Idiomas disponibles
Idiomas disponibles
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.
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
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Omnilux Clear Device is for single person use only.
DO NOT use the Omnilux Clear Device to treat any other conditions apart
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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
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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.
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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
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headaches.
DO NOT use the Omnilux Clear Device if you suffer from any genetic
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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
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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
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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
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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
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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.
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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
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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.
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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).
Warnings
Before using the Omnilux Clear you must carry out a sensitization test
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(see section 6.3).
DO NOT use the Omnilux Clear Device in any way that is not exactly as
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specified in these instructions for use. Use of the Omnilux Clear other than
exactly as specified 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
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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 specified
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by the manufacturer, use of the Omnilux Clear in an environment NOT
specified 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
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your skin feels uncomfortably warm. STOP using the device and contact
your supplier.
STOP using the Omnilux Clear during a treatment if you experience
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severe headache, changes in vision or pain in your eyes. Should this occur,
contact a healthcare professional.
DO NOT use the Omnilux Clear without first removing sunscreens, topical
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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
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the equipment.
DO NOT use the Omnilux Clear if you think it has come into contact
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with water.
Keep the Omnilux Clear away from hot surfaces or direct sunlight.
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The Omnilux Clear contains cables that could have the potential to cause
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strangulation – Keep out of the reach of infants.
DO NOT attempt to modify the Omnilux Clear in any way. Modifying
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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
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cord are damaged in any way.
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