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Syneron Candela VelaShape III System User Manual Download Page 4

Table of Contents                                                                                             

 

 PB81499EN

 

4 

T

ABLE OF 

C

ONTENTS

 

1. Before You Start ....................................................................................................................................... 8

 

Conventions Used in this Manual ........................................................................................................ 8

 

Explanation of the Symbols Used in the System ................................................................................. 9

 

2. Safety ..................................................................................................................................................... 10

 

Introduction ........................................................................................................................................ 10

 

System Safety Features .................................................................................................................... 11

 

Patient and Personnel Safety ............................................................................................................ 11

 

Grounding the System ....................................................................................................................... 12

 

Operating the System ........................................................................................................................ 12

 

Infrared Energy Safety Issues ........................................................................................................... 12

 

Radio Frequency Energy Safety Issues ............................................................................................ 12

 

Mechanical Rollers Safety Issues (Vsmooth Applicator) ................................................................... 13

 

Electrical and Mechanical Safety ....................................................................................................... 13

 

Maintaining the System ..................................................................................................................... 13

 

Fire Hazards ...................................................................................................................................... 14

 

System Classifications ....................................................................................................................... 14

 

System Nameplate ............................................................................................................................ 15

 

3. System Description ................................................................................................................................ 16

 

System Overview ............................................................................................................................... 17

 

Console ......................................................................................................................................... 17

 

Applicators ..................................................................................................................................... 18

 

Anatomy of Cellulite ........................................................................................................................... 20

 

The VelaShape III Procedure ............................................................................................................ 20

 

Heating of Dermis and Hypodermis with elōs .................................................................................... 22

 

Mechanical Effects of Vacuum on the Skin ....................................................................................... 22

 

4. System Installation ................................................................................................................................. 23

 

Unpacking the System ....................................................................................................................... 23

 

Equipment List ................................................................................................................................... 25

 

Cover Packs ...................................................................................................................................... 25

 

System Dimensions ........................................................................................................................... 26

 

Installation Process ............................................................................................................................ 27

 

Moving the System within the Facility ................................................................................................ 30

 

Moving the System to another Facility ............................................................................................... 30

 

Electrical Requirements ..................................................................................................................... 30

 

Environmental Requirements ............................................................................................................ 31

 

5. Operating Instructions ............................................................................................................................ 32

 

Activating the System ........................................................................................................................ 32

 

Automatic Vacuum and RF Test ................................................................................................... 32

 

Setting Treatment Parameters – Tablet Control Panel ..................................................................... 33

 

Default Settings ............................................................................................................................. 35

 

Setting Treatment Parameters – Applicator Control Panel ............................................................... 35

 

Utilities Mode ..................................................................................................................................... 37

 

System Information Screen ........................................................................................................... 37

 

Maintenance Screen ..................................................................................................................... 38

 

Settings Screen ............................................................................................................................. 39

 

User Diagnostics Screen ............................................................................................................... 40

 

Service Mode Screen .................................................................................................................... 41

 

Summary of Contents for Candela VelaShape III

Page 1: ...System User Manual PB81499EN ...

Page 2: ......

Page 3: ...ty rights except as expressly provided in any written agreement from Syneron Medical Ltd Specifications are subject to change without notice Manual Catalog Part Number PB81499EN Revision Release Date January 2015 Before using the device please check local regulations If any local legislation is violated use cannot be authorized In the United States federal law restricts prescription medical device...

Page 4: ...ole 17 Applicators 18 Anatomy of Cellulite 20 The VelaShape III Procedure 20 Heating of Dermis and Hypodermis with elōs 22 Mechanical Effects of Vacuum on the Skin 22 4 System Installation 23 Unpacking the System 23 Equipment List 25 Cover Packs 25 System Dimensions 26 Installation Process 27 Moving the System within the Facility 30 Moving the System to another Facility 30 Electrical Requirements ...

Page 5: ...Protocol of Focal Fat Deposits Using Deep Mode Large and Medium Covers 57 Cellulite Mode Treatment Protocol Using the VSmooth Applicator 63 Treatment Protocol Using Cellulite Mode 63 Treatment Options with Cellulite Mode 68 Endpoints When to Stop Treating an Area 69 Post Treatment Care 70 Treatment Conclusion 70 7 Maintenance 71 Cleaning the Console 71 Cleaning and Maintaining the VSmooth Applicat...

Page 6: ... Buttons 36 Figure 22 Parameter Icons and Level Displays 36 Figure 23 System Information Screen About VelaShape III Tab 37 Figure 24 System Information Screen Counters Tab 37 Figure 25 Maintenance Screen 38 Figure 26 Settings Screen Date Time Tab 39 Figure 27 Settings Screen Display Settings Tab 39 Figure 28 Settings Screen Audio Settings Tab 40 Figure 29 User Diagnostics Screen 40 Figure 30 Servi...

Page 7: ...ure 47 Segment A Treatment Illustration 65 Figure 48 Segment B Treatment Illustration 65 Figure 49 Segment C Treatment Illustration 66 Figure 50 Segment D Treatment Illustration 66 Figure 51 Horizontal Snake Like 67 Figure 52 Vertical Snake Like 67 Figure 53 Removing the VSmooth Replaceable Cover 72 Figure 54 VSmooth Applicator s Internal Components 73 Figure 55 Replacing the VSmooth Applicator s ...

Page 8: ...e III system must be serviced only by Syneron Medical Ltd qualified personnel Conventions Used in this Manual The following conventions in the form of notes cautions and warnings are used in this manual Note The content of this Note offers general information that is important to keep in mind Caution A Caution alerts the user to the possibility of a potentially hazardous situation which if not avo...

Page 9: ...44 CE Compliance Symbol Waste of Electrical and Electronic Equipment WEEE compliance symbol RF Interference may occur in the vicinity of equipment with the following symbol Product Shelf Life product may not be stored for longer than this period after being opened for the first time Fuse Type BF Equipment Manufacturer Authorized Representative in the European Union ...

Page 10: ...a result of an application of a product which is not in strict accordance with the instructions provided with the product The primary consideration should be to maximize safety for both treating attendant and the patient Warning Read this chapter to be familiar with all of its safety requirements and operating procedures prior to operating the system Any intense optical energy or RF device can cau...

Page 11: ...the treating attendant and the patient Follow these personal safety guidelines to maintain a high level of personnel safety Make sure that only well trained attendants perform treatment Before activating the system make sure any long hair of the treating attendant or the patient is safely pulled back and tied Ascertain that all jewelry is removed Prior to scheduling treatments obtain a detailed pa...

Page 12: ...al is achieved and the RF electrodes are in full contact with the treated surface Opaque eye protection should be used when working within a 30 cm 12 proximity to the patient s eyes Do not aim the applicator at anything but the intended target area it should always be oriented toward the treatment area and the trigger button or footswitch pressed only when full contact is made with the skin In rar...

Page 13: ...so isolated from the mains power supply In addition the system s plastic covers serve as a means of isolation Move the system slowly and carefully The system weighs approximately 20 kg 44 lbs and may cause injury if proper care is not used when moving it The system is grounded through the grounding conductor in the power cable This protective grounding is essential for safe operation The RF electr...

Page 14: ...xplosive or flammable materials Do not use flammable substances when preparing the skin for treatment If alcohol is used for disinfecting it must be allowed to dry thoroughly before the system is used System Classifications Electric shock protection Class A Group I Protection against ingress of liquids Ordinary equipment Not suitable for use in presence of flammable substances ...

Page 15: ...99EN 15 System Nameplate The following illustration see Figure 1 displays the location of the system s nameplate which includes the system s identification regulatory and electrical requirement information Figure 1 System Nameplate Location ...

Page 16: ...wing technologies Infrared IR optical energy Bipolar conductive radio frequency RF current Mechanical manipulation vacuum with or without massage rollers These three technologies work together to provide dermal and sub dermal heating and mechanical modifications resulting in improved blood circulation enhanced lymphatic drainage as well as an increased metabolic rate of the adipose tissue While th...

Page 17: ...ncludes three core modules the Console Applicator and Touch Screen Control Panel see Figure 2 Figure 2 VelaShape III System Console The VelaShape III console houses the following components Power supply IR LEDs power supply Vacuum pump Main CPU RF generator Tablet Other power components ...

Page 18: ...ece and a replaceable cover The replaceable covers of the VelaShape III applicators are usable for limited periods of time The replaceable cover of the VelaShape III applicator should be replaced according to the schedule printed on the cover s storage box or sooner if one of the following is observed After cleaning the replaceable cover and applicator spring connectors an Improve Vacuum Seal mess...

Page 19: ...a so that all four edges of the aperture make a seal with the skin This allows the vacuum to be effective and ensures that the RF electrodes are fully coupled to the skin Failure to achieve full contact between the RF electrodes and skin or failure to achieve proper vacuum will result in disabled IR and RF energies indicated by an RF out of range message on the system s control panel and applicato...

Page 20: ... resulting in a dimpled skin appearance The VelaShape III Procedure The application of elōs IR and RF energies to the dermis hypodermis is intended to deploy heat to the tissues that contribute to cellulite The vacuum contributes to increased blood circulation see Figure 6 The blood which is one of the targets of the hyperthermic effect of the IR and RF responds in a higher diffusivity of oxygen T...

Page 21: ... accompanied by shrinkage of the connective tissue septa and facilitate the overall shrinkage of the size of the fat chambers thus leading to a reduction in the appearance of cellulite and a reduction in the circumference of the treated area Figure 7 Before Treatment Figure 8 After VelaShape III Treatment Reduction in the Size of the Fat Cells and Fat Chambers ...

Page 22: ...ive RF energy is emitted from the RF electrodes at a frequency of 1 MHz Maximum electrical power of the RF energy is 150 Watts The heat generated by the RF energy reaches the depth of the hypodermis Mechanical Effects of Vacuum on the Skin When all edges of the applicator are in full contact with the skin a seal is made allowing the vacuum pump to apply gentle suction Negative pressure vacuum dila...

Page 23: ...Styrofoam covers and braces in the event that the system will have to be relocated anytime in the future Unpack the system as follows 1 Cut off and remove the plastic straps that encase the cardboard box 2 Lift the cardboard box up and off the packaged components and set it aside Refer to Figure 9 3 Carefully remove the packed accessories box from inside the Styrofoam brace 4 Finish removing all o...

Page 24: ... Report any missing accessories to your Syneron representative 7 Lift the system up and out of the bottom Styrofoam brace and carefully set it on the floor Warning The system weighs 20 kg 44 lbs and should only be lifted by two people Lift correctly and protect your back 8 Finish unpacking the accessories and continue with the installation process ...

Page 25: ...ver VContour large replaceable cover One pair of protective opaque goggles User Manual Quick Reference Guide Filter extractor Cover Packs Four types of cover packs are available VContour Large Cover Pack contains five large covers and appropriate filters VContour Medium Cover Pack contains five medium covers and appropriate filters VContour Small Cover Pack contains five small covers and appropria...

Page 26: ...uld be prepared according to the system dimensions presented in Figure 10 In order to guarantee proper ventilation always keep the sides of the system at least 0 5m 20 from the wall or from other obstructions to air flow After positioning the system lock the brakes on the rear wheels by pressing the pedals on top of each wheel Figure 10 System Dimensions ...

Page 27: ...manner 1 Unpack the umbilical support mast with the five installed harness loops see Figure 11 Ensure that the harness loop s Allen screws are properly seated in their dimples in the mast Figure 11 Umbilical Support Mast 2 Refer to Figure 11 Figure 12 insert the mast into the hole in the rear handle until it stops Figure 12 Mast and Umbilical Cable Installation ...

Page 28: ...mproper connection Figure 13 Umbilical Connection Port 4 Refer to Figure 12 hook the umbilical cable into the harness loops leaving enough clearance to open the rear compartment door as shown 5 Unpack an applicator and connect it to the umbilical cable It has the same kind of connection port as the one in the console s service panel see Figure 13 6 Hang the applicator in the cradle as shown in Fig...

Page 29: ...t to the footswitch connection port on the system s service panel 2 The connector and connection port are polarized to prevent improper connection Note If the system has been removed from cold storage allow it time to warm up to room temperature 15 30 C 59 86 F before first activation Figure 15 Service Panel Service Panel Connections 1 USB communications port used only by Syneron service engineers...

Page 30: ...g the system s panels and strap the system to the wall 5 Upon arrival at the new facility position the system in its new location using the system handle 6 Reconnect the applicator footswitch and the power cable Caution Do not lay the system on its back or sides Doing so may damage the vacuum pump Electrical Requirements The system incorporates a universal power supply module that allows it to be ...

Page 31: ...ized Syneron technicians are qualified to service the system Environmental Requirements Corrosive materials can damage electronic parts therefore the system should operate in a non corrosive atmosphere Metallic dust can damage electrical equipment Dust particles absorb light and heat up Hot particles located on the aperture guide can damage it therefore dust particles should be kept to a minimum F...

Page 32: ...switch on the service panel to the On position the system initiates an automatic vacuum and RF test When this test is completed the system is ready for operation Automatic Vacuum and RF Test The VelaShape III is equipped with an automatic vacuum and RF self test routine The test is performed after the applicator is connected During the test the VelaShape III system is tested for radiofrequency and...

Page 33: ...easured by the applicator s temperature sensor in degrees Celsius 2 Target Skin Temperature this is the target temperature of the skin in degrees Celsius set by the operator using the slide control 3 Slide Control this control sets the target temperature of the skin Use your finger to slide the control up or down to achieve the desired target temperature 40 45 C 4 RF On Off Indicator RF is On when...

Page 34: ...ty levels 0 1 2 or 3 2 RF Level using your finger to tap on the RF Radio Frequency button in order to toggle between these intensity levels 0 1 2 or 3 3 VAC Level using your finger to tap on the VAC Vacuum button in order to toggle between these intensity levels 0 1 2 or 3 The large electrode cover has four vacuum intensity levels 4 End Treatment press this button to end the patient s session rese...

Page 35: ...ion main On Off switch the system starts the automatic vacuum and RF self test routine When complete the display on the connected applicator initializes while displaying an icon of the connected type of cover for several seconds Press the central OK button see Figure 21 to toggle between views of the current temperature sensor see Figure 19 the parameter setting icons see Figure 22 and information...

Page 36: ... T reading on left side current temperature reading reading on right side is only for use of Syneron technical personnel Refer to Figure 21 press the or buttons to toggle between the parameter icons IR RF or VAC Press the or button to select the desired intensity level for that parameter You may now proceed with the treatment procedure Figure 22 Parameter Icons and Level Displays Note The applicat...

Page 37: ...basic console information including hardware serial numbers and version numbers of the various software packages Press the Back button to return to the Main Treatment screen Figure 23 System Information Screen About VelaShape III Tab Counters Tab press this tab to display a screen that displays information concerning the disposable cover connected to the applicator see Figure 24 allowable time lim...

Page 38: ...n this screen Update Software and GUI Update From Network deal with upgrading the software packages on the system Consult with your Syneron service representative before doing anything in this screen Press the Back button to return to the Main Treatment screen Figure 25 Maintenance Screen ...

Page 39: ... date and time into the VelaShape III system Press the Back button to return to the Main Treatment screen Figure 26 Settings Screen Date Time Tab Display Settings Tab see Figure 27 use the touch control tools in this screen to adjust the LCD display brightness Press the Back button to return to the Main Treatment screen Figure 27 Settings Screen Display Settings Tab ...

Page 40: ...ton to return to the Main Treatment screen Figure 28 Settings Screen Audio Settings Tab User Diagnostics Screen This screen see Figure 29 is used to assist your Syneron service representative with system troubleshooting Consult with the service representative before doing anything in this screen Press the Back button to return to the Main Treatment screen Figure 29 User Diagnostics Screen ...

Page 41: ...ly to Syneron qualified service personnel Press the Back button to return to the Main Treatment screen Warning Operating controls and changing parameters inside this area of the software by people who are not trained for this purpose can cause the VelaShape III system to operate outside of its therapeutic envelope can possibly cause injury to patients and damage the system Figure 30 Service Mode S...

Page 42: ...one for viewing as follows Press the Video List tab two selection buttons appear see Figure 31 Figure 31 Video List Selection Tab Maintenance Videos pressing this button will display a list of videos that will assist you in performing various maintenance procedures on the VelaShape III system i e Upgrade VelaShape III Software see Figure 32 Figure 32 Maintenance Videos example ...

Page 43: ...ou have prepared the system and defined your treatment settings you are ready to begin treatment Apply the applicator with moderate pressure to the first treatment section and press the trigger on the applicator handle or the footswitch To stop the treatment release the trigger or the footswitch If desired you may pull up the Options tab to keep the parameter setting icons in view while you are pe...

Page 44: ...he treatment regimen Some patients respond better than others The treatment results are temporary and one maintenance treatment session every 2 3 months is essential to sustain them A healthy lifestyle diet and exercise may help to obtain better results but is not essential However weight gain may have a negative effect on the results Indications USA The VelaShape III system is indicated for tempo...

Page 45: ...abnormal wound healing as well as very dry and fragile skin History of bleeding coagulopathies or use of anticoagulants Use of medications herbs food supplements vitamins known to induce photosensitivity to light exposure at the wavelengths used such as Isotretinoin Accutane within the last 6 months tetracyclines or St John s Wort within the last 2 weeks Any surgical procedure in the treatment are...

Page 46: ...0 Possible Side Effects Certain side effects may be experienced during treatment or shortly afterwards usually as a result of improper use of the system Although these side effects are rare and temporary they should be reported immediately to a physician for proper treatment These are the side effects that may appear in the treatment area Pain Excessive skin redness erythema Hair pulling by mechan...

Page 47: ...low marker as cellulite or contour may change characteristics when the patient is lying down Make sure that all the applicators parts are clean and intact Make sure that the RF electrodes are clean and intact not chipped When using the VSmooth applicator verify that the rollers function smoothly Make sure that the cover filters are clean and correctly inserted replace them if not Ensure that the r...

Page 48: ... VSmooth Three bi weekly sessions 5 Localized Fatty Deposits plus Cellulite Abdomen Thighs Buttocks VContour followed by VSmooth Large followed by VSmooth Three bi weekly sessions VelaShape III Measurement In order to establish a baseline for the VelaShape III treatment and follow up on the results it is advised to weigh the patient photograph assess the cellulite degree and measure the circumfere...

Page 49: ...ration of Circumference Measurements A Fixed Distance between the Legs B Labeling the circumference C Measuring Horizontally D Labeling the Arm Against a Wall 4 During the entire measurement procedure the distance between the patient s feet must remain constant 5 At least four marks should be made with a white make up pencil on each measured area usually front back and both sides while the patient...

Page 50: ...ling is seen on the skin when the patient is standing but undulations bumps and lumps on the skin surface can be seen on pinching the skin or during muscle contraction see Figure 35 B 3 Stage Two the orange peel or mattress dimpling appearance is evident when standing without the use of any manipulation skin pinching or glutens muscle contraction see Figure 35 C 4 Stage Three presence of alteratio...

Page 51: ...excluding treatment where the vacuum is turned off and energy will be delivered into the skin If you hear air being suctioned into the applicator chamber this indicates that the applicator is not positioned properly on the skin If adequate coupling between the RF electrodes and the skin is not achieved the RF and IR will be disabled and an Improve Vacuum Seal message will appear on the screen You ...

Page 52: ...and Cover Treatment Using the VContour Applicator Treatment can performed with two different protocol modes Circumference Mode Deep Mode The Circumference Mode treatment protocol for circumference reduction supports two types of covers When treating larger treated areas such as abdomen arms thighs use the Medium Cover as a standalone When treating smaller treated areas such as submental use the Sm...

Page 53: ... Cover define the size of the targeted sub area large medium or small and divide it into segments Large size sub area 25 x 20 cm will be divided into 20 segments Medium size sub area 15 x 20cm will be divided into 12 segments Small size sub area 10 x 20 cm will be divided into 8 segments Each segment of the sub area is the size of the Medium Cover 5 x 5cm Figure 36 Sub Area Divided into Segments F...

Page 54: ...for increased depth Do not increase 1 for loose skin areas RF 3 Maintain RF Level at 3 whenever possible to achieve an optimized result Cycle 1 Treat each segment from A1 to A20 in the Horizontal Snake Like treatment technique see Figure 38 with five consecutive stacking pulses then four consecutive pulses then three consecutive pulses and then two consecutive pulses Continue treating each sub are...

Page 55: ...ure reaches 43 45 C or the patient cannot tolerate further heat Cycle 4 Optional If the total time duration of Cycles 1 2 and 3 is less than 15 minutes continue with the Vertical Snake Like treatment technique see Figure 39 and apply one pulse per sub area until the 15 minute treatment duration for all four cycles is reached Note When coupler agent is added over the treatment area continue treatme...

Page 56: ...and divide it into segments The appropriate size of the targeted sub area 2 x 24 cm contains two 2 sets of eight 8 segments 1 x 3 cm Figure 40 Sub Area Divided into Segments Treatment Parametersd Applicator Cover Parameter Level VContour Applicator Small Cover Vacuum 1 RF 1 2 Start at level 1 if enabled increase the RF to level 2 during the subsequent treatments Cycle 1 Start with a sub area set i...

Page 57: ...ub area 2 x 24cm set includes 16 segments that should be treated in two cycles Each subject will be treated with three bi weekly treatments Treatment Protocol Using Deep Mode Treatment Protocol of Focal Fat Deposits Using Deep Mode Large and Medium Covers Zone Segmentation Select the appropriate zone for treatment of focal fat deposits using the Deep mode protocol combining the Large Cover followe...

Page 58: ...t of Focal Fat Deposit The Deep Mode treatment protocol includes two cycles performed with the VContour applicator and the Large Cover without vacuum manipulation in cycle 1 while in cycle 2 the applicator is used with the Medium Cover and vacuum manipulation In order to achieve good clinical results it is recommended to reach 43 45 C on the skin surface maintaining it for at least 5 minutes in ea...

Page 59: ...laSpray Ease lotion at minimum intervals of one minute in each step of each cycle 2 Use the Quick Technique mannerg when stacking one pulse 3 Only after trying both options 1 2 above and the patient still feels uncomfortable reduce the RF level to 2 e Maintain RF Level at 3 whenever possible to achieve an optimized result f Option to increase vacuum from 1 2 3 based on patient tolerance in areas w...

Page 60: ... then three consecutive stacking pulses and then two consecutive stacking pulses Continue treating each segment of the sub area from 1 to 9 with two stacking pulses in the Horizontal Snake Like manner until the treated area reaches two full minutes of treatment After two full minutes of treatments continue treating each segment of the sub area from 1 to 9 with one pulse in the Horizontal Snake Lik...

Page 61: ... minutes of treatment Figure 45 Cycle 1 Step 2 Vertical Snake Like Cycle 1 Step 3 RF level should be maintained at level 3 Apply a thin layer of VelaSpray Ease lotion on the sub area Treat each segment of the sub area from 1 to 9 stacking two 2 pulses in the Horizontal Snake Like manner Continue treat each segment of the sub area from 1 to 9 stacking one pulse in the Horizontal Snake Like manner u...

Page 62: ...level 3 Apply a thin layer of VelaSpray Ease lotion on the sub area Treat each segment of the sub area from 1 to 9 stacking two 2 pulses in the Vertical Snake Like manner Continue treat each segment of the sub area from 1 to 9 stacking one pulse in the Vertical Snake Like manner until the treated area reaches five full minutes of treatment Cycle 2 Step 3 RF level should be maintained at level 3 Ap...

Page 63: ...ment of cellulite and skin laxity first define the area to be treated in Cycle 1 according to Deep Mode Zone Segmentation For Cycle 2 define the size of the targeted sub area as approximately 20 x 25cm each sub area will be divided into four elliptical overlapping segments as shown in Figure 46 Figure 46 Cellulite Mode Protocol Sub Area Segmentation Figure 46 above demonstrates single sub areas se...

Page 64: ... areas Right Left Treatment Parameters Applicator Cover Step Parameter Level Note VSmooth Large Electrode All Steps Step 1 to Step 6 RF 3 Maintain RF Level at 3 whenever possible to achieve optimized results IR 1 3 Start at 1 Start with IR level 1and increase according to patient s tolerance from 1 2 3 Vacuum 1 3 Start at 1 May increase if needed for increased depth Do not increase 1 for loose ski...

Page 65: ...n a gliding technique until the skin surface at the treated segment reaches 43 45 C or the patient cannot tolerate the heat Step 2 Maintain the RF at level 3 IR level at 1 and Vacuum level at 1 on the touch screen or on the applicator Apply a thin layer of VelaSpray Ease lotion on the sub area Treat segment B in a circular horizontal Clock Wise manner see Figure 48 in a gliding technique until the...

Page 66: ...face at the treated segment reaches 43 45 C or the patient cannot tolerate the heat Step 4 Maintain the RF at level 3 IR level at 1 and Vacuum level at 1 on the touch screen or on the applicator Apply a thin layer of VelaSpray Ease lotion on the sub area Treat segment D in a circular horizontal Clock Wise manner see Figure 50 in a gliding technique until the skin surface at the treated segment rea...

Page 67: ... level at 1 and Vacuum level at 1 on the touch screen or on the applicator Apply a thin layer of VelaSpray Ease lotion on the sub area Treat all treated sub area in the Vertical Snake Like manner see Figure 52 in a gliding technique until the skin surface at the treated segment reaches 43 45 C or the patient cannot tolerate the heat Treatment Time In order to achieve good clinical results it is re...

Page 68: ...de Thighs Three 3 sub areas Anterior lateral Anterior inner Posterior 15 minutes per sub area with Circumference Mode 10 minutes per sub area with Cellulite Mode Abdomen Normal Size one 1 sub area 15 minutes with Circumference Mode 15 minutes with Cellulite Mode Large Size divide abdomen into half two 2 sub areas 15 minutes per sub area with Circumference Mode 15 minutes per sub area with Cellulit...

Page 69: ... treatment and apply cooling Caution Release the trigger or footswitch before you lift the applicator from the skin Note Compliance with the treatment protocol is essential to achieving the desired results Always maintain complete contact between the applicator chamber and the skin For small zones such as the navel area treat twice but with less stacks until the endpoint is reached and ensure a 5 ...

Page 70: ...t treatment overheating e g Jacuzzi sauna etc or risk of physical damage Treatment Conclusion Treatment should be concluded when the results are satisfactory to the patient or according to the operator s discretion Improvement will take some time to be apparent and is affected by clinical conditions at the start of the treatment regimen Main impacts may be Transient skin texture that may show impr...

Page 71: ... when required Note Each patient should be assigned with his her own set of covers in order to provide safe and hygienic treatments This also allows the patient to keep track of the number of treatment hours administered Warning The symbol located near the power cable s connection port indicates WARNING DISCONNECT POWER SUPPLY CABLE BEFORE MAINTENANCE OR SERVICE PROCEDURES TO AVOID ELECTRIC SHOCK ...

Page 72: ...rom getting into the applicator s filters The replaceable cover of the VSmooth applicator should be replaced according to the schedule printed on the new cover s box label or sooner if one of the following is observed Rollers appear damaged discolored or their movement is impaired Roller axis appears to wear out color turns from silver to copper Proceed as follows 1 Turn the system off and disconn...

Page 73: ...ntain alcohol until all residual VelaSpray Ease is removed Wipe and dry the cover with a soft cloth Reconnect the cover only when completely dry 3 Clean the VSmooth applicator s interior components at the end of every day as follows see Figure 54 Replace the two filters see Figure 55 according to the schedule printed on the cover s box Never use a pair of filters for more than 10 accumulative hour...

Page 74: ...r to Figure 55 1 Use the supplied filter extractor to pull the two filters out of the body of the applicator as shown in view A Discard the used filters 2 Unpack a pair of new filters and firmly insert them into the filter chambers as shown in view B Figure 55 Replacing the VSmooth Applicator s Filters Caution Make sure that the interior of the applicator is completely dry before inserting the fil...

Page 75: ... and a mild disinfectant alcohol free soap until all residual VelaSpray Ease is removed Wipe and dry the cover with a soft cloth and store it in the patient s kit Re use the cover only when completely dry 4 Allow the cover to dry overnight with the RF electrodes facing up 5 There are two filters per cover one inserted and one spare after each treatment the filter should be removed the spare filter...

Page 76: ...ve the filter from the cover if it becomes necessary to clean or replace it 1 Use the supplied filter extractor to pull the filter out of the cover as shown in Figure 57 2 Wash the filter and allow it to dry completely before reusing it 3 Firmly insert the clean filter into the filter chamber Figure 57 Replacing the VelaShape III Applicator s Filter Note The image in the figure is for illustration...

Page 77: ...lity cabinet to access the filter assembly 3 Release Screw 1 on the bottom of the filter cup to open the cup and wipe off the dust and debris 4 Release Screw 2 to remove the filter wash it with water and soap and set it aside to dry 5 When the filter is completely dry fit it back into place or put a new filter and secure the filter cup using the screws 6 The same filter may be re used after washin...

Page 78: ...ive Table 4 offers a list of possible system errors that will be displayed on the control panel s display and how to correct them If the corrective actions listed in the table do not solve the problem contact your Syneron representative Table 5 offers several fault situations that may occur with no operator panel indication or control panel display and their appropriate corrective actions If these...

Page 79: ...ver and patient skin Make sure there is an adequate amount of gel Make sure the applicator is placed on the skin appropriately No applicator No Tip System freezes no RF or IR pulses emitted to the patient s skin even if footswitch trigger is pressed Let go of footswitch trigger and make sure that the applicator and tip are well connected and sealed Let go of footswitch trigger and wait 10 minutes ...

Page 80: ...ilter cover is properly fastened the cover s sealing O ring should be properly installed 3 Check the applicator connection to the umbilical cable and the umbilical cable s connection to the system 4 Verify that the cover is correctly attached to the applicator 5 Replace applicator filters or cover No IR output 1 Turn the system off 2 Call your Syneron representative for further instructions ...

Page 81: ...um Cover Up to 50 W average per duty cycle RF Power Large Cover Up to 75 W average per duty cycle VSmooth Applicator IR Electrical Power Up to 3 2 W RF Power Up to 75 W average per duty cycle Treatment Area Footprints VContour Applicator Large Cover 25 mm x 50 mm Medium Cover 25 mm x 30 mm Small Cover 10 mm x 13 mm VSmooth Applicator Cover with Rollers 40 mm x 40 mm Control Panel Tablet computer w...

Page 82: ...rage Transportation Temperature 10 55 C 50 131 F Relative humidity 10 80 Air pressure range 70 106 kPa Degree of Protection Against Ingress of Water IPX0 Ordinary Equipment System Console Dimensions W x D x H 38 x 49 x 132 cm 15 x 19 x 51 8 inches Weight VelaShape III system 20 kg 44 1 lbs VContour Applicator 0 4 kg 0 9 lbs VSmooth Applicator 1 0 kg 2 2 lbs ...

Page 83: ...t Compliance CISPR 11 RF Emissions Class A IEC 61000 3 2 Harmonic Emissions N A IEC 61000 3 3 Voltage fluctuations flicker emissions N A The VelaShape III system is suitable for use in all establishments other than domestic and may be used in domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provid...

Page 84: ...UT 95 dip in UT for 0 5 cycle 40 UT 60 dip in UT for 5 cycles 40 UT 60 dip in UT for 5 cycles 70 UT 30 dip in UT for 25 cycles 70 UT 30 dip in UT for 25 cycles 5 UT 95 dip in UT for 5 cycles 5 UT 95 dip in UT for 5 cycles Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Mains power quality should be that of a t...

Page 85: ...ation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17 SQRT P 1 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 en...

Page 86: ...ded below according to the maximum output power of the communications equipment For transmitters rated at a maximum output power not listed below the recommended separation distance d in meters M can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter s manufacturer Rate...

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