Hairmax Laser202 Hair Growth Laser Light Device User Manual
- June 5, 2024
- hairmax
Table of Contents
- Hairmax Laser202 Hair Growth Laser Light Device
- WHO IS THE BEST CANDIDATE FOR THE HAIRMAX® LASER DEVICE?
- WARNINGS AND CAUTIONS
- RISKS | SYMBOLS | TESTING FOR SENSITIVITY
- HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF
- SUMMARY OF CLINICAL STUDY IN MEN
- SUMMARY OF CLINICAL STUDY IN WOMEN
- PARTS
- GETTING STARTED | CHARGING
- PROPER USE
- TREATMENT INSTRUCTIONS
- WHAT IS INCLUDED
- TROUBLESHOOTING
- MAINTENANCE | CLEANING YOUR HAIRMAX® LASER DEVICE | DISPOSAL INSTRUCTIONS
- WARNING LABEL | LASER PARAMETERS | USE CONDITIONS | POWER SUPPLY
- ELECTRICAL SAFETY
- ELECTROMAGNETIC IMMUNITY GUIDANCE
- ELECTROMAGNETIC DISTANCE RECOMMENDATIONS
- LIMITED WARRANTY
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
Hairmax Laser202 Hair Growth Laser Light Device
INTRODUCTION
It is important that you read and understand the content of this user manual before using your HairMax Laser Device.
Introduction of HairMax Laser Device
Your HairMax Laser Device is a home-use laser device that utilizes Clinically
Proven Technology to treat male and female pattern hair loss, also known as
hereditary hair loss in men and women. HairMax Laser Device is an over-the-
counter (OTC) device that can be sold directly to the public.
Your HairMax Laser Device can be worn by itself or inserted into your favorite
sports cap (Sports cap is provided).
Indications
HairMax Laser devices are indicated to promote hair growth in males with Androgenetic alopecia who have Norwood-Hamilton Classifications of Ila – V, and in females with Androgenetic alopecia who have Ludwig (Savin) Classifications I – II or frontal patterns of hair loss and who both have Fitzpatrick Skin Types I – IV.
How HairMax Laser Device works
HairMax Laser Device works by providing laser energy to stimulate hair follicles.
Treatment with HairMax Laser Device
The HairMax Laser Device should be used 3 times per week, on non-consecutive days. For example, Monday, Wednesday, Friday. The HairMax Laser Device should not be used more than the recommended treatment time per day. Clinical studies using HairMax technology demonstrate that most users see benefits in as little as 16 weeks.
HairMax Laser Device Benefits
A clinical study using this technology was conducted in men and women over a six month time period. The study showed that 90% of the men and women had an increase in the hair count of 129 additional hairs per inch square. See pages 8-9 for detailed results of the study.
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX® LASER DEVICE?
How do you know if the HairMax Laser Device is right for you?
The HairMax Laser Device 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. Below are the pictures of the scales. The shaded areas show the type of hair loss that can be treated with HairMax Laser Device.
HairMax® technology was studied in very white to brown skin tones (Types 1, 2,
3, 4) as described in the Fitzpatrick scale below.
This does not mean it will not work on the darkest skin tones. Due to
limitations of digital photography and hair counting software we were unable
to test the darkest skin tones.
Fitzpatrick Skin Type Classification Guide:
A way to describe your skin type based on your complexion and what happens to your skin in sunlight
Type 1| Clinically Tested to be effective for these skin types| Very white or
freckled skin, always burns with sun exposure (very fair; often in people with
red or blond hair and blue eyes)
---|---|---
Type 2| White skin, usually burns with sun exposure
(fair; often in people with red or blond hair and blue, green, or hazel eyes)
Type 3| White or olive skin tone, sometimes burns with sun exposure (fair;
seen in people with any hair or eye color)
Type 4| Brown skin, rarely burns with sun exposure
(common in people of Mediterranean descent)
Type 5| Not Clinically Tested for these skin types| Dark brown skin, very
rarely burns with sun exposure (common in people of Middle-Eastern descent)
Type 6|
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.
WARNINGS AND CAUTIONS
WARNINGS
- Do not stare directly at the red laser light or its reflection in a mirror because it can temporarily irritate your eyes. If you stare at the light for too long, it could harm your eyes. Also, never use a magnifying glass when using HairMax Laser Device because it can cause temporary irritation to your eyes.
- Keep the HairMax Laser Device out of the reach of children and pets.
- Do not drop your HairMax in water because you may get an electrical shock. If your HairMax Laser Device gets damaged by water, contact customer service toll-free at the numbers provided below.
- If the cord is damaged on your HairMax Laser Device, do not use the device because you could get an electrical shock. If the cord gets damaged, contact customer service toll-free at the numbers provided below.
- Do not use your HairMax Laser Device near any heated surfaces because this could cause the device not to work properly and may cause an electrical shock. Contact customer service toll-free at the numbers provided below.
- Laser light – avoid direct eye exposure.
- This is a harmless low-level ESD (Electrostatic Discharge) sensitive device. Please do not touch the charging contacts or USB-port. (see page 10). Touching the contacts or
- USB-port is not of the essential performance and will not cause a basic safety issue. If touching the contacts or USB-port causes the device to malfunction, reset your device by powering off and back on.
- No modification of this equipment is allowed.
- This equipment has no user-serviceable parts. Do not attempt to modify or repair this equipment.
- Do not attempt to modify or service while the equipment is in use.
- If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use. Contact Lexington International customer service toll free at the numbers provided below.
CAUTIONS
- If you are taking any medications or products that make you sensitive to light, you should test your HairMax Laser Device to make sure you do not have a reaction. Some of the things that can cause increased sensitivity to your HairMax Laser Device could be medicines for colds, allergies, pain medicine and drugs to treat infections. To test your HairMax Laser Device for sensitivity, turn the device on, hold the device on one spot, shining the light on your forearm. After two minutes, turn the device off and set aside. Look at the spot where you held the laser light over the next five minutes. If you see any reaction such as redness or rash, do not use your HairMax Laser Device and contact our customer service toll-free at the numbers provided below for information on how to return your product and get a refund.
- Only use your HairMax Laser Device as directed. Do not try to change the way your HairMax Laser Device operates. Altering controls, adjustments, performance or procedures other than those specified herein may result in hazardous radiation (laser) exposure. Contact customer service toll-free at the numbers provided below.
- Never use acetone or other solvents on any part of your HairMax Laser Device.
United States and Canada 1-866-527-3726
United Kingdom 0808-134-9868
Australia +61 7 3198 2484
RISKS | SYMBOLS | TESTING FOR SENSITIVITY
Risks
HairMax® technology has been clinically tested on both men and women. In the clinical study for men, 5% of the men said they had itching or tingling from using this technology. None of the women in the clinical study reported any of these side effects. If you have itching, tingling or any other side effect that bothers you, stop using your device and contact customer service toll- free at the numbers provided below.
Symbols
Before beginning treatment, be sure to test your HairMax Laser Device for
sensitivity. You only need to do this once to test your skin for any reaction
to light therapy. Make sure your device is fully charged (see page 11). Place
your Laser Device face down on a table.
Turn on the device by pressing the Bottom Button on the Controller/Battery
Pack. Wait for the Laser Device to initialize. Place your hand inside the
Laser Device, you will see the Red Laser Light.
Allow your hand to stay in the light for 2 minutes. Turn the device off by
pressing the Bottom Button until you hear the double beep.
Look at your hand. If you don’t experience any reaction, proceed with the
treatment instructions on page 13. If you see any reaction such as redness or
rash, do not use your device. Contact customer service toll-free at the
numbers provided below or your place of purchase.
United States and Canada
1-866-527-3726
United Kingdom 0808-134-9868
Australia +61 7 3198 2484
HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF
YOUR DEVICE
How to Monitor Device Activity
Your HairMax Laser Device is carefully inspected and tested during production.
When working properly, the Indicator Light
( ) and Red Laser Lights on the device turn on.
DO NOT look directly at the laser light.
Shine the laser light onto the palm of your hand to see if the red laser light
appears.
If the device Indicator Light is not lit, or if the Red Laser Lights do not
appear, contact customer service toll-free at the numbers provided below.
Device Failure Mode
The laser light does not fade or diminish over time. At the end of the laser’s life or if it fails for any other reason, the red laser light will no longer shine out of the device.
Expected Life of Your Device
HairMax Laser Device is a medical device manufactured under strict quality controls and validated through GMP (Good Manufacturing Practices). HairMax contains high quality laser diodes designed for optimal performance.
Based on that rating and the durability of the components being used, your
HairMax Laser Device is designed to last many years of regular use.
Please take time to read this entire user manual before operating your HairMax
Laser Device.
United States and Canada
1-866-527-3726
United Kingdom 0808-134-9868
Australia +61 7 3198 2484
SUMMARY OF CLINICAL STUDY IN MEN
Clinical studies on HairMax® technology were conducted at multiple locations
in the
United States. Participants in the study were males diagnosed with
Androgenetic alopecia, which includes hereditary hair loss, and had light to
brown skin tones.
Subjects were divided into two groups, active group and a control group. The
control device looked and sounded like the active 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.
During the 6 month clinical study, subjects treated their hair once per day, 3
times per week on non-consecutive days. The number of thick, normal healthy
hairs in the target zone were counted at Week 1, Week 16 and Week 26.
Results at the 26 week visit showed that over 90% of the men saw an increase
in hair counts.*
No subjects in the study experienced any serious adverse events. In fact, the
number and types of adverse events were similar in the active and control
groups.
Hair Count Change
In the clinical study, after 26 weeks of treatment with the active device versus the control device, the following increases in hair count were found. *Based on a minimum of 5 new hairs per square centimeter/32 new hairs per square inch being observed at the follow up visit
SUMMARY OF CLINICAL STUDY IN WOMEN
A clinical study on HairMax® technology was conducted at multiple locations in
the United States. All participants in the study were females, diagnosed with
Androgenetic alopecia, which includes hereditary hair loss, and had light to
medium skin tones.
Subjects were divided into two groups. One group used the active device and
the other group used a control device. The control device looked and sounded
like the active 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.
During the 6 month study, subjects treated their hair once per day, 3 times
per week, on non-consecutive days. The number of thick, normal, healthy hairs
in the target area were counted at Week 1, Week 16 and Week 26.
Results at 26 weeks showed that over 90% of the women saw increases in hair
counts.*
No subjects in the study experienced any serious adverse events. In fact, the number and types of adverse events were similar in the active and control groups.
Hair Count Change
In the clinical study, after 26 weeks of treatment with the active and a control device, the following increases in hair count were found.
*Based on a minimum of 5 new hairs per square centimeter/32 new hairs per square inch being observed at the follow up visit
PARTS
A. Storage/Travel Case
B. Sports Cap
C. Laser Device
D. Controller/Battery Pack
E. Power Cord
F. Power Supply
G. Controller Cable
H. Laser Connector
I. Warning Labels
J. Serial Number
GETTING STARTED | CHARGING
Getting Started
Read this user manual completely before you start to use
your device. The instructions in this user manual are intended for individuals
with a minimum of an eighth grade education.
HairMax Laser Devices are safe for home use.
The patient is the intended operator of this equipment.
When you receive your device, take all the parts out of the case. Make sure
your device is clean and dry before beginning the treatment.
Your HairMax Laser Device comes with a rechargeable Controller/Battery Pack.
You must charge the Controller/Battery Pack for 6-8 hours before initial use.
ONLY UTILIZE THE PROVIDED CONTROLLER/BATTERY PACK WITH YOUR HAIRMAX LASER DEVICE. PLUGGING INTO ANY OTHER POWER SOURCE MAY DAMAGE THE DEVICE AND VOID YOUR WARRANTY.
Charging
Charge your HairMax Laser Device by plugging the small end of the Power Cord
into the socket on the bottom of the Controller/Battery Pack (Figure A).
Plug the other end of the Power Cord into the USB socket of the Power Supply
(Figure B). Plug the Power Supply into an electrical wall outlet.
The indicator lights on the side of the Controller/Battery Pack will flash
during the charging process. Four steady blue Indicator Lights indicate your
device is fully charged (Figure C).
When your HairMax Laser Device is turned on, the indicator lights will
illuminate to display the battery level. As the battery charge diminishes, the
Indicator Lights will turn off
in a sequence to indicate the remaining charge level of the battery:
4 lights = full
3 lights = 75%
2 lights = 50% (time to recharge)
1 ligh t = 25%
PROPER USE
Before Starting Your Treatment:
- Make sure the battery is FULLY CHARGED per the instructions on page 11.
- Test your HairMax Laser Device for sensitivity (see page 6 of this User Manual).
Proper Use
Your HairMax Laser Device should be used three times per week, on non-
consecutive days. For example, Monday, Wednesday, Friday.
You can use your HairMax Laser Device for 15 minutes in the default,
Continuous-On Mode or 30 minutes in the Pulse Mode. See page 13 for
instructions on how to select mode. Choose only one mode per treatment. Either
mode provides the identical laser therapy treatment.
We recommend you use the default 15-minute, Continuous-On Mode. If you feel uncomfortable warmth in this mode, switch to the 30-minute Pulse Mode. Since the lasers are switching on and off in the Pulse Mode, less warmth is generated.
When charging is complete, disconnect the Power Cord from the
Controller/Battery Pack and store it for future charging.
Connect the Controller Cable to the USB socket on the bottom of the
Controller/Battery Pack, the same socket you used to charge the battery
(Figure D).
Plug the other end of the Controller Cable into the Laser Connector coming out of the back of the HairMax Laser Device (Figure E).
The connectors on the Controller Cable are identical and can be used in either
direction.
Push the cable into the Laser Connector Socket until it is securely joined.
The device will not function properly unless the cables are connected
properly.
You are now ready to start your treatment.
TREATMENT INSTRUCTIONS
Place the device on your head in a comfortable relaxed position (Figure F).
Press the Bottom Button (Figure G). You will hear a beep and the display will
illuminate (Figure H).
By pressing the Top Button while the display is still flashing (within the
first four seconds), the device will toggle between the default 15-minute
Continuous-On Mode and the 30-minute Pulse Mode.
We recommend using the default 15-minute Continuous-On Mode.
The display will flash for 4 seconds and the Laser Indicator Light on the
Controller/Battery Pack will illuminate (Figure H).
The Laser Indicator Light on the Controller/Battery Pack (Figure H) will indicate your lasers are on and functioning properly.
Once your treatment is completed (either 15 minutes or 30 minutes), the
Controller/Battery Pack will beep twice and turn off.
If you choose to power off your device before the treatment is complete, press
the Bottom Button until you hear the double beep (Figure G).
Once your treatment is completed, disconnect the Controller Cable from the
Controller/Battery Pack. Then charge the Controller/Battery Pack as indicated
on page 11 so it will be ready for your next treatment.
NOTE – your HairMax Laser Device cannot be used while being charged.
ATTENTION
The HairMax Laser Device must be plugged into the Controller/Battery Pack in
order to operate.
ONLY UTILIZE THE PROVIDED CONTROLLER/BATTERY PACK WITH YOUR HAIRMAX LASER
DEVICE. PLUGGING INTO ANY OTHER POWER SOURCE MAY DAMAGE THE DEVICE AND VOID
YOUR WARRANTY.
WHAT IS INCLUDED
Notice: Entire HairMax assembly is considered as a Type BF applied part.
TROUBLESHOOTING
ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS AS INSTRUCTED BY LEXINGTON INTERNATIONAL CUSTOMER SERVICE, WILL VOID YOUR WARRANTY.
Your HairMax Laser Device has advanced electronics to ensure that the device is working like it is supposed to and that the proper amount of laser energy is being delivered. If for some reason you are experiencing difficulties with your device, please try one of the tips below:
Your laser device will not turn on
- Make sure your HairMax Laser Device is fully charged
- Make sure the laser device and the Controller/Battery Pack are properly connected
Your laser device is turning off during use
- Make sure your HairMax Laser Device is fully charged
- Make sure the laser device and the Controller/Battery Pack are properly connected
Your laser device is not lighting up, but the Controller/Battery Pack is fully charged
- Contact customer service to determine if we need to send you a replacement unit
Your Controller/Battery Pack does not show the blue indicators
- Contact customer service to request a replacement Controller/Battery Pack
If you have trouble understanding any of these instructions, contact customer service toll-free at the numbers provided below.
Corporate Office – Customer Service – Warranty Repairs
Lexington Intl., LLC
1040 Holland Drive
Boca Raton, Florida 33487 USA
Direct line +1 561-417-0200
United States and Canada
1-866-527-3726
United Kingdom 0808-134-9868
Australia +61 7 3198 2484
Monday – Friday 9 AM – 5 PM ET
MAINTENANCE | CLEANING YOUR HAIRMAX® LASER DEVICE | DISPOSAL INSTRUCTIONS
Maintenance
Your HairMax Laser Device is designed to last for many years.
It does not require any maintenance other than periodic cleaning.
Cleaning your HairMax Laser Device
- Turn off the HairMax Laser Device by pressing the Bottom Button until you hear the double beep.
- Disconnect the Power Cord from the Controller/Battery Pack.
- Unplug the USB device cable from the Laser Connector coming out of the back of the HairMax Laser Device and Controller/Battery Pack.
- Clean your device with a soft, slightly moistened cloth before and after each treatment.
Disposal Instructions
This symbol on the product or on its packaging indicates that this product must not be disposed of with your other household waste. Instead, it is your responsibility to dispose of your waste equipment by handing it over to a designated collection point for the recycling of waste electrical and electronic equipment. The separate collection and recycling of your waste equipment at the time of disposal will help to conserve natural resources and ensure that it is recycled in a manner that protects human health and the environment. For more information about where you can drop off your waste equipment for recycling, please contact your local city office or your household waste disposal service.
WARNING LABEL | LASER PARAMETERS | USE CONDITIONS | POWER SUPPLY
SPECIFICATIONS
Power Supply Specifications
Output = 5V DC-1.0 A
The power supply for the HairMax Laser Device 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, use an
international plug adapter (not supplied with the device).
LASER PARAMETERS | USE CONDITIONS
Wavelength:| 655nm +/_ 10nm visible red light
Laser Power for classification:| <5mW CW
Divergence:| 57 mrad
Number of lasers:| 202 or 272
This Laser Product is designated as Class 3R during all procedures of
operation.
Note: HairMax laser devices have no user-serviceable parts.
Warning label location:| on the back side of the laser device
Laser MTBF: mean time between failures:| 10,000 hours at 25ºC ambient
temperature
Operating temperature/altitude/atmospheric pressure/ humidity:| 5ºC to 35ºC/0
to 2,000 m/80kPa to 106kPa/ 0% to 90%, relative humidity
Storage & transportation temperature/humidity/ atmospheric pressure:| -20ºC to
60º C / 0% to 90%, relative humidity/
50kPa to 106kPa
Ingress of water or particulate matter:| IP22
Battery charging cycles:| 300 cycles
ROHS: restriction of hazardous substances:| 2011/65/EU
Device size and weight:| 21 x 18 x 9 cm/641 grams
Product Warranty| 2 Years
Age of Use| Adult
ELECTRICAL SAFETY
Basic safety precautions should be observed when using this, or any other electrical device, especially when children are present.
WARNING: Keep away from water. Contact with water may result in an
electrical shock.
To reduce the risk of hazard by electric shock:
- Do not use while bathing.
- Do not place or store your HairMax Laser Device where it can fall or be pulled into a tub or sink.
- Do not expose your HairMax Laser Device to running water, or drop into water or any other liquid.
- If your HairMax Laser Device falls into water, unplug it immediately from the power outlet. If using your HairMax Laser Device near water, the use of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended.
- Do not dispose of your HairMax Laser Device in a fire or store in high temperatures greater than 140°F (60°C).
- Do not turn on or use your HairMax Laser Device while it is charging.
- Power supply cannot be separated during use. Do not position the equipment in a manner that will make it difficult to plug in or remove the power cord.
- If you have any problems with this device, such as setting up, maintaining or using, please contact customer service.
- Please report to customer service if any unexpected operation or events occur.
- After drop/shock that may cause changes in the performance, please contact customer service.
- Be careful, do not put the power cord around your neck, it may cause strangulation.
- Keep the device out of the reach of children/pets to avoid inhalation or swallowing of small parts.
- Do not use the device if it is damaged in any way. The continuous use of a damaged unit may cause injury, improper results, or serious danger.
- The device should be used only with the accessories recommended for use by the manufacturer.
- When not in use, store the device with the adapter in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight.
- Never place any heavy objects on the storage case.
ELECTROMAGNETIC IMMUNITY GUIDANCE
Guidance and manufacturer’s declaration – electromagnetic emission – for all EQUIPMENT AND SYSTEMS
The HairMax Laser Device is intended for use in the electromagnetic
environment specified below. The customer or the user of the HairMax Laser 272
should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment-
guidance
RF emissions CISPR 11| Group 1| The HairMax Laser Device 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.
RF emissions CISPR 11| Class B| The HairMax Laser Device 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
Guidance and manufacturer’s declaration-electromagnetic immunity
The HairMax Laser Device is intended for use in the electromagnetic environment specified below. The customer or the user of the HairMax Laser Device should assure
that it is used in such an environment.
Immunity test| IEC 60601 test level| Compliance level|
Electromagnetic environment-guidance
Electrostatic 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
| ± 2kV for power supply lines
± 1kV for input/output lines
| ± 2kV for power supply lines| Mains power quality should be that of a
typical commercial or hospital environment.
Surge IEC 61000-4-5| ± 1kV differential mode
± 2kV common mode
| ± 1kV differential mode
± 2kV common mode
| Mains power quality should be that of a typical commercial or hospital
environment.
Voltage Dips, short interruptions and voltage variations on power supply input
lines IEC 61000-4-11| 0% UT; 0,5 cycle g) At 0˚, 45˚, 90˚,
135˚,180˚, 225˚, 270˚, and 315˚
0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0˚
0% UT; 250/300 cycle
| 0% UT; 0,5 cycle g) At 0˚, 45˚, 90˚, 135˚,180˚,
225˚, 270˚, and 315˚
0% UT; 1 cycle and 70% UT; 25/30 cycles Single phase: at 0˚
0% UT; 250/300 cycle
| Mains power quality should be that of a typical commercial or hospital
environment. If the user of the HairMax Laser Device requires continued
operation during power mains interruptions, it is recommended that the HairMax
Laser Device be powered from an interruptible power supply or a battery.
Power frequency (50, 60 Hz) magnetic
field IEC 61000-4-8
| 3 A/m| 3 A/m| Power frequency magnetic fields should be at levels
characteristic of a typical location in a typical commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.
Guidance and manufacturer’s declaration – electromagnetic immunity – for
EQUIPMENT and SYSTEM that are not LIFE-SUPPORTING
The HairMax Laser Device is intended for use in the electromagnetic environment specified below. The customer or the user of the HairMax Laser Device 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
6 V in ISM and amateur radio bands between 0,15 MHz and 80 MHz
|
3 V
6 V
10 V/m
| Portable and mobile RF communications equipment should be used no closer to any part of the HairMax Laser Device including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.
Recommended separation distance:
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 meters (m).b Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a 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:
| 10 V/m|
| 80 MHz to 2.7 GHz|
NOTE1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
a The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,765 MHz to 6,795 MHz, 13,553 MHz to 13,567MHz; 26.957 MHz to 27,283 MHz; and 40,70 HMz. The amateur radio bands between 0,15 HMz and 80 MHz are 1,8 HMz to 2,0 HMz, 3,5 MHz to 4,0 MHz, 5,3 MHz to 5,4 MHz, 7 MHz to 7,3MHz, 10,1 MHz to 10,15 MHz, 14 MHz to 14,2 HMz, 18,07 MHz to 18,17 MHz, 21,0 MHz to 21,0 MHz to 21,4 MHz. 24,89 MHz to 24,99 MHz, 28,0 MHz to 29,7 MHz and 50,0 MHz to 54,0 MHz.
b Field strength from fixed transmitters, such as base stations for radio (cellular/cordless) telephone 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 HairMax Laser 272 is used exceeds the applicable RF compliance level above, the HairMax Laser 272 should be observed to verify normal operation. if abnormal performance in observed, additional measures may be necessary, such as reorienting or relocating the HairMax Laser 272.
c Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3V/m.
ELECTROMAGNETIC DISTANCE RECOMMENDATIONS
Recommended separation distances between portable and mobile RF communications equipment and the EQUIPMENT or SYSTEM for EQUIPMENT and SYSTEMS that are not LIFE-SUPPORTING
The HairMax Laser Device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the HairMax Laser Device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the HairMax Laser Device 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
outside ISM and amateur radio bands
| 150 kHz to 80 MHz
outside ISM and amateur radio bands
| 80 MHz to 800 MHz| 800 MHz to 2.7 GHz
| |
0.01| 0.12| 0.20| 0.035| 0.07
0.1| 0.38| 0.63| 0.11| 0.22
1| 1.2| 2.0| 0.35| 0.70
10| 3.8| 6.32| 1.10| 2.21
100| 12| 20.00| 35| 70
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer. NOTE1 At 80 MHz and 800 MHz, the separation distance
for 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.
LIMITED WARRANTY
ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY LEXINGTON
INTERNATIONAL CUSTOMER SERVICE, WILL VOID YOUR WARRANTY
To validate your warranty, please register online at:
www.hairmax.com/warranty
THE DEVICE IS WARRANTED BY LEXINGTON INTERNATIONAL, LLC (“LEXINGTON”) AGAINST
DEFECTS IN MATERIALS OR WORKMANSHIP FOR 12 MONTHS FROM DATE OF PURCHASE. IF
THIS PRODUCT IS DETERMINED TO BE DEFECTIVE, LEXINGTON WILL REPAIR OR REPLACE
IT, AT ITS OPTION, AT NO CHARGE DURING THE WARRANTY PERIOD. THE WARRANTY
PERIOD IS NOT EXTENDED IF LEXINGTON REPAIRS OR REPLACES THE PRODUCT. AFTER THE
WARRANTY PERIOD, THE USER MUST PAY FOR ALL PARTS AND LABOR CHARGES. IF THE
PRODUCT IS REPAIRED OR REPLACED, EITHER WITHIN OR OUTSIDE THE WARRANTY PERIOD,
LEXINGTON RESERVES THE RIGHT TO PROVIDE EQUIVALENT PARTS IN DIFFERENT COLORS
TO YOUR ORIGINAL PRODUCT.
THIS WARRANTY DOES NOT COVER DAMAGES CAUSED BY ACTS OF GOD, MISUSE, NEGLIGENCE, ACCIDENT, MODIFICATION OF OR TO ANY PART OF THE PRODUCT. THIS WARRANTY DOES NOT COVER DAMAGE DUE TO IMPROPER OPERATION OR MAINTENANCE, CONNECTION TO IMPROPER VOLTAGE SUPPLY, OR ATTEMPTED REPAIR BY ANYONE OTHER THAN LEXINGTON. THIS WARRANTY IS VOID IF PRODUCT IS TAMPERED WITH.
TO OBTAIN WARRANTY SERVICE, YOU MUST CALL LEXINGTON INTERNATIONAL CUSTOMER SERVICE TO REQUEST AN AUTHORIZATION NUMBER. YOU MUST DELIVER THE PRODUCT FREIGHT PREPAID, IN EITHER ITS ORIGINAL PACKAGING OR PACKAGING AFFORDING AN EQUAL DEGREE OF PROTECTION, TOGETHER WITH YOUR NAME, ADDRESS AND AUTHORIZATION NUMBER, TO:
Lexington International, LLC, 1040 Holland Drive, Boca Raton, FL 33487, USA
LEXINGTON INTERNATIONAL, LLC SHALL NOT BE LIABLE FOR ANY SPECIAL, PUNITIVE,
INCIDENTAL OR CONSEQUENTIAL DAMAGES THAT ARE DIRECTLY OR INDIRECTLY RELATED
TO THE USE OF, OR THE INABILITY TO USE, THE PRODUCT, 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 SPECIAL, PUNITIVE, INCIDENTAL
OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY
TO YOU. THIS WARRANTY IS THE ONLY WRITTEN OR EXPRESS WARRANTY GIVEN BY
LEXINGTON INTERNATIONAL, LLC. ALL IMPLIED WARRANTIES FOR THE PRODUCT,
INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE, ARE LIMITED IN TIME TO THE TERM OF THIS
WARRANTY. SOME STATES DO NOT ALLOW LIMITATIONS ON HOW LONG AN IMPLIED WARRANTY
LASTS, SO THE ABOVE LIMITATION MAY NOT APPLY TO YOU.
GOVERNING LAW; JURISDICTION AND VENUE: THIS WARRANTY, AND THE TERMS OF SALE OF
THE PRODUCT, SHALL BE GOVERNED BY AND CONSTRUED IN ACCORDANCE WITH
THE LAWS OF THE STATE OF FLORIDA WITHOUT REGARD TO PRINCIPLES OF CONFLICTS OF
LAWS. THE PARTIES IRREVOCABLY SUBMIT AND CONSENT TO THE SOLE AND EXCLUSIVE
JURISDICTION AND VENUE OF THE FLORIDA STATE COURTS IN AND FOR PALM BEACH
COUNTY, FLORIDA, U.S.A. AND THE FEDERAL COURTS IN AND FOR THE SOUTHERN
DISTRICT OF FLORIDA, U.S.A. THE PARTIES AGREE NOT TO RAISE THE DEFENSE OF
FORUM NON CONVENIENS.
WARRANTY OUTSIDE THE U.S.A.
THE WARRANTY ON THIS PRODUCT SHALL COMPLY WITH APPLICABLE LAW WHEN SOLD BY AN
AUTHORIZED DEALER TO A CONSUMER OUTSIDE OF THE UNITED STATES, INCLUDING
EXTENDED WARRANTY COVERAGE PERIODS AS MAY BE LEGALLY REQUIRED IN SUCH
JURISDICTIONS.
AUTHORIZED REPRESENTATIVE IN EUROPE (REGULATORY AFFAIRS ONLY): EMERGO EUROPE,
PRINSESSEGRACHT 202514 AP THE HAGUE THE NETHERLANDS.
TEL: +31 (0) 70 345-8570 FAX: +31 70-346-7299
WARRANTY
Your Hairmax device has a limited warranty against defects in materials or workmanship from Lexington International, LLC. Items that are damaged or abused are not covered under the warranty and will be charged at their regular repair rates. Any attempt to self-service your device, unless instructed by LEXINGTON INTERNATIONAL CUSTOMER SERVICE, will void your warranty. Please refer to our website for complete warranty terms.
To validate your warranty, register online at
www.hairmax.com/warranty
If you do not have a computer you can register by phone at the following
numbers:
Direct line +1 561-417-0200
United States and Canada
1-866-527-3726
United Kingdom 0808-134-9868
Australia +61 7 3198 2484
Monday – Friday 9AM – 5PM ET
Corporate Office – Customer Service – Warranty Repairs
Lexington Intl., LLC
1040 Holland Drive
Boca Raton, Florida 33487 USA
Direct line +1 561-417-0200
United States and Canada 1-866-527-3726
United Kingdom 0808-134-9868
Authorized Representative in Europe (Regulatory Affairs Only):
Tel: +31 (0) 70 345-8570 Fax: +31 70-345-7299
Australian Sponsor: Emergo Australia
Level 20, Tower II Darling Park, 201 Sussex Street Sydney, NSW 2000 Australia
References
- ClinicalTrials.gov
- Hairmax® | Regrow Your Hair with the Ultimate Laser Treatment
- Warranty Registration – Hairmax
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>