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1. 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 Proper Use The LaserComb should be used for 11 minutes Use a watch or clock to time your treatment First press the power button and hold it down for 3 seconds and the power button light will light up green Second press the laser button which will light up red That means the LaserComb is ready to be used Shine the LaserComb 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 LaserComb if the device is damaged or defective instead call Customer Service toll free at 1 866 52 37 26 a IT ml Pe a g gt AJ IT IU U JI U IT JJ C 02 IT Y Z O Q Y Z LU lt LU Ge Treatment Instructions Before beginning treatment be sure to test the HairMax LaserComb for sensitivity Page 5 After you have turned on the LaserComb place it flat on your scalp so that both rows of the teeth are touching your scalp Figure A Next move the LaserComb against the way your hair grows from front to back Figure B Move the LaserComb slowly in a combing motion leaving it on one spot for 4 seconds TREATMENT INSTRUCTIONS Next move the LaserComb against the way your hair grows from front to back Now move the LaserComb2. such as redness or rash do not use the LaserComb and contact our Customer Service toll free at 1 866 52 3726 to return your product and get a refund Only use the LaserComb as directed Do not try to change the way the LaserComb operates Changes may result in harmful laser exposure Contact Customer Service toll free at 1 866 52 3726 for repairs Never use acetone or other solvents on any part of the LaserComb 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 LaserComb yourself This appliance has no user serviceable parts Use the LaserComb only for its intended use as described in this manual Contact Customer Service toll free at 1 866 52 3726 RISKS TESTING FOR SENSITIVITY Risks HairMax LaserComb has been clinically tested on both men and women In the clinical study for men 5 of the men said they had itching or tingling from using the LaserComb None of the women in the clinical study reported any of these side effects from using the LaserComb If you have itching tingling or any other side effect that bothers you stop using the LaserComb and contact Lexington s Customer Service toll free at 1 866 52 37 26 Testing the LaserComb for sensitivity Before beginning treatment be sure to test the HairMax LaserComb for sensitivity Turn the device on hold the LaserComb on one spot shining the light on your forearm After two min
3. Do not use the 5 times per week LaserComb more than 11 minutes per treatment day Most users see benefits in as little as 16 weeks based on clinical studies When you receive the LaserComb take all the parts out of the case Remove the safety label located between the laser button and power button You must charge your LaserComb before using Charging Methods METHOD 1 Charging the LaserComb using the charging cradle stand and power cord Plug the power cord into the cradle and the other end into an electrical wall outlet While the device is charging you will see a red light on the charging cradle After Q e about 2 3 hours the light on the charging cradle will turn green which means that the LaserComb is fully charged and ready to use During this charging method the light on the device will not light up METHOD 2 Charging the LaserComb by placing the power cord directly into the handle end of the Laser Comb and the other end into an electrical wall outlet a j GETTING STARTED PROPER USE When the LaserComb requires charging the laser will turn off anf the red laser indicator Item B on page 9 will start to blink ae You will have to charge your LaserComb with one of the charging methods DMA Ye oO as described on page 10 as Please Note If your device needs to be recharged during your treatment simply insert the power cord directly into the
4. EGLIGENCE 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 HAIRMAX LASERCOMB 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 WHOLLY 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 O 70 345 8570 FAX 31 0 70 345 7299 To validate your warranty please register online at www hairmax com warranty or call Customer Service toll free at 1 866 527 3726 W WARRANTY CARD The HairMax LaserComb has a 2 year warranty against defects in materials or workmanship from Lexington International LLC Items that are damaged or abused are not covered under the
5. 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 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 International LLC 777 Yamato Road Suite 105 Boca Raton FL 33431 USA LIMITATION OF LIABILITY INDEMNITY EXCEPT AS EXPRESSLY SET FORTH ABOVE LEXINGTON INTERNATIONAL 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 HAIRMAX LASERCOMB EVEN IF LEXINGTON INTERNATIONAL LLC HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES WHETHER IN AN ACTION OF CONTRACT N
6. Fitzpatrick Skin Types to IV How the LaserComb works The LaserComb works by providing laser energy to stimulate hair follicles For optimal results the laser must not be blocked by the hair and must have an unobstructed path to the It is important that you read and understand the content of this User Manual before using your HairMax LaserComb scalp The LaserComb has teeth that part the hair and allow the maximum amount of laser energy to reach the scalp Treatment with HairMax LaserComb The LaserComb should be used for 11 minutes per treatment 3 times per week soaced out every other day For example Monday Wednesday Friday The LaserComb should not be used more than the recommended treatment time per day Clinical studies demonstrate that most users see benefits in as little as 16 weeks HairMax LaserComb 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 NOILONGOdLNI See pages 8 for detailed results of the study F LLI z O a Z lt Z LLI 2 ad O LL FA O T O LL Y Y lt O WHO IS THE BEST CANDIDATE FOR HAIRMAX LASERCOMB How do you know if the HairMax LaserComb is right for you The LaserComb can be used by men and women with thinning hair or pattern baldness caused b
7. HAIRMAXx The science of hair growth HAIRMAX COM For International Translations visit www hairmax com manual HAIRMAX COM 1 866 LASERCOMEB 1 866 527 3726 LIT UMHM4 O1 03 12 HAIRMAX The science of hair rowth USER MANUAL Y ps Z Lu A QO HL O Lu m a TABLE OF CONTENTS nroduc tiO ieissa E 1 Who is the best candidate Classifications male female 2 Who is the best candidate Fitzpatrick Skin Types 3 Warnings and Cautions c ccsscssssssssssesssssssecssecssessscssessnesssesssecsseesees 4 RISKS TESTING for SESIUIVILY scccsscausaversassisasartcntaserciepinnriaonnnitaviterse 5 How to Monitor Device Activity sessssssessssssssssssesessessesseseeees 6 Device Failure Mode escsssssssssscssesssesssssssssssssssssssssessseesscssessseesses 6 Expected Life of the HairMax LaserComb ccccessessessesses 6 Summary of Clinical Study in Meni ccssssesssesssecsssccssecsecsseeeees 7 Summary of Clinical Study in WOMEN sssessssesssessseesssecsseecsseesses 8 HairMax Laser C Om Parts cscsssscscmesvteecenuienenaumnarans 9 Getting STAG Cia sscsssecssssvssnesnsssosvesdsnsuetoseavctadstusestssnsrssorsavedeyservraterne 10 Prop r USec Eae eiaei AERE RE a aaa 1 Treatment INStructiONns csscsssssssssssecsesscsssecssescsessesseessesseseeseenss 12 What your HairMax LaserComb comes With csecssecseesees 13 TROCHSISS OO UNE avectenrcrsgnsteraranasie nen adaeneadeeenarne 14 Safety Lab
8. ed their hair once per day Mean Terminal Hair Count Changes 3 times per week on non consecutive days The number of thick From Baseline in FEMALES normal healthy hairs in the target area were counted at Week 1 26 Weeks Observed Hair Count Week 16 and Week 26 Results at 26 weeks showed that over 90 of the women saw some increases in hair counts based on a minimum of 32 new hairs per square inch being observed at the follow up visit No subjects in the study experienced any serious adverse events In fact the number and types of adverse events were similar in 16 the HairMax LaserComb and control groups Hair Count Change s In the clinical study after 26 weeks of treatment with the LaserComb and a Control Device the following increases 2 in hair count were found HAIRMAX Control Device POWER BUTTON LASER BUTTON POWER CORD SAFETY LABEL TEETH LASER WINDOW WARNING LABEL CHARGING CRADLE STAND CHARGING CRADLE INDICATOR HAIRMAX LASERCOMB PARTS SLUVd AGNOODUASV 1 XVWAIVA a LLI QX mi Y OD Z LLI OD GETTING STARTED Read this manual completely before you start to use your LaserComb so you understand all about the device Refer to page 9 for detailed description of your device Use the LaserComb 11 minutes per treatment three treatments per week The treatments should be spaced every other day for example Monday Wednesday Friday
9. eek 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 being observed at the follow up visit No subjects in the study experienced any serious adverse events In fact the number and types of adverse events were similar in the LaserComb and Control Groups Hair Count Change In the clinical study after 26 weeks of treatment with the LaserComb devices versus the Control Device the following increases in hair count were found Mean Terminal Hair Count Changes From Baseline in MALES 26 Weeks Observed Hair Count HAIRMAX Control Device NAW NI AGALS TVOINTTO AO AAVWWNS Z L gt z gt QO me lt 1 9 va E LL gt ox lt gt 2 N 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 hereditary hair loss which is called Androgenetic Alopecia and had light to medium skin tones Subjects were divided into two groups One group used the LaserComb and the other group used a Control Device The Control Device looked and sounded like the LaserComb 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 study subjects treat
10. el csccsssssssssssscsssscssecsnscsssssssecssesssnsssnscssscsenscsnsecsseesnecsssssess 15 Power SUD ONY Specification S eran scascasracnmnaewanan 15 Cleaning Your HairMax LaserComb u ecsessessesssessesseesseesneeses 16 Electrical Salo CY secccnanciecaseoncsneucniatnneenaanaannnes 17 NY estates exonyscccnconpusesneascousvp cb cenvoesecsxyot ereasrectnsessededsnessevactnspeenoncieedss 18 Wai ora CAN Cla anaeanssmeert E E E T 19 Mailing Address Lexington International 1 561 41 7 0200 11 Yamato Rd Ste 105 Email info hairmax com Boca Raton FL 33431 HAIRMAX com USA HairMax Customer Service Phone 1 866 52 3 26 To view videos about usage quality and safety visit www hairmax com videos www hairmax com QualitySafety Copyright 2012 Lexington Intl LLC All rights reserved INTRODUCTION Introduction of HairMax LaserComb The HairMax LaserComb is a home use laser device that has been Clinically Proven to treat heredity hair loss in men and women The LaserComb is an over the counter OTC device that can be sold directly to the public The LaserComb features a cordless design that can be used with or without the included power cord Indications The LaserComb is indicated to treat Androgenetic Alopecia hereditary hair loss and promote hair growth in females who have Ludwig Savin l 4 II 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
11. ered If for some reason you are experiencing difficulties with your device please try one of the tios below if Your LaserComb will not turn on e Make sure your LaserComb is fully charged e Insert power cord into the LaserComb then press the power button for 4 seconds and then the laser button e Try another electrical wall outlet Your LaserComb is turning off during use e Make sure your LaserComb is fully charged e Insert power cord into the LaserComb then press the power button for 4 seconds and then the laser button e Try another electrical wall outlet Your LaserComb will not turn off e Press and hold power button for 5 seconds e If using power cord unplug the LaserComb and press power button for 5 seconds Your LaserComb beeps irregularly or doesn t beep e If using power cord unplug the LaserComb Plug in power cord again and press the power button then the laser button Your LaserComb beeps but you do not see the laser e If using power cord unplug the LaserComb Plug in power cord again and press the power button then the laser button You have trouble understanding any of these instructions e Contact Customer Service toll free at 1 866 521 3126 Lexington Intl LLC 777 Yamato Road Suite 105 Boca Raton FL 33431 Tel 561 417 0200 Toll Free 1 866 527 3726 info hairmax com www hairmax com SAFETY LABEL LASER PARAMETERS POWER SUPPLY SPECIFICATIONS SAFETY LABEL LASER PARAMETERS Wavele
12. ngth 655nm 10nm visible red light Laser Power for classification lt 5mW CW This Laser Product is designated as Class 3R during all procedures of operation LaserComb Advanced has no user serviceable parts On the underside of the handle Model version varies Power Supply Specifications Output 6VDC 1 0A Plug Imm x 3 5mm center positive The power supply for the HairMax LaserComb can be used in the United States and Internationally This power supply will adapt to all power supplies from 110 volt 60 cycle US to 240 volt 50 cycle If outlets in your country have different plugs than the power supply that comes with the HairMax LaserComb use an inexpensive plug adapter not supplied with the device N gt TI IT lt m gt UJ W m ay gt AN IT AJ Ay gt AT gt x IT S IT AT N U IT AI N U Z lt aa 2 O O cx TT N lt gt lt lt gt lt TR md gt O 2 Z lt 1 Lu z O CLEANING YOUR HAIRMAX LASERCOMB Cleaning your HairMax LaserComb Keep your LaserComb clean Turn off the LaserComb by pressing the power button Unplug the power cord from the device and from the electrical wall outlet Clean the laser window with a soft slightly moistened cloth To clean the comb teeth gently remove any hairs or dust with a slightly moistened towel Don t use any acetone soap or detergents only warm water To clean the tee
13. r 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 HairMax LaserComb The HairMax LaserComb is a medical device manufactured under strict quality controls and validated through GMP Good Manufacturing Practices The HairMax LaserComb 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 LaserComb is 10 15 years of regular use Please take time to read this entire instruction manual before operating the HairMax LaserComb 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 hereditary hair loss which is called Androgenetic Alopecia and had light to medium skin tones Subjects were divided into two groups LaserComb Group and a Control Group The Control Device looked and sounded like the LaserComb 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 times per week on non consecutive days The number of thick normal healthy hairs in the target zone were counted at week 1 week 16 and week 26 Results at the 26 w
14. rarily 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 LaserComb because it can cause temporary irritation to your eyes Keep the LaserComb out of the reach of children Do not drop the LaserComb in water because you may get an electrical shock If the LaserComb gets damaged by water contact Customer Service toll free at 1 866 52 3726 If the cord is damaged on the LaserComb do not use the device because you could get an electrical shock If the cord gets damaged contact Customer Service toll free at 1 866 527 3726 Do not use the LaserComb near any heated surfaces because this could cause the device not to work properly and may cause an electrical shock Contact Customer Service toll free at 1 866 527 3726 Laser light avoid direct eye exposure A A CAUTIONS If you are taking any medications or products that make you sensitive to light you should test the LaserComb to make sure you do not have a reaction Some of the things that can cause increased sensitivity to the LaserComb could be medicines for colds allergies pain medicine and drugs to treat infections To test the LaserComb for sensitivity turn the device on hold the device on one spot shining the light on your forearm 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
15. side to side Figure C Repeat these passes within the required treatment of 11 minutes If you have long hair use your fingers to lift your hair out of the way allowing the LaserComb to deliver the laser light to the scalp Figure D Turn off the LaserComb by pressing and holding the power button down for 3 seconds Figure E Remove the power cord from the electrical wall outlet rest the device in the charging cradle or return the device and power cord to the case for storage TREATMENT INSTRUCTIONS WHAT IS INCLUDED IMPORTANT Do not lift the LaserComb off your head when moving every 4 seconds The LaserComb features a pair of comb teeth that part the hair so the light can more effectively reach the scalp 5 times per week Please Note e It is important to move the LaserComb very slowly Remember you are bathing the scalp with laser light If you move it too fast the treatment will will not achieve the optimal results to promote hair growth e Total time required for treatment is 11 minutes What is included PUA avis Storage Case Charging Cradle Universal Adaptor User Manual i a a GAGNIONI SI LVHM SNOILONYLSNI LNAWLVSYL pm UO L O HE 7A Lu mM ma TROUBLESHOOTING Troubleshooting The LaserComb 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 deliv
16. th more thoroughly gently pull out the comb teeth from the center Then you can separately wash them using soap and warm water e After you dry the comb teeth put them back on the device by inserting the top tabs into place and then press the bottom of the teeth with your thumb until they click into place If you need to replace the teeth you can order online at hairmax com or call Customer Service toll free at 1 866 52 3726 ELECTRICAL SAFETY Electrical Safety Basic safety precautions should be observed when using this or any other electrical device especially when children are present A DANGER 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 LaserComb from the power outlet immediately after using e Do not use while bathing e Do not place or store the LaserComb where it can fall or be pulled into a tub or sink Do not expose the LaserComb to running water or drop into water or any other liquid If the LaserComb falls into water unplug it immediately from the power outlet e f using the LaserComb near water the use of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended Aay Uy Slab Or ils gt Z lt 1 A a WARRANTY THE HAIRMAX LASERCOMB IS WARRANTED BY LEXINGTON INTERNATIONAL LLC MANUFACTURER AGAINST DEFECTS IN MATERIALS OR WORKMANSHIP FOR 24 MONTHS
17. utes 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 HairMax LaserComb and contact Customer Service toll free at 1 866 52 3 26 to return your product and get a refund If you don t experience any reaction proceed with the treatment instructions on page 12 ALIAILISNAS JOJ ONILSAL SHS Lu L A TT Lu O gt lt Lu Lu QO gt Lu lt L Lu 9 a Lu O Z laa m Z gt Os HOW TO MONITOR DEVICE ACTIVITY DEVICE FAILURE MODE EXPECTED LIFE OF LASERCOMB How to Monitor Device Activity Your HairMax LaserComb is inspected and tested during production When working properly both the green and the red light indicators above 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 You will also hear a beep tone If one or both of the light indicators is not lit the laser light does not appear or there is no beep tone contact Customer Service toll free at 1 866 52 3 726 for repair or replacement Device Failure Mode The HairMax LaserComb 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 lase
18. warranty and will be charged at their regular repair rates Lexington Intl 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 located on yellow safety label Date of Purchase Pe on the bottom of the device Where did you purchase this product Reseller Name v What factors influenced your purchase of this product l o O Please fill out this form detach it place it in the envelope or fold out and mail it directly back to us with a postage stamp HAIRMAXx The science of hair rowth HairMax Customer Service Phone 1 866 52 3 26 1 561 41 O200 Email info hairmax com HAIRMAX com as Oc Qa o o TA f Y Mailing Address Lexington International 1 Yamato Rd Ste 105 Boca Raton FL 33431 USA 2901 Clint Moore Road 260 Lexington International LLC Boca Raton FL 33496 To view videos about usage quality and safety visit www hairmax com videos www hairmax com QualitySafety Copyright 2012 Lexington Intl LLC All rights reserved WY G O C J or Q 2 a gt O N
19. y 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 LaserComb Norwood Hamilton Classification Males i ss a Va v Ludwig Savin Classification Females The HairMax LaserComb has not been clinically tested for hair loss outside of the shaded areas WHO IS THE BEST CANDIDATE FOR THE HAIRMAX LASERCOMB The LaserComb 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 LaserComb 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 be effective for these skin types O O oO ax O 2 Dark brown skin very rarely burns with sun exposure common in people of Middle Eastern descent Black skin never burns with sun exposure Not Clinically Tested for these skin types NOILVOIAISSV 1D AdAL NIAS AWOldLVdZ 114 Ta Z O lt O Z lt Tg a Z Z ma x gt gt WARNINGS AND CAUTIONS WARNINGS Do not stare directly at the red laser light or its reflection in a mirror because it can tempo
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