HairMax LaserBand 82 User Manual
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HairMax LaserBand 82 User Manual

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Summary of Contents for HairMax LaserBand 82

  • Page 1 LaserBand 82...

  • Page 2: Table Of Contents

    Maintenance/Cleaning/Disposal Instructions......16 How to Monitor Device Activity...........6 Replacing the Teeth ..............17 Device Failure Mode..............6 Electrical Safety................18 Expected Life of your HairMax ..........6 Electromagnetic Immunity Guidance ........19 Summary of Clinical Study in Men..........7 Electromagnetic Distance Recommendations......22 Summary of Clinical Study in Women..........8 Warranty Card.................23...

  • Page 3: Introduction

    *Based on a minimum of 5 new hairs per square centimeter/32 new hairs per path to the scalp. square inch being observed at the follow up visit It is important that you read and understand the content of this User Manual before using your HairMax.

  • Page 4: Who Is The Best Candidate? (Classifications Male/Female)

    How do you know if the HairMax is right for you? HairMax can be used by men and women with thinning hair (including color treated hair) or pattern baldness caused by a hereditary condition. Doctors use a system known as the Norwood Hamilton Classification (men) and the Ludwig-Savin Classification (women) to describe the degree of hair loss.

  • Page 5: Who Is The Best Candidate? (Fitzpatrick Skin Types)

    Black skin, rarely burns with sun exposure Adapted from Fitzpatrick’s Dermatology in General Medicine. McGraw-Hill Professional; 5th edition. Please note that HairMax was only tested on light to brown skin tones. This does not indicate that it will not work on darker skin tones.

  • Page 6: Warnings And Cautions

    If you stare at the light for too long, it could light, you should test the your HairMax to make sure you do not have a harm your eyes. Also, never use a magnifying glass when using HairMax reaction.

  • Page 7: Risks/Symbols/Testing For Sensitivity

    Place your Symbols forearm with your palm facing upward under the arc of your HairMax. Allow your arm to stay European Conformity Power On/Off in the light for 2 minutes. Turn your HairMax off and Refer to instruction manual set it aside.

  • Page 8: How To Monitor Device Activity

    HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF YOUR HAIRMAX How to Monitor Device Activity Expected Life of the HairMax Your HairMax is carefully inspected and tested during HairMax is a medical device manufactured under strict production.

  • Page 9: Summary Of Clinical Study In Men

    Subjects were divided into two groups, HairMax group and a control group. The control device looked and sounded like the HairMax device but did not include a laser light. The Clinical studies adhered to all GCP (Good Clinical Practice) guidelines, were approved by an IRB (Institutional Review Board) and listed on www.clinicaltrials.gov.

  • Page 10: Summary Of Clinical Study In Women

    Androgenetic Alopecia, which includes hereditary hair loss, and had light to medium skin tones. Subjects were divided into two groups. One group used the HairMax and the other group used a control device. The control device looked and sounded like the HairMax, but did not include a laser light. The Clinical studies adhered to all GCP (Good Clinical Practice) guidelines, were approved by an IRB (Institutional Review Board) and listed on www.clinicaltrials.gov.

  • Page 11: Parts

    PARTS POWER BUTTON INDICATOR LIGHT POWER CORD USAGE LABEL TEETH LASER WINDOW WARNING LABEL SERIAL NUMBER (located under the teeth) USB CHARGING PORT...

  • Page 12: Getting Started

    When you receive your HairMax, take all the parts out of three quick pulses. When this happens, charge your the case.

  • Page 13: Proper Use

    (see page 5 of the User Manual). Your Press the power button once to HairMax should be used for as little as 90 seconds, select the 30-second treatment three times per week. The treatments should be method. Your HairMax will vibrate spaced out every other day.
  • Page 14 After treatment, turn off your HairMax at your hairline and leave it in place until it vibrates. HairMax by pressing the power button until the indicator light turns off. Remove your HairMax from your head and plug it into the charger for future use.

  • Page 15: What Is Included

    TREATMENT INSTRUCTIONS | WHAT IS INCLUDED glide lift-and-place What is included: LaserBand Power Cord User Manual Quick Start Guide Notice: Entire LaserBand assembly is considered as a Type BF applied part.

  • Page 16: Troubleshooting

    TROUBLESHOOTING ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY HAIRMAX CUSTOMER SERVICE, WILL VOID YOUR WARRANTY. Your LaserBand vibrates, but you HairMax has advanced electronics to ensure that the device is do not see the laser light working like it is supposed to and that the proper amount of laser If using the power cord, unplug the LaserBand.

  • Page 17: Other Useful Information Safety Label

    Fuhua UE05WCP-050100SPC or similar. Output = 5V DC-1.0A. Plug: 9mm x 3.5mm, center positive. The power supply for the HairMax LaserBand can be used in the United States and internationally. This power supply will adapt to all power supplies from 100 volt/60 cycle (US) to 240 volt/50 cycle. If outlets in your country have different plugs than the power supply that comes with the HairMax LaserBand, use an inexpensive plug adapter (not supplied with the device).

  • Page 18: Maintenance/Cleaning/Disposal Instructions

    Keep your HairMax clean. collection point for the recycling of waste Turn off the HairMax by pressing the power button electrical and electronic equipment. The until the light turns off. separate collection and recycling of your waste...

  • Page 19: Replacing The Teeth

    To remove the teeth from your LaserBand, pull down from the finger slot (Figure A). To replace the teeth, insert and align the teeth and press on either side of your LaserBand until they snap in place (Figure B).

  • Page 20: Electrical Safety

    Do not use while bathing. Do not place or store your HairMax where it can fall or be pulled into a tub or sink. Do not expose your HairMax to running water, or drop into water or any other liquid.

  • Page 21: Electromagnetic Immunity Guidance

    Guidance and manufacturer’s declaration-electromagnetic emissions The LaserBand 82 is intended for use in the electromagnetic environment specified below. The customer or the user of the LaserBand 82 should assure that it is used in such an environment. Emission test Compliance...
  • Page 22 Guidance and manufacturer’s declaration-electromagnetic immunity The LaserBand 82 is intended for use in the electromagnetic environment specified below. The customer or the user of the LaserBand 82 should assure that it is used in such an environment. Immunity test IEC 60601 test level...
  • Page 23 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 LaserBand 82 is used exceeds the applicable RF compliance level above, the LaserBand 82 should be observed to verify normal operation.

  • Page 24: Electromagnetic Distance Recommendations

    LaserBand 82 The LaserBand 82 is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the LaserBand 82 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LaserBand 82 as recommended below, according to the maximum output power of the communications equipment.

  • Page 25: Warranty Card

    Under the teeth - Under the teeth - right side of the device. right side of the device.

  • Page 27: Warranty

    FOR ANY SPECIAL, INDIRECT, OR CONSEQUENTIAL DAMAGES THAT ARE DIRECTLY OR INDIRECTLY RELATED TO THE USE OF, OR THE INABILITY TO USE, THE HAIRMAX, EVEN IF LEXINGTON INTERNATIONAL, LLC HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES WHETHER IN AN ACTION OF CONTRACT, NEGLIGENCE OR OTHER TORTUOUS ACTION. SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU.

  • Page 28: Corporate Office - Customer Service - Warranty Repairs

    Corporate Office – Customer Service – Warranty Repairs Lexington Intl., LLC 1040 Holland Drive Boca Raton, Florida 33487 USA Direct line +1 561-417-0200 Toll Free 1-866-527-3726 Monday - Friday 9 AM - 5 PM EST United States 1-866-527-3726 United Kingdom 0808-134-9868 Australia 1-800-937-358...

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