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206458TXT.24.1010.2.

TABLE OF CONTENTS
Page
Section 1 Introduction
1.1 Purpose of the Manual _________________________________ 1
1.2 Customer Service _____________________________________ 1
1.3 Disclaimer ___________________________________________ 1
1.4 Copyright ___________________________________________ 2
1.5 Prescribing Information _________________________________ 2
Section 2 Safety
2.1 Safety Overview ______________________________________ 3
2.2 Safety Features ______________________________________ 3
2.3 Explanation of Symbols ________________________________ 4
2.4 Explanation of Warnings _______________________________ 4
2.5 Labels ______________________________________________ 5
Section 3 Product Introduction
3.1 TRIO XT Clinical Theory ________________________________ 6
3.2 TRIO XT Radiofrequency (RF) Modality ___________________ 8
3.3 TRIO XT Components _________________________________ 10
Section 4 Pre-Treatment Considerations
4.1 General Pre-Treatment Considerations and Recommendations _ 15
4.2 Pre-Treatment Consideration and Recommendations for RF
Treatments __________________________________________ 15
Section 5 TRIO XT Treatment Protocols
5.1 TRIO XT RF Pre-Set Parameter Settings __________________ 17
5.2 TRIO XT RF Treatment Procedure _______________________ 17
5.3 Specific Area Treatment Recommendations ________________ 18
Face Treatment Program _______________________________ 19
Forehead Treatment Program ___________________________ 20
Peri-Orbital (Eye) Treatment Program _____________________ 21
Peri-Oral (Mouth) Treatment Program _____________________ 22
Neck Treatment Program _______________________________ 24
Abdomen Treatment Program ___________________________ 25
Cellulite Treatment for Thighs and Buttocks Program _________ 26
Back Treatment Program _______________________________ 28
Buttocks Treatment Program ____________________________ 29
Arms Treatment Program _______________________________ 30
Hands Treatment Program ______________________________ 31
Legs Treatment Program _______________________________ 33

TABLE OF CONTENTS
Page
5.4 Post-RF Treatment Recommendations ____________________ 34
5.5 TRIO XT Recommended Number of Treatments and
Treatment Intervals ____________________________________ 34
5.6 Considerations for All Treatments ________________________ 34
5.7 Post-Treatment Considerations __________________________ 35
5.8 Recommended Maintenance Program _____________________ 35

SECTION 1: INTRODUCTION
1.1

Purpose of This Manual

This manual explains how to correctly install, operate and get the best performance from your TRIO
XT System. It will help you understand the basic technological principles and procedures that are
utilized by the TRIO XT method. It may be used as a guide, suitable for all levels of technical
expertise, in determining and servicing mechanical and electrical difficulties. This manual is
organized as a quick reference guide. Any additional updated or supplemental information for this
reference guide will be distributed to you as needed. Please read this manual carefully before
administering treatments with your system and keep it nearby for quick reference.

1.2

Customer Service

We welcome and appreciate your comments, questions, and suggestions in order to offer the highest
quality products, accessories, and services to our customers continually. Our qualified professional
teams are ready to assist you with a prompt response to any question communicated to us by
telephone, e-mail, and/or fax.

1.3

Disclaimer

While every attempt is made to ensure the accuracy and completeness of the information in this
document, some errors may exist. Sybaritic, Inc. does not accept responsibility of any kind for
customer loss due to use of or reliance upon this document.

Sybaritic, Inc. reserves the right to make changes without notice in the product described or
contained herein in order to improve design and/or performance. Sybaritic, Inc. assumes no
responsibility or liability for the use of the product, conveys no license or title under any patent,
copyright, or trademark right to this product or processes and makes no representation or
warranty that this product is free from patent, copyright, or trademark right infringement, unless
otherwise specified. Applications that are described herein for the product are for illustrative
purposes only. Sybaritic, Inc. makes no representation or warranty that such applications are
suitable for the specified use without further testing or modification.

1.4

Copyright

This manual is protected by copyrights. All rights are reserved. No part of this publication may be
reproduced, stored in a retrieval system, or transmitted in any form or by any means: electronic,
mechanical, photocopying, recording, or otherwise without the prior written permission from the
author and publisher. All inquiries should be addressed to Sybaritic, Inc. at the headquarters
address listed inside the front cover of this manual, along with a date from a copy of the original
purchase receipt of the TRIO XT System. No attempt has been made to designate as
trademarks or service marks all words or terms in which proprietary rights might exist. The
inclusion, exclusion, or definition of a word or term is not intended to affect, or to express a
judgment on, the validity or legal status of the word or term as a trademark, service mark, or
other proprietary term.

1.5

Prescribing Information

This manual is intended to be used as an educational aid for clinicians incorporating


energy-based technologies for treatment of aesthetic conditions. Although every effort has been
made to ensure that treatment protocols and recommended treatment parameter selections are
presented accurately herein, the ultimate responsibility for all clinical determinations and
applications rests with the prescribing physician. Sybaritic, Inc. shall not be held responsible for
errors or any direct loss (including legal costs and expenses), injury or damage including death,
economic loss, indirect loss and consequential loss or liability incurred or suffered by any party
acting or purporting to act, or as a result of the actions of a third party, in reliance on or arising
from the use of the information contained herein.

SECTION 2: SAFETY
2.1

Safety Overview

As with any medical device, appropriate care must be taken to ensure proper and safe use. This
entire manual should be thoroughly reviewed before operating the instrument. Further, the
physician should attend a certified training course before using the TRIO XT System for medical
treatments.
All users should become familiar with the requirements for safe use of medical RF and
ultrasound systems as described in the American National Standards Institute (ANSI)
publications.

Electrical and Mechanical Safety:


o Due to high voltage, only personnel authorized by Sybaritic, Inc. may service
inside the protective covers of the TRIO XT System.
o Keep all covers of the TRIO XT System closed. Removing the covers creates a
safety hazard.
o The TRIO XT System produces high voltage, which may be dangerous. Some
components may retain a charge after the power supply has been turned off,
therefore no part of the cover should be removed, except by personnel authorized
by Sybaritic, Inc.
o The TRIO XT System is grounded through the grounding conductor in the power
cable. This protective grounding is essential for safe operation. Make sure your
electrical outlet has proper grounding.

2.2

Safety Features

The TRIO XT System is equipped with the following safety features:

Standby/Ready Controls
The unit will not output RF or ultrasound energy when in the STANDBY mode.

Key Switch
Limits the accessibility of the machine to only those that have access to the operating
key. Only those with appropriate training and knowledge of the safe use of the TRIO
XT System should have access to the operating key.

Emergency Stop Button


In the event of an accident, press the emergency stop button.
3

This will immediately

power the machine down. To resume normal operation, rotate the emergency stop
button in the direction of the arrow (clockwise) the button will return to its normal
position and system power will resume.

2.3

Explanation of Symbols
This symbol indicates power is ON.

This symbol indicates power is OFF.

2.4

Explanation of Warnings

DANGER
Indicates an imminent situation in which the
possibility of exposure to electrical shock or a fire
hazard could result in serious injury to the
practitioner, patient, or staff.

WARNING
Indicates a potentially hazardous situation in
which the possibility of exposure to electrical
shock may occur that could result in serious injury
to the practitioner, patient, or staff.

CAUTION
Indicates a potentially hazardous situation that, if
not avoided, could result in damage to the
equipment.

2.5

Labels

The labels shown are affixed to the TRIO XT device console. Users should be familiar with the
location and meaning of these labels and should review them regularly.
220V system
Affixed to the rear panel of

TRIO XT device console

SYBARITIC, INC.
9220 James Ave., S.,
Minneapolis, MN 55431 USA

*Notes
MODEL:

TRIO XT

220v/50-60Hz

The symbol (triangle with


exclamation mark means:
MODEL NUMBER: 304405

Attention, consult accompanying


documents

2010

IFE0911001

PLACE OF MANUFACTURER: USA-XAOB

On rear panel of the device

FUSE

console (above power inlet)

5x20T

On the shipping carton

220VAC

SECTION 3: PRODUCT INTRODUCTION


3.1

TRIO XT Clinical Theory

RADIOFREQUENCY MECHANISM OF ACTION


RF current is formed when charged particles flow through a closed circuit. As the RF energy
meets resistance in the tissue, heat is produced. The amount of heat will vary depending on the
amount of current, the RF frequency utilized, the resistance levels in the targeted tissue and the
characteristics of the electrodes. As heat is generated and deposited deeply into the dermis,
immediate collagen contraction and subsequent regeneration lead to improvement in wrinkles
and skin laxity. Provided that the heat is deposited in amounts sufficient to raise the temperature
in the dermis to approximately 65 degrees C.and maintained for a suitable time period
collagen in the dermis will undergo a denaturation process which causes collagen fibers to
shorten and shrink and optimal clinical effectiveness can be achieved. The TRIO XT RF
System offers a more exact treatment method for targeted tissue than traditional wrinkle removal
treatments. The thermal effects of RF energy can also help reduce cellulite and excess body fat
as shown below.

(Left): After its three-dimensional helix structure unwinds, collagen fibers start to shrink. The skin
will become smoother and tighter and wrinkles will diminish.
(Right): Skin rejuvenation is the achieved result from the hyperplasia of collagen fibers.

Reduction and recombination of adipose cells.

3.2
3.2.1

TRIO XT Radiofrequency (RF) Modality


Definition of Radiofrequency

Radiofrequency (RF) current is formed when charged particles flow through a closed circuit. As
the energy meets resistance in the tissue, heat is produced. The amount of heat will vary
depending on the amount of current, the resistance levels in the targeted tissue and the
characteristics of the electrodes. The amount of RF energy applied can be configured to target
specific tissues.
RF energy is a form of electromagnetic energy ranging from 3 kHz to 300 mHz. RF affects skin
by emitting high-frequency radio waves that mimic the thermal effects of lasers and intense
pulsed light sources. RF energy is similar to optical energy in that it interacts with the tissue to
produce a thermal change.

3.2.2

Bi-Polar and Tri-polar RF (Two or Three Electrodes)

The TRIO XT System enables you to use either a bi-polar and tri-polar electrode configuration.
With a bi-polar system, the current flows between the positive and negative electrode. With a
tri-polar system, the current flows between three identical electrodes that are set at fixed
distances apart. When using the tri-polar hand piece, the TRIO XT electronic system
continuously switches the polarity between pairs of electrodes. Since the distances between
these electrodes vary, the end result is that different depths of penetration of the RF energy are
reached. The level of current is safely limited by the volume of tissue between each pair of
electrodes. No grounding pad is necessary. Multi-polar systems avoid the unpredictability of
mono-polar (single electrode) systems resulting from current passing through the body to the
grounding electrode. The fact that the distribution of the current in the tissue is safer and more
controlled is a major advantage of multi-polar technology.

3.2.3

TRIO XT Alternating Depth Focus Technology

The TRIO XT System utilizes cutting edge


Tri-Polar and bi-polar radio frequency technology
that can deliver RF energy to different tissue
depths and to specified areas of targeted tissue.
As the RF energy reaches the targeted tissue, a
stress reaction is produced. The stress reaction
leads to heat production which results in skin
tightening, facial rejuvenation, body shaping and
cellulite
reduction.
The
advantage
and
breakthrough in TRIO XT technology lies in the
ability to deliver energy to different skin layers
depending on the treatment objective. The TRIO
XT System has also been designed to be
user-friendly. The operation of the TRIO XT
system is surprisingly easy because the display screen allows the operator to deliver effective
treatments by simply following the touch screen prompts. The TRIO XT System allows the user
to select different tissue depths and specified areas of targeted tissue. As a result, heating the
dermal layer will target collagen fibers in the dermis. When collagen is heated to approximately
60 degrees C. it will undergo denaturation, causing the immediate collapse and unraveling of
the collagen molecule and resulting shrinkage and tightening. After TRIO XT RF energy is
applied to the targeted tissue, the collagen remodeling process will continue for months after the
procedure. Optimal clinical effectiveness often requires a three to six month series of treatments.
The TRIO XT System provides safe and non-invasive treatments for all skin types and all areas
of the body. The system is effective for both female and male patients. Patients can return to
normal activities immediately following TRIO XT treatments. After several months of treatments
in the initial TRIO XT clinical pilot study, nearly 95% of patients expressed their satisfaction with
the treatments. The overall treatment experience has proven to be enjoyable and dramatic,
providing a significant catalyst for new and repeat business.

3.2.4

Determining the Clinical Effect of Radiofrequency

A number of factors determine the clinical effect of RF energy. Basic output parameters are power
output, pulse width, and RF frequency.

RF Power Output: RF power output is measured in watts.

Pulse Width is the duration of a pulse and is measured in milliseconds or seconds.


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3.3

RF Frequency is generally measured in megahertz (mHz) which is the measurement


of the number of cycles which occur each second. One Megahertz equals one million
cycles per second.

TRIO XT COMPONENTS

TRIO XT RF HANDPIECES AND APPLICATIONS


The Mini Handpiece:
Delivers RF energy to eyes, nose, hands, peri-orbital and
peri-oral area. Removes and reduces wrinkles and bags under
eyes, and tightens large pores.

The Bi-Polar Facial Handpiece:


Delivers RF energy to face, neck, arms and hands. Removes and
reduces wrinkles, shapes body figure, enhances flexibility of skin,
tightens large pores, lightens freckles and helps smooth skin.

Bi-Polar Body Handpiece:


Delivers RF energy to the main body. Shapes body figure,
helps eliminate toxins and enhances epidermal tissue.

Tri-Polar Body Handpiece:


Uses a proprietary focused alternating depth (FAD) technology
to deliver RF energy to the abdomen, thighs, buttocks, legs,
upper arms, and cellulite reduction areas. The handpiece
provides two different depths of energy in an alternating pattern
every one (1) minute.

10

Start

System checking

Select Language

Treatment area selection (front)

Touch Front or Back for Treatment area selection

11

PROGRAM ICONS
Custom programming key (set parameters accordingly)

Back key (return to main menu)

Forehead button
EYE Peri-orbital button
Face button
Neck button

Face Button: press Face to enter treatment program.


Forehead Button: press Forehead to enter treatment program.
Neck Button: press Neck to enter treatment program.
EYE Peri-Orbital Button: press EYE to enter treatment program.

12

PROGRAM ICONS
Flashes to alert for abnormal coolant flow

Flashes to alert for abnormal coolant temperature

Flashes to alert of lack of coolant

(return

main menu)

to

Focus Depth Selection (Epidermis, Dermis and Subcutaneous tissue)

Pause key

Ready to DELIVER TREATMENT

13

SETTNG ADJUSTMENTS
Press

to adjust settings manually.

Timer: time setting key max. (60 min)


Cooling: cooling setting key (cooling range 1 snowflake 10C, 2 snowflakes
2.5C, 3 snowflakes -5C.
Energy: energy setting key (energy range 10%-100%)

ALARM
If alarm sounds during Ready mode, system will switch to standby mode automatically,

and

key is not available until error is corrected.

Press

key to return to treatment area selection interface.

TRIO XT HANDPIECE ICONS


Bi-Polar

Mini

facial

handpiece

Bi-Polar Facial handpiece (with contact


cooling)

Bi-Polar

Body

handpiece

Tri-Polar Body handpiece

14

SECTION 4: PRE-TREATMENT CONSIDERATIONS

4.1 GENERAL PRE-TREATMENT CONSIDERATIONS AND RECOMMENDATIONS


Before the initial treatment the practitioner should examine the areas intended for treatment and
explain to the patient the treatment procedure, expected results, and the possibility of potential
side effects. The practitioner will first make sure that there are no contraindications to treatment
(see list below) and that the patient can safely undergo the treatment. After explaining the
possibilities and limitations of the procedure, the practitioner will determine which areas can be
treated and what length and number of treatments will ne necessary to obtain satisfactory results.
The full treatment program will be determined by the desired end result of the patient. For best
results, the patient should be willing to complete a full treatment regimen to enjoy the benefits of
the treatment. In addition, the practitioner should advise the patient that there may be some mild
discomfort associated with the treatment, and that side effects such as erythema, edema or
blistering may appear after treatment. Also, there is a minimal risk that adverse side effects such
as changes in texture, and hypo or hyperpigmentation may occur. Before administrating the
treatment, the area(s) to be treated should be cleansed with a mild cleanser, dried, and outlined
with a marker or white eyebrow pencil.

4.2 PRE-TREATMENT CONSIDERATIONS AND RECOMMENDATIONS FOR RF


TREATMENTS
4.2.1 TREATMENT CONTRAINDICATIONS FOR RF MODALITY
1. Pregnancy
2. Application to abdomen (during menstrual period)
3. Audiphones, cardiac pacemaker, etc. or other metal medical apparatus or metal/plastic
implant in the body (if you have a question, consult a physician)
4. Implanted intrauterine device (IUD)
5. Gold wire implant
6. The patient wearing a watch, necklace, or other metal jewelry.
7. Physical skin disease or inflammation of the skin.
8. Do not use directly on upper eyelid, throat (Adams apple or thyroid glands), behind the
knee or on overly sensitive areas.

4.2.2 PRE-TREATMENT CONSIDERATIONS (RF MODALITY)

Patient must read, understand and sign appropriate Informed Consent (invite to ask
any questions and provide answers to patients satisfaction)

15

Cleanse face with soapy water (do NOT apply moisturizer after cleansing) and dry
thoroughly.

Take before photos (5 views plus areas of opportunity, following clinic photography
protocol)

Ensure and reinforce appropriate expectations are set (treatment experience,


moderate improvement of wrinkles and fine lines, timing of results, etc.)

Ask if patient has a pacemaker or ICD (internal defibrillator), and confirm whether patient
is, or could be pregnant. If yes, discontinue procedure.

Ask patient about specific allergies to medications.

Ask patient to remove all jewelry, shirt or blouse, and put on gown.

Apply alcohol to thoroughly cleanse the face and neck.

If applying topical anesthesia, apply a minimum of 45 minutes prior to


procedure start time.

Prior to TRIO procedure, if topical was applied, remove topical completely and
cleanse area with acetone. Then apply treatment grid markings (for face and
neck use 4 x 4 cm squares; for the body use 8 x 8 cm squares) with washable
skin marker.

4.2.3 PRE-TREATMENT STEPS FOR RF PROCEDURE


1. Select hand piece in accordance with the area you are treating:
a. Mini Hand piece: For use around eyes, nose and mouth;
b. Facial Hand piece (with integrated contact cooling): For use on face, neck, arms
and hands;
c. Body Hand piece: For use on the body.
2. Apply a generous coating of conductive gel to area(s) to be treated.
3. Depress foot switch to activate RF energy. Release the foot switch to pause or halt the
emission of RF energy.
4. Always keep face of hand piece flat on skin with both electrodes in contact at all times
(apply very slight pressure) and keep moving hand piece slowly back and forth or in
small circular motions in treatment area (4 x 4 cm or 8 x 8 cm) until target temperature (40
degrees C.) is reached.
5. Be careful not to lift the hand piece off the skin until you have first released the foot switch.
This will be more comfortable for the patient.
6. The STANDBY key must always be pressed before you change hand pieces, energy
levels, cooling selection (if applicable), or time selection. Press READY key to resume.

16

SECTION 5: TRIO XT TREATMENT PROTOCOLS


5.1 TRIO XT RF PRE-SET PARAMETER SETTINGS

Treatment Area

Treatment
Time
(minutes)

Cooling
Setting

Energy
Level

Handpiece

Face
Forehead

20
5

**
**

20%
20%

Facial
Facial

Eyes (Peri-Orbital)

**

20%

Facial

Neck
Abdomen
Legs
Back
Feet
Buttocks
Arm
Hand

10
20
20
20
20
20
20
15

**
NA
NA
NA
NA
NA
NA
NA

40%
60%
60%
50%
40%
60%
50%
40%

Facial
Body
Body
Body
Body
Body
Body
Body

5.2

TRIO XT RF TREATMENT PROCEDURE


1. Begin each treatment at the 50% energy setting and apply current to first section (either
4 x 4 cm if treating FACE or 8 x 8 cm area if treating BODY) for approximately one
minute. At the one minute point, check skin temperature with supplied IR thermometer.
The target endpoint for each treated section is to comfortably reach a target
surface skin temperature of 40 Celsius.
2. Throughout the procedure, periodically ask patient about her comfort level and adjust
energy setting accordingly.
3. Avoid stopping movement of the hand piece while the foot switch is depressed and
energy is active as this may cause rapid tissue heating and sudden discomfort.
4. If the skin temperature is below 40 C. in the section being treated, increase energy level
in increments of 10% and continue as shown in steps 1 3 above. Go as high as 100%
energy if necessary to achieve the desired 40 degrees C. endpoint as long as the patient
can tolerate the heat.
17

5. Once the section being treated reaches 40C, this temperature must be maintained for
at least one (1) minute. In order to do this without causing discomfort to the patient, it
is helpful follow these steps:
a. Move to an immediately adjacent area and apply the hand piece for 10- 15
seconds;
b. Move back to the section that you are maintaining at 40C, and continue working the
area until the clinical end point has been maintained for at least a full minute. Continue in
this manner until the entire desired facial or body area has been treated.
6. Sensitivity levels around the eyes may make the treatment more uncomfortable and
should be adjusted to provide lower energy settings than other areas of the face.
7. Note: The average face will require treatment of approximately 16 4 x 4 cm treatment
zones. If you spend approximately one minute on each area to reach the target end point
temperature and maintain for one additional minute, the average face should take from
30 to 40 minutes to treat with a single pass. Multiple passes are not recommended.

5.3 SPECIFIC AREA TREATMENT RECOMMENDATIONS

Note: Use of the Audible Treatment Metronome (ATM) to help utilize the optimal speed of
movement of the treatment hand piece when performing the RF treatments is optional.

18

FACE TREATMENT PROGRAM

1)Touch AVATARs head on LCD touch screen.


2) Press FACE key.
3)Set Focus Depth for dermal layer.

Press Foot Pedal to

4)Select the facial handpiece.

Activate Handpiece

5)Select energy %.
6)Set Audible Treatment Metronome (ATM).
7)Press READY key to start program.
8)Press foot pedal to activate handpiece.

Program Settings: Start new patients with the lowest setting;


continue to move energy and ATM settings according to the
chart on this page:

Step1: Cleanse

Bi-Polar
Energy level

ATM Setting

40%

50 beats/ minute

60%

55 beats/ minute

Step 2: Apply conductive gel to local area being treated

Step 3: Move handpiece slowly from center to temple in 4 cm x 4 cm sections at a slow constant speed in a
back and forth motion until skin slowly reaches temperature is 40 degrees C. Treat all sections on the
upper portion of the face.
Step 4: Move handpiece from corners of the mouth to temple at a slow constant speed to treat the lower
portion of the face.
19

Full Face Treatment Time: 40 minutes total (20 minutes each side).
Treatment Tips:
I.

Move the handpiece slowly on the face at a slow constant circular or back and forth motion, in
4 cm x 4 cm sections.

II.

Release foot pedal and lift entire handpiece off skin.

III.

Handpiece must make contact with skin before pressing foot pedal or a shock to the patient
may result.

IV.
V.

Check the surface skin temperature frequently with IR external thermometer (40 degrees C)
During operation, ask the patient if she feels warmth and adjust the energy setting accordingly,
energy setting is a guideline only, the setting may go higher than guideline.

FOREHEAD TREATMENT PROGRAM


1) Touch AVATARs head on LCD touch screen. 2) Press
FOREHEAD button. 3) Adjust Focus Depth to dermal/
epidermal layer depth. 4) Select the facial or mini
handpiece. 5) Select energy %.

6) Set Audible

Treatment Metronome (ATM). 7) Press READY key to


start program. 8) Press foot pedal to activate handpiece.
Program Settings: Start new patients with the lowest settings;
continue

Adjust energy level and ATM settings according to the chart on this page:

Bi-Polar

Step 1: Cleanse

Press Foot Pedal to Activate

Energy level

ATM Setting

40%

35 beats/ minute

60%

55 beats/ minute

Handpiece

Step 2: Spread conductive gel to local treatment area. Step 3: Move handpiece slowly from center to
temple in 4 cm x 4 cm sections at a slow constant speed in a back and forth motion until skin slowly
reaches temperature is 40 degrees C.

20

Time: 5 minutes entire forehead (2.5 minutes for each side).


Treatment Tips:
I.

The forehead is a sensitive area, so a lower energy setting may be indicated.

II.

Move the handpiece slowly on the face at a slow constant circular or back and forth motion, in
small trirants.

III.

Always remove handpiece from the forehead with two poles at the same time.

IV.

Make full contact with treatment area before pressing or depressing foot pedal or a shock to
the patient may result.

V.

Energy setting is a guide only energy may be set higher than these guide lines.

VI.

Check the surface skin temperature frequently with IR external thermometer (goal is to
maintain 40 degrees C for one minute)

VII.

During operation, ask the patient if she feels warmth and adjust the energy setting accordingly,
energy setting is a guideline only, settings may need to be higher to achieve 40 degrees C.).

PERI-ORBITAL (EYE) TREATMENT PROGRAM


1) Touch AVATARs head on LCD touch screen.
2) Press EYE key.
3) Adjust Auto Focus to dermal epidermal layer depth.
4) Select the FACIAL or MINI-PROBE handpiece.
5) Select energy %. 6) Set Audible Treatment Metronome
(ATM). 7) Press READY key to start treatment. 8) Press foot pedal to
activate
handpiece.
Program Settings: Start new patients with the lowest setting.
Continue to adjust energy and ATM settings according to the chart on this
page:
Press Foot Pedal

Bi-Polar Facial or Mini Probe

to Activate

Energy level

ATM Setting

40%

90 beats/ minute

60%

90 beats/ minute

Step 1: Cleanse Step 2: Spread cooling gel to one eye area and then next eye area. Step 3: Move
handpiece around the outside corner of each eye in a small circular motion, concentrating on visible crows
21

feet Move at constant slow speed. Be careful not to stop movement. Eye area is sensitive, adjust energy
level accordingly.

Time: 10 minutes total (5 minutes per side)


Treatment Tips:
I.

Move the handpiece slowly on the face at a slow constant circular or back
and forth motion, in small quadrants

II.

During operation, ask the patient if she feels warmth and adjust the energy
setting accordingly, The recommended energy settings are guidelines only
(higher settings may be required to reach 40 degrees C.).

III.

Make full contact with treatment area before pressing foot pedal or a patient
shock may result.

IV.

Check the surface skin temperature frequently with IR external


thermometer (40 degrees C for one full minute is the goal)

PERI-ORAL (MOUTH) TREATMENT PROGRAM


1) Touch AVATARs head on LCD touch screen. 2) Press FACE key..
3) Adjust Focus Depth to select dermal/epidermal junction. 4) Select the mini
probe hand piece.
5) Select energy %. 6) Set Audible Treatment Metronome
(ATM).

7) Press READY key to start program. 8) Press foot pedal to

activate handpiece.
Program Settings: Start new patients with the lowest recommended settings;
Continue to adjust energy and ATM settings according to the chart on this
page:

22

Press Foot Pedal

Bi-Polar Mini Probe

to Activate

Energy level

ATM Setting

40%

90 beats/ minute

60%

90 beats/ minute

Step 1: Cleanse
Step 2: Spread cooling gel. Step 3: Move mini handpiece in small circular motions surrounding the mouth
at constant speed. Do not move hand piece too slowly (this can cause sudden hot spots and patient
discomfort).

Time: 5 minutes total ( 2.5 minutes per side)


Treatment Tips:
I.

Give additional time to deeper wrinkles as necessary.

II.

Avoid touching the lips with the applicator.

III.

Move the handpiece slowly on the face at a slow constant circular or back and forth
motion, in small quadrants (4 cm x 4 cm grids).

IV.

Make full contact with treatment area before pressing or depressing foot pedal or a
patient shock may result.

V.

Check the surface skin temperature frequently with IR external thermometer (40
degrees C) for one full minute is the goal.

VI.

During operation, ask the patient if she feels warmth and adjust the energy setting
accordingly, The energy setting is a guideline only (energy may go higher than
guideline to reach 40 degrees C.).

23

NECK TREATMENT PROGRAM


1) Touch AVATARs head on LCD touch screen. 2) Press NECK key.
3) Adjust Focus Depth to select dermal layer. 4) Select the
facial handpiece.
5) Select energy %. 6) Set Audible Treatment Metronome (ATM).
7) Press READY key start program. 8) Press foot pedal to activate
handpiece.
Program Settings: Start new patients with the lowest setting;
continue to move energy and ATM settings according to the chart on this
page:

Press Foot Pedal to

Facial Hand Piece

Activate Handpiece

Energy level

ATM Setting

40%

50 beats/ minute

60%

55 beats/ minute

Step 1: Cleanse
Step 2: Spread cooling gel to one side of neck and then the other

Step 3: Move the facial handpiece from collar bone to mandible in 4 cm x 4 cm sections at a slow constant
speed (Do NOT apply hand piece directly above the Adams apple.
Time: 20 minutes total time (10 minutes per side).
Treatment Tips:
I.

Move the handpiece slowly on the neck at a slow constant circular or back and forth motion, in
small quadrants. Always move in a parallel direction to the treatment electrodes.

II. Make full contact with treatment area before pressing or depressing foot pedal or a patient shock
may result.
III. Check the surface skin temperature frequently with IR external thermometer (goal is 40 degrees
C.).
24

IV. During the procedure, ask the patient if she feels warmth and adjust the energy setting accordingly.
The energy setting is a guideline only (energy may to be higher to maintain 40 degree skin
temperature).

ABDOMEN TREATMENT PROGRAM

1) Touch front of AVATARs body on LCD touch screen. 2) Press ABDOMEN key 3) Adjust Focus Depth to
the deepest dermal layer. 4) The body handpiece is pre-set on screen, but use of the quad-polar body
hand piece is optional) 5) Select energy %. 6) Set Audible Treatment Metronome (ATM). 7) Press READY
key to start program. 8) Press foot pedal to activate handpiece.
Program Settings: Start new patients with the lowest setting. Adjust energy and ATM settings according to
the chart on this page:

Press Foot Pedal to

Quad-Polar Body

Bi-Polar Body

Hand Piece

Hand Piece

Energy level

ATM Setting

Energy level

ATM Setting

40%

30 beats/ minute

40%

50 beats/ minute

60%

40 beats/ minute

60%

60 beats/ minute

80%

50 beats/ minute

80%

100 beats/ minute

Activate Handpiece

Step 1: Cleanse Step 2: Divide abdomen into 8 cm x 8 cm grids, and apply conductive gel one half of
abdomen. Step 3: Move the body handpiece to the first side of the abdomen in a linear 8 cm x 8 cm
sections at a slow constant speed, moving the hand piece in a back and forth motion at a speed set by the
ATM. Step 4: Move the handpiece from outside of the waist to the inside. Step 5: Repeat steps 2 through
4 for the other side of the abdomen.

25

Time: 40 minutes total (20 minutes per side).


Treatment Tips:
I.

Move the handpiece on the abdomen at a slow constant back and forth motion (8cm x 8cm
sections).

II. Make full contact with treatment area before pressing or depressing foot pedal or a patient shock
may result.
III. Check the surface skin temperature frequently with IR external thermometer (40 degrees C. is
goal).
IV. During the procedure, ask the patient if she feels warmth and adjust the energy setting accordingly.
Energy setting is a guideline only (settings may need to be higher than guideline to achieve 40
degrees C.).
V.

CELLULITE TREATMENT (CUSTOM PROGRAM) FOR THIGHS


AND BUTTOCKS
Press CUSTOM Key
Set time to 20 minutes (per side)

Select body handpiece


Plug in the quad-polar handpiece
Set energy at 40%-80%

1) Select CUSTOM key. 2) Select the body handpiece button/ plug in quad-polar handpiece/ set time to
20 minutes/ set energy %. 3)

Adjust Focus Depth to the deepest level. 4) Set Audible Treatment

Metronome (ATM). 5) Press READY key to start program. 6) Press foot pedal to activate handpiece.

26

Program Settings: Start new patients with the lowest setting; continue to move energy and ATM settings
according to the
chart on this page:

TRI-Polar Body

Bi-Polar Body

Energy level

ATM Setting

Energy level

ATM Setting

40%

30 beats/ minute

40%

40 beats/ minute

60%

40 beats/ minute

60%

60 beats/ minute

80%

50 beats/ minute

80%

100 beats/ minute

Press Foot
Pedal to
Activate
Handpiece

Step 1: Have patient lay on her stomach, Cleanse treatment area. Step 2: Use washable skin marker to
mark off 8 cm x 8 cm square grids. Step 3: Apply conductive gel to first area. Step 4: Apply the handpiece
to the treatment area and move it using a slow back and forth or circular motion, covering the entire
treatment area until the target skin
temperature of 40 degrees C. is
reached. Step 5: Re set timer to 20
minutes and repeat steps 1-4 in each
remaining treatment area.

Time: 40-80 minutes total (20 minutes per area/total time depends on the number of 8 x 8 cm grids
treated).
Treatment Tips:
I.

Move the handpiece slowly on the thigh and buttocks at a slow constant circular or back and
forth motion, in 8 cm x 8 cm quadrants.

II.

Make full contact with skin before pressing or depressing foot pedal or a patient shock may
result.

III.

Check the surface skin temperature frequently with IR external thermometer (each quadrant
must reach the target temperature of 40 degrees C. and maintain for a full minute).

IV.

During the procedure, ask the patient if she feels warmth and adjust the energy setting
accordingly. The energy setting is a guideline only (the setting may need to be higher to
achieve 40 degrees C.).

27

BACK TREATMENT PROGRAM

1) Touch the back of the AVATARs body on LCD touch screen. 2) Press the BACK key. 3) Adjust
Focus Depth to the deepest dermal layer. 4) The body handpiece is pre-set, but use of the
quad-polar handpiece is highly recommended.. 5) Select energy %. 6) Set Audible Treatment
Metronome (ATM). 7) Press READY key to start program. 8) Press foot pedal to activate
handpiece.
Program Settings: Start new patients with the lowest setting.

Adjust the energy and ATM settings

according to the chart


on this page:

Quad-Polar Body

Bi-Polar Body

Energy level

ATM Setting

Energy level

ATM Setting

40%

30 beats/ minute

40%

40 beats/ minute

60%

40 beats/ minute

60%

60 beats/ minute

80%

50 beats/ minute

80%

100 beats/ minute

Press Foot Pedal to


Activate Handpiece

Step 1: Cleanse. Step 2: Divide area of treatment into 8 cm x 8 cm grids. Step 3. Apply conductive gel to
the first grid area (start at the lower back center of one side of back). Step 4: Apply hand piece to the body
and move out to the sides and back to the center at a slow constant speed. Move the handpiece in a linear
motion and treat entire 8cm x 8cm section (do NOT treat directly on the spine). Step 5: Move upward
towards the shoulders and treat additional sections in the same manner. Step 6: Repeat steps 3 through 5
on the other side of the back.

Time: 40- 60 minutes total (20 minutes per 8 cm x 8 cm area). Total time depends on size of area treated.

28

Treatment Tips:
I.

Move the handpiece slowly on the back at a slow constant circular or back and forth motion.
Be sure to treat each entire 8 cm x 8 cm section.

II.

Make full contact with treatment area before depressing foot pedal or a patient shock may
result.

III.

Check the surface skin temperature frequently with IR external thermometer (objective is to
reach and maintain an external skin temperature of 40 degrees C. for one full minute in each
area).

IV.

During the procedure, ask the patient if she feels warmth and adjust the energy setting
accordingly. The energy setting is a guideline only. The setting may need to be higher than the
guidelines to achieve target skin temperature of 40 degrees C.

BUTTOCKS TREATMENT PROGRAM


1) Touch the BACK of the AVATARs body on the LCD
touch screen. 2) Press the BUTTOCKS key. 3) Adjust
Focus Depth to the deepest dermal layer. 4) The body
handpiece is pre-set, but use of the quad-polar hand
piece is highly recommended. 5) Select energy %. 6)
Set Audible Treatment Metronome (ATM). 7) Press the
READY key to start program. 8) Press foot pedal to
activate handpiece.

Program Settings: Start new patient with the lowest settings. Adjust energy and ATM settings according
to the chart on this page:
Bi-Polar Body

Quad-Polar Body
Press Foot Pedal to
Activate Handpiece

Energy level

ATM Setting

Energy level

ATM Setting

40%

40 beats/ minute

40%

60 beats/ minute

60%

55 beats/ minute

60%

80 beats/ minute

Step 1: Cleanse Step 2: Use washable marker to mark off 8 cm x 8 cm grids on treatment area and apply
conductive gel to first area.
Step 3: Apply hand piece to the first treatment area and move from the center out to the sides at a slow
constant speed. Move the handpiece in a slow constant circular or back and forth motion throughout the
entire treatment grid area until the skin surface reaches 40 degrees C.. Maintain this temperature for one
29

full minute. Step 4: Repeat steps 2 and 3 for the other treatment grids until the entire buttocks area has
been treated.
Time: 30 to 60 minutes totaldepending on total size of area being treated (15 minutes per grid area).
Treatment Tips:
I.

Move the body handpiece slowly throughout entire 8 cm x 8 cm grid area in a slow constant
back and forth motion until goal temperature is reached.

II.

Make full contact with treatment area before pressing or depressing foot pedal or a patient
shock may result.

III.

Check the surface skin temperature frequently with IR external thermometer (goal is 40
degrees C.).

IV.

During the procedure ask the patient if she feels warmth and adjust the energy setting
accordingly. The energy setting may need to be higher than the guideline to reach and
maintain the 40 degrees C. goal temperature.

ARMS TREATMENT PROGRAM

1) Touch AVATARs arm, 2) Press the ARM key, 3) Adjust Focus Depth to deepest level.
4) Select handpiece (facial or body handpiece can be used). 5) Select energy %
6) Set Audible Treatment Metronome (ATM), 7) Press READY key to start program 8) Press foot switch
to start emission of energy.
Program Settings: Start new patients with the lowest energy setting recommended; continue to adjust
energy and ATM settings according to the
chart on this page:
Press Foot Pedal to
Activate Handpiece

Quad-Polar Body Hand Piece


Energy level

ATM Setting

50%

50 beats/ minute

60%

55 beats/ minute

Step 1: Cleanse

30

Step 2: Spread conductive gel to the back of one arm area and treat.

Step 3: Move the handpiece in a back and forth linear motion from elbow to the upper arm on the back and
front of arm in 8 cm x 8cm sections until each section reaches goal temperature of 40 degrees C. Step 4:
Repeat steps 2 and 3 on the other arm. Step 5: Repeat steps 2 and 3 on the lower portions of the arms
(below elbow) if necessary.
Time: 30 45 minutes total, 15 minutes per area (total time required depends on size of total area treated).
Treatment Tips:
I.

Move the handpiece slowly using circular or back and forth motions being sure to treat
entirety of each 8cm x 8cm section.

II. Make full contact with treatment area before depressing foot pedal or a patient shock
may result.
III. Check the surface skin temperature frequently with IR external thermometer (goal is to
maintain 40 degrees C. temperature for one full minute).
IV. During the procedure, ask the patient if she feels warmth and adjust the energy setting
accordingly. The recommended energy setting is a guideline only (higher energy may be
needed to reach 40 degrees C.).

HANDS TREATMENT PROGRAM

1) Touch AVATARs Arm 2) Press the HAND key 3) Adjust Focus Depth to epidermal/ dermal junction.
4) Select mini probe handpiece and select energy % 5) Set Audible Treatment Metronome (ATM)
6) Press READY key to start program 7) Press foot switch to start emission of energy.
Programs Settings: Start new patients with the lowest setting. Adjust energy and ATM settings
according to the chart on this page:
31

Bi-Polar Mini Probe

Press Foot Pedal to

Energy level

ATM Setting

60%

50 beats/ minute

Activate Handpiece

Step 1: Cleanse Step 2: Apply conductive gel to area of treatment.

Step 3: Move the mini probe handpiece from the finger base to the tip of the finger of each hand at a
constant speed according to the ATM and continue the application of RF energy until the skin reaches goal
temperature of 40 degrees C.
Time: 20 minutes total (10 minutes per hand).
Treatment Tips:
I.

Move the handpiece slowly on the hand and fingers at a slow constant
back and forth motion.

II.

Make full contact with treatment area before depressing foot switch or a
patient shock may result.

III.

Check the surface skin temperature frequently with IR external


thermometer (objective is to reach and maintain 40 degrees C.)

IV.

During the procedure, ask the patient if she feels warmth and adjust the
energy setting accordingly. The recommended energy settings are
guidelines only (the actual energy level used may need to be higher
than guideline to reach 40 degrees C.).

32

LEGS TREATMENT PROGRAM

1) Touch AVATARs Leg. 2) Press the LEG key. 3) Adjust Focus Depth to deepest layer
4) Body Handpiece selected. Plug in quad-polar handpiece. 5) Select energy %
6) Set Audible Treatment Metronome (ATM) 7) Press READY key to start program 8) Depress foot
switch to begin emission of energy.
Program Settings: Start new patients with the lowest recommended setting. Continue to adjust energy and
ATM settings according to the chart on this page:
Quad-Polar Body Hand Piece

Press Foot Switch to


Activate Handpiece

Energy level

ATM Setting

50%

50 beats/ minute

Step 2: Mark off 8 cm x 8 cm grids on legs and

60%

55 beats/ minute

apply conductive gel to first section (start at

80%

70 beats/ minute

Step 1: Cleanse treatment area.

bottom of legs).

Step 3: Starting at the bottom of the leg, move the handpiece in back and forth vertical movements up the
back of the leg toward the knee at a constant speed until the skin temperature of 40 degrees C. is reached.
Step 4: Repeat steps 2 and 3 for other sections of legs. For upper legs, turn patient over and repeat steps 2
and 3 on front of upper legs.
Time: 40 60 minutes total (depending on size of area treated).
Treatment Tips:

Move the body handpiece at a slow, constant speed throughout each area.
Do NOT treat area behind the knee (popliteal).
33

Make full contact with treatment area before pressing or depressing foot pedal or a patient
shock may result.
Check the surface skin temperature frequently with IR external thermometer (goal is to reach
and maintain skin temperature of 40 degrees C.).
During the procedure, ask the patient if she feels warmth and adjust the energy setting
accordingly. The energy setting recommendation is a guideline only (actual settings may
need to be higher to reach 40 degrees C.).

5.4

POST-RF TREATMENT RECOMMENDATIONS

Post procedure: Cleanse face with gentle cleanser to remove any remaining conductive gel
and grid markings. Follow with application of moisturizer and sunscreen.

Be sure to take post treatment photographs (using the same 5 view as pre photos),
and schedule I month, 3 month, & 6 months follow up photo sessions and
evaluations.

Post-operative care instructions: Moisturizer with sunscreen as aftercare and may use cold
compresses (i.e., ice packs) if experiencing discomfort.

5.5 TRIO XT RECOMMENDED NUMBER OF TREATMENTS AND TREATMENT


INTERVALS

FACE
BODY

Recommended No. of
Treatments
4 to 6
8 to 10

Recommended Treatment
Interval
1 Per Week
1 Per Week

5.6 CONSIDERATIONS FOR ALL TREATMENTS:

Recommend that your patients stay well hydrated during the treatment program.
(Drink minimum of 8 glasses (8 fl. oz.) of water per day)

Program Settings: Start new patients with the lowest recommended parameter settings;
continue to adjust energy and ATM settings according to the chart (shown above) on
each page

34

During the procedure, ask about the patients comfort and adjust the energy setting to the
highest level that is still comfortable for the patient.

Use the Audible Treatment Metronome (ATM) to help determine the proper speed you
should move the handpiece (optional).

Skin surface temperature levels must be checked frequently to ensure the desired
temperature is achieved. Repeated motions in the same area (about 10 times) on the
skin surface should reach the clinical end point of 40 degrees C. Follow the ATM
guidelines for each indication.

Hand piece should be applied with gentle pressure. Always keep the handpiece moving
at a slow constant speed. Never stop on a treatment area with foot switch depressed or
discomfort may result. Always remove the entire handpiece from the skin in a single
motion or a shock may result (release foot switch first, then remove hand piece).

Move the handpiece in small circular or back and forth motions at the recommended
speed with the assistance of the ATM.

The skin around the eyes and forehead are more sensitive therefore, energy levels
around the eyes and forehead may need to be turned down to a lower level than on other
areas of the face.

5.7 POST-TREATMENT CONSIDERATIONS

After the treatment, patients can immediately resume their normal daily activities. There is no
down time or recuperation period required, and no need for follow up visits except for the next
TRIO XT treatment which should be scheduled approximately one week after the previous
treatment. Patients report that there is no post-treatment pain or discomfort, and that the skin
surface is not disrupted or bruised as a result of the treatment.

5.8 RECOMMENDED MAINTENANCE PROGRAM


Following the initial treatment series of 6 to 10 sessions, the recommended maintenance
program includes one treatment session per month for 4 months. For the fifth month and
thereafter, one maintenance treatment every three months is recommended to maintain optimal
results.

35

Treatment Time Parameters:

Treatment

Total
treatment
time in
minutes

Cooling
Setting

Energy

Handpiece

40-60%

Bi Facial

**
***

40-60%

Bi Facial

Peri-Orbital(eye)

10

No

40-60%

Bi Mini

Peri-Oral Mouth

No

40-60%

Bi Mini

20

**

40-60%

Bi Facial

Full Face

40

Forehead

Neck

TRI or Bi
Abdomen

40

No

40-80%
Body

36

TRI or Bi
Back

40

No

40-80%
Body

Arms

30

No

50-60%

TRI Body

Hands

20

No

60%

Bi Mini

Legs

40

No

50-80%

TRI Body
TRI or Bi

Buttocks

30

No

40%-60%
Body

37

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