iRESTORE ID-505 Laser Hair Growth System User Manual

Advanced low-level light technology
FDA-cleared for men and women.

ID-505 Laser Hair Growth System

User Manual
iRESTORE PROFESSIONAL

Helmet hair never looked so good.

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 confident version of yourself.

PURPOSE (INDICATIONS OF USE)
The iRestore Professional is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to 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 (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.

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 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 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.

• 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.

• 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 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.

PRODUCT DESCRIPTION

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.

PACKAGE INCLUDES (ACCESSORIES LIST):

The iRestore Professional components are shown below:

PRODUCT DIAGRAM

| 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 Wire| 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 only when it is placed on the head in the recommended position

WHO SHOULD USE THE iRESTORE PROFESSIONAL?

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 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 13) and Fitzpatrick Skin Types I to IV (refer to the Fitzpatrick Scale on page 13).
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 13) and Fitzpatrick Skin Types I to IV (refer to the Fitzpatrick Scale on page 13).
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 Ludwig-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 Fitzpatrick Classification of Skin Type on page 13), 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.

IS THE iRESTORE PROFESSIONAL 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 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)

HOW TO USE THE iRESTORE PROFESSIONAL

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.

| 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.
| 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.

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. 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.

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.

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 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.

PRODUCT SPECIFICATIONS

5V,2.4A
Input| 100 – 240V
Operating Environment Temperature| 41°F–104°F (5°C-40°C)
Operating Environment Humidity| 15%–90% RH
Operating Environment Pressure| 700 HPA TO 1060 HPA
Storage & Transportation Temperature| -13°F–158°F (-25°C-70°C)
Storage & Transportation Humidity| 10%–90% RH
Electrical Safety Classification| 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
Life Time| 5 YEARS
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).| 20 MINUTES
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).| 0 MINUTES
Maximum Operating Time| 25 MINUTES
Applied Part under the temperature of 104°F (40°C), LED/Laser temperature reached| 115.88°F (46.6°C) LED
LED/Laser temperature reached| 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 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°.

Labels on package and device are in compliance with IEC 60825-1 Standard:

Complies with 21 CFR 1040.10 and 1040.11 except for deviations Pursuant to Laser Notice No.50 dated June 24, 2007

Freedom Laser Therapy, Inc.
iRestore Professional
Input: DC5V **** 2.4A
Use only the power adapter
Model: E013-1D050240VU-W
Applied Part: Laser & LED
Class 3R Laser Product
Manufactured by: REMAX MEDI-TECH (SHENZHEN) CORPORATION
Room 303 of Factory Building, No. 32, Hui Ming Yi Road, Guihua Community, Guanlan St., Longhua Dist., Shenzhen
Guangdong Province, 518110, China

MANUFACTURED EXCLUSIVELY FOR FREEDOM LASER THERAPY, INC.
16782 VON KARMAN AVE, UNIT 15
IRVINE, CA 92606 USA
1-888-373-7425 TOLL FREE

EMC INFORMATION

The following information is provided in accordance with EN IEC 60601-1-2.
The iRestore Professional device is compliant with IEC 60601-1-2.

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.
Emissions test| Compliance| Electromagnetic environment – guidance
CE emissions CISPR11| Group 1| 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.
RE emissions CISPR11| Class B| 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.
Harmonic emissions IEC 61000-3-2| Class A
Voltage fluctuations/ flicker emissions
IEC 61000-3-3| Complies
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.
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.
NOTE: UT is the A.C. mains voltage prior to application of the test level.
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.
Immunity test| IEC 60601 test level| Compliance level| Electromagnetic environment – guidance
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| 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.
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:
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.
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.
Recommended separation distances between portable and mobile RF communications equipment and the iRestore Professional

The iRestore Professional is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the iRestore Professional can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the iRestore Professional as recommended below, according to the maximum output power of the communications equipment.
Rated maximum output power of transmitter (W)| Separation distance according to frequency of transmitter (M)
150 kHz to 80 MHz
d=1.2√P| 80 MHz to 800 MHz
d=1.2√P| 800 MHz to 2.5 GHz
d=2.3√
0.01| 0.12| 0.12| 0.23
0.1| 0.38| 0.38| 0.73
1| 1.2| 1.2| 2.3
10| 3.8| 3.8| 7.3
100| 12| 12| 23
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.
WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas), diathermy, electrocautery, and RFID should be used no closer than 30cm (12 inches) to any part of the iRestore Professional, including cables specified by manufacturer. Otherwise, degradation of the performance of this equipment could result.

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
+86-755-28012955

WARRANTY

iRestore has a 24-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.irestorelaser.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, battery leakage, or damage resulting from battery leakage.
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.

iRESTORE ID-505 IS MANUFACTURED EXCLUSIVELY FOR:
FREEDOM LASER THERAPY, INC.
16782 VON KARMAN AVE, UNIT 15
IRVINE, CA 92606 USA
1-888-373-7425 TOLL FREE

FREEDOM LASER THERAPY, INC.
16782 VON KARMAN AVE, UNIT 15
IRVINE, CA 92606 USA
1-888-373-7425 TOLL FREE
WWW.IRESTORELASER.COM
U.S PATENT D896.977.
©2023 FREEDOM LASER THERAPY, INC.
VERSION: A/6

References

• iRESTORE Laser Hair Growth System | FDA-Cleared Hair Loss Treatment – iRESTORE Hair Growth System
• Warranty — Register Your iRestore Hair Growth System – iRESTORE Hair Growth System

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