Bellus Medical SkinPen Precision Mode D'emploi page 3

PRE-PROCEDURE PRECAUTIONS
• Avoid excessive sun exposure/burns 24 hours prior to procedure.
• Discontinue use of topical retinoids 24 hours prior to procedure.
• Avoid treatment on patients with active breakouts or open lesions.
• Allow at least 24 hours after autoimmune therapies before a SkinPen
• Wait six months following oral isotretinoin use.
• Although not seen in the clinical study, in Fitzpatrick IV–VI, pigment may darken prior
to lightening.
PROCEDURE INSTRUCTIONS
1. Have patient complete consent form.
2. Explain the SkinPen ® procedure to the patient and set expectations.
3. Apply single use, non-latex gloves.
4. Cleanse patient's face with a gentle cleansing complex to effectively remove makeup,
sunscreen and surface oils.
5. Take "before" pictures of the procedure area.
6. Open the SkinPen Treatment Kit and remove all contents.
®
7. Apply the disposable BioSheath to the SkinPen
8. Install the cartridge onto SkinPen
®
*NOTE: The cartridge contains a lock-out feature and cannot be re-installed on the
SkinPen Precision device once removed. This safety feature ensures only a sterile
®
single-use application.
9. If a numbing agent was applied to provide patient comfort, the numbing agent must be
removed from the skin with an antiseptic solution prior to the microneedling procedure.
10. Apply a thin layer of Skinfuse ® Lift HG to protect the skin against abrasion and friction during
the SkinPen Precision treatment. If the layer is too thick the microneedle cartridge may
®
become clogged.
Please refer to Skinfuse Lift HG instructions for additional details.
11. Ensure the needle is set to "0" before starting a new procedure.
12. Power on by pressing and holding the on/off button on the front of SkinPen
two seconds.
13. Adjust needle depth settings on the SkinPen
indicated by a "click" into place.
14. Select SkinPen ® Precision microneedle position based on patient needs. Start at a depth
setting of 0.25mm. Increase in increments of 0.25 mm or 0.5mm until desired erythema is
reached, with a maximum depth of 1.5 mm on the face. Lower to 0.25-0.5 mm to perform
procedure around orbital rim.
Procedure Depth (Suggested Guidelines)
Forehead (0.25-1.0 mm)
Around the Orbital Rim (0.25-0.5 mm)
*
Nose (0.25-0.75 mm)
Facial Scars (up to 1.5 mm)
Note: treatment can be performed around but
*
not within the orbital rim
2 PN#16130014 | Rev. C | International
® Precision treatment.
.
®
.
® Precision for
Precision cartridge. New settings will be
®
Orbital Rim Guide
Orbital Rim
Treatment area
Microneedling
should not be
used within the
orbital rim
15. Divide the face into four quadrants. Start with the right cheek, move to the chin/perioral/
nose, then to left cheek, and finish with forehead.
16. Hold the skin taut and glide the pen in controlled horizontal motions. Repeat with vertical
motions in the same area. Repeat the pattern if the erythema endpoint is not reached. Depth
may be increased within guidelines if necessary. Gentle, one-directional circular motions in
small targeted areas is acceptable if needed to assist in reaching the erythema endpoint.
17. For additional treatment of scar tissue, such as facial acne scars, a needle depth of 1.5mm
may be used on the face.
NOTE: Microneedling should not be used within the orbital rim, such as the eyelids.
IMPORTANT: Microchannels created during the procedure may remain open up to 24 hours.
NOTE: This product is not intended for transdermal (under the skin) delivery of cosmetics, drugs,
or biologics.
Unexpected complications may occur when products not proven safe for use with
microneedling are applied post-procedure.
POST PROCEDURE INSTRUCTIONS
1. Gently use sterile gauze to pat down the affected area.
2. Apply a generous layer of Skinfuse Lift HG after the procedure.
®
3. Skinfuse Lift HG may be applied additionally the day of the procedure to prevent the
®
skin from drying out post procedure. The patient can re-apply, as needed, up to 24 hours
post procedure.
4. Skinfuse RESCUE cosmetic calming complex may be applied the day after the procedure as
®
needed to help soothe and calm the skin.
5. Advise patient to avoid sweaty exercise and sun exposure for 72 hours post-procedure.
6. It is recommended to avoid other facial aesthetic treatments the month following the SkinPen
Precision treatment.
7. Schedule next appointment after at least 4 weeks.
8. Take "after" pictures before next appointment.
NOTE: The purpose of a sheath is to provide a covering that helps prevent the transmission
of pathogens from one patient to another. SkinPen Precision is intended to be used only with
provided BioSheath.
CLINICAL STUDY SUMMARY
A clinical study was conducted to support the safety and effectiveness of the SkinPen Precision
System for the treatment of acne scars on the face.
The study was conducted at a single center and included treatments on day 1, day 30, and day 60,
with follow-up visits at 1 month and 6 months after the final (day 60) treatment. Treatments were
conducted by a trained aesthetician (skin care specialist). The face was cleaned and numbed
prior to treatment. A thin layer of Skinfuse Lift HG was applied prior to treatment to protect
against abrasion and friction during the procedure. The aestheticians were instructed to start at
the lowest depth setting and gradually increase the depth until erythema was observed, with
a maximum depth of 1.5mm. The instructions included a precaution that microneedling was
used around but not within the orbital rim. The face was divided into quadrants for treatment
to ensure that all acne scars were treated. Following treatment, Skinfuse Lift HG was applied to
prevent the skin from drying out post procedure.
A total of 41 subjects completed the study. Only 20 of these subjects were treated with the
SkinPen Precision System. The other 21 subjects were treated with a prototype device. There
are technological differences between the SkinPen Precision System and the prototype device,
including a greater number of needles in the SkinPen Precision cartridge and faster motor speed
PN#16130014 | Rev. C | International 3