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Invasix InMode Operator's Manual

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Operator Manual
InMode
™
System
Version: DO606736C
wT

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Summary of Contents for Invasix InMode

  • Page 1 Operator Manual InMode ™ System Version: DO606736C...
  • Page 2 Operator Manual: InMode™ System with Diolaze™ / DiolazeXL™ 755/810, 810, 810/1064 / Lumecca™ / Fractora™ / Forma™ / Plus™ / BodyFX™ / MiniFX™ DO606736C Copyright © Invasix Ltd. Date: June 2018 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of Invasix Ltd.

  • Page 3: Table Of Contents

    Table of Contents Section 1: Introduction ........................................Before You Start ....................System Overview ................Conventions Used in the Manual ........... Explanation of the Symbols used on the System Section 2: Safety ..
  • Page 4 Section 6 – Diolaze Treatment Information ................................Indications for Use ....................Contraindications ..................Possible Adverse Effects ............... Pre-treatment Recommendations ..............Tip Cleaning Instructions Prior to Use ................Treatment Recommendations ......

  • Page 5: Indications For Use

    Section 10: Forma/Plus Treatment Information ..............................Instructions for Use 10.1 ....................Contraindications 10.2 ..................Possible Adverse Effects 10.3 ............. Handpiece Cleaning Instructions Prior to Use 10.4 ..............Pre-Treatment Recommendations 10.5 .....

  • Page 6: Section 1: Introduction

    System. System Overview The InMode™ System is employing three different technologies for various aesthetic applications – Laser, Intense Pulsed Light (IPL), and Radiofrequency (RF). The System operates while in contact with any of the following Handpieces: Diolaze™, DiolazeXL™...

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

    InMode Without Vasculaze 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 B Equipment.

  • Page 8: Section 2: Safety

    Protective eyewear must be used by patient during Diolaze and DiolazeXL lasers or Lumecca IPL treatments. Treating Attendant Only authorized individuals with appropriate training and knowledge should operate, assist in the operation of, or provide maintenance to the InMode System. 3 of 96...

  • Page 9: Cautions

    InMode Without Vasculaze Operator Manual Section 2: Safety 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 10: Ocular Safety Considerations

    InMode Without Vasculaze Operator Manual Section 2: Safety Never look directly into the laser aperture at the distal end of the Handpiece, even if you are wearing safety glasses. Serious eye injury or blindness could result. Avoid directing the laser beam anywhere other than the calibration port or intended treatment area.

  • Page 11: Fire Hazards

    InMode Without Vasculaze Operator Manual Section 2: Safety  Move the System slowly and carefully. The System weighs approximately 32kg (70lb.) and may cause injury if proper care is not used when moving it.  For RF Handpieces provide as much distance as possible between the system and other electronic equipment as the activated RF generator may cause interference between them.
  • Page 12 InMode Without Vasculaze Operator Manual Section 2: Safety  Temperature monitoring disables the System operation if the Handpiece sapphire temperature is outside the operating range for Diolaze and DiolazeXL and Lumecca Handpieces.  The power electronics cannot be fully activated unless the laser or RF Handpieces and Footswitch have been connected to the System.

  • Page 13: Safe Use Of The Active Accessories

    Do not immerse the Applicator under water at any time. This equipment is for use only by trained, licensed physicians. Only Handpieces manufactured or approved by Invasix 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 14 The optical or RF energy and heating associated with the System can provide an ignition source. Observe fire precautions at all times. When using InMode in the same room with any of these substances or gases, prevent their accumulation or pooling within the area where InMode procedures are performed.

  • Page 15: Device Labels

    As required by national and international regulatory agencies, appropriate warning and information labels have been attached to specific locations on the instrument as identified below. The following device labels are located on the InMode device console: -1: System Certification and Identification Label...
  • Page 16 InMode Without Vasculaze Operator Manual Section 2: Safety -3: Laser Interlock Label Figure -4: IPL Warning Label Figure -5: IPL Emission Warning Label Figure 11 of 96...

  • Page 17: Handpiece Labels

    InMode Without Vasculaze Operator Manual Section 2: Safety -6: Emergency Stop Label on the emergency Red Button Figure -7: Footswitch Label for All Application Figure 1.11 Handpiece Labels The Handpieces certification and identification labels are attached to connectors on the Handpieces. It states that the product conforms to the performance standards, and indicates the manufacturer’s name, date of manufacturing, model and serial...
  • Page 18 InMode Without Vasculaze Operator Manual Section 2: Safety The following labels are located on the Handpieces: -8: All Handpieces Identification Labels Figure 13 of 96...

  • Page 19: Equipment Classification

    InMode Without Vasculaze Operator Manual Section 2: Safety -9: DiolazeXL Handpieces Connector Labels Figure -10: Diolaze and DiolazeXL Handpiece Label for Laser Aperture Figure -11: 10 Lumecca Handpiece Label for IPL Aperture Figure 1.11 Equipment Classification The following is a list of the different equipment used and their classifications.
  • Page 20 Caution - Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous laser radiation exposure. The InMode System with IPL Handpiece is classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE marking.

  • Page 21: Section 3: System Installation

    InMode Without Vasculaze 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 22: Unpacking

    InMode Without Vasculaze Operator Manual Section 3: System Installation  User protective goggles.  Patient eyewear.  Laser and IPL “Danger” door signs, as applicable. Unpacking In order to unpack the device: Remove the paper strip and open the box Remove accessories and foams around the device.

  • Page 23: Installation

    -1: Harness Support Assembly Figure Filling Water The InMode System and Diolaze, DiolazeXL and Lumecca Handpieces are shipped without water. Distilled water must be used and failure to do so will void the service warranty. For detailed instructions refer to System Maintenance.

  • Page 24: System Disposal

    InMode Without Vasculaze Operator Manual Section 3: System Installation  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 25: Section 4: Device Description

    InMode Without Vasculaze 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.

  • Page 26: Front Panel And Operator Control Panel

    InMode Without Vasculaze Operator Manual Section 4: Device Description -1: Two RF Connectors on the Rear Panel (Arrows) Figure 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 with four buttons.

  • Page 27: Software Screens

    InMode Without Vasculaze Operator Manual Section 4: Device Description Emergency Stop Stops the power instantly in emergency conditions. Button LCD Screen The LCD screen shows information about the System mode and treatment parameters. The Panel allows changing treatment parameters and System mode.
  • Page 28 InMode Without Vasculaze Operator Manual Section 4: Device Description -4: Login Screen Figure 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. -5: Menu Screen...
  • Page 29 InMode Without Vasculaze Operator Manual Section 4: Device Description -6: Utilities Screen Figure The Utility Screen contains: Volume This function allows the user to adjust the System volume. Drain/Fill Water Drain water from the Handpiece (Diolaze, DiolazeXL and Lumecca only) and device prior to shipment and fill water during installation.
  • Page 30 InMode Without Vasculaze Operator Manual Section 4: Device Description -7: Diolaze/DiolazeXL Treatment Screen Figure The Dioalaze/DiolazeXL Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by functional keys. Fluence: Fluence (light energy density) is changed within the limits from 15 to 60J/cm²...
  • Page 31 InMode Without Vasculaze Operator Manual Section 4: Device Description System Mode The System has four treatment modes: Standby mode: allows the user to set treatment parameters. Activation of energy is not allowed in Standby mode. Armed mode: when the Footswitch is pressed, before the Hand Trigger.
  • Page 32 InMode Without Vasculaze Operator Manual Section 4: Device Description Pulse Mode Repeat mode in Normal or Fast repetition rate or in Off as a single pulse mode. Counter Reset The Counter can be reset. Pulse Counter Shows the number of pulses delivered from the beginning of the treatment.
  • Page 33 InMode Without Vasculaze Operator Manual Section 4: Device Description Pulse Mode Allows choosing between single pulse and pulse trains ranging from 0.5 to 2 pulses per second (pps). Counter Reset The Counter can be reset. Pulse Counter Shows the number of pulses delivered on one zone, and the total number of pulses from the beginning of the treatment.
  • Page 34 InMode Without Vasculaze Operator Manual Section 4: Device Description The Forma/Plus Treatment Screen contains: Selection Frame The frame selects parameters that can be changed by functional keys. Applicator Allows selecting between Forma and Plus Handpieces. Energy Delivered energy is changed from level 20 to 62 energy levels and the System starts up at the minimal energy setting.
  • Page 35 InMode Without Vasculaze Operator Manual Section 4: Device Description -11: BodyFX/MiniFX Treatment Screen Figure The BodyFX or MiniFX Screen contains: Screen Name The BodyFX or MiniFX is determined by the Handpiece that is connected to the System. Selection Frame The frame selects parameters that can be change by functional keys.

  • Page 36: Sound Indicator

    InMode Without Vasculaze 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 Footswitch to activate the energy. Any attempt to change the treatment settings switches the System to Standby mode.
  • Page 37 InMode Without Vasculaze Operator Manual Section 4: Device Description The DiolazeXL Handpiece contains: Applicator Diolaze comprises diode laser with linear scanning system, cooled sapphire output window (8 x 50mm), and electronic shutter. DiolazeXL diode laser (the bars vary according to wavelength –...
  • Page 38 InMode Without Vasculaze Operator Manual Section 4: Device Description -14: Fractora Handpiece Figure The Fractora Handpiece contains: Handle The Handpiece handle is made of metal and has ergonomic design for easy treatment with high visibility of the treated area -14).
  • Page 39 InMode Without Vasculaze Operator Manual Section 4: Device Description -17: Plus Handpiece Figure The Forma/Plus Handpieces contain: Is a part of the 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.
  • Page 40 InMode Without Vasculaze Operator Manual Section 4: Device Description The BodyFX/MiniFX Handpieces contain: Handle The Handpiece Handle is made of 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 optimal Cleaner heating.

  • Page 41: Section 5: System Operation

    InMode Without Vasculaze 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 42: System Shutdown

    InMode Without Vasculaze Operator Manual Section 5: System Operation – After pressing the Hand Trigger as well, the icon will change to Trigger, and the laser can be emitted to start the treatment. Lasing is apparent by the blue LED running around the window in the Handpiece, and by an audio signal.
  • Page 43 InMode Without Vasculaze Operator Manual Section 6 – Diolaze Treatment Information Section 6 – Diolaze Treatment Information Diolaze hair removal treatment is based on principles of selective photothermolysis. The light penetrates into the skin and is selectively absorbed by melanin of the hair shaft.
  • Page 44 InMode Without Vasculaze Operator Manual Section 6 – Diolaze Treatment Information  Certain delay is recommended if other recent treatments like light, laser or RF were performed on the same area.  Lasers can cause increased hair growth in some individuals with the highest risk groups for being females of Mediterranean, Middle Eastern, and South Asian heritage treated on the face and neck.
  • Page 45 InMode Without Vasculaze Operator Manual Section 6 – Diolaze Treatment Information  Determine why the patient is seeking treatment and what his/her expectations are.  Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort.
  • Page 46 InMode Without Vasculaze Operator Manual Section 6 – Diolaze Treatment Information Set treatment parameters. Typical treatment parameters are shown in the table here: Skin Pulse Max. Fluence [J/cm Cooling Type Width Speed 30-40 Short Strong/Medium/ Fast Weak Test - Wait at least 15-30 min.
  • Page 47 InMode Without Vasculaze Operator Manual Section 6 – Diolaze Treatment Information reach the results. Stronger cooling allows better epidermis protection, but may compromise results on very superficial hair e.g. upper lip or Asian skin in general. Reduce fluence on thin skin and in bone proximity along with a thicker layer of gel.

  • Page 48: Contraindications

    DIiolazeXL 755/810, while DiolazeXL 810/1064 is more suitable for very dark skin and deep hair. Indications for Use The InMode System with the DiolazeXL Handpieces is intended for hair removal. Contraindications  Hair removal by lasers or intense pulse light sources can cause increased hair growth in some individuals.

  • Page 49: Possible Adverse Effects

    InMode Without Vasculaze Operator Manual Section 7: DiolazeXL Treatment Information  Use of Isotretinoin (Accutane®) within 6 months prior to treatment.  Known skin photosensitivity or using drugs increasing skin photosensitivity.  Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria.

  • Page 50: Pre-Treatment Recommendations

    InMode Without Vasculaze Operator Manual Section 7: DiolazeXL Treatment Information Pre-Treatment Recommendations During the patient’s first visit the treating attendant should:  Complete or update the patient's medical and physical history.  Exclude from treatment anyone with the listed contraindications.
  • Page 51 InMode Without Vasculaze Operator Manual Section 7: DiolazeXL Treatment Information Prior to using water-based gel, ensure that the container of ultrasound gel has not passed the expiration date. Make a test-spot with Normal/Strong Cooling to see epidermal end-points of perifollicular erythema/edema. Change to Strong Cooling while treating for better comfort and safety.

  • Page 52: Treatment Recommendations

    InMode Without Vasculaze Operator Manual Section 7: DiolazeXL Treatment Information In a single mode (Pulse Mode at Off) - move Handpiece to adjacent site and apply next pulse to cover all treatment area. If end-points are not obvious, or if gaps are apparent, perform another pass, preferably in a different direction, when general erythema subsides.
  • Page 53 InMode Without Vasculaze Operator Manual Section 8: Lumecca Treatment Information Section 8: Lumecca Treatment Information IPL Lumecca treatment is based on principles of selective photothermolysis. The light penetrates into the skin and is selectively absorbed by lesion chromophore (melanin or hemoglobin) having darker color than surrounding tissue. Absorbed energy is converted into heat, coagulating the lesion which fades during a few weeks following the treatment.
  • Page 54 InMode Without Vasculaze Operator Manual Section 8: Lumecca Treatment Information  Vitiligo.  Skin type V and VI and excessively tanned skin from sun, tanning beds or tanning creams and sprays within the last two weeks.  As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

  • Page 55: Tip Cleaning Instructions Prior To Use

    InMode Without Vasculaze Operator Manual Section 8: Lumecca Treatment Information  Instruct the patient about the safety warnings.  Advise the patient to avoid skin irritation or skin tanning for at least 2 weeks. Sunscreen is advisable during outdoor activity at daylight hours.

  • Page 56: Post-Treatment Recommendations

    InMode Without Vasculaze Operator Manual Section 8: Lumecca Treatment Information Skin Lesions Pulse Handpiece Fluence Cooling type type width I-II Pigmented 515nm Short Strong lesions 12J/cm² Long Vascular 515nm Short Strong lesions 16J/cm² Long III-IV Pigmented 580nm Short Strong lesions 12J/cm²...

  • Page 57: Treatment Schedule

    InMode Without Vasculaze Operator Manual Section 8: Lumecca Treatment Information Treatment Schedule The number of treatments typically varies from 2-5 sessions every 3-4 weeks. Pigmented lesions usually require less sessions than vascular lesions. Treatment should be concluded when the results are satisfactory to the patient or at the discretion of the physician.

  • Page 58: Fractional Skin Resurfacing

    Instructions for Use The InMode System with the Fractora Handpiece is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. Contraindications ...
  • Page 59 InMode Without Vasculaze Operator Manual Section 9: Fractora Treatment Information  Patients with history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.  Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.
  • Page 60 InMode Without Vasculaze Operator Manual Section 9: Fractora Treatment Information Possible Adverse Effects Possible adverse 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, and burn), change of pigmentation (hyper- and hypo-pigmentation), and scarring.
  • Page 61 InMode Without Vasculaze Operator Manual Section 9: Fractora Treatment Information  Stop anticoagulants 7-10 days prior to treatment, if medically permitted.  Clean the treatment area.  Apply anesthesia: – Many patients can tolerate the treatment with no anesthesia at low energy levels of 5-20 energy levels and sometimes more.
  • Page 62 InMode Without Vasculaze Operator Manual Section 9: Fractora Treatment Information  Establish and confirm treatment parameters: if the desired end-point of erythema and edema – in a tip-shaped pattern – has not been achieved within 10-15 minutes, increase the RF energy. If the response is excessive, decrease the parameters.
  • Page 63 InMode Without Vasculaze Operator Manual Section 9: Fractora Treatment Information Down Weeks Clinical Treatment Number Energy Time between Area Sessions Indications Sessions Level Days Deep Soft tissue 25-50 wrinkles, scars Deep Bony area 20-30 wrinkles, scars Lax skin Soft tissue...

  • Page 64: Post-Treatment Recommendations

    InMode Without Vasculaze Operator Manual Section 9: Fractora Treatment Information Move to adjacent areas with no overlapping of side-electrodes (30-50% overlap). Occasionally, additional 1-2 passes may be applied to reinforce results on the full area or on selected spots. Gaps may be treated after the full area is done.
  • Page 65 InMode Without Vasculaze Operator Manual Section 9: Fractora Treatment Information  During the first two days following treatment the skin should be kept clean to avoid contamination or infection; any mechanical or thermal damage to the area must be avoided.

  • Page 66: Instructions For Use

    Section 10: Forma/Plus Treatment Information 12.1 Instructions for Use The InMode system with the Forma Handpiece is intended for use in dermatologic procedures for noninvasive treatment of mild to moderate facial wrinkles and rhytides. The Plus Handpiece is intended for non-invasive and non-ablative treatment of the tissue to trigger collagen remodeling for the treatment of wrinkles 12.1...
  • Page 67 Handpiece Cleaning Instructions Prior to Use These cleaning instructions are for clinical use only. The following processes are validated for the InMode Forma/Plus Handpieces 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 68: Contraindications

    InMode Without Vasculaze Operator Manual Section 10: Forma/Plus Treatment Information Cleaning Procedure: Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec and repeat as necessary Leave it to dry completely. 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 69 InMode Without Vasculaze Operator Manual Section 10: Forma/Plus Treatment Information 12.2 Treatment Recommendations Ensure that skin is clean and dry. Follow Device Start-Up procedure from Section 5. Set treatment parameters. Suggested facial treatment parameters for Forma are shown in the table below:...
  • Page 70 InMode Without Vasculaze Operator Manual Section 10: Forma/Plus Treatment Information Any combination of treatment parameters should be according to skin response and patient tolerance. Always start with low settings and observe the skin's reaction and patient comfort before increasing the RF energy.
  • Page 71 InMode Without Vasculaze Operator Manual Section 10: Forma/Plus Treatment Information should be constant and its amplitude should be at least double of Handpiece spot size to avoid hot spots. Continue to treat the area in this fashion. Always start with a low setting level to check the patient’s tolerance to the treatment parameters and increase the...
  • Page 72 InMode Without Vasculaze Operator Manual Section 10: Forma/Plus Treatment Information  Patient should avoid very hot water for 2 days after the treatment.  Patient should avoid scrubbing, pinching and etc. of the treated area.  Moisturizer and makeup may be applied to the skin surface immediately post treatment.
  • Page 73 InMode Without Vasculaze Operator Manual Section 11: BodyFX/MiniFX Treatment Information Section 11: BodyFX/MiniFX Treatment Information 11.1 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 and pain, relief of muscle spasm, temporary improvement of local blood circulation.

  • Page 74: Possible Adverse Effects

    InMode Without Vasculaze Operator Manual Section 11: BodyFX/MiniFX Treatment Information  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. ...

  • Page 75: Pre-Treatment Recommendations

    InMode Without Vasculaze Operator Manual Section 11: BodyFX/MiniFX Treatment Information We recommend the usage of the following cleaning agent that was tested in our company for material compatibility as 70% alcohol solution. Cleaning Procedure: Thoroughly clean the Handpiece with 70% alcohol absorbed pad for at least 30 sec.

  • Page 76: Treatment Recommendations

    InMode Without Vasculaze Operator Manual Section 11: BodyFX/MiniFX Treatment Information 11.2 Treatment Recommendations Ensure that skin is clean and dry. No gel allowed! Follow Device Start-Up Procedure from Section 5. Set the treatment parameters. Suggested parameters are shown in the table...
  • Page 77 InMode Without Vasculaze Operator Manual Section 11: BodyFX/MiniFX Treatment Information Reduce Pulse Width if bruises appear and with MiniFX restrict Pulse Width to 1-3sec. Divide treatment area to zones of about the size of a large hand palm, 4 foot- prints of the Vacuum Chamber (full normal size abdomen = 6 treatment zones), and 3-4 foot-prints for MiniFX.

  • Page 78: Treatment Schedule

    InMode Without Vasculaze Operator Manual Section 11: BodyFX/MiniFX Treatment Information 11.2 Treatment Schedule  The number of treatment sessions depends on the individual patient and is typically 8 sessions, once a week. Some patients may get satisfactory results after 6 sessions. Some patients may need 2-4 additional sessions and very few do not respond to treatment.
  • Page 79 InMode Without Vasculaze Operator Manual Section 12: System Maintenance Section 12: System Maintenance 11.1 Maintenance & Frequency The following list suggests how often each of the maintenance procedures should be performed by the operator. 11.1 Before and after each treatment Wipe the device with a damp soft cloth.
  • Page 80 Handpieces! 11.2 Filling Water for Diolaze, DiolazeXL and Lumecca InMode System, Diolaze, DiolazeXL and Lumecca handpieces are shipped without water. Distilled water must be used and failure to do so will void the service warranty. During water filling, air bubbles can form inside the hoses which may cause water flow issues.
  • Page 81 InMode Without Vasculaze Operator Manual Section 12: System Maintenance Pressing the Up arrow will activate the Pump and count down from 600 -6). seconds (10 minutes) to 0 seconds (Figure -4: Menu Screen Figure -5: Utilities Screen Figure -6: Time Counter Water Pump Current Value...
  • Page 82 11.2 Draining Water for Diolaze, DiolazeXL and Lumecca For shipping and storage, the InMode systems and Handpieces must be drained of water during freezing temperature. Failure to do so will void the service warranty. Frozen water in the system and Handpiece hoses can lead to damages.
  • Page 83 When only applicators are shipped or stored, follow applicators draining instructions below. It is possible to connect them to the system and perform the draining procedure, as above. It is also possible to use the Invasix Water-draining tool (Figure -10).
  • Page 84 InMode Without Vasculaze Operator Manual Section 12: System Maintenance Hold the Handpiece and the Draining Tool over a sink and start pumping air through the Handpiece until no more water drains out. Disconnect the Handpiece from the Water Draining Tool.
  • Page 85 InMode Without Vasculaze Operator Manual Section 12: System Maintenance 11.12 Replacing the Capsule Filter For safety, and proper System performance, replace the cooling water with fresh distilled water only. To remove the Capsule Filter: Drain the water from the System following “Draining Water” procedure Turn the System Off.
  • Page 86 InMode Without Vasculaze Operator Manual Section 12: System Maintenance 11.11 Air Filter Systems marked by the Service Revisions listed in the table below are equipped with new air filters. The Filters are intended to reduce dust and debris entering and accumulating inside the System.
  • Page 87 InMode Without Vasculaze Operator Manual Section 12: System Maintenance Dust Filter ordering  In order to add a back cover with Dust Filter to existing Systems, order the parts as listed in the table.  For Systems which already have a support for the back door, order a Mesh for Cabinet Back Cover (part number MM607749X).
  • Page 88 InMode Without Vasculaze Operator Manual Section13: Troubleshooting Section13: 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.
  • Page 89 InMode Without Vasculaze Operator Manual Section13: Troubleshooting Problem Description and Checks Fault H800E- System Call Technical Service if the problem persists. Incompatible Software Version Fault H800F- System Call Technical Service if the problem persists. Memory Fault Fault H8010- System Call Technical Service if the problem persists.
  • Page 90 InMode Without Vasculaze Operator Manual Section 14: System Specifications Section 14: 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...
  • Page 91 InMode Without Vasculaze Operator Manual Section 14: System Specifications MiniFX Applicator 0.750kg [1.653 lb] Diolaze Output Parameters Wavelength 81010 nm Fluence Short 10 – 40 J/cm² Variable, maintaining highest peak Long 15 – 60 J/cm² power Pulse width (duration) Short/Long...
  • Page 92 InMode Without Vasculaze Operator Manual Section 14: System Specifications Fractora Output Parameters RF Energy 5 – 62 energy levels Frequency Forma Output Parameters RF Energy 20 – 62 energy levels Frequency 1MHz Plus Output Parameters RF Energy 20 – 62 energy levels...
  • Page 93 InMode Without Vasculaze Operator Manual Section 14: System Specifications -1: Fractora 24 Pin Output Power versus Impedance Figure -2: Fractora 60 Pin Output Power versus Impedance Figure -3: Forma Output Power versus Impedance Figure 88 of 96...
  • Page 94 InMode Without Vasculaze Operator Manual Section 14: System Specifications -4: Plus Output Power versus Impedance Figure -5: BodyFX Output Power versus Impedance Figure -6: MiniFX Output Power versus Impedance Figure 89 of 96...
  • Page 95 InMode Without Vasculaze Operator Manual Section 14: System Specifications 11.1 EMC Safety 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 96 InMode Without Vasculaze Operator Manual Section 14: System Specifications Guidance and manufacturer’s declaration – electromagnetic emissions The InMode System is intended for use in the electromagnetic environment specified below. The customer or the user of the Optimas should assure that it is used in such an environment.
  • Page 97 InMode Without Vasculaze Operator Manual Section 14: System Specifications Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
  • Page 98 InMode Without Vasculaze Operator Manual Section 14: System Specifications Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user should assure that it is used in such an environment.
  • Page 99 InMode Without Vasculaze Operator Manual Section 14: System Specifications a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
  • Page 100 InMode Without Vasculaze Operator Manual Table from IEC60601-1-2, / 5.2.2.1 C & F Table from IEC60601-1-2, / 5.2.2.1 C & F 95 of 96...
  • Page 101 InMode Without Vasculaze Operator Manual Table from IEC60601-1-2, / 5.2.2.1 C & F 96 of 96...

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