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Summary of Contents for Bellus Medical SkinPen Precision
- Page 1 MICRONEEDLING SYSTEM User Manual SkinPen Precision Device ® SkinPen Precision Charger Base ® Engineered, Designed & Made in the USA Inductive Charging SMART Technology Patented Reciprocating Mechanism INTERNATIONAL English...
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Page 3: Table Of Contents
Table of Contents Section Page Device Description ..................2 Intended Use ....................3 Contraindications ..................4 Warnings ......................4 Precautions ..................... 4 Electrical Safety Warnings ................. 5 Instructions for Use ..................6 Procedure Instructions, Post-Procedure Instructions, Post-Procedure Care ................... 10 Cleaning of SkinPen Precision &... -
Page 4: Device Description
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. ®... -
Page 5: Intended Use
SKINPEN PRECISION TREATMENT KIT ® 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 ®... -
Page 6: Contraindications
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 •... -
Page 7: Electrical Safety Warnings
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). •... -
Page 8: Instructions For Use
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. - Page 9 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.
- Page 10 How to install/uninstall disposable SkinPen Precision cartridge: ® Clear Faults • 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 ®...
- Page 11 Additional SkinPen Precision Cartridge Instructions: ® How to adjust needle length: • To increase the needle length, adjust according to indicated INCREASE tick marks on the cartridge. New settings will be indicated by a “click” into place. • Needle settings should be selected based on patient needs. •...
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Page 12: Post-Procedure Instructions, Post-Procedure Care
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. -
Page 13: Storage
• 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. -
Page 14: Faq/Troubleshooting
› 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. - Page 15 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.
- Page 16 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.
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Page 17: Specifications
SkinPen Precision Handpiece ® Model Number SkinPen Precision Charger Base ® Model Number 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... -
Page 18: Environmental Conditions
® 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. - Page 19 SYMBOL LEGEND Manufacturer's Manufacturer's trade name catalogue code and address Serial Number Batch code Authorized CE mark (made in Representative compliance with in the European 93/42EEC Directive Community on medical devices) Do not re-sterilize Do not re-use Sterilized using Consult Instructions ethylene oxide for Use Do not use if...
- Page 20 5005 Lyndon B. Johnson Frwy., Ste. 370 Dallas, TX 75244, USA info@bellusmedical.com www.skinpen.com/international www.bellusmedical.com/international 30 August 2019 | Rev. A 2797 5005341...
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