Page 3 - Table Of Contents
3 Table Of Contents Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . ....
Page 4 - Glossary
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...
Page 5 - Inflamed pimples and pustules (visible accumulation; Glossary — continued
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
Page 6 - Product Description
6 The ClearWave ® Phototherapy System for Acne is an over-the-counter phototherapeutic device designed to treat mild to moderate inflammatory acne. Contents Include: a. ClearWave ® Phototherapy System (Device) ( a 1 ) Light emitting surface with 32 LED lamps b. Device Body c. Replaceable Treatment H...
Page 7 - Product Description — continued; Dimensions
7 Product Description — continued Controlsa. Power Button b. Head Latch Buttons Status Indicatorsc. Information Display d. Battery Life Indicator Lights e. Treatment Head Life Indicator Lights f. 32 LED Lamps b. f. a. c. d. e. Treatment Specification • Peak Wavelength: 414 nm • Treatment time: 3 min...
Page 8 - READ ALL INSTRUCTIONS BEFORE USE; Indications for Use
8 The ClearWave ® 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 pregnant until your healthcare provider autho...
Page 9 - — continued
9 — continued WARNING: • TO REDUCE THE RISK OF FIRE, ELECTRIC SHOCK OR PERSONAL INJURY: 1. Always attach the AC/DC power adapter to device first, then into the outlet. 2. Do not place or store the device where it can fall or be pulled into a tub or sink. Do not place in or drop into water or other l...
Page 11 - functioning properly.; SAVE THESE INSTRUCTIONS
11 — continued CAUTION: • Keep the cord away from heated surfaces.• Never drop or insert any object into any openings on the device.• Use only the power adaptor provided with the ClearWave Phototherapy System.• Do not operate this device in an environment where other devices, which intentionally rad...
Page 12 - increased sensitivity to the sun.; Risks; Benefits of using the ClearWave system; Benefits
12 Risks associated with the ClearWave ® system Individuals taking medications that cause photosensitivity cannot use the ClearWave system. The product can cause these individuals redness, rashes or burning. Individuals that are photoreactive and not taking medications that cause photosensitivity wi...
Page 13 - Decision Framework; Acne Type; *Not for treatment of non-inflammatory blackheads or whiteheads.
CARE & CLEANING 13 Decision Framework The ClearWave ® Phototherapy System for Acne is an over-the-counter device designed to treat mild or moderate inflammatory acne. There are clinically defined levels of acne. The definitions below are provided as a guide for you to determine if this device is...
Page 15 - Before Procedure or Treatment Information
15 Before using the device it is necessary to conduct a skin sensitivity test.Ensure that you follow the instructions to completely charge the device found on page 16. Step 1 Read the Important Safeguards section on pages 8-11 to ensure you do not fall into any of the categories mentioned. If you do...
Page 16 - Getting Started; Instructions, Operation and Directions for Use; Step 1
CARE & CLEANING 16 Getting Started Before you use the ClearWave ® Phototherapy System, you will need to install the battery (see page 21 - How to replace the battery) and fully charge the device. It takes approximately 12 hours to fully charge the battery for the first time. Instructions, Operat...
Page 17 - Instructions, Operation and Directions for Use — continued; Directions for Using the ClearWave
17 Instructions, Operation and Directions for Use — continued Directions for Using the ClearWave ® Phototherapy System for Acne Normal Use OperationStep 1 Wash your face or the area which will be treated with the ClearWave device with a neutral pH cleanser. Step 2 Verify that you know the area you w...
Page 18 - Interrupted Treatment; skin prior to the completion of a 3 minute treatment cycle.
18 Instructions, Operation and Directions for Use — continued Step 5 Place the device against the desired treatment area 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 ...
Page 20 - Replacing the Treatment Head; Push and release
CARE & CLEANING 20 Replacing the Treatment Head Note: The device monitors each treatment cycle to ensure that the Treatment 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 Treatme...
Page 21 - How to Replace the Battery; Care and Maintenance
CARE & CLEANING 21 How to Replace the Battery Instructions, Operation and Directions for Use — continued Step 1: With the charger 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 ...
Page 22 - Cold Protection Mode; period between treatment cycles.
22 Instructions, Operation and Directions for Use — continued 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 temperature before...
Page 24 - Troubleshooting; The Issue
CARE & CLEANING 24 Please refer to page 20 for troubleshooting the installation of the Treatment Head. Troubleshooting 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 sig...
Page 25 - Call your Healthcare Provider; discontinue use and call your healthcare provider.; When to Call your Healthcare Provider; If problems occur with the ClearWave; Travel with the Device
CARE & CLEANING 25 Call your Healthcare Provider If you are unsure if the medication you are taking may cause a light sensitive reac- tion, contact your healthcare provider.• If you are unsure of the type of acne you have, are currently being treated for acne or have severe acne, do not use this...
Page 27 - One Year Limited Warranty; DO NOT; Proof of purchase is required for all warranty claims.; Return Authorization is required for all returns.
27 One Year Limited Warranty ATTENTION! ONCE OPENED, PLEASE DO NOT RETURN THIS PRODUCT TO THE STORE WHERE IT WAS PURCHASED FOR REPAIR 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 hour...
