Phototherapy System for Acne CW01
Please read the entire instruction manual before operating the ClearWave® Phototherapy System for Acne.
Table Of Contents Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 Important Safeguards. . . . . . . . . . . . . . . . . . . . . . . . . .
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 and the hair follicles within which they are found are called sebaceous follicles. These follicles open onto the skin through pores.
Glossary — continued 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.
Product Description The ClearWave® Phototherapy System for Acne is an over-the-counter phototherapeutic device designed to treat mild to moderate inflammatory acne. a1 Contents Include: a. a. ClearWave® Phototherapy System (Device) (a1) Light emitting surface with 32 LED lamps b. Device Body c. Replaceable Treatment Head b. New Treatment Heads may be purchased at www.verilux.com or by calling Customer Service at 1-800-786-6850 d. Charging Stand e. Power Supply (adapter) f. Rechargeable battery g.
Product Description — continued f. Controls a. Power Button b. Head Latch Buttons b. a. Status Indicators c. Information Display d. Battery Life Indicator Lights e. Treatment Head Life Indicator Lights f. 32 LED Lamps c. d. e. Electrical • Input: 10.5 VDC, 0.75 A • Electrical Class: Class 2 ( ) ) • Electrical Type: Class BF ( • Battery: Nickel Metal Hydride (NiMH) Battery Pack: 7.2 VDC, 300 mAh • Power Adapter: • Medical grade power adapter • Model No.: UE15WCP-105075SPA • Part No.
READ ALL INSTRUCTIONS BEFORE USE Indications for Use The ClearWave® Phototherapy System for Acne is intended to treat mild to moderate inflammatory acne. It is intended for over the counter use. Contraindications None known. Important Safeguards WARNING: • Do not use this device if you are pregnant until your healthcare provider authorizes you to use it. • Do not use this device over any lesion other than mild to moderate inflammatory acne. Failure to do so can result in delaying best medical treatment.
WARNING: — continued • TO REDUCE THE RISK OF FIRE, ELECTRIC SHOCK OR PERSONAL INJURY: 1. A lways the AC/DC power power adapteradapter to device first, then 1. Aattach lways attach the AC/DC to device first,into then into the outlet. the outlet. 2. D o not storeorthe device where itwhere can fall or be a tub 2. Dplace o notor place store the device it can fallpulled or be into pulled intoora sink. Do not place in or drop into water or other liquid. tub or sink.
CAUTION: — continued • Discontinue use if you encounter any discomfort. You may have sensitivity to light or other condition which can result in skin discoloration, discomfort or pain. Consult with your healthcare provider. • Adjustments or performance of procedures other than those specified herein may result in injury. • Read all instructions before using your Clearwave Phototherapy System. Failure to do so may result in failure to understand safety information or how the device is used.
CAUTION: — continued • 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 radiate electromagnetic energy in an unshielded manner, are being used. Portable or mobile Radio Frequency communication equipment can affect the ClearWave Photothearpy System.
Risks 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 will also experience redness, rashes or burning. Patients with severe acne cannot use this device. Their acne will not improve with use of this device.
Decision CARE & CLEANING 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 right for you. Dermatologists are specialized in the treatment of acne and should be consulted for an assessment of acne. This device is not intended for severe acne.
Decision CARE Framework & CLEANING — continued 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 called “razor bumps”. When cut close to the skin, curly neck hairs bend under the skin and produce pimples.
Before Procedure or Treatment Information 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 fall into any of the categories, do not use the device. Step 2 Wash the proposed test area on your forearm with a pH neutral cleanser.
Instructions,CARE Operation and Directions for Use & CLEANING 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. Step 1 Connect the power adapter to the Charging Stand and the adapter into a 110 VAC grounded electrical outlet.
Instructions, Operation and Directions for Use — continued To Charge WITHOUT Charging Stand: Step 1 C onnect the power adapter to the device and adapter into a 110 VAC grounded electrical outlet. Step 2 T he Battery Life Indicator Lights will provide information to you on the status while charging. Step 3 W hen all 3 Battery Indicator Lights are illuminated (as shown), the battery is fully charged and the device is ready for use.
Step 3 Instructions, Operation and Directions for Use — continued Step 5 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 H old the device in place until the device beeps 2 times, indicating the completion of a 3-minute treatment cycle.
Instructions, Operation and Directions for Use — continued Checking the Status of the Clearwave® Device Step 1 B e sure the device is turned off. To place the device into status mode, press and quickly release the power button. The device will remain in status mode for approximately 30 seconds. Step 2 T he battery life indicator displays the respective status of battery charge levels. The display will show the number of cycles remaining on the Treatment Head.
Instructions, Operation CARE and & Directions CLEANINGfor Use — continued 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 Treatment Head will expire and the device will cease to function until the Treatment Head is replaced.
Instructions, Operation CARE and & Directions CLEANINGfor Use — continued How to Replace the Battery Step 1: W ith the charger unplugged, loosen the screw to the battery compartment using a Philips head screwdriver. Step 2: U nplug the battery cable attached to the battery. Step 3: R emove the battery and dispose in accordance with local environmental regulations. Step 4: I nsert new battery and plug in cable. Step 5: R eplace the compartment cover and tighten the screw.
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 using. Heat Protection Mode Note: Consecutive uses and high ambient temperatures can cause the Treatment Head surface to become hot.
After Procedure Treatment Information After treatment, you will not see noticeable changes to your skin immediately. The visible results may take some time. Visible results may be seen between 4 and 11 weeks. Individual results do vary. It is recommended to continue treating the area three times a day. The device should be used 2-3 times per week for a maximum of 33 treatments in 11 weeks. It is not recommended to treat any single area for more than 3 minutes, three times per day.
CARE Troubleshooting & CLEANING Please refer to page 20 for troubleshooting the installation of the Treatment Head. The Issue The audio signals: 5 beeps The Information Display signals: The Problem The Solution Treatment head may not be attached, or the Treatment head is defective Properly and fully attach treatment head. The treatment head has no remaining treatment cycles Replace the treatment head. The battery is low Recharge the battery.
When to Call CARE your & CLEANING Healthcare Provider Call your Healthcare Provider If you are unsure if the medication you are taking may cause a light sensitive reaction, 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 device until you have consulted your healthcare provider.
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 hours. This limited warranty is provided by: Verilux, Inc.
June 2011 This product is covered by US Patent(s) and foreign equivalents. Other patent(s) pending. CW01-MAN-Rev50 Manufactured for Verilux, Waitsfield, VT 05673 Printed in China for Verilux, Inc. © Copyright 2011 Verilux, Inc. All rights reserved.
