Omnilux MINI User manual
User Guide
Blemish Eraser
2 3
OMNILUX™ MINI BLEMISH ERASER
It is mandatory that users of this device read and
comprehend all information in this User Guide prior
to use of the Omnilux™ Mini Blemish Eraser device.
You must follow all the instructions in the User Guide.
Please contact us if you have any comments about the Blemish
Eraser device or this User Guide or if you experience any side
effects that are not mentioned in this User Guide or are more
severe than those described in the User Guide.
www.omniluxled.com
GlobalMed Technologies Co. KD&A PTY LTD
163 Camino Dorado Suite B 288 Flinders Street
Napa, CA 94558 Adelaide SA 5000
Tel: +1-707-224-0200 RP: Certainty IP Ltd
www.omniluxled.com Dublin, D18 CV48
+353 1582 9003
The information in this document is proprietary to
iSMART Developments Ltd, and supplied on the
understanding that it shall be kept condential to
recipients and that it shall not be reproduced and/or
used for commercial purposes without the written
consent of iSMART Developments Ltd.
2 3
USER GUIDE
It is mandatory that users of this device read and
comprehend all information in this User Guide prior
to use of the Omnilux™ Mini Blemish Eraser device.
You must follow all the instructions in the User Guide.
Please contact us if you have any comments about the Blemish
Eraser device or this User Guide or if you experience any side
effects that are not mentioned in this User Guide or are more
severe than those described in the User Guide.
www.omniluxled.com
GlobalMed Technologies Co. KD&A PTY LTD
163 Camino Dorado Suite B 288 Flinders Street
Napa, CA 94558 Adelaide SA 5000
Tel: +1-707-224-0200 RP: Certainty IP Ltd
www.omniluxled.com Dublin, D18 CV48
+353 1582 9003
The information in this document is proprietary to
iSMART Developments Ltd, and supplied on the
understanding that it shall be kept condential to
recipients and that it shall not be reproduced and/or
used for commercial purposes without the written
consent of iSMART Developments Ltd.
Contents
Who should use the Blemish Eraser device..................... 4
Device Description....................................................5
Intended Use...........................................................7
Contraindications, Warnings and Precautions...................7
Contraindications...........................................7
Warnings ..................................................9
General Safety ............................................11
Precautions ...............................................11
Risks and Benets ....................................................12
Potential Risks.............................................12
Potential Benets ..........................................13
First Time Setup ......................................................13
Unpacking and charging the Blemish Eraser device..............13
Charging the Blemish Eraser device ..........................13
Charging Status of the Blemish Eraser device..................14
Sensitization test .....................................................15
Using the Blemish Eraser device ..................................16
Treatment Recommendations................................16
Carrying out a treatment ....................................16
How to use the Hydrocolloid Patches............................18
Care and Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Cleaning the Blemish Eraser Device..............................21
Disposal/Recycling...................................................22
Troubleshooting ......................................................22
Labeling ................................................................24
Technical specication ..............................................24
Explanation of symbols .............................................25
Warranty................................................................27
Standard Warranty .........................................27
Warranty exceptions .......................................27
What to do if your product is faulty ...........................27
4 5
OMNILUX™ MINI BLEMISH ERASER
Before using the Blemish Eraser device you must
carry out a sensitization test and wait 6 hours.
Who should use the Blemish Eraser device
Thank you for choosing the
Blemish Eraser
device.
The
Blemish Eraser device
is suitable for persons ≥14 years of
age who are suffering from mild to moderate acne vulgaris.
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
the Blemish Eraser
device
is suitable for you
.
Acne type Description Suitable for the
Blemish Eraser device
Clear skin
No pimples or
spots or yellow
pus-lled spots.
No whiteheads
or blackheads
NO
the Blemish
Eraser device
is NOT
indicated for clear skin.
The Blemish Eraser
device
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
the Blemish
Eraser device
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
the Blemish
Eraser device
4 5
USER GUIDE
Acne type Description Suitable for the
Blemish Eraser device
Severe acne
Many pimples
or spots, many
pus-lled spots.
Some nodules.
Many whiteheads
or blackheads
NO
the Blemish
Eraser device
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
the Blemish
Eraser device
is NOT
indicated for whiteheads
or blackheads.
Please consult your
doctor for a more
appropriate treatment
If you have purchased the
Blemish Eraser device
and nd
that it is NOT suitable for you, please contact your supplier
to return the device within 30 days with proof of purchase.
Device Description
The Blemish Eraser device is a battery operated; cordless
wearable Light emitting diode (LED) device intended to
emit light in the blue (415nm) and red (630nm) regions of
the light spectrum for the treatment of mild to moderate
acne vulgaris.
The Blemish Eraser device system consists of the following
key components.
1. 1 x Silicone LED Patch
2. 1 x Magnetic 2 pin, 4mm to USB A Charging Cable
3. 14 x Individually Wrapped Hydrocolloid Patches including
1 Sensitization Test Patch
4. 1 x User Guide
6 7
OMNILUX™ MINI BLEMISH ERASER
The Blemish Eraser device is a silicone exible patch
containing LEDs. The LEDs generate the light.
The LEDs produce blue (415nm ± 10nm) and red (630nm
± 10nm) light in the visible spectrum. The device works
through a non-thermal mechanism called endogenous
photodynamic therapy.
The LEDs are driven by an integrated 3.7V, 37mAh Lithium
Polymer battery.
The battery is charged via a magnetic 2 pin, 4mm to
USB A connector that plugs into a standard 5v USB A
power adaptor. The device cannot be operated while
in charging mode. The charging status of the device is
indicated by a single indicator LED on the rear of the
Blemish Eraser device and the treatment LEDs.
In charging mode.
i. Solid green – battery is fully charged.
ii. Solid orange – battery charging.
The Blemish Eraser device contains a simple ON/OFF
button ( ) that switches the LEDs ON/OFF. The treatment
time is 10 minutes. The device automatically turns OFF
after the 10-minute treatment cycle. The user may stop the
treatment program during the 10 minutes by pressing the
ON/OFF button.
The LED device is worn on the face and held in place by
an adhesive hydrocolloid patch. The adhesive hydrocolloid
patch is impregnated on both sides with an elastomer and
hydrogenated petroleum resin that acts as an adhesive.
The hydrocolloid patch contains the following ingredients:
CMC Carboxymethyl cellulose (Cellulose Gum), Styrene/
Isoprene Copolymer, Hydrogenated Rosin, Homopolymer,
Parafnum Liquidum (Mineral oil), PET, Niacinamide,
Camellia Sinensis Leaf Extract (Green Tea), Sodium
6 7
USER GUIDE
Hydroxide, Sodium Hyaluronate, Salicylic Acid and
Pentaerythritol Tetrakis.
You are supplied with a set of 14 adhesive hydrocolloid
patches for treatment, one of which must be used to
carry out a Photosensitivity patch test before starting your
treatment course.
The equipment is not used to make measurements of any
sort, or to draw any conclusions regarding the indication to
treat. The equipment does not require checks on the light
output as the LEDs do not dim with age to any practical
extent.
Intended Use
The
Blemish Eraser device
is an over-the-counter device
intended to emit energy in the red and blue region of
the light spectrum, specically indicated to treat mild to
moderate acne vulgaris of the face.
The Blemish Eraser device
is intended to be used in the
home by people ≥ 14 years of age.
Contraindications, Warnings and Precautions
Contraindications
• DO NOT
reuse the hydrocolloid patches between treatment
sessions. The hydrocolloid patches are for single use only.
• DO NOT share the Blemish Eraser device device with any other
person.
The
Blemish Eraser
device is for single person use only.
• DO NOT use the Blemish Eraser device to treat any other
conditions apart from those listed in the intended use. The
Blemish Eraser device has not been tested for any other
conditions than those listed, and the risk is unknown.
8 9
OMNILUX™ MINI BLEMISH ERASER
• DO NOT use the Blemish Eraser device if you are pregnant,
planning on becoming pregnant or breastfeeding. The Blemish
Eraser device has NOT been tested on pregnant or breast-
feeding women and therefore the risk to the foetus, neonate or
pregnant women is unknown.
• DO NOT use the Blemish Eraser device if you are a child
under 14 years of age or on children 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 the Blemish Eraser device on open cuts,
wounds, oozing acne pustules and broken skin.
• DO NOT use the Blemish Eraser device if you have an
allergy to Silicone or Polyethylene terephthalate. The
treatment surfaces of the Blemish Eraser device contain
medical grade Silicone and Polyethylene terephthalate.
• DO NOT use the Blemish Eraser device if you have an
allergy to Hydrocolloid bandages or any of the ingredients
in the hydrocolloid patches outlined above. The LED
device xes to you face using an adhesive hydrocolloid
patch.
• DO NOT use the Blemish Eraser device if you suffer from
light induced headaches.
• DO NOT use the Blemish Eraser device if you suffer from
any genetic conditions of the eyes. If you are unsure about
any related eye condition and using the Blemish Eraser
device contact a health care professional
• DO NOT use device if you suffer from lupus
erythematosus, photosensitive eczema, or albinism.
If you use the Blemish Eraser device to treat lupus
erythematosus, photosensitive eczema, or albinism you
may cause a severe skin reaction.
8 9
USER GUIDE
• DO NOT use device if you suffer from any photosensitive
disorder (sensitization to light). If you use the Blemish
Eraser device and you suffer from a photosensitive
disorder, you may cause a severe skin reaction.
• DO NOT use device if you are taking any medication that
can cause photosensitivity. If you use the Blemish Eraser
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
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,
articial 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 Blemish Eraser device you must carry out
a sensitization test. Please read the section
“Sensitization test” on how to carry out the test.
10 11
OMNILUX™ MINI BLEMISH ERASER
• DO NOT over ex the Blemish Eraser device. Although it
is exible, it is not designed to withstand excess bending
or folding.
• Keep the Blemish Eraser device away from Sharp Objects.
• DO NOT use the Blemish Eraser device in any way that
is not exactly as specied in this User Guide. Use of the
Blemish Eraser device other than exactly as specied
in this User Guide has not been tested and the risk is
unknown.
• DO NOT use the Blemish Eraser device in an environment
that is NOT specied by the manufacturer, as this may
cause damage to the device or harm to the user.
• TURN OFF and REMOVE the Blemish Eraser device
immediately if it feels hot or your skin feels uncomfortably
warm. DO NOT continue treatments and contact
customer services.
• STOP using the Blemish Eraser device during a treatment
if you experience headaches or changes in vision. DO
NOT continue treatments and contact customer services.
• DO NOT use the Blemish Eraser device without rst
removing 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 Blemish Eraser device without removing
these products, you may cause a skin reaction, or may
reduce the effect of the treatment.
• Only use the adhesive hydrocolloid patches
recommended. Other adhesive patches are available but
have not been tested with the device and may block light
penetration and reduce the effects of the treatment.
• DO NOT use the hydrocolloid after its expiry date.
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