Contraindications; Warnings; Precautions; Electrical Safety Warnings - Bellus Medical SkinPen Precision Manual Del Usuario

3. CONTRAINDICATIONS

The use of the SkinPen Precision System should not be used on patients who:
• 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.

4. WARNINGS

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.
Do not use any equipment not designed specifically for SkinPen
to avoid interference with the device's intended performance.

5. PRECAUTIONS

Safety and Effectiveness for setting greater than 1.5 mm has not
been evaluated.
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 (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.
4 PN#16130015 | Rev. C | International

6. ELECTRICAL SAFETY WARNINGS

• No modification of this equipment is allowed. Only use included SkinPen
Precision adapter and charger base.
• Do not plug product into outlet with a voltage other than specified on the
charger. (90-264 Vac).
• Never force plug into an outlet if it does not easily fit into the outlet,
discontinue use.
• Discontinue use if product appears damaged in any way.
• Do not use or charge if cord or plug is damaged.
• Keep cord away from heated surfaces.
• Do not store the pen and/or charger base near a sink or where it can fall or
be pulled into water.
• This device complies with Part 15 of the FCC Rules. Operation is subject
to the following two conditions: (1) this device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
• For your safety from electrical shock, the SkinPen® Precision and/or
SkinPen
Precision as
®
trouble-shooting purposes. There are no user serviceable parts.
• Do not use any equipment not designed specifically for SkinPen Precision as
to avoid interference with the device's intended performance.
• WARNING: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper operation.
• WARNING: 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.
• The EMISSIONS characteristics of this equipment make it suitable for use in
industrial areas and hospitals (CISPR 11 class A).
• The charger base transmitting frequency is between 110kHz and 205kHz
with efficiency around 73%.
• SkinPen Precision & Charger base is suitable for use in industrial areas
and hospitals
Precision Charger base should not be opened or disassembled for
®
PN#16130015 | Rev. C | International
®
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