iRESTORE ESSENTIAL User manual

1
iRESTORE ESSENTIAL
User Manual
Advanced laser hair growth technology.
Clinically tested for men and women.

2
Helmet hair
never looked
so good.

3

4

5
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

6
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.

7
The iRestore Essential is indicated to treat androgenetic alopecia for men and
women. It is designed to promote hair growth in males who have Norwood-Hamilton
Classications of Ila to V and in females who have Ludwig-Savin Classications of I to
II. All users should also have Fitzpatrick Skin Types 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

8
YES
• 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.
NO
NO
NO
NO
WARNINGS AND PRECAUTIONS
NO
NO
NO

9
• 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
86°F (30˚C). This could cause dryness, redness or
irritation of your scalp.
YES
YES
NO
NO
NO
NO
1 METER
WARNINGS AND PRECAUTIONS
YES

10
The iRestore Essential components are shown below:
Accessories
The iRestore Essential
Power Adapter
Controller
User Manual
Quantity
1
1
1
1
FRONT SIDE INSIDE
The iRestore Essential is a laser hair therapy device indicated to promote hair growth.
The iRestore Essential uses 51 low-level lasers and 69 light-emitting diodes (LEDs). The
lasers are Class 3R (<5mW). The lasers and LEDs have wavelengths of 655nm.
PRODUCT DESCRIPTION
PACKAGE INCLUDES (ACCESSORIES LIST):

11
Description Function
Laser Dome Housing
Stretcher Housing
Power Wire
Controller
Silicone Pad
Light Emitting Diode (LED)
Laser Diode (Class 3R)
Safety Sensor
Plastic laser dome congured with 51 Class 3R lasers (<5mW) and 69
LEDs (655nm) to provide low-level light therapy treatment to the scalp
Plastic headband-used as mounting base for laser dome housing
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
69 LEDs (655nm) are the light source for treatment
51 lasers (<5mW) are the light source for treatment
An electronic sensor that permits use of the iRestore only when it
is placed on the head in the recommended position
1
2
3
4
5
6
7
8
PRODUCT DIAGRAM
SILICONE PAD
LASER
HEADBAND
LED
LASER DOME
SILICONE PAD
SAFETY SENSOR
CONTROLLER
DC 5V POWER ADAPTER
POWER WIRE

12
The iRestore Essential 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 ESSENTIAL?

13
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 Essential 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 Essential 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 ESSENTIAL RIGHT FOR YOUR HAIR LOSS?
Norwood-Hamilton Scale (Male) Ludwig-Savin Scale (Female)

14
You should use the iRestore Essential 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.
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.
In its upright position to the top of the head, position the device on your
head like the image to the left and ensure that the front portion of the
iRestore device does not cover your eyes.
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 ESSENTIAL

15
• 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

16
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 ESSENTIAL, ID-500
WHITE
655NM ± 10NM
<5MW, LASER CLASS 3R
1.03LBS
10.21 X 9.13 X 6.29 IN.
51
69
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
0 MINUTES
0 MINUTES
25 MINUTES
104°F (40°C)
Life Time
The time required for the iRestore Essential 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 Essential 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 86°F (30°C), LED/Laser temperature reached
PRODUCT SPECIFICATIONS

17
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
Laser Aperture

18
The following information is provided in accordance with EN IEC 60601-1-2.
The iRestore Essential is compliant with IEC 60601-1-2.
EMC INFORMATION

19

20
Recommended separation distances between portable and mobile
RF communications equipment and the iRestore Essential.
MANUFACTURED BY:
REMAX MEDI-TECH (SHENZHEN) CORPORATION
ROOM 303 OF FACTORY BUILDING, NO. 32,
HUI MING YI ROAD, GUIHUA COMMUNITY,
GUANLAN STREET, LONGHUA DISTRICT, SHENZHEN,
GUANGDONG PROVINCE, 518110, CHINA
[phone]