HairMax LaserBand 82 User manual

H
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LaserBand 82
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TREATMENT INSTRUCTIONS
© Copyright 2015 Lexington Intl, LLC. All rights reserved.
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TABLE OF CONTENTS
TABLE OF CONTENTS
TABLE OF CONTENTS
What you should know before you start
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 LaserBand....................................6
Summary of Clinical Study in Men................................................7
Summary of Clinical Study in Women............................................8
HairMax LaserBand
HairMax LaserBand Parts...........................................................9
Getting Started...........................................................................10
Charging Options.......................................................................10
Proper Use...................................................................................11
Treatment Instructions.................................................................12
What your HairMax LaserBand comes with.................................13
Troubleshooting............................................................................14
Other Useful Information
Safety Label.................................................................................15
Power Supply Specifications......................................................15
Cleaning Your HairMax LaserBand...........................................16
Electrical Safety...........................................................................17
Disposal Instructions ..................................................................17
Warranty Card...............................................................................19
Warranty .....................................................................................20
HairMax Customer Service:
Phone: [phone]
[phone]
Email: [email protected]
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
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INTRODUCTION
1
INTRODUCTION
Introduction to the HairMax®LaserBand
The HairMax LaserBand is a home-use laser device that
has been Clinically Proven to treat hereditary hair loss in
men and women. The LaserBand is an over-the-counter
(OTC) device that can be sold directly to the public.
Indications
The HairMax LaserBand 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 LaserBand works
The LaserBand 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 LaserBand has teeth that part the hair and allow the
maximum amount of laser energy to reach the scalp.
Treatment with the HairMax LaserBand
The LaserBand should be used 3 times per week,
spaced out every other day. For example, Monday,
Wednesday, Friday. Recommended treatment is less
than 90 seconds.The LaserBand will turn off
automatically after 5 minutes. Clinical studies
demonstrate that most users see benefits in as little as
16 weeks.
HairMax LaserBand 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 LaserBand.
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CLASSIFICATION FOR MEN AND WOMEN
2
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX LASERBAND?
How do you know if the HairMax LaserBand is right for you?
The LaserBand 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 LaserBand.
Ludwig-Savin
Classification - Females
Norwood Hamilton
Classification - Males
The HairMax LaserBand has not been clinically
tested for hair loss outside of the shaded areas.
2
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FITZPATRICK SKIN TYPE CLASSIFICATION
3
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX LASERBAND?
The LaserBand 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 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 The LaserBand was
only tested on light to brown skin tones. This does not indicate that it will not work on darker skin tones.
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WARNINGS AND CAUTIONS
4
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 LaserBand because it can cause
temporary irritation to your eyes.
Keep the LaserBand out of the reach of children.
Do not drop the LaserBand in water because
you may get an electrical shock. If the LaserBand
gets damaged by water, contact Customer Service
toll-free at 1-866-527-3726.
If the power cord is damaged do not use the device
or the power cord 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 LaserBand near any heated surfaces
because this could cause the device not to work
properly and may cause an electrical shock. If your
device does not work, 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 first test the LaserBand
to make sure you do not have a reaction. Some of the
things that can cause increased sensitivity to the
LaserBand could be medicines for colds, allergies,
pain medicine and drugs to treat infections. To test the
LaserBand 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 LaserBand and contact
our Customer Service toll-free at 1-866-527-3726 to
return your product and receive a refund.
Only use the LaserBand as directed. Do not try to change
the way the LaserBand 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
LaserBand. 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 LaserBand yourself. This appliance has no user-serviceable parts.
Use the LaserBand only for its intended use as described in this manual. Contact Customer Service toll-free at 1-866-527-3726.
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RISKS | TESTING FOR SENSITIVITY
5
RISKS | 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 HairMax.
None of the women in the clinical study reported any
of these side effects from using HairMax. If you have
itching, tingling or any other side effect that bothers
you, stop using HairMax and contact Lexington’s
Customer Service toll-free at 1-866-527-3726.
Testing the LaserBand for Sensitivity
Before beginning treatment, be sure to test the
LaserBand for sensitivity. You only need to do this
once to test your skin for any reaction to light therapy.
Make sure your LaserBand is fully charged (see page
10). Turn on your device (see page 12). Place your
forearm under the arc of the LaserBand.
Raise your arm towards the LaserBand and place the
LaserBand on your arm as
shown. Allow your arm to
stay in the light for 1
minute. Turn your
LaserBand off and set it
aside.
If you see any reaction such
as redness or rash, do not use
the HairMax LaserBand and contact Customer Service
toll-free at 1-866-527-3726 to return your product and
receive a refund. If you don’t experience any reaction,
proceed with the treatment instructions on page 12.
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MONITORING DEVICE | FAILURE MODE | EXPECTED LIFE
6
HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF LASERBAND
How to Monitor Device Activity
Your HairMax LaserBand is carefully inspected and
tested during production. When working properly, the
light indicator on the power buttons turns on. A red
laser light shines through the window at the bottom of
the device.
Place the LaserBand on your scalp. You can check a
mirror to ensure that it is working properly.
If the light indicator 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 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 LaserBand
The HairMax LaserBand is a medical device
manufactured under strict quality controls and
validated through GMP (Good Manufacturing
Practices). The HairMax LaserBand contains
high quality, medical grade, 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
LaserBand is 10-15 years of regular use. Please take
time to read this entire instruction manual before
operating the HairMax LaserBand.
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SUMMARY OF CLINICAL STUDY IN MEN
7
SUMMARY OF CLINICAL STUDY IN MEN
Clinical studies were conducted at ultiple locations in the United States. Participants in the study were
ales diagnosed with Androgenetic Alopecia, which includes hereditary hair loss, and 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- onth clinical study, subjects treated their hair once
per treat ent, 3 ti es per week on non-consecutive days. The
nu ber of thick, nor al, 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 en
saw an increase in hair counts (based on a ini u 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 nu ber and types of adverse events were si ilar in
the HairMax and Control Groups.
Hair Count Change
In the clinical study, after 26 weeks of treat ent with the HairMax
devices versus the Control Devices, the following increases in hair
count were found.
0
10
20
30
40
50
60
70
80
90
100
110
120
130
140
0
10
20
30
40
50
60
70
80
90
100
110
120
130
140
27.7
Hairs/in2
Mean Terminal Hair Count Changes
From Baseline in MALES
26 Weeks
Control Device
139.3
Hairs/in2
27.7
Hairs/in2

SUMMARY OF CLINICAL STUDY IN WOMEN
8
SUMMARY OF CLINICAL STUDY IN WOMEN
A clinical study was conducted at ultiple locations in the United States. All participants in the study were fe ales,
diagnosed with Androgenetic Alopecia, which includes hereditary hair loss, and had light to brown skin tones.
Subjects were divided into two groups. One group used the HairMax and the other group used a Control Device.
The Control Device looked and sounded like the HairMax, 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- onth study, subjects treated their hair once per treat ent,
3 ti es per week, on non-consecutive days. The nu ber of thick,
nor al, 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 wo en saw
increases in hair counts (based on a ini u 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 nu ber and types of adverse events were si ilar in
the HairMax and control groups.
Hair Count Change
In the clinical study, after 26 weeks of treat ent with the
HairMax 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
0
10
20
30
40
50
60
70
80
90
100
110
120
130
140
Mean Terminal Hair Count Changes
From Baseline in FEMALES
26 Weeks
Control Device
17.4
Hairs/in2
132.2
Hairs/In2

A
B
C
D
E
F
G
H
POWER BUTTON
INDICATOR LIGHT
POWER CORD
USAGE LABEL
TEETH
LASER WINDOW
SAFETY LABEL
SERIAL NUMBER
(located under the teeth)
G
A
B
C
D
E
F
HMLC00010000
H
HAIRMAX LASERBAND PARTS
HAIRMAX LASERBAND PARTS
9
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GETTING STARTED
10
GETTING STARTED
Charging
Charge your LaserBand for 2-3 hours before initial use.
Charge the LaserBand by plugging the power cord
directly into the charging socket on the bottom right side
of the LaserBand. Plug the other end into an electrical
socket.
The indicator light on the power
button will flash blue during the
charging process. A steady blue
light indicates your LaserBand is
fully charged.
When the LaserBand is turned on,
the indicator light will be green. As the
battery power diminishes, the light will be blinking slowly
between green and orange. When the battery is getting
low and needs to be recharged, the light will start to flash
rapidly between green and orange. The lasers will turn off
and the vibrator puts out three quick pulses. When this
happens, charge your LaserBand as described above.
Your LaserBand comes with a rechargeable battery
permanently installed. Read this manual completely
before you start to use your LaserBand.
Use the LaserBand for less
than 90 seconds, 3 times a
week. The treatments should
be spaced every other day,
for example Monday,
Wednesday, Friday. Do not use the LaserBand 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 LaserBand, take all the parts out
of the case. Remove the red safety label. The power
button is located under the red safety label. You must
charge your LaserBand for 2-3 hours before initial use.
90
seconds
less than
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PROPER USE | TREATMENT INSTRUCTIONS
11
PROPER USE | TREATMENT INSTRUCTIONS
Proper Use
POSITION THE LASERBAND WITH THE POWER
BUTTON ON THE RIGHT SIDE OF YOUR HEAD.
• Before beginning treatment, test the LaserBand for
sensitivity (see page 5 of the User Manual). Your
LaserBand should be used for less than 90 seconds,
three times per week. The treatments should be
spaced out every other day. For example Monday,
Wednesday, Friday.
To start your treatment, turn the
LaserBand on by pressing the
power button once to activate
the 4-second treatment
method OR twice for the
30-second treatment method.
Treatment Instructions
Choose either the 4-second OR the 30-second treatment
method. (Do not treat your hair with both methods).
4-SECOND TREATMENT METHOD
Press the power button once to
select the 4-second treatment
method. The LaserBand will vibrate
every 4 seconds. When you feel the
vibration, it is time to move the
LaserBand to the next part of your
scalp. Place the LaserBand at your
hairline and leave it in place until it
vibrates.
Next, slide the LaserBand to the
middle portion of your scalp using
light pressure so the teeth can
separate your hair, moving it aside
to allow the maximum amount of
therapeutic light to reach your scalp.
4 sec
4 sec
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TREATMENT INSTRUCTIONS
12
TREATMENT INSTRUCTIONS
When your LaserBand vibrates
again, slide it to the last spot on
your scalp. This completes the
first pass of your treatment.
Repeat this process 6 times to
complete today’s treatment.
30-SECOND TREATMENT METHOD
Press the power button twice to
select the 30-second treatment
method. The LaserBand will
vibrate every 30 seconds. When
you feel the vibration, it is time
to move the LaserBand to the
next part of your scalp. Place the
LaserBand at your hairline and
leave it in place until it vibrates.
Next, slide the LaserBand to the
middle portion of your scalp
using light pressure so the teeth
can separate your hair, moving
it aside to allow the maximum
amount of therapeutic light to
reach your scalp.
When your LaserBand
vibrates again, slide it
to the last spot on your scalp.
You have completed today’s
treatment.
After treatment, turn off the
LaserBand by pressing and
holding the power button
until the indicator light turns
off. Remove the LaserBand from
your head and plug it into the
charger for future use.
4 sec
30 sec
30 sec
30 sec
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13
TREATMENT INSTRUCTIONS | WHAT IS INCLUDED
TREATMENT INSTRUCTIONS | WHAT IS INCLUDED
Please Note:
• It is important to glide the LaserBand instead of lifting it off your scalp
and placing it back. Remember, you are bathing the scalp with laser
light. If you move the LaserBand too fast, the treatment will not achieve
the optimal results to promote hair growth.
• Time required for treatment with the LaserBand is less than 90 seconds.
What is included:
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glide lift-and-place
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14
TROUBLESHOOTING
The LaserBand 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 LaserBand will not turn on
Make sure your LaserBand is fully charged.
Insert the power cord into the LaserBand,
then press the power button for 4 seconds
and then the laser button.
Try another electrical wall outlet.
Your LaserBand is turning off during use
Make sure your LaserBand is fully charged.
Insert the power cord into the LaserBand then
press the power button.
Try another electrical wall outlet.
Your LaserBand will not turn off
Press and hold the power button for 4 seconds
If using the power cord, unplug the LaserBand
and press the power button for 4 seconds
Your LaserBand vibrates irregularly
or doesn’t vibrate at all
If using the power cord, unplug the LaserBand.
Plug in the power cord again and press the power
button.
Your LaserBand vibrates, but you
do not see the laser light
If using the power cord, unplug the LaserBand.
Plug in the power cord again and press the power
button.
If you have trouble understanding any of these
instructions contact Customer Service toll-free
at 1-866-527-3726.
Lexington Intl., LLC • 777 Yamato Road, Suite 105 • Boca Raton • FL 33431 • Tel. [phone] • Toll-Free 1-866-527-3726
[email protected] • www.hairmax.com
ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY HAIRMAX CUSTOMER SERVICE, WILL VOID YOUR WARRANTY.
A
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TROUBLESHOOTING
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15
SAFETY LABEL | LASER PARAMETERS | POWER SUPPLY SPECIFICATIONS
SAFETY LABEL | LASER PARAMETERS
Wavelength: 655nm +/_10nm visible red light
Laser power for classification <5mW CW
Divergence 57 mrad
Number of lasers 82
This laser product is designated as Class 3R during all procedures of operation.
Note: HairMax LaserBand has no user-serviceable parts.
Location: On the underside of the handle | Model version varies
Power Supply Specifications
Output = 5VDC 1.0A. Plug: USB to USB micro B connector.
The power supply for the HairMax LaserBand 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 LaserBand, use
an inexpensive plug adapter (not supplied with the device).
SAFETY LABEL | LASER PARAMETERS | POWER SUPPLY
Safety label
Serial number
HMLC00010000
(located under the teeth)
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CLEANING YOUR HAIRMAX | ELECTRICAL SAFETY
16
CLEANING YOUR HAIRMAX LASERBAND/ELECTRICAL SAFETY
Cleaning your HairMax LaserBand
Keep your LaserBand clean.
Turn off the LaserBand by pressing and
holding the power 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 teeth, gently remove any
hair or dust with a slightly moistened towel.
Don’t use any acetone or solvents
To clean the teeth more thoroughly, remove them
from your LaserBand by gently pulling in either
bottom of the teeth frame. Clean the teeth with
soap and water. Avoid any solvents or harsh
cleansers on any part of your LaserBand.
To replace the teeth, insert and
align the teeth and press on
either side of the LaserBand
until they snap in place. Please
note, there is a front and back
to the teeth. They will only fit
properly in one direction.
If you need to replace the teeth, 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.
H
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17
ELECTRICAL SAFETY | DISPOSAL INSTRUCTIONS
ELECTRICAL SAFETY | DISPOSAL INSTRUCTIONS
Electrical Safety - continued
To reduce the risk of hazard by electric shock:
Do not use while bathing.
Do not place or store the LaserBand where it can fall or be pulled into a tub or sink.
Do not expose the LaserBand to running water or drop into water or any other liquid.
If the LaserBand falls into water, unplug it immediately from the power outlet.
If using the LaserBand near water, the use of an electrical outlet protected by a Ground Fault Circuit
Interrupter is recommended.
Do not dispose of the LaserBand in a fire or store in temperatures greater than 140°F (60°C).
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.
Disposal Instructions
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Process CyanProcess CyanProcess MagentaProcess MagentaProcess YellowProcess YellowProcess BlackProcess Black