Bellus Medical SkinPen User manual

User Manual
SkinPen
®
Precision Device
SkinPen
®
Precision Charger Base
Engineered, Designed
& Made in the USA
Inductive Charging
SMARTTechnology
Patented
Reciprocating
Mechanism
Microneedling System

TableofContents
Section Page
1. Device Description ................................................................. 2
2. Intended Use...................................................................... 3
3. Contraindications................................................................... 4
4. Warnings ............................................................................... 4
5. Precautions ............................................................................ 4
6. Electrical Safety Warnings ..................................................... 5
7. Instructions for Use ............................................................ 6
8. Procedure Instructions,
Post-Procedure Instructions,
Post-Procedure Care ................................................................. 10
9. Cleaning of SkinPen
®
Precision & Charger Base .................... 10
10. Storage .......................................................................................... 11
11. Disposal ........................................................................................ 11
12. Warranty ................................................................................... 11
13. FAQ&Troubleshooting ................................................................. 12
14. Specifications ................................................................................ 15
15. Environmental Conditions ............................................................. 16
1033001 0 |Rev. A 1

2 10330010 |Rev.A
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 andaccessory will be explained to understand
how SkinPen
®
Precision works.
A SkinPen Precision Handpiece - Part #10130010 / 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 #10130012
G Inductive Charging Base - Part #10130011 / REF 101
CAUTION: Federal law restricts this device to sale by or on the order
ofa physician.
D
C
B
Fig1.
E
A
F
G
SkinPen
®
Precision Components

10330010|Rev.A 3
SKINPEN
®
PRECISION TREATMENT KIT
INCLUDES:
SkinPen Precision Cartridge
Part#10230010/REF014
EO (Ethylene Oxide) Sterilized, disposable needle cartridge
packaged and labeled individually. Proprietary needle
cartridge. *Cartridges are notto beresterilzed orreused.
SkinPenPrecisionBioSheath
Part #10130001
The SkinPen
®
Precision and needle cartridge interface
with a nonsterile and disposable BioSheath to prevent
contamination of the SkinPen Precision
®
.
LIFTHG
Part #11720001
Lift HG is a hydrogel wound dressing (without drugs and/
or biologics) to protect against abrasion and friction during
themicroneedlingprocedure.Itmaybeappliedadditionally
the day of the procedure to prevent the skin from drying
outpostprocedure
2. INTENDED USE
The SkinPen Precision system is a microneedling device and accessories
intended to be used as a treatment to improve the appearance of facial acne
scars in adults aged 22 years or older.

4 10330010 |Rev.A
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 theingredient 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 itcould result in improper operation. Use ofaccessories other
than those specified or provided by the manufacturer of this equipment could
result in increased electromagnetic emissions or decreased electromagnetic
immunityofthisequipmentandresultinimproper operation.
Do not use any equipment not designed specifically for SkinPen
®
Precision as
to avoid interference with the device’sintended performance.
5. PRECAUTIONS
Safety and Effectiveness for setting greater than 1.5 mm has not
been evaluated.
The SkinPen Precision System has not be evaluated in the following patient
populations(i.e.patients withthefollowing conditionsortaking thefollowing
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, orviral (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.
PLEASE NOTE: The SkinPen Precision device allows for incremental increase
in settings of up to 2.5 mm to allow for the variabilityin thickness of healthy skin
and acne scar tissue. However,the device has not been clinically evaluated at
cartridge settings of greater than 1.5 mm. As there are fine structures (i.e., nerve
branches andaccompanying blood vessels) that run under the skin and are
essential to proper tissue function, it is not recommended to treat at needle
depths greater than 1.5mm. It is essential that the thickness of the patient’s
skin in each anatomical area to be treated is assessed by a qualified clinician to
address any potential risk of injuring these structures. Such structures include
(but are not limited to)the supra orbitalnerve (the terminal branch of the frontal

10330010|Rev.A 5
nerve that provides the sensory innervations for the skin of the forehead,
mucosa of frontalsinus, and the skin of the upper eyelid) and the temporal,
buccal and marginal mandibular branches of the facial nerve (motornerve that
controls facial muscle movement). No adverse events were observed relating
to such structures in the SkinPen Precision clinical study when treating at
needle depth of up to 1.5 mm. Please refer to Bellus provided training module
onsuperficial nerve and vesselfacialanatomy foradditional information.
6. ELECTRICAL SAFETY WARNINGS
• No modification of this equipment is allowed. Only use included SkinPen
®
Precision adapter andcharger 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 anyway.
• 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 anyinterference 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 thedevice's intended performance.
• WARNING: Use of this equipment adjacent to or stacked with other
equipmentshouldbeavoided because itcouldresultinimproperoperation.
• WARNING: Use of accessories other than those specified or provided by the
manufacturerofthis equipmentcouldresultinincreased electromagnetic
emissions ordecreased electromagneticimmunity ofthis 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 110kHzand 205kHz
withefficiencyaround 73%.
• SkinPen Precision & Charger base is suitable for use in industrial areas
and hospitals

6 10330010 |Rev.A
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)
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.

10330010|Rev.A 7
Howto remove the BioSheath and clean the SkinPen PrecisionDevice:
• 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
asharpscontainer.
• 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 Sani-Cloth HB Wipes, See section 9-
Cleaning of SkinPen Precision and Charger Base.
• After removal of the BioSheath and disinfection with Sani-
Cloth HB wipes isperformed, 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
notreuse 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.

8 10330010 |Rev.A
Howtoinstall/uninstall disposable SkinPen
®
Precision cartridge:
•Ensure SkinPen
®
Precision is powered off.
• Open thecartridge packageby holding itright-sideupand
pulling back the protective coveringatthe sealed chevron.
• Align the lock and key mechanism on the SkinPen
®
Precision
microneedling cartridge and theSkinPen
®
Precision device.
• Startwith 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 ofthe
cartridgeafteruse.
• Dispose of used SkinPen
®
Precision
cartridge via a Sharps container.
*IfaSkinPen
®
PrecisionCartridge becomesinadvertently
contaminated before or during installation (ie. Dropped on floor,
open/broken package, needles subjected to possible contamination),
discard, and obtain new SkinPen
®
Precision cartridge.
MALE
FEMALE
LOCK UNLOCK

10330010|Rev.A 9
Additional SkinPen
®
Precision Cartridge Instructions:
Howtoadjustneedle length:
INCREASE
DECREASE
• To increase the needle length,adjust on the cartridge
according to indicated tick marks on thecartridge. 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
theface.
*Lower the setting of the cartridge to0.25-0.5mm to perform the
procedure around the orbital rim.
CLICK
• Decrease the needle length by adjusting according to the tick
marks on the cartridge. New settings will be indicated by a
“click” into place.
Acne Scar 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 Acne Scars (up to 1.5
mm)
*Note: treatment can be performed around but not within the orbital rim

10 10330010 | Rev.A
Howtocharge:
• 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.
9. CLEANINGOFSKINPEN® PRECISION AND CHARGER BASE
*EnsureSkinPen
®
Precisiondeviceispowereddown beforecleaning,
and SkinPen
®
Precision chargerbase 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.
• Sani-Cloth HB
®
wipes should be used to clean the SkinPen
®
Precision after
each procedure. Sani-Cloth HB
®
wipes may also be used to clean the SkinPen
®
Precision Charger Base. Sani-Cloth HB Wipes should be used to carefully
wipe the SkinPen
®
Precision for more than 1 minute, according to their
directions for use, found on the Sani-Cloth HB
®
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.
• Sani-Cloth HB
®
wipes 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.

10330010|Rev.A 11
CLEANING PROCEDURE: Blood and other body fluids must be thoroughly
cleaned fromsurfacesandobjects before application of the disinfectant.
DISPOSAL OF INFECTIOUS MATERIALS: Blood and other body fluids should be
autoclaved anddisposed ofaccording to federal, state and local regulations for
infectious waste disposal.
CONTACT TIME: Leave surfaces wet for 30 seconds and 10 minutes for HIV-1
and HBV, respectively. Use the 10 minute contact time to mitigate other viruses,
bacteria andfungi listed onthe label.
• Donotimmerse 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,contactlocalauthoritiesforproperdisposalandrecyclingoptions.
12. WARRANTY
• One year under normal use after its original purchase.
• Warrantyextends only to the original purchaser and purchase date.
• Contact Bellus Medical, LLC.Customer Service at1.888.372.3982 for
warranty inquiries.
• Warranty does not cover:
• Defects due to negligence, alteration, modification, or installation by
anyoneotherthanfactoryauthorizedpersonnel.
• Abuse or misuse.
• Attemptedoractualdismantling,disassembling, service,orrepairnot
specifically authorizedbyBellusMedical,LLC.

12 10330010 | Rev.A
13. FAQ/TROUBLESHOOTING
Fault Indications:
• MotorSpeed 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
3
will continue for an additional 10 seconds before the device
2
1
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.
›Theovercurrentfaultwillstopthemotorandbeepfor10
sec.
3
›The fault indication on the LEDs will continue for an
2
additional 10 seconds before the device powers off.
1
›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.
3
›The fault indication on the LEDs will continue for an
2
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.
• MotorPosition Fault:
3 LED 1, 2 alternating at 0.25 sec. rate.
2
›If device is unable to stop at the home position then fault is
1
indicated by beeping for10sec.
›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
asthe needles may not befully retracted.
1

10330010|Rev.A 13
Battery percentage indications in Running state:
3
•BatteryCharged>70%:
2
LED1,2,3ON.
3
•30% < Battery Charge ≤70%:
2
1
LED 1, 2 ON.
3
•15% < Battery Charge ≤30%:
2
1
LED 1 ON.
3
•1% < Battery Charge ≤15%:
2
LED 1 flash on/off 1 sec. rate.
1
3
•Ifthe battery charge is <1% and the user attempts to
2
power on the device, LED 1 will flash at 0.5 second rate
1
for 10 seconds and return to off mode.
1

14 10330010 | Rev.A
BatteryChargeIndicatorinChargingstate:
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.
3
•Battery Charge = 100%:
2
LED 1, 2, 3 OFF to maintain battery longevity.
3
•Battery Charge > 90%:
2
1
LED1,2,3ON.
3
•70% < Battery Charge ≤90%:
2
LED1,2ON,LED 3repeaton/off1sec.
• 30% < Battery Charge ≤70%:
2
1
LED1ON,LED2repeaton/off1sec.
3
2
•Battery Charge ≤30%:
1
LED 1 repeat on/off 1 sec.
3
2
1
1
1
3

10330010|Rev.A 15
14. 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%
Chargewithin 14hours
Working Time >6hours
(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 at50-60 Hz
Charger base transmitting frequency Between 110kHz and 205kHz
with efficiency around 73%

16 10330010 | Rev.A
15. 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'slicense-exempt RSS. Operation
is subject to the following two conditions: (1) This device may not cause
interference; (2) This device must acceptany 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
editionofthismanual.
Declaration of Conformity
Bellus Medical, LLC. Declares that the SkinPen
®
Precision and SkinPen
®
Precision
charger base complies with the following normative documents:
IEC62133,IEC60601-1,IEC60601-1-2,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.

10330010|Rev.A 17
SYMBOL LEGEND
Manufacturer's
trade name
and address
Manufacturer's
catalouge code
Serial Number Batch code
Authorized
Representative
in the European
Community
CE mark (made in
compliance with
93/42EEC Directive
on class I medical
devices)
Do not re-sterilize Do not re-use
Sterilized using
ethylene oxide
Consult Instructions
for Use
Caution
Donotuseif
package
is damaged
Temperature
shipment limits Humidity limitation
Keep dry Not for
general waste
This device includes
RF transmitters
Direct Current
Positive Polarity Use-by date