Centre Light Solutions Strialite 1011 Instructions For Use Manual

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Instructions

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Centre Light Solutions, LLC

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Summary of Contents for Centre Light Solutions Strialite 1011

Page 1 Instructions for Use Centre Light Solutions, LLC...
Page 2 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...
Page 3: Table Of Contents
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 ....................
Page 7: General Information What Is Strialite
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.
Page 8: Description Of The Strialite Device
Description of the Strialite Device: Power Cord (Attached power supply plugs into AC wall outlet) Handle (To easily hold the device) On/Off Button (Press to turn the device on and off) Figure 1...
Page 9 Heated Treatment Plate (Also contains the LEDs) LEDs (Red light emitting diodes) Figure 2...
Page 10: Unpacking The Device
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 ...
Page 11: Precautions
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.
Page 12: Safety Features
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. ...
Page 13: Procedure For Use Instructions
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.
Page 14: Recommended Treatment Schedule
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.
Page 15: Troubleshooting
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 Unplug the device, reinsert it into the and the treatment plate does not outlet, and press in on the power button become warm.
Page 16: Clinical Studies
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.
Page 17: Compliance And Symbols
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...
Page 18: Warranty
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.
Page 19 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...
Page 21 Revised 2/16 650001...