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Summary of Contents for Bellus Medical SkinPen
- 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...
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Page 3: Table Of Contents
Electrical Safety Warnings ............. 5 Instructions for Use ............6 Procedure Instructions, Post-Procedure Instructions, Post-Procedure Care ..............10 Cleaning of SkinPen Precision & Charger Base ....10 ® 10. Storage ..................11 11. Disposal ..................11 12. Warranty ................... 11 13. -
Page 4: Device Description
CAUTION: Federal law restricts this device to sale by or on the order of a physician. Fig 1. SkinPen Precision Components ® SkinPen Precision Handpiece - Part #10130010 / REF 100 Power Indicator Light Power On/Off Button Charge Level Indicator Microneedling Connector Ergonomic Handle Grip... -
Page 5: Intended Use
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. -
Page 6: Contraindications
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 •... -
Page 7: Electrical Safety Warnings
® 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. -
Page 8: Instructions For Use
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. - 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 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.
- Page 11 Additional SkinPen Precision Cartridge Instructions: ® How to adjust needle length: • To increase the needle length, adjust on the cartridge INCREASE according to indicated tick marks on the cartridge. New settings will be indicated by a “click” into place.
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Page 12: Procedure Instructions
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. • Sani-Cloth HB... -
Page 13: Storage
• 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 ®... -
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
14. SPECIFICATIONS Technical Information of SkinPen Precision ® Product Name SkinPen Precision ® 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. -
Page 18: Environmental Conditions
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. - Page 19 SYMBOL LEGEND Manufacturer's Manufacturer's trade name catalouge code and address Serial Number Batch code CE mark (made in Authorized compliance with Representative 93/42EEC Directive in the European on class I medical Community devices) Do not re-sterilize Do not re-use Sterilized using Consult Instructions ethylene oxide for Use...
- Page 20 4505 Excel Parkway, Suite 100 Addison, TX 75001, USA 1.888.372.3982 info@bellusmedical.com www.skinpen.com www.bellusmedical.com 1033001 | Rev. 0086 5005341...
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Questions and answers
My device is charged completely full it won't be able to turn on so I reset it still won't turn on, I also cleaned up with Cavi wipes still won't turn on. Can you please tell me what is problem is?
If your Bellus Medical SkinPen won't turn on despite being fully charged and cleaned, it could be due to a Motor Speed Fault. This fault is indicated by LEDs 1 and 3 alternating at a 0.25-second rate, and the motor will stop after 10 seconds if the fault persists. If this occurs, check for the LED fault indication and listen for the fault sound. If the issue continues, contact Bellus Medical Customer Service for further assistance.
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