ID-500P iRESTORE Essential Laser Hair Growth System User Manual

ID-500P iRESTORE Essential Laser Hair Growth System

Product Information

The iRestore Essential is an advanced laser hair growth technology that has been clinically tested for both men and women. It is designed to treat androgenetic alopecia, promoting hair growth in individuals with specific hair loss classifications and skin types.

Purpose (Indications of Use)
The iRestore Essential is indicated to treat androgenetic alopecia for men and women. It is specifically designed to promote hair growth in males with Norwood-Hamilton Classifications of Ila to V and females with Ludwig-Savin Classifications of I to II. Users should have Fitzpatrick Skin Types I to IV.

Contraindications
iRestore is contraindicated in certain situations, although they are not specified in the provided text.

Product Description
The iRestore Essential is a laser hair therapy device that uses 51 low- level lasers and 69 light-emitting diodes (LEDs). These lasers and LEDs are Class 3R, which means they are safe and regulated for consumer use.

Product Usage Instructions

1. Ensure that you meet the criteria for using the iRestore Essential: Norwood-Hamilton Classifications Ila to V for males, Ludwig-Savin Classifications I to II for females, and Fitzpatrick Skin Types I to IV.
2. Before using the device, thoroughly read the user manual and understand the warnings and precautions.
3. Position the iRestore Essential helmet comfortably on your head, ensuring that the lasers and LEDs are in contact with your scalp.
4. Press the power button to turn on the device.
5. Follow the recommended treatment duration as specified in the user manual. Typically, sessions last for a specific time period, such as 25 minutes.
6. During the treatment session, you may adjust the helmet’s position slightly to ensure optimal contact with your scalp.
7. After the treatment session is complete, press the power button to turn off the device.
8. Store the iRestore Essential in a safe and dry place when not in use.
9. Refer to the user manual for additional information on product specifications, EMC information, and warranty details.

For any concerns or questions, please reach out to our customer support team.
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 Essential is indicated to treat androgenetic 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 Ludwig-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 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 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.

• 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 to an 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 86°F (30˚C). This could cause dryness, redness or irritation of your scalp.

PRODUCT DESCRIPTION

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.

PACKAGE INCLUDES

(ACCESSORIES LIST):

The iRestore Essential components are shown below:

PRODUCT DIAGRAM

| Description| Function
---|---|---
1| Laser Dome Housing| Plastic laser dome configured with 51 Class 3R lasers (<5mW) and 69 LEDs (655nm) to provide low-level light therapy treatment to the scalp
2| Stretcher Housing| Plastic headband-used as mounting base for laser dome housing
3| Power Wire| Connect device and controller
4| Controller| External system control to operate on/off, built-in timer and start/pause
5| Silicone Pad| Padding around the protective shield to increase comfort
6| Light Emitting Diode (LED)| 69 LEDs (655nm) are the light source for the treatment
7| Laser Diode (Class 3R)| 51 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 position

WHO SHOULD USE THE iRESTORE ESSENTIAL?

• 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 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 ESSENTIAL 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 that 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)

HOW TO USE THE iRESTORE ESSENTIAL

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.

• Preparation
  Remove the iRestore device from the packaging.
  Position the device on your head in a comfortable position.

• Step 1
  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.

• 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 a 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 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 it 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

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 the 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:

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 Essential is compliant with IEC 60601-1-2.

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 manufactured parts. This limited warranty does not provide coverage for equipment that 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.

restore ID-500 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
US PATENT D777.339
©2023 FREEDOM LASER THERAPY, INC. VERSION: A/4

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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