Hairmax Laserband 41 User Manual
HairMax
®
LaserBand 41
USER MANUAL
© Copyright 2016 Lexington Intl., LLC. All rights reserved.
TABLE OF CONTENTS
What you should know before you start
Introduction .......................................................................1
Who is the best candidate? (Classications male/female) .2
Who is the best candidate? (Fitzpatrick Skin Types) ..........3
Warnings and Cautions .....................................................4
Risks/Symbols/Testing for Sensitivity .................................5
How to Monitor Device Activity ........................................6
Device Failure Mode .........................................................6
Expected Life of your HairMax ..........................................6
Summary of Clinical Study in Men .....................................7
Summary of Clinical Study in Women ...............................8
HairMax LaserBand
Parts ...................................................................................9
Getting Started ................................................................10
Charging Options ............................................................10
Proper Use .......................................................................11
Treatment Instructions .....................................................11
What is Included ..............................................................13
Troubleshooting ..............................................................14
Other Useful Information
Safety Label .....................................................................15
Laser Parameters .............................................................15
Use Conditions ................................................................15
Power Supply Specications............................................15
Maintenance and Cleaning .............................................16
Disposal Instructions .......................................................16
Electrical Safety ...............................................................17
Electromagnetic Guidance ..............................................18
Electromagnetic Distance Recommendations .................21
Warranty Card..................................................................22
Warranty ..........................................................................24
TABLE OF CONTENTS
________________________________________________
Corporate Ofce
Lexington Intl., LLC
777 Yamato Road, Suite 105
Boca Raton, Florida 33431 USA
Customer Service – Warranty Repairs
Lexington Intl., LLC
1040 Holland Drive, Suite 1
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
© Copyright 2016 Lexington Intl., LLC. All rights reserved.
INTRODUCTION
Introduction to HairMax
Your HairMax is a home-use laser device that has
been Clinically Proven to treat hereditary hair loss
in men and women. The HairMax is an over-thecounter (OTC) device that can be sold directly to
the public.
Indications
HairMax devices 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 Classications of IIa to V and
who both have Fitzpatrick Skin Types I to IV.
How HairMax works
HairMax works by providing
INTRODUCTION
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.
Treatment with HairMax
HairMax should be used 3 times per week,
spaced out every other day (for example, Monday,
Wednesday, Friday). The HairMax should not be
used more than the recommended treatment time
per day. Clinical studies demonstrate that most
users see benets in as little as 16 weeks.*
HairMax Benets
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.
See pages 7-8 for detailed results of the study.
*Based on a minimum of 5 new hairs per square centimeter/32 new hairs
per square inch being observed at the follow up visit
HairMax has teeth that part the hair and allow the
maximum amount of laser energy to reach the
scalp.
It is important that you read and understand the content of this User Manual before using your HairMax.
1
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX?
How do you know if the HairMax is right for you?
HairMax 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
Classication (men) and the Ludwig-Savin Classication (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 HairMax.
Norwood Hamilton
Classication - Males
Ludwig-Savin
Classication - Females
CLASSIFICATION FOR MEN AND WOMEN
HairMax has not been clinically tested for hair loss
outside of the shaded areas.
2
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX?
The HairMax 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 limitations of digital
photography and hair counting software we were unable to test the darkest skin tones.
Fitzpatrick Skin Type Classication Guide: A way to describe your skin type based on your complexion
and what happens to your skin in sunlight.
Type 1
Type 2
Type 3
Clinically Tested to
Type 4
Type 5
FITZPATRICK SKIN TYPE CLASSIFICATION
Type 6
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.
Tested for
Not Clinically
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
these skin types
Brown skin, rarely burns with sun exposure
(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
these skin
3
WARNINGS AND CAUTIONS
WARNINGS
Do not stare directly at the red laser light or its reection 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 HairMax because it
can cause temporary irritation to your eyes.
Keep the HairMax out of the reach of children and pets.
Do not drop your HairMax in water because you may get
an electrical shock. If your HairMax gets damaged by water,
contact Customer Service toll-free at the numbers provided
below.
If the cord is damaged on your HairMax do not use the
device because you could get an electrical shock. If the cord
gets damaged, contact Customer Service toll-free at the
numbers provided below.
Do not use your HairMax 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 the numbers provided below.
Laser light - avoid direct eye exposure.
This is a harmless low-level ESD (Electrostatic Discharge)
sensitive device. Please do not touch the USB port (see
page 9). Touching the contacts or USB port is not of the
essential performance and will not cause a basic safety issue.
If touching the contacts or USB port causes the device to
malfunction, reset your device by powering off and back on.
A risk of re and/or explosion exists when the LASER
OUTPUT is used in the presence of ammable materials,
solutions or gases, or in an oxygen enriched environment.
The high temperatures produced in NORMAL USE of the
laser equipment may ignite some materials, for example
cotton wool when saturated with oxygen. The solvents of
adhesives and ammable solutions used for cleaning and
disinfecting should be allowed to evaporate before the laser
equipment is used. Attention should also be drawn to the
danger of ignition of endogenous gases.
No modication of this equipment is allowed.
This equipment has no user-serviceable parts. Do not attempt
to modify or repair this equipment.
Do not attempt to modify or service while the equipment is
in use.
If this equipment is modied, 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 your HairMax to make
sure you do not have a reaction. Some of the things that
can cause increased sensitivity to your HairMax could be
medicines for colds, allergies, pain medicine and drugs to
treat infections. To test your HairMax 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
ve minutes. If you see any reaction such as redness or rash,
do not use your HairMax and contact our Customer Service
toll-free at the numbers provided below for information on
how to return your product and get a refund.
Only use your HairMax as directed. Do not try to change the
way your HairMax operates. Altering controls, adjustments,
performance or procedures other than those specied herein
may result in hazardous radiation (laser) exposure. Contact
Customer Service toll-free at the numbers provided below.
Never use acetone or other solvents on any part of your
HairMax. Use of solvents on the window can block the laser
light from coming through.
United States 1-866-527-3726
United Kingdom 0808-134-9868
Australia 1-800-937-358
WARNING AND CAUTIONS
4
RISKS | SYMBOLS | TESTING FOR SENSITIVITY
Risks
HairMax 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 HairMax. None of the women in the clinical
study reported any of these side effects. If you
have itching, tingling or any other side effect that
bothers you, stop using your HairMax and contact
Customer Service at the numbers provided below.
Symbols
European Conformity
WEEE
!
Warning
!
Caution
Laser
Laser warning
RISKS | SYMBOLS | TESTING FOR SENSITIVITY
Laser aperture indication
Laser warning label
Power On/Off
Refer to instruction
manual
RF interference
Type BF Applied Part
Serial Number
Degree of moisture
resistance
Testing HairMax for sensitivity
Before beginning
treatment, be sure to test
your HairMax for sensitivity.
You will only need to do
this once to test your skin
for any reaction to light
therapy. Make sure your
HairMax is fully charged
(see page 10). Turn on your
device by pressing the
power button once. Place your forearm with your
palm facing upward under the arc of your HairMax.
Allow your arm to stay in the light for 2 minutes.
Turn your HairMax off and set it aside.
If you do not see a reaction, proceed with the
treatment instructions on page 11. If you see a
reaction, such as redness or rash, do not use your
HairMax. Contact HairMax Customer Service at the
numbers provided below or your place of purchase.
United States 1-866-527-3726
United Kingdom 0808-134-9868
Australia 1-800-937-358
5
HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF YOUR HAIRMAX
How to Monitor Device Activity
Your HairMax is carefully inspected and tested
during production. When working properly, the
indicator light turns on and the red laser lights will
shine form the underside 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 the indicator light is not lit, or if the laser light
does not appear, contact HairMax Customer
Service at the numbers provided below.
United States 1-866-527-3726
United Kingdom 0808-134-9868
Australia 1-800-937-358
Device Failure Mode
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 your HairMax
HairMax is a medical device manufactured under
strict quality controls and validated through GMP
(Good Manufacturing Practices). HairMax 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 your
HairMax is 10-15 years of regular use. Please take
time to read this entire instruction manual before
operating your HairMax.
MONITORING DEVICE | FAILURE MODE | EXPECTED LIFE
6
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