Verilux CW01 manual

CW01 Phototherapy System for Acne[...]

2 Please r ead the entir e instruction manual befor e operating the ClearW ave ® Phototherapy System for Acne.[...]

3 T able Of Contents G l o s s a r y ................................................. 4 P r o d u c t D e s c r i p t i o n ........................................ 6 I n d i c a t i o n s f o r U s e ......................................... 8 C o n t r a i n d i c a t i o n s .......................................... 8 I m p o r t a n t S a f e[...]

4 Glossary Acne: Acne is the term for plugged pores (blackheads and whiteheads), pimples and even deeper lumps (cysts or nodules) that occur on the face, neck, chest, back, shoulders and even the upper arms. The sebaceous glands lie just beneath the skin’ s surface. They produce oil called sebum, the skin’ s natural moisturizer . These glands a[...]

5 Severe Nodular Acne: Inflamed pimples and pustules (visible accumulation of pus in skin) with a few deep nodular lesions (solid mass can be felt under skin) that may be raised. Glossary — continued[...]

6 The Clea rW ave ® Photo the rapy Syste m for Ac ne is an o ver -th e-cou nter pho tothe rapeu tic device designed to treat mild to moderate inflammatory acne. Contents Include: a. ClearW ave ® Phototherapy System (Device) ( a 1 ) Light emitting surface with 32 LED lamps b. Device Body c. Replaceable T reatment Head d. Charging Stand e. Power S[...]

7 Product Description — continued Controls a. Power Button b. Head Latch Buttons Status Indicators c. Information Display d. Battery Life Indicator Lights e. T reatment Head Life Indicator Lights f. 32 LED Lamps b. f. a. c. d. e. T reatment Specification • Peak W avelength: 414 nm • T reatment time: 3 minutes • Max Operating T emperatur e:[...]

8 The ClearW ave ® Phototherapy System for Acne is intended to treat mild to moderate inflammatory acne. It is intended for over the counter use. READ ALL INSTRUCTIONS BEFORE USE None known. Indications for Use WARNING: • Do not use this device if you are pr egnant until your healthcare pr ovider authorizes you to use it. • Do not use this de[...]

9 — continued WARNING: • TO REDUCE THE RISK OF FIRE, ELECTRIC SHOCK OR PERSONAL INJUR Y : 1. Always attach the AC/DC power adapter to device first, then into the outlet. 2. Do not place or store the device wher e it can fall or be pulled into a tub or sink. Do not place in or drop into water or other liquid. 3. Keep away all electrical applian[...]

10 — continued CAUTION: • Discontinue use if you encounter any discomfort. Y ou may have sensitivity to light or other condition which can result in skin discoloration, discomfort or pain. Consult with your healthcare pr ovider . • Adjustments or performance of procedur es other than those specified herein may result in injury . • Read all[...]

11 — continued CAUTION: • Keep the cord away fr om heated surfaces. • Never drop or insert any object into any openings on the device. • Use only the power adaptor provided with the ClearW ave Phototherapy System. • Do not operate this device in an environment wher e other devices, which intentionally radiate electromagnetic ener gy in an[...]

12 Risks associated with the ClearW ave ® system Individuals taking medications that cause photosensitivity cannot use the ClearW ave system. The product can cause these individuals redness, rashes or burning. Individuals that are photoreactive and not taking medications that cause photosensitivity will also experience redness, rashes or burning. [...]

CARE & CLEANING 13 Decision Framework The ClearW ave ® Phototherapy System for Acne is an over -the-counter device designed to treat mild or moderate inflammatory acne. Ther e are clinically defined levels of acne. The definitions below are pr ovided as a guide for you to determine if this device is right for you. Dermatologists are special[...]

CARE & CLEANING 14 Decision Framework — continued Guide for Use in the Home or in a Mobile Environment What other conditions can imitate acne A number of skin conditions have commonly been mistaken for acne. The device is not intended for people with other skin conditions known to resemble acne. Pseudofolliculitis (PFB) This is sometimes call[...]

15 Before using the device it is necessary to conduct a skin sensitivity test. Ensure that you follow the instructions to completely char ge the device found on page 16. Step 1 Read the Important Safeguards section on pages 8-11 to ensur e you do not fall into any of the categories mentioned. If you do fall into any of the categories, do not use th[...]

CARE & CLEANING 16 Getting Started Before you use the ClearW ave ® Phototherapy System, you will need to install the battery (see page 21 - How to replace the battery) and fully char ge the device. It takes approximately 12 hours to fully char ge the battery for the first time. Instructions, Operation and Directions for Use Step 1 Step 2 Step[...]

17 I ns tr uc t io ns , O pe ra t io n an d D ir ec ti o ns f or Us e — c on ti n ue d Directions for Using the ClearW ave ® Phototherapy System for Acne Normal Use Operation Step 1 W ash your face or the area which will be treated with the ClearW ave device with a neutral pH cleanser . Step 2 V erify that you know the area you will tr eat and t[...]

18 I ns tr uc t io ns , O pe ra t io n an d D ir ec ti o ns f or Us e — c on ti n ue d Step 5 Place the device against the desired treatment ar ea of your skin. The treatment lights will automatically turn on once in contact with the skin. This indicates that the treatment cycle is beginning. Step 6 Hold the device in place until the device beeps[...]

19 Checking the Status of the Clearwave ® Device Step 1 Be sure the device is turned off. T o place the device into status mode, press and quickly release the power button. The device will r emain in status mode for approximately 30 seconds. Step 2 The batte ry lif e ind icator displ ays t he r espect ive s tatus of bat tery char ge le vels. The d[...]

CARE & CLEANING 20 Replacing the T reatment Head Note: The device monitors each treatment cycle to ensure that the T reatment Head is delivering a complete and effective dose. Once the LEDs have passed their guaranteed 100% output life where a complete treatment dose cannot be assured, the T reatment Head will expire and the device will cease t[...]

CARE & CLEANING 21 How to Replace the Battery I ns tr uc t io ns , O pe ra t io n an d D ir ec ti o ns f or Us e — c on ti n ue d Step 1: With the char ger unplugged, loosen the screw to the battery compartment using a Philips head screwdriver . Step 2: Unplug the battery cable attached to the battery . Step 3: Remove the battery and dispose [...]

22 I ns tr uc t io ns , O pe ra t io n an d D ir ec ti o ns f or Us e — c on ti n ue d Cold Protection Mode When the “Information Display” is displaying “CP”, the device has been exposed to temperatures below -15° Celsius (5°F) and will not operate properly . Set the device aside and allow it to reach room temperatur e before using. Hea[...]

23 After treatment, you will not see noticeable changes to your skin immediately . The visible results may take some time. Visible r esults may be seen between 4 and 11 weeks. Individual results do vary . It is recommended to continue tr eating the area three times a day . The device should be used 2-3 times per week for a maximum of 33 treatments [...]

CARE & CLEANING 24 Please refer to page 20 for tr oubleshooting the installation of the T reatment Head. T roubleshooting The Issue The treatment cycle will not start Device shuts off in cycle The audio signals: 5 beeps The Information Display signals: The Information Display signals: The audio signals: 3 beeps The T reatment Head Indicator Lig[...]

CARE & CLEANING 25 Call your Healthcare Pr ovider If you are unsur e if the medication you are taking may cause a light sensitive reac- tion, contact your healthcare pr ovider . • If you are uns ure o f the t ype of acne you have, ar e curr ently being t reate d for acne or hav e se vere acne, d o no t use t his device unti l you h ave consul[...]

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27 One Y ear Limited W arranty A TTENTION! ONCE OPENED, PLEASE DO NOT RETURN THIS PRODUCT TO THE STORE WHERE IT WAS PURCHASED FOR REP AIR OR REPLACEMENT! Many questions may be answered by visiting www .verilux.com, or you may call our Customer Service Department at 800-786-6850 during normal business hours. This limited w arranty is pr ovided by: V[...]

CW01-MAN-Rev50 Manufactured for V erilux, W aitsfield, VT 05673 Printed in China for V erilux, Inc. © Copyright 2011 V erilux, Inc. All rights reserved. June 2011 This product is cover ed by US Patent(s) and foreign equivalents. Other patent(s) pending.[...]