InMode BodyTite Operator's Manual
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InMode BodyTite Operator's Manual

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Operator Manual
BodyTite
InMode RF
Version: DO607095B

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Summary of Contents for InMode BodyTite

  • Page 1 Operator Manual BodyTite InMode RF Version: DO607095B...
  • Page 2 Operator Manual: BodyTite™ System DO607095B Copyright © InMode MD Ltd. Date: October 2017 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...

  • Page 3: Table Of Contents

    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............1 Section 2: Safety ..................... 3 The Patient ........................3 Treating Attendant .......................
  • Page 4 Treatment Recommendations ................... 23 Post-Treatment Recommendations ................23 System Maintenance .................... 24 Cleaning the Device ....................24 Troubleshooting ....................25 Description of Faults ....................25 System Specifications.................... 27 BodyTite Output Power Curves .................. 28 EMC Safety for the BodyTite Device ................29...

  • Page 5: Section 1: Introduction

    System. System Overview The BodyTite™ device is based on the InMode RF™ platform. BodyTite employs radiofrequency (RF) energy for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The System operates when the Handpiece is connected.
  • Page 6 BodyTite Operator Manual Section 1: Introduction 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 HF Isolated Patient Circuit This equipment intentionally supplies non-ionizing RF energy...

  • Page 7: Section 2: Safety

    Section 2: Safety Section 2: Safety This chapter describes safety issues regarding the use and maintenance of the BodyTite 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 8: Treating Attendant

    Treating Attendant ▪ Only authorized individuals with appropriate training and knowledge should operate, assist in the operation of, or provide maintenance to the BodyTite System. ▪ Personnel should not operate the System until they have been fully educated in its use.

  • Page 9: Fire Hazards

    BodyTite Operator Manual Section 2: Safety Fire Hazards ▪ Do not use the System in the presence of explosive or flammable materials. ▪ Materials conducting RF energy may cause temperature rise of the absorbing material. Do not use the System in the presence of explosive or flammable materials conductive to RF.

  • Page 10: Safe Use Of The Active Accessories

    Warnings This equipment is for use only by trained, licensed physicians. Only Handpieces manufactured or approved by InMode MD Ltd. should be used with the BodyTite 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 11 – The RF energy and heating associated with the System can provide an ignition source. Observe fire precautions at all times. When using BodyTite in the same room with any of these substances or gases, prevent their accumulation or pooling within the area where BodyTite procedures are performed.

  • Page 12: Device And Handpiece Labels

    The following device labels are located on BodyTite device console and the handpieces: Figure 2-1:System Certification and Identification Label Figure 2-2: 2 Footswitch label for all applications...

  • Page 13: Equipment Classification

    BodyTite Operator Manual Section 2: Safety Figure 2-3: BodyTite Handpiece Labels 2.10 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.

  • Page 14: Section 3: System Installation

    BodyTite 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 15: Unpacking

    BodyTite 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 16: Installation

    BodyTite 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. ▪ Connect the Footswitch.

  • Page 17: System Disposal

    BodyTite Operator Manual Section 3: System Installation System Disposal 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.

  • Page 18: Section 4: Device Description

    BodyTite Operator Manual Section 4: Device Description Section 4: Device Description Rear Panel Power cord inlet 100-240V~, 1A, 50-60Hz. Fuse holder Rating is T 2A, 250V. Replace fuses if it is needed only with fuses having exactly the same rating.

  • Page 19: Front Panel And Operator Control Panel

    BodyTite 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 screen with touch panel. On the front panel there is a black On/Off switch on the left, and handpiece connector on the right.
  • Page 20 BodyTite Operator Manual Section 4: Device Description After entering the individual code in the Login Screen, the system allows access to the Treatment Screen. Default Login code 1234 can be changed in the Utilities Screen. The Volume level can also be reduced in the Utilities Screen.
  • Page 21 BodyTite Operator Manual Section 4: Device Description Item Function ▪ The frame selects parameters that can be changed. Selection Frame ▪ This indicator shows the skin Cut-Off temperature, which is External Cut-Off adjustable between 35-42 C, with increments of 1 C in the tissue.

  • Page 22: Sound Indicator

    BodyTite Operator Manual Section 4: Device Description 4.3.1 Sound Indicator ▪ Periodic beeping signal is emitted when RF energy is delivered. ▪ Warning sound tone indicates Bad Coupling. ▪ When the measured temperature approaches the Cut-off temperature, the tone beeps double in speed. It becomes faster when the Cut-off temperature is reached.
  • Page 23 BodyTite Operator Manual Section 4: Device Description Figure 4-5: Handpiece HP101306A Figure 4-6: Handpiece HP172206A Figure 4-7: Handpiece HP172246A ▪ The Handpiece active internal electrode is an insulated metal Internal Electrode tube with conductive area at the distal part, but not at the tip.

  • Page 24: Section 5: System Operation

    BodyTite 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 Handpiece, inspect the System and Handpiece for possible mechanical damage.

  • Page 25: Section 6: Treatment Information

    This manual is not intended to be a complete clinical guide to the use of the System. All users should be trained prior to operating the BodyTite. Updated treatment protocols and recommendations are presented in the Quick Reference Guide (QRG).

  • Page 26: Possible Adverse Effects

    BodyTite Operator Manual Section 6: Treatment Information ▪ History of skin disorders, keloids, abnormal wound healing. ▪ History of bleeding coagulopathies. ▪ Any surgical procedure in the treatment area within the last 3 months or before complete healing. ▪ Any therapies or medications which may interfere with treatment.

  • Page 27: Pre-Treatment Recommendations

    BodyTite Operator Manual Section 6: Treatment Information The internal electrode is covered by a transparent sleeve (unlike a white sleeve of the autoclavable handpiece). Pre-Treatment Recommendations ▪ Make sure that the Handpiece is intact and sterile.  There are a few signs to recognize the gamma-sterilized hand pieces as specified in items 1-5 above.

  • Page 28: System Maintenance

    BodyTite Operator Manual System Maintenance System Maintenance Cleaning the Device ▪ Wipe the device, including the footswitch with a damp, soft cloth. ▪ Liquid disinfecting solution may be used. ▪ Avoid using flammable solutions. ▪ Do not immerse any part of the system.

  • Page 29: Troubleshooting

    BodyTite Operator Manual Troubleshooting Troubleshooting The BodyTite System provides monitoring of all critical parameters to ensure safety of the patient and user. If any of the following faults are detected the System automatically disables RF output and goes to an Error Screen.
  • Page 30 BodyTite Operator Manual Troubleshooting Problem Checks ▪ Bad Coupling Indicator Check that there is a water based gel applied to the skin exists at all times during surface,and ensure that proper tumescent infiltration has treatment been done. Reboot the system.

  • Page 31: System Specifications

    BodyTite Operator Manual System Specifications System Specifications Category Item Detail Inut Power Main Line Frequency 50 - 60Hz (nominal) 100 - 240VAC Input Voltage (nominal) Input Current (rms) Operating Ambient Temperature 15° – 35°C [59° – 95°F] Parameters Range 30% to 80%, non-condensing...

  • Page 32: Bodytite Output Power Curves

    BodyTite Operator Manual System Specifications BodyTite Output Power Curves The following curves depict the BodyTite output Power vs. Range of Load Impedance. BodyTite Output Power vs. Impedance 40.00 35.00 30.00 25.00 20.00 15.00 10.00 5.00 0.00 0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800 850 900...

  • Page 33: Emc Safety For The Bodytite Device

    Connect the device into an outlet on a circuit different from that which was previously used. ▪ Consult InMode MD 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 34 BodyTite Operator Manual System Specifications 30 of 30...

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