ematrix manual
Contents
1. Align this dot With this arrow Figure 3 2 Connecting the Applicator 2 To disconnect the applicator turn the black ring C counter clockwise in the direction of the arrow until it releases and then pull the connector out 3 Seat the applicator in its cradle see Figure 3 3 Align this circle with this circle Figure 3 3 Applicator in Cradle 3 4 PB75531EN eTwo eMatrix Console User Manual Operating Instructions 4 OPERATING INSTRUCTIONS Warning A e Ensure that the power cable is connected properly before turning the system on e Dangerous voltage is present inside the system e The applicators should always be connected and positioned in their respective cradles during system start up e Always turn the system off before connecting disconnecting the applicators e Never direct the applicator s tip at anything other than the treatment site System Operation 1 Press the system s On Off switch shown by the red arrow in Figure 4 1 Figure 4 1 On Off Switch PB75531EN ae Operating Instructions Syneron 2 The system starts a self test of controller memory while displaying a startup animation When complete the Login screen will be displayed Syneron Figure 4 2 Login Screen 3 First Time Operation press the OK button on the touch screen no password is required until one2. No display on the LCD LCD malfunction Call Syneron Service Sublative D tip ceases to function e Tip disconnected e System is restarted e System was shut down as a result of a power failure Replace the tip with a new one No light emitted from the Sublime applicator s IR lamp IR lamp malfunction Check for IR lamp operation by pressing the trigger in Ready mode with the tip pressed against the skin call Syneron Service if not functioning PB75531EN 6 3 eTwo eMatrix Console User Manual System Specifications 7 SYSTEM SPECIFICATIONS Sublative RF Output Parameters e Total RF energy Up to 62 milliJoules per pin mJ pin e Programs RF energy gt Program A 10 30 mJ pin in 5 mJ increments gt Program B 32 48 mJ pin in 4 mJ increments gt Program C 50 62 mJ pin in 3 mJ increments e Power range 20 75 W Impedance 200 2 500 Ohms Max Voltage output applicator electrodes 275 Vrms without load Electrodes Two active and bi polar applicator electrodes no neutral electrode Sublative RF Power Characteristics IEC 60601 2 2 2006 CI 6 8 3 bb 1 Output Power versus Load impedance at Half and Full Output Control The power curve of the Sublative RF applicator with 144 pins tip is shown in Figure 7 1 below Half and Full output control diagrams are identical 80 70 PR O 500 1000 1500 2000 2500 3000 3500 4000 4500
3. The patient should wear Syneron provided protective eyewear during the treatment For more detailed information please refer to the Clinical Guides in this manual Treating Attendant Personnel should not operate the system until they have been fully trained in its use Cautions There are no user serviceable parts inside the system ONLY SYNERON AUTHORIZED PERSONNEL MAY SERVICE THE SYSTEM ESPECIALLY INSIDE ITS CABINET Do not use the system if it has been dropped or if any other type of excessive force has been applied The system must be examined by Syneron for safe operation after such an occurrence Keep the bodies of the applicators clean pay particular attention to the Sublime applicator tip s output lightguide and electrodes as well as the RF electrodes of the Sublative RF applicator Check the integrity of all components Do not allow the applicators to come in contact with hard materials that could damage the tips Make sure that all treatment personnel are familiar with the system s controls and know how to shut down the system instantly in case of an emergency Patients with cochlear implants should not be treated on skin areas within a 1 centimeter 0 4 radius of the implant s location Patients with cardiac pacemakers or other active implants should not be treated with the eTwo eMatrix system a possible hazard exists because of interference with the action of the pacemaker Never use the system to treat on
4. System Error Messages and Malfunctions Troubleshooting Table 6 4 provides the list of system error messages that may appear on the LCD screen during operation A system error will disable further use of the system until the problem is resolved If the corrective action does not resolve the problem contact Syneron s Service Center Table 6 4 System Error Messages System Error Message Probable Cause Corrective Action Applicators are not connected properly or are disconnected Turn the system off check applicator connection and turn system on Software malfunction Restart the system If problem persists contact Syneron Service Center Cooling system malfunction Turn the system off allow to cool for several minutes and restart If problem persists contact Syneron Service Center Software malfunction Restart the system If problem persists contact Syneron Service Center Symptoms without Messages Table 6 5 lists several possible symptoms indicating malfunctions that do not appear on the LCD panel If the corrective action listed in the table does not solve the problem contact Syneron Service Center Table 6 5 System Malfunctions Troubleshooting Guide Symptom Probable Cause Corrective Action System does not start Power cable disconnected e Check power cable e Plug cable into wall Blown fuse s Replace fuses refer to Maintenance section
5. eTwo eMatrix Console User Manual Maintenance Software Update Procedure The Software Update feature in the Utilities screen see Figure 4 8 allows you to easily update the eTwo eMatrix system s software application package after receiving a new version from Syneron The new software package will be delivered to you by one of the following methods e A USB flash drive disk on key with loaded software will be mailed to you or e The software package will be emailed to you unzip the package directly onto your own blank disk on key To update the software access the Utilities screen and press the Update Software button a pop up window will appear with complete instructions on how to install the new software Follow the on screen instructions until the installation is complete Caution N It is very important that during the update process the system does not lose power or be interrupted in any way System Integrity PB75531EN Inspect the eTwo eMatrix system on a regular basis and at least once a month for damage to the applicators umbilical cables and system base If any evidence of broken cut or otherwise damaged parts are detected contact the Syneron Service Center to correct this Using the system when it is damaged may cause unexpected results 5 3 eTwo eMatrix Console User Manual Troubleshooting 6 TROUBLESHOOTING The eTwo eMatrix system is equipped with a self testing software routine that continu
6. Ohm Figure 7 2 Sublime Power versus Load Impedance 7 2 PB75531EN eTwo eMatrix Console User Manual System Specifications TEC 60601 2 2 2006 Cl 6 8 3 bb 2 Output Power versus Output Control at a Specified Load Output power of the Sublime applicator at 2000 a typical tissue load is 175W for the whole range of output control TEC 60601 2 2 2006 Cl 6 8 3 cc Peak Output Voltage versus Output Control Peak output voltage of the Sublime applicator is 300V for the whole range of output control Electrical Requirements 100 240 VAC 10 3A 50 60Hz Single Phase Environmental Requirements Treatment Room Temperature 15 30 C 59 86 F Relative humidity 10 80 Air pressure range 700 1060 hPa 0 70 1 06 Bars Storage Transportation Temperature 10 55 C 50 131 F Relative humidity 10 80 Air pressure range 700 1060 hPa 0 70 1 06 Bars System Display e High resolution color 15 LCD screen with touch screen technology System Dimensions PB75531EN Closed system W x D x H Open system W x D x H Sublative RF applicator W x H Sublime applicator W x H Applicator umbilical cable 53 x 30 x 23 cm 21 8 x 11 8 x 9 1 53 x 30 x 40 cm 21 8 x 11 8 x 15 7 15x 16 cm 5 9 x 6 3 20 x 20 cm 7 8 x 7 8 190 cm 74 8 7 3 System Specifications Syneron System Weight e eTwo eMatrix system e Sublative RF applicato
7. file These log files may be downloaded to a flash drive disk on key and then emailed to Syneron for troubleshooting purposes Refer to the Utilities Screen Elements section starting on page 4 12 Home pressing the Home button will transition the system to the Home screen see Figure 4 3 on page 4 2 PB75531EN 4 7 lt Operating Instructions gt yneron System Sound Effect Definitions The following table defines the various sound effects emitted by the eTwo eMatrix system and to which actions they relate If you are reading a PDF copy of this manual click the speaker icons in the table to hear the sound effect sample for each of the actions Description Definitions Demonstration 1 On screen parameter changes 2 Treatment pulse that generates a Green Click skin feedback bar or if Training Sound D is turned off an Orange skin feedback bar will be accompanied by a Dry the skin message Treatment pulse that generates an Orange skin feedback bar when the Training Sound feature is toggled on This will be accompanied by a Dry the skin message Single Tone Double Tone feedback bar This will be accompanied by a Clean Tip Check Contact message Tip cleaning is required the system will Down Scaled transition to Standby mode This will be Whistle accompanied by a Clean Tip Check Contact message Treatment pulse that generates a Red skin O Warning This sound is generated when t
8. is displayed by the following color bars e Green Bar optimal delivery of energy this pulse is accompanied by a single click sound This pulse will be counted by the Pulses counter PB75531EN 4 5 Operating Instructions S yneron Orange Bar non optimal delivery of energy accompanied by a corrective action message Dry the skin and a single click sound The pulse delivered energy to the treatment spot yet it may need to be repeated This pulse will NOT be counted by the Pulses counter O O If the Training Sound mode is turned on refer to Utility Screen Elements starting on page 4 8 a single tone will sound Red Bar High Impedance a high impedance red bar means that the pulse was cut before energy was delivered to the treatment site due to debris on the tip or incomplete contact with the skin this pulse is accompanied by a corrective action message Clean Tip Check Contact and a double tone This pulse will NOT be counted by the Pulses counter Clean the tip gt Note If the Clean Tip Check Contact message appears on the skin feedback bar set the system to Standby mode and clean the tip s matrix according to instructions starting on page 5 1 Tip Type Indicator indicates the type of Sublative iD tip currently connected to the applicator Standard 64 or High Density 144 Pulses Counter when a new tip
9. is connected the bar starts at 0 and progresses up to 100 as the tip is used until completion When a tip reaches the end of its pulse life a message will be displayed warning that the tip has expired and needs to be replaced The pulse life indicator will reset to zero when the tip is replaced with a new one If no tip is connected to the applicator and you attempt to set the system to Ready mode the system will display a message No Tip Detected requiring a tip to be connected before proceeding 10 Impedance Pulses Graph displays a forward moving average of the impedance measured by the pulses Each point in the graph on the Y axis represents the average impedance of the previous five pulses the next point of the graph will show the average impedance of the previous five pulses P Note e During the first four pulses of the treatment session before a 5 pulse average can be established each point on the graph represents the measured impedance of only that pulse The moving average begins at the fifth pulse emitted e The measured impedance of each pulse is displayed on the skin feedback bar in Ohms 4 6 PB75531EN eTwo eMatrix Console User Manual Operating Instructions 11 12 13 Selected Program Indicator displays which Sublative RF treatment program was selected for use A Low Impact B Medium Impact or C High Impact Log File denotes the name of the currently open system log
10. is set in the Utilities area of the program the system will display the Home screen see Figure 4 3 gt Note e Syneron strongly recommends setting a security password to protect the system from unauthorized use Password configuration instructions are on page 4 12 e Once the password is configured it will be required by the Login screen see Figure 4 2 every time the system is turned on c gt ynerom Select Applicator Figure 4 3 Home Screen 4 2 PB75531EN eTwo eMatrix Console User Manual Operating Instructions Utilities Lock From this screen you can advance to the following areas of the program by pressing the appropriate button on the screen e Sublative RF treatment mode e Sublime treatment mode e Utilities screen Pressing the Lock button will return the system to the Login screen see Figure 4 2 the system password will have to be keyed in again in order to continue operation Select the applicator you wish to use for the current treatment by pressing the appropriate button the button will turn blue as an indicator that this applicator is now active e If you pressed the Sublative RF button the Treatment Program Selector screen will appear see Figure 4 4 e When the Sublime button is pressed no program selection is required the system transitions directly into the Sublime Treatment screen see Figure 4 7 PB75531EN Note If one or both of the applicators is n
11. of the applicator illuminates indicating that the system is charged and ready to emit a pulse 4 4 PB75531EN eTwo eMatrix Console User Manual Operating Instructions Sublative RF 2 Sublative Rejuvenation Syneron sera Ha 11 e 190 I 12 gt 321 5 Tip Used 2 Standby y 3 fi E o 13 gt Home 7 Figure 4 5 Sublative RF Treatment Screen Elements 4 Requested Energy Selection Bar press anywhere inside the bar or on the A or Y buttons to increase or decrease the RF energy mJ pin within program A B or C gt Note Pressing the A or Y buttons after reaching the extreme end or beginning of the treatment program s energy range will transition the system to the next higher or lower treatment program as exhibited by the Program tag shown by arrow 11 in Figure 4 5 5 Tissue Effect Illustration displays effect of the RF energy penetration into the skin The illustration changes intuitively as the levels of requested RF energy mJ pin are adjusted 6 Auto Off and Auto On toggle the Auto Repeat mode that enables continuous pulsing at a fixed repetition rate of 1 pulse per second Hz by pressing the Auto On button 7 Skin Feedback Bar after a pulse is emitted this bar exhibits four indications the skin s impedance Ohms the RF energy delivered mJ pin corrective action on Orange or Red and the type of pulse delivered The pulse type
12. or in proximity to open healing wounds Never use the system in the presence of explosive or flammable gasses such as flammable anesthetics oxidizing gasses etc If alcohol is used for cleaning and disinfecting 1t must be allowed to dry thoroughly before the system is set to Ready mode When treating with the Sublime applicator always use a thin layer of clear coupling gel recommended by Syneron that has the appropriate optical transparency and electrical conductivity properties 2 2 PB75531EN eTwo eMatrix Console User Manual Safety Optical Safety Refer to the Sublime applicator user s manual PB7555 x for complete optical safety information concerning the Sublime applicator RF Safety For complete RF safety information concerning the Sublative RF and Sublime applicators refer to e Sublative RF applicator user s manual e Sublime applicator user s manual Electrical Safety Issues e Keep all covers and panels of the system closed Removing the covers creates a safety hazard e Always make sure the system is turned off before connecting disconnecting the applicators to from the system e Keep hands away from the applicators during system start up e Do not allow contact between the patient and earthed metal components If this cannot be achieved use antistatic sheeting to protect the patient e Never use the system in the presence of explosive or flammable materials e Do not immerse any part of
13. system with only the Sublative RF applicator the system will be named eMatrix Before You Start Syneron Explanation of the Symbols Used in the System Symbol Description on system Attention Consult Accompanying Document gt gt on packages of high density 144 pin tips Caution Use with Low Energy Settings IN 0344 CE Compliance Symbol C Cc US 212603 CSA Compliance Symbol T 10 08 2012 EES Discard Product After Expiration Date Product was Sterilized by Ethylene Oxide Process i Waste of Electrical and Electronic Equipment WEEE compliance symbol ZZZ n Me RF Interference may occur in the vicinity of equipment with the following symbol Single Use Only Fuse Type BF Equipment E gt e Manufacturer m El Authorized Representative in the European Union PB75531EN eTwo eMatrix Console User Manual Safety 2 SAFETY This chapter describes the safety issues regarding the use and maintenance of the eTwo eMatrix system with special emphasis on electrical safety Introduction The system is designed for safe and reliable treatment when used in accordance with proper operation and maintenance procedures Only trained practitioners are qualified to operate the system The user and all other personnel operating or maintaining the system should be familiar with the safety information provided in this chapt
14. the system into liquids Co e Portable and mobile RF communications equipment can affect medical electrical equipment interference may occur in the vicinity of the equipment e The use of accessories and cables other than those specified may result in increased emissions or decreased immunity of the device It is forbidden to connect any third party equipment to the system without written approval from Syneron Medical Warning AN e To avoid the risk of electric shock this equipment must be connected only to an electrical supply outlet with protective earth e Do not touch the tip connectors of the Sublative RF applicator while the system is turned on this may cause electrical shocks e Press the trigger to activate the applicator only when the applicator s tip is in full contact with the skin PB75531EN 2 3 Safety Syneron Fire Hazards e The absorption of energy raises the temperature of the absorbing material Do not use the system in the presence of explosive or flammable materials e Keep drapes and towels moist to prevent them from igniting and burning e If alcohol is used for cleaning and disinfecting it must be allowed to dry thoroughly before the system is set to Ready mode System Safety Features The system incorporates the following safety features All personnel operating the system should be familiar with these features e The eTwo eMatrix operating system is password protected Protect
15. the treatment area and proceed with normal operation The internal temperature of the Sublime applicator has risen above its design limit and the system has disabled operation until it cools down wait several minutes and proceed with normal operation The system has detected that the Sublime IR lamp is not functioning correctly and must be replaced Contact your local Syneron representative System Warning Messages Table 6 3 provides the list of system warning messages that may appear on the LCD screen during operation A system warning will disable further use of the system until the problem is resolved If the corrective action does not resolve the problem contact Syneron s Service Center Table 6 3 System Warning Messages System Warning Message Probable Cause Corrective Action The applicator has been Connect the applicator to the disconnected while the system is in Standby or Ready mode system and proceed with normal operation The Sublime applicator will require service in the near future Contact Syneron Service Center to schedule service The Sublime applicator requires service before it can be used Contact Syneron Service Center to schedule immediate service The wrong Sublative RF applicator is connected to the system Connect and use only the Sublative RF delivered with this system FG7054 x 6 2 PB75531EN eTwo eMatrix Console User Manual
16. 5000 R Ohm Figure 7 1 Power versus Load Impedance Sublative RF 144 Pins TEC 60601 2 2 2006 CI 6 8 3 bb 2 Output Power versus Output Control at a Specified Load Output power of the Sublative RF applicator with 144 pins tip at 5000 as a typical load is 70W for the whole range of output control TEC 60601 2 2 2006 Cl 6 8 3 cc Peak Output Voltage versus Output Control Peak output voltage of the Sublative RF applicator with 144 pins tip is 275V for the whole range of output control PB75531EN 7 1 System Specifications Syneron Sublative iD Treatment Tips Sublative iD Standard tip gt Tip footprint Sublative iD High Density tip gt Tip footprint Sublime Output Parameters RF energy density Optical fluence Wavelength Power range Pulse repetition rate Tip footprint 64 electrode pins 12 x 12 mm 144 electrode pins 12 x 12 mm 40 100 J cm 6 W cm 20 700 2000 nm 70 200 W Impedance 50 500 Ohms 1 Hz 8x 12 mm Max Voltage output applicator electrodes Electrodes Sublime Power Characteristics 300 Vrms without load Two active and bi polar applicator electrodes no neutral electrode IEC 60601 2 2 2006 CI 6 8 3 bb 1 Output Power versus Load Impedance at Half and Full Output Control The Power curve of the Sublime applicator is shown in Figure 7 2 below Half and Full output control diagrams are identical 0 100 200 300 400 500 600 R
17. Area and Sensitive Area Modes determine if the treatment area is to be considered Normal or Sensitive and select the appropriate mode e The Sensitive Area mode should be employed when treating bony areas such as the forehead around the eyes or other bony or thin skinned areas known to be sensitive Otherwise use the Normal Area mode e Sensitive Area mode will reduce the selected RF energy level by 30 Normal Area will increase the RF energy level back to the selected level 4 10 PB75531EN eTwo eMatrix Console User Manual Operating Instructions PB75531EN Sublime 2 Wrinkle Treatment Siero 14 7 y 5 E 12 gt 164 u Reset Counter Standby 3 13 Bad Coupling bad skin contact Figure 4 7 Sublime Treatment Screen Elements 8 Auto Off and Auto On toggle the Auto Repeat mode that enables continuous pulsing at a fixed repetition rate of 1 pulse per second Hz by pressing the Auto On button 9 Pulses represents the accumulated number of pulses in the current treatment 10 Reset Counter press this button to reset the Pulses counter back to 0 zero 11 Message Area informative cautionary or error messages generated by the system are displayed in this box 12 Log File denotes the name of the currently open eTwo eMatrix system log file These log files may be downloaded to a flash drive disk on key and then emailed to Syneron for troubleshooting purposes Refer to the Utilities
18. Cla evatrx Sublative Rejuvenation and Wrinkle Treatment System Console User Manual S yneron Copyright O 2011 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 However Syneron Medical Ltd assumes no responsibility for its use No license is granted by its implication or otherwise under any patent or patent rights of Syneron Medical Ltd No part of this document may be produced or transmitted in any form or by any means electronic or mechanical for any purpose without the express written permission of Syneron Medical Ltd Data is subject to change without notification Syneron Medical Ltd has patents and pending patent applications trademarks copyrights or other intellectual property rights covering subject matter in this document The furnishing of this document does not give you any license to these patents trademarks copyrights or other intellectual property rights except as expressly provided in any written agreement from Syneron Medical Ltd Syneron the Syneron logo eTwo eMatrix Sublative RF and Sublime are trademarks of Syneron Medical Ltd Sublime is a trademark for an applicator and does not intend to present any claim Specifications are subject to change without notice Manual Ca
19. Follow the on screen instructions above the keypad to change the password e Enter the old current password and press OK Y e Enter the new password and press OK Y e Enter the new password again for confirmation and press OK Y 4 12 PB75531EN eTwo eMatrix Console User Manual Operating Instructions gt Note Press the Cancel X button to exit without changing the password Copy Data to USB the system s save log files may be downloaded to a flash drive disk on key and then emailed to Syneron for troubleshooting purposes e Press this button a pop up window will appear e Follow the on screen instructions Update Software refer to the Software Update Procedure section beginning on page 5 3 Home pressing this button will transition the system to the Home screen see Figure 4 3 on page 4 2 Audio Settings Box 8 Audio Level adjust the volume level of the voice messages and action tones emitted by the system 9 Voice On Off the system emits messages and instructions in a human voice This feature may be turned off X or back on Y by toggling this button 10 Training Sound Sublative RF only when set to On every emitted pulse O that generates an orange skin feedback bar will also sound this single tone instead of the normal click sound This feature may be turned On Y or back Off X by toggling this button Display Settings Box 11 Brightness adju
20. How to Clean the Tip e Clean the tip s matrix with a gauze pad slightly moistened with 70 alcohol e Use a dry gauze pad to absorb all the alcohol Make sure the tip is completely dry before beginning to treat again e When finished reset the system to Ready mode and continue the treatment Caution e Ensure clean tips accumulated debris or non dry skin may lead to pain e Discard used Sublative iD tips as bio hazardous waste PB75531EN 5 1 Maintenance Syneron Fuse Replacement To replace burnt fuses 1 2 Turn off the system and disconnect the power cable from the outlet Unplug the power cable from the cable s connection port on the service panel Remove the fuse housing as shown in Figure 5 1 Remove the burnt fuses from the housing and replace them with new ones Make sure that the fuses fit snugly within the fuse housing Insert the fuse housing into its receptacle and push it in until it snaps into place Connect the power cable to the system and to the power outlet Turn on the system and verify that it is functioning properly Caution A e Make sure that the type and rating of the new and the replaced fuses match e Always replace both fuses at the same time e oo Lo Le USB port for software update dsk on hey orty Do not connect any 1 100 240V 3A un HA 2 x T4A 250V ee ITA Figure 5 1 Fuses Replacement 5 2 PB75531EN
21. Screen Elements section starting on page 4 12 13 Home pressing the Home button will transition the system to the Home screen see Figure 4 3 4 11 Operating Instructions Syneron Utilities Screen Elements Figure 4 8 presents the Utilities screen The numbered tags in the illustration correspond to the following numbered explanations and definitions of the screens elements System Information Box 1 Software Version displays the version of the software package currently installed in your eTwo eMatrix system 2 Sublative RF Applicator Pulses this open ended counter displays the accumulated number of pulses emitted by the Sublative RF applicator This count value will be displayed only when the applicator is connected to the system 3 Sublime Applicator Pulses this open ended counter displays the accumulated number of pulses emitted by the Sublime applicator This count value will be displayed only when the applicator is connected to the system Maintenance Change Password Copy Data to USB 7 f Update Software Home Audio Settings 4 5 6 lt gt ynerom System Information Software Version 303 1 SubRF Applicator Pulses 2383 TT 2 Sublime Applicator Pulses 2535 amp T_ 3 Display Settings Figure 4 8 Utilities Screen Elements Maintenance Box 4 Change Password press this button a virtual keypad screen similar to the Login screen will appear
22. e of Contents Sublative RF Power Characteristics ii 7 1 Sublative iD Treatment Tips it dt 7 2 Sublime Output Parameters nn nn nnnnr nn nn nnnn nn nn naar rn n ran NEEE Ennen Enne 7 2 Sublime Power Characteristics era deetara REENEN 7 2 Electrical Requirements A RL 7 3 Environmental Requirements 7 3 Treatment Room vicari nr i i ee 7 3 Storage TAS ir AA iaia 7 3 ERR BI TEE 7 3 System DIMENSIONS A ia 7 3 System Weight Ans beni ina it th to ia 7 4 LIST OF FIGURES Figure 3 1 Applicator Connection Porte 3 3 Figure 3 2 Connecting the Applicator e 3 4 Figure 3 3 Applicator in Cradle A 3 4 Figure 4 12 Ewescht Ae ROEDER ai iii 4 1 Figure 4 2 Login Screen ia alii aL 4 2 Figure 4 3 Home Screen i 4 2 Figure 4 4 Treatment Program Selection Screen nana nan cnc crac 4 4 Figure 4 5 Sublative RF Treatment Screen Elements nana nnnc cc nn canaria nn rra 4 5 Figure 4 6 Charge Indication Light Bar 4 9 Figure 4 7 Sublime Treatment Screen Elements 4 11 Figure 4 8 Utilities Screen Elements 4 12 Figure 5 1 Fuses Replacement nac 5 2 Figure 7 1 Power versus Load Impedance Sublative RF 144 PiNS ii 7 1 Figure 7 2 Sublime Power versus Load Impedance 7 2 PB75531EN 5 eTwo eMatrix Console User Manual Before You Start 1 BEFORE YOU START Read this manual to become familiar with all safety require
23. eating Alto EE 2 2 CAMION iii e i o i a 2 2 OpticallSaleW al e e i n 2 3 Sao ile ne alle in 2 3 Electrical Safety ISSUCS ulti tal aaa 2 3 A E 2 4 System Safety Feature uma 2 4 Equipment Classification RE 2 4 System Nameplate acotada aree 2 5 Applicator Namepl ates a 22 2 e edd d e a a ee edie 2 5 AS AS A ie 3 1 Equipment AO 3 1 Electrical Eu IC 3 2 Environmental Requirements nn nc naar nc nn anar nc rra nn rr nan nr rc cnn nn nr naar nnncinns 3 2 Connect the Applcators i 3 3 4 Qperating BE EE 4 1 System Operation sta ET ea 4 1 Sublative RF Treatment Mode AA 4 4 System Sound Effect Definiti0NS crac rra 4 8 Charging and Emitting a Pulse ii 4 9 Sublime Treatment Mode AA 4 10 Utilities Screen Elements 4 12 By Mamona excita ao Doa 5 1 Cleaning the System cr 5 1 Cleaning the Application u rennen again aapa do 5 1 Cleaning the Sublative iD Tip nr 5 1 How to Clean the Tipo cueros illecito 5 1 FuseReplacement 4 2n i le li ee En 5 2 Software Update Procedure i 5 3 System le ee EE 5 3 Geelen e DEER 6 1 Sublative iD Tip Related Messages 6 1 Sublime Related Messages ii 6 2 System Warning Messages ii 6 2 System Error Messages and Malfunctions tenent 6 3 Symptoms without Messages ieri tidad 6 3 EE Ee le le EE 7 1 Sublative RF Output Parameters mirra dadas 7 1 4 PB75531EN eTwo eMatrix Console User Manual Tabl
24. en The numbered tags in the illustration correspond to the following numbered explanations and definitions of the screens elements 1 Name and Illustration nametag and illustration of the currently active applicator Description this tag describes the function of the currently active applicator Standby and Ready Buttons press the Ready button to set the system to Ready mode light pulses and RF energy will be emitted through the applicator tip when the trigger is pressed Press the Standby button to set the system back to Standby mode When the system is in Ready mode pressing any other button will automatically return the system to Standby mode Requested RF Energy Selection Bar select the desired RF energy to be delivered to the treatment site by pressing anywhere inside the bar or on the A or Y buttons to increase or decrease the RF energy anywhere from a minimum of 40 J cm up to a maximum of 100 J cm in increments of 10 J cm gt Note The optical energy is automatically set without user input 5 Tissue Light amp RF Effect Illustration displays the relative depth penetration into the skin of the light and RF energies The illustration changes intuitively as the level of applied RF energy is adjusted Select the desired mode for the level of tip cooling in the Sublime applicator s tip e Cooling Normal temperature default selection 15 C 59 F e Cooling Strong temperature 10 C 50 F Normal
25. er 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 or its operation by non authorized personnel The primary consideration should be to maximize safety for both treating attendant and the patient Warning AN e Read this chapter to be familiar with all of its safety requirements and operating procedures prior to operating the system e Any radiofrequency RF device can cause injury if used improperly e High voltage is present inside the system e Always be aware of the possible dangers and take proper safeguards as described in this manual e Failure of the RF device could result in an unintended increase of output power e In the event of adverse effects or injury illness immediately contact In North America Syneron Inc In Europe CEpartner4u B V Outside North America and Europe Syneron Medical Ltd e For complete contact information please refer to page 3 of this manual Patient Safety PB75531EN Patient safety is primarily assured by a well trained staff A complete medical history of the patient should be completed and patient eligibility assessed prior to scheduling treatment with the system Patients should be fully informed of the treatment protocol the likely results and any risks associated with the treatment 2 1 Safety Syneron
26. he Bell system detects an error situation An appropriate error message is displayed on A the screen Down Scaled This sound is generated when the system O Chime transitions to Standby mode 4 Up Scaled This sound is generated when the system O Chime transitions to Ready mode y Voice The system delivers several instructions or selection indications in the form of a voice P Message J message click the icon to hear a sample 4 8 PB75531EN eTwo eMatrix Console User Manual Operating Instructions Charging and Emitting a Pulse PB75531EN The eTwo eMatrix applicators emit a radiofrequency pulse when charged and the applicator s trigger is pressed The green RF indication light bar on the applicator illuminates when the applicator is sufficiently charged and ready to emit the pulse see Figure 4 6 The indication light bar goes off during pulse discharge and remains off until the applicator is recharged and ready for the next pulse If a pulse was not delivered or delivery of energy was not optimal the indication light bar will flash amber light until the applicator is properly charged for the next pulse green light bar Sublative RF Sublime Green light bar Green light bar Ready to pulse Ready to pulse Figure 4 6 Charge Indication Light Bar 4 9 lt Operating Instructions yneron Sublime Treatment Mode Figure 4 7 presents the main Sublime Treatment scre
27. isconnecting the applicators Refer to Figure 3 1 e Connect the Sublative RF applicator to the connector on the right side of the system console e Connect the Sublime applicator to the connector on the left side of the system console gt Note To prevent mistakes when connecting the applicators the system and the applicator umbilical cables have been marked with matching images see Figure 3 1 e The system s platform above the Sublative RF connector and the Sublative RF applicator s umbilical cable are marked with a single grey colored circle e The system s platform above the Sublime connector and the Sublime applicator s umbilical cable are marked with a double grey colored circle Double Single Circle Circle Figure 3 1 Applicator Connection Ports PB75531EN 3 3 System Setup Syneron Both the Sublative RF and Sublime applicators are connected in the same manner Refer to Figure 3 2 1 Connect the applicator s cable connector A to the system s connection port B e Align the white dot on the connector with the white arrow on the connection port e Another way to properly insert the connector A is to align the single or double circle on the applicator umbilical cable with the single or double circle on printed on the console see Figure 3 3 e Push the connector in until you feel it snap into place d ES To release turn connector in direction of arrow
28. ments and operating procedures before attempting to operate the system A Caution e Any radiofrequency RF device can cause injury if used improperly e The eTwo eMatrix system must be serviced only by Syneron Medical Ltd qualified personnel Warning High voltage is present inside the system Always be aware of the possible dangers and take proper safeguards as described in this manual Conventions Used in this Manual PB75531EN 1 The following conventions in the form of notes cautions and warnings are used in this manual P Note The content of this Note offers general information that is important to keep in mind A Caution A Caution alerts the user to the possibility of a potentially hazardous situation which if not avoided may result in minor or moderate injury to the user and or patient or damage to the equipment A Warning A Warning alerts the user to the possibility of injury death or serious adverse reactions associated with the use or misuse of the system 2 In many places throughout this manual you will see words or phrases in the text which are bolded in a sans serif typeface such as this These are words and phrases that you will see on the LCD display of the control panel 3 System Name if you have ordered and received a system with both Sublative RF and Sublime applicators the system will be named e T wo If you have ordered and received a
29. ntervals or events clean the tip per instructions resume Ready mode and proceed with normal operation This message will pop up if the tip is inadvertently disconnected during operation reconnect the tip press Cancel and proceed with normal operation If the problem persists replace the tip with a new one This message will pop up when the connected tip reaches the end of its pulse life discard the used tip connect a new tip press Cancel and proceed with normal operation The system has detected that an old style tip is connected to the applicator The old tips are no longer supported by the system discard all old style tips from your stock and use only the new tips lt Troubleshooting gt yneron Sublime Related Messages Table 6 2 provides a list of Sublime applicator related pop up messages that may appear on the LCD screen during the normal course of patient treatment follow the actions required by the pop up message and resume normal operation If the corrective action does not clear the pop up message restart the system and try again If the problem persists contact Syneron s Service Center Table 6 2 Sublime Related Messages Message Required Action The system has detected that light RF energy transfer to the skin is less than optimal probably because there is not full contact or not enough coupling gel applied to the treatment area Ensure full contact or apply more coupling gel to
30. ormation Applicator Nameplates PB75531EN The Sublative RF and Sublime applicator ID nameplate labels are adhered to the umbilical cable of each applicator near the connector and they include the applicator s identification and electrical output information Do not operate the eTwo eMatrix system before verifying that the following information is printed on the labels of the Sublative RF and or Sublime applicators e Verify that the Sublative RF applicator s label has this printed on it Rated Voltage 275 Vrms e Verify that the Sublime applicator s label has this printed on it Rated Voltage 300 Vrms 2 5 eTwo eMatrix Console User Manual System Setup 3 SYSTEM SETUP The system is designed for operation in a clinical environment and it may be easily transported inside a protective carrying case The eTwo eMatrix system is set up by doing the following 1 2 Unpack the system Check the integrity of the system and all components Connect the Sublative RF and or Sublime applicators to the system platform Connect the power cable to the system cable connection port Plug the system s power cable into an appropriate electrical outlet Turn the system on Equipment List The following equipment is delivered in the shipping pack eTwo system console if system ordered with Sublative RF AND Sublime applicators or eMatrix system console if system ordered ONLY with Sublative RF applicator Sublative iD
31. ot connected to the system when it is turned on the applicator selection button s will not appear on the screen indicating that the mode is disabled 4 3 Operating Instructions Syneron Sublative RF Treatment Mode Select a Treatment Program there are three treatment programs to choose from each offering different levels of ablation and resurfacing to the skin at different intensities of impact Select program A Low Impact B Medium Impact or C High Impact the Treatment screen will appear see Figure 4 5 Syneror Select Applicator Program B Med Impact Program A Low Impact gram C act ES Utilities Figure 4 4 Treatment Program Selection Screen Figure 4 5 presents the main Sublative RF Treatment screen The numbered tags in the illustration correspond to the following numbered explanations and definitions of the screens elements 1 Name and Illustration nametag and illustration of the currently active applicator 2 Description this tag describes the function of the currently active applicator 3 Standby and Ready Buttons press the Ready button to set the system to Ready mode RF pulses will be emitted through the applicator tip when the trigger is pressed Press the Standby button to set the system back to Standby mode When the system is in Ready mode pressing any other button will automatically return the system to Standby mode Note Wait until the green LED bar on the rear
32. ously monitors system operation If a system malfunction is detected an error message will appear on the LCD screen The following troubleshooting tables do not attempt to list all possible system failures Any fault not listed should be referred to Syneron s Service Center Sublative iD Tip Related Messages Table 6 1 provides a list of Sublative 1D tip related pop up messages that will appear on the LCD screen during the normal course of patient treatment follow the actions required by the pop up message and resume normal operation If the corrective action does not clear the pop up message restart the system and try again If the problem persists contact Syneron s Service Center Table 6 1 Sublative iD Tip Related Messages Message PB75531EN Required Action The system has detected that a new tip is connected to the applicator during transition to Ready mode press OK observe Tip Type display at the top right corner of the treatment screen and proceed with normal operation During transition to Ready mode the system has detected that no tip is connected to the applicator ensure that a valid tip is connected press OK and proceed with normal operation During transition to Ready mode the system has detected that you have connected an expired tip to the applicator discard the expired tip connect a new tip press OK and proceed with normal operation This message will pop up during treatment after specific i
33. r e Sublime applicator 8 5 kg 18 7 lbs 0 5 kg 1 1 Ibs 1 0 kg 2 2 Ibs 7 4 PB75531EN
34. st the brightness level of the LCD screen 12 Display Log Name when active the name of the log file csv will be PB75531EN displayed on the Treatment screen directly under the icon of the active applicator This feature is useful when performing clinical trials with the eTwo eMatrix system or for troubleshooting purposes This feature may be turned on Y or back off X by toggling this button 4 13 eTwo eMatrix Console User Manual Maintenance 5 MAINTENANCE Cleaning the System Clean the system at least once a week Turn the system off and wipe all surfaces with a soft damp non abrasive cloth Be careful not to spill any liquids on or into the system The LCD screen should be cleaned with a dedicated LCD cleaning solution this can be obtained from any office supply store Cleaning the Applicator Wipe the body of the applicator with alcohol chloride acetone free disinfectant after each treatment session Pay special attention to the tip of the Sublime applicator light guide and electrode rails Cleaning the Sublative iD Tip Ablated debris may accumulate on the tip s pin matrix during treatment The system will switch to Standby mode and display a message requiring cleaning of the tip at specific intervals dependent on the energy level used The higher the energy level the more often the system will stop for tip cleaning After cleaning the tip as instructed press Ready to continue treatment
35. talog Part Number PB75531EN Revision Release Date October 2011 e Before using the device please check local regulations If any local legislation is violated use cannot be authorized R Only e In the United States federal law restricts prescription medical devices to be sold by or on the order of a physician or properly licensed practitioner Syneron makes no representations regarding federal state or local laws or regulations that might apply to the use and operation of this device Contact information for equipment manufacturer and technical services e Syneron Inc 3 Goodyear Suite A Irvine CA 92618 USA Tel 1 866 259 6661 toll free e CEpartner4u B V Esdoornlaan 13 REP 3951 DB Maarn The Netherlands Tel 31 343 442 524 Fax 31 343 442 162 e Syneron Medical HK Ltd Room 504 Chinachem Tower 34 37 Connaught Road Central Hong Kong Tel 852 2543 4326 Fax 852 2543 4327 e Syneron Medical Ltd P O Box 550 ui Industrial Zone Tavor Building Y okneam Illit 20692 Israel Tel 972 73 244 2200 Fax 972 73 244 2202 0344 e Website WWW syneron com e E mail info syneron com PB75531EN 3 lt Table of Contents yneron TABLE OF CONTENTS Te Betore dE SE 1 1 Conventions Used in this Manual nennen 1 1 Explanation of the Symbols Used in the System 1 2 22 DAILY estara it 2 1 INYOQUCION 2 td ii 2 1 Patient Safety ii A A A Ra A a aaa 2 1 Tr
36. the password to avoid unauthorized use of the system The password may be changed in the Utilities menu e The treatment mode cannot be activated unless an applicator has been connected to the system e An adjustable audible tone indicates system transition from Standby to Ready mode when a treatment pulse can be emitted e During startup the system performs an internal self test of its hardware and software e Hardware is tested while the system is idling not emitting pulses to ensure proper operation of its electrical circuitry When a problem is detected the system is disabled and an appropriate error message appears on the screen refer to the Troubleshooting chapter e On line monitoring of output energy prevents accidental energy emission to the patient Equipment Classification e Electric shock protection Class L Type BF e Protection against ingress of liquids Ordinary equipment e Mode of operation Continuous e Not suitable for use in presence of flammable substance e The eTwo eMatrix system and applicators comply with the U S Federal Regulations e The eTwo eMatrix system is classified as a Ila device defined by the Medical Device Directive 93 42 EEC for CE marking 2 4 PB75531EN eTwo eMatrix Console User Manual Safety System Nameplate The system s ID nameplate is located on the bottom panel of the system and it includes the system s identification regulatory and electrical requirement inf
37. treatment tips 2 x 10 packs User manual eTwo eMatrix system console User manual Sublative RF applicator User manual Sublime applicator Ultrasound gel for Sublime treatment liter bottle x1 Delivered only with eTwo system for the Sublime applicator PB75531EN 3 1 System Setup Syneron Electrical Requirements The eTwo eMatrix system incorporates a universal power supply module that allows it to be connected to standard electrical outlets anywhere The system s electrical requirements are e 100 240 VAC 10 3A 50 60Hz Single Phase The electrical requirements are printed on the system s nameplate located on the system s bottom panel Warning AN e For continued protection against fire replace the fuse only with one of the same type and rating e Proper grounding is essential for safe operation Environmental Requirements e Corrosive materials can damage the system s elements therefore the system should operate in a non corrosive atmosphere e Metallic dust can damage electrical equipment e For optimal operation of the system maintain room temperature between 15 30 C 59 86 F and relative humidity of 10 80 e Dueto the ablative nature of the treatment always work in a well ventilated room 3 2 PB75531EN eTwo eMatrix Console User Manual System Setup Connect the Applicators Warning Turn the system off and disconnect the power cable before connecting or d
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