Exilis: Operator's Manual

Exilis
(Elite Technology)
Operator’s Manual
301FD2013/09/05EN
BEFORE YOU START
Dear Customer,
Thank you for purchasing the Exilis advanced aesthetic

system for your clinic. All of us at BTL wish you every
success with your new device. We pride ourselves on being
as responsive as possible to our customer’s needs. Your
suggestions and comments are always welcome since we
believe an ongoing relationship with our customers is
critically important to our future product line.
While we would like you to start using your new equipment

right away, we encourage a thorough reading of this manual
in order to fully understand the operational features of the
system.
BTL Industries, Ltd.
EXILIS - OPERATOR’S MANUAL l PAGE 2 OF 39

CONTENTS
1 SAFETY PRECAUTIONS................................................................................................................5
1.1 MAINTENANCE .....................................................................................................................5
1.1.1 CLEANING THE APPLICATOR AND COMPONENTS ....................................................6
1.1.2 USING APPLICATOR TIP COVER ...................................................................................6
1.2 FUSE REPLACEMENT ..........................................................................................................7
1.3 SYMBOLS AND ABBREVIATIONS USED .............................................................................8
1.4 GENERAL SAFETY INFORMATION AND PRECAUTIONS ..................................................8
1.4.1 GENERAL CAUTIONS ......................................................................................................8
1.4.2 BURN HAZARDS...............................................................................................................9
1.4.3 EXPLOSION AND FIRE HAZARDS ............................................................................... 10
1.4.4 HIGH VOLTAGE HAZARDS ........................................................................................... 10
1.4.5 RADIO FREQUENCY OPERATIONAL SAFETY ........................................................... 10
2 GENERAL CHARACTERISTICS ................................................................................................. 12
2.1 THE SYSTEM...................................................................................................................... 12
2.2 INTENDED USE AND INDICATIONS FOR USE ................................................................ 12
3 TREATMENT SAFETY................................................................................................................. 13
3.1 EXPECTED DEVICE-RELATED TREATMENT SEQUELAE ............................................. 13
3.2 POSSIBLE ADVERSE EFFECTS OF TREATMENT .......................................................... 13
3.3 CONTRAINDICATIONS ...................................................................................................... 13
3.4 PRE-TREATMENT INFORMATION.................................................................................... 14
3.5 COUNSELING..................................................................................................................... 15
3.6 SPECIAL CONSIDERATIONS AFFECTING SUCCESSFUL OUTCOME .......................... 15
4 SYSTEM DESCRIPTION.............................................................................................................. 16
4.1 FRONT PANEL CONTROLS AND FEATURES .................................................................. 16
4.2 REAR PANEL FEATURES .................................................................................................. 17
5 ASSEMBLY AND PUTTING INTO OPERATION ........................................................................ 18
5.1 UNPACKING THE SYSTEM ............................................................................................... 18
5.2 SAFETY PRECAUTIONS REGARDING THE SYSTEM ASSEMBLY................................. 18
6 OPERATING INSTRUCTIONS .................................................................................................... 19
6.1 USE OF SYSTEM SCREEN................................................................................................ 19
6.1.1 WELCOME SCREEN ..................................................................................................... 19
6.1.2 TOUCH SCREEN ........................................................................................................... 19
6.1.3 NUMERICAL KEYBOARD .............................................................................................. 19
6.2 PERFORMING THE THERAPY .......................................................................................... 19
6.2.1 SELECTION OF APPLICATORS ................................................................................... 19
6.2.2 SESSION SCHEDULE ................................................................................................... 19
6.2.3 APPLICATOR MOTION .................................................................................................. 20
6.2.4 WARNINGS .................................................................................................................... 20
6.2.5 THE APPLICATOR DISPLAY......................................................................................... 21
6.2.6 GENERAL RECOMMENDATIONS ................................................................................ 24
6.2.7 PLACE THE REFERENCE PATCH ELECTRODE ........................................................ 24
6.2.8 PREPARE THE TREATMENT AREA............................................................................. 25
6.2.9 SET THE POWER .......................................................................................................... 26
6.2.10 SET THE COOLING TEMPERATURE ...................................................................... 26
6.2.11 SET THE DUTY FACTOR .......................................................................................... 26
6.2.12 SET THE THERAPY TIME ......................................................................................... 26
6.2.13 START THE THERAPY.............................................................................................. 26
6.2.14 PAUSE THE THERAPY ............................................................................................. 27
6.2.15 EMITTING THE ENERGY .......................................................................................... 27
6.2.16 STOP THE THERAPY................................................................................................ 27
6.3 USER MENU ....................................................................................................................... 29

6.3.1 CLIENTS ......................................................................................................................... 29
6.4 MENU .................................................................................................................................. 29
6.4.1 ACCESSORIES .............................................................................................................. 29
6.4.2 UNIT SETTINGS............................................................................................................. 29
6.4.3 SPECIFIC SETTINGS .................................................................................................... 31
7 LIST OF STANDARD AND OPTIONAL ACCESSORIES ........................................................... 32
8 TECHNICAL PARAMETERS ....................................................................................................... 33
8.1 OUTPUT CHARACTERISTICS........................................................................................... 34
8.1.1 LARGE APPLICATOR (215/1) ....................................................................................... 34
8.1.2 SMALL APPLICATOR XP (215/3) .................................................................................. 35
8.2 EMC DECLARATION .......................................................................................................... 36
8.3 MANUFACTURER .............................................................................................................. 39

1 SAFETY PRECAUTIONS
The information provided in this manual is not intended to replace the professional
knowledge, experience, and/or training of the healthcare professional regarding the clinical
use of the system.
1.1 MAINTENANCE
All maintenance and service must be carried out by BTL authorized technical personnel. BTL
bears no responsibility for repairs or service performed by personnel not directly trained by
the company.
Safe operation of this medical device requires close attention to detail during normal
operation. Please check the following items on a regular basis.
Applicator thermometer sensor: regularly clean oil from the thermometer sensor’s surface
(e.g. using a clean soft cotton cloth) to ensure correct temperature reading.
Applicator surface: always clean oil or gel from the applicators and from the applicator tips.
Applicators and applicator tips must be kept clean at all times. Do not use abrasive cleaners.
Caution
Never use acid cleaners (such as those containing phosphorus acid) to clean the applicator
and the applicator tip. Use of cleaning agents containing acids will cause damage to the
coating of the applicator and the applicator tip.
Applicator cables: check for kinks and frayed insulation. Keep the press fastener that
attaches the patch electrode cable to the applicator clean. Keep the cable contacts clean
from oil.
Power cord and plug: check for frays and kinks. Ensure that the insulation is not damaged
in any way.
System component cables, electrodes and leads: check for frays, cuts or tears in the
insulation. Do not use damaged components and contact your BTL authorized service
provider for service. Always route electrical cords and cables away from user or patient foot
traffic areas where they could increase the chance of a tripping related accident.

All maintenance by the operator must only take place when the system is shut down, and
disconnected from the power source.
Caution
With the exception of surface cleaning of the console and components and the replacement
of the fuse, the system has no user-serviceable activities, parts, or assemblies. Do not
remove the instrument covers under any circumstances. Call your distributor for advice
about any malfunction.
The system prevents connection of any accessories not supplied by the manufacturer.
1.1.1 CLEANING THE APPLICATOR AND COMPONENTS
The surfaces of the applicators, the applicator cables, and the system console should be
cleaned immediately after use to prevent debris from becoming affixed.
To clean the surface of the applicator, the applicator cables, and the system console:
• The outer surface of the applicator, the applicator cables, and the system console
may be wiped clean with a soft cotton cloth that has been moistened in 70% alcohol.
• If alcohol is used to clean and disinfect any part of the system, allow it to dry
thoroughly before operating the equipment.
• After wiping, inspect the surfaces for any debris. If debris is present, repeat the
wiping step until all visible debris is removed.
• Never spray aerosol cleaners directly onto the equipment. Aerosol spray cleaners are
permitted to clean the cabinet, but the cleaner should be sprayed onto a clean cloth
which may then be used to wipe the dirty area.
1.1.2 USING APPLICATOR TIP COVER

For an additional protection, we recommend that a single use applicator tip cover be used.
The applicator tip cover tested with this device is is Latex-free Transducer CoverCIV-Flex™,
manufactured by CIVCO. Do not use covers by other manufacturers.
To use the cover, follow the operating instructions attached with the cover.
• Make sure the cover foil is intact, and that it is within expiry date. Remove the cover
from the protective package-
• Place an appropriate amount of gel inside cover and on applicator tip..
• Insert applicator into cover, making sure to use proper sterile technique. Pull cover
tightly over applicator to remove wrinkles and air bubbles, Do not puncture or
damage the cover.
• Secure cover with enclosed bands.
• Inspect cover to ensure there are no holes or tears.

1.2 FUSE REPLACEMENT
The fuses are located in the black fuse housing on the rear panel of the console. Ensure that
the type and rating of the new and the replaced fuses match.
1. Turn off the system and disconnect the power cable from the system and the outlet.
2. Remove the fuse housing by using a screwdriver or coin.
3. Remove the burnt fuse.
4. Insert the new fuse. Make sure the fuse is seated within the fuse housing.
5. Connect the power cable to the system and to the mains outlet.
6. Turn on the system.

1.3 SYMBOLS AND ABBREVIATIONS USED
“General warning, caution, risk or danger.”
or “Non-ionized radiation” and is intended to indicate elevated, potentially

dangerous, levels of non-ionizing radiation.
Electrical equipment type BF.
Class II electrical equipment.
BNC A BNC (Bayonet Neill-Concelman) connector; connects the applicator to the

output socket
Prescription Use Only.
1.4 GENERAL SAFETY INFORMATION AND PRECAUTIONS
1.4.1 GENERAL CAUTIONS
Personnel operating the system must read this manual thoroughly and
become familiar with all its safety requirements and operating procedures prior to use of
the device.
• The system is not intended for use during surgery requiring the use of sterile or
aseptic technique.
• The system is not intended for use in wet environmental conditions.
• Keep the equipment out of the reach of children.
• The system should only be repaired by BTL authorized service personnel.

• Do not use sharp objects or ballpoint pens to operate the touch screen. A special,
soft tip stylus is provided for this purpose. Alternatively, the user may use their
fingers to operate the touch screen buttons.
• Malfunction of the system could result in an unintended increase of power output and
unintended injury to the patient. If the system shows any deviations from a normal
operating situation, discontinue use and report the fault to BTL authorized service
personnel.
• With the exception of the use of reference patch electrodes, accessories that are not
manufactured by BTL for use with the system must not be attached to the system to
prevent potential harm to the patient and/or damage to the system.
• Avoid the use of liquids in the immediate vicinity of the system. Any liquid spilled onto
the cabinet may cause serious damage to the system’s internal components. To
avoid serious damage to the system’s internal components, never spray aerosol
cleaners directly onto the system.
• Do not cover the cooling vents to avoid the equipment overheating.
1.4.2 BURN HAZARDS
• The device is a radiofrequency system. The system emits radiofrequency that can
damage the skin if excessive power is used.
• Keep the power as low as possible to achieve the desired effect in order to avoid
inadvertent burns.
• Follow closely the operational instructions in this manual to avoid damage to the skin.
• Make sure that the patient’s skin is clean and dry and that the reference patch
electrode fully adheres to the skin. There is risk of burns under the electrode if the
electrode is not properly attached to the skin or if the electrode is attached to irritated,
damaged or excessively wet skin.
• Never press the applicator trigger without direct and firm contact as well as
continuous movement of the applicator tip with the patient’s skin.

1.4.3 EXPLOSION AND FIRE HAZARDS
• The system is not suitable for use in the presence of flammable materials.
• Do not operate the system in the presence of volatile solvents, such as alcohol,
gasoline or other solvents to prevent explosions and/or fire.
• Do not use any flammable substances such as alcohol or acetone to prepare skin for
treatment.
• If alcohol is used to clean and disinfect any part of the system, allow it to dry
thoroughly before operating the equipment.
1.4.4 HIGH VOLTAGE HAZARDS
• Make sure the electrical network in your facility is in compliance with the applicable
national and local electrical codes, and that the equipment is electrically grounded.
• Do not dismantle the equipment under any circumstances. Removal of protective

covers can result in danger of electrical injury.
• The connectors must only be used for what they are designed for, otherwise there is
a danger of electric shock injury and serious damage to the equipment.
1.4.5 RADIO FREQUENCY OPERATIONAL SAFETY
• Allow access to the treatment room only to personnel who have been well trained in
the required safety procedures.
• Make sure all operators are familiar with the system’s controls.
• Never use an applicator which has a damaged tip.
• Always clean the tip properly before treatment.

• Never place the applicator in contact with, or direct it at, anything other than the
target area.
• Never apply therapy to damaged skin.
• Position the electrode cables in such a way to avoid contact with the patient or with
other leads.
• Position the patient to avoid skin-to-skin contact, such as between the arms and the
torso.
• The patient should not come into contact with any grounded metal parts or grounded
metal structures such as the examination table supports.
• Check that all parameters are correctly set before starting therapy.
• Using this equipment in close proximity to other equipment may cause

electromagnetic interference.
• Exercise caution when using this equipment in close proximity to other equipment
that may cause electromagnetic interference.

2 GENERAL CHARACTERISTICS
2.1 THE SYSTEM

The Exilis with Elite technology is a state-of-the-art radiofrequency device that enables the
application of therapy by a non-invasive, high-frequency field.
The unique features of the device include the built-in thermometer which enables
homogenous energy distribution without constant rechecking of tissue temperature. The
installed software controls the energy flow and automatically eliminates energy peaks,
ensuring uniform energy distribution. The control unit of the system is fitted with a color
touch screen, to facilitate use of the device. The on-screen information guides the operator
through the entire therapy. For easier control, the applicator is equipped with buttons,
enabling operation of the device during therapy. An easy to read display shows the selected
and in treatment parameters.
The device is placed in a specially designed cart, the shape of which provides maximum
operator comfort and easy movement of the device in the office or surgery.
2.2 INTENDED USE AND INDICATIONS FOR USE
The Exilis is indicated for non-invasive body shaping and skin tightening procedures,
treatment of skin laxity, and treatment of wrinkles and rhytids.

3 TREATMENT SAFETY
3.1 EXPECTED DEVICE-RELATED TREATMENT SEQUELAE

The use of the system may cause:
• Erythema: may be present in the treated area and will likely disappear after 24 hours.
• Very intense heating sensation or mild pain: patient should experience a very intense
heating sensation during or just following the treatment. Such pain is expected to be
mild and resolve within few minutes.
• Dry skin: may occur during the first 12 post-treatment hours. It will usually resolve
within 48 hours.
3.2 POSSIBLE ADVERSE EFFECTS OF TREATMENT
• The system emits radiofrequency that can damage the skin if the
device is not used in accordance with this manual.
• Make sure that the patient’s skin is clean and dry and that the
reference patch electrode fully adheres to the skin. There is risk of skin damage
under the electrode if the electrode is not properly attached to the skin or if the
electrode is attached to irritated, damaged or excessively wet skin.
3.3 CONTRAINDICATIONS
Do not treat patients if the following conditions are present:
• Bacterial or viral infection, acute inflammations
• Impaired immune system
• Isotretinoin in the past 12 months
• Scleroderma
• Radiation therapy
• Burns in the treatment area
• Poor healing in the treatment area
• Metal implants

• Implantable pacemaker or automatic defibrillator / cardioverter
• Ablative / non-ablative cosmetic intervention (deep peeling) in the past 3 months
• Cancer
• Active collagen diseases
• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease,

thrombophlebitis and thrombosis)
• Pregnancy or IVF procedure
• Acute neuralgia and neuropathy
• Blood disorders, risk of bleeding, bleeding tissues, peptic ulcers
• Eczema
• Rosacea
• Febrile conditions
• Kidney or liver failure
• Patients undergoing radiological procedures
• Pronounced edemas, ascites, exudates
• Sensitivity disorders in the treatment area
• Tuberculosis
• Varicose veins
3.4 PRE-TREATMENT INFORMATION

During the first visit, the physician should:
• take a detailed patient medical history, including previous treatment modalities, and
examine the general suitability of the patient for treatment
• determine why the patient is seeking treatment and understand their expectations
• discuss the treatment regimen with the patient
• inquire for contraindications

3.5 COUNSELING
The physician should inform the patient that:
1. Acceptable results will likely take a number of sessions
2. There may be very mild discomfort associated with the treatment
3. Transient erythema and local edema may appear immediately after the treatment
4. The patient should be directed to drink plenty of non-carbonated water the day before
and after treatments
5. Patient should be informed that the treatment area must be free from hair. The patient
must shave area prior to treatment or the area will be shaved at the treatment visit
3.6 SPECIAL CONSIDERATIONS AFFECTING SUCCESSFUL OUTCOME
• Smoking
• Excess alcohol consumption
• Recent surgical procedures
• On-going medication
• Patient not well hydrated
• Eating disorders

4 SYSTEM DESCRIPTION
4.1 FRONT PANEL CONTROLS AND FEATURES
1. touch screen
2. esc key (to cancel selection)
3. enter key (to confirm selection)
4. on/off switch (blue backlight when the device is on)
5. start / stop key (to start / stop therapy)
6. select knob (to set parameters)
7. large applicator
8. button to select power and temperature
9. button to select menu
10. arrow key to increase values
11. arrow key to decrease values
12. patch electrode connector
13. applicator holder
14. small applicator XP
15. buttons to select menu
16. arrow key to decrease power
17. arrow key to increase power

4.2 REAR PANEL FEATURES
18. USB port in the space of the grip of the device

19. tip of the large applicator
20. trigger button on the large applicator for the start of therapy
21. trigger button on the small applicator XP for the start of therapy
22. tip of the small applicator XP
23. labels containing manufacturing details and warning symbols
24. large applicator cable
25. small applicator XP cable
26. mains fuses type T4A
27. mains on/off switch
28. mains cable socket 110-240 V

5 ASSEMBLY AND PUTTING INTO OPERATION
5.1 UNPACKING THE SYSTEM
• Inspect the box for damage and report any damage to the carrier and your dealer. Do
not proceed with installation and assembly if the box is damaged.
• Unpack the system and place it on a stable horizontal surface.
5.2 SAFETY PRECAUTIONS REGARDING THE SYSTEM ASSEMBLY
Warnings
• When bringing the console from a cold to a warm environment, allow it to adjust to
the new temperature for approximately 2 hours before use. Do not expose the device
to very hot or very cold climatic conditions.
• Always position the device out of direct sunlight.
• Do not expose the device to direct heat.
• Do not cover the cooling vents located on the rear panel and at the bottom of the
device. The control unit is self-cooled by forced air circulation.
• Leave at least 10 cm (4 inches) between the rear panel of the device console and the
wall.
• Do not position the device on a soft surface as this may obstruct air flow to the
bottom cooling vents.
• Do not put any heat-producing devices or objects containing water or other liquid on
the device console.
• Do not place the console close to appliances producing strong electromagnetic,

electric or magnetic field (such as diathermy or X-rays).
• Retain original packaging for future transport.

6 OPERATING INSTRUCTIONS
6.1 USE OF SYSTEM SCREEN
6.1.1 WELCOME SCREEN
The initial welcome screen informs the operator about the connected applicators.
6.1.2 TOUCH SCREEN
The touch screen simplifies the use of the system. Only use the touch screen stylus or your
fingers to touch the screen. To prevent damage to the touch screen do not use sharp
objects, such as pens.
6.1.3 NUMERICAL KEYBOARD
To set the treatment parameters either use the “numerical keyboard” or the select knob (2).
Press the button to open the numerical keyboard window. Enter the values. Press
enter to confirm and return to the previous screen. Press esc to exit without change.
If you set a number beyond the allowed value range, or if the system cannot set the required
value, the value will be rounded to the closest available number.
6.2 PERFORMING THE THERAPY
6.2.1 SELECTION OF APPLICATORS
The device is equipped with a large applicator for treating large body areas, and a small
applicator XP for treating hard-to-reach and smaller areas, such as facial areas, forehead,
cheeks perioral areas, and neck. The large applicator has built-in cooling and built-in
thermometer and is able to penetrate deeper into the tissue. The small applicator XP is
designed to treat more superficial skin.
6.2.2 SESSION SCHEDULE
4 sessions are recommended, with 7 – 14 days between each session.

6.2.3 APPLICATOR MOTION
During therapy, keep the applicator in constant motion across

the selected treatment area. Use a circular motion.
Maintain good skin contact throughout the session. For safety
reasons, the system will pause every 30 seconds. Re-start the
therapy by pressing the applicator trigger button until the
session is finished.
6.2.4 WARNINGS
• To avoid burns, make sure that the applicator is in good contact with
skin prior to pressing the applicator trigger button. Always stop treatment by pressing
the applicator trigger button to OFF before removing applicator from skin.
• To avoid burns, decrease the power if the patient comments that the
treatment is “too hot” or that they are experiencing a burning sensation. If possible,
do not stop treatment for more than 15 seconds in order to maintain the required
temperature.
• To avoid burns or harm to body organs, do not use the large

applicator on the head.
• Protective eyewear is not required – however, if used, they must be

made of plastic only.
Note: The patient should be told to immediately tell the treating healthcare professional if
the treatment becomes uncomfortable, if the sensation of heat becomes intolerable, or if
they experience a burning sensation so that the treatment parameters (energy level and/or
duty factor) can be reduced.
The temperature in the therapy room should be between 18-28oC (65oF to 85oF).

6.2.5 THE APPLICATOR DISPLAY
6.2.5.1 LARGE APPLICATOR
The large applicator display screen shows the following information:
System off Therapy is ready Therapy running
Applicator not in contact with skin
Use the tab button to select

and change parameters:
Power Cooling temperature off

Use the up and down arrow
buttons to change the
parameter values:
Change power Change cooling temperature
6.2.5.2 SMALL APPLICATOR XP
The applicator display screen shows the following information:
Therapy is ready. Patch electrode shorted. Patch electrode insufficiently

(patch electrode contact (conductivity too high) adhered to patient’s skin.
good) (contact quality too low)

• If the conductivity is too high (“H”), the patch electrode is shorted and/or the
conductivity of the patch electrode location on the patient’s body is too high. Change
the patch electrode location and/or change the patch or electrode cable.
• If the contact quality is too low (“L”), the patch electrode is insufficiently adhered to
the patient’s skin. Change the patch electrode location, electrode cable and/or
change the patch electrode. Make sure the skin is dry and clean. Otherwise clean the
skin with alcohol.
Illuminated Applicator Tip Signalization
1. Steady light. – The applicator is in proper contact with the skin, therapy is in process
and the energy flows into the tissue.
2. Flashing light – The applicator is not in proper contact with the skin.
3. Illumination is off – The therapy is off.
The applicator tip illumination is just an approximate indication. Always

check the main display of the unit to learn about treatment status.
The applicator tip will flash and the audible signal will sound if the
applicator is not in proper contact with the skin.
LED Settings
To change the brightness and flashing speed of LED illumination, press the menu button on
the home screen. Select accessories and LED settings. In the presentation mode, the
treatment tip will light without flashing.

6.2.6 GENERAL RECOMMENDATIONS
Initial Energy Level
Recommended initial level of energy when using the large applicator is 40-70. The
recommended initial level of energy when using the small applicator XP is 40-50.
Skin Temperature and Power Setting
The power on the applicators should be set to the level where the patient feels an intense
heat sensation. The patient should not feel an unpleasant burning or pain sensation.
Increase the power gradually according to the patient’s feedback. When using the large
applicator, the therapeutic temperature (approximately 40°C) should be reached within 1 to
1.5 minutes. Stay at therapeutic temperature for the remainder of the treatment. Once
therapeutic temperature is reached, it will require less heat to maintain the temperature and
therefore, it may be necessary to decrease power to avoid overheating the tissue and to
maintain patient comfort. When treating with the small applicator XP, patient feedback and
skin response (erythema) are indicators of reaching the therapeutic temperature. Patient
feedback is always critical and must be used to determine proper settings in order to avoid
possible burns.
The built-in thermometer in the large applicator is for skin temperature

reference only. Patient feedback is critical and must be requested and used to determine
proper settings in order to avoid possible burns.
Pressure
The pressure on the applicator should be sufficient to ensure good contact. The applicator
displays contact quality.
Time
The typical therapy treatment time varies for different zones and generally ranges from 4
minutes to 10 minutes. Treatments are administered approximately 7 to 14 days apart.
6.2.7 PLACE THE REFERENCE PATCH ELECTRODE
Before starting the therapy, the operator must place the reference patch electrode on the
patient’s skin. During therapy, the high-frequency electric current flows between the
reference patch electrode and the applicator.
Prior to use of an electrode, make sure the skin is clean and dry. Do not use
reference patch electrode on damaged, irritated or wet skin to avoid burns under the
electrode.

If the electrode does not adhere to the skin, clean the skin properly, and make
sure the skin is clean and dry. Use a new electrode. Do not re-use the original electrode.
Make sure the electrode fully adheres to the skin. There is risk of skin
damage if the electrode is not properly attached to the skin, or if the electrode is attached to
irritated, damaged or excessively wet skin.
To place the patch electrode on the patient’s skin:
1. Remove the protective sheet from the patch electrode.

2. Place the electrode on clean skin. The whole surface of the electrode must be in contact
with the skin. To assure complete contact, rub the electrode on the skin for several
seconds.
3. Locate the electrode close to the place of application. Always select a place with muscle
or fatty tissue. The buttock is the optimal location for all treatment areas. Other areas
that can be used to place the electrode are anterior/posterior thighs and back.
4. Never locate the electrode across the spine, breast, neck or head.
5. Place the electrode on the body.
6. Connect the connector of the patch electrode with the applicator cable.
7. Insufficient contact is indicated by an audible signal and the blinking figure symbol. Press
the electrode firmly against the tissue surface to achieve better contact. Alternatively,
clean the surface under the electrode more thoroughly, or replace the electrode.
8. On the large and small applicator XP, the quality of electrode adhesion is indicated by
the bar graph on the left side of the applicator screen.
Caution: Check the expiration date of the electrode. Do not use the
electrodes after their expiration date. Use only electrodes approved by the manufacturer.
6.2.8 PREPARE THE TREATMENT AREA
• Remove any jewelry from the area to be treated.

• Clean the skin to remove any make–up or other cosmetics.
• When treating body areas apply mineral oil, such as Johnson and Johnson mineral
oil.
• When treating the face apply conductive contact gel to the treatment area to ensure
good energy flow.
• Treatment area should be free from hair. Shave treatment area if necessary.

6.2.9 SET THE POWER
• To set the power value, press the power button and turn the select knob. For fine
settings, press the numerical keyboard button and set the desired value. The
maximum selectable value is 120 on the large applicator, and 90 on small applicator
XP. The factory pre-set value is 5. The power can also be modified by the buttons on
the applicator.
• Press enter to confirm the selected value.
6.2.10 SET THE COOLING TEMPERATURE

• To set the cooling temperature value (large applicator only), press the cooling button
and turn the select knob. The cooling button enables selection of 10, 20 and 30oC
or switching the cooling off. For fine settings, press the numerical keyboard button
and set the desired value, e.g. 25oC. The factory pre-set value is 10 oC.
• Press enter to confirm the selected value.
6.2.11 SET THE DUTY FACTOR

• Press the duty factor button on the console screen to select duty factor (small
applicator XP only). The values of 20%, 40%, 60%, 80% and 100% are available.
6.2.12 SET THE THERAPY TIME
• Press the time button and turn the select knob to set the desired value. For fine
settings, use the numerical keyboard button. Press enter to confirm.
• The factory pre-set time is between 4 to 10 minutes per section.
6.2.13 START THE THERAPY

• Verify that the operating parameters are correct for the indication to be treated.
• Start the therapy by pressing the start/stop key on the control panel. The therapy
status on the applicator display changes from off to ready.
• Assure the applicator tip is in full contact with the skin.
• Press the applicator trigger button once (in the SWITCH mode). Press and keep the
trigger pressed during the full duration of energy emission (in the PRESS mode). The
applicator emits energy. The therapy status on the applicator screen changes from
ready to on. The therapy is also indicated by a regular intermittent tone.
• Move the applicator tip (with full tissue contact) over the treated area. Randomly
move the applicator around the treated area to ensure even energy distribution and
heating. Continuously monitor patient’s feedback and skin temperature (large
applicator) on the applicator.

6.2.14 PAUSE THE THERAPY
• To pause the therapy, press the applicator trigger button once (in the SWITCH
mode). Release the applicator button (in the PRESS mode).
• As a safety measure, the therapy is automatically paused every 30 seconds.
• To restart the paused therapy, press once the trigger button on the applicator.
• You can re-set the therapy parameters during the pause.
Do not stop moving the applicator unless you are certain the RF delivery has
stopped (audible signal stops).
6.2.15 EMITTING THE ENERGY

During the therapy, the display on the device console shows the remaining operation time
and the power and duty factor. The time is also monitored on the applicator screen.
The applicator screen shows when the system is ready to emit energy (READY), when the
system is not in operation (OFF), and when the system emits energy (ON).
Before and during the therapy, the applicator must be connected to the patch electrode.
• Increase power according to the patient‘s tolerance - carefully monitor

feedback from the patient and increase the power gradually.
• The patient should feel a significant heat sensation within the first 1.0
to 1.5 minutes of treatment. Skin erythema (redness) is an indication that the proper
therapy temperature has been reached. Maintain or adjust the power so the redness
and/or heat sensation is experienced for the remainder of the treatment time.
• Every patient is different and presents with varying degrees of laxity,

wrinkles and skin tone. Increase the power / duty factor / cooling / time to the
maximum level tolerable by the patient to achieve better efficacy.
6.2.16 STOP THE THERAPY

• The therapy end is signalled by longer audible tone.
• To terminate the therapy at any time: SWITCH mode: Press the applicator trigger
button. Next, press the start/stop key. Next, press the esc key. PRESS mode:
Release the applicator trigger button. Next press the start/stop key. Next, press the
esc key.

WARNINGS
• To avoid burns, assure the applicator tip is in full contact with skin
prior to pressing the trigger button.
• To avoid burns, never stop moving the applicator while in contact with
the skin. Applicator motion should be uninterrupted to keep the patient’s heat
sensation at the tolerable level at all times.
• Cover the entire area evenly with the energy. The built-in
thermometer on the large applicator allows for continuous skin temperature
monitoring to be used only as a reference. Patient feedback is critical and must be
requested and used to determine proper setting in order to avoid possible burns.
• The large applicator has built-in non-contact infrared thermometer to

measure skin temperature of the treatment area. Keep the thermometer clean. Any
soiling, even by the oil used during the treatment, may cause inaccurate temperature
measurements.
• If the patient feels excessive heat or burning, cool the skin either using
the applicator tip without RF or let the skin cool down. Decrease the RF power output
to continue therapy.
• The safety system continuously checks the quality of the contact

between the applicator’s tip and the patient’s skin. If the contact quality is not
sufficient, the system disables energy emission until the contact quality is sufficient.
• Patient should not feel any heat under the grounding electrode.
Patient needs to be advised to report any heat sensation under the grounding
electrode immediately - the treatment needs to be interrupted immediately. If this
occurs, remove the electrode, and assess the area for injury. Use a new grounding
electrode and place the electrode in a different area on the body.

6.3 USER MENU
Press the user button to access the following item:
• clients (i.e., patients)
6.3.1 CLIENTS
Enter, edit and delete patient information. Performed therapies can be assigned to each
patient.
6.4 MENU
Press the menu button and use the select knob to scroll through the following options:
• accessories
• unit settings
• special settings
6.4.1 ACCESSORIES
This menu item displays information about the connected applicator, such as type and serial
number.
6.4.2 UNIT SETTINGS

This submenu enables the operator to set:
6.4.2.1 Password Setting

Set and change password required by the system after the switch-on. The system comes
with this function disabled.
6.4.2.2 Screen Saver and Auto Switch-off

Set up the screen saver type, the screen saver activation time, the period of time before
which the screen will switch off and idle time for the system.
To cancel the screen saver mode, press the esc key on the device. Save the settings by
pressing the enter key.
6.4.2.3 Color Setting

Set the colors of all items displayed on the screen. Select from wide range of factory preset
color schemes, or personalize your own color schemes.
6.4.2.4 Date and Time Setting

Set the date and time for the system.

6.4.2.5 Language Setting
Set the language. The factory default is English.
6.4.2.6 Touch Panel Calibration

If the touch screen buttons do not react when pressed, the touch screen needs to be
calibrated. During the calibration process, use the touch-pen (stylus) and follow the on-
screen instructions.
Calibration can be interrupted at any time by pressing the esc button.
To verify the touch screen adjustments, use the touch panel function test function.
6.4.2.7 User Options

This submenu allows the setting and displaying of the following parameters:
• direction of movement of menu (standard / reverse)
• tabs position (top / bottom)
• speaker volume
6.4.2.8 Time of Usage

This function counts the time of performed therapies. The time is counted after the start key
is pressed each time, regardless of whether or not the applicator generates energy. The time
is not counted when the therapy is paused.
6.4.2.9 Setting of HW Key

The system can be remotely reconfigured. The manufacturer or dealer will send a 64-digit
code (referred to as the “HW key”) that when entered will reconfigure the system hardware.
For the HW configuration see the next entry, Unit Information.
6.4.2.10 Unit Information

This submenu contains information about the device: the serial number, the device type, the
firmware version, etc. If the operation of the device is time restricted, this submenu will
indicate the date through which the device remains fully functional.
6.4.2.11 Unlock Code

If a time restriction was placed on the system operation, a new time limit can be set, or any
time restrictions placed on the use of the system operation can be removed by entering the
unlock code.
6.4.2.12 Service Functions
• repair of files
Checks the file storage system. It repairs errors, deletes empty files, etc. Use in case
of a lack of memory space, if you have difficulties saving data, or if you suspect loss
of data.

• file system formatting
Use only if the repair of files did not help. When used, the entire memory is re-
formatted and all the user-data and the user setup are lost.
• delete accessories
Deletes all the previously installed accessory data. Use in case of incorrectly installed
applicators, or when the connected applicators cannot be detected (question mark on
the tab).
• default setting without loss of the user data
Restores all functions of the device to the factory default settings. All user–created
data will remain saved.
• unit log data export
6.4.3 SPECIFIC SETTINGS
6.4.3.1 Sound in Running Therapy

Select the sounds emitted during therapy. Each sound can be set in two different volumes
(lower and higher). This sound cannot be turned off.
6.4.3.2 Applicator Trigger Button Function

PRESS mode: The system emits energy only when the trigger button on the applicator is
continuously depressed.
SWITCH mode: The system starts to emit energy when the trigger button on the applicator
is depressed once. Pressing the trigger button a second time stops the therapy.
6.4.3.3 Therapy Log Settings

It is recommended that this function is kept on for future reference.

7 LIST OF STANDARD AND OPTIONAL ACCESSORIES
The system consists of the following accessories:
Standard accessories:
• 1x large applicator
• 1x mains cable
• 1x USB cable
• 2x spare fuse T4A/250V for the control unit
• 2x patch electrode cable for large applicator
• 25x patch electrodes (Fiab L216xH106)
• 1x stylus (touch-pen)
• 1x operator’s manual
To refill the coolant (to be done by a BTL authorized service personnel):
• 1x funnel
• 1x hose
Optional accessories:
• small applicator XP
• small applicator XP holder with 2 screws
• 25x patch electrodes (Fiab L216xH106)
• patch electrode cable for large applicator
• patch electrode cable for small applicator XP

8 TECHNICAL PARAMETERS
Device name Exilis (Elite Technology)
Operating conditions
Ambient temperature + 18°C to + 30°C
Relative humidity 60% to 75%
Atmospheric pressure 700hPA to 1060hPA
Position On castors
Transport and storage conditions

Ambient temperature - 10°C to + 55°C
Relative humidity 25% to 85%
Atmospheric pressure 650hPA to 1100hPa
Position Any
Time of storage Max. 1 year
Additional conditions Transport only in supplied packaging
Power supply
Maximum power input 400VA
Mains voltage ~ 100V to 240V alternating
Frequency 50Hz to 60Hz
Electrical protection class II (according to IEC 536)
External exchangeable fuse 2 x T4A / 250V, tube fuse 5 x 20mm, acc. to IEC 127-2
Mains switch according to IEC 60601-1 On the rear side of the device, positions 0 and I
Contact quality monitoring system

Measurement frequency 80kHz ±10kHz
Acceptable resistance range 25-90Ω
Audible alarm 65dBA/1m from rear panel
Design
Weight - unit Max. 30kg (66lb)
Weight – large applicator Max. 1500g incl. cable (3.3lb)
Weight – small applicator XP Max. 700g incl. cable (1.54lb)
Dimensions – sytem console (W x H x D) 1000 x 600 x 600mm (39” x 24” x 24”)
Dimensions – large applicator (W x H x D) 100 x 70 x 180mm (4” x 2.75” x 7”)
Dimensions – small applicator XP (W x H x D) 108 x 66 x 180mm (4.25” x 2.6” x 7”)
Display elements
Graphic color touch screen Diagonal 8.4“ / 21.5cm, 640x480 pixels
Classification
Applied parts type BF
Class according to MDD 93/42 EEC IIb
High frequency leakage currents Less than 150mA RMS
Reference patch electrode referenced to earth
International protection rating IP20
Adjustable values
Power – large applicator Continuous 1 to 120 (units relative to rated power)
Power – small applicator XP Continuous 1 to 90 (units relative to rated power)
Cooling Continuous from 10°C to 30°C
Therapy cycle time 30 sec

8.1 OUTPUT CHARACTERISTICS
8.1.1 Large applicator (215/1)
Acceptable loads 100Ω-400Ω*

Rated load 250Ω
Rated power 170W
Maximum output voltage (electronically limited) <250V
* No power generated above specified value

8.1.2 Small applicator XP (215/3)
Acceptable loads 100Ω-400Ω*

Rated load 350Ω
Rated power 120W
Maximum output voltage (electronically limited) <250V
* Power less than 6W is generated above specified value

8.2 EMC DECLARATION
Guidance and manufacturer’s declaration – electromagnetic emissions

EXILIS is intended for use in the electromagnetic environment specified below. The customer or the user of the
EXILIS should assure that it is used in such an environment.
Emissions
Compliance Electromagnetic environment – guidance
test
RF
Exilis must emit electromagnetic energy in order to perform its
emissions Group 2
intended function. Nearby electronic equipment may be affected.
CISPR 11
RF
emissions Class A
CISPR 11
Harmonic
emissions
Class A Exilis is suitable for use in all establishments
IEC 61000-
other than domestic and those directly connected to the
3-2
public low-voltage power supply network that supplies
Voltage buildings used for domestic purposes.
fluctuations/
flicker
Complies
emissions
IEC 61000-
3-3
Guidance and manufacturer’s declaration – electromagnetic immunity
Exilis is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The
customer or the user of Exilis can help prevent electromagnetic interference by maintaining a minimum distance
between portable and mobile RF communications equipment (transmitters) and Exilis as recommended below,
according to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter

Rated (m)
maximum
output power
of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
W d=[3,5/V1]√P d=[3,5/E1]√P d=[7/E1]√P
0,01 0,12 0,12 0,23
0,1 0,38 0,38 0,73
1 1,2 1,2 2,3
10 3,8 3,8 7,3
100 12 12 23

EXILIS is intended for use in the electromagnetic environment specified below. The
customer or the user of the EXILIS should assure that it is used in such an environment.
IEC 60601 TEST Compliance Electromagnetic environment
IMMUNITY test
LEVEL level – guidance
Portable and mobile RF
communications equipment
should be used no closer to
any part of EXILIS, including
cables, than the
recommended separation
Conducted RF 3 Vrms
3V distance calculated from the
IEC 61000-4-6 150 kHz to 80 MHz
equation applicable to the
frequency of the transmitter.
Recommended separation
distance
800 MHz to 2,5 GHz
d=[3,5/E1]√P 80 MHz to 800

MHz
d=[7/V1]√P 800 MHz to 2,5

GHz
where P is the maximum

output power rating of the
transmitter in watts (W)
according to the transmitter
manufacturer and d is the
recommended separation
distance in metres (m).
Radiated RF 3 V/m Field strengths from fixed RF

3 V/m
IEC 61000-4-3 80 MHz to 2,5 GHz transmitters, as determined
by an electromagnetic site
survey, (a) should be less
than the compliance level in
each frequency range.(b)
Interference may occur in the

vicinity of equipment marked
with the following symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the EXILIS is used exceeds the applicable RF
compliance level above, the EXILIS should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the EXILIS.
b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than [V1] V/m.

EXILIS is intended for use in the electromagnetic environment specified below. The
customer or the user of EXILIS should assure that it is used in such an environment.
Electromagnetic environment
IEC 60601
IMMUNITY test Compliance level –
test level
guidance
Floors should be wood,
concrete or ceramic tile. If
Electrostatic
± 6 kV contact ± 6 kV contact floors are covered with
discharge (ESD)
± 8 kV air ± 8 kV air synthetic material, the relative
IEC 61000-4-2
humidity should be at least 30
%.
Mains power quality should

Electrical fast ± 2 kV for power ± 2 kV for power
be that of a
transient/burst supply lines supply lines
typical commercial or hospital
IEC 61000-4-4
environment.

± 1 kV line(s) to ± 1 kV line(s) to
Surge be that of a typical
line(s) line(s)
IEC 61000-4-5 commercial or hospital
± 2 kV line(s) to earth ± 2 kV line(s) to earth
environment.
<5 % UT <5 % UT
(>95 % dip in UT) (>95 % dip in UT)
be that of a typical
for 0,5 cycle for 0,5 cycle
commercial or hospital
40 % UT 40 % UT
Voltage dips, short environment. If the user of
(60 % dip in UT) (60 % dip in UT)
interruptions and voltage EXILIS requires continued
for 5 cycles for 5 cycles
variations on power supply operation during power mains
70 % UT 70 % UT
input lines interruptions, it is
(30 % dip in UT) (30 % dip in UT)
IEC 61000-4-11 recommended that the EXILIS
for 25 cycles for 25 cycles
be powered from an
<5 % UT <5 % UT
uninterruptible power supply
(>95 % dip in UT) (>95 % dip in UT)
or a battery.
for 5 s for 5 s
Power frequency magnetic

Power frequency fields should be at levels
(50/60 Hz) characteristic of a typical
3 A/m 3 A/m
magnetic field location in a typical
IEC 61000-4-8 commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

8.3 MANUFACTURER
This product is manufactured by:
BTL Industries Ltd.

161 Cleveland Way
Stevenage
Hertfordshire
SG1 6BU
United Kingdom
th
Date of last revision: 5 September 2013
© All rights reserved. No part of this manual may be reproduced, saved or transferred by any means including electronic,
mechanical, and photographic without the prior written approval from BTL Industries Limited.
715-80MANEN301

Exilis: Operator's Manual

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Exilis

Thank you for purchasing the Exilis advanced aesthetic

While we would like you to start using your new equipment

BTL Industries, Ltd.

EXILIS - OPERATOR’S MANUAL l PAGE 2 OF 39

EXILIS - OPERATOR’S MANUAL l PAGE 3 OF 39

EXILIS - OPERATOR’S MANUAL l PAGE 4 OF 39

EXILIS - OPERATOR’S MANUAL l PAGE 5 OF 39

1.1.1 CLEANING THE APPLICATOR AND COMPONENTS

1.1.2 USING APPLICATOR TIP COVER

EXILIS - OPERATOR’S MANUAL l PAGE 6 OF 39

EXILIS - OPERATOR’S MANUAL l PAGE 7 OF 39

“General warning, caution, risk or danger.”

or “Non-ionized radiation” and is intended to indicate elevated, potentially

Electrical equipment type BF.

Class II electrical equipment.

BNC A BNC (Bayonet Neill-Concelman) connector; connects the applicator to the

Prescription Use Only.

1.4 GENERAL SAFETY INFORMATION AND PRECAUTIONS

1.4.1 GENERAL CAUTIONS

• The system is not intended for use in wet environmental conditions.

• Keep the equipment out of the reach of children.

• The system should only be repaired by BTL authorized service personnel.

EXILIS - OPERATOR’S MANUAL l PAGE 8 OF 39

• Do not cover the cooling vents to avoid the equipment overheating.

1.4.2 BURN HAZARDS

EXILIS - OPERATOR’S MANUAL l PAGE 9 OF 39

1.4.4 HIGH VOLTAGE HAZARDS

• Do not dismantle the equipment under any circumstances. Removal of protective

1.4.5 RADIO FREQUENCY OPERATIONAL SAFETY

• Never use an applicator which has a damaged tip.

• Always clean the tip properly before treatment.

EXILIS - OPERATOR’S MANUAL l PAGE 10 OF 39

• Never apply therapy to damaged skin.

• Using this equipment in close proximity to other equipment may cause

EXILIS - OPERATOR’S MANUAL l PAGE 11 OF 39

2.1 THE SYSTEM

2.2 INTENDED USE AND INDICATIONS FOR USE

EXILIS - OPERATOR’S MANUAL l PAGE 12 OF 39

3.1 EXPECTED DEVICE-RELATED TREATMENT SEQUELAE

3.2 POSSIBLE ADVERSE EFFECTS OF TREATMENT

• Bacterial or viral infection, acute inflammations

• Impaired immune system

• Isotretinoin in the past 12 months

• Burns in the treatment area

• Poor healing in the treatment area

EXILIS - OPERATOR’S MANUAL l PAGE 13 OF 39

• Ablative / non-ablative cosmetic intervention (deep peeling) in the past 3 months

• Active collagen diseases

• Cardiovascular diseases (such as vascular diseases, peripheral arterial disease,

• Pregnancy or IVF procedure

• Acute neuralgia and neuropathy

• Blood disorders, risk of bleeding, bleeding tissues, peptic ulcers

• Kidney or liver failure

• Patients undergoing radiological procedures

• Pronounced edemas, ascites, exudates

• Sensitivity disorders in the treatment area

3.4 PRE-TREATMENT INFORMATION

• discuss the treatment regimen with the patient

• inquire for contraindications

EXILIS - OPERATOR’S MANUAL l PAGE 14 OF 39

1. Acceptable results will likely take a number of sessions

2. There may be very mild discomfort associated with the treatment