English; Intended Use - Bellus Medical SkinPen Manual Del Usuario

ENGLISH

OVERVIEW
SkinPen Precision is an automated, non-surgical microneedling device designed for use by
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licensed healthcare practitioners or individuals directed by practitioners. The device incorporates
a sterile microneedle cartridge and BioSheath for single use only.
SkinPen Precision Handpiece Model #100
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SkinPen Precision Charger Base Model #101
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INTENDED USE

SkinPen Precision is a microneedling device that utilizes Collagen Induction Therapy to treat
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Melasma, acne and surgical scars.
CONTRAINDICATIONS
Are there any reasons why a patient should not receive SkinPen
the SkinPen Precision System should not be used on patients who:
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• Have active skin cancer in the treatment area(s)
• Have open wounds, sores, or irritated skin in the treatment area(s)
• Have an allergy to stainless steel or anesthetics
• Have a hemorrhagic (bleeding) disorder or hemostatic (bleeding) dysfunction
• Are pregnant or nursing
• Are currently taking drugs with the ingredient isotretinoin (such as Accutane)
NOTE: This product is not intended for transdermal (under the skin) delivery of topical products
such as cosmetics, drugs, or biologics.
WARNINGS
Do not use any equipment not designed specifically for SkinPen
interference with the device's intended performance.
Use of this equipment adjacent to or stacked with other equipment should be avoided because
it could result in improper operation. Use of accessories other than those specified or provided
by the manufacturer of this equipment could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment and result in improper operation.
PRECAUTIONS
What precautions should patients be advised about?
Universal precautions are necessary during microneedling. Microneedling should not be used
within the orbital rim of the eye, such as the eyelids.
The SkinPen Precision System has not been evaluated in the following patient populations
(i.e. patients with the following conditions or taking the following medications): Actinic (solar)
keratosis; active acne; collagen vascular diseases or cardiac abnormalities; diabetes; eczema,
psoriasis and other chronic conditions in the treatment area or on other areas of the body;
immunosuppressive therapy; history of contact dermatitis; raised moles in the treatment area;
rosacea; active bacterial, fungal, or viral infections (i.e. herpes, warts); keloid scars (a scar that
grows outside of the boundaries of an original scar); patients on anticoagulants; scars and stretch
marks less than one year old; scleroderma; and wound-healing deficiencies.
SKINPEN PRECISION CHARGING:
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Ensure the charger base is plugged into an outlet and the SkinPen
onto the base with the power button facing up.
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Precision treatments? The use of
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Precision as to avoid
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Precision handpiece is placed
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