USER MANUAL
Contents
1. 9 2 o Note The HairMax will automatically emit a beep tone every four 4 seconds This is an indication for the user to move the HairMax to the next portion of the scalp For adjusting beep function please refer to page 15 4 Place the HairMax flat on your scalp making sure that both rows of teeth are touching the scalp illustration 3 5 Start at your hairline Move the HairMax slowly in combing motion by placing the device on a spot and leaving it there for 4 seconds Once you hear the beep The HairMax features an audible beep tone every 4 seconds which can aid you in timing the movements move the HairMax about 1 2 inch 1 cm to the next spot without lifting the device off your head You will make a couple of complete passes over your scalp For the first pass move the HairMax front to back illustration 4 and side to side on the second pass illustration 5 Repeat these passes within the recommended 10 to 15 minutes IMPORTANT Do not lift the HairMax off of the head v when moving every 4 seconds The HairMax features a pair of comb teeth that part the hair so the light can more effectively penetrate to the scalp 6 If you have long hair use an ordinary comb or your hand to lift the long hair out of the way allowing the HairMax to deliver the laser light to the scalp Illustr 6 7 Turn off the HairMax by pressing and holding the POWER BUTTON right button down for 2 3 seconds Illustr 7 Place yo2. HAIRMAX D 2 USER MANUAL Lent To validate your warranty please register online at www hairmax com warranty To view our safety and usage videos visit www hairmax com videos aspx Copyright 2010 Lexington International LLC All rights reserved TABLE OF CONTENTS 4 5 EROS 6 6 7 Eeetrical BETIS NENNT 8 Adica BONS ssc tha RR eo 8 RISKS ON NEN 9 Benelli cocos dU imus ad ud sua ON 9 Usage 10 Summary of Clinical Data 10 Information COR UD 11 Norwood Hamilton Classification 11 HairMax LaserComb and Parts eritis 12 Methods of Charging the HairMax 5 Charging Instructions 13 Instructions for DSBiuoui cinereis rh ass rds 14 16 Power Supply SpecificaliOris u us iocis a reet eR oci Ga 16 Maintenance Evae 17 WATE INDY 18 How to Monitor Device 19 Device Failure ModE 19 Expected Life of the HairMax 1 lt 19 WR ONS
3. Tel 561 417 0200 info hairmax com www hairmax com 20 a deqs ode MUI OAL 74 XV VNHINH Place Stamp Here Lexington International LLC 2901 Clint Moore Rd 260 Boca Raton FL 33496 USA Warranty Card The HairMax has a 2 year warranty against defects in materials or workmanship from Lexington International LLC Items that damaged or abused are not covered under the warranty and will be charged at their regular repair rates Lexington 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 please return this completed warranty card or register online at www hairmax com warranty Serial Number Date of Purchase Address ZIP 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 fold it staple or tape it at the designated area place postage stamp and mail it back to us HAIRMAX To validate your warranty please return this Completed warranty card or register online at www hairmax com warranty To view our safety and usage videos visit www hairmax com videos aspx www HairMax com Patented in the USA Patent Pending in 104 countries HairMax is a Registered Trademark of Lexington In
4. Device Activity Your HairMax LaserComb is inspected and tested during production When working properly both the green and the red lights above the 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 at the palm of your hand to see red laser light speckles appear You will also hear a beep tone If one or both of the indicator lights is not lit the laser light does not appear or there is no beep tone contact Lexington International LLC 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 lasers life or if it fails for any other reason no red light will shine out of the device Do not look directly at the laser light Direct the laser light at the palm of your hand to see red laser light speckles appear If no light appears contact Lexington International LLC for repair or replacement Expected Life of the HairMax LaserComb The HairMax LaserComb is a medical device manufactured under strict quality controls and validation through GMP Good Manufacturing Practices The HairMax LaserComb contains a high quality laser diode 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 HairMax LaserComb is 10 15 year
5. OO 1 54 toin qon dein 20 Warranty Card RE o S 2122 GLOSSARY Crown The top or highest part of the head Fitzpatrick Skin Type Classification Guide A system that classifies your skin type based on your complexion and responses to sun exposure Type 1 Highly sensitive always burns never tans Type 2 Very sun sensitive burns easily tans minimally Type 3 Sun sensitive skin sometimes burns slowly tans to light brown Type 4 Minimally sun sensitive burns minimally always tans to moderate brown Type 5 Sun insensitive skin rarely burns tans well Type 6 Sun insensitive never burns deeply pigmented Hair Density The amount of hairs on the head Generally it is measured by counting the number of hairs found in one square centimeter of scalp LASER Light Amplification by Stimulated Emission of Radiation is an optical source that emits photons in a coherent beam Low Level Laser Also know as soft laser cold laser or laser biostimulation The HairMax LaserComb uses this type of laser Mean Terminal Hair Density The average number of thick pigmented hairs in the specific area Non consecutive days A day in between the treatment days Norwood Hamilton Scale Systern that classifies the different ways in which baldness progresses in men Placebo Device A device that looks and sounds like the HairMax LaserComb The placebo device does not have a laser This device was used in
6. The HairMax LaserComb is warranted by Lexington International 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 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 indi rectly related to the use of or the inability to use t
7. the study to test the effectiveness of the HairMax LaserComb Terminal hairs thick pigmented hairs Vellus hair fine non pigmented hair HairMax LaserComb The HairMax LaserComb is the First and Only home use medical laser device that has been Clinically Proven and FDA Cleared class 11 for Marketing to Promote Hair Growth The HairMax provides the convenience of treatment in your own home Our new HairMax Premium model provides the same safe and effective at home treatment as the original HairMax but now is cordless This HairMax features a sleek ergonomic design with a rechargeable lithium ion battery to give you the freedom of movement as you treat your hair The HairMax LaserComb works directly on your scalp by parting your hair with two rows of teeth The teeth are aligned with a row of laser beams The teeth part your hair forming a clear path for the light to reach the scalp during use This path is a critical feature to the success of the treatment Without the teeth your hair would block the laser beams from reaching the scalp Parting the hair provides direct access to the scalp Like brushing your teeth to maintain healthy teeth amp gums regular HairMax LaserComb usage is required Three times a week on non consecutive days for 10 to 15 minutes a session is all that is needed to achieve results over time Over the next few months you may notice a gradual increase in the number of hairs in a specific lo
8. ISKS Harm to Eyes Do Not shine the light from the HairMax LaserComb directly into your eyes Prolonged direct exposure to your eyes can cause harm to your eyes Scalp Itching Less than 5 of the subjects in the clinical trial of the HairMax LaserComb reported mild scalp itch during the usage of the HairMax LaserComb If you experience more than mild itching consult a physician Tingling Less than 4 of the subjects in the clinical trial reported a mild and temporary tingling feeling This lasted for a short period of time after applying the treatment If the problem persists consult a physician Increased blood flow to the scalp Less than 1 of the subjects in the clinical trial reported a mild increase in blood flow also known as vasodilatation to the scalp This lasted for a short period of time after applying the treatment If the problem persists consult a physician BENEFITS The HairMax LaserComb is a home use Low Level Laser treatment to promote hair growth in men The HairMax LaserComb uses laser light to treat and stimulate your scalp Individual results may vary Your hair grows at a slow pace Increases in the number of hairs in one specific location hair density are difficult to notice and are not immediately visible A typical user will notice some increase in hair density within the first few weeks Over time you will begin to re grow hair Proper use according to the instructions leads to positive results I
9. arging the laser will turn off and the RED LASER INDICATOR item d page 12 will start to blink Proceed with the steps 5 through 7 above to recharge your HairMax Please Note If your device needs to be recharged during your treatment simply insert the POWER CORD directly to the end of the device and other end into electrical wall outlet and continue with your treatment see step 5 above The Power Button Indicator will flash green during this charging process When finished allow the device to fully charge Anytime your device is placed the Charging Cradle there won t be any illumination on the device Charging status will be indicated by the Charging Cradle only 13 HAIRMAX LASERCOMB INSTRUCTIONS FOR USE New HairMax Premium can function by either using the power cord or cordless when properly charged please refer to Methods of Charging on page 13 1 Read and follow all directions prior to use 2 Charge your per Methods of Charging on page 13 or use an optional power cord Illustr 1a and 1b 3 Press and hold the POWER BUTTON right button down for a couple of seconds to turn on the device The GREEN POWER INDICATOR will light up Next press the LASER BUTTON Illustr 2 The RED LASER INDICATOR will light up which means the laser is functioning You can clearly see the laser light when the HairMax is operating Avoid Direct Eye Exposure when the laser is illuminated The HairMax is now ready for use
10. ax using the CHARGING CRADLE stand and power cord See graphic Method 2 Charging the HairMax by placing the POWER CORD directly into the handle end of the HairMax See graphic B CHARGING INSTRUCTIONS 1 Read and understand all instructions prior to use 2 Make sure to fully charge your HairMax prior to using it for the first time 3 Remove the HairMax CHARGING CRADLE and POWER CORD from the case 4 Remove the SAFETY LABEL to gain access to the POWER and LASER BUTTONS 5 Connect one end of the POWER CORD to the CHARGING CRADLE and insert the other end of POWER CORD to an indoor electrical wall outlet 6 Place the HairMax in the CHARGING CRADLE The charging process will begin The CHARGING CRADLE Indicator will light up RED during charging Within approximately 2 3 hours the CHARGING CRADLE Indicator will turn GREEN which means that the device is fully charged and ready for use 7 As an option the POWER CORD can be inserted directly to the end of HairMax and be charged in that manner Plug the POWER CORD into the end of the HairMax as shown above B Plug the other end into an indoor electrical wall outlet The GREEN POWER INDICATOR on the HairMax will flash during charging item c page 12 When fully charged the GREEN POWER INDICATOR light will stop flashing and remain constant GREEN Your HairMax is now ready for use It can be used with or without the POWER CORD 8 When the Lithium lon Battery requires ch
11. cation Hair Density Most users notice continued improvement as they continue to use the HairMax LaserComb If you stop treating your scalp with the HairMax LaserComb after you see hair growth this improvement may gradually disappear Indication FDA 510 k Cleared for marketing to promote hair growth in males with Androgenetic Alopecia male pattern hair loss with Norwood lla to V with Fitzpatrick skin types I to IV No prescription needed CONTRAINDICATION If you are taking any photosensitizing medications or receiving any therapy that sensitizes the skin to light DO NOT use the HairMax LaserComb Please consult your physician if you have any other concerns A WARNINGS WARNING Do not allow children to use or play with the HairMax LaserComb Keep out of reach of children It is not a toy WARNING Avoid getting the HairMax LaserComb wet Contact with water may result in an electrical shock WARNING Never use the HairMax LaserComb if the cord or plug is damaged Such use can cause the HairMax LaserComb to malfunction and produce an electrical shock If the HairMax LaserComb is not working properly or if it has been dropped damaged or exposed to water contact Lexington International LLC at 561 417 0200 WARNING Avoid using the HairMax LaserComb near heated surfaces Contacting a heated surface with the cord or plug can cause the product to malfunction and produce an electrical shock WARNING Only use the HairMax LaserC
12. ed for remaining classifications Il Va and VII An estimated 50 million men in the United States experience AGA A person s tendency to lose hair can be inherited from either side of a person s family or from both parents Men of all races and ethnicities lose their hair By age 40 nearly forty percent of men have visible signs of AGA By age 50 fifty percent of men show signs of the condition HAIRMAX LASERCOMB AND PARTS view nousie HOUSING c GREEN POWER INDICATOR POWER BUTTON ejPOWER CORD d RED LASER INDICATOR b LASER BUTTON A SAFETY LABEL BOTTOM VIEW HOUSING POWER CORD g TEETH h WINDOW i WARNING LABEL SIDE VIEW HOUSING CHARGING CRADLE STAND g TEETH PARTS a POWER BUTTO b LASER BUTTO k CHARGING CRADLE INDICATOR 5 2 c GREEN POWER INDICATOR d RED LASER INDICATOR POWER CORD e POWER CORD f SAFETY LABEL removable PLEASE REFER TO OUR USER MANUAL BEFORE USING THIS PRODUCT g TEETH h WINDOW i WARNING LABEL j CHARGING CRADLE STAND k CHARGING CRADLE INDICATOR 12 METHODS OF CHARGING THE HAIRMAX The HairMax is equipped with a built in Lithium lon Battery and once charged can be used without the attached power cord The battery can be recharged thousands of times to provide years of continuous use Charging can be accomplished in the two following ways A Method 1 Charging the HairM
13. f you stop treating your scalp with the HairMax LaserComb after you see hair growth this improvement may gradually disappear USAGE RECOMMENDATION Use the HairMax LaserComb 3 times per week with at least a day between each treatment non consecutive days For example Monday Wednesday and Friday The total time of each treatment is 10 15 minutes More frequent or longer usage will not increase results Maximum results will not be seen if you do not follow the recommended treatment schedule Like brushing your teeth to maintain healthy teeth and gums ongoing HairMax LaserComb usage is needed to maintain healthy hair growth If you stop using the HairMax LaserComb any benefit may gradually disappear Summary of Clinical Data A study was conducted at 4 different locations around the country All participants in the study ages 30 60 were males diagnosed with hereditary hair loss which is called Androgenetic Alopecia and light to medium skin tones A total of 123 men participated in the study Subjects were divided into two groups One group used the HairMax LaserComb The second group used a placebo device that looked and sounded like the HairMax LaserComb but did not include a laser The first group included 82 participants The second group included 41 participants Subjects performed treatments 3 times per week on non consecutive days for 6 months Hair growth was monitored during the study The number of thick pigmented ter
14. he HairMax LaserComb even if Lexington International 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 limita tion 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 juris diction 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 70 345 8570 Fax 31 0 70 345 7299 Congratulations on becoming a HairMax LaserComb user To validate your warranty please register online at www hairmax com warranty or call 561 417 0200 18 How to Monitor
15. minal hairs in a specific area were compared from the beginning to the end of the study 67 of 72 93 of men using the HairMax LaserComb who completed the study had some increase in the number of terminal hairs in that area The average number of terminal hairs per square centimeter mean terminal hair density measured in this study increased by 19 over a 6 month period The area measured was roughly the size of a dime No subjects experienced any serious or adverse events The number and types of adverse events were similar in both groups 10 Information on Condition Androgenetic Alopecia AGA is a condition involving both genetic inherited and hormonal factors AGA in men Usually begins at the hairline The hairline gradually recedes to form shape The hair becomes finer and shorter The hair at the top of your head also called the crown begins to thin Over time the top of the hairline meets the thinned crown leaving a pattern of hair around the sides of your head A system called the Norwood Hamilton classification system is used to determine the extent of hair loss The following chart will assist in determining your stage of hair loss Norwood Hamilton classification system D 4 lt LaserComb is indicated for use males with Norwood Hamilton Classification through V These classifications are shaded in the above diagram Not recommend
16. ols or adjustments or performance of procedures other than those specified herein may result in harmful laser exposure NOTICE If any malfunction occurs do not attempt to repair it yourself This appliance has no user serviceable parts Use the HairMax LaserComb only for its intended use as described in this manual Contact Lexington International LLC for repairs at 561 417 0200 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 Always unplug the HairMax LaserComb from the power outlet immediately after using Do not use while bathing Do not place or store the HairMax LaserComb where it can fall or be pulled into a tub or sink e Do not expose the HairMax LaserComb to running water or drop into water or any other liquid If the HairMax LaserComb falls into water unplug it immediately from the power outlet e Do NOT reach into or touch the water e If using the HairMax LaserComb near water the use of an elec trical outlet protected by a Ground Fault Circuit Interrupter is rec ommended INDICATIONS The HairMax LaserComb is indicated to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V and Fitzpatrick Skin Types to IV R
17. omb according to the instructions provided Any other use is not recommended WARNING Do Not stare directly at the laser light or its reflection off a mirror like surface Doing so can cause temporary irritation to your eyes Prolonged direct exposure can harm your eyes PRECAUTIONS CAUTION Never leave the LaserComb unattended when plugged into a power outlet An electrical malfunction can result in a fire CAUTION Do Not put strain on the cord when untangling or straightening it Doing so can break the cord causing it not to work CAUTION Never use magnifying optical instruments with the HairMax LaserComb Their use with this product can cause temporary irritation to the eyes CAUTION Never use acetone or other solvents on any part of the HairMax LaserComb Use of solvents on the window can block the laser light from coming through CAUTION Not recommended for use by men with Norwood Hamilton Classification Va or VII See drawings on 12 of the User Manual because they are not likely to experience hair growth from using the HairMax LaserComb CAUTION There is currently no validated scientific evidence supporting the effectiveness of the HairMax LaserComb on women CAUTION The safety or effectiveness of the HairMax LaserComb in men with Fitzpatrick Skin Types V and VI see the description on these skin types on page 4 of the user manual has not been evaluated CAUTION Use of contr
18. s of regular use Please take time to read this entire instruction manual before operating the HairMax TROUBLESHOOTING Before sending your HairMax in for repair please try these helpful items If these do not resolve your problem please contact Lexington s warranty department My HairMax will not turn on Make sure your HairMax is fully charged Please refer to Methods of Charging on page 13 Insert power cord into the HairMax Press the POWER button then the LASER button Try another wall electrical outlet My HairMax is turning off during use Make sure your HairMax is fully charged Please refer to Methods of Charging on page 13 Insert power cord into the HairMax Press the POWER button then the LASER button Try another wall electrical outlet My HairMax will not turn off Press and hold the POWER button for 5 seconds If using a power cord unplug the HairMax and press the POWER button for 5 seconds My HairMax beeps irregularly or doesn t beep If using a power cord unplug the HairMax Plug in the power cord again and press the POWER button then the LASER button My HairMax beeps but I do not see the laser If using a power cord unplug the HairMax Plug in the power cord again and press the POWER button then the LASER button If these helpful tips did not resolve your problem please contact Lexington Intl LLC for repair or replacement Lexington International LLC 777 Yamato Road Suite 105 Boca Raton FL 33431
19. ternational Copyright 2010 Lexington International LLC All rights reserved LEX12001 02 07 10
20. tlets 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 MAINTENANCE INSTRUCTIONS Always unplug the HairMax LaserComb from the power outlet before cleaning DO NOT use acetone or any other solvents on any part of the HairMax LaserComb Use of acetone or other solvents to clean the window can immediately block most of the laser light from coming through To clean the laser WINDOW from where the laser light shines through unplug the device turn power off and gently clean with a soft slightly moistened cloth Do not use any soaps or detergents just warm water Cleaning comb TEETH To keep the TEETH of the combs clean gently remove any hairs or dust with a slightly moistened towel For a more thorough cleaning gently pull out comb TEETH from the center TEETH can be washed using soap and water Dry combs thoroughly and replace them by inserting the top of the TEETH first Then press the bottom of the TEETH with your thumb until they click into place To order replacement combs please order online at www hairmax com or contact Lexington International at 561 417 0200 If the POWER CORD becomes twisted unplug and straighten it prior to use Do not put strain on POWER CORD if you need to untangle or straighten it Only use directions cleaning methods and operating procedures as specified in this manual WARRANTY
21. ur device to the CHARGING CRADLE for future usage or return the POWER CORD the HairMax and CHARGING CRADLE to the case for storage AUDIBLE BEEP TONE TIMER The HairMax is most effective when used correctly In order to help time the movements the HairMax will automatically emit an audible tone every 4 seconds The audible beep can be turned off by pressing the LASER BUTTON Pressing it once turns on laser and beep Pressing it a second time turns off the beep but the laser will remain on To re activate the beep simply press the LASER BUTTON again Please Note Total time required for treatment with the HairMax should be 10 to 15 minutes It is important to move the HairMax very slowly Remember you are bathing the scalp with laser light If you move it too fast the treatment will not be as effective The following laser safety label can be found on this product wavelength 655 5nm visible red light Class 3R cassis M Note HairMax LaserComb has E user serviceable parts Location On the underside of the handle Please visit http www hairmax com QualitySafety aspx for more information or call 561 417 0200 POWER SUPPLY SPECIFICATIONS Output 6VDC 1A Plug 9mm 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 ou
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