Related Manuals for Bellus Medical SkinPen Precision 100
Summary of Contents for Bellus Medical SkinPen Precision 100
- Page 1 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...
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Page 2: Table Of Contents
Table of Contents Device Description....................2 Intended Use......................4 Contraindications....................4 Warnings........................4 Precautions......................4 Electrical Safety Warnings................4 Intended Use......................5 Procedure Instructions, Post-Procedure Instructions, Post-Procedure Care..................7 Cleaning of SkinPen Precision & Charger Base........7 ® Storage........................7 Disposal........................8 Warranty.........................8 FAQ & Troubleshooting..................8 Specifications......................10 Environmental Conditions................10 1 SkinPen Precision Rev.V1.0 ®... -
Page 3: Device Description
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. ®... - Page 4 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.
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Page 5: Intended Use
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 ®... -
Page 6: Intended Use
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. - Page 7 *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: • To increase the needle length, adjust on the cartridge according to indicated tick marks on the cartridge.
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Page 8: Procedure Instructions, Post-Procedure Instructions, Post-Procedure Care
• 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. •... -
Page 9: Disposal
• 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 Fault Indications: Speed Fault •... - Page 10 Over Motor Temperature Position Clear Fault Fault Faults • 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. Battery percentage indications in running state: • Battery Charged > 70%: LED 1, 2, 3 ON.
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Page 11: Specifications
® 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. - Page 12 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...
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