Hairmax 82 LaserBand comfortflex User Manual

: June 5, 2024
: hairmax

Table of Contents

82 LaserBand comfortflex
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82 LaserBand comfortflex

HairMax ®

LaserBand 82
comfortflex
USER MANUAL

Corporate Office Customer Service Warranty Repairs Lexington Intl., LLC 1040 Holland Drive Boca Raton, Florida 33487 USA
Email: [email protected] www.HairMax.com
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
For more information about usage, quality and safety, visit: www.hairmax.com/videos and www.hairmax.com/QualitySafety
©Copyright 2022 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.

Treatment with HairMax HairMax

should be used 3 times per week, spaced out every other day. For example, Monday, Wednesday, 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

laser hair A clinical study using HairMax 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 number of hairs.
See pages 7-8 for detailed results of the study.

HairMax has teeth that part the hair and allow the maximum amount of laser energy to reach the scalp.

It is important that you read and understand the content of this User Manual before using your HairMax. 1

CLASSIFICATION FOR MEN AND WOMEN
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. The HairMax is indicated for adults 18 years of age and older.

Norwood Hamilton Classification – Males

norwood

Ludwig-Savin Classification – Females

HairMax has not been clinically tested for hair loss outside of the shaded areas.

WHO IS THE BEST CANDIDATE FOR THE HAIRMAX®?

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

skin type

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, pets and pests.
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 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 HairMax customer service toll free at the
numbers provided below.
In case of a serious incident, seek medical attention immediately.
If you are experiencing any allergic reaction from handling or using the device, stop
using the device immediately.
Only use the power supply and power cord provided by the manufacturer, any other
power supply or power cord may damage your device.

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 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. Use of solvents on
the window can block the laser light from coming through.
It is suggested to charge the device every 3 months even if it is not used.
For assistance setting up, using or maintaining the device, or to report unexpected
operations or events, contact the manufacturer.
Do not place the power adapter where it is difficult to disconnect and where the cable
may be stepped on.

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 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 tollfree at the numbers provided below.

Symbols

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. Place your forearm near the lasers, you may feel a slight warming effect. 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 tollfree 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

MONITORING DEVICE | FAILURE MODE | EXPECTED LIFE

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

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 the durability of the lasers, electronic components and charging cradle, your HairMax is designed to last for 5 years of regular use. Your battery is rated for at least 300 cycles and may need to be replaced during the 5 years of the product expected life cycle, please refer to the warranty section on pages 23 and 24 for additional details on warranty.
Please take time to read this entire user manual before operating your HairMax.

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, 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 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 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.

*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 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 HairMax and control groups.

Hair Count Change In the clinical study, after 26 weeks of treatment with the HairMax 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

parts detailed 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)

This is a harmless low-level ESD (Electrostatic Discharge) sensitive device. Please do not touch the charging contacts or USB-port. 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.

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. The instructions for this device are intended
for individuals with a minimum of an eighth grade education.
HairMax is safe for home use. The patient is the intended
operator of this equipment.

Use the HairMax LaserBand
for as little as 90 seconds 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

charge 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 HM on the charging stand. The white indicator light on
the device will flash during the charging process. A steady white
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.

charging usb 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.

PROPER USE | TREATMENT INSTRUCTIONS

The device indicator white light will flash during the charging
process. A steady light indicates your HairMax is fully charged.
For best results, charge your device after every use. Your device
can be stored on the charging cradle.
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 90 seconds, three times per week. The treatments should be
spaced out every other day (for example, Monday, Wednesday,
Friday).
To start your treatment, turn your HairMax on by pressing the
power button. The device indicator light will illuminate, and the
red laser light will shine from the bottom of the device. Do not
stare directly at the red laser light or its reflection in a mirror.

Treatment Instructions
Your HairMax will be used in 3 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 part of your
scalp.
To start your treatment, press the power
button once. Place your HairMax at your
hairline and leave it in place until it vibrates.
This is position 1.
When
you feel the vibration, slide your
HaiMax backwards about 3 inches to
position 2, the middle portion of your scalp.
Use light pressure so the teeth can separate
your hair. Leave it in position 2 until you
feel the vibration again.
Repeat the 30 second procedure on
position 3. You have now completed
today’s treatment. Store your device in the
cradle until your next treatment.

TREATMENT INSTRUCTIONS

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 10 minutes.

glide

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 90 seconds.

WHAT IS INCLUDED

package

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
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 page 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 lights
• 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

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

WARNING LABEL | LASER PARAMETERS | USE CONDITIONS | POWER SUPPLY

SPECIFICATIONS

WARNING LABEL | LASER PARAMETERS | USE CONDITIONS

Wavelength:

|

655nm +/_ 10nm visible red light

Laser Power for classification:

|

<5mW CW

Mode of operation:

|

Continuous

Divergence:

|

57 mrad

Number of lasers:

|

82

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 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

Battery shelf life:

|

Equivalent to the warranty period of the device

ROHS: restriction of hazardous substances:

|

2011/65/EU

Device size and weight:

|

17.8 x 12.7 x 7.6 cm/326 grams

Cradle size and weight:

|

19 x 32 x 8.9 cm/340 grams

Product warranty:

|

2 years

Age of use:

|

Adult

Power Supply Specifications

Output = 5V DC-1.0A. 5 Watts. Plug: USB to USB micro C connector. Class II.

The power supply for your HairMax can be used in the United States and internationally. Only use the power supply and power cord provided by the manufacturer, any other power supply or power cord may damage your device. 15

MAINTENANCE | CLEANING YOUR HAIRMAX | 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. Your HairMax is
intended for individual 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 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.
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 s mall 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

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.
- 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.
Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation.
- Caution: this machine should not be used adjacent to or stacked with other equipment and that 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 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

|

Electromagnetic environment-guidance

RF emissions

CISPR 11

|

Group 1

|

The LaserBand 82 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 82 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 82 is intended for use in the electromagnetic environment specified below. The customer or the user of LaserBand 82 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 82 requires continued operation during power mains interruptions, it is recommended that the LaserBand 82 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 82 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 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

|

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 kHz

10 V/m

80 MHz to 2.7 GHz 80% AM at 1 kHz

|

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 kHz

10 V/m

80 MHz to 2.7 GHz 80% AM at 1 kHz

|

WARNING: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the LaserBand 82.

Portable and mobile RF communications equipment should be used no closer to any part of the LaserBand 82 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 82 is intended for use in the electromagnetic environment (for home healthcare) specified below. The customer or the user of LaserBand 82 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 82.

The LaserBand 82 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 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.

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 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.

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 9AM – 5PM 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 Y

DOES NOT COVER DAMAGE DUE TO IMPROPER OPERATION OR MAINTENANCE, CONNECTION TO IMPROPER VOLTAGE SUPPLY, OR ATTEMPTED REPAIR BY ANYONE OTHER THAN T

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 R

PRODUCT FREIGHT PREPAID, IN EITHER ITS ORIGINAL PACKAGING OR PACKAGING AFFORDING AN EQUAL DEGREE OF PROTECTION, TOGETHER WITH YOUR NAME, ADDRESS AND A

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 M

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

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