HairMax LaserBand 82 User manual

LaserBand 82
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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/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 Specifications......................................................15
Maintenance/Cleaning/Disposal Instructions.........................16
Replacing the Teeth ................................................................17
Electrical Safety...........................................................................18
Electromagnetic Immunity Guidance ....................................19
Electromagnetic Distance Recommendations.........................22
Warranty Card.........................................................................23
Warranty .....................................................................................25
Phone: [phone]
[phone]
Email: [email protected]
HAIRMAX.com
Lexington International, LLC
1040 Holland Drive
Boca Raton, FL 33487
USA
For more information about usage, quality and safety, visit:
Hairmax.com/videos and Hairmax.com/QualitySafety
TREATMENT INSTRUCTIONS
TABLE OF CONTENTS
TABLE OF CONTENTS
Corporate Office – Customer Service – Warranty Repairs
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TREATMENT INSTRUCTIONS
INTRODUCTION
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
Classifications 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 benefits in as little as
16 weeks.*
HairMax 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.
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
It is important that you read and understand the content of this User Manual before using your HairMax.
INTRODUCTION
1
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WHO IS THE BEST CANDIDATE FOR THE HAIRMAX?
CLASSIFICATION FOR MEN AND WOMEN
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 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 HairMax.
Ludwig-Savin
Classification - Females
Norwood Hamilton
Classification - Males
HairMax has not been clinically tested for hair loss
outside of the shaded areas.
2
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WHO IS THE BEST CANDIDATE FOR THE HAIRMAX?
FITZPATRICK SKIN TYPE CLASSIFICATION
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 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.
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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 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 modification 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 modified, 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 the 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 five minutes. If you see any reaction such as
redness or rash, do not use your HairMax and contact our customer service
at the numbers provided below for information on how to return your
product and get a refund.
Only use the your HairMax as directed. Do not try to change the way your
HairMax operates. Altering controls, adjustments, performance or
procedures other than those specified 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
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RISKS | SYMBOLS | TESTING FOR SENSITIVITY
RISKS | SYMBOLS | TESTING FOR SENSITIVITY
5
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 Lexington’s 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 toll-free 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
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MONITORING DEVICE | FAILURE MODE | EXPECTED LIFE
6
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 light indicator
on the power buttons 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 light indicator 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 instruction manual before operating
your HairMax.
United States 1-866-527-3726
United Kingdom 0808-134-9868
Australia 1-800-937-358
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SUMMARY OF CLINICAL STUDY IN MEN
7
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, 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 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
21.6
Hairs/cm2
139.3
Hairs/in2
4.3
Hairs/cm2
27.7
Hairs/in2
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SUMMARY OF CLINICAL STUDY IN WOMEN
8
SUMMARY OF CLINICAL STUDY IN WOMEN
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 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 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.*
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
and a 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
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PARTS
9
PARTS
A
B
C
D
E
F
G
H
I
POWER BUTTON
INDICATOR LIGHT
POWER CORD
USAGE LABEL
TEETH
LASER WINDOW
WARNING LABEL
SERIAL NUMBER
(located under the teeth)
USB CHARGING PORT
G
A
B
C
D
E
F
HMLC00010000
H
I
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Charging
Charge your HairMax 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 during the
charging process. A steady
light indicates your HairMax
is fully charged.
When your HairMax is turned on,
the indicator light will illuminate. As
the battery power diminishes, the light
will be blinking slowly. When the battery is getting low
and needs to be recharged, the light will start to flash
rapidly, the lasers will turn off and the vibrator puts out
three quick pulses. When this happens, charge your
HairMax as described above.
Your LaserBand comes with a rechargeable battery
permanently installed. Read this user manual completely
before you start to use your HairMax. The instructions in
this user manual are intended for individuals with a
minimum of an eighth grade education. HairMax is safe
for home use. The patient is the intended operator of
this equipment.
Use the HairMax LaserBand
for as little as 90 seconds per
treatment, three treatments
per week. The treatments
should be spaced every
other day, for example
Monday, Wednesday, Friday. Most users see benefits in
as little as 16 weeks (based on clinical studies).
When you receive your HairMax, take all the parts out of
the case. You must charge your HairMax for 4-5 hours
before initial use.
90
seconds
as little as
GETTING STARTED | CHARGING
GETTING STARTED | CHARGING
10
IMPORTANT: The USB micro connector on your power cord will only fit in the USB micro socket on the
LaserBand when inserted the right way. You will note that the socket has a long side and a short side. Match
the shape of the micro connector to the socket and gently insert. If inserted correctly, it will go in without
resistance. Do not forcibly push in or you can potentially cause damage to the device and render it unusable.
INCORRECT CORRECT
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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 your HairMax for
sensitivity (see page 5 of the User Manual). Your
HairMax should be used for as little as 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 your
HairMax on by pressing the
power button once to activate
the 30-second treatment
method OR twice for the
4-second treatment.
Treatment Instructions
Choose either the 30-second OR the 4-second treatment
method. (Do not treat your hair with both methods).
30-SECOND TREATMENT METHOD
Press the power button once to
select the 30-second treatment
method. Your HairMax will vibrate
every 30 seconds. When you feel
the vibration, it is time to move your
HairMax to the next part of your
scalp. Place your HairMax at your
hairline and leave it in place until
it vibrates.
Next, slide your HairMax 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.
30 sec
30 sec
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When your HairMax vibrates
again, slide it to the last spot on
your scalp. You have completed
today’s treatment.
4-SECOND TREATMENT METHOD
Press the power button twice to
select the 4-second treatment
method. Your HairMax will
vibrate every 4 seconds. When
you feel the vibration, it is time
to move your HairMax to the
next part of your scalp. Place your
HairMax at your hairline and leave
it in place until it vibrates.
Next, slide your HairMax 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 HairMax 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.
After treatment, turn off your
HairMax by pressing the power button until the
indicator light turns off. Remove your HairMax from
your head and plug it into the charger for future use.
30 sec
4 sec
4 sec
4 sec
TREATMENT INSTRUCTIONS
12
TREATMENT INSTRUCTIONS
—OR —
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TREATMENT INSTRUCTIONS | WHAT IS INCLUDED
13
TREATMENT INSTRUCTIONS | WHAT IS INCLUDED
Please Note:
• It is important to glide your HairMax instead of lifting it off your scalp
and placing it back. Remember, you are bathing the scalp with laser
light. If you move your HairMax too fast, the treatment will not achieve
the optimal results to promote hair growth.
• Time required for treatment with the LaserBand is as little as 90 seconds.
What is included:
L
as
e
r
B
a
n
d
P
o
w
e
r
C
o
r
d
U
ser
M
a
n
u
a
l
Q
u
i
c
k
S
t
a
r
t
G
u
i
d
e
glide lift-and-place
Notice: Entire LaserBand assembly is considered as a Type BF applied part.
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HairMax 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 HairMax is fully charged.
Insert the power cord into your HairMax,
then press the power button for 4 seconds
Try another electrical wall outlet.
Your LaserBand is turning off during use
Make sure your HairMax is fully charged.
Insert the power cord into the HairMax 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 the numbers provided
below.
Customer Service – Warranty Repairs
Lexington Intl., LLC
1040 Holland Drive
Boca Raton, Florida 33487 USA
Direct line [phone]
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
ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY HAIRMAX CUSTOMER SERVICE, WILL VOID YOUR WARRANTY.
14
TROUBLESHOOTING
TROUBLESHOOTING
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15
WARNING LABEL | LASER PARAMETERS | USE CONDITIONS | POWER SUPPLY SPECIFICATIONS
WARNING LABEL | LASER PARAMETERS | POWER SUPPLY
Warning label
Serial number
HMLC00010000
(located under the teeth
- right side)
WARNING LABEL | LASER PARAMETERS | USE CONDITIONS
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 laser devices have no user-serviceable parts.
Warning label location : left side
MTBF: mean time between failures :10,000 hours at 25ºC ambient temperature
Operating temperature/altitude/atmospheric
pressure/humidity:
5ºC to 35ºC / 0 to 2,000 m / / 80kPa to 106kPa /
0% to 90%, relative humidity
Storage & transportation temperature/humidity/
atmospheric pressure:
-20ºC to 60º C / 0% to 90%, relative humidity/
50kPa to 106kPa
Ingress of water or particulate matter:
IP22
Battery charging cycles : 300 cycles
ROHS: restriction of hazardous substances: 2011/65/EU
Device size and weight:
22 x 9 x 15 cm / 454 grams
Power Supply Specifications
Fuhua UE05WCP-050100SPC or similar. Output = 5V DC-1.0A. Plug: 9mm x 3.5mm, center positive.
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).
(01)0 0856823 00615 2
(11)170314
(21)LB820001000
S/N: LB820001000
or
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16
MAINTENANCE | CLEANING YOUR HAIRMAX | DISPOSAL INSTRUCTIONS
MAINTENANCE | CLEANING YOUR HAIRMAX | DISPOSAL INSTRUCTIONS
Maintenance
HairMax is designed to last for 10-15 years.
It does not require any maintenance other than
periodic cleaning.
Cleaning your HairMax
Keep your HairMax clean.
Turn off the HairMax by pressing 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 HairMax 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 HairMax.
Disposal Instructions
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.
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REPLACING THE TEETH
17
REPLACING THE TEETH
To remove the teeth from your LaserBand, pull down from the
finger slot (Figure A).
To replace the teeth, insert and align the teeth and press on
either side of your LaserBand until they snap in place (Figure B).
Please Note:
There is a RIGHT and LEFT side to the teeth. They will only fit in one direction.
AB
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18
ELECTRICAL SAFETY
ELECTRICAL SAFETY
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.
To reduce the risk of hazard by electric shock:
Do not use while bathing.
Do not place or store your HairMax where it can fall or be pulled into a tub or sink.
Do not expose your HairMax to running water, or drop into water or any other liquid.
If your HairMax falls into water, unplug it immediately from the power outlet.
If using your HairMax near water, the use of an electrical outlet protected by a Ground Fault
Circuit Interrupter is recommended.
Do not dispose of your HairMax in a fire or store in high temperatures greater than 140°F (60°C).
Do not turn on or use your HairMax while it is charging.
Power supply cannot be separated during use. Do not position the equipment in a manner that
will make it difficult to plug in or remove the power cord.
If you have any problems with this device, such as setting up, maintaining or using, please contact
customer service.
Please report to customer service if any unexpected operation or events occur.
After drop/shock that may cause changes in the performance, please contact customer service.
Be careful, do not put the power cord around your neck, it may cause strangulation.
Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
Do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause
injury, improper results, or serious danger.
The device should be used only with the accessories recommended for use by the manufacturer.
When not in use, store the device with the adapter in a dry room and protect it against extreme moisture,
heat, lint, dust and direct sunlight. Never place any heavy objects on the storage case.
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