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InMode EVOKE Operator's Manual

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Operator Manual
EVOKE System
Version: DO608239B

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Summary of Contents for InMode EVOKE

  • Page 1 Operator Manual EVOKE System Version: DO608239B...
  • Page 2 DO608239B Copyright © InMode Ltd. Date: January, 2020 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of InMode Ltd.. InMode Ltd. Tabor Building, Industrial Park South Yokneam 2069206, POB 533, Israel...
  • Page 3 Table of Contents Section 1: Introduction ....................1 Before You Start ..................... 1 System Overview ....................1 Conventions Used in the Manual ................1 Explanation of the Symbols used on the System ........... 2 Section 2: Safety ......................4 The Patient ......................4 Treating Attendant ....................
  • Page 4 Section 6: Evoke Treatment Information ..............28 Indications for Use ....................28 Contraindications ....................28 Possible Adverse Effects..................29 Applicator Cleaning Instructions Prior to Use ............29 Pre-Treatment Recommendations ..............30 Treatment Recommendations ................31 Post-Treatment ....................32 Treatment Schedule ..................... 32 Section 7: System Maintenance ..................
  • Page 5 Read this manual to become familiar with all safety requirements and operating procedures before attempting to operate the System. System Overview The EmFace Platform with Chin and Cheek Applicators is marketed as the Evoke System which employs Radio-frequency (RF) technologies for various aesthetic applications.
  • Page 6 Evoke System Operator Manual Section 1: Introduction Explanation of the Symbols used on the System Symbol Description CSA marking (212603 CSA master contract number) Do not discard in trash. Electronic equipment should be disposed of in an appropriate manner Fuse Type BF Equipment Type B Equipment.
  • Page 7 Evoke System Operator Manual Section 1: Introduction Symbol Description Symbol for date of manufacture. This symbol is accompanied by a date Symbol for manufacturer. This symbol is accompanied by the name and address of the manufacturer Symbol for do not reuse/single use only. This symbol...
  • Page 8 Section 2: Safety Section 2: Safety This chapter describes safety issues regarding the use and maintenance of the Evoke System, with a special emphasis on electrical safety. The system is designed for safe and reliable treatment when used in accordance with proper operation and maintenance procedures.
  • Page 9 Evoke System Operator Manual Section 2: Safety There are no user-serviceable parts in the System, and all service and repair must be performed only by the factory or authorized field service technicians. Cautions The following cautions should be heeded for safe System use: ▪...
  • Page 10 Evoke System Operator Manual Section 2: Safety ▪ If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly before the System is used. Safety Features of the System The system incorporates the following safety features. All personnel operating the system should be familiar with these features.
  • Page 11 Do not immerse the Applicator under water at any time. This equipment is for use only by trained personnel. Only Applicators manufactured or approved by InMode Ltd. should be used with Evoke System. Connect the power cord to a properly polarized and grounded power source with the frequency and voltage characteristics that match those listed on the back of the unit.
  • Page 12 As required by national and international regulatory agencies, appropriate warning and information labels have been attached to specific locations on the instrument as identified below. The following device labels are located on the Evoke device console and the Applicator: Figure 2-1: Device Identification Label...
  • Page 13 Evoke System Operator Manual Section 2: Safety Figure 2-2: Hand-held Switch Label Applicators Labels Manufacturer identification labels are placed on the Cheek and Chin Applicators. Figure 2-3: Cheek and Chin Applicators Identification Labels 9 of 39...
  • Page 14 Evoke System Operator Manual Section 2: Safety Figure 2-4: Cheek and Chin Belt Set Identification Labels Equipment Classification The following is a list of the different equipment used and their classifications. ▪ Electric shock protection: Class I, Defibrillation-proof Type BF.
  • Page 15 Evoke System Operator Manual Section 3: System Installation Section 3: System Installation Electrical Requirements ▪ The System will require a separate line supply of single phase (100Vac; 15A) or (115Vac; 15A) or (230Vac; 15A) or (240Vac; 15A) 50-60Hz. ▪ Power receptacles must be within 15 feet of the System site.
  • Page 16 Evoke System Operator Manual Section 3: System Installation Unpacking In order to unpack the device: Remove the paper strip and open the box Remove accessories and foams around the device. Take the device out of the box using top and bottom handles.
  • Page 17 Evoke System Operator Manual Section 3: System Installation ▪ Connect the Hand-held switch (Treatment Deactivation button) ▪ Connect the power cord to the System inlet. ▪ Plug the System power cord into an appropriate electrical outlet. Moving the System To move the System: ▪...
  • Page 18 Evoke System Operator Manual Section 4: Device Description Section 4: Device Description Rear Panel Power Cord Inlet 100-240V~, 15A, 50-60Hz. Fuse Holder Rating is T 6.3A, 250V. Replace fuses if needed, only with fuses having exactly the same rating. Software Flash Memory Plug The software plug is a flash memory with the machine software.
  • Page 19 Evoke System Operator Manual Section 4: Device Description Figure 4-1: Evoke System Rear View Figure 4-2: Applicator’s connectors 15 of 39...
  • Page 20 Evoke System Operator Manual Section 4: Device Description Figure 4-3: Lower rear Evoke connectors Front Panel and Operator Control Panel The Operator Control Panel is located on the upper side of the System. The Operator Control Panel consists of an LCD touch screen.
  • Page 21 Evoke System Operator Manual Section 4: Device Description Figure 4-4: Evoke System Front View Software Screens The Splash screen appears after the On-Off switch is turned on. Figure 4-5: Splash Screen After entering the individual code on the Login Screen, non-authorized use of the device is prevented.
  • Page 22 Evoke System Operator Manual Section 4: Device Description Figure 4-6: Login Screen Software is loaded from the plug and self-test of the System modules is performed. After the end of the self-test the Menu Screen appears. Figure 4-7: Menu Screen The Menu Screen allows the selection of the connected Applicator, or entry to the Utilities Screen.
  • Page 23 Evoke System Operator Manual Section 4: Device Description Figure 4-8: Utility Screen The Utility Screen contains: Volume This function allows the user to adjust the System volume. Change Change the password by entering the old password and then Password entering another 4-digit password.
  • Page 24 Evoke System Operator Manual Section 4: Device Description The Cheek Treatment Screen contains: Elapsed Time This indicator shows elapsed time from the beginning of treatment activation. Start / Pause This button activates the treatment. After pressing the ‘Start’ button, the system is in ‘Active’ mode. The icon will then change to ‘Pause’...
  • Page 25 Evoke System Operator Manual Section 4: Device Description Figure 4-10: Chin Treatment Screen The Chin Treatment Screen contains: Elapsed Time This indicator shows elapsed time from the beginning of treatment activation. Start / Pause This button activates the treatment. After pressing the ‘Start’...
  • Page 26 Evoke System Operator Manual Section 4: Device Description Applicators Status These indicators show online the measured skin Indicators (1-2) surface temperature for each of the connected Applicators. The color of the buttons is in accordance with the temperature scale above. The grey color indicates that Applicator is not connected or not recognized.
  • Page 27 Evoke System Operator Manual Section 4: Device Description Applicators The Cheek Applicator comprises eight RF units with RF electrodes, and a temperature sensor in each unit. The four left units and the right four units are connected to the mask by magnets and may be detached for cleaning. When reassembling, it is crucial to keep the same sides.
  • Page 28 Evoke System Operator Manual Section 4: Device Description The Chin Applicator comprises two RF units with RF electrodes, Cable, Connector and a temperature sensor located in the middle RF electrode of each unit. Figure 4-11: Chin Applicator The Chin Applicator contains:...
  • Page 29 The Belt Set is not intended to be reprocessed and used on another patient The Evoke System is equipped with an adjustable strap set. The straps enable an easy and comfortable setting of the applicator onto the patient skin.
  • Page 30 Evoke System Operator Manual Section 5: System Operation Section 5: System Operation This section of the manual explains how to start the device, operate it, and turn it off.  Prior to using or connecting the Applicator, inspect the System and Applicator for possible mechanical damage.
  • Page 31 Evoke System Operator Manual Section 5: System Operation System Shutdown To shut down the System, turn the On-Off switch located at the front to Off (Figure 5.2). Turn the Main Power switch located at the backside of the System to Off at the end of the day (Figure 5.1).
  • Page 32 Section 6: Evoke Treatment Information Indications for Use The Evoke System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
  • Page 33  These cleaning instructions are for clinical use only. The following processes validated for the Evoke Applicators when used in accordance with the instructions provided for cleaning products and/or processes. Any deviation from said instructions or the cleaning agents listed below may affect the performance or durability of the product, and it’s prohibited.
  • Page 34 Evoke System Operator Manual Section 6: Evoke Treatment Information Clean the Applicator units thoroughly with alcohol absorbed pad and repeat as necessary. Leave it for complete drying. Pre-use Check Before each use of the Applicator, the device must pass the following: Check to ensure proper cleaning and drying of the Applicator.
  • Page 35 Evoke System Operator Manual Section 6: Evoke Treatment Information Treatment Recommendations 1. Follow Device Start-Up from Section 5. Set treatment parameters. Suggested treatment parameters are shown in the table below: Cut-Off Skin Temperature Treatment time RF Power [ºC] [min] 10-30...
  • Page 36 Evoke System Operator Manual Section 6: Evoke Treatment Information Post-Treatment ▪ After each treatment session, the patient should be advised to contact the physician if there is any indication of infection, excessive swelling, redness, pain, or any other unusual or untoward symptom.
  • Page 37 Evoke System Operator Manual Section 7: System Maintenance Section 7: System Maintenance Maintenance & Frequency The following list suggests how often each of the maintenance procedures should be performed by the operator. Before and after each treatment Wipe the device with a damp soft cloth. The Applicator elements that are in contact...
  • Page 38 Evoke System Operator Manual Section 8: Troubleshooting Section 8: Troubleshooting The Evoke System provides monitoring of all critical parameters to ensure safety of patient and user. If any of the following faults are detected system automatically goes to Stand By mode.
  • Page 39 Evoke System Operator Manual Section 8: Troubleshooting Problem Description and Checks Faults H83XX, H84XX, H82XX Call Technical Service if the problem persists. Faults H8003, H8006, H8007 - Call Technical Service if the problem persists. RF Related Faults Power Interruption System will turn off, then when power gets back on,...
  • Page 40 Evoke System Operator Manual Section 9: System Specifications Section 9: System Specifications Input Power Main Line Frequency (nominal) 50-60Hz Input Voltage (nominal) 100-240VAC Input Current (rms) 3.5A Operating Parameters Ambient Temperature Range 15 – 35°C [59 – 95°F] Relative Humidity...
  • Page 41 Evoke System Operator Manual Section 9: System Specifications Output Power Curves The curves that follow depict the changes for each RF mode at specific power settings. EmFace Series1 Series2 1000 Load [ ] Figure 9-1: Evoke Output Power versus Impedance 37 of 39...
  • Page 42 Connect the device into an outlet on a circuit different from that which was previously used. ▪ Consult InMode Ltd. service personnel for help. Interference to the device may be caused by portable and mobile RF communication equipment. In case of an interruption, beware of such a device in the vicinity.
  • Page 43 Evoke System Operator Manual EMC Compliance IEC 60601-1-2 Edition 4.0 (2014): Environment of intended uses: - Professional Healthcare Facility Environment Summary of Test Results Test Test Standard Class/ Severity level result Emission (IEC 60601-1-2 section 7.1 & 7.2 & IEC 60601-2-2 )