USER MANUAL

FRAXFACE
FRACTIONAL RADIO FREQUENCY
ABOUT THIS MANUAL
Version: V.25.09.18
Year: 2018
Language: English

All the rights to this manual are reserved, especially reproduction, publication and translation rights. No portion of
this manual may be reproduced by no means (photocopy, microfilm or other methods) without previous written
authorization from ECLERIS. Neither can it be reproduced, multiplied or published through any electronic data
processing form.

The information contained in this manual may be modified or broaden without previous notification, without it
representing any responsibility to ECLERIS.

ECLERIS S.R.L.
FRANCISCO N. LAPRIDA 4955. VILLA MARTELLI
(B1603ABK) BUENOS AIRES. ARGENTINA
Tel/Fax: +54 11 48383200
Web: www.ecleris.com
E-Mail: [email protected]

Technical Director: Farm. Doris Inés Rasi Sanchez, MN: 12856

Authorized by ANMAT PM-1120-42
Sale condition: “Exclusive sales professionals and healthcare
institutions”
 USER’S MANUAL – FRAXFACE

CONTENT

1. SYMBOLS ...................................................................................................................................................................................... 5
2. SECURITY WARNINGS ............................................................................................................................................................ 5
2.1 WARNINGS ................................................................................................................................................................................ 5
2.2 CAUTION .................................................................................................................................................................................... 6
2.3 CONTRAINDICATIONS ......................................................................................................................................................... 7
3. DESCRIPTION ............................................................................................................................................................................. 8
3.1 EXPECTED USE ........................................................................................................................................................................ 8
3.2 EXPECTED USER ..................................................................................................................................................................... 9
3.3 ENVIRONMENT OF USE ....................................................................................................................................................... 9
3.4 COMPONENTS.......................................................................................................................................................................... 9
3.4.1 MAIN UNIT ......................................................................................................................................................................10
3.4.2 HANDPIECE ....................................................................................................................................................................10
3.4.3 CONTACT TIPS ..............................................................................................................................................................11
4. INSTALLATION ........................................................................................................................................................................11
5. INSTRUCTIONS FOR USE .....................................................................................................................................................12
5.1 START UP .................................................................................................................................................................................12
5.2 TREATMENT PROGRAMS .................................................................................................................................................13
5.3 SECURITY FEATURES .........................................................................................................................................................14
6. CLINICAL GUIDE ......................................................................................................................................................................14
6.1 ADVERSE EFFECTS ..............................................................................................................................................................14
6.2 EXPECTATIONS OF THE TREATMENT ........................................................................................................................15
6.3 PRE-TREATMENT ................................................................................................................................................................15
6.3.1 FIRST CONSULTATION ..............................................................................................................................................15
6.3.2 PROOF PROCEDURE ...................................................................................................................................................15
6.3.3 PREPARATION OF THE PATIENT .........................................................................................................................16
6.3.4 APPLICATION TECHNIQUE......................................................................................................................................16
6.3.5 GENERAL RECOMMENDATIONS DURING THE TREATMENT ..................................................................17
6.3.6 POST-TREATMENT CARE .........................................................................................................................................17
6.3.7 TREATMENT PLAN .....................................................................................................................................................18
7. MAINTENANCE ........................................................................................................................................................................18
7.1 CHANGING THE ELECTRODE IN THE APPLICATOR HEAD ................................................................................18
7.2 CLEANING ................................................................................................................................................................................19
7.2.1 MAIN UNIT ......................................................................................................................................................................19
7.2.2 TOUCH SCREEN ............................................................................................................................................................19
7.3 CHANGE OF FUSES ...............................................................................................................................................................19

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7.4 REPACKAGING AND TRANSPORTATION ...................................................................................................................19

8. TECHNICAL SPECIFICATIONS ...........................................................................................................................................20
8.1 SUBLATIVE CHARACTERISTICS OF RF POWER ......................................................................................................20
9. ELIMINATION ...........................................................................................................................................................................21
10. TROUBLESHOOTING.........................................................................................................................................................22
11. ACCESSORIES AND SPARE PARTS ..............................................................................................................................22
12. TECHNICAL SERVICE........................................................................................................................................................23
13. WARRANTY ..........................................................................................................................................................................23
14. ELECTROMAGNETIC COMPATIBILITY – GUIDANCE AND MANUFACTURER’S DECLARATION.......24

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1. SYMBOLS
Identify the following symbols used on labels and packaging as an indication of information, or
safety to avoid physical or material damage:

(BLUE) The user has the obligation

Alternative current
to consult the attached documents

Manufacturer information Fuse

Manufacturing date On

Serial number Off

Order number Protect from water

Single use This side up

RF interference on nearby
Fragile
electrical devices
The product must be discarded
according to RAEEs directives
Temperature limits
(electrical and electronic
equipment waste)

Warning! Pressure limits

Type of applied BF equipment Humidity limits

2. SECURITY WARNINGS
This manual contains all the relevant information on the appropriate care and handling of the
device while on operation, as well as information about its accessories.

Please read carefully this manual in whole, before using the device for the first time.

NOTE: Reinforce very important information.

2.1 WARNINGS
 To avoid risk of electric shock, the equipment must be connected to an AC (Alternative Current)
power supply with protective ground
 To reduce the risk of fire, use the equipment in well-ventilated areas and do not use it in the
presence of potentially explosive or flammable materials, such as environments rich in oxygen or
the presence of flammable anesthetic gases.
 The equipment may cause radio interference or may affect the operation of nearby equipment. It
may be necessary to reorient or relocate it.
 Connect it to power supply with the specified voltage (100-230V, 50/60 Hz)

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 Do not install the equipment near heat sources, such as stoves.

 To reduce the risk of the device heating up, do not obstruct the ventilation grilles so that there is
good air circulation.
 The use of cords, handpieces or electrodes of another manufacturer, or the replacement of
internal components could increase the RF emissions, decrease the device’s immunity or impact
on its essential performance. Ecleris will not be held responsible for those consequences.
 To reduce the risk of electric shock, regularly inspect the AC power cord and check that it has not
frayed or split.
 To reduce the risk of strangulation, dispose the cords so that they do not get tangled.
 Turn off the switch before connecting / disconnecting accessories (tips).
 Do not reuse the tip in different patients.
 Only use disposable tips provided by Ecleris.
 Do not use the tips if the packaging is damaged.
 Throw the tips in the proper waste.
 Do not send to the autoclave any part or component of this device.
 Make sure that the device is placed in a comfortable way for the operation.
 The handpiece has sensitive electronic devices. Avoid mechanical shocks.
 Turn off the device and disconnect from the electrical network before cleaning or performing any
revision or maintenance work.
 Do not use flammable substances to treat the patient’s skin.
 Do not apply RF through the clothes.
 The treatments with FRAXFACE shall only be performed by Medical estheticians or
dermatologists.
 Do not apply this treatment to people with implanted metal or electronic system (eg, cardiac
pacemaker).
 To avoid possible injury to the patient due to the use of the device, evaluate in advance if the
patient is apt to receive treatments with the FRAXFACE (See: CONTRAINDICATIONS)

2.2 CAUTION
To avoid possible damage to the equipment, use only the cleaning and disinfection products and
follow the procedures indicated in this manual.

To avoid damage, do not drip or spray liquids directly on any part of the equipment.

The FRAXFACE has been designed to work in certain environmental conditions. Respect the
following conditions:

Operation Transport

Temperature 10°C-40°C -30°C-50°C

50ºF – 104ºF -22ºF – 122ºF

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Relative humidity 30-75% 10-95%

Always transfer it in its original packaging.

NOTE: The images shown in this manual may not exactly match that of your equipment.

Should any anomaly be detected on using the device, please contact your local distributor's
Technical Service Department or the nearest ECLERIS office.

2.3 CONTRAINDICATIONS
Although you can treat people with any type of skin (phototypes according to Fitzpatric scales)
there are few medical reasons why patients should not undergo this treatment.

FRAXFACE generates non-ionizing radiation. Patients with implanted electronic devices such
as cardiac pacemakers, defibrillators, cochlear implants, bone growth stimulators should not
be treated with radiofrequency, even if the stimulator has been turned off.

 Patients with a pacemaker or other implanted electronic devices (cochlear implant, etc.). If the
patient has hearing aids, they should be removed since they may suffer irregularities in their
functioning.
 Pregnancy and lactation.
 Patients with skin infections or skin diseases in the area to be treated (such as psoriasis, sores
and any type of rash).
 Treatment in areas of damaged / sick skin or with unhealed wounds.
 People with a tendency to skin disorders (such as keloids, the process of healing alteration) and
extremely dry and fragile skin.
 Patients with epilepsy or heart problems.
 Treatment in people who can not express or reveal abnormal sensations (children, the elderly).
 Treatment in tattooed areas or with permanent makeup.
 Treatment over areas with permanent implants (silicones, metal plates, or other non-absorbable
substances).
 Patients with coagulopathies or under anticoagulant treatments.
 Patients with immunosuppressive diseases (such as HIV positive) or use of immunosuppressive
drugs.
 Patients with a history of recurrent herpes in the area to be treated (should be medicated
eventually before the application of radiofrequency).
 Skin cancer (active or in the past), pre-malignant moles, malignancy (active or recent) or history
of some type of cancer.
 Endocrine disorders (such as diabetes or thyroid disease).
 Plastic surgery such as face lifting or eyelid surgery in the last 12 months.
 Use of Accutane in the last 6 months.
 Augmentation procedures with injection of biomaterials (such as injection of botulinum toxin,
collagen protein or fat) in the last 6 months.

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 Natural filling (such as hyaluronic acid) in the area treated in the last 6 months.
 Surgical procedure in the area treated in the last 6 months (or during the healing process).
 Some aesthetic treatment with light (such as IPL, or laser device), radiofrequency or other
devices in the area treated in the last 3 months.
 Extremely tanned skin (including sunbeds or tanning creams) in the last 2 weeks.
 Use of non-steroidal anti-inflammatory drugs 7 days before and 7 days after each treatment.
 Controlled facial abrasion (dermabrasion, or chemical peel) in the last 3 months.
 Allergic to Copper and Tin (Cu / Sn).

3. DESCRIPTION
Radiofrecuency is a technology widely used in medicine, and in the last few years, in aesthetics too.
FRAXFACE uses bipolar and fractioned RF, producing both dermic and epidermic effects on small
micro-metric sectors of the skin, leaving small gaps unscathed, which will be responsable of skin
regeneration and collagen stimulation. This produces visible results on the skin tone, brightness
and texture, on superficial scars, pores, stains and fine lines, and its general aspect.

FRAXFACE consists of a RF generator that transmits trough an amplifier to a tip that has 64 micro-
metric points of contact with the skin. These points interact with the cutaneous tissue, producing
thermal effects, coagulation, and micro-ablation, depending on the power utilized. The tissue
surrounding each of these points remains unscathed. Tips are of one use only, and must be
discarded.

Pulses generated with FRAXFACE are highly stable both in intensity and time, allowing total control
on energy discharges on the skin, completely eliminating the risk of damaged tissue. Pulses can be
adjusted in power according to skin type, skin issue, personal tolerance, or profesional indication.

FRAXFACE can be used all over the body, although is most used on face, neck, hands and cleavage.
Treatment is totally tolerable, with moderate discomfort.

On the following pages, useful information will be found in order to use the product in the most
appropriate way. It is advised to read thoughtfully these instructions before using FRAXFACE.
Information should be conserved in case any future consult is required.

It should be noticed that FRAXFACE must be used exclusively according to its conforming use.

FRAXFACE must be used exclusively under continuous control of qualified personnel.

FRAXFACE must be used only at authorized centers that comply all local and international current
laws.

3.1 EXPECTED USE

FRAXFACE fractional bipolar radiofrequency is intended to treat and improve the texture, tone and
laxity of the skin superficially. Deep dermal heating reaches the collagen fibers that cause
immediate and long-term effects. It can be used to treat:

 Rejuvenescence and facial resurfacing

 Improvement of the texture and tone of the epidermis
 Correction of acne scars

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 Skin tightening
 Reduction of scars
 Effect of skin lifting
 Stretch marks

3.2 EXPECTED USER

Facial rejuvenation procedures must be performed by qualified physicians who specialize in
cosmetic and aesthetic procedures, such as aesthetic doctors or dermatologists. The suitability
criterion of the users will be in accordance with local market regulations.

The correct use of the equipment, application of treatments, handling and use of disposables (to
avoid the risk of cross-contamination) requires qualified personnel.

3.3 ENVIRONMENT OF USE

The use of the equipment is intended to be used in medical offices or aesthetic cabinets.

It is not intended to be used in an operating room or in the presence of flammable liquids, nor in the
presence of flammable anesthetic gases (oxygen or nitrogen).

The equipment is not designed to be used in the direct presence of sources of heat or cold, direct
sunlight, energy, dust, sand or any other chemical substance.

The user and / or the doctor are responsible for ensuring that the equipment is stored and used in
appropriate environmental conditions.

3.4 COMPONENTS
The FRAXFACE includes the following components and elements which are necessary for
installation:

 Main unit
 Fractional RF applicator (handpiece)
 Disposable tips with 64 contact electrodes (box of 10 units)
 Detachable power supply cord
 User’s manual

NOTE: It is recommended to identify and verify the existence of components and accessories before
proceeding with the installation of the equipment.

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3.4.1 MAIN UNIT

3 4

Figure 1: Front panel Figure 2: Rear panel

1. Touch screen
2. On/off switch
3. Handpiece holder
4. Aeration grid
5. Connector for the power supply cable with fuse holder
6. Connector for the handpiece

3.4.2 HANDPIECE

Figure 3: Handpiece – RF Applicator

1. RF electrodes
2. Push button
3. Plug connector to the equipment

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3.4.3 CONTACT TIPS

Each of the disposable tips contains a matrix (8x8) of bipolar electrodes. It connects with the
applicator in contact with the 2 electrodes.

Figure 4: Disposable Contact Tips

4. INSTALLATION
The installation has to be carried out by qualified personnel. It is the responsibility of the
user to follow the procedures appropriately.

Unpack the equipment carefully and place it on a flat, firm surface before connecting the
accessories.

1. Connect the applicator (handpiece) so that the pins match with the connector (female)
located on the rear panel of the equipment (6). Push it until it fits and rotate the locking ring
so that it is secured.
2. Place the handpiece in the holder (5).
3. Connect the power cord to the power connector located on the rear part of the equipment
(5)
4. Open the individual wrapping and remove the matrix tip.
5. Take the tip of both sides, place it on the tip of the applicator and press until the side flaps
lock with a "click”.
6. To remove it, press the side flaps and slide back the tip.
7. Turn on the equipment from the ON / OFF switch (2)

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Figure 5: Disposable Tip Connection

5. INSTRUCTIONS FOR USE

The applicator must be connected and placed in the holder during system startup.

Always turn off the equipment before connecting / disconnecting the applicator tips and
/ or the applicator.

Never point the tip of the applicator at anything other than the treatment area.

Insert the disposable tip at the time of starting a treatment.

5.1 START UP
Press the on/off button located on the rear panel of the equipment. A green pilot light will light,
indicating it is on.

When the system starts it performs a self-check:

Figure 6: Start of the system

After a few seconds the screen will show the Fractional RF Treatment Menu:

4
3

Figure 7: Main menu

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1. Indication of the active Menu

2. Treatment programs
3. Technical service tools
4. Screen retraction

5.2 TREATMENT PROGRAMS

Three treatment options can be selected, according to the defined energy levels (Programs 1, 2 and
3). Each program has a pre-established energy level, which can vary within a limited range. They
have a released pulse counter during the treatment which can be restarted at the time you want.
And it shows information of each released pulse

Program 1: Low Power

Energy Range released: from 2 to 10 Joules.

Figure 8: Program 1

Program 2: Medium Power

Energy range released: from 8 to 16 Joules.

Figure 9: Program 2

Program 3: High Power

Energy range: from 12 to 20 Joules.

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Figure10: Program 3

The screens have the BACK function, indicated with this symbol. Press it to return to the
previous screen.

NOTE: It is not necessary to use maximum power to achieve better results, but the right power
depending on the problem to be treated, the sensitivity and characteristics of the skin and the
indication of the professional.

5.3 SECURITY FEATURES

When the equipment is turned on, it performs a self-check in which any abnormality in its
functioning is detected.

The equipment detects the contact with the skin so that in case the contact with the patient is not
adequate, the equipment does not emit RF energy and sends an error message and an audible
signal.

The equipment does not perform multiple shots, until the trigger is released again.

6. CLINICAL GUIDE
The information provided in this section is not intended to cover all problems and / or prevail over
the knowledge and experience of the operator.

The operator must ensure that the patient to be treated does not present any
contraindication.

6.1 ADVERSE EFFECTS

Improper use of the system can result in side effects. Although these effects are very rare and
are expected to be solved in a short time, any adverse reaction should be reported to a
physician and ECLERIS immediately.

The appearance of adverse effects can occur during or immediately after the application of RF.

The following effects can appear:

 Feeling of discomfort, mild pain

 Appearance of any pigmentation (hyperpigmentation or hypopigmentation)
 Changes in the texture of the skin, such as burns, blisters and scabs
 Edema on the skin and / or erythema.
 Urticaria (hives)

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 Scars
 Red hair

6.2 EXPECTATIONS OF THE TREATMENT

It is extremely important for the success of treatment and patient satisfaction to establish realistic
expectations and advise the client of the following:

After the treatment edema or erythema is likely to appear in the treated area. The edema generally
disappears after a few hours, while the erythema may persist for more than 24 hours.

The degree of response to treatment, and the number of treatment sessions required will vary
between patients and will depend on the clinical and physiological condition at the beginning of the
treatment.

Maintenance sessions may be required

After the treatment and during healing, small spots (scabs) may form in the treatment area,
especially at the points of contact between the microelectrodes and the skin. These scabs disappear
by natural exfoliation

6.3 PRE-TREATMENT
6.3.1 FIRST CONSULTATION
The first visit of any patient should be devoted to analyze treatment possibilities, evaluate
contraindications and perform a test to define optimal treatment parameters and decide if the
patient is an appropriate candidate for treatment.

After the initial visit of the patient, professionals should follow these steps during a consultation
meeting:

 Determine the patient's needs.

 Establish the patient's expectations and the desired result for the treatment.
 Prepare a clinical history and evaluate the contraindications of the patient.
 Review with the patient the method of application and operation, the expected results of the
treatment and the possible side effects and adverse effects during and / or after the
treatment.

Before starting treatment sessions, advise the patient to:

 Avoid skin irritation or sun exposure and the use of any topical irritant for at least 2 to 3
days before the session.
 Signature of the patient in a consent form that includes all the information above.
 Determine a treatment schedule.
 Take photos, etc.

6.3.2 PROOF PROCEDURE

Before the patient undergo a FRAXFACE session a test is recommended (this can be done during the
initial consultation meeting).

The test procedure serves several purposes:

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 Establish whether the client is an appropriate candidate for treatment (evaluating the skin
response, tolerance to treatment and expected results).
 Offer the client the opportunity to experience the FRAXFACE treatment.
 Find the correct parameters according to the tolerance of the patient and test the
application technique (Consult the application technique).
 Minimization of possibilities of adverse effects.

NOTE: For phototypes I, II and III, wait at least 48 hours to evaluate the skin's response. For
phototypes IV, V, and VI, wait a week to evaluate the skin's response.

Phototypes V and VI are generally more sensitive to treatment. Lower energy levels must be
used.

6.3.3 PREPARATION OF THE PATIENT

Before carrying out the test or any treatment, follow the following steps:

The area to be treated should be free of hairs. This can affect the contact of the skin's
microelectrode and could cause burns.

Clean the area to be treated with water and neutral soap. Dry the area well.

If you wish, you can use local topical water-based anesthesia to reduce the pain of the procedure.
Follow the manufacturer's instructions.

If you have used anesthesia, wash the area to be treated with water and neutral soap and dry the
area thoroughly.

When the skin is clean, sterilize the area with 70% alcohol.

The skin should be dry before starting the treatment.

Place the tip (tip) on the handpiece and make sure it is firmly placed.

Areas of metal dental implants (such as braces, ferrules and crowns) may be more sensitive to RF
energy. In that case, the operator can isolate the area with gauze and dental rolls.

6.3.4 APPLICATION TECHNIQUE

It must be carried out before establishing a treatment schedule.

Place the applicator on the skin and emit a single RF pulse by pressing the push button on the
handpiece. Wait about 10 minutes or until the pattern appears, whichever comes first..

If the pattern does not appear, increase the energy, and emit a single pulse adjacent to the previous
one.

The appropriate point is when a pattern corresponding to the tip matrix appears accompanied by
erythema and edema.

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6.3.5 GENERAL RECOMMENDATIONS DURING THE TREATMENT

During the treatment and in each session the patient's medical history should be monitored
and updated, and be aware of medication, interventions or any change in their health.

Set the parameters (energy) of treatment according to the results of the test.

Place the tip (applicable part) so that it makes contact with the skin on its entire surface and then
press the trigger, you will hear a beep indicating that an RF pulse has been released. Release the
trigger and repeat the operation in an adjacent area

Do not overlap the RF shots.

With your free hand you can help tense the skin to facilitate the application of pulses.

After 8 or 10 shots, it is recommended to clean the surface of the tip with dry gauze to prevent the
deposit of carbonized tissue (black).

Make sure that the pin has not been damaged or a pin is missing. In which case you must replace it
immediately.

RF should not be used in the eyelids, lips, or mucous surfaces.

Do not use the same tip to treat different patients.

When cleaning the tip, avoid pressing the RF trigger.

Do not repeat the procedure, in some skins it may take time to observe the erythema.

If an adverse effect is observed, stop the treatment immediately.

6.3.6 POST-TREATMENT CARE

It will be observed that throughout the area that has been treated, erythema of smaller or greater
magnitude is produced depending on the program used.

If the patient has any sensation of heat cold cloths, cold bags (not frozen) or refreshing aloe vera
gel can be used.

If adverse effects occur, tell the patient to consult a doctor immediately.

In the following days small scabs may appear in the area of contact between the tip and the
epidermis (normal effect). It is important to warn the patient to avoid scratching or touching the
scabs. These disappear after a few days by natural exfoliation.

The evaluation of the patient is recommended within 72 hours after the session.

The patient should avoid:

 Being exposed to the sun, use protection SPF 30 or higher.

 Mechanical or thermal injury in the area.
 The use of hot water and rubbing the area.
 It is recommended to wait 24 hours after the application for the use of soap and makeup,
and 12 hours for the use of moisturizers.

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6.3.7 TREATMENT PLAN

The duration of the sessions may depend on the area to be treated, attributes and patient response.

It is suggested:

Session Time 15 minutes

Number of sessions 3 or 4 sessions

Intervals between 4 to 6 weeks

sessions

Maintenance 1 session every 6 or 12 months or

when it is necessary

Do not perform more than 5 sessions, until evaluating the final result of the treatment. The
final result of the treatment must be evaluated between 60 and 90 days after the end of the
last session.

7. MAINTENANCE
NOTA: It is the responsibility of the user to comply with the information provided in this section

The procedures detailed below must be performed by the operator. For other maintenance or
repair, contact technical support or an authorized maintenance representative.

7.1 CHANGING THE ELECTRODE IN THE APPLICATOR HEAD

Turn off the equipment before replacing the electrode (tips) in the applicator.

Replace the electrode every time a treatment begins.

Press the flaps on both sides of the applicator so that the Tip is released. With the other hand, slide
the electrode forward. Discard it.

Figure 11: Replacement of the electrode

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7.2 CLEANING
Carry out the cleaning taking great care not to introduce water or humidity to the equipment or its
parts.

7.2.1 MAIN UNIT

Do not use harsh chemicals.

Use a soft cloth to remove dust. In case the dirt is abundant you can go over the outer surface with a
slightly dampened cloth that does not drip. Let it dry before turning it on again.

7.2.2 TOUCH SCREEN

Keep the surface of the screen clean with commercially available solvents, especially for cleaning
LCD screen surfaces (wipes or sprays). Follow the manufacturer's instructions.

It is recommended to clean at least once a week.

7.3 CHANGE OF FUSES

Replace the fuses as detailed below:

1. Under the connector for the power cord there is a small box where the fuses are housed
(Figure 12).
2. Open the fuse compartment. To do this insert a flat head screwdriver into the notch and
gently lift the fuse compartment with a slight downward and outward movement.
3. The fuse needs to be replaced if it appears black or burned
4. Replace it with a T6AL250V fuse.
5. Close the lid of the fuse box until you hear a "Click".
6. Connect the power cord to the equipment.

Figure 12: Location of the fuses

NOTE: It is convenient to have two spare fuses, in case a replacement is necessary.

7.4 REPACKAGING AND TRANSPORTATION

To avoid possible damage, always transport it with the original packaging and make sure that the
environmental conditions of transport are met.

ECLERIS will not be responsible for any damage or defects caused during transportation that are
connected to poor packaging.

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8. TECHNICAL SPECIFICATIONS
Output parameters
Max energy 20 Joules
Pulse duration 10 a 100 ms
Max applicator output voltage 168 Vrms (no load)
Program 1 Energy 2-10 Joules
Program 2 Energy 8 – 16 Joules
Program 3 Energy 12 – 20 Joules

Electrode
Treatment area 8mmx8mm (64 points)
Type Bipolar Matrix
Disposable

Operating mode Pulsed-Continuous

Screen 5 "LCD screen with touch technology.
Resolution: 480x272 pixel RGB

8.1 SUBLATIVE CHARACTERISTICS OF RF POWER

Output power versus load impedance with output control at half and maximum: The power curve
of the sublative RF applicator is shown below in Figure 13 (The output power diagrams with the
control to the half and at maximum are identical).

Figure 13: Power vs. load impedance

Feeding:
Supply voltage: 100-240V ~ 50-60hz
Consumption: 300VA
Fuse: 2x T6AL250V

Service environment conditions:

10°C-40°C
700-1060 hPa
30-75% (relative humidity in air)

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Storage / transport conditions:

-10°C-45°C
500-1060 hPa
10-95% (relative humidity in air)

Electrical safety:
Classification (IEC60601-1): Protection against electric shock: Class I, Type: BF
Protection against the entry of water or particles: IPX0
NOT suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or
nitrous oxide

Standards and regulations:

IEC60601-1: Electrical medical equipment: general requirements for essential operation and
basic safety.
IEC60601-1-2: Medical equipment, part 1-2: general requirements for essential operation and
basic safety. Collateral standard: electromagnetic disturbances.

9. ELIMINATION
Discard all parts removed from the device according to local, community and national regulations
and following the protocols of the health institutions in order to protect the environment.

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10. TROUBLESHOOTING
The following table indicates the most frequent problems and their quick solutions. Please consult
this table for any difficulty you may encounter.

PROBLEM PROBABLE CAUSE ACTION

The device does not turn on. It is not connected to the Connect the power supply cable to
electrical network the electrical network.

The power supply cable is Change the power supply cable.

broken or cut.

The plug is in bad condition. Change the plug.

The fuse is broken or burnt. Change the fuse

The equipment is not Turn on the device using the ON /

switched on OFF button.

The green pilot light from Defective board or touch Restart the system (ON/OFF).
the on/off switch turns ont screen,
but the screen does not.

If the problem persists,

contact the nearest
Technical Service.

The emission does not work. Defective applicator Check the connection and
condition of the applicator cord.
Replace the applicator.

If the problem cannot be solved, please contact your local distributor or the nearest ECLERIS office
and request technical service.

11. ACCESSORIES AND SPARE PARTS

Below there are the parts and accessories provided by Ecleris, which are compatible with the
FRAXFACE. Contact your Ecleris representative to order these parts.

Only connect parts and accessories approved by Ecleris. The replacement of any of its parts
could affect its operation.

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Part ID#

Electrode –tips (box of 10 RF240

units)

Handpiece RF212

12. TECHNICAL SERVICE

FRAXFACE should be repaired and/or maintained exclusively by ECLERIS trained and qualified
personnel in authorized installations and must only be repaired the parts of the device that
ECLERIS state as repairable. ECLERIS will provide under request circuits, list of components,
description calibration instructions or any other information in order to assist the ECLERIS
authorized technical personnel.

We recommend using the following procedure to expedite repair service and reposition of
products under guarantee.

1. Contact the technical service department of your local distributor or nearest ECLERIS
office.
2. Provide detailed information on the problem.
3. If the problem cannot be solved through troubleshooting, it must be sent for repair.

The following information should be sent with the product:

 Owner’s name
 Owner’s address
 Person to contact and a telephone number
 Product serial number
 Problem description

The shipment should be done in the original packaging to avoid damage to the equipment during
the transportation. ECLERIS will not be responsible for damage caused during the transportation
due to improper packaging

13. WARRANTY
ECLERIS declares that FRAXFACE has passed our Quality Control and no defects have been found
in its manufacture, therefore guarantees proper working order under adequate conditions that
are indicated in this manual. The guarantee is for the term of one (1) year starting on the purchase
date.

ECLERIS shall not be responsible for damage caused by/to the FRAXFACE and its power supplies
for inadequate use, neglect, incorrect cleaning or storage. Any repairs carried out by anyone other
than ECLERIS authorized personal will annul this warranty. This warranty is only valid for the
original buyer.

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Without regarding the warranty, all shipping cost to and from ECLERIS authorized installations
are exclusive responsibility of the client.

14. ELECTROMAGNETIC COMPATIBILITY – GUIDANCE AND

MANUFACTURER’S DECLARATION
Guidance and manufacturer's declaration -Electromagnetic emissions

The device is indicated for use in the electromagnetic environment specified below. The client or
user of the equipment must ensure that it is used in such environment.

Emissions test Compliance Electromagnetic environment-

Guide

RF Emissions CISPR 11 Group 2 The device emits electromagnetic

energy to perform its intended
function. Nearby electronic
equipment may be affected.

RF emissions CISPR 11 Class A The device is not suitable for use in

places connected to a low voltage
power supply network. Not
suitable for domestic use
Harmonic Emissions IEC61000-3-2 Class A

Flickers IEC61000-3-3 Complies

Guidance and Manufacturer’s declaration – Electromagnetic Immunity

The FRAXFACE unit is intended for use in the electromagnetic environment specified below. The
customer or user of the unit must ensure that it is used in this environment.
Immunity Test Level Compliance Electromagnetic environment
Test IEC 60601 Level -guide
Electrostatic ± 6 kV contact ± 6 kV contact The floors must be made of
discharge (ESD) wood, concrete or ceramic tile.
IEC 61000-4-2 If the floors are covered with
± 8 kV air ± 8 kV air synthetic material, the relative
humidity must be at least 30%
Electrical fast ± 2 kV for power ± 2 kV for power The quality of the network
transient burst lines lines power must be that of a
IEC 61000-4-4 ± 1 kV for output- ± 1 kV for output- commercial environment or
input lines input lines hospital.
Power Surge ± 1 kV Line to earth The quality of the network
(Surge) Line to line ± 1 kV power must be that of a
IEC 61000-4-5 ±2 kV Line to earth commercial environment or
Line to earth ±2 kV hospital.
Voltage drops, < 5% UT < 5% UT The quality of the network
short interruptions and (>95% drop in UT) (>95% drop in UT) power must be that of a
variations of for 0,5 cycles for 0,5 cycles commercial environment or
voltage in power input 40% UT 40% UT hospital.
line (60% drop in UT) (60% drop in UT) If the user of the equipment

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IEC 61000-4-11 For 5 cycles for 5 cycles requires continuous operation

70% UT 70% UT during power network
(30% drop in UT) (30% drop in UT) interruptions, it is
For 25 cycles For 25 cycles recommended that the
< 5% UT < 5% UT equipment be activated from
(>95% drop in UT) (>95% drop in UT) an uninterrupted power supply
for 5 s for 5 s or a battery.
Power Frequency 3 A/m 3 A/m Industrial frequency magnetic
(50/60 Hz) fields must be at the levels of a
Magnetic Field commercial environment or
IEC 61000-4-8 hospital.
NOTE: UT is the voltage of the AC network before the application of the test level.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The FRAXFACE equipment is intended for use in the electromagnetic environment specified
below. The client or user of the equipment must ensure that it is used in this environment.
Immunity Test Level Compliance Electromagnetic environment – Guide
test IEC 60601 Level
RF Driven 3 V rms 3 V rms Portable or mobile RF communications
IEC 61000-4-6 150 kHz to 80 MHz equipment should not be used closer to
any part of the unit, including cords, than
the recommended separation distance
calculated from the equation applicable to
the transmitter frequency.
Recommended separation distance:

d = 1,2 √P
d = 1,2 √P 80 MHz a 800 MHz
RF radiated 3 V/m 3 V/m d = 2,3 √P 800 MHz a 2,5 GHz where P is
IEC 61000-4-3 80 MHz to 2,5 GHz the maximum rated output power of the
transmitter in watts (W) according to the
manufacturer of the transmitter and d is
the recommended separation distance in
meters (m).
The field intensity of fixed RF transmitters,
determined by an electromagnetic revision
of the area, A must be less than the
compliance level in each frequency range.
B Interference may occur near the
equipment 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.
The field intensity of fixed RF transmitters, such as base equipment for radio (cellular / cordless)
telephones and mobile field radios, Amateur Radio, AM and FM radio stations and TV stations can not be
predicted theoretically with accuracy. To evaluate the electromagnetic environment due to fixed RF
transmitters, an Electromagnetic analysis of the area should be considered. If the field resistance

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measured at the location in which the equipment is used exceeds the applicable RF compliance level
above mentioned, the equipment must be examined to verify normal operation. If abnormal performance
is observed, additional measures may be necessary, such as reorienting or relocating the equipment.
b In the frequency range 150 kHz to 80 MHz, the field intensity should be less than 3 V / m.

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