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Related Manuals for Syneron Candela VelaShape III
Summary of Contents for Syneron Candela VelaShape III
- Page 1 System User Manual PB81499EN...
- Page 3 Copyright © 2015 Syneron Medical Ltd. All rights reserved. Syneron Medical Ltd. reserves the right to make changes to its products or specifications to improve performance, reliability, or manufacturability. Information furnished by Syneron Medical Ltd. is believed to be accurate and reliable.
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Page 4: Table Of Contents
Table of Contents ABLE OF 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 ...................... - Page 5 VelaShape III User Manual Table of Contents Video List Screen .......................... 42 Initiating Treatment ..........................43 6. Clinical Guide: Cellulite and Circumference Treatment ................. 44 Realistic Expectations ........................44 Indications ............................44 Contraindications ..........................44 Possible Side Effects ......................... 46 Pre-Treatment Preparation ........................
- Page 6 Table of Contents Recommended Separation Distances ....................86 IST OF IGURES Figure 1: System Nameplate Location ....................... 15 Figure 2: VelaShape III System ......................... 17 Figure 3: VContour Applicator [Left: Operator Panel / Right: Applicator Elements]........18 Figure 4: VSmooth Applicator Elements ....................19 Figure 5: Anatomy of Cellulite ........................
- Page 7 VelaShape III User Manual Table of Contents Figure 42: Deep Mode protocol Segmentation ..................57 Figure 43: Flanks (A) and Middle Back (B) Segmentation for the Treatment of Focal Fat Deposit ..58 Figure 44: Cycle 1-Step #1 “Horizontal Snake-Like” ................. 60 Figure 45: Cycle 1 –...
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Page 8: Before You Start
● The VelaShape 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... -
Page 9: Explanation Of The Symbols Used In The System
VelaShape III User Manual Before You Start Explanation of the Symbols Used in the System Symbol Description Refer to instruction manual/booklet Caution! CE Compliance Symbol 0344 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... -
Page 10: Safety
Syneron Medical Ltd. assumes no liability whatsoever for any damage or injury as a result of an application of a product which is not in strict accordance with the instructions provided with the product. -
Page 11: System Safety Features
VelaShape III User Manual Safety System Safety Features The VelaShape III system incorporates the following safety features: ● The power electronics cannot be activated unless an applicator has been connected to the system. ● Upon system activation, IR, RF, and Vacuum are at Level on the control panel. -
Page 12: Grounding The System
Safety Grounding the System When installing the system, ensure that the system is grounded through the grounding conductor in the power cable. This protective grounding is essential for safe operation. Operating the System ● Keep all system panels closed. Do not remove the panels and do not touch any of the system's inner components. -
Page 13: Mechanical Rollers Safety Issues (Vsmooth Applicator)
Syneron Medical. Maintaining the System ● Only authorized Syneron technicians are qualified to service the system. ● Shut down the system and disconnect the power cable before performing any maintenance procedures (see Chapter 7). -
Page 14: Fire Hazards
Safety Fire Hazards ● The absorption of optical energy or conduction of RF raises the temperature of the absorbing material. Do not use the system in the presence of explosive or flammable materials. ● Do not use flammable substances when preparing the skin for treatment. ●... -
Page 15: System Nameplate
VelaShape III User Manual Safety 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 PB81499EN... -
Page 16: System Description
System Description 3. S YSTEM ESCRIPTION elōs The VelaShape III is a device that combines technology (electro optical synergy) with mechanical manipulation of the skin using gentle vacuum suction. The system is designed for use in medical and aesthetic practices, to be user- friendly, safe and reliable. -
Page 17: System Overview
VelaShape III User Manual System Description System Overview The system includes 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 ●... -
Page 18: Applicators
System Description Applicators The VSmooth and VContour applicators are used for the physical implementation of the RF current, IR energy and mechanical manipulation treatment parameters. The VContour applicator (see Figure 3) utilizes RF and mechanical manipulation by vacuum. It is used for circumference reduction and focal fat deposit treatment in different body areas such as: abdomen, flanks, thigh, arms, middle-back, submental, etc. -
Page 19: Figure 4: Vsmooth Applicator Elements
VelaShape III User Manual System Description Figure 4: VSmooth Applicator Elements Note The images in the figures are for illustration purposes only. The applicator is applied to the treatment area 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. -
Page 20: Anatomy Of Cellulite
System Description Anatomy of Cellulite Cellulite is characterized by Dimpled Skin Surface – mattress- like appearance (see Figure 5). The fat cells are located in chambers which are separated by vertical and horizontal Connective Tissue are anchored Septae. Septae rigid fibers that do not stretch with the skin as the volume within the walls of the chamber increases. -
Page 21: Figure 7: Before Treatment
VelaShape III User Manual System Description Both actions, reducing the size of the fat cells and draining excess fluids to the lymphatic system, are 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. -
Page 22: Heating Of Dermis And Hypodermis With Elōs
System Description Heating of Dermis and Hypodermis with elōs Light Energy (see Figure 6): ● IR light at wavelength of 850 nm and maximum power of 3.3 Watts. ● Maximum electrical power of the IR light is 9 Watts (9 J/sec). ●... -
Page 23: System Installation
Unpacking the System After unpacking the system, Syneron recommends that you retain the shipping box and the internal Styrofoam covers and braces in the event that the system will have to be relocated anytime in the future. - Page 24 6. Compare the accessories you unpack to the equipment list (next section) to ensure that all accessories are present. 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.
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Page 25: Equipment List
VelaShape III User Manual System Installation Equipment List The VelaShape III system is delivered with the following: ● VelaShape III system console. ● Umbilical cable mast. ● Accessories kit, including: VSmooth Applicator (includes one replaceable cover). VContour Applicator (includes one medium-size replaceable cover). ... -
Page 26: System Dimensions
System Installation System Dimensions Space should be allocated with adequate ventilation and free airflow. The working area for the system should 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. -
Page 27: Installation Process
VelaShape III User Manual System Installation Installation Process After unpacking the VelaShape III system, install the applicator in the following 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. -
Page 28: Figure 13: Umbilical Connection Port
System Installation 3. Refer Figure 13: insert the applicator's umbilical connector into the applicator's connection port, and press it in until it 'clicks' into place. The connector and connection port are polarized to prevent improper connection. Figure 13: Umbilical Connection Port 4. -
Page 29: Figure 15: Service Panel
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). 2. Footswitch connection port. 3. Umbilical connection port. 4. Main On/Off switch. -
Page 30: Moving The System Within The Facility
System Installation Moving the System within the Facility 1. Turn the system off and disconnect the power cable. 2. Disconnect the applicator and place it in a safe location. 3. Release the wheel brakes at the base of the system. 4. -
Page 31: Environmental Requirements
VelaShape III User Manual System Installation It is recommended that the system be connected to a separate power line with separate circuit breakers. Syneron cannot guarantee performance unless the system is connected to a dedicated circuit. Warning ● For continued protection against fire, replace the fuses only with those of the same type and rating. -
Page 32: Operating Instructions
Operating Instructions 5. O PERATING NSTRUCTIONS This chapter will assist you to operate the system for the first time, and will guide you through the initial setup procedures needed to perform in order to start operating the system. Activating the System 1. -
Page 33: Setting Treatment Parameters - Tablet Control Panel
VelaShape III User Manual Operating Instructions Setting Treatment Parameters – Tablet Control Panel After activation (main On/Off switch), the system starts the automatic vacuum and RF self-test routine while displaying a startup animation. When complete, the Main Menu screen will be displayed (see Figure 16). Figure 16: Main Menu Screen The numbered tags in Figure 16 correlate to the following numbered explanations and definitions of the screens elements. -
Page 34: Figure 17: Treatment Settings Ribbon
End Treatment – press this button to end the patient's session, reset the clocks and be ready for the next patient. – for use only by Syneron-trained system engineers, or under direct Utilities instructions from the Syneron Service Center. PB81499EN... -
Page 35: Default Settings
VelaShape III User Manual Operating Instructions Default Settings The intensity level of each parameter setting is displayed in the following illustrations: Figure 18: Default Settings Setting Treatment Parameters – Applicator Control Panel After activation (main On/Off switch), the system starts the automatic vacuum and RF self-test routine. -
Page 36: Figure 20: Applicator Control Panel Display
● (reading on left side) current temperature reading (reading on right side is only for use of Syneron technical personnel). Figure 20: Applicator Control Panel Display Refer to Figure 21: press the ► or ◄ buttons to toggle between the parameter icons ( Press the ▲... -
Page 37: Utilities Mode
VelaShape III User Manual Operating Instructions Utilities Mode Utilities mode is accessible by pressing the Utilities button on the Treatment Settings ribbon (see arrow # 5 in Figure 17). System Information Screen ● Pressing the button displays the screen in the Utilities System Information tab (see Figure 23). -
Page 38: Maintenance Screen
Update Software , deal with upgrading the software packages on the Update From Network system. Consult with your Syneron service representative before doing anything in this screen. Press the Back button to return to the Main Treatment screen. -
Page 39: Settings Screen
VelaShape III User Manual Operating Instructions Settings Screen ● (see Figure 26) use the touch-control tools in this screen to Date & Time Tab set the current date and time into the VelaShape III system. Press the Back button to return to the Main Treatment screen. -
Page 40: User Diagnostics Screen
Main Treatment 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... -
Page 41: Service Mode Screen
VelaShape III User Manual Operating Instructions Service Mode Screen This screen is designed for use ONLY by Syneron-qualified service personnel. It is password protected and is accessible only to Syneron-qualified service personnel. Press the Back button to return to the Main Treatment screen. -
Page 42: Video List Screen
Operating Instructions Video List Screen Two categories of video clips are available in the system's software for viewing by clinic staff and/or patients. Select any one for viewing as follows: ● Press the Video List tab; two selection buttons appear (see Figure 31): Figure 31: Video List Selection Tab ●... -
Page 43: Initiating Treatment
VelaShape III User Manual Operating Instructions ● (see Figure 33) pressing this button will Practice Enhancement Videos display a list of videos that will assist you in performing selected sections of the clinical procedure, or explanatory videos presenting the system and its capabilities. -
Page 44: Clinical Guide: Cellulite And Circumference Treatment
Cellulite and Circumference Treatment 6. C LINICAL UIDE ELLULITE AND IRCUMFERENCE REATMENT This chapter provides you with the information required to treat cellulite and circumferences with the VelaShape III system. The entire treatment protocol is to the cleared indication, and unless otherwise specified, for each application specific procedure should be applied. - Page 45 VelaShape III User Manual Cellulite and Circumference Treatment ● Severe concurrent conditions, such as cardiac disorders. ● Pregnancy and nursing as well as 4-5 months post- natural delivery, or at least 6 months post-cesarean section, or until normal hormonal balance is regained. ●...
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Page 46: Possible Side Effects
Cellulite and Circumference Treatment Note ● In case of uncertainty regarding applicability or potential side effects, have the patient consult his/her physician and bring a written consent for treatment. ● Always test a small area with the selected parameters, and wait several minutes to detect results of the tested area before proceeding with the whole area treatment. -
Page 47: Selecting The Appropriate Treatment Type
VelaShape III User Manual Cellulite and Circumference Treatment ● Advise the patient to exfoliate the skin with appropriate creams before treatment. The patient should come to the treatment with clean, dry skin (no perfume, no lotion). ● Hair may impair the movement of the applicator and/or overheat the treatment area. -
Page 48: Velashape Iii Measurement
Cellulite and Circumference Treatment ● The VContour applicator is used for circumference reduction and focal fat deposit treatment in different body areas such as: abdomen, flanks, thigh, arms, middle-back, submental, etc. The applicator has three types of covers: Large, Medium and Small. ●... -
Page 49: Circumference
VelaShape III User Manual Cellulite and Circumference Treatment Circumference The suggested circumference measurement method is: 1. The patient should stand in an upright position adjacent to a wall, barefoot and with both legs attached or at a fixed distance (see Figure 34 [A]). 2. -
Page 50: Cellulite
Cellulite and Circumference Treatment Cellulite The suggested cellulite classification method is according to the Nurnberger- Muller Scale that classifies cellulite into four categories using the pinch test. By gently pinching a few inches of skin between your thumb and forefinger, in the area intended for treatment, we can distinguish four (4) stages of cellulite appearance (Hexsel et al.): 1. -
Page 51: Treatment Procedure
VelaShape III User Manual Cellulite and Circumference Treatment Treatment Procedure ● Always inspect the applicator for cleanliness and integrity. Make sure that there are no cracks or other damage to any of the applicator's components. ● Select the parameters as suggested in the Treatment Parameters section of each treatment procedure. -
Page 52: Applicator Positioning
Cellulite and Circumference Treatment Note The most accurate skin temperature is read directly underneath the IR thermometer aperture. Applicator Positioning Position the applicator perpendicular to the skin and apply light but sufficient pressure to ensure good contact. Test Spot Before starting treatment, test a small area with the selected parameters and wait several minutes to observe the results. -
Page 53: Treatment Protocol Using The Circumference Mode
VelaShape III User Manual Cellulite and Circumference Treatment Treatment Protocol Using the Circumference Mode Treatment Protocol of Large Areas Using Circumference Mode (Medium Cover) Zone Segmentation Select the appropriate zone for treatment of circumference reduction using the Medium Cover; define the size of the targeted sub-area, large, medium or small, and divide it into segments: ●... - Page 54 Cellulite and Circumference Treatment Note If the patient has a high BMI, additional sub-areas will be added and treated according to the same treatment protocol. Each sub-area will be treated individually in the same session. Treatment Parameters Applicator Cover Parameter Level Notes May increase if needed for...
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Page 55: Figure 39: Cycle 2 "Vertical Snake-Like
VelaShape III User Manual Cellulite and Circumference Treatment Cycle # 2: In this cycle, the same sub-area set (A1-A20) will be started and treated with two consecutive stacked pulses using the “Vertical Snake-Like” treatment technique (see Figure 39) until the surface temperature reaches 43-45°C or the patient cannot tolerate further heat. -
Page 56: Treatment Protocol Of Small Areas Using Circumference Mode (Small Cover)
Cellulite and Circumference Treatment For the medium and small size sub-areas set (including segments A1-A12 and A1-A8 respectively) treatment protocol is similar, and will be performed with the same three consecutive cycles. Treatment Time The large size sub-area (25 x 20 cm) set includes 20 segments (A1-A20), the medium size sub-area (15 x 20 cm) set includes 12 segments (A1-A12) and the small size sub-area (10 x 20 cm) set includes 8 segments (A1-A8). -
Page 57: Treatment Protocol Using Deep Mode
VelaShape III User Manual Cellulite and Circumference Treatment Cycle #2: A second cycle of same sets of sub-areas should be re-treated in the same manner (sub-area set A1 to A8, then sub-area set B1 to B8) with 2 stacking pulse until the surface temperature reaches 43-45°C, or the patient cannot tolerate further heat. -
Page 58: Figure 43: Flanks (A) And Middle Back (B) Segmentation For The Treatment Of Focal Fat Deposit
Cellulite and Circumference Treatment In some cases, large areas can contain the 15cm x 15cm sub-area more than once. In this case each sub-area will be treated according to the treatment protocol. Figure 43: Flanks (A) and Middle Back (B) Segmentation for the Treatment 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... -
Page 59: Figure 38: Cycle
VelaShape III User Manual Cellulite and Circumference Treatment Treatment Parameters Applicator Cover Cycle Step Parameter Level Vacuum Step #1 Vacuum Large Cycle #1 Step #2 3 / 2 Vacuum Step #3 3 / 2 VContour Vacuum 1 – 3 Step #1 3 / 2 Vacuum 1 –... -
Page 60: Figure 44: Cycle 1-Step #1 "Horizontal Snake-Like
Cellulite and Circumference Treatment Cycle #1 – Step #1: ● Attach the Large Cover to the VContour applicator. ● Set the RF level to 3. ● Apply a thin layer of VelaSpray Ease lotion on the sub-area. ● Treat each segment from 1 to 9 in the “Horizontal Snake-Like”... - Page 61 VelaShape III User Manual Cellulite and Circumference Treatment Cycle #1 – Step #2 ● 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 “Vertical Snake-Like”...
- Page 62 Cellulite and Circumference Treatment ● Treat each segment from 1 to 9 in the “ ” manner Horizontal Snake-Like with four consecutive stacking pulses, then three consecutive stacking pulses and then two consecutive stacking pulses. Continue treating each segment of the sub-area (from 1 to 9) stacking two pulses in the “...
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Page 63: Cellulite Mode Treatment Protocol Using The Vsmooth Applicator
VelaShape III User Manual Cellulite and Circumference Treatment Cellulite Mode Treatment Protocol Using the VSmooth Applicator Cellulite mode is the treatment protocol of choice for cellulite and skin laxity. It is supported by the elōs technology, combining RF and IR energy with mechanical manipulation via vacuum and massage. - Page 64 Cellulite and Circumference Treatment ● Example # 1: Thighs area can be divided up into three sub-areas: Anterior lateral Anterior inner Posterior ● Example # 2: Anterior abdomen area can be divided up into two sub-areas: Right ...
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Page 65: Figure 47: Segment A Treatment Illustration
VelaShape III User Manual Cellulite and Circumference Treatment Step #1: ● Attach the Large electrode cover to the VSmooth applicator. ● Set the RF level on 3; IR level on 1; and Vacuum level on 1 on the touch screen or on the applicator. -
Page 66: Figure 49: Segment C Treatment Illustration
Cellulite and Circumference Treatment Step #3: ● 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. ●... -
Page 67: Figure 51: Horizontal Snake-Like
VelaShape III User Manual Cellulite and Circumference Treatment Step #5: ● 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. -
Page 68: Treatment Options With Cellulite Mode
Cellulite and Circumference Treatment Treatment Options with Cellulite Mode The Cellulite Mode treatment protocol can be used as: ● Standalone for the treatment of cellulite and skin laxity. ● Combined treatment with Circumference Mode for circumference reduction in addition to the treatment of cellulite and skin laxity. ●... -
Page 69: Endpoints (When To Stop Treating An Area)
VelaShape III User Manual Cellulite and Circumference Treatment Endpoints (When to Stop Treating an Area) ● Use the radiant thermometer to measure the temperature on the skin surface, skin temperature should be 43-45°C. ● If the patient feels an intolerable heat sensation before reaching 43-45°C, try to re-apply some VelaSpray Ease lotion, if patient still cannot tolerate the heat, lower the RF and continue treatment. -
Page 70: Post-Treatment Care
Cellulite and Circumference Treatment Post-Treatment Care ● If heat sensation is excessive, cool the area with conventional cooling methods such as cold (not frozen) packs, air cooling with SynerCool, etc. ● In case of side effects such as burns, stop treatment; apply cooling and appropriate creams. -
Page 71: Maintenance
AINTENANCE While the VelaShape III system should not be serviced by anyone other than an authorized Syneron representative, the system requires regular preventive maintenance and cleaning to ensure optimal system performance. This chapter describes the routine maintenance procedures that operators may perform: ●... -
Page 72: Cleaning And Maintaining The Vsmooth Applicator
Maintenance Cleaning and Maintaining the VSmooth Applicator Caring for the VSmooth applicator involves the following maintenance procedures before and after each treatment: ● Removing, cleaning and replacing the replaceable cover. ● Cleaning the interior of the applicator. ● Replacing the applicator's filters. Caution While gently cleaning the interior of the applicator, avoid moisture and dirt from getting into the applicator’s filters. -
Page 73: Figure 54: Vsmooth Applicator's Internal Components
VelaShape III User Manual Maintenance Note The image in the figure is for illustration purposes only. 2. If it becomes necessary to clean the applicator cover during treatment: ● While the system is on, clean the rollers of the VSmooth applicator while pressing the trigger, with all modes at level , while rolling over a mild disinfectant-dampened tissue (that does not contain alcohol). -
Page 74: Replacing The Vsmooth Applicator's Filters
Maintenance Caution Verify that the vacuum's aperture does not become clogged during cleaning. Avoid inserting spray residue into the aperture. Replacing the VSmooth Applicator's Filters Refer 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 . -
Page 75: Cleaning And Maintaining The Vcontour Applicator
VelaShape III User Manual Maintenance Cleaning and Maintaining the VContour Applicator The replaceable cover of the applicator should be replaced according to the schedule printed on the cover's box label, or sooner if one of the following is observed: ● After cleaning the replaceable cover and the applicator's pin connectors, an message appears on the control panel (inadequate Improve Vacuum Seal coupling). -
Page 76: Cleaning The Vcontour Applicator's Filter
Maintenance Caution Make sure that the interior of the applicator and the cover are completely dry before inserting the filter and reconnecting the cover. Cleaning the VContour Applicator's Filter Remove the filter from the cover if it becomes necessary to clean or replace it. 1. -
Page 77: Cleaning The System Air Filter
VelaShape III User Manual Maintenance Cleaning the System Air Filter While the system air filter should be cleaned at least once a week, the filter cup needs to be checked daily and cleaned according to the amount of dust and debris that accumulates. -
Page 78: Troubleshooting Guide
The following troubleshooting guides do not attempt to list all possible system failures. Any error not listed should be referred to your Syneron representative. Table 4 offers a list of possible system errors that will be displayed on the control panel's display, and how to correct them. - Page 79 VelaShape III User Manual Troubleshooting Table 4: System Errors Messages Displayed On Screen and/or Applicator Panel Message Symptom Corrective Action ● Remove and clean the applicator cover. ● Replace the cover filter. Improve Vacuum Vacuum is not implemented ● Put on a new cover. Seal correctly upon the skin.
- Page 80 4. Verify that the cover is correctly attached to the applicator. 5. Replace applicator filters or cover. 1. Turn the system off. No IR output 2. Call your Syneron representative for further instructions. PB81499EN...
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Page 81: System Specifications
VelaShape III User Manual Specifications 9. S YSTEM PECIFICATIONS Output Parameters Console Peak RF Power 150 Watts RF Frequency 1 MHz RF Mode Bi-Polar Light Wavelength 850 nm Vacuum (-200) to (-390) Millibars Pulsed VContour Applicator IR Power Up to 1.7 W Up to 10 W (average per duty cycle) RF Power –... -
Page 82: Environmental Requirements
Specifications Environmental Requirements Treatment Room ● Temperature: 15 – 30°C [59 – 86°F] ● Relative humidity: Up to 80% ● Air pressure range: 70 – 106 kPa Storage/Transportation ● Temperature: 10 – 55°C [50 – 131°F] ● Relative humidity: 10% – 80% ●... -
Page 83: Electromagnetic Compliance
VelaShape III User Manual Electromagnetic Compliance 10. E LECTROMAGNETIC OMPLIANCE Electromagnetic Emissions The VelaShape III system is intended for use in the following electromagnetic environment. The owner of the system and/or the user must ensure that it is operated the correct environment. Emissions Test Compliance CISPR 11: RF Emissions... -
Page 84: Electromagnetic Immunity
Electromagnetic Compliance Electromagnetic Immunity Immunity Test IEC 60601 Test Level Compliance ±2, 4, 6 kV Contact IEC 61000-4-2: Electrostatic ± 6 kV contact ± 8 kV air Discharge (ESD) ±2, 4, 6, 8 kV Air ± 2 kV for power supply lines ±2 kV IEC 61000-4-4: Electrical Fast Transient/Burst... - Page 85 VelaShape III User Manual Electromagnetic Compliance Electromagnetic Immunity (continued) IEC 60601 Immunity Test Compliance Guidelines Test Level d =1.17 * SQRT(P) 80 MHz to 800 MHz d =2.33 * SQRT(P) 800 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...
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Page 86: Recommended Separation Distances
Electromagnetic Compliance Recommended Separation Distances The following are the recommended separation distances between portable and mobile RF communications equipment and the VelaShape III system. The VelaShape III system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The owner of the system and/or the user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the VelaShape III system as recommended below, according to...
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