theradome LH80 Pro Laser Hair Growth Helmet Instruction Manual

theradome LH80 Pro Laser Hair Growth Helmet

OTHER MODEL

• **THERADOME PRO LH80

**

• THERADOE ® EVO LH40

Please read this first

before you begin using your device. Please confirm that you area candidate for Theradome using the Hamilton-Norwood Scale for men or the Ludwig-Savin Scale for women in this booklet.

This warning symbol appears next to information about possible safety risks. Please be sure to follow all warning and safety information. Save these instructions for future reference.
If you are under a physicians care, please contact your doctor about possible medical issues prior to using your Theradome device You can email us at support@theradome.com, call us from within the US. on +1-855-549-6757. Our Help Center also answers over 1,000 questions about Theradome and Hair Loss. Please visit: theradome.com/help-center

Welcome

What is Theradome?
The Theradome PRO and Theradome EVO are Laser Phototherapy (LPT) devices used to promote hair growth. They are lightweight, one-size-fits all helmets that you can wear for at-home treatments. Both the The radomePRO and Theradome EVO devices utilize coherent light diodes for hands-free operation during treatment The devices feature voice guided treatments with a built-in audible timer that aUtomatically turns off the device after the treatment is complete.

How does it work?
The Theradome PRO and Theradome EVO devices use
state-of-the art Laser Phototherapy (LPT) to stimulate the base of hair follicles at a cellular level. Theradome’s advanced laser technology does three things:

• Slows and stops hair loss
• Thickens existing hair follicles
• Promotes new hair growth

Is it safe?

Yes! The Theradome PRO and Theradome EVO devices use cold (or low level) coherent-light, which penetrates the scalp to reach the base of hair follicles with zero side effects.

Numerous studies confirm that LPT has no harmful side effects. It is recommended, however, that you read all precautions in this manual before starting treatment.

THERADOME PRO

THERADOME EVO

Identifying Your Device

THERADOME PRO LHB80

• **A** Rubber Pegs: Help provide a soft comfortable it

• B Light Apertures x 80: Provides precise coherent-light beam emission

• **C** Speaker: Audio response for various master switch modes

• **D** serial Number: Serial number used for warranty.

• E Master Switch: Controls system and provides feedback

• **F** Micro-UsB: Charge port

Place the helmet on your head with the Master Switch at the back of your head.

THERADOME EVO LH40

• **A** Rubber Pegs : Help provide asof, comfortable fit

• **B** Light Apertures x 40 : Provides precise coherentight beam emission

• **C** Speaker: Audio response for various master switch mode

• **D** Serial Number: Serial number used for warranty

• **E** Master Switch: p Controls system and provides feedback

• F Micro-USB: Charge port
  

What’s in the Box?

Indication for Use

Indication for Use

The Theradome PRO and Theradome EVO devices are over- the-counter (OTC) therapedtic devices intended to treat Androgenetic Alopecia and promote hair growth in males who have Hamilton-Norwood Classifications of IIa to V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 11 to1-4, 111, 11-2; both with Fitzpatrick Skin Types I to V.

Contraindications

Theradome devices should not be used in the case of current or past scalp cancer. The stimulates activity in both healthy and unhealthy cells.
If you are undergoing treatment for cancer, we recommend you consult your physician for any medical advice. Theradome has not been tested on people with scalp cancer.
We do not recommend using the Theradome while pregnant or breastfeeding.
Use Theradome after you finish breastfeeding.
Theradome devices shall not be used by people with an Ommaya reservoir under their scalp without the approval of a specialist.
Discontinue use AT ONCE should the device appear to be malfunctioning.

Warnings

DO NOT use the charger if the cable or plug is damaged,
DO NOT use the Theradome helmet or its power supply if either has been exposed to water or liquid.
DO NOT use the Theradome helmet as a head protective device. The device is not intended to be used in this manner.
DO NOT place device or its charging system near any water or liquid. If exposed to any liquid substance, unplug the device immediately from the power outlet If the helmet has been dropped into water or any type of liquid, DO NOT attempt to pick. up the helmet, and DO NOT come into contact with the substance(s).
DO NOT use your Theradome helmet when your hair is wet.
DO NOT use the Theradome helmet if you are pregnant or breastfeeding unless specifically approved by your physician
DO NOT use the Theradome helmet if you have or have had scalp cancer. The coherent light stimulates activity in both healthy and unhealthy cells. Please consult your physician.
DO NOT drop or insert objects into any vents or openings of the device. The helmet’s lights are electrostatic discharge sensitive.
DO NOT expose the underside of the Theradome helmet to static or other high voltage sources.
DO NOT charge the Theradome helmet in an outlet that is blocked by furniture or isn’t easily accessible in case of a hazard.
DO NOT use accessories, detachable parts, and materials for purposes unrelated to the proper Use of the device. Using the Theradome helmet near other electronic devices does not pose significant risk for electromagnetic interference. Using a . mirror or lens to direct the light toward the eye will increase potential eye hazards.
Keep the Theradome helmet away from children and pets.

Use the Theradorme helmet ONLY for is intended use as described in this manual.
To avoid overheating during treatment, ALWAYS Use the Theradome helmet away from any heat sources, including sunlight . To avoid damage or possible injury, DO NOT store the Theradome helmet in dusty, humid, or soiled areas, or in any environment that has a freezing temperature (below 0°C). When
using the Theradome helmet, ALWAYS exercise caution in order to avoid:

1. strangulation due to charging cables,
2. potential allergic reactions to helmet and equipment materials, and
3. contact injuries.

What Do the Symbols Mean?

CAUTION
COHERENT-LIGHT RADIATION AVOID DIRECT EYE EXPOSURE CLASS 3R LIGHT PRODUCT
5mw 680nm CW IEC 608250-1;2014

Men’s Hamilton-Norwood Scale for Hair Loss

The Theradome PRO and Theradome EVO are over the-counter (OTO therapeutic devices intended to treat Androgenetic Alopecia and promote hair growth in males who have Hamilton-Norwood Classification of la to V pattern of hair loss with Fitzpatrick Skin Types to V, as seen below:

Hamilton-Norwood Scale Male Hair Loss Classification

Theradome PRO and EVO are FDA Cleared to effectively and safely treat hair loss levels I, Il lla, 11l vertex, IV, IVa and V

Disclosure : Treatment for other levels has not been documented

Women’s Ludwig-Savin Scale for Hair Loss

The Theradome PRO and Theradome EVO are over the counter (OTC) therapeutic devices intended to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale l-1 to I-4, II-2 patterns of hair loss with Fitpatrick skin types I to IV, as seen below;

Ludwing-Savin Scale
Female Hair loss Classification

Theradome PRO and EVO are FDA cleared to effectively and safely treat hair loss levels I-1, 1-2,1-2, 14, 111, 112 and frontal hair loss

Disclosure : Treatment for levels Frontal,ll,l and Advanced have not been documented.

Fitzpatrick Skin Type

Compare your skin type to the chart below. The Theradome PRO and Theradome EVO devices have been FDA cleared to promote hair growth in skin types 1- 4.

The Fitzpatrick Skin Type Scale

The Theradome has been tested to effectively treat skin types: 1,2,3,and 4.

Disclosure: Treatment of skin types 5 and 6 has not been documented due to a limited number of test subjects.

Master Switch Modes and Function

When Charging:

Briefly press and release to hear a voice readout of your number of completed treatments,

(e “Lifetime Counter Reader” section, pg, 17).

Treatment Mode:

Press the master switch for 1 second (without holding it down) to turn on the helmet.

Your helmet will say “Ready for treatment, place on head”
During a treatment while on your head, double click to change voice volume. Choices are HIGH, MEDIUM, LOW, and MUTE.
Press and hold for 4 seconds to enter deep sleep mode for shipping and/or long-term storage; resume normal operation by connecting the charger.

System Paused Mode:

Connect the helmet to the charger and plug charger into an outlet. Helmet will say, “System resumed.”

Unplug the charger and press the master switch button to start a treatment

(ee pg, 29 for more information on system paused.)

Master Switch Light Indications

During Charge

During Treatment

Blinking bright green: Standby mode; place on head as verbally instructed.
Solid bright green: Treatment in progress.

Blinking Orange: Treatment paused due to anomaly – eg, treatment error; press to refry. See troubleshooting section.
Blinking red: Battery was replaced or master switch was pushed down for more than 1 second or new firmware was installed, causing system reset. See troubleshooting section.

• Turns on/off in 1/2 second intervals
  **Blinking is defined as flashing bursts every 2 seconds with the same color

Lifetime Treatment Counter

Lifetime Treatment Counter
The lifetime treatment counter tracks all completed sessions on both PRO and EVO. Use the lifetime counter to monitor the number of treatment sessions that you have completed to date.

Access the counter by pressing the master switch while your device is charging or before starting each treatment. You will hear a voice readout of your total completed treatments.

**THERADOME PRO LH80

**

THERADOME EVO LH40

Operations

Treatment Mode

Press the master switch to initiate treatment. Place the helmet on your head. Lights will turn on and treatment will begin.

Removing the helmet from your head will pause the current treatment. You have up to 5 minutes to resume the treatment before a session is terminated,

(See Master Switch Light Indications During Treatment’ section, pg. 16.)

Turning Off

The unit automatically turns off when the treatment is completed. To abort a current session, press and hold the master switch unti voice says “Treatment aborted”

Getting Started – Operation

Step 1 : Charge the Theradome for 2-3 hours before use.

Attach the USB cable end to the AC adapter.
When plugged in the master switch will pulse/rotate through setting colors until it is charged.

Please remember to use an accessible outlet to charge the Theradome should you need to disconnect it in case of a hazardous situation.

Plug the AC adapter into an outlet that will allow the Theradorme to it upright in a secure location, as shown on the left.

Aftach the micro-USE cable end to the correct outlet. This outlet is located under the master switch in the rear of the Theradome.

Charging the Theradome will depend on your frequency of treatments. If you are a frequent user, we recommend charging your helmet after every 4 to 5 treatment sessions, or after receiving a battery low warning If you plan on conducting infrequent treatments, please keep. your helmet charged at all times so that you can perform sessions as needed (See Master Switch Light Indications During Charge section, pg. 16)

Step 2: Prepare your scalp for treatment.

Your Theradome can be used at anytime during the day or night. Theradome is effective on dry or damp hair, some users will dampen their hair slightly and use a comb or brush to further expose their desired treatment area.

Do not use Theradorme with wet hair to prevent water from getting into the device.

Step 3: Begin your treatment session.

Briefly press and release (ess than 1 second), the master switch of your fully charged Theradome to enter treatment mode. Place the Theradome on your head to begin your treatment.

Step 4: Enjoy your treatment session.

You can enjoy light activities during your treatment such as browsing the Internet or watching TV. Avoid more rigorous activties such as jogging,
The Theradome will provide treatment updates every 5 minutes automatically and shut down when complete.
If you would like the know the remaining time manually, press the master switch (less than 1 second) during treatment to hear a voice readout indicating the remaining time of your current session.
Removing the helmet from your head will pase the current treatment. You have Upto 5 minutes to resume the treatment before a session is terminated.
Theradome turns off automatically when the treatment is completed. To abort a current session, press and hold the master switch.

Step 5: Following treatment, remember to:

Remove the device from your head.

Plugin the charger and attach the micro-USB cable to the charging port.
Apply hair products as desired.

Treatment Schedule

Repair – Growth Stages

Theradome PRO is FDA cleay red for two, 20-minute sessions per week.

Theradome EVO is FDA cleared for four, 20minute sessions per week.

For Best Results :

• Use indoors; the device is not designed for outdoor use.
• Use only on dry or da The Theradome lights op air; do not use on wet hair.
• The Theradome lights operate best in a cool environment (68°F/20°C)
• Only apply topical scalp or hair products after a theradome treatment, as opposed to before.
• Expose your scalp by brushing and parting your hair prior to treatment.
• Do not discontinue any existing hair/scalp regimens when starting theradome treatments Consult your physician to design a plan to reduce dosage over time.
• Do not pause your Theradome during treatment.
• Overuse and under use may decrease the effectiveness of treatment. Visit theradome.com for any questions.
• Take monthly photos of your hair growth and scalp, under consistent natural lighting , positioning and same hair styles to track progress. (See Taking Before and After Photos’ section pg.23).
• Remain committed and be patient! This should be part of your regular routine, similar to brushing your teeth.

Treatment Stages

What to expect

THERADOME PRO LH8O

THERADOME EVO LH40

‘Treatment Stages of the Theradome PRO and Theradome EVO

Based on clinical trials, the diagrams below illustrate the progression most people can anticipate when performing the recommended amount of treatments per week.

Progressive stages when PRO is used for two 20-minute sessions per week and when EVO is used for four 20-minute sessions per week (or every other day)

| Repair| 1-3 Months
---|---|---
| Healthy Hair| 2-4 Months
| Healthier Hair| 4-6 Months
| Groth| 6-9 Months
| Maintenance| 9 Months +

Individual User Result may very.

Please be patient, this is the best thing you can do for your scalp and the Theradome does work!
Theradome treatments should be a routine similar to brushing one’s teeth.

Taking Before and After Photos

Taking before and after photos is a key part of your hair restoration journey, so don’t skip this step! It allows you to track your progress regularly s0 that you can accurately gauge when hair becomes thicker and new hair begins to grow in. If you are working with a doctor or hair care professional, you can also share your photos with them to guide your treatment plan.

For Best Before and After Photo Results:

• Maintain consistency in positioning, lighting, and camera angle for all photos.
• Enlist the help of another as photographer. Don’t try to take your photos yourself as we want you to get the best possible photo to track your progress!
• DO NOT use the camera’s flash. – Only use natural lighting
• Set the camera to auto-focus.
• Use the highest magnification and pixel density possible while still maintaining a global view of your head.
• Recommended shots :
  • Frontal view – lean head forward and shoot from the front.
  • Rear view – lean head backward and shoot from the back.
  • Vertex – shoot directly from above.
• Checkall photos for clarity and focus before concluding the photo session
• Clean, dry and style your hair in the same way for each photo session
• View your progress photos n consistent surroundings and lighting for best Interpretation of your results.

Taking Before and After Photos

Setting Up the Photo:

1. Make sure you are in a well-lit room

2. Always use natural lighting

3. Always position yourself in front of a white, gray, or neutral-colored background.

Taking Your Photos:

4. Hold the camera roughly 18″ away from your head (or dose enough to capture the entire scalp).

5. Angle the lens at a 45° angle from your scalp. .

6. Take the photo.

Your Personal Record

My Device (Please Check on option)| Theradome PRO
Theradome EVo
---|---
Hair Loss Classification (Please Check one option)| Male
IIa  III IIIV IV V| Female

I-1 I-2 I-3 I-4 II-1 II-2

Treatment schedule (Please check one option)| Theradome PRO
Two 20min sessions/week
Theradome EVO
Four 20min sessions/week
Before Photo| Yes| No

Cleaning Instructions

DO NOT place Theradome or electrical adapter in water or other liquids, If any components get wet, do not use the device. Call customer care at 1-855-549-6757 for help on how to proceed Awet device or battery can cause an electrical shock. Make sure all equipment s turned off and unplugged from any electrical outlet If necessary, remove dirt or debris caught underneath the helmet’s plastic shell –

• Use a damp cloth to clean plastics.  Do not get water in dome vents.
• Using acetone o other solvents is not recommended
• The lights do not require cleaning or servicing.
• To maintain high quality performance, remember to clean your
• Theradome after each treatment session.

Operating and Storage Environment

Operation :

• temperature between 0 °C and 30 °C / 32 °F and 86 °F.
• relative humidity between 30 and 75 %, no condensation
• atmospheric pressure between 70 kPa and 105 kPa

Transport and Storage:

• temperature between -20 °C and 70 °C /4 °Fand 158 °F
• relative humidity between 10 and 90 %, no condensation
• atmospheric pressure between 70 kPa and 105 kPa
• altitude (relative to sea level) 400 to 4500 meters

Dimensions and Weight:

• height: 17.5cm
• width: 19.5 cm
• length: 26,8 cm
• weight 15 oz, incl. battery
• maximum head size: 65 4cm (25 %in) Coherent-Light: 680nm, SmW CW Class 3R Beam Divergence: 8.8°

AC Charger: Input: 100-240V, 50 Hz/60 Hz; Output: SVDC, 154

Battery: Li-lon 3.7V 2200mAh
1P22 – Ingress Protection Rating
IEC 60601-1-2 Compliant, Edition 4.0
IEC 60601-1 Compliant, Edition 3.0
IEC 60825-1 Compliant, Edition 3.0 See product label on underside of helmet.

Answers to Frequently Asked Questions

average over 50-100 hairs per day.
What causes hair loss?| Hair loss is commonly caused by genetics; however, other factors like medication, skin disorders, hormonal changes, stress and chemicals can also cause hair loss,
Who’s a good candidate for using Theradome?| See hair loss and skin type charts on pages 12-14 for more information.
When can | expect to see results?| See the treatment stages chart on page 22 for more information
How long will | need to continue treatment?| You will need to use Theradome regularly until you achieve your desired results, followed by less frequent maintenance sessions.
Can | use other treatments simultaneously?| Yes, using fine staride, minoxidil or undergoing hair transplant procedures can be used/ performed concurrently with Theradome. Always make sure your scalp is clean and free of any product during treatment. Apply products only after your 20-minute sessions.
What are cold conerent lights?| Low-Level Laser Therapy is often called cold coherent-ight therapy. Theradome uses cold coherent-lights that deliver energy to the base of hair folicles for effective stimulation. Our lights do not generate heat.
Are there any potential side effects?| During the repair phase, treatments may be associated with scalp tingling itchiness, or mild headaches, which are signs of increased blood flow and hair growth.
Question| Answer
---|---
What shampoo should | use with treatment?| We recommend shampooing with medicated, antifungal shampoo to reduce inflammation of the scalp, clean the hair and eradicate any existing fungus loads.
Will treatment be effective on blonde, white, or dyed hair?| The Theradome is effective on any hair color, whether natural or dyed
Canl use the Theradome if| am pregnant or breastfeeding?| We do not recommend using the Theradome if you are pregnant or breasteeding, unless specifically approved by your physician,
Will | need to use the Theradome in perpetuity after my hair grows back?| After achieving your desired results, simply reduce the frequency of treatments in order to maintain your new hair growth.
Is the helmet supposed to fit loosely on my head?| The device is not designed to fit tightly. The supplied foam pads enable a better fit for head sizes smaller than 22″, Avoid physical activity during your 20-minute treatment sessions. Activities such as browsing the Internet, watching TV, or reading a book are perfectly compatible with using the Theradome.
My skin is darker; can still use the Theradome?| The Theradome is FDA decleared for Fitzpatrick skin types 1-4. Due to a limited number of subjects, data for skin types 5-6 Is currently unavailable.

Troubleshooting

Theradome shuts off during treatment, and the master switch is pulsing with a green light. The voice readout says, ‘Place on head.”| Remember to place your Theradome correctly on your head and to keep the helmet flat during treatment, otherwise the device will stop working
Your Theradome shuts off during treatment, and the master switch is pulsing with an orange light. The voice readout says, “Error – battery low”| The battery s low. Please charge your Theradome by connecting it to its charging unit
Theradome shuts off during treatment, and the master switch is a solid yellow color. The voice readout says, “Warning – temperature high”| This is not the result of the helmet overheating this merely indicates that the room temperature is too high, Move to a cooler environment (less than 72° F) before pressing the master switch to resume treatment. In the future, avoid undergoing treatment in a room above 72°F. The optimal operating temperature should stay between 68° and 72° F. The Theradome should never be used outdoors
Your Theradome shuts off during treatment, and the master switch is blinking with an orange light. The voice readout says, “system error.”| Your Theradome requires one of the following:

1. Tobe charged or
2. May need a new battery or
3. Contact customer care so we can troubleshoot with you.

Theradome shuts off mid-treatment.| Your Theradome is’n it fully charged. Connect the helmet to its charging unit If you are still experiencing problems, try plugging the helmet into a different AC outlet
When Theradome is plugged in for charging the master switch flashes with an orange light| First try to connect your Theradome to a different AC outlet. Second, you may need a new AC charger adapter or battery as the USB port has lost power or battery is depleted and requires replacing. Contact customer care s that we can troubleshoot with you
Battery low| Please verify that your Theradome is fully charged. If the battery low message is still present, then a new battery should be purchased, directly from our website: theradome.com. You will need your Theradome serial number when placing a battery order.
Laser error message| Please verify that your Theradome battery is full charged. If the laser error message is still present, please contact customer are 50 we can troubleshoot with you.
System error message| Unplug your helmet completely and press the master switch button once briefly (do not hold down). You should hear the words “system resumed”
Unplug your helmet and flip it upside down (lasers facing up) and place it on a flat surface.
System paused| If you receive 3 “system paused” message, the master switch was held down for too long.
To get out of “system paused” mode, plug. the helmet into the charger. The helmet will say “system resumed” and you can unplug the charger and press the master switch button to start a treatment.
If you do not receive the “system resumed” message, plug the charger into a wall outlet and plug the charger USB back into the helmet. Press and hold the master switch for 3 seconds.
Then unplug the helmet from the charger and press the master switch for one second (do not hold)
If you are still unable to get out of “system paused,” please contact customer care.

Warranty and Refund Policy

Customer Support

We want you to have a successful experience with your Theradome. If for any reason you are unhappy with our product or have any questions, please call our customer care phone number at 1-855- 549-6757 or email us at: support@theradome.com.

Refund Policy

Please review our website for information concerning eligibility and other requirements related to our refund policy. If you have any questions, please call customer care at 1-855-549-6757.

1-Year Limited Warranty

Our Theradome helmets have a 1-yearlimited warranty for purchases made through our website or authorized resellers. We warrant our |aser helmets against defects in materials and workmanship, battery or charger failure for a period of one year from the original retail purchase date. Our warranty does not cover accidental damage or misuse.

Warranty Limitations

This warranty does not apply to: (a) damage caused by accident, abuse, misuse, misapplication, of the Theradome PRO and Theradome EVO; (b) damage caused by service (Including upgrades and expansions) performed by any non-athorized Theradome Service Provider, (c) products or parts that have been modified

Warranty and Refund Policy

DomeCare Extended Warranty

Protect your hair restoration results with our extended warranty program. Please note that this is only for US customers.
The Domecare extended warranty and protection plan provides full coverage and support on any accidental damage or misuse and any mechanical or operational faults for an addition 2 years on top of your 1-year warranty.

Get your extended warranty coverage by calling 1-855-549-6757 or by visiting theradome.com

Environmental Notice

The Theradome PRO and Theradome EVO devices include alithium-on battery as well as other electrical components.

Some of these components are classified as non-hazardous waste, although disposal regulations vary based on national, state, and local regulations.

To extend the battery life of your device, do not subject the helmet to high temperatures.

CUSTOMER SUPPORT

Theradome, Inc.
4900 Hopyard Road, Suite 100,Pleasanaton, CA 94588 1-855-549-6757
support@theradome.com
Advena Ltd.
Tower Businees Center 2nd fir, Tower street Swater, BKR 4013, Malta
To learn more about our new features,
please visit our website at theradome.com For further assistance, please contact us at:
Phone: 1-855-549-6757
Email: support@theradome.com
Website: theradome.com

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