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Summary of Contents for Ecleris FRAXFACE
- Page 1 USER MANUAL FRAXFACE FRACTIONAL RADIO FREQUENCY...
- Page 2 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.
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Page 3: Table Of Contents
USER’S MANUAL – FRAXFACE CONTENT SYMBOLS ...................................... 5 SECURITY WARNINGS ................................5 2.1 WARNINGS ....................................5 2.2 CAUTION ....................................6 2.3 CONTRAINDICATIONS ................................. 7 DESCRIPTION ..................................... 8 3.1 EXPECTED USE ..................................8 3.2 EXPECTED USER ..................................9 3.3 ENVIRONMENT OF USE ............................... 9 3.4 COMPONENTS .................................. - Page 4 USER’S MANUAL – FRAXFACE 7.4 REPACKAGING AND TRANSPORTATION ........................19 TECHNICAL SPECIFICATIONS ............................20 8.1 SUBLATIVE CHARACTERISTICS OF RF POWER ...................... 20 ELIMINATION ................................... 21 TROUBLESHOOTING ................................. 22 ACCESSORIES AND SPARE PARTS ..........................22 TECHNICAL SERVICE ................................ 23 WARRANTY ..................................23 ELECTROMAGNETIC COMPATIBILITY –...
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Page 5: Symbols
USER’S MANUAL – FRAXFACE 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... -
Page 6: 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... -
Page 7: 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. -
Page 8: Description
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. -
Page 9: Expected User
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 ... -
Page 10: Main Unit
USER’S MANUAL – FRAXFACE 3.4.1 MAIN UNIT 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... -
Page 11: Contact Tips
USER’S MANUAL – FRAXFACE 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. -
Page 12: Instructions For Use
USER’S MANUAL – FRAXFACE 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. -
Page 13: Treatment Programs
USER’S MANUAL – FRAXFACE 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. -
Page 14: Security Features
USER’S MANUAL – FRAXFACE 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. -
Page 15: Expectations Of The Treatment
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: Page 15 of 26... -
Page 16: Preparation Of The Patient
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). -
Page 17: General Recommendations During The Treatment
USER’S MANUAL – FRAXFACE 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. -
Page 18: Treatment Plan
USER’S MANUAL – FRAXFACE 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... -
Page 19: Cleaning
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. -
Page 20: Technical Specifications
USER’S MANUAL – FRAXFACE 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 –... -
Page 21: Elimination
USER’S MANUAL – FRAXFACE 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... -
Page 22: Troubleshooting
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. ACCESSORIES AND SPARE PARTS Below there are the parts and accessories provided by Ecleris, which are compatible with the FRAXFACE. -
Page 23: Technical Service
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. -
Page 24: Electromagnetic Compatibility - Guidance And Manufacturer's Declaration
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... - Page 25 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.
- Page 26 USER’S MANUAL – FRAXFACE 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.
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