BELLUS MEDICAL 101 SkinPen Precision Charger User Manual Manual
BELLUS MEDICAL, LLC SkinPen Precision Charger Manual
Manual
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| Document Description | Manual |
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| Date Submitted | 2016-05-05 00:00:00 |
| Date Available | 2016-05-05 00:00:00 |
| Creation Date | 2016-04-10 20:02:16 |
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| Document Lastmod | 2016-04-10 20:02:23 |
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User Manual
SkinPen® Model #100
SkinPen® Charger Base Model #101
Engineered
& Designed
in the USA
Made in the USA
Inductive Charging
SMART Technology
Patented
Reciprocating
Mechanism
Table of Contents
1.
Device Description...............................................................................................2
2.
Intended Use.........................................................................................................4
3.
Contraindications.................................................................................................4
4.
Warnings................................................................................................................4
5.
Precautions............................................................................................................4
6.
Electrical Safety Warnings................................................................................4
7.
Intended Use.........................................................................................................5
8.
Procedure Instructions,
Post-Procedure Instructions,
Post-Procedure Care..........................................................................................7
9.
Cleaning of SkinPen® Precision & Charger Base........................................7
10.
Storage....................................................................................................................7
11.
Disposal..................................................................................................................8
12.
Warranty.................................................................................................................8
13.
FAQ & Troubleshooting......................................................................................8
14.
Specifications......................................................................................................10
15.
Environmental Conditions..............................................................................10
1 SkinPen® Precision Rev.V1.0
1. DEVICE DESCRIPTION
The SkinPen® Precision device consists of a microneedling pen, sterile
needle cartridge, and hydrogel. The accessories are a charging base and a
BioSheath. Each component and accessory will be explained to understand
how SkinPen® Precision works.
Fig 1.
SkinPen® Precision Key Components
Power Indicator
Power On/Off Button
Charge Level Indicator
Microneedling Connector
Ergononic Handle Grip
Base Charger AC/DC Adapter
Inductive Charging Base
SkinPen® Precision Rev.V1.0 2
SKINPEN® TREATMENT KIT
INCLUDES:
Microneedling Cartridge
EO (Ethylene Oxide) Sterilized, disposable
needle cartridge packaged and labeled individually.
Proprietary needle cartridge.
BioSheath
The SkinPen® Precision and needle cartridge interface
with a nonsterile and disposable BioSheath to prevent
contamination of the SkinPen® Precision.
LIFT HG
Lift HG is a hydrogel wound dressing without drugs
and/or a biologic to protect against abrasion and friction
during the microneedling procedure.
RESCUE Calming Complex
Key ingredients assist in reducing the risk of prolonged
inflammation post-procedure.
NUMB Topical Analgesic
Skinfuse® NUMB is a OTC 5g individual pre-procedure
packet (4% lidocaine) that will provide patient comfort
during the procedure by topically numbing the area
receiving the microneedling procedure. The single-use
packet reduces the risk of cross-contamination.
3 SkinPen® Precision Rev.V1.0
2. INTENDED USE
SkinPen® Precision is a microneedling device to improve the appearance of
fine lines, wrinkles, and scars on the face and body. Rx Only.
3. CONTRAINDICATIONS
The use of SkinPen® Precision should not be used on patients with active skin
cancer or active bacterial, fungal or viral (i.e. herpes, warts) skin infections in
the treatment area(s).
4. WARNINGS
SkinPen® Precision has not been evaluated in the following patient populations,
and as such, precautions should be taken when determining whether to treat
patients with a history of the following conditions: Eczema, psoriasis, and other
chronic conditions in the treatment area; herpes simplex infections; keloid
scars; patients on anticoagulants; scars and stretch marks less than one year
old; scleroderma; and wound-healing deficiencies.
5. PRECAUTIONS
Universal precautions are necessary during microneedling. Microneedling
should not be used within the orbital rim, such as the eyelids. Special care
needs to be exercised on patients with the following conditions or on the
following medications: Actinic (solar) keratosis; active acne; allergies to
stainless steel; collagen vascular diseases or cardiac abnormalities; diabetes;
eczema, psoriasis and other chronic conditions on other areas of the body;
immunosuppressive therapy; irritated skin in the treatment area; history
of contact dermatitis; hemorrhagic disorder or hemostatic dysfunction;
isotretinoin drugs, pregnancy or nursing; open wounds or sores; irritated
skin; raised moles in the treatment area; and rosacea.
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. (90-264Vac).
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
SkinPen® Precision Rev.V1.0 4
•
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.
7. INTENDED 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 install/uninstall disposable SkinPen cartridge:
Clear
Faults
• Ensure SkinPen® Precision is powered off.
• Align the lock and key mechanism on the
SkinPen® Precision microneedling cartridge and
the SkinPen® Precision device.
MALE
FEMALE
LOCK
• Rotate counterclockwise onto the SkinPen® Precision
until secure.
• To remove the cartridge rotate clockwise 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.
UNLOCK
5 SkinPen® Precision Rev.V1.0
*If a SkinPen® Precision Cartridge becomes inadvertently
contaminated during installation (ie. Dropped on floor, needles
subjected to possible contamination), discard, and obtain new
SkinPen® Precision cartridge.
Additional SkinPen® Precision Cartridge Instructions:
How to adjust needle length:
INCREASE
• To increase the needle length, adjust on the cartridge
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.
DECREASE
• If even erythema (redness) is not seen, gradually increase
the depth to a maximum of 1.5mm on the face and
up to 2.5mm on the body.
*Lower the setting of the cartridge to 0.25-0.5mm 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.
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.
SIV
HE
AD
• 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.
SIV
HE
AD
SkinPen® Precision Rev.V1.0 6
• To remove BioSheath simply peel off of the
SkinPen® Precision and *discard appropriately.
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”.
Clear
Power:
Faults
• ON: Press and hold power button for 2 seconds.
• OFF: Press and hold power button for 2 seconds.
8. PROCEDURE INSTRUCTIONS,
POST-PROCEDURE INSTRUCTIONS,
POST-PROCEDURE CARE
•
For Procedure, Post-Procedure instructions, and Post-Procedure
Care refer to SkinPen® IFU Rev.V1.0.
9. CLEANING OF SKINPEN PRECISION AND CHARGER BASE
*Ensure SkinPen® Precision device is powered down before cleaning,
and SkinPen® Precision charger base is unplugged.
•
•
•
Sani-Cloth® wipes may be used to clean SkinPen® Precision after
each procedure. Sani-Cloth® wipes may also be used to clean the
SkinPen® Precision Charger Base.
Do not immerse in liquids.
Do not use solvents to clean device.
10. STORAGE
•
For optimal performance of you SkinPen® Precision, ensure the
device is turned off and store the device in the SkinPen® Precision
charging base when not in use.
7 SkinPen® Precision Rev.V1.0
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 battery, SkinPen® Precision must be
disposed of separately from household waste. When SkinPen®
Precision reaches its end of life, contact local authorities to learn
bout disposal and recycling options.
12. WARRANTY
•
•
•
One year under normal use after its original purchase.
Warranty extends only to the original purchaser and purchase date.
Contact Bellus Medical, LLC Customer Service at 1.888.372.3982
for warranty inquiries.
•
Warranty does not cover:
• Defects due to negligence, alteration, modification,
or installation by anyone other than factory
authorized personnel.
• Abuse or misuse.
• Attempted or actual dismantling, disassembling, service,
or repair not specifically authorized by Bellus Medical, LLC.
13. FAQ/TROUBLESHOOTING
Motor
Speed
Fault Indications:
Fault
• Motor Speed Fault:
LED 1, 3 alternating at 0.25 sec. rate.
›
Device will turn off and fault is indicated by
beeping for 10 sec.
Over
Over
Current
Fault
Temperature
Fault
• Over Current Fault:
LED 3 flashing at 0.25 sec. rate.
›
Device will turn off and fault is indicated by
beeping for 10 sec.
Over
Motor
Temperature Position
Fault
Fault
• Over Temperature Fault:
LED 2 flashing at 0.25 sec. rate.
Temperature
is over 65°C.
› Device will turn off and fault is indicated by
beeping for 10 sec.
SkinPen® Precision Rev.V1.0 8
Over
Motor
Temperature Position
Fault
Fault
Clear
Faults
• Motor Position Fault:
LED 1, 2 alternating at 0.25 sec. rate.
1
› If device is unable to stop at the home position
then fault is indicated by beeping for 10 sec.
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, LED1 will flash at 0.5 second rate
for 10 seconds and return to off mode.
Battery Charge Indicator in Charging state:
70% <
Battery
Charge
30% <
• Battery Charge > 90%:
LED 1, 2, 3 ON.
• 70% < Battery Charge ≤ 90%:
LED 1, 2 ON, LED 3 repeat on/off 1 sec.
Battery
Charge
• 30% < Battery Charge ≤ 70%:
LED 1 ON, LED 2 repeat on/off 1 sec.
• Battery Charge ≤ 30%:
LED 1 repeat on/off 1 sec.
9 SkinPen® Precision Rev.V1.0
14. SPECIFICATIONS
Technical Information of SkinPen® Precision
Product Name SkinPen® Precision
SkinPen® Precision Model Number
100
SkinPen® Charger Base Model Number
101
Bellus Medical FDA Registration #
# 3010392991
Weight and Unit
5oz / 155mm length and
max. outer diameter of 34mm
Electrical Requirements
Input voltage: 4.2V
Output voltage:
5V battery
Charger Time
From 10% charge to 90%
charge within 12 hours
Working Time
> 6 hours
(under normal use conditions)
Speed 6300RPM – 7700RPM
Needles
14 pin, 32g, Stainless Steel
Operation Cordless
AC Adapter
Medical Grade, 5VDC +/- 5%,
1A minimum, 59” length
15. ENVIRONMENTAL CONDITIONS
Operating conditions:
Temperature: 15-30°C
Relative humidity: 30-75%
relative humidity non-condensing
Transportation conditions:
Temperature: -20-60°C
Relative humidity: 10-98%
relative humidity non-condensing
This user manual is valid for SkinPen® Precision, the SkinPen® Precision
Charger Base (with AC adapter), SkinPen® Precision BioSheath and
SkinPen® 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.
SkinPen® Precision Rev.V1.0 10
SkinPen® Precision Rev.V1.0
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, IEC60601-1-2, IEC 60601-1, IEC 62366,
ISO 14971:2012, IEC 62304, ISO:13485:2003, MDD 93/42/EEC, RoHS,
ISO15223:2012, IEC 60601-1-6, IEC 60529, IEC 62304, ISO 10993-1,
ISTA-2A, IEC 62133, UN 38.3
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.
12001 North Central Expressway
Suite 250
Dallas, TX 75243
1.888.372.3982
info@bellusmedical.com
www.skinpen.com
www.bellusmedical.com
SkinPen® Precision Rev.V1.0
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