Tria SRL Instructions For Use Manual

AGE-DEFYING LASER
Instructions for Use
®
2
WELCOME
ENJOY PR OFESS IONAL A NTI-AG ING LA SER RE SULTS AT HOME .
With the Tria Age-Defying Laser, you can treat multiple signs of aging, restoring your
skin’s natural radiance. Your new device offers a true revolution in personal skincare,
giving you professional anti-aging laser results with short, simple, daily treatments in
the comfort of your own home.
Youthful skin is rich in collagen, which is what gives your skin lift and support. Over time,
the body produces less collagen, and exposure to sunlight slows the development
of new collagen. This can result in wrinkles, especially around the eyes (“crow’s feet”).
The laser light can activate your body’s own natural collagen renewal process to stimulate
the growth of new skin cells to reduce fine lines and produce smoother skin.
Now you have the professional technology dermatologists have been using for years
and can start enjoying visible results in as few as two weeks.
Before you use your Tria Age-Defying Laser, please read these Instructions for Use
and watch our How to Use video, available at triabeauty.com/how-to-use, for important
safety information and to ensure best results.
TABLE OF CONTENTS
GETT ING TO KN OW YOUR TRIA AG E-DEFYI NG LAS ER 2
WHO SHOULD USE THE TRIA AGE-DEFYING LASER (INDICATIONS FOR USE) 4
WHEN N OT TO USE THE T RIA AGE- DEF YING L ASER (CO NTRAI NDIC ATIONS) 4
IMPO RTANT SAFET Y INFO RMATION 6
BEFORE USIN G YOUR TRI A AGE-D EFYI NG LASER FOR THE FIRS T TIME 13
HOW TO USE YOU R TRIA AGE -DEFYIN G LASE R 15
HOW OFT EN TO USE YOU R TRIA AGE -DEF YING LASE R 19
WHAT TO EXPEC T 19
HELPFUL TIP S FOR BES T RESU LTS 20
TAKING CARE OF YOUR T RIA AGE- DEF YING L ASER 21
TROUBLESHOOTING 22
WARRANTY 25
TECHNICAL SPECIFICATIONS 30
triabeauty.com 32
WHAT’S INCLUDED:
IMPORTANT FEATURES:
• TRIA AGE-DEFYING LASER
• CHARGING CRADLE
• POW ER SUP PLY AND CORD
• INSTRUCTIONS FOR USE
• QU ICK START G UIDE
GETTING TO KNOW YOUR TRIA AGE-DEFYING LASER
CHARGING CRADLE
Holds and charges
the device.
CONTACT LIGHT
Glows purple when
gliding & making
skin contact.
DISPLAY
LASER TREATMENT TIP
Emits laser light
during treatment.
TRIA AGE-DEFYING LASER
POWER SUPPLY
AND COR D
Connects the
charging cradle to
a power outlet.
DEVICE LOCK IN DICATOR
Lights if the device is locked.
TREATMENT
COMPLETION INDICATOR
Lights when treatment
is complete.
POWER B UTTON
Turns the device on/off and
adjusts the treatment level.
DEVICE FAULT
INDICATOR
Lights if there is a device
fault/error.
TREATMENT LEVEL
INDICATOR
Shows the selected
treatment level.
BAT TE RY IND IC ATO R
Lights when battery is low,
flashes when charging.
DISPLAY
LOCK FEATURE
When the device is locked it will not power on. The blue padlock
icon will light when you press the power button.
To lock the device: First, turn on your Tria Age-Defying Laser.
Then press the power button for several seconds until the padlock
icon illuminates on the display.
To unlock the device: Press and hold the power button until you
hear four beeps. Then release your finger from the power button.
triabeauty.com 54
WHO SHOULD USE THE TRIA AGE-DEFYING LASER (INDICATIONS FOR USE)
WHEN NOT TO USE THE TRIA AGE-DEFYING LASER (CONTRAINDICATIONS)
The Tria Age-Defying Laser is indicated
for the treatment of periorbital wrinkles
(“crow’s feet”), which may result in smoother
appearing skin in the treated area.
Use this chart to see if the Tria Age-Defying
Laser is right for you. The Tria Age-Defying
Laser can be used to treat the skin condition
marked “OK to use”. If you are not sure
whether the Age-Defying Laser is right for
you do not use your device until you have
contacted Tria Beauty Customer Care or a
health care professional for more information.
Do not use the device on skin that is
infected, burned, or cut as this could
cause discomfort or irritation. Wait until
the infection, burn, or cut has healed
before using the laser.
SKIN CONDITION DESCRIPTION
USE TRIA AGE-DEFYING LASER
EXAMPLES
Periorbital wrinkles
Wrinkles around the eye (also called “crow’s feet”).
ü
OK to use.
Other skin conditions
Skin conditions other than wrinkles may not be treated effectively by the Tria Age­Defying Laser.
Pimples
X Do not use. The laser
may not be eective on pimples.
Veins
X Do not use. The laser
may not be eective on veins.
Dyschromia
X Do not use. The laser
may not be eective on dyschromia. You may want to see your doctor.
Freckles
X Do not use. The laser
may not be eective on freckles.
triabeauty.com 76
IMPORTANT SAFETY INFORMATION
Read the following important safety
information before using the device. If you
have any questions contact Tria Beauty
Customer Care or a health care professional.
WARNINGS
• Do not use to treat your eye or eyelids
or aim the device directly into your eyes.
Doing this could cause serious eye injury
such as a permanent or temporary decrease
in vision or permanent blindness. Treat
around the eyes only where you can feel
bone beneath the skin.
• Do not use on tattooed skin or areas with
permanent makeup. Doing this could result
in a damaged tattoo or increased risk of
skin injury.
• Do not treat a zone on your face more
than once per day (once every 24 hours).
Doing this could result in increased risk
of skin irritation.
• After treatment is completed and the
device automatically turns off, wait at least
24 hours to begin a new treatment session.
Failure to do so may increase skin irritation.
• Do not use the device if you are under the
age of 18. The use of the device on or by
anyone under the age of 18 has not been
tested and could result in serious skin or
eye injury.
• Do not use if you are pregnant. The device
has not been tested for safety on pregnant
women and the risks are unknown.
• Do not use the device if it is wet, or if it
or the charger could fall into water while
it is plugged in. If the device or charger
has fallen into water, do not touch until
you first unplug it. Touching the device
while it is wet could result in possibly fatal
electric shock.
• Do not use the device if you experience
skin color darkening. Failure to follow
these instructions may cause further skin
color darkening that may take more than
3 months to diminish.
• Do not use the device to treat skin which
is painful to touch, raised (higher than
surrounding skin), crusting or bleeding. This
may be a sign of a more serious condition
and should be checked by your doctor.
• Do not treat if your skin is significantly
red or swollen from a previous treatment.
Wait until the redness and swelling have
disappeared before treating again. If you
have skin redness or swelling that lasts for
more than a week, stop using the device
and contact a health care professional.
• Invisible laser light. Do not view directly with
optical instruments. Class 1M Laser Product.
PREC AUTION S
• Do not use the device on any area of the
body other than the face. Using the device
on other areas of the body has not been
tested and the risks are unknown.
• The device has only been clinically tested
on periorbital wrinkles. Using the device
on other wrinkle areas may not improve
their appearance.
• Applying treatment applications in the
exact same spot without moving the device
will increase redness and swelling and
could potentially lead to blisters or scabs.
• Do not use the device if you have a skin
condition or are recovering from professional
cosmetic treatments, such as a skin peel,
skin resurfacing, injectable toxins or fillers.
• If the area of skin for which you are using
the device to treat wrinkles appears to
be worsening, you should cease use and
check with your doctor to make sure you
do not have a more serious condition.
• Only store the device in a dry room at
a temperature between -20°C to 50°C.
Use the device only in a normal room
temperature environment.
• Do not drop the device on hard surfaces,
as this could damage it. Using a damaged
device could result in serious skin or
eye injury.
• Only use the provided charging cradle
and power supply to recharge the device.
Using different equipment could damage
the device.
• Do not attempt to open or repair the
device, charging cradle, or power supply.
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RISKS
The side effects that appeared most
frequently after treatment in the clinical
trial included: redness (57 of 60 subjects),
stinging or prickling sensation (55 of 60
subjects), burning sensation (50 of 60
subjects) and warmth sensation (47 of 60
subjects). Clinical results show that these
side effects usually resolved within several
minutes or hours after a treatment. When
using the device daily, these side effects
may diminish and resolve before your next
daily treatment, however, depending on
how your skin responds to treatment, some
may not fully resolve before your next
daily treatment. Do not perform another
treatment until all side effects have fully
resolved. In the clinical study, all of these
side effects resolved within 4 weeks after
stopping treatment.
Other side effects reported in the
clinical study included: dry skin (21 of 60
subjects), acne flare (14 of 60 subjects),
headache (4 of 60 subjects), temporary
small brown dots (7 of 60 subjects),
skin sensitivity (8 of 60 subjects), macule
(5 of 60 subjects), skin roughness (3 of 60
subjects), skin tenderness (2 of 60 subjects),
and skin peeling (2 of 60 subjects). Other
side effects that were each reported in
one subject included cold sore, dry lips,
ecchymosis, excoriation, and venodilation.
Not all of these side effects may have been
caused by the device.
Skin darkening that lasted more than
3 months after treatment was reported
in 4 of 60 subjects. If you experience skin
color darkening, you should discontinue
use of the device.
The benefits and risks of the Tria Age-
Defying Laser were tested in a clinical
study involving 60 participants, ages
32-70. Participants treated the skin on
their face 5 days a week for 12 weeks
and were evaluated throughout the study
for skin improvement and side effects.
BENEFITS
Based on the clinical study, Treatment
Levels 2 and 3 were shown to significantly
improve periorbital wrinkles for most
participants. Better results were obtained
when using Treatment Level 3. Improvements
were determined by doctors who graded
the fine lines and wrinkles around the eyes
using photographs and who did not know
which photographs were before or after
treatment. Improvement was defined as at
least a 1-point change on a 9-point scale,
as judged by at least 2 of the 3 grading
doctors. Participants also evaluated their
own level of improvement.
Four weeks after the last treatment, 45 of
60 participants (75%) had improvement
in periorbital wrinkles. Twelve weeks after
the last treatment, 37 of 60 participants
(62%) had improvement in periorbital
wrinkles. Please note that the observed
improvement could be in part due to
other non-device-specific effects. Based
on subject satisfaction results, 36 of 47
participants (77%) noted improvement in
their periorbital wrinkles 4 weeks after the
last treatment and 41 of 55 participants (75%)
noted improvement in their periorbital
wrinkles 12 weeks after the last treatment.
Your results may vary because of how you
use your Tria Age-Defying Laser or how
your skin responds to treatment.
BENEFITS AND RISKS
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