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Verilux ClearWave CW01 Manual

Phototherapy system for acne
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Phototherapy System for Acne
CW01
CW01_MAN_Rev52.indd 1
8/2/11 12:38 PM

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Summary of Contents for Verilux ClearWave CW01

  • Page 1 Phototherapy System for Acne CW01 CW01_MAN_Rev52.indd 1 8/2/11 12:38 PM...
  • Page 2 Please read the entire instruction manual before operating the ClearWave Phototherapy System for Acne. ® CW01_MAN_Rev52.indd 2 8/2/11 12:38 PM...

  • Page 3: Table Of Contents

    Table Of Contents Glossary ..........4 Product Description .

  • Page 4: Glossary

    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.
  • Page 5 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. CW01_MAN_Rev52.indd 5 8/2/11 12:38 PM...

  • Page 6: Product Description

    ) Light emitting surface with 32 LED lamps b. Device Body c. Replaceable Treatment Head 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.
  • Page 7 Product Description — continued Controls a. Power Button b. Head Latch Buttons Status Indicators c. Information Display d. Battery Life Indicator Lights e. Treatment Head Life Indicator Lights f. 32 LED Lamps Electrical • Input: 10.5 VDC, 0.75 A • Electrical Class: Class 2 ( •...

  • Page 8: Indications For Use

    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.
  • Page 9 WARNING: — continued • TO REDUCE THE RISK OF FIRE, ELECTRIC SHOCK OR PERSONAL INJURY: 1. Always attach the AC/DC power adapter to device first, then into 1. Always attach the AC/DC power adapter to device first, then into the outlet. the outlet.
  • Page 10 CAUTION: — continued • Discontinue use if you encounter any discomfort. You may have sensitivity to light or another 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.
  • Page 11 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.

  • Page 12: Risks, Benefits And Alternative Procedures And Treatments

    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.

  • Page 13: Decision Framework

    Decision Framework CARE & CLEANING 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.

  • Page 14: Guide For Use In The Home Or In A Mobile Environment

    Decision Framework — continued CARE & CLEANING 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 hairs bend under the skin and produce pimples.

  • Page 15: Before Procedure Or Treatment Information

    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.

  • Page 16: Instructions, Operation And Directions For Use

    CARE & CLEANING Instructions, Operation and Directions for Use 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.
  • Page 17 Instructions, Operation and Directions for Use — continued To Charge WITHOUT Charging Stand: Step 1 Connect the power adapter to the device and adapter into a 110 VAC grounded electrical outlet. Step 2 The Battery Life Indicator Lights will provide information to you on the status while charging.
  • Page 18 Instructions, Operation and Directions for Use — continued Step 3 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.
  • Page 19 Instructions, Operation and Directions for Use — continued Checking the Status of the Clearwave Device ® Step 1 Be 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.
  • Page 20 Treatment Head is replaced. To purchase new Treatment Heads, contact Verilux Customer Service at 1-800-786-6850 or visit www.verilux.com. Dispose of used Treatment Heads per local regulations for electronic waste.
  • Page 21 Do not submerse device in water. This will damage the device electronics. Routinely check before each use to determine that the device functions properly. If the device becomes wet or does not work properly, do not attempt to use. Contact Verilux customer service. ®...
  • Page 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 using.

  • Page 23: After Procedure Treatment Information

    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.

  • Page 24: Troubleshooting

    CARE & CLEANING Troubleshooting Please refer to page 20 for troubleshooting the installation of the Treatment Head. The Issue The Problem The Solution The audio signals: 5 beeps Treatment head may not be Properly and fully attach The Information Display signals: attached, or the Treatment treatment head.

  • Page 25: When To Call Your Healthcare Provider

    If problems occur with the ClearWave device which are not discussed in ® the troubleshooting section, please contact Verilux Customer Service at 1-800-786-6850. Do not disassemble the device. Any damage caused by an attempt to disassemble the ClearWave device will void the warranty. This excludes the Treatment Head which can be replaced.
  • Page 26 CW01_MAN_Rev52.indd 26 8/2/11 12:38 PM...

  • Page 27: Warranty Information

    Verilux warrants this product to be free from defects in material and workmanship for a period of one year from the date of the original retail purchase from Verilux or an authorized Verilux distributor. Proof of purchase is required for all warranty claims. During the limited warranty period, Verilux, Inc.
  • Page 28 June 2011 This product is covered by US Patent(s) and foreign equivalents. Other patent(s) pending. Manufactured for Verilux, Waitsfield, VT 05673 Printed in China for Verilux, Inc. CW01-MAN-Rev52 © Copyright 2011 Verilux, Inc. All rights reserved. CW01_MAN_Rev52.indd 28 8/2/11 12:38 PM...

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