HairMax LaserComb Ultima 9 Classic / 12 Classic Manual

What you should know before you start

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.
*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.

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.

FITZPATRICK SKIN TYPE CLASSIFICATION

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

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.

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

	European Conformity
	WEEE
	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. 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. 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
Australia 1-800-937-358

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 and validated through GMP (Good Manufacturing Practices). HairMax contains high quality laser diodes designed for optimal performance.
Based on that rating and the durability of the components being used, your HairMax is designed to last many years of regular use. Please take time to read this entire instruction manual before operating your HairMax.

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.*
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

HairMax LaserComb Ultima 9 & Ultima 12

PARTS

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

1. POWER BUTTON/INDICATOR LIGHT
2. LASER BUTTON
3. POWER CORD
4. TEETH
5. LASER WINDOW
6. SERIAL NUMBER
7. WARNING LABEL
8. CHARGING CRADLE/STAND
9. USB-PORT
10. CHARGING CONTACTS
11. DC-JACK

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.

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 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 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 the battery is full.

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.

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.
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 hair line.

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.

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.

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.

Turn off your HairMax by pressing and holding the power button (lower button) until 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.

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.
• 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.
• 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.

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.
• 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.

Other Useful Information

WARNING LABEL | LASER PARAMETERS | USE CONDITIONS

Power Supply Specifications

Output = 5V DC-1.0A.
Plug: 9mm x 3.5mm, center positive.
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. If outlets in your country have different plugs than the power supply that comes with the HairMax, use an inexpensive plug adapter not supplied with the device.

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 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 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.

Electrical Safety

Basic safety precautions should be observed when using this, or any other electrical device, especially when children are present.

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.

• 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. 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.

• 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 the 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.

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
Australia 1-800-937-358
Monday - Friday 9 AM - 5 PM ET
For more information about usage, quality and safety, visit: www.hairmax.com/videos and Hairmax.com/QualitySafety