USER MANUAL
Contents
1. Lexington International LLE 2901 Clint Moore Road 260 Boca Raton FL 33496 USA Model 7 41 Serial No 15 POWER BUTTON G LASER BUTTON BATTERY INDICATOR 6 INFORMATION DISPLAY POWERCORD SAFETY LABEL TEETH O LASER WINDOW WARNING LABEL CHARGING CRADLE STAND 9 CHARGING CRADLE INDICATOR A THIS SECTION APPLIES TO FOLIGAIN L12x PROFESS ONAL LASER COMB MODELS ONLY For FOLIGAIN L7x Advanced Laser Comb refer to pages 9 15 for instructions Use the Laser Comb for 8 minutes per Pad MT treatment 3 treatments per week The 8 treatments should be spaced every ur other day for example on Monday Wednesday and Friday Do not use the Laser Comb more than 8 minutes per treatment day Most users see benefits in as little as 16 weeks based on clinical studies When you receive the Laser Comb take all the parts out of the case Remove the red safety label The power button and the laser button are located under the red safety label You must charge your Laser Comb for 2 3 hours before initial use Charging Options Charging can be accomplished by one of the two following options OPTION 1 Charge the Laser Comb using the charging cradle stand and power cord Prior to placing the Laser Comb in the cradle make sure your Laser Comb is turned off and the teeth face away from you Plug the power cord into the cradle and the other end into an electrical wall outlet While the device2. and vibrate feature Top position is laser only Shine the Laser Comb onto the palm of your hand You will see that the laser light is on Do not look at the laser light directly The Laser Comb is now ready for use TREATMENT INSTRUCTIONS FOLIGAIN L7x ADVANCED LASER COMB Treatment Instructions Before beginning treatment be sure to test the FOLIGAIN Laser Comb for sensitivity Page 5 After you have turned on the Laser Comb place it flat on your scalp so that both rows of teeth are touching your scalp Figure E Start at your hairline Move the Laser Comb from front to back of scalp in a slow combing motion stopping every 1 2 inch 1cm and pausing for 4 seconds Figure F Do not lift the Laser Comb off your scalp while combing from front to back Next lift the Laser Comb off your scalp and start at a new position at the hairline Continue in this manner from front to back then side to side until you cover your entire scalp with multiple passes IMPORTANT Do not lift the Laser Comb off your scalp while combing from front to back or side to side unless you are starting at a new position at the hairline The Laser Comb features a pair of comb teeth that part the hair so the light can more effectively penetrate to the scalp You will make a few complete passes over your scalp within recommended treatment time Repeat these passes within the required treatment of 15 minutes If you have long hair use
3. battery door 5 even as the batteries age VVhen the batteries vveaken to the point where they will no longer power the lasers to their optimum power 4 Open the battery compartment level the green battery indicator vvill flash from green to red and the lasers vvill flash This is an indication that the batteries need to be replaced Use the follovving steps to replace the batteries Replacing batteries continued 1 Using a thin coin or your finger nail depress the Battery Cover Tab see Figure A and remove battery door 2 Insert 4 AA batteries Be sure to align batteries as shown on bottom of battery compartment Figure C 3 Replace Battery Cover by aligning bottom of Cover in grooves and then pressing the top of Cover until it snaps into place Do not use the Laser Comb if the device is damaged or defective instead contact HairMax Customer Service at infoQhairmax com PROPER USE FOLIGAIN L7x ADVANCED LASER COMB Proper Use Read and follow all directions prior to use Use the Laser Comb for 15 minutes per 15 treatment three treatments per week ance The treatments should be spaced every other day for example on Monday Wednesday and Friday Do not use the Laser Comb more than 15 minutes per treatment day Most users see benefits in as little as 16 weeks based on clinical studies Slide the power laser button to the middle or top position Figure D Middle position activates the laser
4. THIS WARRANTY DOES NOT COVER DAMAGES CAUSED BY ACTS OF GOD MISUSE NEGLIGENCE ACCIDENT MODIFICATION OF OR TO ANY PART OF THE PRODUCT THIS WARRANTY DOES NOT COVER DAMAGE DUE TO IMPROPER OPERATION OR MAINTENANCE CONNECTION TO IMPROPER VOLTAGE SUPPLY OR ATTEMPTED REPAIR BY ANYONE OTHER THAN LEXINGTON THIS WARRANTY IS VOID IF PRODUCT IS TAMPERED WITH TO OBTAIN WARRANTY SERVICE YOU MUST DELIVER THE PRODUCT FREIGHT PREPAID IN EITHER ITS ORIGINAL PACKAGING OR PACKAGING AFFORDING AN EQUAL DEGREE OF PROTECTION TOGETHER WITH YOUR NAME AND ADDRESS TO Lexington Research LLC 777 Yamato Road Suite 105 Boca Raton FL 33431 USA LIMITATION OF LIABILITY INDEMNITY EXCEPT AS EXPRESSLY SET FORTH ABOVE LEXINGTON RESEARCH LLC SHALL NOT BE LIABLE FOR ANY SPECIAL INDIRECT OR CONSEQUENTIAL DAMAGES THAT ARE DIRECTLY OR INDIRECTLY RELATED TO THE USE OF OR THE INABILITY TO USE THE FOLIGAIN LASER COMB POWERED BY HAIRMAX EVEN IF LEXINGTON RESEARCH LLC HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES WHETHER IN AN ACTION OF CONTRACT NEGLIGENCE OR OTHER TORTUOUS ACTION SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU GOVERNING LAW THE USAGE OF THE FOLIGAIN LASER COMB AND THE INTERPRETATION OF ITS TERMS SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF FLORIDA APPLICABLE TO AGREEMENTS NEGOTIATED EXECUTED AND PERFORMED WH
5. achieve the optimal results to promote hair growth e Total time required for treatment with the Professional Laser Comb is 8 minutes What is included FOLIGAINLA x r pr 1 i USER MANUAL m q ER FOLIGAIN L12x Retail Box Charging Cradle Universal Adaptor User Manual Quick Start Professional Laser Comb Guide 21 ANY ATTEMPT TO SELF SERVICE YOUR DEVICE UNLESS INSTRUCTED BY A HAIRMAX REP WILL VOID YOUR WARRANTY The Laser Comb has advanced electronics to ensure that the device If your Laser Comb will not turn off is working like it is supposed to and that the proper amount of laser e Press and hold power button for 4 seconds energy is being delivered If you are experiencing difficulties with e If using power cord unplug the Laser Comb and press power your device please try one of the tips below button for 4 seconds Your Laser Comb will not turn on If your Laser Comb beeps vibrates irregularly e Make sure your Laser Comb is fully charged or doesn t beep vibrate e Insert the power cord into the Laser Comb press the power e If using power cord unplug the Laser Comb Plug in power cord button for 4 seconds and then press the laser button again and press the power button then the laser button e Try another electrical wall outlet If your Laser Comb beeps and vibrates but you do not see If your Laser Comb is turning off during use the laser light e Make sure your Las
6. is charging you will see a red light on the charging cradle After about 2 3 hours the light on the charging cradle will turn green which means that the Laser Comb is fully charged and ready to use During this charging option the light on the device will not light up OPTION 2 Charge the Laser Comb by placing the power cord directly into the handle end of the Laser Comb and the other end into an electrical wall outlet The battery indicator light on the top of the Laser Comb will show yellow when charging and turn green when fully charged When the Laser Comb requires 1 charging the battery indicator light ll BATTERY eel INFORMATION DISPLAY will flash red and the battery icon on the information display will appear Charge your Laser Comb with charging option 1 or 2 Please Note Proper Use The Professional Laser Comb should be used for 8 minutes Use a watch or clock to time your treatment First press the power button and hold until power button light turns green Second press the laser button which will light up red LASER BUTTON That means the Laser Comb is POWER BUTTON ready for use Shine the Laser Comb onto the palm of your hand and you will see that the laser light is on do not look at the laser light directly Do not use the Laser Comb if the device is damaged or defective instead contact HairMax Customer Service at info hairmax com If your device needs to be recharged during yo
7. your fingers to lift your hair out of the way allowing the Laser Comb to deliver the laser light to the scalp Figure G Turn off the Laser Comb by sliding the power laser button to the lowest position Figure H Store the device in the cradle stand for future use Please Note e It is important to move the Laser Comb very slowly Remember you WHAT IS INCLUDED FOLIGAIN L7x ADVANCED LASER COMB are bathing the scalp with laser light If you move it too fast the treatment will not achieve the optimal results to promote hair growth e Total time required for treatment with the Advanced Laser Comb is 15 minutes 0 FOLIGAIN L7x Advanced Laser Comb Retail Box 15 minutes What is included 4 AA batteries Cradle Stand The Laser Comb is most effective when used correctly In order to help time the movements the Laser Comb will automatically vibrate every 4 seconds The vibration can be turned off by sliding the power laser button to the uppermost top position The Laser Comb should be used for 15 minutes Use a watch or clock to time your treatment FOLIGAIN LASER COMA USER MANUAL m User Manual Quick Start Guide 13 TROUBLESHOOTING FOLIGAIN L7x ADVANCED LASER COMB The Laser Comb has advanced electronics to ensure that the device is working like it is supposed to and that the proper amount of laser energy is being delivered If you are experienci
8. 33496 USA Model Serial h The power supply for the Laser Comb can be used internationally This power supply will adapt to all power supplies from 110 volt 60 cycle US to 240 volt 50 cycle An adapter EX5001 12 V2 OW specific to your country is included vvith your Laser Comb 23 CLEANING YOUR FOLIGAIN LASER COMB e Keep your Laser Comb clean e To clean the teeth more thoroughly gently pull out the comb teeth from the center Then you can separately wash them e Turn off the Laser Comb by sliding the power button to the lowest position FOLIGAIN L7x Advanced or by pressing and holding the power button lower button until green light turns e After you dry the comb teeth put them back on the device by off FOLIGAIN L12x Professional using soap and warm water inserting the top tabs into place and press the bottom of the teeth e Unplug the power cord from the device and from the electrical With your thumb uni ihey ciek wall outlet into place If you need to replace e Clean the laser window with a soft slightly moistened cloth TOP TABS the teeth please contact info anagenresearch com e To clean the comb teeth gently remove any hairs or dust with a slightly moistened towel e Don t use any acetone soap or detergents Use warm water only 24 ELECTRICAL SAFETY Electrical Safety Basic safety precautions should be observed when using this or any other electrical device especially when childre
9. AA ARAN aran HA Ludwig Savin 4 R A Classification Females 6 i SS 3 The Laser Comb has not been clinically tested 12 lu Advanced Frontal for hair loss outside of the shaded areas Norwood Hamilton Classification Males WHO IS THE BEST CANDIDATE The Laser Comb was only studied in light to medium skin tones Types 1 2 3 4 as described in the Fitzpatrick Scale below If your hair loss and skin tone fall into these categories the Laser Comb should work for you Fitzpatrick Skin Type Classification Guide A way to describe your skin type based on your complexion and what happens to your skin in sunlight Very white or freckled skin always burns with sun exposure Type 1 E yP very fair often in people with red or blond hair and blue eyes g z Type 2 557 VVhite skin usually burns vvith sun exposure fee fair often in people with red or blond hair and blue green or hazel eyes Type 3 oy White or olive skin tone sometimes burns with sun exposure O 0 fair seen in people with any hair or eye color Q Tvoe 4 Brown skin rarely burns with sun exposure yP common in people of Mediterranean descent 0 Type 5 0 m Dark brovvn skin very rarely burns vvith sun exposure yp 2 common in people of Middle Eastern descent Oz yz Type 6 S y Black skin rarely burns with sun exposure E Adapted from Fitzpatrick s Dermatology in General M
10. OLLY AND SOLELY WITHIN THE STATE OF FLORIDA THE PARTIES AGREE THAT THE STATE OF FLORIDA S CONFLICTS OF LAWS RULES SHALL NOT APPLY TO THIS AGREEMENT OR ANY TRANSACTION PERFORMED BY OR UNDER THIS AGREEMENT JURISDICTION AND VENUE THE PARTIES IRREVOCABLY SUBMIT AND CONSENT TO THE SOLE AND EXCLUSIVE JURISDICTION AND VENUE OF THE FLORIDA STATE COURTS IN AND FOR PALM BEACH COUNTY FLORIDA U S A AND THE FEDERAL COURTS IN AND FOR THE SOUTHERN DISTRICT OF FLORIDA U S A THE PARTIES AGREE NOT TO RAISE THE DEFENSE OF FORUM NON CONVENIENS AUTHORIZED REPRESENTATIVE IN EUROPE REGULATORY AFFAIRS ONLY EMERGO EUROPE MOLENSTRAAT 15 2513 BH THE HAGUE THE NETHERLANDS TEL 31 0 70 3t5 8570 FAX 31 0 70 345 7299 To validate your warranty please register online at www hairmax com warranty 26 WARRANTY CARD The FOLIGAIN Laser Comb has a 2 year warranty against defects in materials or workmanship from Lexington Research LLC Items that are damaged or abused are not covered under the warranty and will be charged at the regular repair rates ANY ATTEMPT TO SELF SERVICE YOUR DEVICE UNLESS INSTRUCTED BY A HAIRMAX REP WILL VOID YOUR WARRANTY Anagen Research LLC may extend this warranty period under certain product failures Please refer to the User Manual for complete warranty terms We guarantee your satisfaction To validate your warranty card register online at www hairmax com warranty or complete and mail this warranty card Name Seri
11. Please take time to read this entire instruction manual before operating the Laser Comb SUMMARY OF CLINICAL STUDY IN MEN Clinical studies were conducted at multiple locations in the United States Participants in the study were males diagnosed with Androgenetic Alopecia which includes hereditary hair loss and had light to medium skin tones Subjects were divided into two groups Laser Comb Group and a Control Group The Control Device looked and sounded like the Laser Comb device but did not include a laser light The clinical studies adhered to all GCP Good Clinical Practice guidelines were approved by an IRB Institutional Review Board and listed on www clinicaltrials gov During the 6 month clinical study subjects treated their hair once per day 3 Mean Terminal Hale Countehandes From Baseline in MALES hairs in the target zone was counted at week 1 week 16 and week 26 26 Weeks times per week on non consecutive days The number of thick normal healthy Results at the 26 week visit showed that over 93 of the men saw an increase in hair counts based on a minimum of 32 new hairs per square inch 6 45 square cm being observed at the follow up visit 130 No subjects in the study experienced any serious adverse events In fact the number and types of adverse events were similar in the Laser Comb and Control 90 Groups Hair Count Change 50 In the clinical study after 26 weeks of treatment with the Laser Comb devices
12. The Laser Comb should be used 3 times per week spaced out every other day for example on Monday Wednesday and Friday The Laser Comb should not be used more than the recommended treatment time per day Recommended treatment for the FOLIGAIN L7x Advanced Laser Comb is 15 minutes and the FOLIGAIN L12x Professional Laser Comb is 8 minutes Clinical studies demonstrate that most users see benefits in as little as 16 weeks Laser Comb Benefits A clinical study was conducted in men and women over a six month time period The study showed that 93 of the men and women had an increase in the number of hairs based on a minimum of 32 new hairs per square inch being observed at follow up See pages 7 8 for detailed results of the study It is important that you read and understand the content of this User Manual before using your FOLIGAIN Laser Comb CLASSIFICATION FOR MEN AND WOMEN WHO IS THE BEST CANDIDATE FOR THE FOLIGAIN LASER COMB How do you know if The FOLIGAIN Laser Comb is right for you The Laser Comb can be used by men and women with thinning hair including colour treated hair or pattern baldness caused by a hereditary condition Doctors use a system known as the Norwood Hamilton Classification men and the Ludwig Savin Classification women to describe the degree of hair loss Below are the pictures of the scales The shaded areas show the type of hair loss that can be treated with the Laser Comb na AM AA AM AA
13. a 17 o A 18 Treatment instr ciions cu sa a 19 What s included FOLIGAIN L12x Professional Laser Comb 21 o 160 00 EN 22 Safety 00353 io A 23 Power Supply Specifications 23 Cleaning Your Laser Comb ao Ra iba 24 Electrical Safety 662444626 65445 e0ed Rs Bu dn cee Ep oeee oi 25 Vere 26 Wallan A 27 www anagenresearch com Introduction of the FOLIGAIN Laser Comb Powered by HairMax The FOLIGAIN Laser Comb is a home use laser device that has been clinically proven to treat hereditary hair loss in men and women The Laser Comb is an over the counter OTC device that can be sold directly to the public Indications The Laser Comb models are indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig Savin 1 4 Il 1 Il 2 or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of lla to V and who both have Fitzpatrick Skin Types I to IV How the Laser Comb Works The Laser Comb works by providing laser energy to stimulate hair follicles Hair shaft For optimal results the laser must not be blocked by the hair and must have an unobstructed path to the scalp The Laser Comb has teeth that part the hair and allow the maximum amount of laser Blood vessel energy to reach the scalp INTRODUCTION Treatment with the Laser Comb
14. al Number located on yellow safety label on the bottom of the device Date of Purchase Address City 0 State i Z P Postal Code Country Email Where did you purchase this product Reseller Name What factors influenced your purchase of this product Please fill out this form detach it place it in an envelope or fold out and mail it directly to us with a postage stamp LEVEE 14 UOIEY e209 GOL 91 nS Pod ewe 222 371 ydJessay SS DPV UJNJISY ajay ede JO ajdeis CONTACT US ji 1 07 Anagen Research Customer Service Mailing Address Email info anagenresearch com 8560 West Sunset Boulevard Suite 500 www anagenresearch com West Hollywood CA 90069 USA g l r da 07 FOR INTERNATIONAL TRANSLATIONS VISIT www anagenresearch com Pour une traduction internationale visitez www anagenresearch com Para traducciones internacionales por favor visite www anagenresearch com Per traduzioni internazionali per favor visitate www anagenresearch com IDE F r internationale Ubersetzungen besuchen Sie bitte www anagenresearch com Para as tradu es internacionais visite www anagenresearch com www anagenresearch com info anagenresearch com
15. ater om FOLIGAIN LASER COMB H irmax FOLIGAIN L7x Advanced Laser Comb FOLIGAIN L12x Professional Laser Comb USER MANUAL TABLE OF CONTENTS o A s SE EEE SEE EN RK 1 Classifications for Men and VVomen 2 VVho is the best candidate Fitzpatrick Skin Types 3 Warnings and Cautions 4 Risks Testing for Sensitivity 5 How to Monitor Device 6 Device Failure Mode s sseoerseeeerrereerererrrr rr rr rr rer rr bd 6 Expected Life of the FOLIGAIN Laser Comb 6 Summary of Clinical Study in Men 7 Summary of Clinical Study in Women 8 FOLIGAIN L7x Advanced Laser Comb Powered by HairMax FOLIGAIN L7x Advanced Laser Comb Parts 9 Getting Started ss seeds mest enter sab sab bala da EN 10 Replacing the Batteries 10 Proper AA dee saz so de RE R eee 11 Treatment Instructions 12 What s included FOLIGAIN L7x Advanced Laser Comb 13 Troubleshooting EEE serk gt b t andres aran redada a 14 S A 15 FOLIGAIN L12x Professional Laser Comb Powered by HairMax FOLIGAIN L12x Professional Laser Comb Parts 16 Erie AA A 1 Charging se sr see ama proto sia ama B la abb
16. edicine McGraw Hill Professional 5th edition Please note that the Laser Comb was only tested on light to medium skin tones This does not indicate that it will not work on darker skin tones WARNINGS AND CAUTIONS WARNINGS A Do not stare directly at the red laser light or its reflection in a CAUTIONS A Ifyou are taking any medications or products that make you mirror because it can temporarily irritate your eyes If you stare at the light for too long it could harm your eyes Also never use a magnifying glass when using the Laser Comb because it can sensitive to light you should test the Laser Comb to make sure you do not have a reaction Some of the things that can cause increased sensitivity to the Laser Comb could be medicines for cause temporary irritation to your eyes colds allergies pain medicine and drugs to treat infections To test the Laser Comb for sensitivity turn the device on hold the A Keep the Laser Comb out of the reach of children device on one spot shining the light on your forearm After tvvo minutes turn the device off and set aside Look at the spot vvhere Do not drop the Laser Comb in water because you may get an you held the laser light over the next five minutes f you see any electrical shock reaction such as redness or rash do not use the Laser Comb A Do not use the Laser Comb near any heated surfaces because A Only use the Laser Comb as directed Do not try to change the this co
17. er Comb is fully charged If using power cord unplug Laser Comb Plug in power cord e Insert the power cord into the Laser Comb press the power again and press the power button then the laser button button for 4 seconds and then press the laser button If you have trouble understanding any of these instructions e Try another electrical wall outlet Contact Customer Service at info anagenresearch com Anagen Research e 8560 West Sunset Boulevard Suite 500 e West Hollywood CA 90069 22 info anagenresearch com www anagenresearch com SAFETY LABEL LASER PARAMETERS POWER SUPPLY SPECIFICATIONS SAFETY LABEL amp LASER PARAMETERS VVavelength 655nm 10nm visible red light Laser Povver for lt 5mW CW classification Divergence 57 mrad Number of lasers 12 This Laser Product is designated as Class 3R during all procedures of operation Note The Laser Comb has no user serviceable parts t Laser Aperture M LASER LIGHT Location On the underside of the handle Model version varies EE EURO RE CLASS 3R LASER PRODUCT 650nm 10nm lt 5mW CW CLASSIFIED PER IEC 60825 1 Ed 2 2007 03 Power Supply Specifications Output 6VDC 1 0A Plug 9mm x 3 5mm center positive Complies with FDA performance standards for laser products except for deviations pursuant 50 dated dune 24 2007 J V 1 0A sono Manufactured For Lexington International LLC 2901 Clint Moore Road 260 Boca Ne
18. n proceed with the treatment instructions on page 12 for the Advanced Laser Comb model or page 19 for the Professional Laser Comb model HOW TO MONITOR DEVICE ACTIVITY DEVICE FAILURE MODE EXPECTED LIFE OF THE LASER COMB How to Monitor Device Activity Your FOLIGAIN Laser Comb is inspected and tested during production When working properly both the green and the red light indicators on the power and laser buttons turn on A red laser light shines through the window at the bottom of the device Do NOT look directly at the laser light Shine the laser light onto the palm of your hand to see if the red laser light appears If one or both of the light indicators is not lit or if the laser light does not appear contact the warranty provider for repair or replacement Device Failure Mode The Laser Comb is designed to last for 10 15 years of continuous use The laser light does not fade or diminish over time At the end of the laser s life or if it fails for any other reason the red laser light will no longer shine out of the device Expected Life of the FOLIGAIN Laser Comb The Laser Comb is a medical device manufactured under strict quality controls and validated through GMP Good Manufacturing Practices The Laser Comb contains high quality laser diodes designed to last at least 15 000 hours Based on that rating and the durability of the components being used the expected life of the Laser Comb is 10 15 years of regular use
19. n are present A WARNING Keep away from water Contact with water may result in an electrical shock To reduce the risk of hazard by electric shock e Always unplug the Laser Comb from the power outlet immediately after using e Do not use while bathing e Do not place or store the Laser Comb where it can fall or be pulled into a tub or sink Do not expose the Laser Comb to running water or drop into water or any other liquid If the Laser Comb falls into water unplug it immediately from the power outlet e If using the Laser Comb near water the use of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended e Do not dispose of the Laser Comb in a fire or store in high temperatures greater than 140 F 60 C 25 WARRANTY ANY ATTEMPT TO SELF SERVICE YOUR DEVICE UNLESS INSTRUCTED BY A HAIRMAX REP WILL VOID YOUR WARRANTY THE FOLIGAIN LASER COMB POWERED BY HAIRMAX IS WARRANTED BY LEXINGTON RESEARCH LLC MANUFACTURER AGAINST DEFECTS IN MATERIALS OR WORKMANSHIP FOR 24 MONTHS FROM DATE OF PURCHASE IF THIS PRODUCT IS DETERMINED TO BE DEFECTIVE LEXINGTON WILL REPAIR OR REPLACE IT AT ITS OPTION AT NO CHARGE DURING THE WARRANTY PERIOD AFTER THE WARRANTY PERIOD THE USER MUST PAY FOR ALL PARTS AND LABOR CHARGES IF THE PRODUCT IS REPAIRED OR REPLACED EITHER WITHIN OR OUTSIDE THE WARRANTY PERIOD LEXINGTON RESERVES THE RIGHT TO PROVIDE EQUIVALENT PARTS IN DIFFERENT COLORS TO YOUR ORIGINAL PRODUCT
20. n the Laser Comb is on it will beep and vibrate every 4 seconds If you have long hair use your fingers to lift your hair out of the way while using the Laser Comb to be sure that the laser energy reaches your scalp Figure D IMPORTANT Do not lift the Laser Comb off your head when moving every 4 seconds unless you are checking the usage timer on the information display or until you complete the pass The Laser Comb features a pair of comb teeth that part the hair so the light can more effectively reach the scalp 20 When the Laser Comb is on it will beep and vibrate every 4 seconds This means that it s time to move the Laser Comb to the next area of the scalp When you do this do not lift LASER BUTTON the device off of your scalp If you wish to turn off the beep vibration during the treatment press the top laser button once Figure E Your Laser Comb LASER BUTTON and laser will remain on To re POWER BUTTON activate beep and vibration simply press the laser button twice Turn off the Laser Comb by pressing and holding the power button lower button until green indicator light turns off Figure F Store the device in the charging cradle for future use You may leave the power cord plugged into the charging cradle at all times Please Note e It is important to move the Laser Comb very slowly Remember you are bathing the scalp with laser light If you move it too fast the treatment will not
21. ng difficulties with your device please try one of the tips below Your Laser Comb is turning off during use Your Laser Comb vibrates but you do not see the laser e Make sure your Laser Comb has fresh batteries e Make sure your Laser Comb has fresh batteries Your Laser Comb will not turn off You have trouble understanding any of these instructions e Slide the power switch to the lowest OFF position e Contact Customer Service at info anagenresearch com Your Laser Comb vibrates irregularly doesn t vibrate e Make sure the Power Switch is in the middle position Anagen Research 8560 West Sunset Boulevard Suite 500 e West Hollywood e CA 90069 14 info anagenresearch com www anagenresearch com SAFETY LABEL amp LASER PARAMETERS Wavelength 655nm 10nm visible red light Laser Power for lt 5mW CW classification Divergence 57 mrad Number of lasers 7 This Laser Product is designated as Class 3R during all procedures of operation Note The Laser Comb has no user serviceable parts Location On the underside of the handle Model version varies SAFETY LABEL LASER PARAMETERS LExioq i T vi HEB 1 1 Laser Aperture 1 LASER LIGHT AVOID DIRECT EYE EXPOSURE CLASS 3R LASER PRODUCT 655nm lt 5mW CW CLASSIFIED PER IEC 60825 1 Ed 2 2007 03 Complies with FDA performance standards for laser products except for deviations pursuant to Laser Notion No 50 dated June 24 2007 EV 1 04 Manufactured For
22. nge bi In the clinical study after 26 weeks of treatment with the Laser Comb and a 8 Control Device the following increases in hair count were found 10 z p e Laser Comb Control Device Y POWER LASER BUTTON BATTERY INDICATOR SAFETY LABEL 5 TEETH BATTERY COVER TAB LASER WINDOW WARNING LABEL CRADLE STAND FOLIGAIN L7x ADVANCED LASER COMB PARTS GETTING STARTED FOLIGAIN L7x ADVANCED LASER COMB REPLACING BATTERIES THIS SECTION APPLIES TO FOLIGAIN L7x ADVANCED LASER COMB MODEL ONLY For FOLIGAIN L12x Professional Laser Combs refer to pages 16 23 for instructions Your Advanced Laser Comb comes with four AA batteries already 5 Locate and remove the installed To use the Laser Comb you must remove the cardboard cardboard protective strip protective strip located in the battery compartment Follow these steps Figure B 6 Replace Battery Cover by aligning 1 Verify the model your device located on the handle If you bottom of Cover in grooves and purchased a Professional Laser Comb refer to pages 16 23 of then pressing the top of Cover until the User Manual it snaps into place 2 Remove the blue label on the bottom of the Laser Comb 7 Your Laser Comb is now ready for use 3 Using a thin coin or your finger nail depress the Battery Cover Replacing BARSNES Tab see Figure A and remove The Laser Comb designed to provide Me optimum laser output
23. uld cause the device not to work properly and may cause l way the Laser Comb operates Changes may result in harmful an electrical shock laser exposure A Laser light avoid direct eye exposure Never use acetone or other solvents on any part of the Laser Comb Use of solvents on the window can block the laser light from coming through NOTICE If any malfunction occurs do not attempt to repair the Laser Comb yourself This appliance has no user serviceable parts Use the Laser Comb only for its intended use as described in this manual Contact Customer Service at info anagenresearch com 4 RISKS The FOLIGAIN Laser Comb has been clinically tested on both men and women In the clinical study for men 5 said they had itching or tingling from using the Laser Comb None of the women in the clinical study reported any of these side effects from using the Laser Comb If you have itching tingling or any other side effect that bothers you stop using the Laser Comb RISKS TESTING FOR SENSITIVITY Testing the Laser Comb for Sensitivity Before beginning treatment be sure to test the Laser Comb for sensitivity Turn the device on and shine the light on your forearm holding it in one spot After two minutes turn the device off and set aside Look at the spot where you held the laser light over the next five minutes If you see any reaction such as redness or rash do not use the Laser Comb If you don t experience any reactio
24. ur treatment simply insert the power cord directly into the end of the device and other end into an electrical wall outlet and continue with your treatment When finished allow the device to fully charge The information display on the top of the Laser Comb will show you 3 pieces of information 1 USEAGE TIMER 3 MINUTE BARS 1 Usage Timer 2 Laser Symbol 3 Battery Symbol 2 LASER SYMBOL 3 BATTERY SYMBOL 1 Usage Timer Measures duration of treatment session This ensures all areas of your scalp are properly covered 2 Laser Symbol To let you know that the laser is turned on 3 Battery Symbol The battery icon will flash when a charge is needed Treatment Instructions Before beginning treatment be sure to test the FOLIGAIN Laser Comb for sensitivity Page 5 After you have turned on the Laser Comb place it flat on your scalp so that both rows of the teeth are touching your scalp Figure A Start at your hairline Move Laser Comb from front to back of scalp in a slow combing motion pausing every 1 2 inch 1 cm for 4 seconds Figure B Do not lift Laser Comb off your scalp while combing from front to back Next lift the Laser Comb off your scalp and start at a new position at the hairline Continue in this manner from front to back then side to side until you cover your entire scalp with multiple passes Figure C Repeat these passes for the total treatment of 8 minutes Whe
25. versus the Control Device the following increases in hair count were found VV ie Laser Comb Control Device SUMMARY OF CLINICAL STUDY IN WOMEN A clinical study was conducted at multiple locations in the United States All participants in the study were females diagnosed with Androgenetic Alopecia which includes hereditary hair loss and had light to medium skin tones Subjects were divided into two groups One group used the Laser Comb and the other group used a Control Device The Control Device looked and sounded like the Laser Comb but did not include a laser light The clinical studies adhered to all GCP Good Clinical Practice guidelines were approved by an IRB Institutional Review Board and listed on www clinicaltrials gov Mean Terminal Hair Count Changes During the 6 month study subjects treated their hair once per day 3 times per From Baseline in FEMALES week on non consecutive days The number of thick normal healthy hairs in the 26 Weeks target area was counted at Week 1 Week 16 and Week 26 Results at 26 weeks showed that over 9096 of the women saw increases in hair counts based on a minimum of 32 new hairs per square inch 6 45 square cm being observed at the follow up visit 120 subjects in the study experienced any serious adverse events In fact the 90 1322 number and types of adverse events were similar in the Laser Comb and control Hair in2 groups ia 50 Hair Count Cha
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