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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, who had light to medium skin tones. Subjects were divided into two 

groups. One group used the HairMax and the other group used a control device. The control device looked and sounded like the 

HairMax, 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 treated their hair once per day, 3 times per 

week, on nonconsecutive days. The number of thick, normal, healthy hairs in the 

target area were counted at Week 1, Week 16 and Week 26.

Results at 26 weeks showed that over 90% of the women saw increases in hair 

counts.*

No subjects in the study experienced any serious adverse events. In fact, the 

number and types of adverse events were similar in the HairMax and control groups.

Hair Count Change

In the clinical study, after 26 weeks of treatment with the HairMax and a control 
device, the following increases in hair count were found.

*Based on a minimum of 5 new hairs per square centimeter/32 new hairs per square inch being observed at the follow up visit

SUMMAR

Y OF CLINICAL STUDY IN WOMEN

SUMMARY OF CLINICAL STUDY IN WOMEN

20.5

Hairs/cm2

132.2

Hairs/in2

2.7

Hairs/cm2

17.4

Hairs/in2

21.6

Hairs/cm2

139.3

Hairs/in2

4.3

Hairs/cm2

27.7

Hairs/in2

21.6

Hairs/cm2

139.3

Hairs/in2

4.3

Hairs/cm2

27.7

Hairs/in2

Summary of Contents for LaserComb Prima 9

Page 1: ...USER MANUAL HairMax LaserComb Prima 9 ...

Page 2: ...ctions 12 What is Included 14 Troubleshooting 15 Other Useful Information Safety Label 16 Laser Parameters 16 Use Conditions 16 Power Supply Specifications 16 Maintenance and Cleaning 17 Disposal Instructions 17 Electrical Safety 18 Electromagnetic Emissions Guidance 19 Electromagnetic Immunity Guidance 20 Electromagnetic Distance Recommendations 22 Warranty Card 23 Warranty 25 Corporate Office Cu...

Page 3: ...b 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 3 times per week spaced out every other day For example Monday Wednesday Friday The LaserComb should not be used more than the recommended treatment time per day Recommended treatment for Prima 9 is 11 minutes Clinical studies demonstrate that...

Page 4: ...ification 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 CLASSIFICATION FOR MEN AND WOMEN WHO IS THE BEST CANDIDATE FOR HAIRMAX LASERCOMB Norwood Hamilton Classification Males Ludwig Savin Classification Females The HairMax LaserComb has not bee...

Page 5: ...or blond hair and blue eyes Type 2 White skin usually burns with sun exposure fair often in people with red or blond hair and blue green or hazel eyes Type 3 White or olive skin tone sometimes burns with sun exposure fair seen in people with any hair or eye color Type 4 Brown skin rarely burns with sun exposure common in people of Mediterranean descent Type 5 Dark brown skin very rarely burns with...

Page 6: ...attempt to modify or repair this equipment Do not attempt to modify or service while the equipment is in use If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use Contact HairMax customer service toll free at the numbers provided below CAUTIONS If you are taking any medications or products that make you sensitive to light you should test yo...

Page 7: ...for sensitivity Turn the device on hold the LaserComb 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 do not see a reaction proceed with the treatment instructions on page 12 If you see a reaction such as redness or rash do not use your HairMax Contact HairMax Custome...

Page 8: ...de Your HairMax is designed to last for 10 15 years of regular 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 HairMax Your HairMax LaserComb is a medical device manufactured under strict quality controls and validated through GMP Good Manufactu...

Page 9: ... 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 week visit showed that over 90 of the men saw an increase in hair counts No subjects in the study experienced any serious adverse events In fact the number and types of adverse events were similar in the HairMax and control group...

Page 10: ... 3 times per week on nonconsecutive days The number of thick normal healthy hairs in the target area were counted at Week 1 Week 16 and Week 26 Results at 26 weeks showed that over 90 of the women saw increases in hair counts No subjects in the study experienced any serious adverse events In fact the number and types of adverse events were similar in the HairMax and control groups Hair Count Chang...

Page 11: ...S PARTS A B C D E F G POWER BUTTON INDICATOR LIGHT LASER BUTTON POWER CORD SAFETY LABEL TEETH LASER WINDOW WARNING LABEL CHARGING CRADLE STAND CHARGING CONTACTS USB PORT DC JACK A C E F G H B D H I J K I J K ...

Page 12: ...e Remove the red safety label You must charge your HairMax for 4 6 hours before initial use Charging Options Charging can be accomplished in one of the two following options OPTION 1 Charging your HairMax using the charging cradle stand and power cord Prior to placing your HairMax in the cradle make sure your HairMax is turned off and the teeth face away from you Plug the power cord into the cradl...

Page 13: ...ne of the charging options as described on page 10 and 11 Proper Use The LaserComb Prima 9 should be used for 11 minutes Use a watch or clock to time your treatment First press the power button and hold until power button light turns on Second press the laser button The LaserComb is ready for use Shine the LaserComb onto the palm of your hand and you will see that the laser light is on do not look...

Page 14: ... Do not lift the LaserComb off your scalp while combing from front to back Next lift the LaserComb off your scalp and start at a new position at the hairline Continue in this manner from front to back and then side to side until you cover your entire scalp with multiple passes Repeat these passes for the total treatment of 11 min for Prima 9 model If you have long hair use your fingers to lift you...

Page 15: ... 4 seconds This means that it s time to move your HairMax to the next area of the scalp When you do this do not lift the device off of your scalp If you wish to turn off the beep vibration during the treatment press the top laser button once Your HairMax and laser will remain on To re activate beep and vibration simply press the laser button twice Turn off your HairMax by pressing and holding the ...

Page 16: ...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 Total time required for treatment with the LaserComb Prima 9 is 11 minutes Prima 9 LaserComb Power Cord User Manual Quick Start Guide What is included Notice Entire LaseComb assembly is considered as a Type BF applied part ...

Page 17: ... for 4 seconds and then the laser button Try another electrical wall outlet If your HairMax will not turn off Press and hold the power button for 4 seconds If using the power cord unplug the HairMax and press the power button for 4 seconds If your HairMax beeps vibrates irregularly or doesn t beep vibrate at all If using the power cord unplug the HairMax Plug in power cord again and press the powe...

Page 18: ...W Divergence 57 mrad Number of lasers 9 This Laser Product is designated as Class 3R during all procedures of operation Note HairMax laser devices have no user serviceable parts Safety label location On the underside of the handle MTBF mean time between failures 10 000 hours at 25ºC ambient temperature Operating temperature altitude atmospheric pressure humidity 5ºC to 35ºC 0 to 2 000 m 80kPa to 1...

Page 19: ...m water Disposal Instructions This symbol on the product or on its packaging indicates that this product must not be disposed of with your other household waste Instead it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment The separate collection and recycling of your waste equ...

Page 20: ... it is charging Power supply cannot be separated during use Do not position the equipment in a manner that will make it difficult to plug in or remove the power cord If you have any problems with this device such as setting up maintaining or using please contact Customer Service Please report to Customer Service if any unexpected operation or events occur After drop shock that may cause changes in...

Page 21: ...vice pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and if not installed and used in accordance with the instructions may cause harmful interference to radio communications However there is no guarantee that interference wi...

Page 22: ...00 4 5 1kV line s to line s 2kV line s to earth 1kV differential mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 sec 5 UT 95 dip in UT for 0...

Page 23: ... m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol NOTE1 At 80 MHz and 800 MHz the higher frequency range applies NOTE2 These guidelines may not apply in all situations Electromagnetic propagation is aff...

Page 24: ...m output power of transmitter W Separation distance according to frequency of transmitter m 150 kHz to 80 MHz d 1 2 P 80 MHz to 800 MHz d 1 2 P 800 MHz to 2 5 GHz d 2 3 P 0 01 0 12 0 12 0 23 0 1 0 38 0 38 0 73 1 1 2 1 2 2 3 10 3 8 3 8 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the recommended separation distance d in metres m can be estimated using the equat...

Page 25: ...fer to the User Manual for complete warranty terms We guarantee your satisfaction To validate your warranty register online at www hairmax com warranty or complete and mail this warranty card Name Serial Number Date of Purchase Address City State Zip Postal Code Country Email Where did you purchase this product Reseller Name What factors influenced your purchase of this product Please fill out thi...

Page 26: ... Staple or tape here Lexington International LLC 1040 Holland Drive Boca Raton FL 33487 Return address __________________________ __________________________ __________________________ Place stamp here ...

Page 27: ...87 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 EVEN IF LEXINGTON INTERNATIONAL LLC HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES WHETHER IN AN ACTION OF CONTRACT NEGLIGENCE OR ...

Page 28: ...olland Drive Boca Raton Florida 33487 USA Direct line 1 561 417 0200 Toll Free 1 866 527 3726 Monday Friday 9 AM 5 PM EST United States 1 866 527 3726 United Kingdom 0808 134 9868 Australia 1 800 937 358 LIT UMPRM9 01 03 18 Copyright 2018 Lexington Intl LLC All rights reserved ...

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