HairMax LaserBand 41 ComfortFlex User Manual
USER MANUAL
HairMax
®
LaserBand 41
comfort
flex
TABLE OF CONTENTS
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 ............................................................................................ 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/Cleaning/Disposal Instructions .................................... 16
Electrical Safety. ................................................................................. 17
Electromagnetic Emissions Guidance ...............................................18
Electromagnetic Immunity Guidance ................................................ 19
Electromagnetic Distance Recommendations ...................................21
Warranty ............................................................................................ 22
Warranty Card....................................................................................23
Corporate Ofce – Customer Service – Warranty Repairs
Lexington Intl., LLC
1040 Holland Drive
Boca Raton, Florida 33487 USA
Direct line +1-561-417-0200
Email: info@hairmax.com
www.HairMax.com
United States 1-866-527-3726
United Kingdom 0808-134-9868
Australia 1-800-937-358
For more information about usage, quality and safety, visit:
www.hairmax.com/videos and Hairmax.com/QualitySafety
©Copyright 2018 Lexington Intl., LLC. All rights reserved.
Introduction of 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-the-counter (OTC) device that can be sold
directly to the public.
Indications
HairMax 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 Classications of IIa to V and who both have
Fitzpatrick Skin Types I to IV.
How HairMax works
HairMax 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.
HairMax has teeth that part the hair and
allow the maximum amount of laser
energy to reach 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.
INTRODUCTION
INTRODUCTION
It is important that you read and understand the content of this User Manual before using your HairMax.
1
2
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.
CLASSIFICATION FOR MEN AND WOMEN
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX®?
Norwood Hamilton
Classication - Males
Ludwig-Savin
Classication - Females
HairMax has not been clinically tested for hair loss
outside of the shaded areas.
3
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
FITZPATRICK SKIN TYPE CLASSIFICATION
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX?
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.
4
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 charging contacts or 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.
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
WARNINGS AND CAUTIONS
WARNINGS AND CAUTIONS
5
RISKS | SYMBOLS | TESTING FOR SENSITIVITY
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 device and contact customer service toll-free at the
numbers provided below.
Symbols
Testing HairMax for sensitivity
Before beginning treatment, be sure to
test the HairMax for sensitivity. You 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 don’t experience any reaction, proceed with the treatment
instructions on page 11. If you see any reaction such as redness
or rash, do not use your HairMax. Contact customer service tollfree 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
!
!
European Conformity
WEEE
Warning
Caution
Laser
Laser warning
Power On/Off
Refer to instruction manual
RF interference
Type BF Applied Part
Serial Number
Degree of moisture resistance
Laser aperture indication
Laser warning label
HAI
6
How to Monitor Device Activity
Your HairMax is carefully inspected and tested during
production. When working properly, the indicator light on the
device turns 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 the device indicator light is not lit, or if the laser light does
not appear, contact customer service toll-free at the numbers
provided below.
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 the 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 user manual before
operating your HairMax.
United States 1-866-527-3726
United Kingdom 0808-134-9868
Australia 1-800-937-358
MONITORING DEVICE | FAILURE MODE | EXPECTED LIFE
HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF YOUR HAIRMAX
7
SUMMARY OF CLINICAL STUDY IN MEN
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, who had light to brown skin tones. Subjects were divided into two groups,
HairMax group and a control group. The control device looked and sounded like the HairMax 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.*
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 devices versus the
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
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
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