Centre Light Solutions Strialite 1011 User manual

Instructions
for Use
Centre Light Solutions, LLC

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Strialite™ Model #1011
© 2016 Centre Light Solutions, LLC
All Rights Reserved
Printed in the U.S.A.
Patents pending
Trademarks: Strialite™ is a trademark of Centre Light Solutions, LLC.
Centre Light Solutions, LLC
611 East Douglas Road, Suite 108
Mishawaka, IN 46545

Table of Contents
General Information
What is Strialite™?...................................................................................... 1
Indications for Use ...................................................................................... 1
How It Works .............................................................................................. 1
Description of the Strialite Device.............................................................. 2
Unpacking the Device ................................................................................. 3
Precautions, Warnings, Safety Features
Warnings ..................................................................................................... 3
When to Avoid Using Strialite .................................................................... 3
Precautions ................................................................................................. 4
Protecting the User............................................................................... 4
Protecting the Device............................................................................ 4
Safety Features ........................................................................................... 5
Risks and Possible Side Effects.................................................................... 5
Skin Redness ......................................................................................... 5
Procedure for Use
Instructions ................................................................................................. 6
Recommended Treatment Schedule .......................................................... 7
Care of Your Strialite .................................................................................. 7
Disposal at the End of Life .......................................................................... 7
Troubleshooting ............................................................................................... 8
Clinical Studies.................................................................................................. 9
Specifications.................................................................................................... 9
Compliance and Symbols ............................................................................... 10
Customer Service and Assistance .................................................................. 10
Warranty......................................................................................................... 11

1
General Information
What is Strialite™?
Strialite™is a small handheld device for the treatment of stretch marks having
a red appearance. The base (treatment plate) contains 35 red 633 nm +/- 5 nm
light emitting diodes (LEDs) and heating elements that generate temperature
up to 105°F (40°C) that produces a gentle heat, both of which aid in the
reduction of the appearance of stretch marks. The LED light and heat work
together to stimulate the skin at the cellular level, decreasing the appearance
of the stretch mark.
Indications for Use:
Strialite is an over-the-counter device indicated for use in the temporary
reduction of redness in striae rubra (red stretch marks). Strialite does not
remove the stretch marks but may improve their appearance.
How It Works: As our bodies start the natural aging process, the amount of
collagen in the skin starts to diminish. Collagen supports our skin tissues and
helps create that youthful image. Sometimes, when skin is stretched too far
from pregnancy, instances of sudden weight gain or loss, or even just sudden
growth during puberty, stretch marks can occur. A “stretch mark” is a defect
in the skin caused by damaged collagen that occurs from rapid skin stretching
and, in some instances, this damaged area has a red appearance. The
beneficial LED lights on the Strialite device can reduce the appearance of these
stretch marks. Improvement in appearance will be greater with stretch marks
that are darker or brighter than with those that are lighter or more faded.
When used correctly and according to the instructions, Strialite may help
reduce the appearance of stretch marks (striae rubra). Typical areas for
treatment are the abdomen, breasts, back, hips, and thighs.
Before using your Strialite device, read this entire booklet carefully. Pay
particular attention to the sections “Precautions, Warnings, Safety Features,”
“Procedure for Use,”and “Care of your Strialite.”

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Description of the Strialite Device:
Figure 1
Handle
(To easily hold
the device)
Power Cord
(Attached power supply
plugs into AC wall outlet)
On/Off Button
(Press to turn the
device on and off)

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Figure 2
Heated
Treatment
Plate
(Also contains
the LEDs)
LEDs
(Red light
emitting diodes)

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Unpacking the Device:
1. Remove the Strialite device from the packaging.
2. Verify that you have each of the following components and that nothing
appears damaged in any way:
Strialite device and attached power cord (with cord wrap) and power
supply
Instructions for Use booklet
Quick Reference Guide
Precautions, Warnings, Safety Features
Warnings:
Strialite is not intended for use for any purpose other than in the treatment of
red stretch marks (striae rubra).
When to avoid using Strialite:
DO NOT USE the Strialite device if you have any of the following conditions:
open wounds or active infections at the site of treatment;
irritation or inflammation at the site of treatment.
Consult your physician before using the Strialite device.
In addition, DO NOT USE Strialite if you:
are currently or have recently used Alpha-Hydroxi Acids (AHAs), Beta-
Hydroxi Acids (BHAs), Retin-A®, retinoids or azelaic acid at the site of
treatment; 1
are currently, or have been, on a steroid regimen within the past 3
months.
Consult your physician prior to treatment if any of the questionable
conditions exist.
A sudden onset of striae may indicate an underlying medical condition; please
consult your physician if this occurs.
1 Common household items that may include these chemicals include wrinkle creams,
acne cleansers and other skin care products. Refer to the product labeling.

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Precautions:
Protecting the User:
Keep Strialite away from children. This device is intended for use by
those between the ages of 18 and 50; other age groups have not been
tested for safety and efficacy.
Do not use Strialite if you are pregnant. The safety of the device has
not been tested on pregnant woman.
Contact a physician as soon as possible if you suspect that you have
had a reaction from using Strialite, including the development of any
rash, discoloration, or skin reaction in the treatment area.
Avoid looking directly into the LED lights.
Do not use your Strialite when standing in or over water or while
bathing.
Do not use Strialite if it appears damaged in any way. Please contact
the Strialite Customer Service Center (see “Customer Service and
Assistance” section).
Protecting the Device:
Store your Strialite in a dry area, away from heat sources (e.g., radia-
tors, ovens). Heated surfaces may damage the product.
Do not expose your Strialite to direct sunlight or UV light for long
periods of time.
Do not expose your Strialite to wet surfaces; be sure your skin is
completely dry prior to beginning treatment.
DO NOT SUBMERGE the Strialite device in water.
The Strialite device is affected by the surrounding room temperature
while it is being used. Store your Strialite at temperatures of 60°F
(15.5°C) or higher. If it has been exposed to lower temperatures, allow
it to reach room temperature (at least 60°F/15.5°C) for approximately
1 hour before using the device.

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Safety Features:
The Strialite device contains temperature sensors to ensure that the
temperature of the treatment plate does not exceed 106°F (41°C),
which is a safe and comfortable temperature, and will automatically
shut off should the limit be exceeded.
The Strialite will also shut off if the room temperature exceeds 85°F
(29.4°C) for a prolonged period (60-90 minutes) while the device is
being used.
The power cord is permanently attached to the device to prevent
accidental disconnection during use. The cord also eliminates the need
to recharge the device during or after treatments. The attached cord
wrap should be used to gather up excess cord as a safety precaution
and to prevent accidental choking or strangulation.
The power cord includes a wall power supply to reduce the voltage at
the wall outlet to the lower voltage required for the device. If the cord
or power supply appears damaged, do not use the product. Contact
the Strialite Customer Service Center (see “Customer Service and
Assistance” section) for a replacement device.
Risks and Possible Side Effects:
When used according to these Instructions for Use, the risk of side effects and
complications with the use of Strialite is rare. Strialite treatments are typically
very well tolerated; most users feel moderate heat with little or no discomfort.
It is important, however, to understand that any cosmetic procedure, even
those using LED lights and designed for at-home use, involves some degree of
risk. The best way to prevent possible risks associated with the use of Strialite
is to follow the instructions and guidance provided in this booklet.
Skin Redness:
Due to the heat emitted from the LED lights in Strialite, the treated area may
become slightly reddened during and after the procedure. This should
disappear within about 20 minutes after the treatment has ended. If the
redness or additional irritation persists for longer than 1 hour, do not resume
treatments and consult a physician before resuming treatments.

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Procedure for Use
Instructions:
1. Plug the Strialite power supply into an AC outlet that is conveniently
located for your use. You may also use an extension cord to extend the
distance if needed. Be sure the outlet or extension cord can be accessed
easily for disconnecting the power supply. Unwind only as much cord as is
needed, keeping the remaining cord gathered and secured with the cord
wrap to prevent tripping.
2. Choose your treatment area carefully.
3. Gently clean the entire area to be treated to remove any lotions or other
skin care products, using soap and water, then dry thoroughly. Be sure the
area is completely dry before starting the treatment.
4. Press in on the power switch to turn on
your Strialite. The LEDs will light up
immediately. Allow 1-2 minutes for the
device to reach a comfortable tempera-
ture before holding it against the skin.
(You can lay it on its side during this
time.)
5. Holding your Strialite by its handle,
apply the base directly to the treatment
area. The entire panel should be in
contact with the area to be treated. You
should feel a gentle warmth that
penetrates deep into your skin tissue
during treatment; the heat should not
be uncomfortable.
6. Treat the desired area for 20 minutes. Keep the device on the area
continuously for the entire treatment time. If the treatment session is
interrupted, simply resume the treatment when you are able and
complete the treatment time.
7. Repeat steps 5 and 6 for each additional area to be treated.

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8. Press in on the power switch again to turn off the device, then unplug it
from the AC outlet. Re-gather the cord and secure using the attached cord
wrap.
Recommended Treatment Schedule:
For the best results, treat each area twice each week for 4 weeks.
Results will vary and may take more or fewer numbers of treatments to
achieve adequate improvement from one person to another.
Note: It is normal for the skin to be slightly reddened following treatment. If
the redness or additional irritation persists for longer than 1 hour, do not
resume treatments and consult a physician before resuming treatments.
Care of your Strialite:
After you have completed your treatments for the day, wipe off the
treatment plate using a soft cloth dampened with rubbing alcohol (70%–
90% isopropyl alcohol). You may also use an alcohol swab.
CAUTION: Do NOT use any sort of chlorine bleach or soap, as these can
damage the unit.
Store the device in a clean, dry location. Before using, check the treatment
plate for dust or lint; if present, clean the plate as described above before
using.
Disposal at the End of Life:
To protect the environment, do not discard your Strialite with your normal
trash. Take it to an official recycling collection point instead.

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Troubleshooting
Your Strialite is designed to be problem-free. However, if it is not functioning
correctly or you have a question, consult the table below for help.
Problem
Resolution
The lights on the device do not come on
and the treatment plate does not
become warm.
1. Unplug the device, reinsert it into the
outlet, and press in on the power button
again.
2. Be sure the device is plugged into an
active AC outlet.
3. If this does not resolve the problem,
contact the Strialite Customer Service
Center.
The lights come on, but the treatment
plate does not become warm in 1-2
minutes.
There is a malfunction in the device. Contact
the Strialite Customer Service Center.
The treatment plate warms correctly but
the lights do not come on.
There is a malfunction in the device. Contact
the Strialite Customer Service Center.
The power button cannot be pushed
down.
Contact the Strialite Customer Service
Center.
The treatment place continues to
become warmer/becomes too warm
during treatment and/or the device
shuts off from excess heat.
Check the room temperature. If it is 85°F
(29.4°C) or higher, move to a cooler room,
allow the device to cool, and then resume
treatment. If the room temperature is below
85°F (29.4°C), contact the Strialite Customer
Service Center.
Not all lights come on.
There is a malfunction in the device. Contact
the Strialite Customer Service Center.
The device shuts off when it first touches
your skin (this may be due to static
electricity).
Press in on the power button again. If this
does not resolve the problem, contact the
Strialite Customer Service Center.
NOTE: There are no user-serviceable parts in this device.
Strialite Customer Service Center:
Toll Free: 1-844-STRIALITE (1-844-787-4254)
Monday –Friday, 8:00 AM to 5:00 PM Eastern Time

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Clinical Studies
A clinical study was conducted to assess the effect of Strialite on the temporary
reduction of redness of the subjects’ red stretch marks. Thirty of the 33 subjects
enrolled completed the full series of 8 treatments over 4 weeks. Sixteen out of 30
subjects reported, upon self-assessment, improvement of the severity of the redness
of their stretch mark of at least 2 grades when graded on a scale of 1 to 10 from
baseline to post-treatment. As a secondary endpoint, blinded photographic
assessment was performed and the blinded evaluation identified 18 of the 30 subjects
as demonstrating improvement. Two subjects that self-assessed as having the worst
appearing lesions (grade 10) did not show any improvement throughout the study.
Specifications:
Model Number: 1011
Input Voltage: 100V–240 V; 50/60 Hz; 500 mA
Power Supply: Input: 90–264 Volts AC
Output: 12 Volts DC
Current rating: 1 A
Storage Conditions: -13°F–158°F (-25°C–70°C)
Relative Humidity: < 93% noncondensing
Operating Conditions: 60°F–85°F (15°C–29°C)
Relative Humidity: 15%–93% noncondensing
Atmospheric Pressure: 700 hPa–1060 hPa;
0.7 atm–1.6 atm
Light Source: Light Emitting Diodes (LEDs)
Dominant Wavelength: 633 +/–5 nm (red)
Intensity power: 150–200 mW/cm2per LED
Expected Use Life: >1000 hours of operation.
IP Classification: IP50
Degree of Protection Type BF; Applied Parts: enclosure, treatment
Against Electrical Shock: plate, LEDs

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Compliance and Symbols:
The Strialite device is compliant with the following safety standards:
IEC 60601-1, Edition 3.1, Revision 2012-08
IEC 60601-1-2 (2007), Third Edition
IEC 60601-1-6, Edition 3.0, Revision 2010-01
IEC 60601-1-11, Edition 1.0, Revision 2010-04
IEC 60601-2-57: 2011
Degree of protection against electrical shock: Type BF, applied part
Read Instructions for Use before using
Do not operate around water
Customer Service and Assistance:
If your device is broken or in need of repair, or if you need assistance, please
contact the Strialite Customer Service Center toll free:
1-844-STRIALITE
(1-844-787-4254)
The Customer Service Center is available to help you:
Monday –Friday, 8:00 AM to 5:00 PM Eastern Time
You can also email any questions or comments to:
CentreLightSolu[email protected]
For more information about Strialite products, please visit our website at:
www.Strialite.com

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Warranty
TERMS AND CONDITIONS OF SALE/LIMITED AND EXCLUSIVE WARRANTY
The following are the exclusive terms and conditions for the sale of the accompanying CENTRE LIGHT
SOLUTIONS, LLC ("CENTRE LIGHT") product, acceptance of which by you, the customer, shall be deemed
acceptance of these terms and conditions. All contrary terms in any purchase order or other document
are hereby rejected by CENTRE LIGHT, no actual or purported distributor or other retail seller or re-seller
is authorized to make any agreements, representations or warranties on behalf of CENTRE LIGHT, and
any such agreements, representations or warranties are null and void.
LIMITED WARRANTY: CENTRE LIGHT products are made of the finest parts available. If, within one (1)
year of purchase, a defect in material or workmanship should become apparent, and if, in the sole and
exclusive judgment of CENTRE LIGHT, the product has received normal use and care, and if no damage
or wear has resulted from abuse, neglect, misuse, tampering, and/or accident, and if the product has
been used exclusively with CENTRE LIGHT components, CENTRE LIGHT will repair or replace (in its sole
discretion) the product free of charge. This warranty does not extend to any defects in material or
workmanship, or any malfunctions or performance problems of any kind, which arise or become
apparent more than one year after purchase of the product.
WHO IS ENTITLED TO THE PROTECTION OF THIS WARRANTY? Only you, the original purchaser of the
product, are entitled to the protection of this warranty. This warranty is not assignable or transferrable
in any way, and may not be asserted or enforced by any subsequent purchaser, lessee, or other user of
the product. Prior to providing repair services or replacement under this warranty, CENTRE LIGHT may
require proof of purchase in the form of a receipt or invoice, or such other documentation as CENTRE
LIGHT, in its sole discretion, deems appropriate.
HOW DO YOU GET WARRANTY SERVICE? Any claim under this limited and exclusive warranty must be
made by contacting Strialite Customer Service Center to obtain prior return or service authorization. No
products will be accepted for repair or replacement without prior return authorization in the form of a
Return Goods Authorization (RGA) number. To obtain an RGA number, call toll-free 844-STRIALITE (844-
787-4254) or go to the customer service section of http://www.Strialite.com. In order to obtain warranty
service you must comply with all instructions concerning shipment, and must enclose all the required
materials, including acceptable proof of purchase. Damage to the product during shipment is not
covered by this warranty, so it is suggested that you insure the shipment, and that you ship the product
using a tracked method so that you can confirm receipt. You are required to pay all outgoing shipping
charges. If CENTRE LIGHT determines that repair or replacement is appropriate under this warranty,
CENTRE LIGHT will pay packaging and shipping costs to return the repaired or replacement product to
you. If CENTRE LIGHT determines that the product does not exhibit significant defects in materials or
workmanship, and thus is not qualified for repair or replacement under this warranty, you will be
required to pay all shipping and packaging costs for return of the product. CENTRE LIGHT will not honor
any warranty claims which fail to abide by these conditions. All applications for repair or replacement
of the product under this warranty must be actually received by CENTRE LIGHT within one year of your
purchase of the product to be repaired or replaced. Repair or replacement of the product in the event
that significant defects in materials or workmanship are discovered within one year of purchase shall
constitute the sole and exclusive remedy.

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WHAT DOES THIS WARRANTY NOT COVER? This is an exclusive and limited warranty, enforceable by
an exclusive and limited remedy. It does not cover any defect, damage, or malfunction other than
defects in material and/or workmanship which become apparent within one year of purchase. For
example, and without limitation, this warranty does not cover damage to the product or to any other
property, resulting from accident, misuse, abuse, lack of reasonable care, the affixing of any attachment
not provided with the product, use of unauthorized replacement parts, or any use not consist with the
instructions provided in the user manual or instructions.
THIS WARRANTY IS MADE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY
IMPLIED WARRANTIES OF MERCHANTABILITY OR OF FITNESS FOR PARTICULAR PURPOSE. CENTRE
LIGHT'S ONLY OBLIGATION TO THE CUSTOMER SHALL BE TO REPAIR OR REPLACE, AS IN ITS SOLE
JUDGMENT IS NECESSARY, ANY PRODUCTS FOUND BY CENTRE LIGHT TO BE DEFECTIVE WITH RESPECT
TO MATERIALS OR WORKMANSHIP. EXCEPT TO THE EXTENT OF AND IN ACCORDANCE WITH THE
REMEDIES PROVIDED BY THIS LIMITED AND EXCLUSIVE WARRANTY, CENTRE LIGHT SHALL NOT BE LIABLE
FOR ANY DIRECT, INCIDENTAL, OR OTHER DAMAGES ARISING FROM THE SALE OF THE PRODUCTS TO
THE CUSTOMER OR THE CUSTOMER'S USE OF THE PRODUCTS.
CENTRE LIGHT SHALL NOT UNDER ANY CIRCUMSTANCES BE LIABLE FOR ANY CONSEQUENTIAL DAMAGES
INCURRED BY THE CUSTOMER OR ANY THIRD PARTIES AS A RESULT OF ANY ALLEGED DEFECTS IN THE
PRODUCTS, OR OTHERWISE ARISING FROM THE SALE OF THE PRODUCTS TO THE CUSTOMER OR THE
CUSTOMER'S USE THEREOF.
These Terms and Conditions constitute the entire agreement between CENTRE LIGHT and the customer
and contain all the agreements and conditions of sale; no course of dealing or usage of the trade shall
be applicable or shall be deemed to govern the parties' relationship or alter these Terms and Conditions.
These Terms and Conditions may not be added to, modified, superseded or otherwise altered.