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InMode Envision Operator's Manual

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Operator Manual
Envision
Version: DO611646A

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Summary of Contents for InMode Envision

  • Page 1 Operator Manual Envision Version: DO611646A...
  • Page 2 Copyright © InMode Ltd. Date: February 2023 All rights reserved. Contents of this publication may not be reproduced in any form without the written permission of InMode Ltd. InMode Ltd Tavor House, POB 533, Industrial Park South, Yokneam, 2069206, Israel...

  • Page 3: Table Of Contents

    Table of Contents Section 1: Introduction ..................1 1.1. Before You Start ..................... 1 1.2. System Overview ....................1 1.3. Conventions Used in the Manual ................1 1.4. Explanation of the Symbols used on the System ........... 1 Section 2: Safety ....................4 2.1.
  • Page 4 Section 6: Lumecca Treatment Information ............31 6.1. Indications for Use ....................31 6.2. Contraindications ....................31 6.3. Possible Adverse Effects..................32 6.4. Pre-Treatment ...................... 32 6.5. Tip Cleaning Instructions Prior to Use ..............33 6.6. Treatment Recommendations ................33 6.7.
  • Page 5 10 Section 10: Troubleshooting ................53 10.1. Description of Faults with All Handpieces ............53 11 Section 11: System Specifications ..............55 11.1. RF Output RF Power Curves ................. 56 11.2. EMC Safety ......................58...

  • Page 6: Section 1: Introduction

    System. Always be aware of the possible dangers and take proper safeguards as described in the manual. The System must be serviced only by InMode Ltd. qualified personnel). 1.2. System Overview The InMode Platform with Forma-I, Morpheus8 and Lumecca Applicators (marketed as Envision technology) employs two different technologies for various aesthetic applications –...
  • Page 7 Envision System 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 8 Envision System Operator Manual Section 1: Introduction Symbol for “DO NOT USE IF PACKAGE IS DAMAGED Symbol for date of manufacture. This symbol is accompanied by a date Symbol for manufacturer. This symbol is accompanied by the name and address of the manufacturer...

  • Page 9: Section 2: Safety

    Envision System Operator Manual Section 2: Safety Section 2: Safety This chapter describes safety issues regarding the use and maintenance of the Envision™ System with the Forma-I, Morpheus8 and Lumecca™ IPL Handpieces, with a special emphasis on electrical, and optical safety, as applicable.

  • Page 10: Cautions

    Envision System Operator Manual Section 2: Safety Protective goggles must be used by all treatment attendants when using the Lumecca IPL Handpieces. 2.3. Cautions The following cautions should be heeded for safe System use: ▪ Do not touch the System’s inner parts.

  • Page 11: Electrical And Mechanical Safety

    Envision System Operator Manual Section 2: Safety ▪ All persons in the treatment room must wear approved optical safety eyewear. This includes the operator, patient, nurses, and any other persons in the treatment room. ▪ Do not attempt to remove the plastic shell protective covers on the Handpiece which could allow exposure to high intensity light.

  • Page 12: Safe Use Of The Active Accessories

    Do not connect a wet accessory to the System. Do not immerse the Applicator under water at any time. This equipment is for use only by trained, licensed personnel. Only Handpieces manufactured or approved by InMode Ltd. should be used with InMode System. 7 of 60...
  • Page 13 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 14: 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: Figure 2-1: InMode System Identification Label...
  • Page 15 Envision System Operator Manual Section 2: Safety Figure 2-2: IPL Warning Label Figure 2-3: IPL Emission Warning Label Figure 2-4: Emergency Stop Label on the emergency Red Button 10 of 60...

  • Page 16: Handpiece Labels

    Envision System Operator Manual Section 2: Safety Figure 2-5: Footswitch Label for All Applicators (but IPL) 2.12. 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 number of the...

  • Page 17: Equipment Classification

    ▪ Power receptacle must include protective earth and must be checked before connecting the system. ▪ The InMode System with IPL Handpiece is classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE marking. 12 of 60...
  • Page 18 Envision System Operator Manual Section 2: Safety ▪ The InMode System with IPL Handpieces is classified as a Class II in accordance with the 21 CFR 860 USA regulations. ▪ The InMode System Forma-I, Morpheus8 Handpieces is classified as IIb device defined by the Medical Device Directive (93/42/EEC) for CE marking.

  • Page 19: Section 3: System Installation

    Envision System Operator Manual Section 3: System Installation Section 3: System Installation 3.1. 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 20: Unpacking

    Envision System Operator Manual Section 3: System Installation For optical Handpieces: ▪ User protective goggles. ▪ Patient eyewear. ▪ IPL “Danger” door signs, as applicable. 3.4. Unpacking In order to unpack the device: Remove the paper strip and open the box Remove accessories and foams around the device.

  • Page 21: Installation

    Plug the System Power Cord into an appropriate electrical outlet. 3.6. Filling Water The InMode System 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 22: System Disposal

    Envision System Operator Manual Section 3: System Installation 3.8. 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 23: Section 4: Device Description

    Envision System Operator Manual Section 4: Device Description Section 4: Device Description 4.1. 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 24 Envision System Operator Manual Section 4: Device Description 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. Figure 4-2: Front Panel and Operator Control Panel with Optical Handpieces Connector (Arrow) Power On-Off The Power Switch turns the System on and off.

  • Page 25: Software Screens

    Envision System Operator Manual Section 4: Device Description 4.2. Software Screens The Splash Screen appears after the On-Off switch is turned on. Figure 4-3: Splash Screen *The Software version number is displayed on the top of the screen and depends on the product version.
  • Page 26 Envision System Operator Manual Section 4: Device Description 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 4-5: Utilities Screen Figure 4-6: Menu Screen The Menu Screen allows the selection between the connected Handpiece, or entry to the Utilities Screen.
  • Page 27 Envision System Operator Manual Section 4: Device Description treatment selection icons utilize the system Handpiece as follows: • One RF Connector is used for Forma-I Handpiece. The System automatically identifies the connected handpiece and presents the designated Treatment screen •...
  • Page 28 Envision System Operator Manual Section 4: Device Description Figure 4-8: Lumecca 580 Treatment Screen (same screen for the 515) The Lumecca 580 or 515nm Treatment Screen contains: Spot size Allows selecting the spot size. Available spot sizes are: Original, Small (Applicator with the Small Spot Size adaptor on).
  • Page 29 Envision System Operator Manual Section 4: Device Description In Ready mode, the system is waiting for a signal from the Trigger Switch to activate the energy. Any attempt to change the treatment settings switches the system to Standby mode. Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed.
  • Page 30 Envision System Operator Manual Section 4: Device Description Delivered energy for 12, 24 is changed from level 5 to 60 energy levels Energy and for Resurfacing tip from 5-30 energy levels and the System starts up at the minimal energy setting.

  • Page 31: Sound Indicator

    Envision System Operator Manual Section 4: Device Description Delivered energy is changed from level 1 to 9 energy levels Energy and the System starts up at the minimal energy setting. Cut-Off Cut-off temperature settings are changed in the range of 35- 43ºC.
  • Page 32 Envision System Operator Manual Section 4: Device Description Figure 4-12: Forma-I Handpiece Forma-I Handpiece (4-12) comprises applicator, cable, connector and an integral temperature sensor. 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.
  • Page 33 Envision System Operator Manual Section 4: Device Description Figure 4-14: Lumecca Handpiece with Lightguide Adaptor for smaller areas Applicator Comprises flash lamp and reflector emitting optical energy through the pre-cooled light guide (30x10mm) (Figure 4-13). Lightguide Small Spot-size Applicator (8 mm diameter) (Figure 4-14)
  • Page 34 Envision System Operator Manual Section 4: Device Description Figure 4-16: Morpheus8-Resurfacing Tip (Left), Morpheus8-12 Pins Tip (Center), Morpheus8-24 Pins Tip (Right) The tips comprise 24, or 12 needles that are coated along with an insulating material except the distal 0.5mm edge (Figure 4-17). Note the insulation that leaves only the 0.5mm tip exposed.

  • Page 35: Section 5: System Operation

    Envision 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 Handpiece for possible mechanical damage.

  • Page 36: Section 6: Lumecca Treatment Information

    Multiple treatment sessions may be required for best results. 6.1. Indications for Use The InMode IPL Device wavelengths (515-1200nm and 580-1200nm) are indicated for use for the following treatments: ▪ The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles);...

  • Page 37: Possible Adverse Effects

    Envision System Operator Manual Section 6: Lumecca Treatment Information ▪ Diseases that may be stimulated by light, such as epilepsy, lupus and urticaria. ▪ Vitiligo. ▪ Skin type V and VI and excessively tanned skin from sun, tanning beds or tanning creams and sprays within the last two weeks.

  • Page 38: Tip Cleaning Instructions Prior To Use

    Envision System Operator Manual Section 6: Lumecca Treatment Information ▪ Photograph the patient. ▪ Mark the treatment area. ▪ Clean the handpieces parts that come in direct contact with the skin with 70% alcohol. The patient may shave the area to be treated. Long and dark hair may absorb light and leave burn mark on the skin.

  • Page 39: Post-Treatment Recommendations

    Envision System Operator Manual Section 6: Lumecca Treatment Information Apply the Handpiece to the treated. Use slight pressure and activate the Hand Trigger Button to deliver a light pulse. Perform a test spot in the area to be treated on a non-conspicuous spot and wait 10- 15 minutes to check the response.

  • Page 40: Section 7: Morpheus8 Treatment Information

    Envision System Operator Manual Section 7: Morpheus8 Treatment Information Section 7: Morpheus8 Treatment Information 7.1. Sub-dermal Fractional Treatment The Morpheus8 Applicators are designed for delivering RF energy to the dermal and sub- subdermal tissue in a fractional manner with the energy applied to <5% of the total coverage area.

  • Page 41: Possible Adverse Side Effects

    Envision System Operator Manual Section 7: Morpheus8 Treatment Information ▪ History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin. ▪ History of bleeding coagulopathies or use of anticoagulants in the last 10 days ▪...

  • Page 42: Handling Instructions Prior To Use

    Envision System Operator Manual Section 7: Morpheus8 Treatment Information ▪ Complete or update the patient's medical and physical history. ▪ Exclude from treatment anyone with the listed contraindications. ▪ Determine why the patient is seeking treatment and what his/her expectations are.

  • Page 43: Test Spots

    Envision System Operator Manual Section 7: Morpheus8 Treatment Information The Morpheus8 tips arrive sterile and are for single use only! 7.7. Test Spots A small test spot should be performed in a non-conspicuous area of the treatment site, prior to the first complete session. Test spot is performed to establish the following requirements: ▪...

  • Page 44: Treatment Schedule

    Envision System Operator Manual Section 7: Morpheus8 Treatment Information The endpoint is substantial erythema and edema, visible ablative craters, and burnt tissue smell often accompanied by tingling heat sensation. The below list summarizes the Treatment recommendations per each tip type:...
  • Page 45 Envision System Operator Manual Section 7: Morpheus8 Treatment Information ▪ Blisters may be treated with a prescribed antibiotic ointment or burn treatment cream as per physician's discretion. ▪ During the first two days following treatment the skin should be kept clean to avoid contamination or infection;...

  • Page 46: Section 8 : Forma-I Treatment Information

    8.1. Indications for Use The Envision system with the Forma-I Handpiece is intended for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation. FORMA-I is designed for treatment of smaller zones.

  • Page 47: Possible Adverse Side Effects

    8.4. Handpiece Cleaning Instruction Prior to Use The following processes are validated for the Envision System with Forma-I 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 48: Treatment Recommendations

    Envision System Operator Manual Section 8 : Forma-I Treatment Information 4. Inform the patient about treatment arrangement, typical treatment results and possible side effects and discomfort. 5. Instruct the patient about the safety warnings. 6. 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 49: Treatment Schedule

    Envision System Operator Manual Section 8 : Forma-I Treatment Information 15. 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 settings gradually.

  • Page 50: Section 9: System Maintenance

    Envision System Operator Manual Section 9: System Maintenance Section 9: System Maintenance 9.1. Maintenance & Frequency The following list suggests how often each of the maintenance procedures should be performed by the operator. 9.2. 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 51: Filling Water For Lumecca

    9.6. Filling Water for Lumecca InMode System with 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 52 Envision System Operator Manual Section 9: System Maintenance Figure 9-4: Menu Screen Figure 9-5: Utilities Screen Figure 9-6: Time Counter Water Pump Current Value (right side of screen) After 300 seconds (while the Pump is working), unscrew the plastic Cap on the side of the Capsule Filter counter clockwise to release air.

  • Page 53: Draining Water For Lumecca

    9.7. Draining Water for 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 54: Draining The Ipl Handpieces With The Water Draining Tool

    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 InMode Water-draining tool (Figure 9-10). Figure 9-10: Water Draining Tool The Lumecca Handpieces may be damaged in cold (freezing) temperatures that occur during transportation or the local storage environment.

  • Page 55: Replacing The Deionizer Cartridge

    Damage to the system or Handpieces by frozen water will not be covered under System's warranty. Only InMode draining mechanical hand pumps (InMode P/N AT604837x) could be used to drain Lumecca Handpieces. To order the Water Draining Tool, contact our Service department.

  • Page 56: Air Filter

    Envision System Operator Manual Section 9: System Maintenance Holding the Capsule Filter with one hand, loosen the Filter by pressing the upper Black Quick Connector and pulling the Filter out of the Water Hose (Figure 9-12 left). Holding the Capsule Filter with one hand, loosen the filter by pressing the lower black quick Connector and pulling the filter out of the water hose (Figure 9-12 right).
  • Page 57 Envision System Operator Manual Section 9: System Maintenance Figure 9-13: Back Cover Door with Dust Filter Air Filter Maintenance ▪ Dust Filter must be to be cleaned once a week. In dusty environments or desert regions, it should be checked daily.

  • Page 58: Section 10: Troubleshooting

    Envision System Operator Manual Section 10: Troubleshooting 10 Section 10: 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 59 Envision System Operator Manual Section 10: Troubleshooting Fault H8010- System Memory Call Technical Service if the problem persists. Fault Faults H83XX, H84XX, H82XX Call Technical Service if the problem persists. Faults H86XX Water Flow Call Technical Service if the problem persists.

  • Page 60: Section 11: System Specifications

    Envision System Operator Manual Section 11: System Specifications 11 Section 11: 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 61: Rf Output Rf Power Curves

    Envision System Operator Manual Section 11: System Specifications Light guide cooling Strong - 15ºC, Normal - 22ºC Spot size 10mm x 30mm Repetition Rate Forma - I Output Parameters Maximal Output Power 12 W Frequency 1MHz 11.1. RF Output RF Power Curves The curves that follow depict the changes for each RF mode at specific power settings.
  • Page 62 Envision System Operator Manual Section 11: System Specifications Figure 11-2: Forma - I Output Power versus Impedance The curves that follow depict the changes for each RF mode at specific power settings. Figure 11-3: Output Power Versus Impedance 57 of 60...

  • Page 63: Emc Safety

    Connect the device into an outlet on a circuit different from that which was previously used. ▪ Consult InMode 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 64 Envision System Operator Manual Section 11: System Specifications IEC 60601-1-2 Edition 4.0 (2014): Environment of intended uses: Professional Healthcare Facility Environment Summary of Test Results: 59 of 60...
  • Page 65 Envision System Operator Manual Section 11: System Specifications 60 of 60...