USER MANUAL - Lifvation Group
Contents
1. working properly the BATTERY INDICATOR light will illuminate green and red laser light will be visible coming from the laser window 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 feel a vibration every 4 seconds to help time the treatment Do not operate the laser if the unit is defective or damaged If the laser light does not appear or there is no vibrate contact Lexington International LLC for repair or replacement Device Failure Mode 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 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 The HairMax is a Low Level Laser Therapy device manufactured under strict quality controls and validation through GMP Good Manufacturing Practices The HairMax 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 all models of the HairMax will provide you with many years of reliable service Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 15 TROUBLESHOOTING Before sending your HairMax in for rep2. Practices The objectives of the study were to assess the following Promotion of hair growth through changes in hair density Cessation of hair loss Overall scalp health Safety Study Design The study was designed as a multi centered double blinded randomized sham device controlled trial conducted at four sites in the United States Subjects were instructed to use the laser hair growth treatment device three times per week on non consecutive days for a total of 26 weeks Hair density measurements were performed at baseline immediately prior to randomization and again at 26 weeks Subject Population and Demographics The study population included males between the ages of 30 and 60 years with a diagnosis of Androgenetic Alopecia who had been experiencing active hair loss within the last 12 months The inclusion criteria required a Norwood Hamilton Classification of Ila to V and Fitzpatrick Skin Type Classification of to IV Clinical Results Subjects in the HairMax LaserComb laser hair treatment group had significantly greater increase in mean terminal hair density than subjects in the sham group p lt 0 0001 Subjects in the HairMax LaserComb group also had significantly better subjective assessments of overall hair growth than subjects in the sham group p 0 010 No subject experienced a serious adverse event from the laser hair loss treatment and the adverse event profiles were similar between the two treatment
3. or indi rectly related to the use of or the inability to use the HairMax even if Lexington International LLC has been advised of the possibility of such damages whether in an action of contract negli gence or other tortuous action Some states do not allow the exclusion or limitation of inciden tal or consequential damages so the above limitation or exclusion may not apply to you Governing Law The usage of the HairMax 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 user To validate your warranty please register online at www internationalhairmax com warra
4. HAIRMAX Advanced USER MANUAL mig Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 2 HairMax Advanced 7 The HairMax LaserComb has helped hundreds of thousands of people combat their hair loss and grow beautiful hair Now Lexington is proud to introduce the next generation of the revolutionary HairMax LaserComb Introducing the New HairMax Advanced 7 Using advanced laser technology the Advanced 7 provides safe and nourishing laser light energy to weakened hair follicles The laser light energy stimulates the hair follicle promoting new hair regrowth and producing healthier more beautiful hair The new Advanced 7 provides safe and effective at home treatment as the original HairMax but now it is cordless The new Advanced 7 features a sleek ergonom ic design powered by four AA batteries Now that the HairMax is bat tery powered it gives you the freedom of movement as you treat your thinning hair The new HairMax Advanced 7 utilizes Lexington s patented hair parting teeth mechanism Remember the laser treatments are only effective when the laser reaches the scalp The teeth of the HairMax part the hair a y moving it aside allowing the a maximum amount of laser energy to reach the scalp and energize the weakened hair follicles Like brushing your teeth to maintain healthy teeth amp gums regular HairMax usage is recommended Use the HairMax three times a week on non consecutive days for about 15 minut
5. HairMax only for its intended use as described in this manual Contact Lexington International LLC for repairs at 561 417 0200 The following laser safety label can be found on this product Wavelength 650 nm in f en an visible red light AASS 3R LASER PRODUCT This Laser Product is designated as Class 3R during CassiFIED PER IRG 60825 1 all procedures of operation Note HairMax LaserComb has no user serviceable parts Location On the underside of the handle Model version 7 VI Wavelength 650 nm Accessible Laser Power for classification lt SmW CW Laser Beam Diameter lt 5 mm Parameters Divergence 57 mrad Number of lasers 7 Please visit http www internationalhairmax com QualitySafety for more information or call 561 314 2430 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 6 HAIRMAX Advanced 7 PARTS TOP VIEW HOUSING a POWERILASER BUTTON Absence 7 c OPTIONAL POWER CORD not included d SAFETY LABEL powerllaser off O t powerllaser on b BATTERY INDICATOR powerllaserlvibrate on BOTTOM VIEW HOUSING f BATTERY COMPARTMENT SCREW mmm c OPTIONAL POWER CORD not included e TEETH g WINDOW h WARNING LABEL i CRADLE STAND SIDE VIEW HOUSING c OPTIONAL POWER CORD not included PARTS a POWER LASER BUTTON to turn on off the device b BATTERY INDICATOR green when batteries are fully charged
6. air 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 has fresh batteries or it is plugged into the power cord Insert power cord into the HairMax Slide the POWER LASER BUTTON to the on position Try another wall electrical outlet My HairMax is turning off during use Make sure your HairMax has fresh batteries or plugged into power cord Insert power cord into the HairMax Slide the POWER LASER BUTTON to the on position Try another wall electrical outlet My HairMax will not turn off Slide the POWWER SWITCH to the lowest OFF position If using power cord unplug HairMax My HairMax vibrates irregularly or doesn t vibrate at all Make sure the POWER SWITCH is in the middle position My HairMax vibrates but I do not see the laser Make sure your HairMax has fresh batteries or plugged into power cord 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 Tel 561 314 2430 info hairmax com www internationalhairmax com 15 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 16 Warranty Card The HairMax 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 warranty a
7. be powered directly by the optional POWER CORD Plug the power cord into the end of the Advanced 7 Plug the other end into a electrical outlet See graphic C Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 8 PROPER USAGE The HairMax is a very effective product if used correctly The HairMax is manufactured using precision components and should provide years of trouble free service under normal usage Please take time to read this entire instruction manual before operating the HairMax Use the HairMax 3 times per week on non consecutive days For example Monday Wednesday and Friday The total time of each treatment should be 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 using the HairMax as recommended is needed to maintain healthy hair If you stop using the HairMax your hair may regress back to its original state Studies conducted during 20 years of development of the HairMax indicate that there is a maximum rate of return Lexington has determined that using the HairMax for about 15 minutes three times a week will provide the best results While there are no negative side effects from overuse the best results are consistently obtained by using the HairMax according to directions It is recommended that the HairMax be used on a clean scalp after was
8. ced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 12 WARRANTY The HairMax Advanced 7 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 2901 Clint Moore Rd Suite 260 Boca Raton FL 33496 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
9. es a session Over the first few months you may notice a gradual increase in the number of hairs in a specific location Most users realize on going improvements as they continue to use the HairMax If you stop treating your scalp with the HairMax your hair may regress back to its previous state re 7 4 AS N To view our safety and usage videos visit www internationalhairmax com videos 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 3 ABOUT LEXINGTON INTERNATIONAL wtERTer Lexington International LLC is a leader in hair growth hair mn care and hair science The technology behind the HairMax WWS esercomb is a result of 20 years of Research amp Onder Development in Sydney Australia and the USA Our primary objective is to help those suffering from TERTE A yTN Androgenetic Alopecia The goal is to provide an effective treatment that is affordable easy to use and provides wf noticeable results without adverse side effects Lexington bases its success on the number of people whose lives are enriched by our products We truly care about conducting our business ethically and appropriately Because of this Lexington complies with the FDA s Good Manufacturing Practices is ISO 9001 amp 13485 certified in quality standards and our products meet CE requirements for electrical and laser safety Lexington s products are also Patented and Trademarked across the world BENEFITS The HairMax LaserComb i
10. flashing red when batteries need replacement c POWER CORD optional not included d SAFETY LABEL removable PLEASE REFER TO OUR USER MANUAL BEFORE USING THIS PRODUCT e TEETH removable for cleaning f BATTERY COMPARTMENT SCREW remove when replacing batteries g LASER WINDOW do not look ito laser window when laser is turned on See CAUTIONS h WARNING LABEL contains SERIAL NUMBER not removable i CRADLE STAND optional not included 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 7 REPLACING THE BATTERIES The Advanced 7 is powered by four 4 AA batteries Use the following steps to replace the batteries 1 Using an ordinary Phillips screwdriver remove the battery compartment screw See Graphic e on Page 6 The screw will remain attached to the housing 2 Gently lift battery compartment cover A 3 Insert batteries Be sure to align batteries as shown on bottom of battery compartment B 4 Replace cover Tighten screw i The HairMax Advanced 7 is designed to provide the optimum laser output even as the batteries age When the batteries weaken to the point where they will no longer power the lasers to their optimum power level the green BATTERY INDICATOR b will flash from green to red and the lasers will flash This is an indication that the batteries need to be replaced Please follow the instructions above to replace the batteries In addition the Advanced 7 can
11. groups Clin Drug Invest 2009 29 5 283 292 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 5 WARNINGS AND PRECAUTIONS WARNING Only use the HairMax according to the instructions provided Any other use is not recommended WARNING Basic safety precautions should be observed when using this or any other electrical device Do not allow children to use or play with the HairMax Keep out of reach of children It is not a toy WARNING Laser Light Avoid Direct Eye Exposure Do not point laser or allow laser light to be directed or reflected toward other people Never use magnifying optical instruments with the HairMax Do not stare directly at the laser light or its reflection off a mirrorlike surface Doing so can cause temporary irritation to your eyes Prolonged direct exposure can harm your eyes CAUTION If you are taking any photosensitizing medications or receiving any therapy that sensitizes the skin to light use caution when using the HairMax Please consult your physician if you have any other concerns CAUTION Never use acetone or other solvents on any part of the HairMax Use of solvents on the window can block the laser light from coming through CAUTION Never use the HairMax if the cord or plug is damaged Do not put strain on the cord If any malfunction occurs do not attempt to repair the HairMax yourself This appliance has no user serviceable parts and is not to be opened or modified by the user Use the
12. hing Your hair can be wet towel dried or dry If you do not shampoo every day still use the HairMax as directed but check to make sure the laser window is clean The HairMax should be used before applying any other topical treatments gels sprays or concealing products Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 9 INSTRUCTIONS FOR USE HairMax Advanced 7 can function by either using the batteries or directly from the optional power cord please refer to REPLAGNG THE BATTERIES on page 7 GETTING STARTED 1 Read and follow all directions prior to use 2 If youre using POWER CORD optional not included place one end directly into the handle end of the HairMax and the other end into an indoor electrical outlet Illustr 1 3 Slide the POWER LASER BUTTON to the middle or top position Illustr 2 Middle position activates the laser and vibrate feature Top position is laser only 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 Note The HairMax will automatically vibrate every four 4 seconds This is an indication for the user to move the HairMax to the next portion of the scalp For turning off vibration function please refer to page 10 4 Place the HairMax flat on your scalp making sure that both rows of teeth are touching the scalp Illustr 3 5 Start at your hairline Move the HairMax slowly in co
13. mbing motion by placing the device on a spot and leaving it there for 4 seconds Once you feel the vibration move the HairMax about 1 2 inch 1 cm to the next spot without lifting the device off your head You will make a few complete passes over your scalp For the first pass move the HairMax against the direction of the hair growth front to back Illustr 4 and side to side on the second pass Illustr 5 Repeat these passes within the recommended 15 minutes 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 10 IMPORTANT Do not lift the HairMax off of the head 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 5 7 Turn off the HairMax by sliding the POWER LASER BUTTON to the lowest position If using the optional power cord remove the POWER CORD from wall electrical outlet and return the device to the CRADLE STAND for storage Illustr 6 VIBRATION TIMER The HairMax is most effective when used correctly In order to help time the movements the HairMax will automatically vibrate every 4 seconds The vibration can be turned off by sliding the POWER LASER BUTTON to the uppermost top position Please Note It is important to move the HairMax very slowly Re
14. member you are bathing the scalp with laser light If you move it too fast the treatment will not be as effective Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 11 MAINTENANCE INSTRUCTIONS Always unplug the HairMax from the power electrical outlet before cleaning DO NOT use acetone or any other solvents on any part of the HairMax 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 11 4 Advan
15. nd 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 internationalhairmax com warranty Serial Number Date of Purchase Address City State ZIP Postal Code Country Please fill out this form fold it staple or tape it at the designated area place postage stamp and mail it back to us 4 Advanced7DEC09 11638_lex_TXT 12 9 09 ue AM Page 17 ajdegs JO ade XW H Lexington International LLC 2901 Clint Moore Rd 260 Boca Raton FL 33496 USA ss Place Stamp Here Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 18 HAIRMAX Amal To validate your warranty please return this completed warranty card or register online at www internationalhairmax com warranty To view our safety and usage videos visit www internationalhairmax com videos www internationalHairMax com Patented in the USA Patent Pending in 104 countries HairMax is a Registered Trademark of Lexington International Copyright 2009 Lexington International LLC All rights reserved LEX10001 01 11 09 4
16. nty or call 561 314 2430 12 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 13 A ELECTRICAL SAFETY To reduce the risk of hazard by electric shock e Always unplug the HairMax from the power outlet immediately after use Do not use while near water or while bathing Do not place or store the HairMax where it can fall or be pulled into a tub or sink Do not expose the HairMax to running water or drop into water or any other liquid If the HairMax falls into water unplug it immediately from the power outlet Do NOT reach into or touch the water If using the HairMax near water the use of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended Do not use the HairMax near heated surfaces Contacting a heated surface with the cord or plug can cause the product to malfunction and produce an electrical shock RISKS Harm to Eyes Do not shine the light from the HairMax directly into your eyes for extended periods of time Prolonged direct exposure to your eyes may cause harm to your eyes Scalp Itching If you experience more than mild itching during usage of the HairMax please consult a physician Tingling If you feel a more than a mild and temporary tingling lasting for a short period of time after applying HairMax please consult a physician 13 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 14 How to Monitor Device Activity Your HairMax is inspected and tested during production When
17. s a home use Low Level Laser PhotoTherapy device to treat hair loss Androgenetic Alopecia and promote hair growth The Laser PhotoTherapy process bathes the hair and scalp in laser light to energize weakened hair follicles In addition to new hair growth and reduction in shedding many users also routinely report normalization of scalp conditions increased body shine and manageability of their hair Individual results may vary but over time most users continue to see an improvement of their hair and scalp conditions If you stop using the HairMax your hair may regress back to its original state More reasons why HairMax users are satisfied with HairMax Real Results within just weeks Thicker Fuller Healthier Hair Improved Hair Condition Convenient Home Treatment Certified Completely Safe High User satisfaction 4 Advanced7DEC09 11638_lex_TXT 12 9 09 tp AM Page 4 CLINICAL DATA The results of the key clinical study performed with the HairMax LaserComb led to US FDA Clearance to market in January 2007 This was considered a landmark event in the treatment of Androgenetic Alopecia These clinical results were published in Peer Reviewed Joumal HairMax LaserComb Phototherapy Device in the Treatment of Male Androgenetic Alopecia Study Objectives The study was conducted to support the FDA 510 k submission and was subjected to an Investigational Review Board IRB approval and conducted in accordance with GCP Good Clinical
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