InMode System with BodyFX Handpiece Operator's Manual
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InMode System with BodyFX Handpiece Operator's Manual

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Operator Manual
InMode™ SYSTEM With
BodyFX™ Handpiece
DO602777B

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Summary of Contents for InMode InMode System with BodyFX Handpiece

  • Page 1 Operator Manual InMode™ SYSTEM With BodyFX™ Handpiece DO602777B...
  • Page 2 InMode BodyFX Operator Manual...
  • Page 3 Copyright © InMODE MD Ltd, Date: December, 2013 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of InMode MD Ltd. InMODE MD Ltd Tabor House, Industrial Park South POB 44, Yokneam 2069201, Israel...

  • Page 4: Table Of Contents

    ............................28 ONTRAINDICATIONS ..........................29 OSSIBLE DVERSE FFECTS ....................29 ANDPIECE LEANING NSTRUCTION RIOR TO ......................30 REATMENT ECOMMENDATIONS ........................30 REATMENT ECOMMENDATIONS ........................... 31 REATMENT CHEDULE ......................31 REATMENT ECOMMENDATIONS SECTION 7– SYSTEM MAINTENANCE ....................... 33 InMode BodyFX Operator Manual...
  • Page 5 SECTION 8 – TROUBLESHOOTING ......................35 ....................35 ESCRIPTION OF AULTS WITH ANDPIECES SECTION 9 - SYSTEM SPECIFICATIONS ..................... 37 ..........................38 UTPUT OWER URVES EMC S ......................39 AFETY FOR THE EVICE IEC60601-1-2, / 5.2.2.1 & ..................... 43 ABLE FROM InMode BodyFX Operator Manual...

  • Page 6: Section 1 - Introduction

    System. System Overview The InMode System with the BodyFX Handpiece is a medical aesthetic device combining mechanical vacuum skin massaging and non-thermal RF energy for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.

  • Page 7: Explanation Of The Symbols Used On The System

    CE marking Do not discard in trash. Electronic equipment should be disposed of in an appropriate manner. Fuse Type BF Equipment HF Isolated Patient Circuit This equipment intentionally supplies non-ionizing RF energy Follow instructions for use Note InMode BodyFX Operator Manual...

  • Page 8: Section 2 - Safety

    Make sure that all treatment personnel are familiar with the System controls and know how to shut down the System instantly. 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. InMode BodyFX Operator Manual...

  • Page 9: Cautions

     Do not use flammable substances when preparing the skin for treatment. Be especially careful with the use of oxygen.  If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly before the System is used. InMode BodyFX Operator Manual...

  • Page 10: Safety Operational Use Of The System

     Do not wrap the Handpiece cords around metal objects. It may induce current that could lead to electrical shocks, fire or injury to the patient or personal.  Do not connect a wet accessory to the System.  Do not immerse the applicator under water at any time. InMode BodyFX Operator Manual...

  • Page 11: Warnings

    Warnings This equipment is for use only by trained, licensed physicians. Only Handpieces manufactured or approved by InMode MD Ltd. should be used with InMode 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 Labels

    As required by national and international regulatory agencies, appropriate warning and information labels have been attached in specific locations on the instrument as identified below. The following device labels are located on InMode device console: Figure 2.1 Manufacturer System Identification Label InMode BodyFX Operator Manual...
  • Page 13 Figure 2.2 USA Federal Restriction Notice Figure 2.3 System RF output label Figure 2.4 Footswitch Label. InMode BodyFX Operator Manual...

  • Page 14: Handpiece Labels

    Handpiece labels Manufacturer identification labeling is placed on the InMode BodyFX Handpiece: Figure 2.4 The InMode BodyFX Handpiece Label 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: Section 3 - System Installation

     For optimal operation of the System, maintain room temperature between 20º-27ºC (68º-79ºF) and relative humidity of less than 80%. Equipment List The System includes the following:  System platform  BodyFX Handpiece  BodyFX Handpiece cradle  Foot switch  Operator manual  Power cord InMode BodyFX Operator Manual...

  • Page 16: Unpackaging

    Unpackaging In order to unpack the device: 1. Remove the paper strip and open the box 2. Remove accessories and foams around the device. 3. Take device out of the box using top and bottom handles. InMode BodyFX Operator Manual...

  • Page 17: Installation

    To move the System:  Turn the System off.  Disconnect the Power Cord.  Disconnect the Handpieces.  Disconnect the Footswitch.  Release the wheel brakes.  Slowly push or pull the System using the handle. InMode BodyFX Operator Manual...

  • Page 18: Disposal Of System

    Disposal of System To comply with European Commission Directive 2002/96/EC on Waste Electrical and Electronic Equipment (WEEE) and other country and state regulations, please DO NOT dispose of this equipment in any location other than designated locations. InMode BodyFX Operator Manual...

  • Page 19: Section 4 - Description Of Device

    Ready mode. Place the foot switch on the floor near the treatment area. Located on the upper right side of the rear panel and connects to the Handpiece. Handpiece Connector Figure 4.1 RF connector on rear panel (arrow) InMode BodyFX Operator Manual...

  • Page 20: Front Panel And Operator Control Panel

     Power On-Off switch Power switch turns power electronics off.  Emergency Stop Stops the power instantly in emergency conditions.  Button  LCD screen LCD screen shows information about system mode and treatment parameters The panel allows changing treatment parameters and system mode. InMode BodyFX Operator Manual...

  • Page 21: Software Screens

    After entering the individual code in the Login screen, non-authorized use of the device is prevented. Figure 4.4 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. InMode BodyFX Operator Manual...
  • Page 22 Figure 4.5 Menu Screen Menu Screen allows selection of connected Handpiece or entering Maintenance Screen. Figure 4.6 Maintenance Screen Maintenance Screen allows to drain water from the device prior to shipment and to fill water during installation InMode BodyFX Operator Manual...
  • Page 23 This indicators shows on line the skin surface temperature and the Measured Temperature and current negative pressure applied, with a maximal Temperature of 43 And -500mBar maximal Vacuum level. Vacuum The frame selects parameters that can be changed by functional keys. Selection Frame InMode BodyFX Operator Manual...
  • Page 24 Any attempt to change the treatment settings switches the system to Standby mode. When the signal from the footswitch is indicated, the system switches to Active mode. Any attempt to change the treatment settings switches the system to Standby mode. InMode BodyFX Operator Manual...

  • Page 25: Functional Keys

    C is constantly maintained, and when reached, RF delivery is automatically stopped. Temperature is monitored by a temperature sensor in the Handpiece. This is a safety feature which is maintained in addition to the external temperature measurements during treatment. InMode BodyFX Operator Manual...

  • Page 26: Handpiece

    Located in the vacuum chamber and delivers RF energy to mildly warm massaging tissue. Shows measured skin temperature. Screen Has a length of 250cm (100’’). Cable Connector Connector is located in the rear panel. Temperature Located in the vacuum chamber for skin temperature Sensor measurement. InMode BodyFX Operator Manual...

  • Page 27: Section 5 - System Operation

    To shut down the system turn the power-switch off. In case of an emergency, the system may be switched off instantly by pressing the red Emergency Stop Button on the right side of the System’s front panel. InMode BodyFX Operator Manual...

  • Page 28: Section 6 - Treatment Information

    Section 6 - Treatment Information Indications for Use InMode System with the BodyFX Handpiece is intended for the treatment of the following medical conditions using non thermal RF combined with massage:  Relief of' minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

  • Page 29: Possible Adverse Effects

    Warning! These cleaning instructions are for Clinical Use only. The following processes are validated for the InMode BodyFX Handpiece 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 impact the performance or durability of the product and is prohibited.

  • Page 30: Pre-Treatment Recommendations

    4. Set treatment parameters. Suggested treatment parameters are shown in the table below: Measured Treatment RF Power Pulse Width Skin Approach [Sec] Temperature [ºC] Sensitive skin 30-40 38-40 e.g..arm, inner thigh Normal skin 35-45 40-41 e.g. abdomen, flanks Resistant skin e.g. buttocks, outer 40-50 41-43 thigh InMode BodyFX Operator Manual...

  • Page 31: Treatment Schedule

    Post-Treatment Recommendations  Patient should avoid very hot water for 2 days after the treatment.  Patient should avoid scrubbing, pinching and etc. of the treated area.  Moisturizer can be applied to the skin surface. InMode BodyFX Operator Manual...
  • Page 32  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. InMode BodyFX Operator Manual...

  • Page 33: Section 7- System Maintenance

    5. Turn on the machine and plug the IPL Handpiece. 6. Enter the Maintenance Screen and choose Filling/Draining option (wait until the end of the process). 7. Repeat the steps until the bottle filled to the marked sign or until the water drained. InMode BodyFX Operator Manual...

  • Page 34: Cleaning The Device

    Cleaning the Device Wipe the device with a damp soft cloth. The Handpiece elements that are in contact with the skin should be disinfected with 70% alcohol between patients after removal of the residual gel, when applicable. InMode BodyFX Operator Manual...

  • Page 35: Section 8 - Troubleshooting

    Section 8 – Troubleshooting The InMode 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. Description of Faults with All Handpieces System did not turn on ...
  • Page 36 IPL Related Faults – H8401, H8410, H8420, H8421, H8422, H8430, H8431  Call Technical Service if problem persists RF Related Faults – H8202, H8210, H8211, H8220-H8229, H8222A, H8222C, H8222D, H8222E  Call Technical Service if problem persists InMode BodyFX Operator Manual...

  • Page 37: Section 9 - System Specifications

    Handpiece Cable 250 cm [100``] Weight System 30 Kg [66 lbs.] Applicator 1 Kg [2.2 lbs.] Output Parameters Maximum Output Power for BodyFX Handpiece 10-50 [W] RF Output Frequency 1[MHz] ± 2% Vacuum Up to 500mBar InMode BodyFX Operator Manual...

  • Page 38: Output Power Curves

    The curves that follow depict the changes for each mode at specific power settings. RF Output vs Load Full Power Half Power 1000 Load [Ω] Figure 8.1 Output Power versus Impedance Figure 8.2 Peak Voltage Versus Power Setting InMode BodyFX Operator Manual...

  • Page 39: Emc Safety For The Inmode Device

    EMC Safety for the InMode Device The device has been tested and found to comply with the limits for the medical devices to the IEC 60601-1-2. These limits are designed to provide reasonable protection against harmful interference in a typical clinical installation. This device generates uses and can radiate radio frequency energy.
  • Page 40 Guidance and manufacturer’s declaration – electromagnetic emissions The InMode is intended for use in the electromagnetic environment specified below. The customer or the user of the InMode should assure that it is used in such an environment. Electromagnetic environment – guidance...
  • Page 41 Guidance and manufacturer’s declaration – electromagnetic immunity The InMode is intended for use in the electromagnetic environment specified below. The customer or the user of the InMode should assure that it is used in such an environment. Electromagnetic environment – guidance...
  • Page 42 RF communications equipment and the InMode System The InMode is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the InMode can help prevent electromagnetic interference by...
  • Page 43 Table from IEC60601-1-2, / 5.2.2.1 c&f InMode BodyFX Operator Manual...

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