iRESTORE Hair Growth System User manual

ADVANCED LASER HAIR GROWTH TECHNOLOGY
FDA-CLEARED FOR MEN AND WOMEN
USER MANUAL

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iRestore ID-500 is manufactured exclusively for
Freedom Laser Therapy, Inc.
7815 Beverly Boulevard, 3rd Fl.
Los Angeles, CA 90036 USA
1-888-373-7425 Toll Free
1-323-933-0304 Tel

Thank you for purchasing iRestore Laser Hair Growth System, ID-500. You are going
to experience this home-use laser hair therapy system designed to promote hair
growth. There is no need for a medical prescription because the patient is the
intended operator of the device.
PURPOSE (INDICATIONS OF USE)
iRestore Laser Hair Growth System, ID-500, is indicated to treat androgenic
alopecia for men and women. It is designed to promote hair growth in males
who have Norwood-Hamilton Classifications of Ila to V and in females who have
Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin
Types I to IV.
CONTRAINDICATIONS
iRestore is contraindicated in the following situations:
Do not use the iRestore device if you are taking medications or if you have any
medical condition which makes your skin sensitive to sun or light.
Do not use the iRestore device if you have cancer on your scalp.
Do not use the iRestore device if you have sensitive skin or if you are allergic to
this specific wavelength of light (640-665nm). Sensitive skin or an allergic
reaction can result in an itchy sensation of the scalp or sunburn like redness. If
these occur, seek medical care from a physician.
The iRestore device should not be used by or on children under 18 years of age.
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WARNINGS AND PRECAUTIONS
Do not look directly at, or use optical instruments like magnifiers or microscopes
to look at, the laser light or its reflection off a mirror-like surface. The iRestore
device contains Class 3R lasers that may cause harm to the retina and eye
irritation, if the lasers are pointed directly at the eyes.
Discontinue use of the iRestore device if scalp itching or tingling occurs and lasts
more than one (1) hour after completion of a treatment session. If the problem
continues for more than one (1) hour after treatment, discontinue usage and
consult with a physician.
Always unplug the iRestore device from the power outlet and never leave it
unattended while it is plugged in. This may cause an electrical hazard that may
result in fire, injury, or death.
Do not put tension on the cord while handling, untangling or straightening the
cord. The tension may break the cord, which could result in a malfunction or
electrical hazard.
Do not get the iRestore device or adapter wet. This may result in an electric
shock.
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Do not place the iRestore device or adapter where it can fall or be pulled into a
sink or a tub. This could cause an electrical hazard that may result in injury or
death.
If the unit is dropped into water or other liquids, unplug the iRestore device from
the power outlet immediately. Do not touch the water or liquid while the device
is connected to a power outlet. This is an electrical hazard that may result in
injury or death.
Never use the iRestore device while sitting in the bathtub or swimming pool.
Doing otherwise could result in a serious danger resulting in an electrical shock,
injury, or even death.
Always keep the cord away from hot or heated surfaces such as radiators, stoves,
ovens or room heaters. If the cord makes contact with a hot or heated surface, it
can cause the product to malfunction and may result in an electrical shock.
Do not use the iRestore device when your hair is wet from showering, swimming
or bathing. Towel dry your hair before use. Wet hair may result in electric shock
or prevent the laser light from being delivered to the scalp.
Always attach the power supply to the unit first, then connect the plug into
electrical outlet.
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Use only the power adapter provided with the iRestore device.
Do not operate the iRestore device if it has a damaged cord, plug, or helmet. If
you notice damages to the above, return the product to Freedom Laser Therapy,
Inc.
Keep the lasers and device out of reach of children and pets. The laser light may
cause harm or injury to your children and pets if they look directly at the laser
light.
Always unplug the iRestore device from the power outlet prior to cleaning the
device. Failure to do so may result in an electrical hazard that may cause harm or
injury.
Only use the iRestore device according to the instructions provided. Do not use it
for any other purpose. It is not recommended.
Never attempt to repair the iRestore device on your own. Please contact your
distributor or Freedom Laser Therapy, Inc. to request repair or replacement.
Avoid dropping the iRestore device, as this may cause the device to malfunction
and become damaged. If you drop the device or suspect device malfunction (EX:
device exterior cracks, lasers or LEDs do not light up, the device does not turn
on), contact Freedom Laser Therapy, Inc. to request repair or replacement.
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1 Meter

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PRODUCT DESCRIPTION
iRestore Laser Hair Growth System is a laser hair therapy device indicated to
promote hair growth. The iRestore Laser Hair Growth System uses 21 low-level lasers
and 30 light emitting diodes (LED). The lasers are Class 3R (<5mW). The lasers and
LEDs have wavelengths of 640-665nm.
Package includes (accessories list):
Accessories
Quantity
iRestore ID-500 Laser Dome
1
Power Adapter
1
Remote Control
1
User Manual
1
The various iRestore Laser Hair Growth System components are shown below:
Front Side Inside

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Power WireRemote Control
Laser
Foam Pad
LED
Laser Dome
Headband
Safety Sensor
Power Adapter DC5V
Description
Function
1
Laser Dome Housing
Plastic laser dome configured with 21 Class 3R lasers
(<5mW) and 30 LEDs (660 ± 5nm) to provide low-level
light therapy treatment to the scalp
2
Stretcher Housing
Plastic headband. As a mounting base for Laser Dome
Housing
3
Power Wire
Connect device and remote control
4
Remote Control
External system control center. Control the built-in timer,
the on/off switch of light source
5
Foam Pad
Padding around the protective shield to increase comfort
6
Light Emitting Diode (LED)
30 LEDs (660 ± 5nm) are the light source for treatment
7
Laser Diode (Class 3R)
21 lasers (<5mW) are the light source for treatment
8
Safety Sensor
An electronic sensor that permits use of the iRestore only
when it is placed on the head in the recommended

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WHO SHOULD USE IRESTORE LASER HAIR GROWTH SYSTEM?
How to determine if the iRestore Hair Growth System is the right product for you?
The iRestore Laser Hair Growth System is designed to treat androgenic alopecia and
to promote hair growth in men 18-48 years of age and women 18-60 years of age.
The progression of male pattern baldness is generally classified on the Norwood-
Hamilton Scale. The iRestore device is indicated for males who have Norwood-
Hamilton Classifications of Class Ila to V (indicated by the section marked
“Appropriate” in the Norwood-Hamilton Scale on page 10) and Fitzpatrick Skin
Types I to IV (refer to the Fitzpatrick Scale on page 10).
The progression of female pattern baldness is generally classified on the Ludwig-
Savin Scale. The iRestore device is indicated for females who have Ludwig-Savin
Classifications of Class I to II (indicated by the section marked “Appropriate” in the
Ludwig-Savin Scale on page 10) and Fitzpatrick Skin Types I to IV (refer to the
Fitzpatrick Scale on page 10).
iRestore Laser Hair Growth System is indicated to promote hair growth in the
following males and females:
Appropriate indicates who may use the iRestore device
Not Appropriate indicates who may not use the iRestore device
To determine your classification of male or female pattern baldness, match your
appearance of hair loss to the images below from the Norwood-Hamilton Scale or
Ludwig-Savin Scale that best resembles your hair appearance. If your male or female
pattern baldness classification falls in the “Appropriate” section (Class IIa to V for
men, Class I to II for women), the iRestore device is appropriate for you. If your male
or female pattern baldness classification falls in the “Not Appropriate” section (Class
I to VII for men, Class III, Advanced, and Frontal for women), the iRestore device is
not appropriate for you.
If your Fitzpatrick Classification of Skin Type is Type I to IV (refer to Fitzpatrick
Classification of Skin Type on the next page), the device is appropriate for you. If
your Fitzpatrick Classification of Skin Type is Type V or VI, the device is not
appropriate for you.

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Norwood-Hamilton Scale
Ludwig-Savin Scale
The following skin types (Fitzpatrick Classification) can use iRestore Laser Hair
Growth System:
Type I : Highly sensitive, always burns, never tans (EX: red hair with freckles)
Type II : Very sun sensitive burns easily, tans minimally (EX: fair skinned, fair haired
Caucasians)
Type III: Sun sensitive skin, sometimes burns, slowly tans to light brown (EX: darker
Caucasians)
Type IV: Minimally sun sensitive, burns minimally, always tans to moderate brown
(EX: Mediterranean type, Caucasians, some Hispanics)
The following skin types (Fitzpatrick Classification) should not use iRestore Laser
Hair Growth System:
Type V : Sun insensitive skin, rarely burns, tans well (EX: some Hispanics, some
blacks)
Type VI: Sun insensitive, never burns, deeply pigmented (EX: darker blacks)
Fitzpatrick Scale
Not Appropriate
Appropriate
I II Va VI VII
IIa IIIa III IVa
III-vertex IV V
Male
Not Appropriate
Appropriate
Advanced Frontal
I-1 I-2 I-3 I-4 II-1 II-2
III
Female
Not Appropriate
Appropriate
Compatibility
Skin Type
Skin Color
Reaction to Sun
Exposure
Pale, white
skin, freckled
Fair skinned,
beige tint
White to light
brown skin
Moderate brown
or dark olive skin Dark brown skin Black skin
Type I Type II Type III Type IV Type V Type VI
Highly sensitive,
always burns,
never tans
Very sun sensitive,
burns easily,
tans minimally
Sun sensitive,
sometimes burns,
slowly tans to
light brown
Minimally sun
sensitive, burns
minimally, always tans
to moderate brown
Sun insensitive,
rarely burns,
tans well
Sun insensitive,
never burns,
deeply pigmented