Bellus Medical SkinPen User manual

MICRONEEDLING SYSTEM
Engineered, Designed
& Made in the USA
Inductive Charging
SMART Technology
Patented
Reciprocating
Mechanism
User Manual
SkinPen®Precision Device
SkinPen®Precision Charger Base
INTERNATIONAL
English |Danish |Swedish |Norwegian

LANGUAGE GUIDE
Section Page
English .............................................................................................................................2
Danish / Dansk ............................................................................................................19
Swedish / Svenska .....................................................................................................36
Norwegian / Norsk .....................................................................................................53
PN#P5SP048.01 | Scandinavian 1

ENGLISH
Table of Contents
Section Page
1. Device Description........................................................................................ 3
2. Intended Use.................................................................................................. 4
3. Contraindications.......................................................................................... 5
4. Warnings ......................................................................................................... 5
5. Precautions..................................................................................................... 5
6. Electrical Safety Warnings......................................................................... 6
7. Instructions for Use...................................................................................... 7
8. Procedure Instructions,
Post-Procedure Instructions,
Post-Procedure Care ................................................................................... 11
9. Cleaning of SkinPen®Precision & Charger Base.................................. 11
10. Storage............................................................................................................. 12
11. Disposal ........................................................................................................... 12
12. FAQ & Troubleshooting ............................................................................... 13
13. Specifications................................................................................................. 16
14. Environmental Conditions.......................................................................... 17
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Fig 1.
G
F
E
A
B
C
D
1. DEVICE DESCRIPTION
The SkinPen®Precision device consists of a microneedling pen handpiece
and a sterile needle cartridge. The accessories are a charging base and a
BioSheath. Each component and accessory will be explained to understand
how SkinPen®Precision works.
SkinPen®Precision Components
A SkinPen®Precision Handpiece -
Part #F5SP005 / REF 100
A Power Indicator Light
B Power On/Off Button
C Charge Level Indicator
D Microneedling Connector
E Ergonomic Handle Grip
F Base Charger AC/DC Adapter -
Part #P5SP019
• Part #P5SP021 EU Clip
• Part #P5SP022 UK Clip
• Part #P5SP023 AU Clip
G Inductive Charging Base -
Part #F5SP006 / REF 101
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INCLUDES:
SkinPen®Precision Cartridge
Part #F5SP021 / REF 014
EO (Ethylene Oxide) Sterilized, disposable needle cartridge
packaged and labeled individually. Proprietary needle
cartridge. *Cartridges are not to be resterilized or reused.
SkinPen®Precision BioSheath
Part #F5SP022
The SkinPen®Precision and needle cartridge interface
with a nonsterile and disposable BioSheath to prevent
contamination of the SkinPen®Precision.
LIFT HG
Part #F5SP023
Lift HG is a hydrogel wound dressing (without drugs and/
or biologics) to protect against abrasion and friction during
the microneedling procedure. It may be applied additionally
the day of the procedure to prevent the skin from drying
out post procedure.
RESCUE (if provided)
Part #F5SF013
Cosmetic calming complex applied liberally AM/PM, as
needed to soothe and calm skin. Suggested to be used
after 24 hours post treatment.
SKINPEN®PRECISION TREATMENT KIT
2. INTENDED USE
SkinPen®Microneedling System and SkinPen®+Skinfuse®Treatment kit are a
system that utilizes Collagen Induction Therapy to treat Melasma, acne and
surgical scars.
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3. CONTRAINDICATIONS
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
• Have taken drugs containing the ingredient isotretinoin (such as Accutane)
within the past 6 months
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®Precision as
to avoid interference with the device’s intended performance.
5. PRECAUTIONS
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.
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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 AC).
• 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 Charger base should not be opened or disassembled for
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.
6 PN#P5SP048.01 | Scandinavian

ADHESIVE
ADHESIVE
7. INSTRUCTIONS FOR USE
• Only use this device for the recommended applications. This device should
only be used under medical supervision.
• Before administering any treatment, you should become acquainted with
the operating procedures for the treatment, as well as the indications,
contraindications, warnings, and precautions. Consult other resources
(ie. IFU booklet) for additional information regarding the application of
microneedling therapy.
How to apply BioSheath:
• While wearing non-latex gloves, obtain a single use
BioSheath and ensure the SkinPen®Precision is clean/
disinfected.
• While SkinPen®Precision is powered off, insert the SkinPen®
Precision between the white tab and paper backing.
• Push SkinPen®Precision through the BioSheath until the
device is snug inside the BioSheath.
• Peel back the protective BioSheath cover by pulling on the
Blue tab and white paper backing.
• Remove adhesive backing and seal end. SkinPen®Precision is
now protected and ready to use.
ADHESIVE
ADHESIVE
ADHESIVE
ADHESIVE
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How to remove the BioSheath and clean the SkinPen®Precision Device:
• Hold the SkinPen®Precision perpendicular to the floor, or
with the cartridge attachment tip pointing downwards.
Use one hand to remove the cartridge and dispose of the
cartridge in a sharps container.
• Continue to hold the SkinPen®Precision device perpendicular
to the floor, with the cartridge tip pointed downwards, and
pull apart the adhesive strip of the BioSheath.
• Remove the BioSheath by carefully rolling it down the
SkinPen®Precision to prevent soiling the handpiece.
• Dispose of the BioSheath in a biohazard container.
BioSheaths are not intended to be reused.
• Disinfection of the SkinPen®Precision should be completed
with the use of Germicidal disposable wipes. See section 9-
Cleaning of SkinPen®Precision and Charger Base.
• After removal of the BioSheath and disinfection with
Germicidal disposable wipes is performed, users’ gloves
should be removed, hands cleaned, and a new pair of clean
gloves worn before proceeding to the next patient.
Note: Soiled gloves should always be disposed of in a biohazard container. Do
not reuse disposable gloves.
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.
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How to install/uninstall disposable SkinPen®Precision cartridge:
• Ensure SkinPen®Precision is powered off.
• Open the cartridge package by holding it right-side up and
pulling back the protective covering at the sealed chevron.
• Align the lock and key mechanism on the SkinPen®Precision
microneedling cartridge and the SkinPen®Precision device.
• Start with the symbol to the right of the power indicator
and rotate the cartridge left to align with the power indicator.
The SkinPen®Precision cartridge is now secure.
• To remove the cartridge, rotate until the cartridge is removed.
• The SkinPen®Precision cartridge is designed for single use,
with a lock-out feature prohibiting re-installation of the
cartridge after use.
• Dispose of used SkinPen®Precision
cartridge via a Sharps container.
*If a SkinPen®Precision Cartridge becomes inadvertently
contaminated before or during installation (i.e. Dropped on floor,
open/broken package, needles subjected to possible contamination),
discard, and obtain new SkinPen®Precision cartridge.
MALE FEMALE
Clear
Faults
3
2
1
LOCK UNLOCK
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Additional SkinPen®Precision Cartridge Instructions:
How to adjust needle length:
• To increase the needle length, adjust according to indicated
tick marks on the cartridge. New settings will be indicated by
a “click” into place.
• Needle settings should be selected based on patient needs.
• It is recommended to start at a depth setting of 0.25mm.
• Increase by increments of 0.25 mm or 0.5 mm for the desired
amount of erythema with a maximum depth of 1.5mm on
the face.
*Lower the setting of the cartridge to 0.25-0.5mm to perform the
procedure around the orbital rim.
• Decrease the needle length by adjusting according to the tick
marks on the cartridge. New settings will be indicated by a
“click” into place.
INCREASE
DECREASE
CLICK
Procedure Depth (Suggested Guidelines)
Forehead (0.25-1.0 mm) Nose (0.25-0.75 mm)
Around the Orbital Rim*(0.25-0.5 mm) Facial Scars (up to 1.5 mm)
*Note: treatment can be performed around but not within the orbital rim
See Instructions for Use booklet for additional treatment instructions.
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How to charge:
• Inductive charging is used between the SkinPen®Precision
charger base and the SkinPen®Precision device.
• Plug the charger base into a live outlet.
• Place the hand-piece into the base with the power button
facing out. See “FAQ/Troubleshooting” for additional
battery information. Battery charge percentages in “FAQ/
Troubleshooting”.
Power:
*Powering ON/OFF should only be done with the SkinPen®Precision
device disconnected from the charging base.
• ON: Press and hold power button for 1 seconds.
• OFF: Press and hold power button for 0.5 seconds.
8. PROCEDURE INSTRUCTIONS, POST-PROCEDURE
INSTRUCTIONS, POST-PROCEDURE CARE
• For additional information refer to SkinPen®Precision IFU booklet.
9. CLEANING OF SKINPEN®PRECISION AND CHARGER BASE
*Ensure SkinPen®Precision device is powered down before cleaning,
and SkinPen®Precision charger base is unplugged.
• The device should be cleaned while holding the SkinPen®Precision facing
straight down while wiping the rotary area. Do not clean near the seal.
• Germicidal disposable wipes should be used to clean the SkinPen®Precision
after each procedure. Germicidal disposable wipes may also be used to clean
the SkinPen®Precision Charger Base. Germicidal disposable wipes should be
used to carefully wipe the SkinPen®Precision according to their directions
for use found on the Germicidal disposable wipes labeling. Attention should
be paid to clean areas such as crevices, seams, and areas around where the
SkinPen®Precision Cartridge attaches to the device.
Clear
Faults
3
2
1
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• Germicidal disposable wipes that protect against HIV-1 and HBV or surface/
objects soiled with blood/body fluids are recommended to be used.
DIRECTIONS FOR USE:
Special instructions for cleaning & decontamination against HIV-1 and HBV of
surfaces/objects soiled with blood/body fluids:
Personal protection: Specific barrier protection items to be used when handling
items soiled with blood or body fluids are disposable latex gloves, gowns,
masks, or eye coverings.
Cleaning procedure: Blood and other body fluids must be thoroughly cleaned
from surfaces and objects before application of the disinfectant.
Disposal of infectious materials: Blood and other body fluids should be
autoclaved and disposed of according to federal, state and local regulations for
infectious waste disposal.
Contact time: Leave surfaces wet for 30 seconds for HIV-1 and 10 minutes for
HBV. Use the 10 minute contact time to mitigate other viruses, bacteria and
fungi listed on the label.
• Do not immerse in liquids.
• Do not use solvents to clean device.
10. STORAGE
• For optimal performance of your SkinPen®Precision, ensure the device is turned
off and store the device in the SkinPen®Precision charging base when not in use.
• If the device is OFF and not connected to the charging base for 30 minutes,
the device will generate a “Not on Charger” alert by “beeping” repeatedly at 1
second intervals for 1 minute, and then every 10 minutes after as a reminder
to return the SkinPen®Precision to the charger base. Turn off the alert by
connecting the SkinPen®Precision to the charger base.
11. DISPOSAL
• Dispose of cartridges/needle tips as medical waste via a Sharps container.
• Properly dispose of all items in accordance with local regulations.
• You must dispose of SkinPen®Precision, SkinPen®Precision Charger, and all
other SkinPen®Precision components properly according to local laws and
regulations. Because SkinPen®Precision contains electronic components and
a Lithium Ion rechargeable battery, SkinPen®Precision must be disposed of
separately from household waste. When SkinPen®Precision reaches its end of
life, contact local authorities for proper disposal and recycling options.
12 PN#P5SP048.01 | Scandinavian

12. FAQ/TROUBLESHOOTING
Fault Indications:
• Motor Speed Fault:
LED 1, 3 alternating at 0.25 sec. rate.
› The fault indicator will sound as long as the fault persists.
› If fault is indicated the motor will stop after 10 sec.
› In the case that the motor stops, the indication of the LEDs
will continue for an additional 10 seconds before the device
powers off.
› The fault may be generated by over aggressive needling.
› Allow the fault indicator to cease before continuing procedure.
› Discontinue use if the motor speed fault results continuously
and contact Bellus Medical.
• Over Current Fault:
LED 3 flashing at 0.25 sec. rate.
› The over current fault will stop the motor and beep for 10
sec.
› The fault indication on the LEDs will continue for an
additional 10 seconds before the device powers off.
› The fault may be generated by over aggressive needling and/
or by selecting a needle depth greater than necessary.
› Allow the fault indicator to cease before continuing
procedure at a lower depth setting or with less aggressive
force.
• Over Temperature Fault:
LED 2 flashing at 0.25 sec. rate. Temperature is over 65°C.
› The fault will stop the motor and beep for 10 sec.
› The fault indication on the LEDs will continue for an
additional 10 seconds before the device powers off.
› The fault may be generated by over aggressive needling
and/or by selecting a needle depth greater than necessary.
› Allow the device to cool down before continuing
the procedure.
• Motor Position Fault:
LED 1, 2 alternating at 0.25 sec. rate.
› If device is unable to stop at the home position then fault is
indicated by beeping for 10 sec.
› The fault indication on the LEDs will continue for an
additional 10 seconds before the device powers off.
If this fault is indicated, use extra caution in removing the disposable
needle cartridge as the needles may not be fully retracted.
Over
Temperature
Fault
Motor
Position
Fault Clear
Faults
3
2
1
Over
Temperature
Fault
Motor
Position
Fault
3
2
1
Over
Current
Fault
Over
Temperature
Fault
3
2
1
3
2
1
Motor
Speed
Fault
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Battery percentage indications in Running state:
• Battery Charged > 70%:
LED 1, 2, 3 ON.
• 30% < Battery Charge ≤ 70%:
LED 1, 2 ON.
• 15% < Battery Charge ≤30%:
LED 1 ON.
• 1% < Battery Charge ≤ 15%:
LED 1 flash on/off 1 sec. rate.
• If the battery charge is <1% and the user attempts to
power on the device, LED 1 will flash at 0.5 second rate
for 10 seconds and return to off mode.
3
2
1
3
2
1
3
2
1
3
2
1
3
2
1
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Battery Charge Indicator in Charging state:
After 30 minutes of being off the charger the SkinPen®Precision will beep
to remind users that it needs to be placed on the charger. This notification may
be cleared by either simply powering on the device, or by placing the device on
the charger.
• When the SkinPen®Precision is placed on the charger, LED
1, 2, 3 and charger indicator LED will blink sequentially for a
second to indicate it is connected with the charger base.
• When the SkinPen®Precision is removed from the charger
base the LED's stay solid which indicates the charge level in
the battery. They then go off to maintain battery longevity.
• Battery Charge = 100%:
LED 1, 2, 3 OFF to maintain battery longevity.
• Battery Charge > 90%:
LED 1, 2, 3 ON.
• 70% < Battery Charge ≤ 90%:
LED 1, 2 ON, LED 3 repeat on/off 1 sec.
• 30% < Battery Charge ≤ 70%:
LED 1 ON, LED 2 repeat on/off 1 sec.
• Battery Charge ≤ 30%:
LED 1 repeat on/off 1 sec.
70% <
Battery
Charge
3
2
1
3
2
1
Battery
Charge ≤ 30%
Battery
Charge = 100%
3
2
1
3
2
1
30% <
Battery
Charge
3
2
1
3
2
1
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13. SPECIFICATIONS
Technical Information of SkinPen®Precision
Product Name SkinPen®Precision
SkinPen®Precision Handpiece
Model Number 100
SkinPen®Precision Charger Base
Model Number 101
Bellus Medical FDA Registration # 3010392991
FCC ID 2AGLK-101
Weight and Unit ≤ 5oz /155mm length and
max. outer diameter of 34mm
Electrical Requirements Charger Base Input: 5VDC, 2A max
Output voltage: 5W (max)
Charger Time From 10% charge to 90%
Charge within 14 hours
Working Time > 6 hours
(under normal use conditions)
Speed 6300RPM – 7700RPM
Needles • 14 total solid needles
• 32 BWG (gauge)
• <32 RMS (roughness)
• Medical grade Stainless Steel
• EU RoHS compliant
• Sharpness specification within the
Radius 0.005mm (Max)
• Maximum extension of the needles
from the needle head surface is less
than 2.7mm
Operation Cordless
AC Adapter Medical Grade, Universally
compatible power requirements:
100-240 VAC at 50-60 Hz
Charger base transmitting frequency Between 110kHz and 205kHz
with efficiency around 73%
16 PN#P5SP048.01 | Scandinavian

14. ENVIRONMENTAL CONDITIONS
Operating conditions: Temperature: 17-30°C
Relative humidity: 30-75%
relative humidity non-condensing
Atmospheric Pressure: 70 -106 kPa
Transportation conditions: Temperature: -20-60°C
Relative humidity: 10-98%
relative humidity non-condensing
The EMISSIONS characteristics of the SkinPen®Precision & Charger Base make it
suitable for use in industrial areas and hospitals (CISPR 11 class A).
This device complies with Industry Canada's license-exempt RSS. Operation
is subject to the following two conditions: (1) This device may not cause
interference; (2) This device must accept any interference, including interference
that may cause undesired operation of the device.
This user manual is valid for SkinPen®Precision handpiece, the SkinPen®
Precision Charger Base (with AC adapter), SkinPen®Precision BioSheath and
SkinPen®Precision Treatment Kit.
Refer to the SkinPen®Precision Instructions for Use for additional information on
the Procedure Instructions.
This user manual is published by Bellus Medical, LLC. Bellus Medical, LLC. Does
not guarantee its contents and reserves the right to improve and amend it at
any time without prior notice. Amendments will however be published in a new
edition of this manual.
Declaration of Conformity
Bellus Medical, LLC. Declares that the SkinPen®Precision and SkinPen®Precision
charger base complies with the following normative documents:
IEC 62133, IEC 60601-1, IEC 60601-1-2, IEC 62366, ISO 14971:2012,
IEC 62304, MDD 93/42/EEC, RoHS, IEC 60601-1-6, IEC 60529, ISO 10993-1.
This device complies with Part 15 of the FCC Rules.
We Bellus Medical, LLC. accept not having the ETL Mark on the SkinPen®
Precision device label, but our product is 60601 certified.
Conforms to AAMI STD ES 60601-1, Certified to CSA STD C22.2 #60601-1.
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