HAIRMAX Prima 7 Hair Max Laser Comb User Manual

HAIRMAX Prima 7 Hair Max Laser Comb

Specifications

• Model: Prima 7
• Manufacturer: HairMax
• Indicated for: Androgenetic Alopecia
• Treatment Time: 15 minutes per session
• Treatment Frequency: 3 times per week (spaced out every other day)
• Clinically Proven: Yes
• Recommended Treatment Duration: At least 16 weeks

Introduction

The HairMax LaserComb is a home-use laser device that has been clinically proven to treat hereditary hair loss in men and women.
It is an over-the-counter (OTC) device that can be sold directly to the public.

Indications
The HairMax LaserComb Prima 7 model is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss, and in males who have Norwood Hamilton Classifications of IIa to V, and who both have Fitzpatrick Skin Types I to IV.

INTRODUCTION

Introduction of HairMax LaserComb®
The HairMax LaserComb is a home-use laser device that has been Clinically Proven to treat hereditary hair loss in men and women. The LaserComb is an over-the-counter (OTC) device that can be sold directly to the public.

Indications
The HairMax LaserComb Prima 7 model is indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.

How the LaserComb works
The LaserComb works by pro-viding 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 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 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 7 is 15 minutes. 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 90% 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.

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 (including color 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 LaserComb.

The LaserComb was studied in light to brown skin tones (Types 1,2,3,4) as described in the Fitzpatrick scale below. This does not mean it will not work on the darkest skin tones. Due to the limitations in photography equipment and hair counting software it was impossible to test the darkest skin tones.
Fitzpatrick Skin Type Classification Guide: A way to describe your skin type based on your complexion and what happens to your skin in sunlight.

Adapted from Fitzpatrick’s Dermatology in General Medicine. McGraw-Hill Professional; 5th edition.
Please note that HairMax was only tested on light to brown skin tones. This does not indicate that it will not work on darker skin tones.

WARNINGS AND CAUTIONS

WARNINGS

• Do not stare directly at the red laser light or its reflection in a 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 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 1-866-527-3726.

• 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.

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 such as redness or rash, do not use the LaserComb and contact our Customer Service toll-free at 1-866-527-3726 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 1-866-527-3726 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 1-866-527-3726.

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 1-866-527-3726.

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 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 HairMax LaserComb and contact Customer Service toll-free at 1-866-527-3726 to return your product and get a refund. If you don’t experience any reaction, proceed with the treatment instructions on page 12.

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 of the 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 Customer Service toll-free at 1-866-527-3726 for repair or replacement.

Device Failure Mode
The HairMax LaserComb 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 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 Androgenetic Alopecia, which includes hereditary hair loss, and had light to brown
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 week visit showed that over 90% 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.

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 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 treated their hair once per day, 3 times per week, on non-consecutive 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 (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 HairMax LaserComb and control groups.

Hair Count Change
In the clinical study, after 26 weeks of treatment with the LaserComb and a Control Device, the following increases in hair count were found.

HAIRMAX LASERCOMB PARTS

1. POWER BUTTON/INDICATOR LIGHT
2. LASER BUTTON
3. POWER CORD
4. SAFETY LABEL
5. TEETH
6. LASER WINDOW
7. WARNING LABEL
8. STAND

GETTING STARTED

Your LaserComb Prima 7 model comes with a rechargeable battery permanently installed. Read this manual completely before you start to use your LaserComb.

Use the LaserComb Prima 7 for 15 minutes per treatment, three treatments per week. The treatments should be spaced every other day, for example Monday, Wednesday, Friday.

Do not use the LaserComb more than the recommended treatment time per 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 red safety label.

The power button and the laser button are located under the red safety label. You must charge your LaserComb for 2-3 hours before initial use.

Charging
Charge the LaserComb by placing the power cord directly into the handle end of the LaserComb and the other end into an electrical wall outlet. The indicator light on the power button will flash red during the charging process. Once charging is
complete, the red light will stop flashing and remain on. During use, the indicator light will indicate the battery level. A steady, non-flashing light indicates the battery is full.

GETTING STARTED | PROPER USE

When the battery is fully charged, the indicator light will be on. As the battery power diminishes, the light will blink slowly. When the battery is getting low and needs to be recharged, the light will start to flash rapidly. When this happens, charge your LaserComb as described on page 10.

If your device needs to be recharged during your treatment, simply insert the power cord directly into the end of the device and other end into an electrical wall outlet and conti nue with your treatment. When finished, allow the device to fully charge.

Proper Use

• The LaserComb Prima 7 should be used for 15 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 at the laser light directly).

Do not use the LaserComb if the device is damaged or defective, instead call Customer Service toll-free at 1-866-527-3726.

TREATMENT INSTRUCTIONS

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.
Start at your hairline. Move the LaserComb from front to back of scalp in a slow combing motion, pausing every ½ inch (1cm) for 4 seconds. 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 hair line.

Continue in this manner from front to back and then side toside until you cover your entire scalp with multiple passes.

Repeat these passes for the total treatment of 15 min for Prima 7 model.

If you have long hair, use your fingers to lift your hair out of the way while using the LaserComb to be sure that the laser energy reaches your scalp.

TREATMENT INSTRUCTIONS

IMPORTANT: Do not lift the LaserComb off your head when moving from front to back until you complete the pass. The LaserComb features a pair of comb teeth that part the hair so the light can more effectively reach the scalp. You will make a few complete passes over your scalp within recommended treatment time.
When the LaserComb is on it will beep and vibrate every four (4) seconds. This means that it’s time to move the LaserComb 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 LaserComb and laser will remain on. To re-activate beep and vibration, simply press the laser button twice.

• Turn off the LaserComb by pressing and holding the power button (lower button) until indicator light turns off. Store the device in the cradle for future use. Charge as necessary using the method described on page 10.

TREATMENT INSTRUCTIONS | WHAT IS INCLUDED

Please Note

• 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 not achieve the optimal results to promote hair growth.
• Total time required for treatment with the LaserComb Prima 7 is 15 minutes.

What is included

TROUBLESHOOTING

ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY HAIRMAX CUSTOMER SERVICE, WILL VOID YOUR WARRANTY.

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 delivered. If for some reason you are experiencing difficulties with your device, please try one of the tips below:

Your LaserComb will not turn on

• Make sure your LaserComb is fully charged.
• Insert the power cord into the LaserComb,
• then press the power button for 4 seconds and then the laser button.
• Try another electrical wall outlet.

If your LaserComb is turning off during use

• Make sure your LaserComb is fully charged.
• Insert the power cord into the LaserComb then press the
• power button for 4 seconds and then the laser button.
• Try another electrical wall outlet.

If your LaserComb will not turn off

• Press and hold power button for 4 seconds
• If using power cord, unplug the LaserComb and press power button for 4 seconds

If your LaserComb beeps/vibrates irregularly or doesn’t beep/vibrate at all

• If using power cord, unplug the LaserComb. Plug in power cord again and press the power button then the laser button.

If your LaserComb beeps and vibrates, but you do not see the laser light

• If using a power cord, unplug LaserComb. Plug in power cord again and press the power button then the laser button.
• If you have trouble understanding any of these instructions Contact Customer Service toll-free at 1-866-527-3726.

SAFETY LABEL | LASER PARAMETERS | POWER SUPPLY SPECIFICATIONS

Power Supply Specifications

Output = 6VDC 1.0A. 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 100 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.

CLEANING YOUR HAIRMAX LASERCOMB/ELECTRICAL SAFETY

Cleaning your HairMax LaserComb

• Keep your LaserComb clean.

• Turn off the LaserComb by pressing and holding the power button (lower button) until the light turns off.

• 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 teeth more thoroughly, slide the teeth toward the top of the LaserComb and gently pull out. Clean with soap and water.
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• To replace the teeth, align the guides and slide down until they lock into place. If you need to replace theteeth, you can order online at hairmax.com or call customer service toll-free at 1-866-527-3726.

Electrical Safety
Basic safety precautions should be observed when using this, or any other electrical device, especially when children are present.

WARNING : Keep away from water. Contact with water may result in an electrical shock.

ELECTRICAL SAFETY | DISPOSAL INSTRUCTIONS

Electrical Safety – continued
To reduce the risk of hazard by electric shock:

• Do not use it while bathing.
• 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.
• If using the LaserComb near water, the use of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended.
• Do not dispose of the LaserComb in a fire or store in high temperatures greater than 140°F (60°C).

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 equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your waste equipment for recycling, please contact your local city office or your household waste disposal service.

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 warranty and will be charged at their regular repair
rates. ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY HAIRMAX CUSTOMER SERVICE, WILL VOID YOUR WARRANTY. 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

Please fill out this form, detach it, place it in the envelope, or fold it out and mail it directly back to us with a postage stamp.

Lexington International, LLC 777 Yamato Road, Suite 105 Boca Raton, FL 33431

WARRANTY

• ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY HAIRMAX CUSTOMER SERVICE, WILL VOID YOUR WARRANTY.
  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 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, 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 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) (0) 70 345-8570 FAX: (31) (0) 70-345-7299
To validate your warranty please register online at Hairmax.com/warranty

HairMax Customer Service

Phone: 1-866-527-3726 | +1-561-417-0200 | Email: info@hairmax.com | HAIRMAX.COM

Mailing Address:
Lexington International | 777 Yamato Rd., Ste 105 | Boca Raton, FL 33431, USA

To view videos about usage, quality and safety, visit:
Hairmax.com/videos and Hairmax.com/QualitySafety
For International Translations visit Hairmax.com/manual

© Copyright 2015 Lexington Intl., LLC. All rights reserved

References

• Hairmax® | Regrow Your Hair with the Ultimate Laser Treatment
• Hairmax - Lexington Int. LLC - YouTube
• Warranty Registration – Hairmax
• ClinicalTrials.gov
• Hairmax® | Regrow Your Hair with the Ultimate Laser Treatment
• Warranty Registration – Hairmax
• Manual-Hub.com – Free PDF manuals!

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