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InMode EVOLVE X Operator's Manual

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Operator Manual
Evolve System
with Tite, Transform and Tone
Applications
Version: DO610502A

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  • Page 1 Operator Manual Evolve System with Tite, Transform and Tone Applications Version: DO610502A...
  • Page 2 Copyright © InMode Ltd. Date: August 2021 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

    Table of Contents Section 1: Introduction ..................1 Before You Start ..................... 1 System Overview ....................1 Conventions Used in the Manual ................2 Explanation of the Symbols used on the System ........... 2 Section 2: Safety ....................4 The Patient ......................4 Treating Attendant ....................
  • Page 4 Indications for Use ....................27 Contraindications ....................27 Precautions ......................30 Possible Adverse Effects..................31 Applicator Cleaning Instructions Prior to Use ............31 Pre-Treatment Recommendations ..............32 Treatment Recommendations ................33 Treatment Schedule ..................... 34 Post Treatment Recommendations ..............35 Section 7: Tone Treatment Information ............

  • Page 5: Section 1: Introduction

    Evolve System Operator Manual Section 1: Introduction Section 1: Introduction Before You Start The manual and the equipment described are for use only by qualified medical professionals trained in the particular technique to be performed. Federal (USA) law restricts sale of this device by or on the order of a physician. Read this manual to become familiar with all safety requirements and operating procedures before attempting to operate the System.

  • Page 6: Conventions Used In The Manual

    Evolve System Operator Manual Section 1: Introduction ▪ Post-traumatic acute pain The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications. Conventions Used in the Manual The following conventions in the form of notes and warnings are used in this manual: WARNING! This information is extremely important! ATTENTION! Consult Accompanying Document.
  • Page 7 Evolve System Operator Manual Section 1: Introduction Symbol Description Federal (US) law restricts this device to sale by the order of a physician licensed by the law of the state in which he practiced to use or order the use of the device Non-Ionizing Radiation Serial Number...

  • Page 8: Section 2: Safety

    Evolve System Operator Manual Section 2: Safety Section 2: Safety This chapter describes safety issues regarding the use and maintenance of the EvolveX 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: Cautions

    Evolve 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: Safety Features Of The System

    Evolve 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 Evolve System Operator Manual Section 2: Safety Only Applicators manufactured or approved by InMode Ltd. should be used with EvolveX 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: Device And Applicators Labels

    Evolve System Operator Manual Section 2: Safety The operation of the EvolveX may adversely influence the operation of other electronic equipment. The RF treatment mode and EMS/TENS mode should not be used sequentially. To avoid the risk of electric shock, this equipment must only be connected to a main supply with protective earth.
  • Page 13 Evolve System Operator Manual Section 2: Safety Figure 2-3: Belt Label Applicator Labels Manufacturer identification labels are placed on the Tite and Transform Applicators. Figure 2-4: Tite, Transform and Tone Applicators Identification Labels...

  • Page 14: Equipment Classification

    Evolve System Operator Manual Section 2: Safety Equipment Classification The following is a list of the different equipment used and their classifications. ▪ Electric shock protection: Class I, Defibrillation-proof Type BF. ▪ Protection against ingress of liquids: Ordinary equipment. ▪ Not suitable for use in presence of flammable substance.

  • Page 15: Section 3: System Installation

    Evolve 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. Zmax = 0.03Ω. ▪...

  • Page 16: Unpacking

    Evolve System Operator Manual Section 3: System Installation ▪ Treatment Deactivation Switch (Patient Call Button) ▪ Operator manual ▪ Power cord. 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: Installation

    Evolve System Operator Manual Section 3: System Installation Installation The System is designed for installation in a clinic environment. To install the System, perform the following tasks: ▪ Check the System and all its components for damage. ▪ Set harness support (see Figure 3.1) and secure with clamping knobs. ▪...

  • Page 18: System Disposal

    Evolve System Operator Manual Section 3: System Installation ▪ Disconnect and remove the Applicators. ▪ Disconnect the Patient Call Button. ▪ Release the wheel brakes. ▪ Slowly push or pull the System using the handle. ▪ When moving to another facility, disconnect harness support, lift the System to the vehicle and lay it carefully on its side.

  • Page 19: Section 4: Device Description

    Evolve 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 20: Front Panel And Operator Control Panel

    Evolve System Operator Manual Section 4: Device Description 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. Power On-Off Power switch turns System On and Off. The blue switch is located Switch on the Front Panel.

  • Page 21: Software Screens

    Evolve System Operator Manual Section 4: Device Description Software Screens The Splash screen appears after the On-Off switch is turned on. Figure 4-3: Splash Screen *The SW version number will be displayed according to the software version. After entering the individual code on the Login Screen, non-authorized use of the device is prevented.
  • Page 22 Evolve System Operator Manual Section 4: Device Description Figure 4-5: Menu Screen The Menu Screen allows the selection of the connected Applicator, or entry to the Utilities Screen. Figure 4-6: 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...
  • Page 23 Evolve System Operator Manual Section 4: Device Description Figure 4-7: Tite Treatment Screen 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 24 Evolve System Operator Manual Section 4: Device Description Main Menu Return to the Main Menu to select the Applicator. Figure 4-8: Transform Treatment Screen Elapsed Time This indicator shows elapsed time from the beginning of treatment activation. Preheat The device is automatically set to start with PREHEAT sequence: the system will deliver the lowest energy level to preheat the unit and to bring skin and electrodes to the same temperature This button activates the treatment.
  • Page 25 Evolve System Operator Manual Section 4: Device Description Intensity is changed within the limits allowed for the connected Intensity Applicator. Intensity level settings are changed from 1 to 50 energy levels. The System starts up at minimal intensity level setting. Temperature Color temperature scale.

  • Page 26: Sound Indicator

    Evolve System Operator Manual Section 4: Device Description applicators 1&4 and 2&3. The System starts up at minimal intensity level setting. Treatment Time This indicator shows time when energy is applied sequentially to the Applicators. Applicators These indicators show online status for each of the connected Status Indicators Applicators.

  • Page 27: Applicator

    Evolve System Operator Manual Section 4: Device Description Applicator Each Tite Applicator unit comprises an Applicator, Cable, Connector and an Integral Temperature Sensor. Figure 4-10: Tite Applicator The Tite Applicator unit contains: Electrodes Three electrodes located on the side of applicator applied to the skin.

  • Page 28: Patient Call Button (Treatment Deactivation Switch)

    Evolve System Operator Manual Section 4: Device Description Nine electrodes located on the side of applicator applied to the Electrodes skin. Connector Connects applicator to the harness Temperature Each electrode has embedded temperature sensor. Sensors Each Tone Applicator unit comprises 2 electrodes, and a Connector. Figure 4-12: Tone Applicator Unit The Tone Applicator unit contains: Harness...

  • Page 29: Belt Set

    Evolve System Operator Manual Section 4: Device Description Figure 4-13: Patient call button Belt Set The Belt Set is intended to be used on an individual patient during a single procedure and then discarded. The Belt Set is not intended to be reprocessed and used on another patient The EvolveX System is equipped with an adjustable belt set.

  • Page 30: Section 5: System Operation

    Evolve 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. Device Start-Up Connect the Applicators to the harness.
  • Page 31 Evolve System Operator Manual Section 5: System Operation Figure 5-1: On Off Main Power Switch at the Figure 5-2: On Off Switch at the Front Rear (Arrow) (Arrow)

  • Page 32: Section 6: Transform Treatment Information

    Evolve System Operator Manual Section 6: Transform Treatment Information Section 6: Transform Treatment Information Indications for Use The EvolveX System with the Transform Applicator units employs RF technology and EMS-TENS technology for the treatment of selected medical conditions. The Transform Applicator in RF mode is intended for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
  • Page 33 Evolve System Operator Manual Section 6: Transform Treatment Information ▪ Permanent implant in the treated area such as metal plates and screws, silicone implants or an injected chemical substance, unless deep enough in the periostal plane. ▪ Current or history of skin cancer, or current condition of any other type of cancer, or premalignant moles.
  • Page 34 Evolve System Operator Manual Section 6: Transform Treatment Information Contraindications in the use of the EvolveX System in EMS-TENS mode include: ▪ Active electrical implant/device in any region of the body, including pacemaker or internal defibrillator. ▪ Permanent implant in the treated area such as metal plates, screws or silicon, metal piercing or other.

  • Page 35: Precautions

    Evolve System Operator Manual Section 6: Transform Treatment Information weeks for ablative fractional laser resurfacing (according to treatment severity) prior to treatment, except special recommendations. ▪ Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g., ibuprofen- containing agents) one week before and after each treatment session, as per the practitioner’s discretion.

  • Page 36: Possible Adverse Effects

    Evolve System Operator Manual Section 6: Transform Treatment Information Possible Adverse Effects Certain side effects may be experienced during treatment or shortly afterwards which may or may not be a result of improper use of the system. Although these side effects are rare and temporary, they should be reported immediately to a physician for proper treatment.

  • Page 37: Pre-Treatment Recommendations

    Evolve System Operator Manual Section 6: Transform Treatment Information ▪ Check to ensure proper cleaning and drying of the Applicator. ▪ Visually inspect the applicators for residual soil. Repeat the Cleaning Procedure in the event that residual soil is visible. Inspect all components of the applicator for visible damage.

  • Page 38: Treatment Recommendations

    Evolve System Operator Manual Section 6: Transform Treatment Information Treatment Recommendations The treatment recommendations for the EvolveX System with the Transform Applicator in RF mode are as follows: Ensure that skin is clean and dry. Follow Device Start-Up from Section 5.1. Set treatment parameters.

  • Page 39: Treatment Schedule

    Evolve System Operator Manual Section 6: Transform Treatment Information The skin should be observed for excessive erythema or edema. If observed, stop the treatment and move to the next treatment zone. The treatment recommendations for the EvolveX System with the Transform Applicator in EMS-TENS mode are as follows: Ensure that skin is clean and dry.

  • Page 40: Post Treatment Recommendations

    Evolve System Operator Manual Section 6: Transform Treatment Information Post Treatment Recommendations ▪ Skin cooling is NOT recommended. ▪ The patient should avoid very hot water for 2 days after the treatment. ▪ The patient should avoid scrubbing, pinching and etc. of the treated area.

  • Page 41: Section 7: Tone Treatment Information

    Evolve System Operator Manual Section 7: Tone Treatment Information Section 7: Tone Treatment Information Indications for Use The EvolveX System with Tone Applicator is used in EMS mode for: ▪ Prevention or retardation of disuse atrophy ▪ Maintaining or increasing range of motion ▪...

  • Page 42: Precautions

    Evolve System Operator Manual Section 7: Tone Treatment Information ▪ History of bleeding coagulopathies or use of anticoagulants except for low-dose aspirin. ▪ Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.

  • Page 43: Possible Adverse Effects

    Evolve System Operator Manual Section 7: Tone Treatment Information ▪ Caution should be used for patients with suspected or diagnosed epilepsy. ▪ Caution should be used in the presence of the following: a. When there is a tendency to hemorrhage following acute trauma or fracture; b. Following recent surgical procedures when muscle contraction may disrupt the healing process;...

  • Page 44: Pre-Treatment Recommendations

    Evolve System Operator Manual Section 7: Tone Treatment Information The following processes validated for the Tone 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 45: Treatment Recommendations

    Evolve System Operator Manual Section 7: Tone Treatment Information Treatment Recommendations Follow Device Start-Up from Section 5. Up to 4 Applicator units can be applied to the treatment area. Tight Applicator units around the treatment area with a belt to assume good coupling between applicators and skin.
  • Page 46 Evolve System Operator Manual Section 7: Tone Treatment Information ▪ Treatment duration is 20 to 40 minutes according to patient tolerance and conditions. ▪ Treatment should be concluded when the results are satisfactory to the patient or according to the physician’s discretion.

  • Page 47: Section 8: Tite Treatment Information

    Evolve System Operator Manual Section 8: Tite Treatment Information Section 8: Tite Treatment Information Indications for Use The EvolveX System with the Tite Applicator units 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 48: Possible Adverse Effects

    Evolve System Operator Manual Section 8: Tite Treatment Information ▪ History of bleeding coagulopathies, or use of anticoagulants in the last 10 days. ▪ Laser resurfacing and deep chemical peeling within the last 3 months prior Tite treatment. ▪ Having received treatment with light, laser, RF, or other devices in the treated area within 3 months, or before complete healing.

  • Page 49: Pre-Treatment Recommendations

    Evolve System Operator Manual Section 8: Tite Treatment Information 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. ▪ Inspect all components of the Applicator for visible damage Pre-Treatment Recommendations During the patient’s first visit the treating attendant should: ▪...

  • Page 50: Treatment Recommendations

    Evolve System Operator Manual Section 8: Tite Treatment Information Treatment Recommendations The caregiver shouldn’t leave the patient unattended during treatment  The patient can use the Patient call button to pause the treatment if the discomfort becomes excessive The skin should be observed for excessive erythema or edema. If observed, stop the treatment and move to the next treatment zone.

  • Page 51: Treatment Schedule

    Evolve System Operator Manual Section 8: Tite Treatment Information The belt should not be loose. Ensure the belt is taut around the treatment area. Secure the units with additional belt on the top if needed. Up to 8 Applicator units can be applied to the treatment area. Tight Applicator units around the treatment area with a belt to assume good coupling between electrodes and skin.

  • Page 52: Section 9: System Maintenance

    Evolve System Operator Manual Section 9: System Maintenance Section 9: 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 with the skin should be disinfected with 70% alcohol between patients, as described in detail for the Applicator.

  • Page 53: Section 10: Troubleshooting

    Evolve System Operator Manual Section 10: Troubleshooting Section 10: Troubleshooting The EvolveX 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. 10.1 Description of Faults with All Applicators Problem Description and Checks...
  • Page 54 Evolve System Operator Manual Section 10: Troubleshooting Problem Description and Checks Faults H83XX, H84XX, Call Technical Service if the problem persists. H82XX Faults H8003, H8006, Call Technical Service if the problem persists. H8007 - RF Related Faults...

  • Page 55: Section 11: System Specifications

    Evolve System Operator Manual Section 11: System Specifications Section 11: System Specifications Input Power Main Line Frequency (nominal) 50-60Hz Input Voltage (nominal) 100-240VAC Input Current (rms) Operating Parameters Ambient Temperature Range 15 – 30°C [59 – 86°F] Relative Humidity 30% to 80%, non-condensing Atmospheric Pressure 90 - 110kPa Warm-up Time...

  • Page 56: 11.1 Output Power Curves

    Evolve System Operator Manual Section 11: System Specifications RF Maximum Output Power RF Frequency 1Mhz Pulse Duration 2 Sec. Intensity (output voltage) Up to 50 intensity level (=54 Vpeak) Waveform Bi-phasic Pulse shape Rectangular Pulse width 20-400 [µsec] Frequency 3-200 [Hz] Tone Output Parameters Intensity (output voltage) Up to 50 energy level (=54 Vpeak)

  • Page 57: 11.2 Emc Safety

    Connect the device into an outlet on a circuit different from that which was previously used. ▪ Consult InMode 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...
  • Page 58 Evolve System Operator Manual Section 11: System Specifications ▪ Use of the System with any accessory, transducer or cable other than those specified may result in increased EMISSIONS or decreased IMMUNITY than those specified. ▪ The System should not be used adjacent to or stacked with other equipment.

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