Crown Aesthetics SkinPen Precision Elite User Manual

Microneedling system

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MICRONEEDLING SYSTEM

User Manual/

Instructions for Use

SkinPen

Precision Elite Device

SkinPen

Precision Elite Charger Base

Inductive Charging

SMART Technology

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Summary of Contents for Crown Aesthetics SkinPen Precision Elite

Page 1 MICRONEEDLING SYSTEM User Manual/ Instructions for Use SkinPen Precision Elite Device ® SkinPen Precision Elite Charger Base ® Inductive Charging SMART Technology...
Page 3: Table Of Contents
TABLE OF CONTENTS Section Page Device Description.......................2 Intended Use .......................3 Contraindications ......................3 Warnings ........................4 Precautions ........................4 Electrical Safety Warnings ..................4 Instructions for Use ....................13 Cleaning of SkinPen® Precision Elite & Charger Base ..........20 Storage ........................21 Disposal ........................21 Warranty ........................21 FAQ & Troubleshooting ....................22 Specifications ......................23 Environmental Conditions ..................24 Clinical Study Summary –...
Page 4: Device Description
1. DEVICE DESCRIPTION The SkinPen® Precision Elite 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 Elite works. CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Page 5: Intended Use
22 years and older. 3. CONTRAINDICATIONS The use of the SkinPen Precision Elite 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) •...
Page 6: Warnings
• For your safety from electrical shock, the SkinPen® Precision Elite and/or SkinPen® Precision Elite Charger base should not be opened or disassembled for trouble-shooting purposes. • Do not use any equipment not designed specifically for SkinPen Precision Elite as to avoid interference with the device's intended performance.
Page 7 (CISPR 11 class A). • The charger base transmitting frequency is between 110kHz and 205kHz. • SkinPen Precision Elite & Charger base is suitable for use in industrial areas and hospitals • WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the REF 200 SkinPen®...
Page 8 Guidance and manufacturer’s declaration – electromagnetic immunity The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen®...
Page 9 Guidance and manufacturer’s declaration – electromagnetic immunity The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, should assure that it is used in such an environment.
Page 10 Guidance and manufacturer’s declaration – electromagnetic immunity The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, should assure that it is used in such an environment.
Page 11 Recommended separation distances between portable and mobile RF communications equipment as well as RF wireless communications equipment and the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base. The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 12 EMC - BATTERY Guidance and manufacturer’s declaration – electromagnetic emissions The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, should assure that it is used in such an environment.
Page 13 Guidance and manufacturer’s declaration – electromagnetic immunity The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, should assure that it is used in such an environment.
Page 14 Guidance and manufacturer’s declaration – electromagnetic immunity The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in the electromagnetic environment specified below. The customer or the user of the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, should assure that it is used in such an environment.
Page 15: Instructions For Use
Recommended separation distances between portable and mobile RF communications equipment as well as RF wireless communications equipment and the REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base. The REF 200 SkinPen® Precision Elite Handpiece with REF 201 SkinPen® Precision Elite Inductive Charging Base, is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Page 16 PROCEDURE INSTRUCTIONS 1. Have patient complete consent form. 2. Explain the SkinPen® procedure to the patient and set expectations. 3. Apply single use, non-latex gloves. 4. Cleanse patient’s face with a gentle cleansing complex to effectively remove makeup, sunscreen and surface oils. 5.
Page 17 10. Install cartridge when prompted (Note that the arrow will blink) • Open the cartridge package by holding it right-side up and pulling back the protective covering at the sealed chevron. • Grasp cartridge at locking end for attachment to handpiece. Use aseptic technique to ensure depth cup and needles remain sterile.
Page 18 • If either of the following images appear, the device will not function without a new cartridge: o Cartridge is Invalid – means that the cartridge is not valid for use with the SkinPen® Precision Elite device o Used Cartridge– means that the cartridge has been used and cannot be used again.
Page 19 * 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 cartridge. New settings will be indicated by a “click” into place. CLICK 13.
Page 20 When prompted to Remove Cartridge, do the following: • To remove the cartridge, hold the SkinPen Precision Elite perpendicular to the floor, or with the cartridge attachment tip pointing downwards. Use one hand to rotate the cartridge “unlock” position to be in line with the pen tip triangle, and pull the cartridge off the device.
Page 21 Take “after” pictures before next appointment. 20. Remove biosheath. • With the SkinPen Precision Elite device perpendicular to the floor, with the tip pointed downwards, and pull apart the adhesive strip of the BioSheath. • Remove the BioSheath by carefully rolling it down the SkinPen Precision Elite to prevent soiling the handpiece.
Page 22: Cleaning Of Skinpen® Precision Elite & Charger Base
SkinPen® Precision Elite for more than 3 minutes, according to their directions for use, found on the Sani-Cloth AF3 labeling. Attention should be paid to clean areas such as crevices, seams, and areas around where the SkinPen Precision Elite Cartridge attaches to the device. • Sani-Cloth AF3 GUIDELINES FOR USE: SPECIAL INSTRUCTIONS FOR CLEANING &...
Page 23: Storage
• Do not use solvents to clean device unless specified in the General Disinfection Method. 9. STORAGE • For optimal performance of your SkinPen Precision Elite®, ensure the device is turned off and store the device in the SkinPen® Precision Elite charging base when not in use.
Page 24: Faq/Troubleshooting
12. FAQ/TROUBLESHOOTING Fault Indications: the following screen indicates an error in the device. Please refer to the table below for specific error code definition and how to troubleshoot. Error Code Number Error Code Issue How to Troubleshoot System Problem that Try powering off and on again.
Page 25: Specifications
SkinPen® Precision Elite SkinPen® Precision Elite Handpiece Model Number SkinPen® Precision Elite Charger Base Model Number Crown Aesthetics FDA Registration # 3010392991 FCC ID 2AGLK-101 (SkinPen® Precision Elite Charging Base), 2AGLK-REF-200 (SkinPen® Precision Elite Handpiece) 21314-101 (SkinPen® Precision Elite Charging Base), 21314-REF200 (SkinPen®...
Page 26: Environmental Conditions
IEC 62133, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366, ISO 14971 IEC 62304, MDR 2017/745, RoHS, IEC 60601-1-6, IEC 60529, ISO 10993-1. We Crown Aesthetics accept not having the SGS Mark on the SkinPen® Precision Elite device label, but our product is 60601 certified.
Page 27: Clinical Study Summary - Acne Scars
Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Changes or modifications not expressly approved by Crown Aesthetics could void the user's authority to operate the equipment.
Page 28 Table 1: Summary of Demographic Information SkinPen Precision System All Subjects Age (years) Mean (standard deviation) 43.8 (12.7) 44 (11.9) Minimum, Median, Maximum 23, 48, 60 21, 46, 60 Male 31.7 Female 68.3 Ethnicity Hispanic or Latino 31.7 Not Hispanic or Latino 68.3 Race American Indian or Alaska Native...
Page 29 Table 2: Study Endpoints Primary Acne Scar Assessment Scale graded by two blinded dermatologists using effectiveness photographs taken at baseline, day 30, day 60, 1-month post-treatment, and endpoints 6-months post-treatment Clinician’s Global Aesthetic Improvement Assessment graded by two blinded dermatologists using photographs taken at 1-month post-treatment, and 6-months post-treatment Secondary Self-assessed Scar Improvement Scale completed by subjects at baseline,...
Page 30 In addition to the clinician graded effectiveness measures, the following patient-reported measures were recorded throughout the study: • Self-assessed Scar Improvement Scale Table 4: Self-assessed Scar Improvement Scale Rating Description Exacerbation of Acne Scars No change in appearance of acne scars 1% - 25% improvement in appearance of acne scars 25% - 50% improvement in appearance of acne scars 50% - 75% improvement in appearance of acne scars...
Page 31 Results: Safety: At the 6-month post-treatment visit, no adverse events persisted. The following common treatment responses were reported in the subject safety diaries which were sent home with the subject: • Dryness in 5/41 (12%) subjects lasting from 1-6 days o These responses were reported by 3 subjects with FST III, 1 subject with FST VI, and 1 subject with FST V •...
Page 32 Table 6: Results of Photo Grading of Acne Scar Assessment Scale for SkinPen Precision System Time Point Mean Standard Deviation Minimum Median Maximum Baseline 2.80 0.52 2.00 3.00 4.00 Day 30 2.78 0.57 2.00 2.75 4.00 Day 60 2.70 0.55 2.00 2.50 3.50...
Page 33 Patient Satisfaction Questionnaire: The results of the patient satisfaction questionnaire for all subjects indicated that a greater proportion of subjects selected favorable responses regarding treatments at 1 month and 6 months post-treatment for the following inquiries: • Question 1: Do you notice any improvement in how your acne scars look in the treated area? Table 8: Results of Patient Satisfaction Questionnaire - Question 1 Time Point Yes [N (%)]...
Page 34: Clinical Study Summary - Wrinkles
16. CLINICAL STUDY SUMMARY – WRINKLES A clinical study was conducted to support the safety and effectiveness of the SkinPen Precision System for the treatment of wrinkles on the neck. The single center study was conducted on a total of 35 subjects (2 male and 33 female), aged 44 years and older from various ethnic groups with multiple skin tones (pale to dark skin).
Page 35 Table 12: Study Endpoints Primary G. Lemperle Wrinkle Scale graded by two blinded graders using photographs Effectiveness taken at day 1 and 3-months post-treatment Endpoints Secondary Clinician’s Global Aesthetic Improvement Assessment graded by two blinded Effectiveness graders using photographs taken at day 1 and 3-months post-treatment Endpoint Subject Global Aesthetic Improvement Scale completed by subjects at 1-month post-treatment, and 3-months post-treatment...
Page 36 • Subject’s Global Aesthetic Improvement Scale Table 15: Subject Global Aesthetic Improvement Scale Rating Description Very Much Improved: Optimal cosmetic result. Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal. Improved: Obvious improvement in appearance from initial condition. No Change: The appearance is essentially the same as the original condition.
Page 37 Benefits: What will a SkinPen Precision Treatment accomplish, and what did the clinical study show? The study doctors reported using the G. Lemperle Wrinkle Scale: Results of the photo grading indicated a significant improvement in wrinkles on the neck area assessment at 3 months post- treatment.
Page 38 Subjects reported using the Patient Satisfaction Questionnaire: The results of the patient satisfaction questionnaire for all subjects indicated that a greater number of subjects selected favorable responses regarding treatments at 1 month and 3 months post-treatment for the following inquiries •...
Page 39 SYMBOL LEGEND Manufacturer’s Manufacturer’s trade name catalogue code and address Serial Number Batch code Authorized Representative CE mark in the European Community Do not re-sterilize Do not re-use Sterilized using Consult Instructions ethylene oxide for Use Do not use if Caution package is damaged Temperature...
Page 40 5005 Lyndon B Johnson Fwy, Ste 370 Dallas, TX 75244, USA 1.888.372.3982 info@crownaesthetics.com 802628 www.skinpen.com ANSI/AAMI ES60601-1 www.crownaesthetics.com CSA C22.2 No.60601-1 PN#P5SP221...