Hairmax LUX 9, Advanced 7, Professional 12 User Manual
HairMax LaserComb
Advanced 7, Lux 9, Professional 12
®
TABLE OF CONTENTS
Introduction.........................................................................................................1
Who is the best candidate? (Classifications male/female).............2
Who is the best candidate? (Fitzpatrick Skin Types)........................3
Warnings and Cautions...........................................................................4
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
TABLE OF CONTENTS
Proper Use..................................................................................................1 1
Treatment Instructions................................................................................12
What your HairMax Advanced 7 comes with.................................13
Troubleshooting..................................................................................14
Safety Label..................................................................................................15
Power Supply Specifications................................................................15
© Copyright 2014 Lexington Intl, LLC. All rights reserved.
HairMax LaserComb Lux 9, Professional 12
HairMax LaserComb Lux 9, Professional 12 Parts.............................16
Getting Started..........................................................................................17
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
HairMax Customer Service:
Phone: 1-866-527-3726
+1-561-417-0200
Email: info@hairmax.com
HAIRMAX.com
To view videos about usage, quality and safety, visit:
www.hairmax.com/videos
www.hairmax.com/QualitySafety
Mailing Address:
Lexington International
777 Yamato Rd., Ste 105
Boca Raton, FL 33431
USA
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.
INTRODUCTION
It is important that you read and understand the content of this User Manual before using your HairMax LaserComb.
1
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.
Norwood Hamilton
Classification - Males
Ludwig-Savin
CLASSIFICATION FOR MEN AND WOMEN
Classification - Females
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?
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.
FITZPATRICK SKIN TYPE CLASSIFICATION
Type 1
Type 2
Type 3
Type 4
Clinically Tested to
Type 5
Type 6
Not Clinically
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.
Very white or freckled skin, always burns with sun exposure
(very fair; often in people with red or blond hair and blue eyes)
White skin, usually burns with sun exposure (fair; often in people with red or blond hair
and blue, green, or hazel eyes)
White or olive skin tone, sometimes burns with sun exposure
(fair; seen in people with any hair or eye color)
be effective for
Brown skin, rarely burns with sun exposure
these skin types
(common in people of Mediterranean descent)
Dark brown skin, very rarely burns with sun exposure
(common in people of Middle-Eastern descent)
types
Black skin, rarely burns with sun exposure
Tested for
these skin
3
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.
WARNINGS AND CAUTIONS
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.
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.
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.
4
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 for Advanced 7 or page 19
for Lux 9 and Professional 12 models.
RISKS | TESTING FOR SENSITIVITY
5
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 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.
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.
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.
MONITORING DEVICE | FAILURE MODE | EXPECTED LIFE
6
Clinical studies were conducted at multiple locations in the United States. Participants in the study were
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
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).
SUMMARY OF CLINICAL STUDY IN MEN
SUMMARY OF CLINICAL STUDY IN MEN
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.
7
A clinical study was conducted at multiple locations in the United States. All participants in the study were
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
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
SUMMARY OF CLINICAL STUDY IN WOMEN
8
In the clinical study, after 26 weeks of treatment with the
LaserComb and a Control Device, the following increases
in hair count were found.
SUMMARY OF CLINICAL STUDY IN WOMEN
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