User & Product Guide

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Duane Quentin Melton
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1 User & Product Guide

3 quick start guide Please make sure SKINCLINICAL reverse is fully charged before proceeding with these steps. To fully charge the device, attach the USB wall mount charger and plug it into the power outlet until Charge Status indicator on the bottom of the product changes from flashing BLUE color to solid BLUE color. Disconnect charger for treatment. 1. Press the on/off button to power-on. 2. The blue and green lights on the handle will illuminate and the LED lens will glow red, indicating the device is ready for use. 3. Place the device lens in contact with your skin and glide along treatment area until it beeps (3 minutes). Repeat for each treatment area. 4. Press the on/off button to power-off.

5 table of contents Introduction...1 Indications for Use...2 Product Benefits...2 Product Overview...3 Sensitivity Test...6 Treatment Protocol...7 Precautions...8 Product Risks...9 Product Care and Maintenance...9 Product Disposal...10 Labeling...11 Troubleshooting...12 Guidelines for Troubleshooting...12 Warranty...14 Declaration of Conformity...15 Warnings...16

6 introduction Congratulations on selecting SKINCLINICAL reverse for your skincare regimen. SKINCLINICAL reverse is a battery-operated, handheld, lightemitting diode (LED) device for the treatment of fine line facial wrinkles. SKINCLINICAL reverse emits gentle doses of red and infrared light leading to a reduction of these wrinkles. Please refer to the treatment protocol for additional information about treatment of fine line facial wrinkles. Before using SKINCLINICAL reverse, please review this manual in its entirety for the important information it provides. Dermatologists and clinicians worldwide have been using LED emitting clinical devices for many years to treat fine line wrinkles with great success. During the natural aging process, we lose appreciable levels of collagen which is the major supporting protein of the skin s cellular structure. As we age, this collagen depletion causes our skin to become more fragile, less able to maintain moisture and as a result thereof, less flexible. Thus begins the dreaded wrinkling process and the loss of that bright eyed vibrance we enjoyed when we were young. The sun s ultraviolet rays do more than just provide a nice sun tan. These UV rays damage our skin s supportive structure which inhibits the production of new collagen. The lack of sufficient replenishing collagen leads to fine lines and wrinkles. 1

7 indications for use SKINCLINICAL reverse is an Over The Counter (OTC) handheld device intended for use in the treatment of full face wrinkles. product benefits SKINCLINICAL reverse LED therapy works with the body s own natural processes to reduce the appearance of facial wrinkles. The SKINCLINICAL reverse system consists of Medical Grade ABS Plastic, ergonomic handheld treatment unit and a separate wall mounted Lithium Polymer battery charger with a standard micro USB connector similar to chargers used on many mobile phones. Please Note: Alternative Wall Chargers should meet the specifications in the Product Care and Maintenance section. When operating SKINCLINICAL reverse from a fully charged condition, the typical treatment time before the green fully charged Power On/Battery Status Indicator color transitions to the yellow Low Charge color is approximately 60 minutes. SKINCLINICAL reverse is tested as fully compliant with international standards to ensure that the emitted light will not harm your eyes. SKINCLINICAL reverse uses the latest state of the art high luminosity narrow spectral bandwidth LEDs with 4 separate wavelengths or colors of light and sophisticated micro controller, control and safety features in its design. These features make it a robust device that will provide many hours of beneficial treatment time and requires no special care other than a soft dry cloth wipedown from time to time. SKINCLINICAL reverse should be used only for the reduction of fine line facial wrinkles. SKINCLINICAL reverse is FDA cleared and classified as a medical device for treatment and reduction of fine line facial wrinkles. 2

product overview IMPORTANT: Please perform the initial Sensitivity Test (see Sensitivity Test section) before beginning the treatment protocols described in the Treatment Protocol section to

8 product overview IMPORTANT: Please perform the initial Sensitivity Test (see Sensitivity Test section) before beginning the treatment protocols described in the Treatment Protocol section to determine if this product is compatible with your skin type. Please read this User & Product Guide in its entirety in advance of the use of this product. SKINCLINICAL reverse is an FDA cleared, battery operated, handheld, Light Emitting Diode (LED) device for the treatment of facial wrinkles. SKINCLINICAL reverse emits completely safe and gentle combined doses of Red and Infrared light to stimulate deeper skin tissue. This light stimulation leads to a reduction of fine line facial wrinkles. Turn ON: Hold SKINCLINICAL reverse in the palm of your hand. Press the on/off button to power-on. The Treatment LED above the on/off button will turn BLUE indicating the unit is ready to use. The Power LED below the on/ off button will also turn on. Turn OFF: Hold SKINCLINICAL reverse in the palm of your hand. Press the on/off button to power-off. Treatment LED (Blue) on/off button Power LED (Yellow or Green) 3

9 When SKINCLINICAL reverse is ON, the Power LED should be green. Green = good battery charge. If the Power LED is YELLOW, this indicates the battery should be recharged. Please turn the power off, attach the USB wall mount charger and plug it into the power outlet until Charge Status indicator on the bottom of the product changes from flashing BLUE color to solid BLUE color. Once solid, the device is ready for use. The Power LED may change from GREEN to YELLOW color and you will hear a beep every 15 seconds advising you that the battery should be recharged. Once the LED turns YELLOW, there is at least 15 minutes of good usage time to complete your treatment cycle. After completing that treatment cycle, power off the device and attach it to the USB wall mount charger for a full charge before the next treatment. To maximize battery life it is best to charge the device only when the Power LED is yellow. It is normal that the plastic case and Stainless Steel ring of the device become warm to the touch during treatment. SKINCLINICAL reverse reduces facial wrinkles with a 3-minute a day per treatment area schedule. (See Fig. 1 for treatment area examples) SKINCLINICAL reverse uses 4 different colors or wavelengths of high intensity LED light to stimulate collagen activity beneath your wrinkles. 4

10 Fig. 1 : Examples of treatment areas. The following image and information will show what to do to accomplish your wrinkle reducing goal. Fig.1 SKINCLINICAL reverse works best by gliding the unit along small localized areas of the face, similar in size to the bubbles shown in the image. 5

sensitivity test Please Conduct This Test One Time Before Beginning Treatment And Within A 7-Day Period Of Product Purchase. Some people may be sensitive to the light outputs of SKINCLINICAL reverse.

11 sensitivity test Please Conduct This Test One Time Before Beginning Treatment And Within A 7-Day Period Of Product Purchase. Some people may be sensitive to the light outputs of SKINCLINICAL reverse. Should you fall within the sensitive group or experience any adverse reaction (which is defined as any pain or discomfort in the treatment area or any skin redness that lasts for longer than 2 hours after treatment), the device may not be suitable for you. Your sensitivity to the LED output of the device can be established by the following tests. LED Light Sensitivity Test: 1) Turn on SKINCLINICAL reverse unit and touch the aperture to your right forearm leaving it in contact without movement for 4 minutes. (See Fig. 2) Fig.2 2) The light output may result in a slight reddening of your skin for a period of 2 hours after application. This is normal. 3) If any redness or discomfort remains for any period longer than 2 hours, this product is not suitable for you and you may return it with your original receipt within 7 days from the date of purchase for a full refund. 6

12 treatment protocol Before treatment with the device, it is recommended that you use a high quality skin cleanser or exfoliating product to remove cosmetic dirt and oily residues from your face. The treatment protocol is simple: select a treatment area and use SKINCLINICAL reverse for 3 minutes a day on that treatment area. Do this at least 5 days a week for a period of 8 weeks. See Fig. 1 for treatment area examples --- For best results, keep the treatment area for each 3 minute session small and localized, following a 2 inch path along the lines of bubbles shown in Fig 1. Select a few treatment areas to concentrate on and continue the daily regimen for at least 8 weeks. Facial wrinkles do not appear overnight and they will not disappear overnight, so it is important to continue the daily regimen for optimal results. Note: For each treatment session, please keep the device in contact with the skin, while gliding it back and forth along the treatment area. Note: You will hear a beeping sound from SKINCLINICAL reverse as follows: a) Long beep when SKINCLINICAL reverse is turned on. b) Three beeps during treatment advising when the 3-minute treatment time is completed. c) Two beeps when SKINCLINICAL reverse is turned off. d) One single beep every 15 seconds advising you that SKINCLINICAL reverse needs its battery recharged. You should notice a decrease in your wrinkles over a 3 to 7 week period after the completion of the treatment sessions. 7

13 Some people see improvement during the treatment period but predicting results for all users during the treatment period is not possible. SKINCLINICAL reverse LED energy stimulates natural biological processes which lead to reduction of wrinkles. This process is cumulative and continues after the treatment sessions have stopped so it is imperative that you follow the treatment daily usage protocol. precautions For best results, please clean or wipe down SKINCLINICAL reverse before treatment with a clean soft dry cloth. You may use a soft cloth dampened with Isopropyl Alcohol to clean the stainless steel retainer and polycarbonate lens only. For protection from risk of damage to SKINCLINICAL reverse, do not leave any of the components in direct sunlight or in a storage area which may exceed 50 degrees Celsius / 122 degrees Fahrenheit. Charge SKINCLINICAL reverse ONLY with the wall charger unit that is in the product package. 8

14 product risks 1) Please note that in a typical application you may notice a slight reddening (erythema) over the treated area which should clear up within 2 hours. Should this reddening or any perceived discomfort remain longer than 2 hours after treatment, you may be sensitive to one or more of the wavelengths of LED light. If you have this sensitivity response, please cease using SKINCLINICAL reverse and seek advice from a healthcare professional. (Note skin sensitivity test on page 5 of the User Guide.) 2) Please note warnings on Pages of this manual explaining who should or should not use the device and other general warnings noted in this manual. SKINCLINICAL reverse meets or exceeds International eye safe standards ensuring that the LED power and wavelength outputs will not harm your eyes. product care and maintenance Please keep the lens / stainless steel retainer assembly clean and avoid scratching the lens as the LED light may be reduced in efficiency which can lead to a decrease in effectiveness of treatment. SKINCLINICAL reverse s plastic housing may be cleaned ONLY with a clean soft dry NON-ABRASIVE cloth OR an Isopropyl Alcohol wipe. Please follow these guidelines as cleansers or other more caustic materials may damage both the housing and the lens surface. The wall charger unit should not require any cleaning. If you choose to do so, ALWAYS unplug it and ONLY wipe the outside surfaces with a DRY cloth. 9

15 The wall charger unit is designed to operate with an electrical input between Volts, at Cycles. The provided U.L. listed wall charger unit uses a Micro USB type interface plug and is designed to operate with an electrical input between 90 and 250 Volts, at 50 to 60 Cycles. This unit provides a constant current rating of at least 500Ma (the ratings for any wall charger should be printed on the housing of any wall charger unit). NOTE: Any Micro USB Alternate or Substitute wall charger unit MUST comply with the specifications listed above for reliability and safe operation of SKINCLINICAL reverse. For areas outside the United States, please purchase a CE or UL listed approved mating / conversion plug which conforms to the wall socket electrical standards for that country. product disposal To protect our environment, please return SKINCLINICAL reverse in its original packaging to SKINCLINICAL for proper unit and Lithium Battery disposal. 10

16 labeling Labels on the underside of SKINCLINICAL reverse are for indication and operation. The label on the bottom of SKINCLINICAL reverse contains the following information: Model Number, Design / Manufacturer Data and CE marking. A date specific laser etched serial number above the USB connector. The label on the back side of the wall charger unit contains the following information: Model Number Design/ Manufacturer Data CE/UL marking Electrical operational parameters Bottom View Treatment LED (Blue) on/off button Power LED (Yellow or Green) Charge Status Indicator Flashing BLUE = Charging Solid BLUE = Fully charged Charger connection 11

17 troubleshooting SKINCLINICAL records and analyzes all possible faults or issues reported to us as per FDA guidelines. The majority of user issues or difficulties should have a simple solution and are listed in the troubleshooting guidelines below. However, if the recommended procedure did not fix or address the problem or the problem reoccurs, please contact SKINCLINICAL by (customerservice@skinclinical.com) to address the concerns and if necessary to arrange service. Please note that any service under the Warranty MUST be preceded by contact with our service personnel who will provide the required RMA (Return Merchandise Authorization) number for reference. This RMA procedure allows us to improve our product through ISO Quality improvement programs and if needed to accurately track and report issues to the FDA as well as provide tracking date for any warranty repair or replacement of the product. guidelines for troubleshooting 1) No BLUE Treatment light or GREEN or YELLOW Power LED s light up after pressing the on/off button: Quick Solution: Please plug SKINCLINICAL reverse into the wall charger and note the BLUE Charge Status LED located near the USB connector on the bottom of the unit. If this LED is flashing blue, please fully charge the unit until the LED turns solid blue (not flashing). If the BLUE Charge Status LED is solid BLUE, but the Power LED is not GREEN or remains YELLOW, please contact SKINCLINICAL for service. 2) No Red LED light is visible from the lens area with SKINCLINICAL 12

18 reverse powered up (ie: Power LED is GREEN and the Treatment LED is BLUE): Quick Solution: Please touch the lens and stainless steel retainer to your skin, and the light will come on. Note: If the RED LED light from lens area fails to operate with: A) The BLUE Treatment LED visibly bright. B) The GREEN Power LED visibly bright. Please contact SKINCLINICAL for service. 3) Important Note: 4 of the LEDs are Infrared and you will likely not be able to see any light from them. Some people are able to notice a faint orange glow from them but if the RED treatment LEDs are visible from the lens area, then the infrared LEDs will also be on since the same circuitry powers both RED and infrared LEDs. 4) If the Treatment LEDs or any LEDs for battery status or treatment appear to flicker, are intermittent or do not turn on at all, please contact SKINCLINICAL for service. 5) If after any inadvertent impact to your SKINCLINICAL reverse, the plastic housing part becomes cracked, is dislodged or broken off, please immediately discontinue usage and contact SKINCLINICAL for service. Note: No modification of this product is allowed. 13

19 warranty Your SKINCLINICAL reverse is warranted to be free from defect in material and workmanship for a period of one year from its original purchase date. This warranty extends only to the original retail purchaser and only when purchased from an authorized retailer of this product. If the product should become defective within the warranty period, contact SKINCLINICAL via one the following methods for repair or replacement: For Customer Service Team Call the business office at: 1(800) us at: customerservice@skinclinical.com Standard mail correspondence to: SKINCLINICAL 449 N Canon Drive, Beverly Hills, CA SKINCLINICAL reserves the right to replace a defective product with a most comparable product currently available. This warranty does not cover products damaged by the following: Accident, misuse, abuse, alteration, service by unauthorized personnel, use with unauthorized accessories, connection to incorrect current and voltage, and any other conditions beyond our control. SKINCLINICAL SHALL NOT BE RESPONSIBLE FOR ANY INCIDENTAL, SPECIAL, OR CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OF THIS PRODUCT. ALL IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF FITNESS FOR PARTICULAR USE AND MERCHANTABILITY ARE LIMITED IN DURATION TO ONE YEAR FROM THE DATE OF ORIGINAL PURCHASE. 14

20 NOTE: This warranty gives you specific legal rights, and you may also have other rights that vary from state to state. Consult your local consumer protection agencies to verify if the above limitations and exclusions apply to you. declaration of conformity: SKINCLINICAL reverse meets the following International Safety Classifications: EC AND EU DIRECTIVE 2006/25/ECIEC classifies SKINCLINICAL reverse as RG-0 Exempt : no photobiological hazard. SKINCLINICAL reverse emits no potentially hazardous sub-400 nanometer violet radiation and its outputs levels of light energy are far below and outside of levels considered hazardous to the human optical path. SKINCLINICAL reverse meets applicable EMC/EMI IEC Safety criteria and is electrically classified as a home use/user safe CISPR 11Group 1 Class B device. SKINCLINICAL reverse meets applicable safety requirements under ANSI/ANSI :2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Part 1 General Requirements for Basic Safety and Essential Performance. IEC classifies Medical Devices with electrically conductive parts that are isolated or floating from earth ground as Applied Parts. The floating Applied Part on SKINCLINICAL reverse is the Stainless Steel Ring and the International Type symbol for such classification is below: Type-BF 15

21 warnings Contact your healthcare professional as soon as possible if you experience an adverse reaction from the use of the SKINCLINICAL reverse. An adverse reaction is any pain or discomfort in the treatment area or any skin redness that lasts for longer than two hours (please see Sensitivity Test section). Failure to seek medical assistance in the event of suspected adverse reaction may result in the worsening of that reaction. DO NOT use SKINCLINICAL reverse for any purpose other than the reduction of fine line facial wrinkles. DO NOT use SKINCLINICAL reverse if you are or may be pregnant. The safety of the treatment on pregnant women has NOT been tested and the risk is unknown. DO NOT use SKINCLINICAL reverse on the base area of your neck. Light stimulation of the Thyroid Gland located in this area is not advised in any way as the effects are unknown. DO NOT try and force the plug of the wall charger unit into an outlet. The wall charger plug is a standard 2 prong USA configuration and it can be used internationally simply by plugging the 2 prongs into a country specific adapter plug. DO NOT attempt to charge SKINCLINICAL reverse with any alternative wall charger unit that is not identical in performance and safety characteristics to the supplied UL Listed wall charger unit (see Product Care and Maintenance section). 16

22 DO NOT position the wall charger unit near any water source or liquid container. DO NOT use SKINCLINICAL reverse or the wall charger unit when bathing or standing in water. DO NOT use SKINCLINICAL reverse or the wall charger unit if either becomes immersed in any liquid or any appreciable quantity of liquid has spilled onto either. DO NOT use the wall charger unit if the body plug or the cord appears damaged in any way. DO NOT use SKINCLINICAL reverse if it appears damaged in any way. DO NOT remove any covers from SKINCLINICAL reverse or the wall charger unit. There are no user serviceable components on the SKINCLINICAL reverse components. Opening or removing the covers may expose you to dangerous voltages or other risks, and will void the product warranty. DO NOT allow children under the age of 16 to handle or operate the device in any way. DO NOT allow SKINCLINICAL reverse to come in contact with water or water based cleaning products. You may use isopropyl alcohol cloth wipes if desired. DO NOT store or operate SKINCLINICAL reverse in either dusty/dirty areas or direct prolonged sunlight exposure as this may damage or warp the housing assemblies. 17

23 TO REDUCE THE RISK OF SERIOUS INJURY OR FATAL ELECTRICAL SHOCK, always disconnect SKINCLINICAL reverse from the wall charger unit prior to any cleaning. NOTE: SKINCLINICAL reverse WILL NOT turn on or function while plugged into ANY Wall Charger Source. Product specifications are subject to change without notice at the sole discretion of SKINCLINICAL. This manual may not be reproduced, transmitted, transcribed, or translated into any language, in whole or in part, by any means or in any form whatsoever without the prior written consent of SKINCLINICAL. 18

Wrinkle Reducer. Attachment USER MANUAL

Wrinkle Reducer. Attachment USER MANUAL Wrinkle Reducer Attachment USER MANUAL TABLE OF CONTENTS 01 Introduction 02 Ideal User 02 Getting to Know Your Device 02 Before Using Your Attachment 03 Usage Instructions 03 Indications for Use 03 Contraindications