Marys Medicine

Verilux.com

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. 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.
Acne Type
Description of Condition
Total absence of blemishes Several inflamed pimples- red in color. Fewer than 20 whiteheads/blackheads or fewer than 15 inflammatory red pimples or fewer than 30 total pimples not al inflamed Many inflamed pimples (red in color) and pustules (visible accumulation of pus in skin) 20-100 whiteheads/ blackheads or 15-50 inflammatory (red) lesions (pimples) or 30 to 125 total lesions (pimples) not all inflamed (red in appearance) Inflamed pimples and pustules (visible dermatologist for accumulation of pus in skin) recommended with a few deep nodular lesions (solid mass can be felt under skin-can sometimes be raised) Many nodular cystic lesions No. Consult a (with signs of scarring) dermatologist for *Not for treatment of non-inflammatory blackheads or whiteheads. CARE & CLEANING
Decision Framework — 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.
Rosacea This condition is characterized by pimples along with redness, flushing
and superficial blood vessels, however, there are no blackheads or whiteheads in rosacea.
Folliculitis Pimples can occur on other parts of the body, such as the abdomen,
buttocks or legs. These do not represent acne but, rather, inflamed follicles.
If unsure, please consult your healthcare provider.
Guide for Use in the Home or in a Mobile Environment
The ClearWave® Device may be used at home. You may also take it with you on trips.
Step 1 To use the ClearWave device at home or on trips, ensure that the device is
first fully charged before initial use. Refer to the Operation, Directions and Instructions for Use section of this manual for charging methodology.
Step 2 Review the Important Safeguards section in this manual to ensure that
you are not operating the device in an environment where it is not suited. Please refer to the Product Description section for ambient temperature ranges for operation. Please refer to the Important Safeguards section for environments which may be unsuitable for using the device. Examples of such unsuitable environments would be on lakes or on rivers.
Step 3 Review the Travel with the Device section of this manual regarding the
storage of the device prior to plane travel.
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.
Ensure it is dry before treatment.
Step 3 Place the goggles provided with the unit on so that your eyes are covered.
Adjust the strap on the goggles to ensure that they fit snugly. Look through the goggles and ensure that there are no visible cracks. Do not use the goggles or the device if the goggles are cracked, damaged or will not fit snugly on your face.
Step 4 Activate the device by pushing the power button until the device beeps.
Step 5 Place the device on your forearm and complete one 3 minute cycle.
Step 6 If you experience redness, rashes, pain or discomfort during the 24 hours
following this treatment do not use the device again before consulting your Step 7 If no reactions have occurred on your forearm following 24 hours, you may
begin treatment.
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. Step 1 Connect the power adapter
to the Charging Stand and the adapter into a 110 VAC grounded electrical outlet.
Step 2 Place the ClearWave
Phototherapy System for Acne on the Charging Stand as shown.
Step 3 The battery life indicator lights
will provide information to you on the status while charging. Step 4 When all 3 battery indicator lights
are illuminated, the battery is fully charged and the device is ready for use. Once fully charged, the indicator lights will illuminate for 3 minutes, and then turn off. 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.
Step 3 When all 3 Battery Indicator Lights are
illuminated (as shown), the battery is fully charged and the device is ready Directions for Using the ClearWave® Phototherapy System for Acne
Normal Use Operation
Step 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 will treat
and the location of the button to activate the device as the goggles may reduce your visibility.
Step 3 Put on the goggles provided with the unit.
Ensure that the goggles are fitting snugly and are not cracked.
Step 4 Before placing the device onto your skin,
activate the device by pushing the power button until it beeps one time.
peration 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 until the device beeps 2 times, indicating the
completion of a 3-minute treatment cycle. Step 7 For each additional location to be treated, press the button until it beeps
once, place the device against the new area and the light will again illuminate signifying the beginning of the next 3-minute treatment cycle.  Notes: • Treat only one area per treatment cycle.
• Your daily treatment regime should not exceed three treatment cycles per
location. • A second consecutive treatment to the same area may be performed. • Waiting a short time between treatment cycles is suggested to prevent the device from entering heat protection mode. Interrupted Treatment
Note: You can continue treatment of the same area if you remove the device from your
skin prior to the completion of a 3 minute treatment cycle.
Step 1 If the device is removed from the skin during a treatment cycle and 3 minutes
have not elapsed, the device will beep for 30 seconds.
Step 2 If you wish to continue treating the same area you were treating and 30
seconds have not elapsed, reapply the device to your skin.
Step 3 The display on the device will show the remaining treatment time if you do
not reapply the device to your skin. The Treatment Head life indicator and the battery indicator will display the status of the device. If you do not reapply the device to skin in 30 seconds, the device will shut off.
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
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.
Step 2 The battery life indicator displays the respective status of battery charge levels.
The display wil show the number of cycles remaining on the Treatment Head.
Step 3 When 30 seconds have elapsed, the device will shut off.
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
Information Display Indicators
Time remaining on current treatment cycle Number of treatment cycles remaining on head See Page 19 or 20 Treatment Head is exhausted Treament Head is not correctly attached Device requires cooling Device is too cold to operate
Treatment Head Life Indicator and Battery Life Indicator
Treatment Head Life Indicator Light
Battery Life Indicator Light
More than 75 treatments remaining More than 75% of the battery is charged Between 75 and 25 treatments remaining 25% to 75% of the battery is charged Fewer than 25 treatments Less than 25% of the battery is charged Head needs to be replaced Battery needs to be charged Instructions, OperaCARE & CLEANING
tion and Directions for 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. 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.
The number of treatment cycles remaining on a Treatment Head is displayed by both the device's Information Display and on the Treatment Head Life Indicator (See page 19 for additional information.) When the bottom "Treatment Head Life Indicator Light" is flashing and the "Information Display" is displaying "0" the Treatment Head needs to be replaced.
To remove the expired Treatment Head:
Step 1: Press and hold both Head Latch Buttons
shown on each side of the Treatment Head. Step 2: Separate the Treatment Head from the Device
To install a new Treatment Head:
Step 1: Align the three round plastic posts on the
back of the new Treatment Head with the three post sockets on the Device Body. This will also align the square latch holes on the new Treatment Head with the Head Latch buttons on the Device Body.
Step 2: Press and hold both Head Latch Buttons on
each side of the new Treatment Head.
Push and release Step 3: Press the new Treatment Head into place
against the Device Body and release the Head Latch Buttons.
Step 4: Press Power Button for approximately 1
second to activate Status Mode (see page 19). The Information Display should now display the amount of cycles remaining on the new Treatment Head.
Step 5: Three dashed lines will appear if the new
Treatment Head is incorrectly installed. New Treatment Heads may be Repeat the removal and purchased at www.verilux.com installation process if 3 or by calling Customer Service dashed lines appear.
at 1-800-786-6850 Instructions, OperaCARE & CLEANING
tion and Directions for Use — continued
How to Replace the Battery
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 battery and dispose in accordance with
local environmental regulations.
Step 4: Insert new battery and plug in cable.
Step 5: Replace the compartment cover and tighten the screw.
The ClearWave® Phototherapy System for Acne battery is made specially by Verilux®. It is comprised of NiMH (Nickel metal- hydride) cells. Do not attempt to replace with other brands.
Remove battery pack when device is not in use for prolonged periods of time.
Care and Maintenance
Avoid scratching Treatment Head or placing device in a dusty or dirty environment. This may affect the efficiency of your treatment. Using a soft cloth, apply a small amount of rubbing alcohol and clean the surface of the device. Pay particular attention to the clear lens of the Treatment Head. Clean before each use. Do not attempt to use other cleaning products. Use of other cleaning products may damage the plastic. 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. WARNING: TO REDUCE THE RISK OF ELECTRIC SHOCK OR PERSONAL
INJURY: Turn off and unplug device before cleaning.
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. The device monitors the Treatment Head surface temperature during each treatment cycle to ensure that the Treatment Head maintains an optimum temperature. If the device exceeds the optimum temperature limit, it will enter Heat Protection Mode and device will limit operation until sufficient surface cooling has been achieved.
When the "Information Display" is displaying "HP" the device has reached or exceeded its optimum temperature limit and will not continue to operate until a cool down period has been completed.
If your device enters Heat Protection Mode:
The "Information Display" will display "HP" and the device will beep 10 times and
immediately terminate the treatment cycle.
Step 1: Set the device back on the Charging Stand and allow cooling.
Step 2: Once "HP" is no longer visible in the Information display, the device is ready
Step 3: Resume normal operation as outlined on page 18 of this manual.
Note: Heat protection mode can be avoided by allowing the unit a short cool down
period between treatment cycles. An additional head may be purchased and interchanged if many consecutive treatments are required on a regular basis. 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. Two consecutive treatments to one area may be performed. If you observe any adverse reaction such as discomfort, pain, redness or a rash, discontinue use of the device and consult your healthcare provider before using the device again.
Alternative Procedures and Treatments
Topical lotions and gels used to treat mild to moderate acne may contain benzoyl peroxide and salicylic acid. The active ingredient benzoyl peroxide may result in skin irritation or dry skin. The use of topical solutions can result in discoloration or bleaching of fabrics, towels and wash cloths. Another topical acne treatment is commonly sold as Retin-A®, Renova® or Avita™. A dermatologist must be consulted in order to obtain prescription medications. For severe acne cases, a dermatologist may prescribe Isotretinoin, also known as Accutane®, which is a very powerful oral retinoid. Each of these medications is effective on certain types of acne and each has its own benefits, risks and potential side effects.
In addition to providing effective medications for acne treatment, a qualified dermatologist can also administer effective procedures to address an acne problem. Chemical Peels can remove the blackheads and papules associated with mild acne. Pulsed light treatments can be administered by a dermatologist to assist in treatment for the bacteria that causes acne.
CARE & CLEANING
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 The Information Display signals: Properly and fully attach attached, or the Treatment head is defective The audio signals: 3 beeps The Treatment Head Indicator Light displays: The treatment head has no remaining Replace the treatment head.
The Information Display signals: cycle will not start The audio signals: 3 beeps The Treatment Head Indicator Light displays: The battery is low Recharge the battery.
The Information Display signals: The audio signals: 5 fast beeps The Treatment Head Indicator Light displays: The device is too Set the device aside until it reaches room temperature.
The audio signals: 10 beeps The Information Display signals: The device is too Set the device aside until it reaches room temperature.
Battery will not hold a charge The battery needs to Order a replacement battery.
Device will not turn on The battery is dead The audio signals: 10 beeps The Information Display signals: Set the device aside and let it cool down.
CARE & CLEANING
When to Call your Healthcare Provider
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 device until you have consulted your • If you are experiencing prolonged redness or sensitivity of the treatment area, discontinue use and call your healthcare provider.
• If you are experiencing any adverse effect or have a concern regarding use, discontinue use and contact your physician.
User Assistance (toll free number)
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.
Travel with the Device
The ClearWave device battery charger is designed for an input of 100-240 VAC. International use (Europe) will require an adapter to charge the device from household current. In order to conform with airport regulations, the battery pack must be removed from the device prior to packing the device in luggage.
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., 340 Mad River Park, Waitsfield, VT 05673Verilux 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. will, at its option, repair or replace defective parts of this product, at no charge to the customer, subject to the following limitations: This limited warranty does not include any postage, freight, handling, insurance or delivery fees. This warranty does not cover damage, defect or failure caused by or resulting from accident, external destruction, alteration, modification, abuse, misuse or misapplication of this product. This warranty does not cover damage to the product resulting from return shipping or handling. The use of shipping insurance is recommended to help protect your product.
Return Authorization is required for all returns. To obtain a Return Authorization, please
contact the Verilux Customer Service Department at 800-786-6850.
If, during the first year of ownership, this product fails to operate properly*, it should be returned as specified at www.verilux.com/warrantyreplacement or as instructed by a Verilux customer service representative at 800-786-6850.
Note: Verilux recommends using a quality surge suppressor on all electronics equipment.
Voltage variations and spikes can damage electronic components in any system. A quality suppressor can eliminate the vast majority of failures attributed to surges and may be purchased at electronics stores. Due to ongoing improvements, actual product may have slight variations from the product described in this manual. *Failure to operate properly refers to mechanical or electrical malfunctions with the device that did not result from misuse, abuse, accident, alteration or modification. If your acne does not improve, please consult a dermatologist. If you or your healthcare provider determine that you are unable to use the device due to photosensitivity, please contact Customer Service.
Please visit our website at www.verilux.com or call our Customer Service Department at
Representatives are available Monday — Friday, 9am — 5pm ET 340 Mad River Park, Waitsfield, VT 05673 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. Copyright 2011 Verilux, Inc. All rights reserved.

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