no longer charging by unplugging the controller
from the power supply.
• 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
 Beforecarryingoutyourrsttreatmentyoumustcarryouta 
sensitization test. Follow the step-by-step guide below.
1. Connect the Omnilux Clear mask to the controller (see section 6.2)
2. Cleanse your inner arm to remove any skincare such as sunscreens.
3. Place the Omnilux Clear over your inner arm.
4. Press the ON/OFF button on the controller until lights are illuminated and
allow the device to run for its full 10 minute treatment program.
5. At any time if your skin feels HOT or uncomfortable, immediately turn OFF
your device and remove from skin.
6. After the treatment wait at least 6 hours. If your skin on your inner arm is
red or itchy then the Omnilux Clear is unsuitable for you. Return the device
to the retailer.