CW01
Phototherapy System for Acne
Table Of Contents
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Product Description . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Important Safeguards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Risks, Benefits and Alternative Procedures and Treatments . . . . . . . . 12
Decision Framework . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Guide for Use in the Home or in a Mobile Environment . . . . . . . . . . . . 14
Before Procedure or Treatment Information . . . . . . . . . . . . . . . . . . . . . 15
Instructions, Operation and Directions for Use. . . . . . . . . . . . . . . . . . . 16
After Procedure Treatment Information. . . . . . . . . . . . . . . . . . . . . . . . . 23
Alternative Procedures and Treatments . . . . . . . . . . . . . . . . . . . . . . . . 23
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
When to Call your Healthcare Provider . . . . . . . . . . . . . . . . . . . . . . . . . 25
User Assistance (toll free number). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Travel with the Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
Warranty Information. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
3
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. At puberty, increased levels of androgens (male
hormones) cause the glands to produce too much sebum. When excess
sebum combines with dead, sticky skin cells, a hard plug, or comedo, forms
that blocks the pore.
Acne Vulgaris: The medical term for common acne; inflammatory disease of
pilosebaceous glands
Comedones: Uninfected sebaceous plugs impacted within follicles, the
signature of noninflammatory acne. Comedones appear as whiteheads or
blackheads. Whiteheads (closed comedones) are flesh-colored or whitish
palpable lesions 1 to 3 mm in diameter; blackheads (open comedones) are
similar in appearance but with a dark center.
Hair Follicle: A sac from which a hair grows and into which the sebaceous
(oil) glands open. The follicle is lined by cells derived from the epidermal
(outside) layer of the skin.
Mild Acne: Several inflamed pimples - red in color. Less than 20 whiteheads/
blackheads or less than 15 inflammatory red pimples or less than 30 total
pimples not all inflamed.
Moderate Acne: Many inflamed pimples - red in color - and pustules
(visible accumulation of pus in skin) 20-100 whiteheads/blackheads or 15-50
inflammatory (red in appearance) lesions (pimples) or 30-125 total lesions not
all inflamed.
Neutral pH Cleanser: The pH of solutions range from a value of 1 to a value
of 14. Cleansers with a pH of 7 are neutral. Cleansers with a pH above 7 are
alkaline.
NSAID: Non-steroidal anti-inflammatory drugs. These are drugs with
analgesic and antipyretic (fever reducing) effects.
Photosensitivity: Cutaneous reaction to sunlight probably involving the
immune system. It may be due to an unknown cause or occur after exposure
to certain drugs or chemicals, and it is sometimes a feature of systemic
diseases.
Severe Cystic Acne: Many nodular cystic lesions (with signs of scarring).
Scarring occurs when new skin cells are laid down to replace damaged cells.
4
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.
5
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.Protective Eyewear (goggles)
d.
c.
g.
e.
f.
6
Product Description — continued
f.
Controls
a. Power Button
b. Head Latch Buttons
b.
a.
Status Indicators
c. Information Display
c.
d.
d. Battery Life Indicator Lights
e. Treatment Head Life Indicator Lights
f. 32 LED Lamps
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.: UE080820HKKD1-R
• Input: 240 VAC, 50-60 Hz, 400 mA
• Output: 10.5 VDC, 0.75 A maximum
Treatment Specification
• Peak Wavelength: 414 nm
• Treatment time: 3 minutes
• Max Operating Temperature: 41ºC (106°F)
Operating Environmental Specification
• Ambient Temperature: 15ºC to 35ºC (59ºF to 95ºF)
• Relative Humidity: 15% to 75%, non-condensing
Transport and Storage Specification
• Ambient Temperature: 0ºC to 60ºC (32ºF to 140ºF)
• Humidity: 0% to 90%, non-condensing
Dimensions
• 7.0" L x 2.5" W x 2.4" D
• Net Wt: 0.38 lbs
7
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.
• Do not use this product if you are taking any medications or topical creams
that are known to cause photosensitivity. Examples of such medications
include Clemastine (Tavist), Chlordiazepoxide (Limbitrol), Estrogen, Doxycycline
(Vibramycin) or NSAIDS for pain. If you are unsure if medication you are taking
may cause a light sensitive reaction, contact your healthcare provider before using
this product.
• If you are experiencing prolonged redness or sensitivity of the treatment area,
discontinue use and consult a healthcare provider.
• Do not use this product if you believe you have severe acne. If you are unsure of
the type of acne which you may have, are currently being treated for acne or have
a history of sensitivity to acne treatments, you should consult your healthcare
provider or dermatologist before using the ClearWave Phototherapy System for
Acne.
• Do not use over the thyroid gland (neck area). Doing so may stimulate the gland.
• Do not use over topical steroids or a recent steroid injection. Doing so may result
in a photosensitive reaction.
• Do not use this device on children under 10 years of age.
8
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. Awys tae C/C powr dpeo dvistteit
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 liquid.
3. Keep away all electrical appliances (including the ClearWave Phototherapy
System) from water (including bath and shower). If the unit accidentally falls
in water unplug immediately.
4.Turn off and unplug device before cleaning.
• Do not operate the device in close proximity to flammable or combustible vapors,
such as aerosol (spray) products or where oxygen is being administered or where
tanks are stored.
• Always use eye protection while operating the ClearWave® Phototherapy for Acne
to avoid potential eye damage.
• Stop immediately, if you experience any adverse effect or have a concern
regarding use. Contact your healthcare provider. You may be having a
photosensitive reaction.
• Do not use if you are taking drugs known to cause photosensitive reactions. Doing
so can result in skin discoloration, discomfort or pain. Common examples of drugs
that may have made you sensitive to light are: antihistamines, used in cold and
allergy medicines; nonsteroidal anti-inflammatory drugs (NSAIDs), used to control
pain and inflammation in arthritis; and antibiotics, including the tetracyclines and
the sulfonamides, or “sulfa” drugs.
CAUTION:
• No user serviceable parts. Do not attempt to disassemble the ClearWave®
Phototherapy for Acne. This may cause the device to be damaged, malfunction or
may cause personal injury.
• Do not use if you are sensitive to light. Doing so can result in skin discoloration,
discomfort or pain.
• Do not operate the unit if the cord or unit has been damaged. Electric shock could
occur. Refer all servicing to qualified service personnel. Servicing is required when
the apparatus has been damaged in any way, such as power-supply cord or plug
is damaged, liquid has been spilled on or objects have fallen into the apparatus,
the apparatus has been exposed to rain or moisture, the apparatus does not
operate normally or it has been dropped.
9
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.
• Inspect this device prior to each use. Check for damage. Damage includes cracks
in the device, frayed wires, power button not present, broken display, battery
compartment not closed or signs of warping. Failure to do so may result in
improper delivery of the light.
• Persons with known sensitivities to non-drug “sensitizers” could have a
photosensitive reaction, which can result in skin discoloration, discomfort or pain.
Common examples of non-drugs that may make a person sensitive to light are:
deodorants, antibacterial soaps, artificial sweeteners, fluorescent brightening
agents for cellulose, nylon and wool fibers such as in laundry detergent,
naphthalene (mothballs), petroleum products and in cadmium sulfide, a chemical
injected into the skin during tattooing.
• Failure to use and maintain the ClearWave Phototherapy System for Acne
according to instructions will void the warranty.
• Do not place device near any heat sources such as radiators, heat registers,
stoves or other apparatus that produce heat.
• Do not attempt to use alternate battery types or power supplies. Only use
attachments/accessories specified by the manufacturer.
• Do not allow children to use the device unsupervised - Failure to do so can result
in injury to eyes.
• It is recommended that you test a small less sensitive patch of skin (i.e. like your
forearm; refer to page 15 for instructions).
• Use with the protective goggles provided.
• Dispose of device in accordance with local and national regulations and codes.
Failure to do so may result in violation of the law.
• Do not look directly at the light source of the Treatment Head of this device while it
is in operation.
• Turn off immediately, if the ClearWave Phototherapy System begins to overheat.
• This product is not intended to treat non-inflammatory blackheads or whiteheads.
10
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. Doing so may result in the device not
functioning properly.
• Do not scratch, mar or otherwise damage the light emitting surface. To do so may
diminish the effectiveness of the light.
• Do not shine the light source into someone else’s eyes.
• Operate, transport and store the device per manner specified in this manual.
Failure to do so may result in damage to the unit.
SAVE THESE INSTRUCTIONS
11
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.
Benefits
Benefits of using the ClearWave system
The treatment may result in less blemishes. Individuals using the ClearWave system
will not experience prescription medication side effects. Examples of side effects
for antibiotics prescribed to treat acne include potential liver damage (Minocycline),
stomach upset (Tetracycline) or risks associated with birth defects (Accutane).
Individuals with mild to moderate acne using the ClearWave product may not see
results for 4-11 weeks.
Alternative Procedures and Treatments
Risks associated with alternate acne treatment
Retin-A is a prescription treatment. It is meant to be applied twice daily, and it
causes the skin to shed its outer layer and thicken the epidermis at the same time.
It can also cause side effects such as redness, irritation and peeling. Tretinoin is
a prescription medication. Its side effects include redness, itching, peeling and
increased sensitivity to the sun.
Benefits of using alternate acne treatments
Individuals with severe acne should consult a dermatologist for optimal treatment
options. Proper medications for these individuals may result in decreased number of
blemishes.
12
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
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
ClearWave Use
No Acne
Total absence of blemishes
and acne
Not necessary
Mild Acne
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 all inflamed
Yes*
Yes*
Moderate
Acne
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)
Severe
Nodular
Acne
Inflamed pimples
No. Consult a
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)
treatment.
Severe
Cystic Acne
Many nodular cystic lesions No. Consult a
(with signs of scarring)
dermatologist for
recommended
treatment.
*Not for treatment of non-inflammatory blackheads or whiteheads.
13
DecisionFramework—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.
14
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
healthcare provider.
Step 7 If no reactions have occurred on your forearm following 24 hours, you may
begin treatment.
15
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 1
Step 2 Place the ClearWave
Phototherapy System for Acne on
the Charging Stand as shown.
Step 2
Step 3 The battery life indicator lights
will provide information to you
on the status while charging.
Step 3
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.
Step 4
16
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
for use.
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
Step 3
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
Step 4 Before placing the device onto your skin,
activate the device by pushing the power
button until it beeps one time.
17
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 5
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.
f.
Controls
b.
a. Power Button
b. Head Latch Buttons
a.
Status Indicators
c. Information Display
c.
d.
d. Battery Life Indicator Lights
e. Treatment Head Life Indicator Lights
f. 32 LED Lamps
e.
18
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 will show the number of cycles remaining on the Treatment Head.
Step 3 When 30 seconds have elapsed, the device will shut off.
f.
Controls
a.Power Button
b.Head Latch Buttons
b.
a.
Status Indicators
c.Information Display
c.
d.
d.Battery Life Indicator Lights
e.Treatment Head Life Indicator Lights
f. 32 LED Lamps
e.
Information Display Indicators
Display
Mode
Operating
Idle
Explanation
Reference
See Page 18
See Page 19 or 20
See Page 20
See Page 20
See Page 21
See Page 22
See Page 22
Number
Number
0
Time remaining on current treatment cycle
Number of treatment cycles remaining on head
Treatment Head is exhausted
Idle
- - -
Treament Head is not correctly attached
Battery is low
LO
HP
Device requires cooling
CP
Device is too cold to operate
Treatment Head Life Indicator and Battery Life Indicator
Battery Life Indicator Light
Treatment Head Life Indicator Light
More than 75 treatments remaining
Between 75 and 25 treatments remaining
Fewer than 25 treatments
3 lights
2 lights
More than 75% of the battery is charged
25% to 75% of the battery is charged
Less than 25% of the battery is charged
Battery needs to be charged
1 light
Flashing light
Head needs to be replaced
19
Instructions, Operationand Directionsfor 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
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
Body.
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.
Step 3: Press the new Treatment Head into place
against the Device Body and release the Head
Latch Buttons.
Push and release
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.
Repeat the removal and
New Treatment Heads may be
purchased at www.verilux.com
or by calling Customer Service
at 1-800-786-6850
installation process if 3
dashed lines appear.
20
Instructions, Operationand Directionsfor 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.
TO REDUCE THE RISK OF ELECTRIC SHOCK OR PERSONAL
INJURY: Turn off and unplug device before cleaning.
WARNING:
21
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
for use.
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.
22
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.
23
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
The Information Display signals:
Treatment head may not be
attached, or the Treatment
head is defective
Properly and fully attach
treatment head.
The audio signals: 3 beeps
The Treatment Head Indicator Light displays:
The treatment head
has no remaining
treatment cycles
Replace the treatment head.
The Information Display signals:
The treatment
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
cold to operate
Set the device aside until it
reaches room temperature.
The audio signals: 10 beeps
The Information Display signals:
The device is too
hot to operate
Set the device aside until it
reaches room temperature.
The battery needs to
be replaced
Battery will not hold a charge
Device will not turn on
Order a replacement battery.
Charge battery
The battery is dead
The audio signals: 10 beeps
The Information Display signals:
The device needs
to cool down
Set the device aside
and let it cool down.
Device shuts off
in cycle
24
When to Callyour 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
healthcare provider.
• 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.
25
One Year Limited Warranty
ATTENTION! ONCE OPENED, PLEASE DO NOT RETURN THIS PRODUCT TO THE STORE
WHERE IT WAS PURCHASED FOR REPAIR OR REPLACEMENT!
Service Department at 800-786-6850 during normal business hours.
This limited warranty is provided by: Verilux, Inc., 340 Mad River Park, Waitsfield, VT 05673
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. 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
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.
1-800-786-6850
Representatives are available Monday — Friday, 9am — 5pm ET
340 Mad River Park, Waitsfield, VT 05673
27
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.
© Copyright 2011 Verilux, Inc. All rights reserved.
CW01-MAN-Rev50
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