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InMode CONTOURA Operator's Manual

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Operator Manual
Contoura System
Version: DO608402A

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Summary of Contents for InMode CONTOURA

  • Page 1 Operator Manual Contoura System Version: DO608402A...
  • Page 2 DO608402A Copyright © InMode Ltd. Date: August 2019 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of InMode Ltd. �� InMode Ltd Tabor House, Industrial Park South POB 44, Yokneam 2069201, 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 ....................... 3 The Patient ......................3 Treating Attendant ....................
  • Page 4 Contraindications ....................22 Possible Adverse Side Effects ................24 Handpiece Cleaning Instructions Prior to Use ............. 24 Pre-treatment Recommendations ............... 24 Treatment Recommendations ................25 Treatment Schedule ..................... 27 Post-treatment Recommendations ..............27 Section 7: BodyFX/MiniFX Treatment Information ..........28 Indications for Use ....................
  • Page 5 Contoura System which employs Radio-frequency (RF) technologies for various aesthetic applications. The Contoura System with the BodyFX/MiniFX and Plus Handpieces 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 Contoura 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 Treating Attendant Only authorized individuals with appropriate training and knowledge should operate, assist in the operation of, or provide maintenance to the Contoura System. Personnel should not operate the System until they have been fully educated in its use. Make sure that all treatment personnel are familiar with the System controls and know how to shut down the System instantly.
  • Page 8 Contoura 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 9 Contoura 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 10 This equipment is for use only by qualified medical professionals trained in the particular technique to be performed. Only Handpieces manufactured or approved by InMode Ltd. should be used with Contoura 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 Observe fire precautions at all times. When using Cotoura System in the same room with any of these substances or gases, prevent their accumulation or pooling within the area where Contoura procedures are performed. The operation of the Contoura System may adversely influence the operation of other electronic EQUIPMENT.
  • Page 12 Not suitable for use in presence of flammable substance. ▪ Power receptacle must include protective earth and must be checked before connecting the System. ▪ The Contoura Systems is classified as Class II device defined by the Medical Device Directive (93/42/EEC). 8 of 44...
  • Page 13 Contoura 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 14 Contoura System Operator Manual Section 3: System Installation Unpacking In order to unpack the device: 1. Remove the paper strip and open the box. 2. Remove accessories and foams around the device. Take device out of the box using top and bottom handles.
  • Page 15 Contoura System Operator Manual Section 3: System Installation 2. Connect cradle to the device. 3. Connect Handpiece to the connector and place into the cradle. 4. Connect the Footswitch. 5. Connect the power cord to the System inlet. 6. Plug the System Power Cord into an appropriate electrical outlet.
  • Page 16 Contoura 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 12A, 250V. Replace fuses if needed, only with fuses having exactly the same rating. ...
  • Page 17 Contoura System Operator Manual Section 4: Device Description On the front panel there is a black On/Off switch on the left, and handpiece connector on the right. Power On-Off Power switch turns power electronics On and Off. switch LCD Screen LCD Screen shows information about system mode and treatment parameters.
  • Page 18 Contoura System Operator Manual Section 4: Device Description Figure 4-3: 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 4-4: Menu Screen The Menu Screen allows the selection of the connected Handpiece, or entry to the Utilities Screen.
  • Page 19 Contoura System Operator Manual Section 4: Device Description Figure 4-5: Utilities 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 20 Contoura System Operator Manual Section 4: Device Description The frame selects parameters that can be changed by function Selection Frame keys. Energy Delivered energy is changed from level 20 to 62 energy levels and the System starts up at the minimal energy setting.
  • Page 21 Contoura System Operator Manual Section 4: Device Description Figure 4-7: BodyFX/MiniFX Treatment Screen The BodyFx/MiniFx Treatment Screen contains: Screen Name The Screen name BodyFX or MiniFX is determined by the connected Handpiece. The frame selects the parameters that can be changed by the Selection Frame function keys.
  • Page 22 Contoura System Operator Manual Section 4: Device Description Standby mode allows the user to set treatment parameters. Activation of energy is not allowed in Standby mode. In Ready mode, the System is waiting for a signal from the foot switch to activate the energy. Any attempt to change the treatment settings switches the System to Standby mode.
  • Page 23 Contoura System Operator Manual Section 4: Device Description Figure 4-8: Plus Handpiece Is a part of the Handpiece, comprising RF Electrodes and a Temperature Sensor. Is made of metal and has ergonomic design for easy Handle treatment with high visibility of the treated area Cable Has a length of 250cm (100’’).
  • Page 24 Contoura System Operator Manual Section 4: Device Description Handle The Handpiece Handle is made from plastic and has ergonomic design for easy treatment with high visibility of the treated area Vacuum Applied to the skin surface and shape the skin for Chamber optimal heating.
  • Page 25 Contoura 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 Handpiece, inspect the System and Handpieces for possible mechanical damage.
  • Page 26 Contoura System Operator Manual Section 6: Plus Treatment Information Section 6: Plus Treatment Information Indications for Use The Plus hand Handpiece 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 27 Contoura System Operator Manual Section 6: Plus Treatment Information ▪ History of bleeding coagulopathies. ▪ Having received treatment with light, laser, RF, or other devices in the treated area within 3 months, or before complete healing. ▪ Any surgical procedure in the treatment area within the last 3 months or before complete healing.
  • Page 28 Contoura System Operator Manual Section 6: Plus Treatment Information Possible Adverse Side Effects Possible side effects include but are not limited by: discomfort or pain, excessive skin redness (erythema) and/or swelling (edema), damage to natural skin texture (crust, blister, burn), change of pigmentation (hyper- and hypo-pigmentation), scarring.
  • Page 29 Contoura System Operator Manual Section 6: Plus Treatment Information ▪ Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort. ▪ Instruct the patient about the safety warnings. ▪ The patient should discontinue any irritant topical agents for 2-3 days prior to treatment and if medically permitted, anticoagulants should be stopped 1-2 weeks prior treatment.
  • Page 30 Contoura System Operator Manual Section 6: Plus Treatment Information Any combination of treatment parameters should be according to skin response and patient tolerance. Air condition directed at the patient treated area may reduce the skin surface temperature in 1-2°C, and cut-off temperature should be reduced accordingly.
  • Page 31 Contoura System Operator Manual Section 6: Plus Treatment Information The skin should be observed for excessive erythema or edema. If observed, stop the treatment and move to the next treatment zone. Treatment Schedule ▪ The number of treatment sessions depends on the individual patient and is typically 6 weekly sessions, but can vary according to patient response.
  • Page 32 Contoura System Operator Manual Section 7: BodyFX/MiniFX Treatment Information Section 7: BodyFX/MiniFX Treatment Information Indications for Use The BodyFX/MiniFX Handpieces are intended for the treatment of the following medical conditions using RF combined with massage: Relief of minor muscle aches...
  • Page 33 Contoura System Operator Manual Section 7: BodyFX/MiniFX Treatment Information ▪ History of bleeding coagulopathies. ▪ Any surgery in treated area within 3 months prior to treatment. ▪ Having received treatment with light, laser, RF, or other devices in the treated area within 3 months or before complete healing.
  • Page 34 Contoura System Operator Manual Section 7: BodyFX/MiniFX Treatment Information Cleaning Procedure: Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec. Leave it for complete drying. Pre-Use Check: Before each use of the Handpiece, the device must pass the following: Check to ensure proper cleaning and drying of the Handpiece.
  • Page 35 Contoura System Operator Manual Section 7: BodyFX/MiniFX Treatment Information Treatment Recommendations Ensure that skin is clean and dry. No gel allowed! Follow the Device Start-Up Procedure from Section 5. Set treatment parameters. Suggested parameters are shown in the table here:...
  • Page 36 Contoura System Operator Manual Section 7: BodyFX/MiniFX Treatment Information 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.
  • Page 37 Contoura System Operator Manual Section 7: BodyFX/MiniFX Treatment Information Post-Treatment Recommendations ▪ Erythema and occasionally purpura is a common response and will subside naturally within a few days. ▪ Patient should avoid very hot water for 2 days after the treatment.
  • Page 38 Contoura System Operator Manual Section 8: System Maintenance Section 8: 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 Handpiece elements that are in contact with the skin should be disinfected with 70% alcohol between patients, as described in detail for each handpiece in “Handpiece Cleaning Instruction Prior to Use”.
  • Page 39 Contoura System Operator Manual Section 9: Troubleshooting Section 9: Troubleshooting The Contoura 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 40 Contoura System Operator Manual Section 10: System Specifications Section 10: 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...
  • Page 41 Contoura System Operator Manual Section 10: System Specifications Frequency 1 MHz Vacuum Automatically controlled MiniFX Output Parameters RF Power 10 - 25 W Frequency 1 MHz Vacuum Automatically controlled 37 of 44...
  • Page 42 Contoura System Operator Manual Section 10: System Specifications 10.1 Output Power Curves The curves that follow depict the changes for each RF mode at specific power settings. Figure 10-1: Plus Output Power versus Impedance Figure 010-2: BodyFX Output Power versus Impedance...
  • Page 43 Contoura System Operator Manual Section 10: System Specifications Figure 10-3: MiniFX Output Power versus Impedance The following curves depict the Contora Peak Voltage vs. Power Settings. Figure 10-4: Output Power Versus Impedance 10.2 EMC Safety The device has been tested and found to comply with the limits for the medical devices to the IEC 60601-1-2.
  • Page 44 Guidance and manufacturer’s declaration – electromagnetic emissions The Contoura System is intended for use in the electromagnetic environment specified below. The customer or the user of the Contoura System should assure that it is used in such an environment. Emissions test Compliance Electromagnetic environment –...
  • Page 45 Guidance and manufacturer’s declaration – electromagnetic immunity The Contoura System is intended for use in the electromagnetic environment specified below. The customer or the user of the Contoura System should assure that it is used in such an environment. Immunity test...
  • Page 46 Contoura System Operator Manual Section 10: System Specifications The Contoura System is intended for use in the electromagnetic environment specified below. The customer or the user of the Contoura System should assure that it is used in such an environment. IMMUNITY IEC 60601 Compliance Electromagnetic environment –...
  • Page 47 Contoura System The Contoura System is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Contoura System can help prevent electromagnetic interference by maintaining a minimum distance...
  • Page 48 Contoura System Operator Manual Table from IEC60601-1-2 Edition 4.0 Table from IEC60601-1-2 Edition 4.0 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)