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Invasix InMode, Operator'S Manual

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InMode Without Vasculaze Operator Manual

 

Section 4: Device Description

 

 

 

35 of 96

 

 

 

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 

Cleaner

 

Applied to the skin surface and shape the skin for optimal 

heating.

 

RF Electrodes

 

Located in the Vacuum Chamber  and delivers RF energy to the 

treated tissue.

 

Screen

 

Shows the measured temperature.

 

Cable

 

Has a length of 280cm (110’’).

 

Connector

 

The Connector is located on the System Rear Panel.

 

Temperature 

Sensor

 

Located in the Vacuum Chamber for the skin temperature 

measurement.

 

 

Summary of Contents for InMode

Page 1: ...wT System InMode Operator Manual Version DO606736C ...

Page 2: ...reserved Contents of this publication may not be reproduced in any form without the written permission of Invasix Ltd Invasix Ltd Tavor House POB 533 Industrial Park South Yokneam 2069206 Israel For information call 972 4 9096313 I InMode Spain Pati de la Abadia nº1 Breda 17400 Girona Spain Contact person Jorge Alorda Guibernau Tel 34 670 486 026 E mail jalorda inmodemd com ...

Page 3: ...f the Active Accessories 8 2 10 Warnings 8 2 11 Device Labels 11 2 12 Handpiece Labels 12 2 13 Equipment Classification 14 Section 3 System Installation 16 3 1 Electrical Requirements 16 3 2 Environmental Requirements 16 3 3 Equipment List 16 3 4 Unpacking 11 3 5 Installation 18 3 6 Filling Water 18 3 7 Moving the System 18 3 8 System Disposal 11 Section 4 Device Description 21 4 1 Rear Panel 21 4...

Page 4: ...ecommendations 45 7 7 Treatment Schedule 41 7 8 Post Treatment Recommendations 41 Section 8 Lumecca Treatment Information 48 8 1 Instructions for Use 48 8 2 Contraindications 48 8 3 Possible Adverse Effects 41 8 4 Pre Treatment 41 8 5 Tip Cleaning Instructions Prior to Use 51 8 6 Treatment Recommendations 51 8 7 Post Treatment Recommendations 51 8 8 Treatment Schedule 52 Section 9 Fractora Treatme...

Page 5: ... 11 11 6 Treatment Recommendations 11 11 7 Treatment Schedule 13 11 8 Post Treatment Recommendations 13 Section 12 System Maintenance 14 12 1 Maintenance Frequency 14 12 2 Before and after each treatment 14 12 3 Once a Week 14 12 4 Once a Month 14 12 5 Once a Year 14 12 6 Filling Water for Diolaze DiolazeXL and Lumecca 15 12 7 Draining Water for Diolaze DiolazeXL and Lumecca 11 12 8 Draining the L...

Page 6: ...y RF The System operates while in contact with any of the following Handpieces Diolaze DiolazeXL laser hand pieces for hair removal Lumecca IPL for skin rejuvenation Fractora radiofrequency RF for fractional resurfacing Forma Plus RF for facial and body wrinkle treatment and BodyFX MiniFX RF for body contouring fat and cellulite treatment The System provides individual adjustment of treatment para...

Page 7: ...umber Do not discard in trash Electronic equipment should be disposed of in an appropriate manner Fuse Type B Equipment Type BF Equipment HF Isolated Patient Circuit This equipment intentionally supplies non ionizing RF energy Follow the operating instructions Do not reuse single use only This symbol is used for disposable one time use products CE Marking Figure 1 1 Device Symbols ...

Page 8: ...ter to be familiar with all its safety requirements and operating procedures prior to system operation The laser IPL or RF energy can cause injury if used improperly High voltage is present inside the System Always be aware of the possible dangers and take proper safeguards as described in the manual 1 1 The Patient Well trained staff is key for assuring patient safety A patient history report sho...

Page 9: ...r the main power is on in accordance with national and international standards The protective eyewear must have an optical density OD of 5 or greater at the Diolaze and DiolazeXL lasers wavelength of 730 1085nm OD 5 755nm OD 7 1064nm OD 6 at the Lumecca IPL wavelength of 515 1200 nm For users outside the U S the protection values are for 730 1085 DIR LB5 for 755 DIR LB6 IR LB7 and for 1064 DIR LB6...

Page 10: ...rom escaping the laser room Restrict entry to the treatment room when the laser or IPL is in use Allow access to those personnel both essential to the procedure and well trained in safety issues Never direct the laser beam at anything other than the calibration port or the intended treatment site Never look directly into the laser aperture at the distal end of the Handpiece All persons in the trea...

Page 11: ...st to prevent them from igniting and burning Use non flammable prepping solutions Do not use flammable substances when preparing the skin for treatment Be especially careful with the use of oxygen If alcohol is used for cleaning and disinfecting it must be allowed to dry thoroughly before the System is used 1 2 Safety Features of the System The system incorporates the following safety features All...

Page 12: ...Triggers allow laser emission only when the Footswitch is pressed Laser Energy monitoring to verify that the laser output is within specific energy tolerances for every laser pulse If abnormally low or high the laser current indicative of optical energy is detected a System fault is triggered and the user is notified As a safety feature and in compliance with U S and international regulations the ...

Page 13: ...ll electrodes are in full contact with the skin Bad coupling of both electrodes FORMA PLUS BodyFX MiniFX with the skin results in a specific warning sound a message on the screen and disabling of RF 1 12 Warnings 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 physicians Only Handpieces manufactur...

Page 14: ...osion Hazard The following substances will contribute to increased fire and explosion hazards in the operating room Flammable substances such as alcohol based skin prepping agents and tinctures Naturally occurring flammable gases which may accumulate in body cavities such as the bowel Oxygen enriched atmospheres Oxidizing agents such as nitrous oxide N2O atmospheres Endogenous gases The optical or...

Page 15: ...ernational 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 System Certification and Identification Label Figure 2 2 Laser Emission Warning Label ...

Page 16: ...InMode Without Vasculaze Operator Manual Section 2 Safety 11 of 96 Figure 2 3 Laser Interlock Label Figure 2 4 IPL Warning Label Figure 2 5 IPL Emission Warning Label ...

Page 17: ...ure 2 7 Footswitch Label for All Application 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 number of the Handpiece ...

Page 18: ...InMode Without Vasculaze Operator Manual Section 2 Safety 13 of 96 The following labels are located on the Handpieces Figure 2 8 All Handpieces Identification Labels ...

Page 19: ...following is a list of the different equipment used and their classifications Electric shock protection Class I Defibrillation proof Type B for the optical Handpieces Diolaze DiolazeXL and Lumecca and Type BF for the RF Handpieces Fractora Forma Plus and BodyFX MiniFX Protection against ingress of liquids Ordinary equipment Not suitable for use in presence of flammable substance Power receptacle m...

Page 20: ...3 42 EEC The InMode System with Diolaze and DiolazeXL Handpieces is classified as a Class IV laser by the CDRH and as a Class 4 laser by the European Standard EN 60825 l 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...

Page 21: ...and must be checked before connecting the system For continued protection against fire replace the fuse only with one of the same type and rating Proper grounding is essential for safe operation 1 1 Environmental Requirements Corrosive materials can damage electronic parts therefore the System should operate in a non corrosive atmosphere For optimal operation of the System maintain room temperatur...

Page 22: ...User protective goggles Patient eyewear Laser and IPL Danger door signs as applicable 1 1 Unpacking In order to unpack the device 1 Remove the paper strip and open the box 2 Remove accessories and foams around the device 3 Take the device out of the box using top and bottom handles ...

Page 23: ...Fig 4 1 or 4 2 and place in the Cradle Connect the Footswitch Connect the Power Cord to the System inlet Plug the System Power Cord into an appropriate electrical outlet Figure 3 1 Harness Support Assembly 1 2 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 de...

Page 24: ...ction 12 System Maintenance Never lift pull or push the System using the operating panel Always use the handles when moving the System Upon unpacking check the System for mechanical damage e g cracks in the Cable insulation Never leave the system or and handpieces with water in exposed to freezing temperatures 4 C 1 2 System Disposal To comply with European Commission Directive 2002 96 EC on Waste...

Page 25: ... be screwed to the connectors To tighten and or loosen the screws use fingertips only Do not use screwdriver as it can damage the connectors Footswitch Connector The Footswitch is connected to the inlet Footswitch activates RF energy if the System is in Ready mode Place the Footswitch on the floor near the treatment area RF Handpiece Connector Located on the upper right side of the Rear Panel and ...

Page 26: ...n 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 Handpiece Connector Arrow Power On Off Switch The Power Switch turns the System on and off The Switch is located on the Front Panel Optical Handpiece Connector Located in the center of the front panel and connects to one of the o...

Page 27: ...Handpiece is connected to its Connector on the Front or the Rear Panel The System recognizes the connected Handpiece and enables opening only the relevant screen except for Fractora and Forma Plus that have to be chosen manually on the interface 1 1 Software Screens The Splash Progress Screen appears after the On Off Switch is turned on Figure 4 3 Splash Progress Screen The SW version number will ...

Page 28: ...Figure 4 4 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 5 Menu Screen The Menu Screen allows the selection of the connected Handpiece or entry to the Utilities Screen ...

Page 29: ...tallation Change Password Change the password by entering the old password and then entering another 4 digit password Calibration External validation module for optical Handpieces Diolaze DiolazeXL and Lumecca Main Menu Return to the Main Menu to select the Handpiece After returning to the Menu Screen and choosing the application on the Menu Screen the corresponding Treatment Screen appears Pressi...

Page 30: ...olaze and from 5 to 40J cm for Diolaze XL and the System starts up at the minimal setting Cooling Normal and Strong cooling 10 and 2oC respectively can be selected for Diolaze and 12 and 7oC for Diolaze XL Pulse Width Short or Long pulse can be selected Pulse Mode Pps Pulse Per Screen For Diolaze Off Single Normal 0 5pps and Fast 1pps For DiolazeXL Off Single 5 40J cm2 1pps 5 40J cm2 2pps 5 25J cm...

Page 31: ... settings switches the System to Standby mode Active mode when the laser is pulsed by pressing the Hand Trigger Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed Figure 4 8 Lumecca 580 Treatment Screen same screen for the 515 The Lumecca 580 or 515nm Treatment Screen contains Selection Frame The frame selects parameters that can be changed by functi...

Page 32: ...om the Trigger Switch to activate the energy Any attempt to change the treatment settings switches the system to Standby mode When the signal from the trigger is indicated the System switches to Active mode 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 Figure 4 9 Fr...

Page 33: ... number of pulses delivered on one zone and total number of pulses from the beginning of the treatment Return to Main Menu to select another Applicator and change the Applicator if needed The System has three treatment modes Standby Ready and Active 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...

Page 34: ... as the Footswitch is pressed Counter Reset The Counter can be reset Temperature Measure This indicator shows the skin surface temperature as measured by an integral temperature sensor Treatment Time This function shows the total time that RF is activated Main Menu Return to the Main Menu to select another Applicator and change the Applicator if needed System Mode The System has three treatment mo...

Page 35: ... the Cut Off temperature which is adjustable from 35 to 43oC This indicates measured temperature at which the RF delivery is stopped Pulse This indicator shows the time period during which vacuum is applied and RF energy is delivered which is adjustable from 2 to 7sec for BodyFX and from 1 5sec for MiniFX Counter Reset The Treatment Time can be reset Temperature Measure This indicator shows on lin...

Page 36: ...nd tone indicates Bad Coupling 1 2 Cut Off Temperature Control C is constantly o off temperature up to an upper limit of temperature of 43 The cut maintained for Forma Plus and BodyFX MiniFX handpieces 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 and RF is instantly inactivated As soon as t...

Page 37: ...Has a length of 170cm 67 Connector The Connector is connected to the System Each of the Lumecca Handpieces 515 and 580 comprises an Applicator Cable and Connector Figure 4 13 Lumecca Handpiece The Lumecca Handpiece contains Applicator Comprises flash lamp and reflector emitting optical energy through the pre cooled light guide 30x10mm Figure 4 13 Cable Has a length of 170cm Connector The Connector...

Page 38: ...h visibility of the treated area Figure 4 14 Cable Has a length of 280cm 110 Connector The Connector is connected to the System Control Panel Tips Handpiece tips have 2 sizes of pin arrays Figure 4 15 60 pins are 600µ long and 24 pins are 2500µ long Figure 4 15 Fractora Tips Left 60 pin Right 24pin Coated Non coated Forma Plus Handpieces comprise an Applicator Cable Connector and an integral Tempe...

Page 39: ...mperature Sensor Handle Is made of metal and has ergonomic design for easy treatment with high visibility of the treated area Cable Has a length of 280cm 110 Connector The Connector is connected to System Rear Panel BodyFX MiniFX Handpiece comprise a Vacuum Chamber 2 RF Electrodes Temperature Sensor 8 character Screen Handle Cable and Connector Figure 4 18 BodyFX Handpiece Figure 4 19 MiniFX Handp...

Page 40: ... visibility of the treated area Vacuum Cleaner Applied to the skin surface and shape the skin for optimal heating RF Electrodes Located in the Vacuum Chamber and delivers RF energy to the treated tissue Screen Shows the measured temperature Cable Has a length of 280cm 110 Connector The Connector is located on the System Rear Panel Temperature Sensor Located in the Vacuum Chamber for the skin tempe...

Page 41: ... is passed correctly then the System automatically enters the Menu Screen 6 Select Application from the Menu Screen and the System will enter the Treatment Screen 1 Verify on the screen that the software version is properly displayed and that the connected Handpiece type is recognized correctly 8 Select the treatment parameters using Up and Down arrow keys 1 Apply the Handpiece to the treated area...

Page 42: ...g around the window in the Handpiece and by an audio signal 14 During treatment when the laser lightguide is heating up the System will go into Cooling Down mode Wait until the icon changes to Standby mode as no energy is delivered in Cooling Down Mode Press the Standby icon to resume Ready mode 2 1 System Shutdown To shut down the System turn the On Off Switch located at the front to Off Turn the...

Page 43: ...rent or history of skin cancer or current condition of any other type of cancer or pre malignant moles Pregnancy and nursing Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications Patients with history of diseases stimulated by heat such as recurrent Herpes Simplex in the treatment area may be treated only following a prophylactic regi...

Page 44: ...ythema and or swelling edema damage to natural skin texture crust blister and burn change of pigmentation hyper and hypo pigmentation in growing hairs and scarring Peri follicular erythema and edema lasting for a few days after the treatment is a desirable typical treatment end point The patient must understand the importance of pre treatment and post treatment instructions and that failure to com...

Page 45: ...me in contact with the skin with 70 alcohol Treatment area should be shaved prior the treatment Hairs may absorb light and leave burn mark on the skin 2 2 Tip Cleaning Instructions Prior to Use Clean the Handpiece output window with 70 alcohol absorbed pad for at least 30sec and dry completely 2 2 Treatment Recommendations 1 Follow Device Start Up Procedure from System Operation section 2 Shave th...

Page 46: ... 40 Test Wait at least 15 30 min increase or decrease 2 5 J cm by 2 Short Strong Medium Fast IV 20 35 20 40 Test Wait at least 15 30 min increase or decrease 2 3 J cm by 2 Short Long Strong Medium Fast V 15 35 Test Wait at least 2 3 days increase or decrease 2 3 J cm by 2 Long Strong Fast N ormal VI 15 25 Test Wait at least 2 3 days Increase or decrease 2 2 J cm by 1 Long Strong Normal For longer ...

Page 47: ...ing to the speed of your hand movement 11 In a single mode AutoRepeat Off move Handpiece by stamping to adjacent area without overlap and apply next pulse to cover all treatment area 11 If end points are not obvious perform another pass preferably in a different direction when general erythema subsides Occasionally a third pass is applied on light skin Ensure that there is a delay of a few minutes...

Page 48: ...air removal by lasers or intense pulse light sources can cause increased hair growth in some individuals Based upon currently available data the highest risk groups for this response are females of Mediterranean Middle Eastern and South Asian heritage treated on the face and neck Current or history of skin cancer or current condition of any other type of cancer or pre malignant moles Pregnancy and...

Page 49: ...nt Do not treat the upper eyelids and the lips Do not treat over tattoo and permanent makeup 2 1 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 in growing hairs and scarring Peri follicula...

Page 50: ...screen is advisable during outdoor activity at daylight hours The patient should discontinue any irritant topical agents for 2 3 days prior the treatment Stop anticoagulants 7 10 days prior to treatment if medically permitted Photograph the patient Mark the treatment area with a white marker Clean the s parts that come in contact with the skin with 70 alcohol The treatment area should be shaved pr...

Page 51: ...ng Normal IV 10 20 12 25 14 25 Long Strong Normal V 6 15 10 20 12 22 Long Strong VI NA 8 16 10 20 Long Strong 1 Always start with a low settings level to check patient tolerance Test watch epidermal response and increase or decrease settings gradually Darker skin is safer to treat with Long pulse width Lighter hair requires higher fluence to reach the results Stronger cooling allows better epiderm...

Page 52: ...s on the face and every 6 12 weeks on the body Lighter and deeper hair is more resistant and requires more treatment sessions Hair re growth should be observed prior the treatment Treatment should be concluded when the results are satisfactory to the patient or according to the physician s discretion 2 2 Post Treatment Recommendations Following each treatment session the physician should advise th...

Page 53: ...skin cancer or current condition of any other type of cancer or pre malignant moles Pregnancy and nursing Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications Patients with history of diseases stimulated by heat such as recurrent Herpes Simplex in the treatment area may be treated only following a prophylactic regimen Severe concurre...

Page 54: ...ot 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 Erythema lasting not longer than 24h is a typical skin reaction to the Lumecca treatment The patient must understand the importance of pre treatment and post treatment instructions and that failu...

Page 55: ...nd dark hair may absorb light and leave burn mark on the skin 2 2 Tip Cleaning Instructions Prior to Use Clean the light guide with 70 alcohol absorbed pad for at least 30 sec Leave it for complete drying 2 2 Treatment Recommendations 1 Follow Device Start Up Procedure from System Operation section 2 Ensure that skin is clean 3 Apply thin layer of water based gel to the treated area Prior to using...

Page 56: ...est spot in the area to be treated on a non conspicuous spot and wait 10 15 minutes to check the response 1 In a single mode AutoRepeat Off move Handpiece to adjacent area without overlap and apply next pulse to cover all treatment area 11 In a continuous mode slide the Handpiece to adjacent area without overlap and chose Auto Repeat Normal or Fast Mode according to the speed of your hand movement...

Page 57: ...96 2 2 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: ...dures requiring ablation and resurfacing of the skin 2 1 Contraindications Pacemaker or internal defibrillator or other metallic or electronic implant anywhere in the body The Handpiece should be used at least 1cm away from cochlear implants in the ear Permanent implant in the treated area such as metal plates screws and metal piercing or silicon unless deep enough in the periosteal plane Intra de...

Page 59: ...hree months if face is treated Having received treatment with light laser RF or other devices in the treated area within 2 3 weeks for non ablative procedures and 6 12 weeks for ablative fractional laser resurfacing according to treatment severity prior to treatment except special recommendations Use of Isotretinoin Accutane within 6 months prior to treatment Use of non steroidal anti inflammatory...

Page 60: ... pre treatment and post treatment instructions and that failure to comply with these instructions may increase the probability of complications 2 2 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 Determine why the patient is seek...

Page 61: ...re The patient should shave the area to be treated Long and dense hairs prevent electrode contact with the skin s surface 2 2 Tip Cleaning Instructions Prior to Use Clean the tip with 70 alcohol absorbed pad for at least 30sec Leave it for complete drying Before each use of the Fractora Handpiece and tip they must be checked for integrity and proper cleaning and drying The Fractora tip is single u...

Page 62: ...f anesthesia If topical make sure that it is cleaned off the face before treatment and the skin is dried with alcohol 70 2 Ensure that skin is clean and dried with alcohol 70 3 Take an alcohol cleaned and dry tip and connect it to the Handpiece in the groove 4 Connect Handpiece to the system 5 Follow Device Start Up Procedure from System Operation section 6 Set treatment parameters Typical treatme...

Page 63: ...lerance the anesthetic method used and the affordable down time 1 On sensitive thin skin area such as lower eyelid apply lower parameters with more passes rather than higher parameters in one pass It is also applicable to any facial area for new users Use lower energy 20 for thin skin like neck or bony area like forehead When working on thin skin over bone such as hand dorsum or chest further redu...

Page 64: ...3 days after the treatment to ensure safe healing process Treatment should be concluded when the results are satisfactory to the patient or according to the physician s discretion Generally 3 5 sessions are needed for mild to moderate depth settings It is not typical to perform more than five consecutive sessions In some instances 1 2 sessions may be sufficient 2 12 Post Treatment Recommendations ...

Page 65: ... each treatment session Generally 24 hours after treatment patients may use regular soaps but not scrub soaps or exfoliates The patient should use a high factor sunscreen at least 30 SPF and protect the treated area from over exposure to sunlight for at least one month after the treatment starting 24 72 hours post treatment Excessive tanning of any sort sun exposure tanning beds and artificial tan...

Page 66: ...injected chemical substance unless deep enough in the periosteal plane Intra dermal or superficial sub dermal areas that have been injected with HA collagen fat injections or other augmentation methods with bio material during last 6 months Current or history of skin cancer or current condition of any other type of cancer or pre malignant moles Severe concurrent conditions such as cardiac disorder...

Page 67: ... 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 Erythema and edema lasting not longer than 24h is typical skin reaction to the treatment The patient must understand the importance of pre treatment and post treatment instructions and that fai...

Page 68: ... and physical history Exclude from treatment anyone with the listed contraindications 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 Instruct the patient about the safety warnings The patient should discontinue any irritant topical agents for 2 3 days ...

Page 69: ...n layer 2 3mm Thin skin over bone e g forehead temples periorbital 30 35 As high as tolerable C o Starting at 40 Thick layer 3 4mm 4 Suggested body treatment parameters for Plus are shown in the table below Body Treatment Zone RF Energy Level Off Temperature Cut C o Gel Resistant skin in normal size zone of 12x12 cm e g abdomen buttocks 40 50 As high as tolerable C o starting at 40 Thin layer 2 3m...

Page 70: ...dy areas by zones with size of about 2 hand palms 12x12cm such as half of abdominal area flank outer thigh inner thigh buttocks When treating smaller zones as upper arm reduce energy setting to avoid patient discomfort 11 Apply 2 4mm ultrasound gel not oil to the treated zone and to adjacent zone that can serve as a warm gel reservoir for replenishing gel in the treatment zone with minimal delay P...

Page 71: ...r when there is excessive skin response erythema and edema stop treatment and move to the next zone For excessive heat sensation you may increase the movement speed reduce the RF power and lastly reduce the cut off temperature If this does not help move to the next zone The skin should be observed for excessive erythema or edema If observed stop the treatment and move to the next treatment zone As...

Page 72: ...pinching and etc of the treated area Moisturizer and makeup may be applied to the skin surface immediately post treatment 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 ...

Page 73: ...the treated area such as metal plates screws and metal piercing silicone implants or an injected chemical substance unless deep enough in the peri ostal plane Intra dermal or superficial sub dermal areas that have been injected with HA collagen fat injections or other augmentation methods with bio material during last 6 months Current or history of skin cancer or current condition of any other typ...

Page 74: ...11 1 Possible Adverse 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 and burn change of pigmentation hyper and hypo pigmentation scarring and vacuum bruising Erythema and edema lasting not longer than 24h is typical skin reaction to the treatment The patient must unde...

Page 75: ... treating attendant should 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 Inform the patient about treatment arrangement typical treatment results and possible side effects and discomfort Instruct the patient about the safety warnings The p...

Page 76: ...5 3 As high as tolerable C o Starting at 40 BodyFX Resistant skin 40 50 4 As high as tolerable C o Starting at 40 MiniFX Sensitive area 10 1 3 As high as tolerable C o Starting at 40 MiniFX Normal area 15 20 1 3 As high as tolerable C o Starting at 40 MiniFX Resistant area 20 25 1 3 As high as tolerable C o Starting at 40 Any combination of treatment parameters should be according to skin response...

Page 77: ... 30 minutes the longer the better move around the zone evenly maintaining cut off temperature Please note that time is measured once the cut off temperature has been reached 16 Excessive heat sensation after a few passes may call for a faster movement reduced pulse width reduced RF power level and last reduced cut off temperature in this sequence 11 After 15 30 minutes move to the next zone usuall...

Page 78: ...the results are satisfactory to the patient or according to the physician s discretion One session every 3 6 months or as needed may maintain treatment results 11 2 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 Patient should avoid scrubbing pinchi...

Page 79: ... gel before cleaning 11 1 Once a Week Clean the System at least once a week Turn the System off and wipe all surfaces Be careful not to spill any liquids on the System Clean the Dust Cover 11 1 Once a Month Replace the cooling water at least once a month Follow the instruction of Draining Water and Filling Water below 11 2 Once a Year By the operator Replace the Deionizer Cartridge and Capsule Fil...

Page 80: ...ion will help prevent this from occurring 1 Connect one of the Handpieces 2 Open the back cover and take out the Bottle 3 Unscrew the water Bottle Cap Figure 12 1 4 Slowly pour distilled water into the Bottle while the Water Filter and Tube are inside the Bottle to prevent over pouring Figure 12 2 Figure 21 1 Water Bottle Cap Figure 21 2 Distilled Water Filling Figure 21 3 Water Bottle in Bracket ...

Page 81: ...me Counter Water Pump Current Value 12 After 300 seconds while the Pump is working unscrew the plastic Cap on the side of the Capsule Filter counterclockwise to release air Afterwards screw the Cap clockwise to close it Figure 12 7 Ensure that no water is leaking Figure 12 7 Capsule Filter with Plastic Cap 13 Pressing the Down arrow will stop the Water Pump 14 Turn the System Off 15 Repeat steps 2...

Page 82: ...en the back cover and take out the bottle 2 Unscrew the water bottle cap and slowly remove it from the bottle Figure 12 8 Figure 12 8 Water Bottle with Deionizer Cartridge Figure 12 9 Water Bottle in Drain Position 3 Empty the Bottle 4 Place the Bottle inside the Chamber with the black hose outside the Bottle Figure 12 9 5 Connect any Diolaze DiolazeXL or Lumecca Handpiece 6 Turn the System On 1 S...

Page 83: ...ng tool Figure 12 10 Figure 12 10 Water Draining Tool The Diolaze DiolazeXL and Lumecca Handpieces may be damaged in cold freezing temperatures that occur during transportation or the local storage environment In cold climates especially during the winter systems and handpiece may be damaged during transportation or storage when exposed to freezing temperature To Drain the Handpiece 1 Hold the Wat...

Page 84: ...ater with fresh distilled water only To remove the Deionizer Cartridge 1 Drain the water from the System following Draining Water procedure 2 Turn the System Off 3 Push the Slide Latch of the Bottle Door down and remove the Door 4 Holding the Bottle cover with one hand loosen the Bottle by turning it clockwise 5 Disconnect the Deionizer Cartridge from the Water Hoses by pressing the Release Button...

Page 85: ...he filter by pressing the lower black quick Connector and pulling the filter out of the water hose Figure 12 12 right Figure 12 12 Upper Left and Lower Right Filter Quick Connectors To install a new Capsule Filter 1 Hold the Capsule Filter when the arrow on the Filter body pointing upwards 2 Push the lower System Water Hose into lower Filter s Quick Black Connector as much as possible Figure 12 12...

Page 86: ...Part Number Service Revision InMode II AG606666A B04 Optimas AG606991A B04 Triton AG606992A A02 Dust filter are located on inside back over door Figure 12 13 Figure 12 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 Replace the Dust Filter if damaged Cleaning method Remove ba...

Page 87: ...ng 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 Platform Item Description Part Number AG606666A InMode II White Back Cover door with Dust filter AS607830X AG606991A Optimas AG606992A Triton Black back Cover door with Dust Filter AS607831X ...

Page 88: ...Call Technical Service if the problem persists The System shuts down by itself Check the Power Cord connection Check the fuses on the Back Panel of the System Check that the Emergency Button has not been pressed Call Technical Service if the problem persists Checksum The software was not loaded properly from the Software Plug Check the Plug connection and reboot the System Call Technical Service i...

Page 89: ...all Technical Service if the problem persists Faults H83XX H84XX H82XX Call Technical Service if the problem persists Faults H86XX Water Flow Fault Call Technical Service if the problem persists Faults H8003 H8006 H8007 RF Related Faults Call Technical Service if the problem persists Faults H8401 H8410 H8420 H8421 H8422 H8430 H8431 H8481 IPL Related Faults Call Technical Service if the problem per...

Page 90: ...rating temperature range allow one hour for the device to reach room temperature before use Transport and Storage Ambient Temperature Range 14 F 4 C o 65 20 Relative Humidity 0 to 80 non condensing Atmospheric Pressure 50 to 110kPa Dimensions System 46cm W x 46cm D x 100cm H 18 2 W x 18 2 D x 40 H Handpiece Cable 170 280cm L 67 110 L Weight System 32 000 kg 70 548 lb Diolaze Applicator 0 500 kg 1 ...

Page 91: ...ght guide cooling Strong 2ºC Normal 10ºC Weak 15ºC Spot size 8 mm x 50 mm Repetition Rate Long 0 8 Hz Short 0 8 1 Hz DiolazeXL Output Parameters Wavelength Fluence 5 40 J cm Pulse width duration Short Long Light guide cooling Strong 7ºC Normal 12ºC Spot size 11 mm x 27 5 mm Lumecca Output Parameters Wavelength 515 1200nm SR 515 580 1200nm SR 580 Fluence 5 30J cm Pulse width duration Short Long Lig...

Page 92: ... 62 energy levels Frequency 1MHz Plus Output Parameters RF Energy 20 62 energy levels Frequency 1MHz BodyFX Output Parameters RF Power 10 50W Frequency 1MHz Vacuum Automatically controlled MiniFX Output Parameters RF Power 10 25W Frequency 1MHz Vacuum Automatically controlled 11 1 Output Power Curves The curves that follow depict the changes for each RF mode at specific power settings ...

Page 93: ...ze Operator Manual Section 14 System Specifications 88 of 96 Figure 14 1 Fractora 24 Pin Output Power versus Impedance Figure 14 2 Fractora 60 Pin Output Power versus Impedance Figure 14 3 Forma Output Power versus Impedance ...

Page 94: ...t Vasculaze Operator Manual Section 14 System Specifications 89 of 96 Figure 14 4 Plus Output Power versus Impedance Figure 14 5 BodyFX Output Power versus Impedance Figure 14 6 MiniFX Output Power versus Impedance ...

Page 95: ... instrument The user is encouraged to try to correct the interference by one or more of the following measures 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 service personnel for help Interference to the device may be caused by portable and mobile RF c...

Page 96: ...magnetic environment guidance RF emissions CISPR 11 Group 1 The System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class A The System is suitable for use in all establishments other than domestic and those directly connected to the public low voltage power sup...

Page 97: ...ential mode 2 kV common mode 1 kV differential mode 2 kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 95 dip T U 5 for 0 5 cycle T U in 60 dip T U 40 for 5 cycles T U in 30 dip T U 70 for 25 cycles T U in 95 dip T U 5 for 5sec T U in 95 dip for 10 ms ...

Page 98: ...aration distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance 𝑑 3 5 𝑉1 𝑃 3 5 3 65 𝟗 𝟒 𝒎 80 𝑀𝐻𝑧 𝑡𝑜 800 𝑀𝐻𝑧 𝑑 7 𝐸1 𝑃 7 3 65 𝟏𝟖 𝟖𝟏 𝒎 80 𝑀𝐻𝑧 𝑡𝑜 2 5 𝐺𝐻𝑧 Where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths f...

Page 99: ...h radiated RF disturbances are controlled The customer or the user of the System can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment transmitters and the System as recommended below according to the maximum output power of the communications equipment Rated maximum output power of transmitter W Separation distance ...

Page 100: ...InMode Without Vasculaze Operator Manual Table from IEC60601 1 2 5 2 2 1 C F 95 of 96 Table from IEC60601 1 2 5 2 2 1 C F ...

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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