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 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

[email protected]

www.skinpen.com

www.bellusmedical.com

SkinPen

®

 Precision Rev.V1.0

Содержание SkinPen Precision 100

Страница 1: ...Engineered Designed in the USA Made in the USA Inductive Charging SMART Technology Patented Reciprocating Mechanism User Manual SkinPen Model 100 SkinPen Charger Base Model 101...

Страница 2: ...ectrical 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 Warr...

Страница 3: ...and a BioSheath Each component and accessory will be explained to understand how SkinPen Precision works SkinPen Precision Key Components A Power Indicator B Power On Off Button C Charge Level Indicat...

Страница 4: ...sing 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 inflamm...

Страница 5: ...ons 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 bo...

Страница 6: ...ions warnings and precautions Consult other resources ie IFU for additional information regarding the application of microneedling therapy How to install uninstall disposable SkinPen cartridge Ensure...

Страница 7: ...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 Decrease the needle length by adjusting according to the tick marks on the...

Страница 8: ...ONS 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 Ens...

Страница 9: ...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...

Страница 10: ...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 Battery Charge 90...

Страница 11: ...h 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 re...

Страница 12: ...15223 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...

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