iRESTORE Professional User manual

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iRESTORE PROFESSIONAL
User Manual
Advanced low-level light technology
FDA-cleared for men and women.

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Helmet hair
never looked
so good.

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Table of
Contents
7
10
11
12
14
16
18
23
Warnings and Precautions
Product Description
Product Diagram
Who Should Use iRestore
How To Use
Product Specications
EMC Information
Warranty

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Welcome to our community!
You’re going to join hundreds of
thousands like you and embark
on a lifelong hair growth journey.
We’re excited to support you on
this journey to becoming a more
condent version of yourself.

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The iRestore Professional is indicated to promote hair growth in males who have
Norwood-Hamilton Classications of IIa-V, and in females with androgenetic alopecia
who have Ludwig-Savin Classications of I-II, and in both, Fitzpatrick Classication of
Skin Phototypes I to IV.
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 specic wavelength of light (655nm).
Sensitive skin or an allergic reaction can result in an itchy
sensation of the scalp or sun burn 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.
• Caution—use of controls or adjustment or performance of
procedures other than those specied herein may result in
hazardous radiation exposure.
• Do not look directly at, or use optical instruments like
magniers or microscopes to look at, the laser light or its
reflection on 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 comple-
tion of a treatment session. If the problem continues for more
than one (1) hour after treatment, discontinue usage and
consult with a physician.
PURPOSE (INDICATIONS OF USE)
NO
NO
NO
NO
NO
CONTRAINDICATIONS
WARNINGS AND PRECAUTIONS

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• 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 re,
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.
• 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 con-
nected 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.
WARNINGS AND PRECAUTIONS
NO
NO
NO
NO
NO
YES
NO
NO

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• Always attach the power supply to the unit rst, then
connect the plug into electrical outlet.
• 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.
• 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 no light up,
or 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 difcult 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.
WARNINGS AND PRECAUTIONS
YES
YES
YES
NO
NO
NO
NO
1 METER

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The iRestore Professional components are shown below:
Accessories
The iRestore Professional
Power Adapter
Controller
User Manual
Quantity
1
1
1
1
FRONT SIDE INSIDE
The iRestore Professional is a laser hair therapy device indicated to promote hair growth.
The iRestore Professional 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.
PRODUCT DESCRIPTION
PACKAGE INCLUDES (ACCESSORIES LIST):

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

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The iRestore Professional is designed to treat androgenic alopecia and to promote hair
growth for men and women.
The progression of male pattern baldness is generally classied on the Norwood-
Hamilton Scale. The iRestore device is indicated for males who have Norwood-Hamilton
Classications of Class Ila to V (indicated by shaded areas in the Norwood-Hamilton Scale
on page 13) and Fitzpatrick Skin Types I to IV (refer to the Fitzpatrick Scale on page 13).
The progression of female pattern baldness is generally classied on the Ludwig- Savin
Classication. The iRestore device is indicated for females who have Ludwig- Savin
Classications of Class I to II (indicated by shaded areas in the Ludwig-Savin Scale on
page 13) and Fitzpatrick Skin Types I to IV (refer to the Fitzpatrick Scale on page 13).
To determine your classication of male or female pattern baldness, match your
appearance of hair loss to the images below from the Norwood-Hamilton Classication
or Ludwig-Savin Scale that best resembles your hair appearance. If your male or female
pattern baldness classication 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 classication 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 Classication of Skin Type is Type I to IV (refer to Fitzpatrick
Classication of Skin Type on page 13), the device has been clinically tested and indicated
for you. If your Fitzpatrick Classication of Skin Type is V or VI, the device has not been
clinically tested for you.
WHO SHOULD USE THE iRESTORE PROFESSIONAL?

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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 is an 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 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)
IS THE iRESTORE PROFESSIONAL RIGHT FOR YOUR HAIR LOSS?
Norwood-Hamilton Scale (Male) Ludwig-Savin Scale (Female)

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25
You should use the iRestore Professional for 25 minutes, every other day, on
nonconsecutive 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.
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.
Position the device in its upright position on the top of your head, as shown
in the image to the right.
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).
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.
Insert the power adapter pin into the controller.
Plug the power adapter into an electrical outlet.
Remove the iRestore device from the packaging.
Position the device on your head in a comfortable position.
Step 1
Step 4
Step 5
Step 2
Step 3
Preparation
HOW TO USE THE iRESTORE PROFESSIONAL

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• The iRestore should be unplugged prior to any cleaning.
• Use a dry microber 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.
• 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.
• 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 users 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.
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.
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.
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.
Step 6
Step 7
CLEANING INSTRUCTIONS
STORAGE INSTRUCTIONS
TROUBLESHOOTING

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Item Number
Color
Wavelength of Laser & LED
Laser Power for Classication
Net Weight
Size
Number of Lasers
Number of LED
Power Adapter
Input
Operating Environment Temperature
Operating Environment Humidity
Operating Environment Pressure
Storage & Transportation Temperature
Storage & Transportation Humidity
Electrical Safety Classication
iRESTORE PROFESSIONAL, ID-505
WHITE
655+/-10NM
<5MW, LASER CLASS 3R
1.25 LBS
10.91 X 8.74 X 6.06 IN.
82
200
MODEL: E013-1D050240VU-W WHITE(AC100-
240VAC),50/60HZ, 0.6A 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
Life Time
The time required for the iRestore Professional
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
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
LED/Laser temperature reached
PRODUCT SPECIFICATIONS
118.0°F (47.8°C) LASER

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MANUFACTURED EXCLUSIVELY FOR
FREEDOM LASER THERAPY, INC.
16782 VON KARMAN AVE, UNIT 15
IRVINE, CA 92606 USA
1-888-373-7425 TOLL FREE
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 2012/19/EU-WEEE (Waste
Electrical and Electronic Equipment).
IP Ingress protection, protection against solid foreign objects of 12.5mm Ø and
greater and against vertically falling water drops when enclosure tilted up to 15°.
Electromagnetic compatibility complies with IEC 60601-1-2 Standard.
Labels on package and device are in compliance with IEC 60825-1 Standard:
Laser Aperture

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The following information is provided in accordance with EN IEC 60601-1-2.
The iRestore Professional device is compliant with IEC 60601-1-2.
EMC INFORMATION
Emissions test Compliance
CE emissions
CISPR11 Group 1
RE emissions
CISPR11 Class B
Harmonic emissions
IEC 61000-3-2 Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies
Immunity test IEC 60601 test level Compliance level Electromagnetic environment-guidance
Electrical discharge (ESD)
IEC 61000-4-2
±8 kV contact
±15 kV air
±8 kV contact
±15 kV air
Floors should be wood, concrete or
ceramic tile. If floors are covered with
synthetic material, the relative humidity
should be at least 30%.
Electrical fast
transient/burst
IEC 61000-4-4
±2 kV for power supply lines
±1 kV for input/output lines ±2 kV for power supply lines Mains power quality should be that of home healthcare.
Surge
IEC 61000-4-5
±1 kV differential mode
±2 kV common mode
±1 kV differential mode
±2 kV common mode
Mains power quality should be that of
home healthcare.
Voltage dips, short
interruptions and voltage
variations on power supply
input lines
IEC 61000-4-11
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycle
70% UT
(30% dip in UT) for 25 cycle
<5% UT
(>95% dip in UT) for 5 sec
<5% UT
(>95% dip in UT) for 0.5 cycle
40% UT
(60% dip in UT) for 5 cycle
70% UT
(30% dip in UT) for 25 cycle
<5% UT
(>95% dip in UT) for 5 sec
Mains power quality should be that of
home healthcare If the user of the
EQUIPMENT or SYSTEM requires
continued operation during power mains
interruptions, it is recommended that the
EQUIPMENT or SYSTEM be powered from
an uninterruptible power supply or a
battery.
Power frequency(50/60
Hz) magnetic field
IEC 61000-4-8
30 A/m 30 A/m
Power frequency magnetic fields should
be at levels characteristic of a typical
location in home healthcare.
Declaration – electromagnetic emissions
The iRestore Professional is intended for use in the electromagnetic environment specified below. The customer or the user of the
iRestore Professional should assure that it is used in such an environment.
Electromagnetic environment - guidance
The iRestore Professional is suitable for use in all establishments, including
domestic establishments and those directly connected to the public low-
voltage power supply network that supplies buildings used for domestic
purposes.
The iRestore Professional uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.
NOTE: UT is the A.C. mains voltage prior to application of the test level.
Declaration – electromagnetic immunity
The iRestore Professional is intended for use in the electromagnetic environment specified below. The customer or the user of the
iRestore Professional should assure that it is used in such an environment.

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Immunity test IEC 60601 test level Compliance level Electromagnetic environment - guidance
Portable and mobile RF communications
equipment should be used no closer to
any part of the iRestore Professional,
including cables, than the recommended
separation distance calculated from the
equation applicable to the frequency of
the transmitter.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
Recommended Separation Distance
d=1.2√P
d=1.2√P 80 MHz to 800 MHz
d=2.3√P 800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and d is the recommended
separation distance in metres (m).
Field strengths from fixed RF
transmitter,as determined by an
electromagnetic site surveya should be
less than the compliance level in each
frequency range.b
Interference may occur in the vicinity of
equipment marked with the following
symbol:
a Field strengths from fixed transmitter, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur
radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the
location in which the iRestore Professional is used exceeds the applicable RF compliance level above, the iRestore Professional should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
reorienting or relocating the iRestore Professional.
b Over the frequency range 150 kHz to 80 MHz,field strengths should be less than 3V/m.
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
The iRestore Professional is intended for use in the electromagnetic environment specified below. The customer or the user of the
iRestore Professional should assure that it is used in such an environment.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.