THERADOME LH80 PRO Operator's manual

USER INSTRUCTION MANUAL
HAIR GROWTH TECHNOLOGY

Theradome, Inc.
4900 Hopyard Road, Suite 100,
Pleasanton, CA 94588
1-855-549-6757
[email protected]
EC REP Advena Ltd.
Tower Business Centre
2nd Flr, Tower Street
Swater, BKR 4013, Malta

THERADOME
®PRO LH80
THERADOME
®EVO LH40
Please read this first
We recommend that you read all of the instructions in this manual
before you begin using your device. Please confirm that you are a
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 [e-mail], call us from within
the U.S. on [phone]. Our Help Center also answers over
1,000 questions about Theradome and Hair Loss. Please visit:
www.theradome.com/help-center

Intended Use
What is the Theradome?............................................................. 4
How Does it Work?........................................................................ 4
Is it Safe?........................................................................................... 4
How to Identify Your Theradome............................................. 5
Theradome PRO................................................................... 5
Theradome EVO................................................................. 6
What’s in the Box?......................................................................... 7
Theradome PRO................................................................... 7
Theradome EVO.................................................................. 7
Indications for Use........................................................................ 8
Contraindications.......................................................................... 8
Warnings........................................................................................... 9
What do the Symbols Mean?.................................................... 11
Men’s Hamilton-Norwood Scale for Hair Loss........................ 12
Women’s Ludwig-Savin Scale for Hair Loss.............................. 13
Fitzpatrick Skin Types.................................................................... 14
Master Switch Modes, Functions and Volume Control..... 15
Master Switch Light Indications During Charge........................ 16
Master Switch Light Indications During Treatment........................ 16
Lifetime Counter Reader.................................................................... 17
Operations........................................................................................ 18
Theradome PRO............................................................................. 19
Theradome EVO........................................................................... 19
Treatment Schedule.................................................................... 21
Treatment Stages......................................................................... 22
Taking Before and After Photos............................................. 23
Your Personal Record............................................................ 24
Cleaning Instructions................................................................. 25
Operating and Storage Environment................................... 25
FAQ.................................................................................................. 26
Troubleshooting......................................................................... 28
Warranty and Refund Policy.................................................... 31
Contents
Identifying Your
Device
Your Hair Loss
Pattern and
Skin Type
Device Features
Treatment
Before and
After Photos
Care
Instructions
FAQ
Troubleshooting
Warranty
Welcome

What is Theradome?
The Theradome PRO and Theradome EVO are Laser Phototherapy
(LPT) devices used to promote hair growth. They are light-weight,
one-size-fits-all helmets that you can wear for at-home treatments.
Both the Theradome PRO 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.
Welcome
4 | Welcome
THERADOME PRO
THERADOME EVO

THERADOME PRO LH80
Identifying Your Device
5 | Identifying Your Device
F
E
B
ARubber Pegs:
Help provide a soft,
comfortable fit
Light Apertures x 80:
Provides precise
coherent-light beam
emission
A
Master Switch:
Controls system and
provides feedback
Speaker:
Audio response for various
master switch modes
Serial Number:
Serial number used for
warranty
C
Micro-USB:
Charge port
F
E
C
B
D
D
Serial Number
Place the helmet on your head with the
Master Switch at the back of your head.

F
E
B
A
Serial Number:
Serial number used for
warranty
Speaker:
Audio response for various
master switch mode
C
CRubber Pegs:
Help provide a soft,
comfortable fit
Light Apertures x 40:
Provides precise
coherent-light beam
emission
Master Switch:
Controls system and
provides feedback
Micro-USB:
Charge port
THERADOME EVO LH40
Identifying Your Device
A
D
D
B
E
F
6 | Identifying Your Device
Serial Number
Place the helmet on your head with the
Master Switch at the back of your head.

Theradome PRO
or
Theradome EVO
AC Adapter with
Micro USB Cable
Foam Pads
Protective Bag
User Instruction Manual and
Quick Start Guide
What’s in the Box?
7 | Identifying Your Device

Indication for Use
The Theradome PRO and Theradome EVO devices are over-
the-counter (OTC) therapeutic 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 I-1 to I-4, II-1,
II-2; both with Fitzpatrick Skin Types I to IV.
Contraindications
Theradome devices should not be used in the case of current or
past scalp cancer. The coherent-light 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.
Indication for Use
8 | Intended Use

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 specically 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 signicant 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.
Warnings
9 | Intended Use

Warnings
Use the Theradome helmet ONLY for its 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.
10 | Intended Use

1.0 A
680 nm @ 5 mW
MODEL: PRO LH80/EVO LH40
Coherent-Light
Device
Electrostatic
Discharge
Sensitive
Coherent-light
Output
No Conductive
Contact
to Patient
Keep
Dry
What Do the Symbols Mean?
11 | Intended Use
IP22

The Theradome PRO and Theradome EVO are over-the-counter
(OTC) therapeutic devices intended to treat Androgenetic Alopecia
and promote hair growth in males who have Hamilton-Norwood
Classication of IIa to V pattern of hair loss with Fitzpatrick Skin
Types I to IV, as seen below:
Men’s Hamilton-Norwood Scale for Hair Loss
12 | Determining Your Hair Loss Pattern and Skin Type
Disclosure: Treatment for other levels has not been documented.
Theradome PRO and EVO are FDA Cleared to effectively and safely
treat hair loss levels IIa, III, IIIa, III vertex, IV, IVa and V

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
I-1 to I-4, II-1, II-2 patterns of hair loss with Fitzpatrick skin types I to
IV, as seen below:
Women’s Ludwig-Savin Scale for Hair Loss Fitzpatrick Skin Type
13 | Determining Your Hair Loss Pattern and Skin Type
Disclosure: Treatment for levels Frontal, III, and Advanced have
not been documented.

Disclosure: Treatment of skin types 5 and 6 has not been
documented due to a limited number of test subjects.
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.
Fitzpatrick Skin Type
1
2
3
4
5
6
14 | Determining Your Hair Loss Pattern and Skin Type

When Charging:
Briey press and release to hear a voice readout of your
number of completed treatments.
(See “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.
(See pg. 29 for more information on system paused.)
Master Switch Modes and Function
Master Switch Light Indications
15 | Device Features

During Charge
During Treatment
* Turns on/off in ½ second intervals
** Blinking is defined as flashing bursts every 2 seconds
with the same color
Blinking bright green:
Standby mode; place on head as verbally
instructed.
Solid bright green:
Treatment in progress.
Blinking orange:
Treatment paused due to anomaly – e.g.:
treatment error; press to retry. 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.
Green:
Dim green,
charging
complete.
Fade
Yellow-Green:
Charge near
completion.
Fade
Red-Orange:
Battery low;
charging.
Fade
Orange-Yellow:
Battery
charging.
Blinking
Orange:
Charge
adapter;
USB port has
lost power
or battery
is depleted
and requires
replacing.
Master Switch Light Indications
16 | Device Features

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
Lifetime Treatment Counter Operations
17 | Device Features
Treatment 176
complete

Treatment Mode
Press the master switch to initiate treatment. Place the helmet on
your head. Lights will turn on and treatment will begin.
Turning O
The unit automatically turns off when the treatment is completed.
To abort a current session, press and hold the master switch until
voice says "Treatment aborted".
Operations
18 | Device Features
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.)

(See 'Master Switch Light Indications
During Charge' section, pg. 16.)
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 Theradome to
sit upright in a secure location, as
shown on the left.
Attach the micro-USB 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.
Step 1: Charge the Theradome for 2-3 hours before use.
Getting Started - Operation Getting Started - Operation
19 | Getting Started