Hairmax 41 LaserBand comfortflex User Manual

HairMax®
LaserBand 41 comfortflex
USER MANUAL

Corporate Office ­ Customer Service ­ Warranty Repairs
Lexington Intl., LLC 1040 Holland Drive Boca Raton, Florida 33487 USA
Email: info@hairmax.com
www.HairMax.com
Direct line +1 561-417-0200
The United States and Canada 1-866-527-3726
The United Kingdom 0808-134-9868
Australia +61 7 3198 2484
Monday – Friday 9 AM – 5 PM ET
For more information about usage, quality and safety, visit: www.hairmax.com/videos and www.hairmax.com/QualitySafety
©Copyright 2021 Lexington Intl., LLC. All rights reserved.

INTRODUCTION

Introduction of HairMax®
Your HairMax is a home-use laser device that has been Clinically Proven to treat hereditary hair loss in men and women. The HairMax is an over-the- counter (OTC) device that can be sold directly to the public.
Indications
HairMax models are indicated to treat Androgenetic Alopecia, and promote hair growth in females who have Ludwig (Savin) I-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
How HairMax works
HairMax works by providing laser energy to stimulate hair follicles. For optimal results, the laser must not be blocked by the hair and must have an unobstructed path to the scalp.
HairMax has teeth that part the hair and allows the maximum amount of laser energy to reach the scalp.
Treatment with HairMax
HairMax should be used 3 times per week, spaced out every other day. For example, Monday, Wednesday, and Friday. The HairMax should not be used more than the recommended treatment time per day. Clinical studies demonstrate that most users see benefits in as little as 16 weeks.
HairMax Benefits
A clinical study 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 number of hairs.
See pages 7-8 for detailed results of the study.
It is important that you read and understand the content of this User Manual before using your HairMax. 1

WHO IS THE BEST CANDIDATE FOR THE HAIRMAX®?
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. Below are the pictures of the scales. The shaded areas show the type of hair loss that can be treated with HairMax.
Norwood Hamilton Classification – Males
Ludwig-Savin Classification – Females 2
HairMax has not been clinically tested for hair loss outside of the shaded areas.
WHO IS THE BEST CANDIDATE FOR THE HAIRMAX®?
FITZPATRICK SKIN TYPE CLASSIFICATION
The HairMax was studied in light 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® because it can cause temporary irritation to your eyes.
Keep the HairMax 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 gets damaged by water, contact Customer Service toll-free at the numbers provided below. If the cord is damaged on your HairMax, 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 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 9). Touching the contacts or USB port is not of 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 it 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 HairMax 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 to make sure you do not have a reaction. Some of the things that can cause increased sensitivity to your HairMax could be medicines for colds, allergies, pain medicine, and drugs to treat infections. To test your HairMax 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 it 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 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 as directed. Do not try to change the way your HairMax 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. The use of solvents on the window can block the laser light from coming through.
The United States and Canada 1-866-527-3726
The United Kingdom 0808-134-9868
Australia +61 7 3198 2484

RISKS | SYMBOLS | TESTING FOR SENSITIVITY

Risks

HairMax® 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 the HairMax. 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

| European Conformity
---|---
WEEK
Warning
Caution
Laser
Laser warning
Laser aperture indication
Laser warning label
| Power On/Off
---|---
Refer to instruction manual
RF interference
Type BF Applied Part
Serial Number
Degree of moisture resistance
Low-level ESD

Testing HairMax for sensitivity
Before beginning treatment, be sure to test the HairMax for sensitivity. You only need to do this once to test your skin for any reaction to light therapy. Make sure your HairMax is fully charged (see page 10). Turn on your device by pressing the power button once. Allow your forearm to stay in the light for 2 minutes. Turn your HairMax off and set it aside.

If you don’t experience any reaction, proceed with the treatment instructions on page 11. If you see any reaction such as redness or rash, do not use your HairMax. Contact customer service toll-free at the numbers provided below or your place of purchase.
The United States and Canada 1-866-527-3726the
United Kingdom 0808-134-9868
Australia +61 7 3198 2484

HOW TO MONITOR DEVICE ACTIVITY | DEVICE FAILURE MODE | EXPECTED LIFE OF YOUR HAIR MAY

How to Monitor Device Activity
Your HairMax is carefully inspected and tested during production. When working properly, the indicator light on the device turns on. A red laser light shines through the window at the bottom of the device.
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 laser light does 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 the HairMax
HairMax is a medical device manufactured under strict quality controls. HairMax contains high-quality laser diodes designed for optimal performance.
Based on that rating and the durability of the components being used, your HairMax is designed to last many years of regular use. Please take time to read this entire user manual before operating your HairMax.
The 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 using 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, who had light to brown skin tones. Subjects were divided into two groups, the 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.
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 was 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 HairMax and control groups.
Hair Count Change
In the clinical study, after 26 weeks of treatment with the HairMax devices versus the control device, the following increases in hair count were found.
Mean Terminal Hair Count Changes From Baseline in MALES
26 Weeks, Observed Hair Count
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 using 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, who 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.
During the 6 month study, subjects treated their hair once per day, 3 times per week, on nonconsecutive days. The number of thick, normal, healthy hairs in the target area was 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 HairMax and control groups.
Hair Count Change
In the clinical study, after 26 weeks of treatment with the HairMax and a control the device, the following increases in hair count were found.
Mean Terminal Hair Count Changes From Baseline in MALES
26 Weeks, Observed Hair Count
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 POWER BUTTON
B DEVICE INDICATOR LIGHT
C POWER SUPPLY WITH CORD
D TEETH E LASER WINDOW
F SERIAL NUMBER G WARNING LABEL
H CHARGING BASE/CRADLE
I USB CHARGING PORT (DEVICE)
J CRADLE INDICATOR LIGHT
K USB CHARGING PORT (CRADLE)
L CHARGING CONTACTS (DEVICE)

GETTING STARTED | CHARGING OPTIONS

Your LaserBand comes with a rechargeable battery permanently installed. Read this user manual completely before you start to use your HairMax. HairMax is safe for home use. The patient is the intended operator of this equipment.”
Use the HairMax LaserBand for as little as 3 minutes per treatment, three treatments per week. The treatments should be spaced every other day, for example, Monday, Wednesday, Friday. Most users see benefits in as little as 16 weeks (based on clinical studies).
When you receive your HairMax take all the parts out of the case. You must charge your HairMax for 4-6 hours before initial use.
Do not use your HairMax while it is plugged into the power cord.

Charging Options
OPTION 1 Charge your HairMax using the charging stand and power cord. Prior to placing your HairMax on the charging stand, make sure your HairMax is turned off. Plug the power cord into the charging stand and the other end into an electrical wall outlet. A green light will illuminate on the side of the charging stand indicating that your power cord is operating properly. Place your HairMax on the charging stand. The device indicator white light will flash during the charging process. A steady light indicates your HairMax is fully charged.
IMPORTANT: When inserting the power cord connector into the device or stand, it must be inserted completely for proper charging. You will hear a click indicating the connector is fully inserted.

PROPER USE | TREATMENT INSTRUCTIONS

OPTION 2 Charge your HairMax by placing the power cord directly into the charging socket on the bottom left side of your device and the other end into an electrical wall outlet.
The device indicator white light will flash during the charging process. A steady light indicates your HairMax is fully charged.
DURING USE The device indicator white light will flash slowly, indicating a properly charged battery. When the battery is getting low and needs to be recharged, the indicator light will start to flash rapidly. When the battery loses its charge completely, the device will vibrate with 3 quick pulses and the lasers will turn off. When this happens, charge your HairMax as described above.
Proper Use
Prior to treatment, test your HairMax for sensitivity (see page 5 of the user manual). Your HairMax should be used for as little as 3 minutes, three times per week. The treatments should be spaced out every other day (for example, Monday, Wednesday, and Friday).
To start your treatment, turn your HairMax on by pressing the power button.

Treatment Instructions
Your HairMax will be used in 6 positions on your scalp. Leave it in place for a minimum of 30 seconds for each position. It will vibrate every 30 seconds to let you know when to move it to the next position.
To start your treatment, press the power button once. Next, place it on your frontal hairline.
This is position

1. When you feel the vibration, slide it backward about 2 inches (5 cm) to position
2.  Leave it in position 2 until you feel the vibration again.

TREATMENT INSTRUCTIONS

Repeat this process for all six positions on your scalp. The entire treatment should be a minimum of 3 minutes.
After treatment, turn off your HairMax by pressing the power button once. Remove your HairMax from your head and place it on the charging stand for future use.
Your HairMax turns off automatically after 18 minutes.

Please Note:

• It is important to glide your HairMax instead of lifting it off your scalp and placing it back. Remember, you are bathing the scalp with laser light. If you move your HairMax too fast, the treatment will not achieve the optimal results to promote hair growth.
• Time required for treatment with your HairMax is as little as 3 minutes.

WHAT IS INCLUDED

Notice: Entire LaserBand assembly is considered as a Type BF applied part.

TROUBLESHOOTING

ANY ATTEMPT TO SELF-SERVICE YOUR DEVICE, UNLESS INSTRUCTED BY HAIRMAX CUSTOMER SERVICE, WILL VOID YOUR WARRANTY.
HairMax 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 HairMax will not turn on

• Typically indicates your HairMax needs to be charged
• Make sure your device is fully charged by using one of the charging options described on page 10
• Your HairMax cannot be powered on when the power the cord is plugged in

Your HairMax is turning off during use

• Typically indicates your HairMax needs to be charged
• Make sure your device is fully charged by using one of the charging options described on page 10
• Your HairMax cannot be powered on when the power cord is plugged in

Your HairMax will not charge

• Make sure you are using a working electrical wall outlet
• Make sure the power cord is completely inserted into the charging stand
• Try charging directly into the device as described by OPTION 2 on page 10
• Make sure the power cord connector is inserted correctly as described on pages 10
• Using a dry cloth, clean the three charging contacts on the device and charging stand

Your HairMax does not vibrate

• Make sure your device is fully charged by using one of the charging options described on page 10

Your HairMax vibrates but you do not see the laser light s

• Typically indicates your HairMax needs to be charged
• Make sure your device is fully charged by using one of the charging options described on page 10
• Your HairMax cannot be powered on when the power the cord is plugged in

Corporate Office ­ Customer Service ­ Warranty Repairs
Lexington Intl., LLC
1040 Holland Drive
Boca Raton, Florida 33487 the 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

WARNING LABEL | LASER PARAMETERS | USE CONDITIONS | POWER SUPPLY

SPECIFICATIONS

WARNING LABEL I LASER PARAMETERS I USE CONDITIONS

Wavelength:| 655nm +/_ 10nm visible red light
Laser Power for dassification:| <5mW CW
Divergence:| 57 mrad
A number of lasers:| 41
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:| Yellow label
Laser MTBF: mean time between failures:| 10,000 hours at 25°C ambient temperature
Operating temperature/altitude/atmospheric pressure/humidity:| 5°C to 35°C/0 to 2,000 m/80kPa to 106kPa/0% to 90%, relative humidity
Storage & transportation temperature/humidity/atmospheric pressure:| -20°C to 60° 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:| 18 x 13 x 5.5 cm/243 grams
Cradle size and weight:| 18.5 x 4.5 x 7 cm/312 grams
Product warranty| 2 years
Age of use:| Adult

Power Supply Specifications
Fuhua UE05WCP-050100SPC or similar. Output = 5V DC-1.0A. Plug: USB to USB micro C connector. The power supply for your HairMax 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 your HairMax, use a plug adapter (not supplied with the device).

MAINTENANCE | CLEANING | DISPOSAL INSTRUCTIONS

Maintenance
HairMax is designed to last for many years. It does not require any maintenance other than periodic cleaning. Your HairMax is intended for indoor use only.
Cleaning your HairMax

• Keep your HairMax clean.
• Turn off your HairMax by pressing the power button once.
• Unplug the power cord from the device and from the electrical wall outlet.
• Clean the laser window with a soft, slightly moistened cloth. Don’t use any acetone or corrosive solvents.
• To clean the comb teeth, gently remove any hairs or dust with a slightly moistened towel. Don’t use any acetone, soap, or detergents, only warm water.

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.

ELECTRICAL SAFETY

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 where it can fall or be pulled into a tub or sink.
Do not expose your HairMax to running water, or drop it into water or any other liquid. If your HairMax falls into water, unplug it immediately from the power outlet. If using your HairMax near water, the use of an electrical outlet protected by a Ground Fault Circuit Interrupter is recommended.
Do not dispose of your HairMax in a fire or store in high temperatures greater than 140°F (60°C).
Do not turn on or use your HairMax while it is charging.
The 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 operations or events occur.
After drop/shock that may cause changes in the performance, please contact customer service.
Be careful do not to 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 EMISSIONS GUIDANCE

1. This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be affected by portable and mobile RF communications equipment.
2. Do not use a mobile phone or other devices that emit electromagnetic fields, near the unit. This may result in incorrect operation of the unit.
3. Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation.
4. Caution: this machine should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the configuration in which it will be used.

Guidance and manufacturer’s declaration — electromagnetic emissions

The LaserBand 41 is intended for use in the electromagnetic environment specified below. The customer or the user of the LaserBand 41 should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment-guidance
RF emissions CISPR 11| Group 1| The LaserBand 41 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 emission CISPR 11| Class B| The LaserBand 41 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| Compliance

This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
– Reorient or relocate the receiving antenna.
– Increase the separation between the equipment and receiver.
– Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
– Consult the dealer or an experienced radio/TV technician for help.

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) the device must accept any interference received, including interference that may cause undesired operation.

ELECTROMAGNETIC IMMUNITY GUIDANCE

Manufacturer’s declaration – electromagnetic immunity

The LaserBand 41 is intended for use in the electromagnetic environment specified below. The customer or the user of LaserBand 41 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| Contact: ± 8 kV
Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV| Contact: ± 8 kV
Air: ±2 kV, ±4 kV, ±8 kV, ±15 kV| 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 Not Applicable| Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ± 0.5 kV, ± 1 kV line(s) to line(s)
± 0.5 kV, ± 1 kV, ± 2kV line(s) to earth| ± 0.5 kV, ± 1 kV line(s) to line(s) Not Applicable| 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

| Voltage dips:
0% UT; 0,5 cycle
0% UT; 1 cycle
70% UT; 25/30 cycles Voltage interruptions: 0% UT; 250/300 cycle| Voltage dips:
0% UT; 0,5 cycle
0% UT; 1 cycle
70% UT; 25/30 cycles Voltage interruptions: 0% UT; 250/300 cycle| Mains power quality should be that of a typical commercial or hospital environment. If the user of the LaserBand

41 requires continued operation during power mains interruptions, it is recommended that the LaserBand 41 be powered from an uninterruptible power supply or a battery.

Power frequency (50Hz/60Hz) magnetic field IEC 61000-4-8| 30 A/m
50 Hz or 60 Hz| 30 A/m
50 Hz| The LaserBand 41 Power frequency magnetic fields should be at levels characteristic of a typical location in a typical home healthcare environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

ELECTROMAGNETIC IMMUNITY GUIDANCE

Manufacturer’s declaration – electromagnetic immunity

The LaserBand 41 is intended for use in the electromagnetic environment specified below. The customer or the user of the LaserBand 41 should ensure 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
0,15 MHz – 80 MHz
6 Vrms
in ISM and amateur radio bands between 0,15 MHz and 80 MHz
80% AM at 1 kH
10 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz| 3 Vrms
0,15 MHz – 80 MHz
6 Vrmsin ISM and amateur radio bands between 0,15 MHz and 80 MHz
80% AM at 1 kHz
10 V/m
80 MHz to 2.7 GHz
80% AM at 1 kHz| Portable and mobile RF communications equipment should be used no closer to any part of the LaserBand 41 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 2,7 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).
Interference may occur in the vicinity of equipment marked with the following symbol:
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.

ELECTROMAGNETIC IMMUNITY GUIDANCE

Manufacturer’s declaration – electromagnetic immunity

Test specification for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment

The LaserBand 41 is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of LaserBand 41 should assure that it is used in such an environment.
Test frequency (MHZ)| Band a) (MHZ)| Service a)| Modulation b)| Maximum power (W)| Distance (m)| IMMUNITY TEST LEVEL (m)| Compliance LEVEL (V/m) (for home healthcare)
385| 380-390| TETRA 400| Pulse modulation b)18 Hz| 1.8| 0.3| 27| 27
450| 430-470| GMRS 460, FRS 460| FM c) ± 5 kHz deviation 1 kHzine| 2| 0.3| 28| 28
710
745
780| 704-787| LTE Band 13, 17| Pulse modulation b) 217 Hz| 0.2| 0.3| 9| 9
810
870
930| 800-960| GMS 800/900, TETRA 800, IDEN 820, CDMA 850, LTE Band 5| Pulse modulation b) 18 Hz| 2| 0.3| 28| 28
1720
1845
1970| 1700- 1900| GMS 1800; CDMA 1900;GSM 1900;
DECT;
LTE Band 1,3, 4, 25; UMTS| Pulse modulation b)217 Hz| 2| 0.3| 28| 28
2450| 2400-2570| Bluetooth, WLAN, 802.11 b/g/n,RFID 2450, LTE Band 7| Pulse modulation b)217 Hz| 2| 0.3| 28| 28
5240
5500
5785| 5100-5800| WLAN 802, 11 a/n| Pulse modulation b)217 Hz| 0.2| 0.3| 9| 9

NOTE If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m.
The 1 m test distance is permitted by IEC 61000-4-3.
a) For some services, only the uplink frequencies are included.
b) The carrier shall be modulated using a 50% duty cycle square wave signal.
c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be worst case.

ELECTROMAGNETIC DISTANCE RECOMMENDATIONS

Recommended separation distances between portable and mobile RF communications equipment and the LaserBand 41.

The LaserBand 41 is intended for use in an electromagnetic environment (for home healthcare) in which radiated RF disturbances are controlled. The customer or the user of the LaserBand 41 can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the LaserBand 41 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√P
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
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where  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.
NOTE2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.

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 9 AM – 5 PM ET

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 THE 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, too:
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

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
The United Kingdom 0808-134-9868
Australia +61 7 3198 2484
Monday – Friday 9 AM – 5 PM ET
Authorized Representative in Europe (Regulatory Affairs Only):
EMERGO EUROPE  EC/ REP
Prinsessegracht 20 2514 AP The Hague
The Netherlands
Tel: +31 (0) 70 345-8570 Fax: +31 70 346-7299
Australian Sponsor: Emergo Australia
Level 20, Tower II Darling Park, 201 Sussex Street Sydney, NSW 2000 Australia
LUB041CFEDNPX_08_0921

©Copyright 2021 Lexington Intl., LLC. All rights reserved.

References

• ClinicalTrials.gov
• Hairmax® | Regrow Your Hair with the Ultimate Laser Treatment
• Warranty Registration – Hairmax

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