iRESTORE Professional 282 User manual

ADVANCED LOW-LEVEL LIGHT TECHNOLOGY
FDA-CLEARED FOR MEN AND WOMEN
USER MANUAL
iRestore Professional 282

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iRestore is manufactured exclusively for
Freedom Laser Therapy, Inc.
16782 Von Karman Ave, Unit 15
Irvine, CA 92606 USA
1-888-373-7425 Toll Free

Thank you for purchasing the iRestore Professional 282. 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)
The iRestore Professional 282 is indicated to promote hair growth in males who
have Norwood-Hamilton Classifications of IIa-V and in females who have Ludwig-
Savin Classifications I-II, and in both with Fitzpatrick Skin Phototypes I-IV.
CONTRAINDICATIONS
iRestore is contraindicated in the following situations:
Do not use the iRestore if you have a medical condition that makes your skin
sensitive to sun or light or if you are taking photosensitizing medications.
Do not use the iRestore if you have cancer, tumor or skin disease on your scalp.
Use of the device may adversely affect your conditions.
Do not use the iRestore device if you have sensitive skin or if you are allergic to
this specific wavelength of light (655 ± 10nm). 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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NO
NO
NO

WARNINGS AND PRECAUTIONS
Caution—use of controls or adjustment or performance of procedures other than
those specified herein may result in hazardous radiation exposure.
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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NO
NO
NO
YES
NO

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.
Use only the power adapter provided with the iRestore device.
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NO
NO
NO
NO
YES
YES
NO

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.
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 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 (e.g.
device exterior cracks, lasers or LEDs do not light up, the device does not turn
on), contact Freedom Laser Therapy to request repair or replacement.
The adapter plug is served to disconnect the device, do not position the device
to make it difficult to disconnect the adapter plug.
Do not use the device when room temperature exceeds 92°F (33.3˚C). This could
cause dryness, redness or irritation of your scalp.
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YES
NO
NO
1 Meter
NO
NO

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PRODUCT DESCRIPTION
iRestore Professional 282 is a laser hair therapy device indicated to promote hair
growth. The iRestore Professional 282 uses 82 low-level lasers and 200 light-emitting
diodes (LED). The lasers are Class 3R (<5mW). The lasers and LEDs have
wavelengths of 655 ± 10nm.
Package includes (accessories list):
Accessories
Quantity
iRestore Professional 282
1
Power Adapter
1
Controller
1
User Manual
1
The various iRestore Professional 282 components are shown below:
Front Side Inside

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Description
Function
1
Laser Dome Housing
Plastic laser dome configured with 82 Class 3R lasers
(<5mW) and 200 LEDs (655+/-10nm) to provide low-level
light therapy treatments to the scalp
2
Power Cord
Connect device and controller
3
Controller
External system control to operate on/off, built-in timer and
start/pause
4
Silicone Pad
Padding around the protective shield to increase comfort
5
Light Emitting Diode (LED)
200 LEDs (655+/-10nm) are the light sources for treatment
6
Laser Diode (Class 3R)
82 lasers (<5mW) are the light sources for treatment
7
Safety Sensor
An electronic sensor that permits use of the iRestore
Professional 282 only when it is placed on the head in the
recommended position
Power CordController
Laser
Silicone Pad
LED
Silicone Pad
Safety Sensor
DC 5V Power Adapter

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WHO SHOULD USE THE IRESTORE PROFESSIONAL 282?
The iRestore Professional 282 is designed to treat androgenic alopecia and to
promote hair growth for men and women.
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 shaded areas 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 Classification. The iRestore device is indicated for females who have Ludwig-
Savin Classifications of Class I to II (indicated by shaded areas in the Ludwig-Savin
Scale on page 10) and Fitzpatrick Skin Types I to IV (refer to the Fitzpatrick Scale on
page 10).
To determine your classification of male or female pattern baldness, match your
appearance of hair loss to the images below from the Norwood-Hamilton
Classification or Lugwig-Savin Scale that best resembles your hair appearance. If
your male or female pattern baldness classification falls in the shaded areas (Class IIa
to V for men, Class I to II for women), the iRestore device has been clinically tested
and indicated for you. If your male or female pattern baldness classification falls
outside the shaded areas (Class I to VII for men, Class III, Advanced, and Frontal for
women), the iRestore device has not been clinically tested for you.
If your Fitzpatrick Classification of Skin Type is Type I to IV (refer to Fitzparick
Classification of Skin Type on page 10), the device has been clinically tested and
indicated for you. If your Fitzpatrick Classification of Skin Type is V or VI, the device
has not been clinically tested for you.

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NORWOOD-HAMILTON SCALE (MALE) LUGWIG-SAVIN SCALE (FEMALE)
IS IRESTORE PROFESSIONAL 282 RIGHT FOR YOUR HAIR LOSS?
Androgenic alopecia, also known as male or female pattern baldness, is a common
disorder that affects millions of men and women worldwide. It is a genetically-
acquired, progressive condition which worsens over time.
The iRestore Professional 282 is a FDA-cleared device that is intended to treat
hereditary hair loss and help promote hair growth. The areas shaded below
represent the types of hair loss for which low-level light therapy has been clinically
tested and indicated. The iRestore Professional 282 has not been clinically tested for
the types of hair loss outside the shaded areas.
CLINICALLY TESTED FOR THE FOLLOWING FITZPATRICK SKIN TYPES:
Type I: Highly sun-sensitive, always burns, never tans (e.g. pale, freckled or white skin)
Type II: Very sun-sensitive, burns easily, rarely tans (e.g. fair skin)
Type III:Sun-sensitive, sometimes burns, sometimes tans (e.g. light brown or olive skin)
Type IV: Minimally sun-sensitive, burns minimally, tans easily (e.g. brown skin)
NOT CLINICALLY TESTED FOR THE FOLLOWING FITZPATRICK SKIN TYPES:
Type V: Sun-insensitive, rarely burns, always tans (e.g. dark brown skin)
Type VI: Sun-insensitive, never burns, always tans darkly (e.g. black skin)

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HOW TO USE THE IRESTORE PROFESSIONAL 282
You should use the iRestore Professional 282 for 25 minutes, every other day, on
non-consecutive days. Use the iRestore for 16 weeks. Once the 16-week period is
completed, use as frequently as needed to maintain the desired results without
exceeding every other day for 25 minutes. Discontinuing the use of the iRestore
may result in the progression of hair loss.
Preparation: Remove the iRestore device from the packaging. Position the device
on your head in a comfortable position.
Step 1. Position the device in its upright position on the top of
your head, as shown in the image to the right.
Step 2. Insert the power adapter pin into the controller.
Step 3. Plug the power adapter into an electrical outlet.

IMPORTANT: The device is designed to include a power failure memory function.
If power failure occurs during a session (power outage, the adapter accidentally
comes unplugged, etc.), the device will remember treatment time. When power
is restored and while the device is still positioned on the user's head, the device
will resume the session automatically. To turn the device off and start a new
session at another time, hold the power button for 3 seconds to turn off the
device, then follow steps 1-7, listed above.
IMPORTANT: Unless the device is positioned on the user's head, it will not begin
a session. If the device is removed from the head during a session, it will pause
automatically. To resume the session, position the device on the user's head
within 5 minutes and press the (start/pause) button.
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Step 4. Sit down and position the dome comfortably. Press
(power) to turn on the device. (NOTE: If the (start/pause)
button is not pressed within one minute, the device will turn off
automatically.)
Step 5. Press the (start/pause) button to begin the 25-
minute session. A short "beep" indicates the session has started.
Once the session is complete, the device will turn off
automatically with a long "beep" sound.
Step 6. If you need to pause the session at any time, press the
(start/pause) button and the timer will flash. Press the
(start/pause) button to resume the session. An audible “beep”
sound will indicate the session has resumed. If the
(start/pause) button is not pressed within 5 minutes during a
paused session, the device will turn off automatically.
Step 7. To turn off the device, hold the (power) button for 3
seconds. Unplug the power adapter from the electrical outlet.
Pull from the plug and not the cord to avoid damaging the
adapter and cord from tension. The display may remain turned
on due to residual capacitance (leftover charge). It will shut off
automatically after several seconds.

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CLEANING INSTRUCTIONS
The iRestore should be unplugged prior to any cleaning.
Use a dry microfiber cleaning wipe or cloth to clean the device.
Do not use solvents to clean the device.
For stains that cannot be removed with a dry cloth, a lightly water-moistened
cloth may be used to clean the device.
STORAGE INSTRUCTIONS
Keep the device away from sunlight and store the device in a dry location (e.g.
away from windows, sinks, bathtubs, kitchens, and bathrooms) at around room
temperature after each use.
TROUBLESHOOTING
My iRestore is powered on but pressing (start/pause) does not activate the
device.
The lasers and lights will not power on unless the electronic sensor detects that
the device is positioned on the user's head. This is a built-in safety feature to
protect the eyes from direct laser light exposure.
My iRestore is not powering on.
Attempt to use another wall socket to plug the adapter into and turn on again.
My iRestore is not lighting up, but my controller is on.
Contact Freedom Laser Therapy to determine if you need to be shipped a
replacement unit.
My iRestore controllerdoesn’t show the numbers clearly on the timer.
Contact Freedom Laser Therapy to request a replacement unit.
My iRestore doesn’t turn on right away after I press the (power) button.
Hold for 3-5 seconds and allow iRestore’s internal software to reset itself.

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PRODUCT SPECIFICATIONS
Device Name
Color
Wavelength
Laser Power for Classification
Net Weight
Size
Number of Lasers (< 5mW)
Number of LED (655+/-10nm)
Power Adapter
Input
Operating Environment Temperature
Operating Environment Humidity
Operating Environment Pressure
Storage & Transportation Temperature
Storage & Transportation Humidity
Electrical Safety Classification
Life Time
The time required for the iRestore
Professional 282 to warm from the
minimum storage temperature (-13°F/
-25°C) between uses until the iRestore
is ready for its intended use when the
ambient temperature is 68°F (20°C).
The time required for the iRestore
Professional 282 to cool from the
maximum storage temperature
(158°F/70°C) between uses until the
iRestore is ready for its intended use
when the ambient temperature is 68°F
(20°C).
Maximum Operating Time
Applied Part under the temperature
of 104°F (40°C), LED/Laser
temperature reached
iRestore Professional 282, ID-505
White
655+/-10nm
<5mW, Laser Class 3R
1.27 lbs
10.91x8.74x6.06 in.
82
200
Wellmike, Model: ADS012J-W 050240. (AC
100-240Vac), 50/60Hz, 0.5A DC 5V, 2.4A
100–240V
41°F–104°F (5°C-40°C)
15%–90% RH
700 hpa to 1060 hpa
-13°F–158°F (-25°C-70°C)
10%–90% RH
Class II, Type BF, Applied Part LED & Laser
Not suitable for use in the presence of a
flammable anesthetic mixture
Ip22: Enclose equipment without protection
against ingress of water
Continuous operation
5 Years
20 Minutes
0 Minutes
25 Minutes
115.88°F (46.6°C) LED
118.0°F (47.8°C) Laser

Electromagnetic compatibility complies with IEC 60601-1-2 Standard.
BF symbol, which indicates this device is in accordance to the degree of
protecting against electric shock for type BF equipment.
Consult accompanying document.
Dispose of the device in accordance with the directive 2002/96/EC-WEEE
(Waste Electrical and Electronic Equipment).
Labels on package and device are in compliance with IEC 60825-1 Standard:
Manufactured exclusively for
Freedom Laser Therapy, Inc.
16782 Von Karman Ave, Unit 15
Irvine, CA 92606 USA
1-888-373-7425 Toll Free
SN
LASER RADIATION
AVOID DIRECT EYE EXPOSURE
CLASS 3R LASER PRODUCT
Wavelength:653nm, Output:≦5mW, CW
Complies with 21 CFR
1040.10 and 1040.11
except for deviations
Pursuant to Laser
Notice No.50 dated
June 24, 2007
IEC 60825 -1:2007 SAFETY OF LASER PRODUCT
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Freedom Laser Therapy, Inc.
iRestore Professional 282
Input: DC5V 2.4A
Use only the power adaptor
(Brand: Wellmike/
Model: ADS012J-W050240)
Applied Part: Laser & LED
Class 3R Laser Product
Manufactured by: REMAXMEDI-TECH
(SHENZHEN) CORPORATION
301, #21 Runtang Industry Zone, Fumin
Community, Fucheng Street, Longhua
District, Shenzhen City, Guangdong
Province, 518000, P. R. China
January, 2018
2018-01-26
(01)00859690003675
(11)180126
(10)W505180100001
MADE IN CHINA
W505180100001
Laser Aperture
SN

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WARRANTY
iRestore has a 12-month warranty against defects in material or workmanship from
Freedom Laser Therapy. Items that are damaged or abused, as the result of user
error or failure to follow instructions provided, are not covered under the warranty
and will be charged at standard repair rates.
Within 30 days of purchase, validate your warranty by visiting
www.irestore laser.com/warranty
ADDITIONAL TERMS - LIMITED PRODUCT WARRANTY
Please keep this warranty card in a safe place
During the limited product warranty period, Freedom Laser Therapy will repair or
replace, at its sole discretion, any part or parts determined to be defective. In
repairing or replacing the equipment, Freedom Laser Therapy may replace it with a
substitute device or repair the equipment with substitute parts of like kind, quality
and functionality. Substitute equipment or parts may have been remanufactured or
may contain non-original manufacture parts.
This limited warranty does not provide coverage for equipment which has been
subjected to abuse, misuse, exposure to moisture or water, unauthorized
modification or repair, damage due to external causes or an Act of God, normal
wear and tear which does not affect the original manufacturer's intended use.
This limited warranty is non-transferable and does not apply to equipment on which
the serial number has been altered, defaced or is missing.
If a covered product failure occurs, please call Freedom toll free at 1-888-373-7425.
THIS WARRANTY AND THE REMEDIES SET FORTH ABOVE ARE EXCLUSIVE AND
IN LIEU OF ALL OTHER WARRANTIES, REMEDIES AND CONDITIONS, WHETHER
ORAL OR WRITTEN, EXPRESS OR IMPLIED. ANY IMPLIED WARRANTIES,
INCLUDING WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE, SHALL
BE LIMITED TO THE DURATION OF THIS LIMITED WARRANTY; OTHERWISE THE
REPLACEMENT OR REPAIR AS PROVIDED UNDER THIS LIMITED WARRANTY IS
THE EXCLUSIVE REMEDY. TO THE FULL EXTENT PERMITTED BY LAW, IN NO
EVENT SHALL FREEDOM LASER THERAPY BE LIABLE, WHETHER IN CONTRACT
OR TORT, INCLUDING NEGLIGENCE, FOR ANY INDIRECT, INCIDENTAL, SPECIAL
OR CONSEQUENTIAL DAMAGES OF ANY KIND, OR LOSS OF REVENUE OR
PROFITS, LOSS OF BUSINESS, LOSS OF INFORMATION OR DATA, SOFTWARE OR
APPLICATIONS OR OTHER FINANCIAL LOSS ARISING OUT OF OR IN
CONNECTION WITH THE ABILITY OR INABILITY TO USE THE EQUIPMENT OR
REPAIR THE EQUIPMENT.

Freedom Laser Therapy, Inc.
16782 Von Karman Ave, Unit 15
Irvine, CA 92606 USA
1-888-373-7425 Toll Free
www.irestorelaser.com
Manufactured by:
RemaxMedi-Tech(Shenzhen)Corporation
301, #21 Runtang Industry Zone, Fumin
Community, Fucheng Street, Longhua
District, Shenzhen City, Guangdong
Province, 518000, P. R. China
[phone]
iRestore Professional 282
Patent Pending
© 2019 Freedom Laser Therapy, Inc.
Version: A/1