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LaserComb Advanced 7
User Manual
32 pgs2.46 Mb0

HairMax LaserComb Advanced 7, LaserComb Lux 9, LaserComb professional 12 User Manual

HairMax LaserComb
®
Advanced 7, Lux 9, Professional 12
TABLE OF CONTENTS
TABLE OF CONTENTS
Introduction.........................................................................................................1
Who is the best candidate? (Fitzpatrick Skin Types)........................3
Risks/Testing for sensitivity....................................................................5
How to Monitor Device Activity.........................................................6
Device Failure Mode......................................................................................6
Expected Life of the HairMax LaserComb............................................6
Summary of Clinical Study in Men.............................................................7
Summary of Clinical Study in Women..............................................8
HairMax LaserComb Advanced 7
HairMax LaserComb Advanced 7 Parts..................................................9
Getting Started..........................................................................................10
Replacing the Batteries................................................................................10
Proper Use..................................................................................................1 1
Treatment Instructions................................................................................12
Troubleshooting..................................................................................14
Safety Label..................................................................................................15
Power Supply Specifications................................................................15
HairMax LaserComb Lux 9, Professional 12
HairMax LaserComb Lux 9, Professional 12 Parts.............................16
Charging Options...................................................................................17
Proper Use......................................................................................................18
Treatment Instructions................................................................................19
What your HairMax Lux 9 or Professional 12 comes with............21
Troubleshooting..................................................................................22
Safety Label..................................................................................................23
Power Supply Specifications................................................................23
Cleaning Your HairMax LaserComb .....................................................24
Electrical Safety...............................................................................................24
Disposal Instructions ...........................................................................25
Warranty.........................................................................................................26
Warranty Card................................................................................................27
© Copyright 2014 Lexington Intl, LLC. All rights reserved.
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:
www.hairmax.com/videos www.hairmax.com/QualitySafety
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.
Indications
The HairMax LaserComb Advanced 7, Lux9, and the Professional 12 models are 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 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 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; Advanced 7 = 15 minutes, Lux 9 = 11 minutes, Professional 12 = 8 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.
It is important that you read and understand the content of this User Manual before using your HairMax LaserComb.
INTRODUCTION
1
WHO IS THE BEST CANDIDATE FOR HAIRMAX LASERCOMB?
CLASSIFICATION FOR MEN AND WOMEN
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.
Ludwig-Savin
Classification - Females
Norwood Hamilton
Classification - Males
The HairMax LaserComb has not been clinically tested for hair loss outside of the shaded areas.
2
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX LASERCOMB?
FITZPATRICK SKIN TYPE CLASSIFICATION
3
The LaserComb was only studied in light to brown 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.
Type 1
Very white or freckled skin, always burns with sun exposure (very fair; often in people with red 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 sun exposure (common in people of Middle-Eastern descent)
Type 6
Black skin, rarely burns with sun exposure
Clinically Tested to
be effective for
these skin types
Not Clinically
Tested for
these skin
types
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 AND CAUTIONS
4
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 | TESTING FOR SENSITIVITY
5
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 for Advanced 7 or page 19 for Lux 9 and Professional 12 models.
HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF LASERCOMB
MONITORING DEVICE | FAILURE MODE | EXPECTED LIFE
6
How to Monitor Device Activity
Your HairMax LaserComb is inspected and tested during production. When working properly, both of the green and the red 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 continuous 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
SUMMARY OF CLINICAL STUDY IN MEN
7
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 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 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.
0
10
20
30
40
50
60
70
80
90
100
110
120
130
140
139.3
Hairs/In2
27.7
Hairs/in2
Mean Terminal Hair Count Changes
From Baseline in MALES
26 Weeks
M
Control Device
SUMMARY OF CLINICAL STUDY IN WOMEN
SUMMARY OF CLINICAL STUDY IN WOMEN
8
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.
0
10
20
30
40
50
60
70
80
90
100
110
120
130
140
132.2
Hairs/In2
17.4
Hairs/in2
Mean Terminal Hair Count Changes
From Baseline in FEMALES
26 Weeks
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