hairmax Ultima 9 x Laser Comb User Manual

: June 5, 2024
: hairmax

hairmax Ultima 9 x Laser Comb

hairmax-Ultima-9-x-Laser-Comb-product

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
United States and Canada 1-866-527-3726
United Kingdom 0808-134-9868
Monday – Friday 9 AM – 5 PM ET
For more information about usage, quality and safety, visit:
www.hairmax.com/videos and 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.
HairMax has teeth that part the hair and allow 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, 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.
*Based on a minimum of 5 new hairs per square centimeter/32 new hairs per square inch being observed at the follow-up visit
It is important that you read and understand the content of this User Manual before using your HairMax.

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

Ludwig-Savin Classification – Females HairMax has not been clinically tested for hair loss outside of the shaded areas.

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, 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 the 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

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 HairMax and contact Lexington’s customer service toll- free at the numbers provided below.

Symbols

Testing HairMax for sensitivity
Before beginning treatment, be sure to test the HairMax for sensitivity. Turn the device on, hold your HairMax 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 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.
United States and Canada 1-866-527-3726
United Kingdom 0808-134-9868

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, both of the light indicators on the power and laser buttons turn 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 one or both of the light indicators is not lit, or if the laser light does not appear, contact customer service toll-free at the numbers provided below.

Device Failure Mode
Your HairMax is designed to last for many years of regular use. 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’s expected life cycle, please refer to the warranty section on pages 22 and 23 for additional details on warranty.
United States and Canada 1-866-527-3726
United Kingdom 0808-134-9868

SUMMARY OF CLINICAL STUDY IN MEN

Clinical studies 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, 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 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 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 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.* hairmax-Ultima-9-x-Laser-Comb-6

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

Ultima 9 Classic and Ultima 12 Classic are identical models that vary only in the number of diodes and treatment time.

A POWER BUTTON/INDICATOR LIGHT
B LASER BUTTON
C POWER SUPPLY WITH CORD
D TEETH
E LASER WINDOW
F SERIAL NUMBER
G WARNING LABEL
H CHARGING CRADLE/STAND
I USB-PORT
J CHARGING CONTACTS
K DC-JACK

GETTING STARTED | CHARGING OPTIONS

Getting Started
Your HairMax Ultima 9 Classic and Ultima 12 Classic models
come with a rechargeable battery permanently installed. Read this manual completely before you start to use your HairMax. The instructions in this user manual 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 Ultima 9 Classic for 11 minutes per treatment, and HairMax Ultima 12 Classic for 8 minutes per treatment, three treatments per week. The treatments should be spaced every other day,

for example, Monday, Wednesday, Friday. Do not use your HairMax more than the recommended treatment time per day. 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 2-3 hours before initial use.

Charging Options
OPTION 1 Charging your HairMax using the charging cradle (stand) and power cord. Prior to placing your HairMax in the cradle, make sure your HairMax is turned off and the teeth face away from you. Plug the power cord into the cradle and the other end into an electrical wall outlet.

The indicator light on the power button will flash red during the charging process. A completely charged battery will last for a minimum of six treatments.

OPTION 2 Charging your HairMax by placing the power cord directly into the HairMax and the other end into an electrical wall outlet. The indicator light on the power button will flash red during the charging process. Once charging is complete, the light will stop flashing. During use, the indicator light will indicate the battery level. A steady, non-flashing light indicates is full.

PROPER USE | TREATMENT INSTRUCTIONS

When the battery is fully charged, the indicator light will be on. As the battery power diminishes, the light will blink slowly. When the battery is getting low and needs to be recharged, the light will start to flash rapidly. When this happens, charge your HairMax with one of the charging options as described on page 10.

Proper Use
The HairMax Ultima 9 Classic should be used for 11 minutes and HairMax Ultima 12 Classic for 8 minutes. Use a watch or clock to time your treatment. First, press the power button and hold until power button light turns on. Second, press the laser button. Your HairMax is ready for use.

Shine the HairMax onto the palm of your hand and you will see that the laser light is on (do not look at the laser light directly). Do not use your HairMax if the device is damaged or defective,
contact HairMax customer service or your place of purchase

Treatment Instructions
Before beginning treatment, be sure to test the HairMax for sensitivity (Page 5).

After you have turned on your HairMax, place it flat on your scalp so that both rows of the teeth are touching your scalp.
Start at your hairline. Move your HairMax from front to back of scalp in a slow combing motion, pausing every ½ inch (1cm) for 4 seconds. Do not lift your HairMax off your scalp while combing from front to back. Next, lift your HairMax off your scalp and start at a new position at the hairline.

TREATMENT INSTRUCTIONS

Continue in this manner from front to back and then side to side until you cover your entire scalp with multiple passes.
Repeat these passes for the total treatment of 8 min for Ultima 12 and 11 min for Ultima 9 models. hairmax-Ultima-9-x-Laser-Comb-15

If you have long hair, use your fingers to lift your hair out of the way while using your HairMax to be sure that the laser energy reaches your scalp.

IMPORTANT: Do not lift your HairMax off your head when moving from front to back (unless you are checking the usage timer on the information display or until you complete the pass). Your HairMax features a pair of comb teeth that part the hair so the light can more effectively reach the scalp. You will make a few complete passes over your scalp within recommended treatment time.

When your HairMax is on it will beep and vibrate every four (4) seconds. This means that it’s time to move your HairMax to the next area of the scalp. When you do this, do not lift the device off of your scalp.
If you wish to turn off the beep/ vibration during the treatment, press the top laser button once. Your HairMax and laser will remain on. To re-activate beep and vibration, simply press the laser button
twice. hairmax-Ultima-9-x-Laser-Comb-16
Turn off your HairMax by pressing and holding the power button (lower button) until the indicator light turns off. Store the device in the charging cradle for future use. You may leave the power cord
plugged into the charging cradle at all times.

WHAT IS INCLUDED

Please Note:

It is important to move your HairMax very slowly. Remember, you are bathing the scalp with laser light. If you move it too fast, the treatment will not achieve the optimal results to promote hair growth.
Total time required for treatment with the HairMax Ultima 9 Classic is 11 minutes and HairMax Ultima 12 Classic is 8 minutes.

What is included:

Notice: Entire HairMax device 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.
If 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.
If your HairMax will not turn off
Press and hold power button for 4 seconds.
If your HairMax beeps/vibrates irregularly or doesn’t beep/ vibrate at all
Make sure your device is fully charged by using one of the charging options described on page 10.

If your HairMax beeps and vibrates, but you do not see the laser light

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.
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 EST

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:| 9 (Ultima 9 Classic model), 12 (Ultima 12 Classic model)
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:| White label above the teeth
Laser MTBF: mean time between failures:| 10,000 hours at 25ºC ambient temperature
Operating temperature/altitude/atmospheric pressure/humidity:| 0ºC to 40ºC/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:| 25.5 x 6.3 x 5 cm / 218 grams
Product warranty:| 2 years
Age of use:| Adult

hairmax-Ultima-9-x-Laser-Comb-18

Power Supply Specifications
Output = 5V DC-1.0A. 5 Watts. Plug: 9mm x 3.5mm, center positive. Class II.
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 Hz (US) to 240 volt/50 Hz. Only use the power supply and power cord provided by the manufacturer, any other power supply or power cord may damage your device.

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 the HairMax by pressing and holding the power button (lower button) until the light turns off.
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 solvents.
To clean the teeth more thoroughly, slide the teeth towards the top of the HairMax and gently pull out. Clean with mild soap and water. Avoid any solvents or harsh cleansers on any
part of your HairMax.
• To replace the teeth, align the guides and slide down until they lock into place. If you need to replace the teeth, you can order online at hairmax.com or call customer service.

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 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

Guidance and manufacturer’s declaration – electromagnetic emissions

The Ultima 12(KM908) and Ultima 9(KM907) are intended for use in the electromagnetic environment specified below. The customer or the user of the Ultima 12(KM908) and Ultima 9(KM907) should assure that it is used in such an environment.
Emission test| Compliance| Electromagnetic environment- guidance
RF emissions

CISPR 11

| Group 1| The Ultima 12(KM908) and Ultima 9(KM907) use 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 Ultima 12(KM908) and Ultima 9(KM907) are 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

Guidance and manufacturer’s declaration – electromagnetic immunity

The Ultima 12(KM908) and Ultima 9(KM907) are intended for use in the electromagnetic environment specified below. The customer or the user of the Ultima 12(KM908) and Ultima 9(KM907) 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

| ± 6 kV contact

± 8 kV air

| ± 6 kV contact

± 8 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 Not Applicable| Mains power quality should be that of a typical commercial or hospital environment.
Surge IEC 61000-4-5| ± 1kV line(s) to line(s)

± 2kV line(s) to earth

| ± 1kV differential mode 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

| <5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT)for 5 sec

| <5% UT (>95% dip in UT) for 0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 sec

| Mains power quality should be that of a typical commercial or hospital environment. If the user of the Ultima 12(KM908) and Ultima 9(KM907) require

continued operation during power mains interruptions, it is recommended that the Ultima 12(KM908) and Ultima 9(KM907) be powered from an uninterruptible power

supply or a battery.

Power frequency (50Hz/60Hz) 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

The Ultima 12(KM908) and Ultima 9(KM907) are intended for use in the electromagnetic environment specified below. The customer or the user of the Ultima 12(KM908) and Ultima 9(KM907) 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

3 V/m

80 MHz to 2.5 GHz

|

3 Vrms

3 V/m

| Portable and mobile RF communications equipment should be used no closer to any part of the Ultima 12(KM908) and Ultima 9(KM907) 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 2,5 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).

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:

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 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones 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 Ultima 12(KM908) and Ultima 9(KM907) are used exceeds the applicable RF compliance level above, the Ultima 12(KM908) and Ultima 9(KM907) should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Ultima 12(KM908) and Ultima 9(KM907).

b Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

ELECTROMAGNETIC DISTANCE RECOMMENDATIONS

Recommended separation distances between portable and mobile RF communications equipment and the Ultima 12(KM908) and Ultima 9(KM907)

The Ultima 12(KM908) and Ultima 9(KM907) are intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Ultima 12(KM908) and Ultima 9(KM907) can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Ultima 12(KM908) and Ultima 9(KM907) 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.

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 ERCHANTABILITY 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 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
Australia +61 7 3198 2484
Monday – Friday 9 AM – 5 PM ET

Authorized Representative in Europe (Regulatory Affairs Only): 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