InMode MD CONTOURA Operator's Manual
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InMode MD CONTOURA Operator's Manual

Medical aesthetic device wich combines mechanical vacuum skin massager and non-thermal rf energy exposure
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Operator Manual
CONTOURA SYSTEM
DO607093A

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Summary of Contents for InMode MD CONTOURA

  • Page 1 Operator Manual CONTOURA SYSTEM DO607093A...
  • Page 2 Copyright © InMode MD Ltd, Date: August, 2016 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 3: Table Of Contents

    SECTION 4 - DESCRIPTION OF DEVICE .................... 18 ..............................18 ANEL ..................18 RONT ANEL AND PERATOR ONTROL ANEL ..........................20 OFTWARE CREENS ............................25 OUND NDICATOR ......................25 EMPERATURE ONTROL ..............................26 ANDPIECE SECTION 5 - SYSTEM OPERATION ..................... 29 .............................29 EVICE TART CONTOURA Operator Manual...
  • Page 4 ............................42 NCE A SECTION 8 – TROUBLESHOOTING ..................... 43 ..................43 ESCRIPTION OF AULTS WITH ANDPIECES SECTION 13 - SYSTEM SPECIFICATIONS ..................44 RF O ........................45 UTPUT OWER URVES EMC S RF D ......................45 AFETY FOR THE EVICE CONTOURA Operator Manual...

  • Page 5: Section 1 - Introduction

    System. System Overview The CONTOURA System based on InmodeRF platform 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 6: Explanation Of The Symbols Used On The System

    Follow operating instructions 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. CONTOURA Operator Manual...

  • Page 7: 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. CONTOURA Operator Manual...

  • Page 8: Cautions

    System is used. Safety Operational Use of the System The System incorporates the following safety features. All personnel operating the System should be familiar with these features.  System has unique password to avoid device operation by non-authorized personnel. CONTOURA Operator Manual...

  • Page 9: Safe Use Of The Active Accessory

    Bad coupling of both electrodes with the skin result in a specific warning sound, a message on the screen, and disabling of RF.  Do not connect a wet accessory to the System.  Do not immerse the applicator under water at any time. CONTOURA Operator Manual...

  • Page 10: Warnings

    CONTOURA procedures are performed. The operation of the CONTOURA may adversely influence the operation of other electronic EQUIPMENT. To avoid the RISK of electric shock, this equipment must only be connected to a SUPPLY MAINS with protective earth.

  • Page 11: 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 CONTOURA device console: Figure 2.1 System certification and identification label Figure 2.2 Footswitch label...
  • Page 12 Handpiece. The following labels are located on the Handpieces: Manufacturer identification labeling is placed on the hand pieces. Figure 2.3 The BodyFX Handpiece label CONTOURA Operator Manual...
  • Page 13 Figure 2.4 The MiniFX Handpiece label Figure 2.5 The FORMA-PLUS Handpiece label CONTOURA Operator Manual...

  • Page 14: Equipment Classification

     Not suitable for use in presence of flammable substance.  Power receptacle must include protective earth, and must be checked before connecting the system. The System with the BodyFX/MiniFX/FORMA PLUS Handpieces is classified as class II device by FDA. CONTOURA Operator Manual...

  • Page 15: Section 3 - System Installation

    20º-27ºC (68º-79ºF) and relative humidity of less than 80%. Equipment List The System includes the following:  System platform  BodyFX Handpiece  MiniFX Handpiece  FORMA PLUS Handpiece  Handpieces cradles  Foot switch  Operator manual  Power cord CONTOURA Operator Manual...

  • Page 16: Unpackaging

     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:  Turn the System off.  Disconnect the Power Cord. CONTOURA Operator Manual...

  • Page 17: 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. CONTOURA Operator Manual...

  • Page 18: Section 4 - Description Of Device

    Located on the front top side of the rear panel and connects to the Handpiece. Handpiece Connector 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 and four buttons. CONTOURA Operator Manual...
  • Page 19 The panel allows changing treatment parameters and system mode. Power electronics is not activated if no Handpiece is connected to its connector on the front or the rear panel. The system recognizes the connected handpiece and enables opening the relevant screen. CONTOURA Operator Manual...

  • Page 20: Software Screens

    Non-authorized use of the device is prevented by entering the individual code on the Login screen. Figure 4.3 Login Screen Software is loaded from the plug and self-test of the System module is performed. After the end of the self-test, the Menu Screen appears. CONTOURA Operator Manual...
  • Page 21 4 digit numerical password. Password Calibration Not applicable. Main Menu Return to Main Menu to select BodyFX/MiniFX applicator. After returning to the Menu Screen and choosing the application on the Menu Screen the corresponding Treatment Screen appears. CONTOURA Operator Manual...
  • Page 22 RF energy is delivered, which is adjustable from 2 to 7sec for BodyFX and from 1-5sec for MiniFX. Counter Reset Treatment Time can be reset. Temperature This indicator shows online the skin surface temperature, with a maximal Temperature of 41 Measure CONTOURA Operator Manual...
  • Page 23 Standby mode. Plus screen shown in Figure below. Figure 4.6 FORMA-PLUS Treatment Screen The frame selects parameters that can be changed by functional keys. Selection Frame Applicator Allows selecting between FORMA and FORMA-PLUS Handpieces. CONTOURA 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. CONTOURA Operator Manual...

  • Page 25: Sound Indicator

    RF is instantly inactivated. As soon as the temperature drops below the Cut-off temperature, RF starts again, thus maintaining the desired temperature with safety and when reached, RF delivery is automatically stopped. Temperature is monitored by a temperature sensor in the Handpiece and serves as a safety feature. CONTOURA Operator Manual...

  • Page 26: Handpiece

    Handpiece BodyFX/MiniFX Handpiece comprises a vacuum chamber, 2 RF electrodes, temperature sensor, 8-character screen, handle, cable and connector. Figure 4.7 BodyFX Handpiece Figure 4.8 MiniFX Handpiece CONTOURA Operator Manual...
  • Page 27 Temperature Sensor measurement. Figure 4.9 FORMA-PLUS Handpiece Is a part of Handpiece, comprising RF electrodes and temperature sensor. Handle Is made of metal and has ergonomic design for easy treatment with high visibility of the treated area. CONTOURA Operator Manual...
  • Page 28 Has a length of 280cm (110’’). Cable It is connected to the rear panel of the system. Connector CONTOURA Operator Manual...

  • Page 29: Section 5 - System Operation

    8. Select Ready mode to confirm the selected parameters. The System is ready for pulsing. 9. Press footswitch to start the treatment. System Shutdown To shut down the system turn the On-Off switch off. Turn the Main Power switch off at the end of the day. CONTOURA Operator Manual...

  • Page 30: Section 6 - Treatment Information Bodyfx/Minifx

    Simplex in the treatment area, may be treated only following a prophylactic regimen.  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.  Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. CONTOURA Operator Manual...

  • Page 31: Possible Adverse Effects

    70% alcohol solution. Cleaning Procedure: 1. Thoroughly clean the Handpiece with alcohol absorbed pad for at least 30 sec. 2. Leave it for complete drying. CONTOURA Operator Manual...

  • Page 32: Pre-Treatment Recommendations

     Mark the treatment area.  Clean the Handpiece with alcohol 70% or other disinfectant. Use alcohol-soaked cotton buds to clean inside the Handpiece cavity. Long and dense hairs may affect the treatment, and may be shaved according to physician’s discretion. CONTOURA Operator Manual...

  • Page 33: Treatment Recommendations

    8. Divide treatment area to zones of about the size of a large hand palm, 4-8 foot-prints of the vacuum chamber (full abdomen = 4 treatment zones), and about half for MiniFX. Mark the treatment area and zones. The smaller the zone and the thinner the fat, the lower the RF Power. CONTOURA Operator Manual...

  • Page 34: Treatment Schedule

     Patient should avoid very hot water for 2 days after the treatment.  Patient should avoid scrubbing, pinching, etc. of the treated area.  Moisturizer can be applied to the skin surface. CONTOURA Operator Manual...
  • Page 35  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. CONTOURA Operator Manual...

  • Page 36: Section 7 - Treatment Information Forma-Plus

    Simplex in the treatment area, may be treated only following a prophylactic regimen.  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.  Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. CONTOURA Operator Manual...

  • Page 37: Possible Adverse Effects

    We recommend the usage of the following cleaning agent that was tested in our company for material compatibility as 70% alcohol solution. Cleaning Procedure: 1. Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec and repeat as necessary. 2. Leave it for complete drying. CONTOURA Operator Manual...

  • Page 38: Pre-Treatment Recommendations

     Photograph the patient.  Mark the treatment area.  Clean the handpiece parts that come in contact with the skin with 70% alcohol. Long and dense hairs may affect the treatment, and may be shaved according to physician’s discretion. CONTOURA Operator Manual...

  • Page 39: Treatment Recommendations

    9. Water based gel should be applied to the treatment zones, one at a time, to couple the RF and to enable smooth movements on the skin. Prior to using water based gel, ensure that the container of ultrasound gel has not passed the expiration date. CONTOURA Operator Manual...

  • Page 40: Treatment Schedule

    Treatment should be concluded when the results are satisfactory to the patient or according to the physician's discretion. One session every 1-3 months, or as needed, may maintain treatment results. CONTOURA Operator Manual...

  • Page 41: Post-Treatment Recommendations

     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.  The Handpiece should be cleaned from the gel and disinfected by 70% alcohol. CONTOURA Operator Manual...

  • Page 42: Section 8- System Maintenance

    System. Once a Year By Authorized Service personnel only: System and Hand pieces full test and calibration is required to be done. Please make sure to contact your local service center to perform this process. CONTOURA Operator Manual...

  • Page 43: Section 8 - Troubleshooting

     Replace Handpiece  Call Technical Service if problem persists Fault H8005 – System Memory Fault  Call Technical Service if problem persists Faults H8003, H8006, H8007 - RF Related Faults  Call Technical Service if problem persists CONTOURA Operator Manual...

  • Page 44: Section 13 - System Specifications

    40’’ H] Handpiece cable 250 cm L [100`` L] Weight System 20 Kg [44 lb] Handpiece 0.2 Kg [0.4 lb] Output Parameters RF Power Up to 60 W RF Frequency 1 MHz Tissue impedance 50 -600 Ohm CONTOURA Operator Manual...

  • Page 45: Rf Output Power Curves

     Reorient or relocate the receiving device.  Increase the separation between the devices.  Connect the device into an outlet on a circuit different from that which was previously used.  Consult InMode MD Ltd. service personnel for help. CONTOURA Operator Manual...
  • Page 46  The system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used. CONTOURA Operator Manual...

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