USER MANUAL
Contents
1. 5 TRILIPO TIME press TIME 5 HIN 1 RF POWER RF POHER Ei POHER PULSE HIDTH 68 us 1 WHIDTH 68 US FREQUENCY 8 78 HZ FREQUENCY sa li PROGRAM TLP UM PROGRAM TREATMENT COUNTER Boies C e Note that TriLipo power is set to Zero by default It is recommended to increase the amplitude to 10 using the TriLipo power Jog on the front panel TIME OK T ERES TIME TRILIPO RF POWER 05 RF POKER POWER PULSE WIDTH 68 PEN 5 PULSE WIDTH amp FHELDBUENMCC He e FREQUENCY PROGRAM TLP p PROGRAM TREATMENT T TREATMENT COUNTER 65 COUNTER e Position the clean Applicator onto the skin of the patient and start moving it Then press the Foot Switch for treatment to begin press TIME 5 HIN TRILIPO i RF POHER J paesi PULSE WIDTH 68 US FREQUENCY 8 78 uz PROGRAM TLP nee TREATMENT COUMTER _ e Apply the applicator with mild pressure and use a rubbing massaging technique linear circular etc depending on the area All electrodes should be in complete contact with the skin When administrating the treatment the applicator should move at all time on the skin e Monitor muscle activation sensation verbally amp regularly throughout treatment Patient might feel slight tingling sensation During treatment the TriLipo Muscle amplitude should be adjusted increased or decreased to the ma2. 26 Maximus Non invasive body shaping System User Manual Version 7 4 3 5 Choosing the preset PROGRAMS Highlight the PROGRAMS option using the UP DOWN keys and press the OK key Select wanted PROGRAM using the UP DOWN keys Press OK to confirm Note BUTTOCKS TIME 25 MIN RF POHER 58 PULSE WIDTH 2800 US FREQUENCY 0 78 HZ OGRE TLP RF POHER PULSE HIDTH FREBUENCY RF READY LIE te EX FOO SHITCHBBISE L3 2 e Pulse width may be changed from 20 to 400 uSec e Pulse frequency may be changed from 0 78 to 12 5 HZ e For safety reasons Pulse Width and Frequency settings are limited in different treatment areas See Table 4 4 4 Operation TIME 25 HIN RF POHER mI d PULSE HIDTH 2800 US FRERUENCY PROGRAM PRESS CONFIRM Ta UP DOMN H TS HZ T THE 35 IN POHER 2B PULSE HIDTH 26060 US FREQUENCY 4 78 HF PROGRAM MF PRESS DK TO CONF IRA Ex UP DOWN BEER TIS ia Treatment may be started any time after relevant parameters has been selected Note The READY indication appears on the screen Starting the Treatment Press the Foot Switch to start the treatment Counter will indicate the treatment duration time of the procedure chosen The count down will begin once the Foot Switch has been pressed Trilipo Muscle power regulation Raise the TriLipo Power output by turning regulation Jog clockwise During treatment Power may be changed whethe
3. 3 3 2 Foot Switch connection e Position the connector in accordance to the arrow marks e Push the connector into its receptacle marked with label until hearing a click sound e Check if connector is properly connected and locked 3 3 3 Bio Feedback Control connection e Position the connector in accordance to the arrow marks Push the connector into its receptacle marked with label until hearing a click sound e Check if connector is properly connected locked Proprietary Information of Po O g 19 Maximus Non invasive body shaping System User Manual Version 7 3 3 4 Applicator 1 connection t Applicator E APPLICATOR receptacle Verify the applicator number on with positioning grooves applicator label Attach and superpose the applicator connector with positioning grooves on its receptacle marked with label on the back panel e Push the connector inside and fasten the connector nut properly e Make sure the red mark on the connector receptacle is totally covered with the nut 3 3 5 Connect Applicator 2 connection Attach and superpose the applicator connector with positioning grooves on its receptacle marked with label e Push the connector inside and fasten the connector nut properly Make sure the red mark on the connector receptacle is totally covered with the nut 3 3 6 Connect Applicator 3 connection Attach and superpose
4. Connect Bio Feedback Control see Figure 3 If System still does not operate properly contact local Pollogen representative for service owitch OFF the system and then switch ON again If there is still no display on LCD contact local Pollogen representative for service owitch OFF the system and then switch ON again If LCD still does not operate properly contact local Pollogen representative for service owitch OFF the system and then switch ON again If display still does not operate properly contact local Pollogen representative for service owitch OFF the system and then switch ON again to check Foot Switch If System still does not operate properly contact local Pollogen representative for service Ensure that there is voltage in power supply socket If ON OFF switch is still not illuminated in ON position contact local Pollogen representative for service Unplug the device Contact local Pollogen representative for service 42 Maximus Non invasive body shaping System User Manual Version 7 Fan or fan connection failure Unit Fan is not operating Fan is not operating One or more keys on the control panel are not operating TriLipo Energy cannot be Function key failure One or more keys on the control panel are not operating No feedback on LCD when Jog is adjusted Jog failure adjusted Failure to enter TriLipo Mode EPG Failure Tri
5. USER MANUAL Pollogen s Proprietary Information Version 7 0 May 1 2012 C 0344 Maximus Non invasive body shaping System User Manual Version 7 Pollogen Ltd reserves the right to make changes without notice to its products or specifications to improve performance reliability or manufacturability All information supplied by Pollogen Ltd is believed to be accurate and reliable However Pollogen Ltd assumes no responsibility for its use No license is hereby granted by its implication or otherwise under any patent or patent rights of Pollogen Ltd This document in part or entirety is not to be produced reproduced or transmitted in any form or by any means electronic or mechanical for any purpose without the express written permission of Pollogen Ltd Pollogen Ltd has patents and pending patent applications trademarks copyrights and or other intellectual property rights covering the subject matter in this document Providing of this document does not give any license to these patents trademarks copyrights and or other intellectual property rights unless otherwise expressly provided in any written agreement from Pollogen Ltd All data is subject to change without prior notification Pollogen Ltd 6 Kaufman St PO Box 50320 Tel Aviv 68012 Israel Obelis S A Boulevard G n ral Wahis 53 1030 Brussels BELGIUM Lk 32 0 2 732 5954 Fax 32 0 2 732 6003 GSM 32 47545 4660 e mail mail obelis n
6. ARE ALLOWED TO SERVICE THIS EQUIPMENT WARNING ANY MODIFICATIONS MADE TO THE EQUIPMENT WITHOUT EXPLICIT APPROVAL FROM POLLOGEN LTD VOIDS ALL WARRANTY AND SERVICE CONTRACT OBLIGATIONS AND POSES A POTENTIAL SAFETY THREAT TO BOTH OPERATOR AND PATIENT WARNING DO NOT TREAT ON THE SKIN OVER THE EYE SOCKET DO NOT TREAT GENITALS BREASTS THORAX OR UNDERARMS WARNING TO AVOID RISK OF ELECTRIC SHOCK THIS EQUIPMENT MUST ONLY BE CONNECTED TO A SUPPLY MAIN WITH PROTECTIVE EARTH AND MUST BE USED WITH THE CABLE SUPPLIED 11 Proprietary Information of Po o g an JHC ES Maximus Non invasive body shaping System User Manual Version 7 The primary consideration is to maximize safety for both operator and patient Read this chapter to become familiar with all its safety requirements ea and operating procedures prior to System operation High voltage is present inside the System Always be aware of the possible dangers and always take proper precautions as described in this manual 2 3 2 Safety Features of the System A General e The Maximus system is intended for safe and reliable procedures for non invasive body shaping procedures All Maximus users should strictly adhere to the safety precautions outlined in this section e An independent electronic circuit stops the operation of the system in case of a software error Patient safety is subjected to a well trained staff
7. Patient education is also important so information about the nature of the treatment and its expectations should be provided prior to commencement of the treatment e Prior to commencement of the treatment the patient should be given the Bio Feedback Control with a full explanation of its proper use see section 5 7 Performing Treatment Procedure B Connections Maximus was designed to maximize safety for both patient and operator The following are some of the Maximus safety precautions e he Foot Switch must be connected to the system and locked prior activation BB Connect and lock Foot switch e he Bio Feedback must be connected to the system and locked prior activation Bio feedback he Applicators must be connected to the system and locked prior activation Connect and lock 12 Proprietary Information of Pi 5 lo sen 5 Maximus Non invasive body shaping System User Manual Version 7 C Indicators The following indications specify proper functioning of the system TriLipo RF energy After each press and release of the Foot Switch the indicator light guide ring turns Green Indicator light guide ring will turn Orange when the Foot Switch is pressed and power is transmitted to the electrodes After press and release of the Foot Switch the indicator light guide ring will turn green e When the Foot Switch is pressed and power is transmitted to the electrodes the indicat
8. Power inlet wifuses Figure 3 Back Panel The Back Panel includes the placement of the applicator holder ON OFF switch Bio Feedback Control connector Applicator no 1 connector Applicator no 2 connector Application no 3 connector device S N label Foot Switch connector power inlet with fuses and program plug 2 1 4 Applicator No 1 intended for the treatment of large body areas Figure 4 Applicator No 1 Applicator No 1is connected to the main unit using a cable comprised of electrical wires and a connector It is also consists of a plastic body with an integrated electronic system 6 electrodes and indication light guide ring When not in use the applicator should be stored in its cradle 2 1 5 Applicator No 2 intended for the treatment of medium size body areas and face Figure 5 Applicator No 2 Proprietary Information of Po lo g e Applicator No 2 is connected to the main unit using a cable comprised of electrical wires and a connector It is also consists of a plastic body with an integrated electronic system 3 electrodes and indication light guide ring When not in use the applicator should be stored in its cradle Maximus Non invasive body shaping System User Manual Version 7 2 1 6 Applicator No 3 intendeds for the treatment of very small facial areas and hands Applicator No 3 is connected to the main unit using a cable comprised of electrical wires and a con
9. controls and technical specifications Please review this chapter carefully to familiarize yourself with the controls ports and connectors used during treatment 2 1 System Components and Controls The Maximus system consists of the following main components o Main Unit System Console Applicator No 1 intended for the treatment of large body areas Applicator No 2 intended for treatment of medium size body areas and face Applicator No 3 intended for treatment of very small facial areas and hands Foot Switch Bio Feedback Control Applicator holder Cable holders 3 pcs Non Contact Infrared Thermometer Proprietary Information of Pe J lo E enn 2 Maximus Non invasive body shaping System User Manual Version 7 2 1 1 Main Unit System Console The Main Unit controls the operation of the entire system Figure 1 It contains the following parts 7 Applicator holder Applicalor 2 j User Interface ZEE Apoplicaior 1 1 6 i 1 E Eh b Cable holder Apnplicator 3 c BioFeedback with Cabla Device Handle Unit Fan Unit console Applicator 1 Cabe Connector Applicator 2 Dewees B p vice Arpa Applicator 3 Cable Connector Foot swibh Fact Switch connector Wheel with brake 7 niel Power Gord Wiha Figure 1 General View Maximus Main System Components Proprietary Information of Po lo g an 6
10. Labels affixed to the System Proprietary Information of Po lo g 16 Maximus Non invasive body shaping System User Manual Version 7 3 INITIAL SET UP The System is designed for simple installation To install the system follow the subsequent procedure 3 1 Unpacking the System Unpack the System and verify that the system is intact and that all its components are present It is recommended for future safe transport of the device that the original box and internal packaging be saved Make sure to remove all covers and wraps from all parts prior to the installation of the system The system is comprised of the following modules Main Unit Applicator No 1 Applicator No 2 Applicator No 3 Foot Switch Bio Feedback Control Power Cable 1 Applicator Holder base with 4 fixation screws 3 Cable holders with 3 fixation screws 0 User Manual a daa Figure 10 Unpacking the System 3 2 General overview and Installation Requirements Electrical Requirements The System has a universal power inlet Single phase 100 240 VAC 2 2A 50 60Hz The system must be connected to a grounded power outlet 3 pin Only supplied cable is to be used Cable 10A 250V 1 8m length Environmental Requirements Corrosive materials can damage electronic parts Therefore the System should only be operated in a non corrosive atmosphere For optimal operation of the System main
11. Power Level Default 30 15 15 5 al a Pulse width Default Frequency Defaut 0 78 078 O78 Hz pamm 5 e o Default TP I R n a Pulse Pulse amplitude maximum maximum Table 4 2 Parameters for A2 33 Proprietary Information of ollogen 2 Maximus Non invasive body shaping System User Manual Version 7 5 6 3 Applicator 3 parameters Paameter Face Hands Time Default min Power Level RF Default 8 Pulse width Default Sec Frequency Default 078 078 O78 Hz Program Defaut RE TP Available RF RF TLP TLP TLP PULSE PULSE Pulse amplitude maximum Table 4 2 Parameters for A3 Notes e The tables represent the recommended default parameters to start with a new patient e Maximal levels of parameters are specified the table respectively e Refer to the treatment procedures below for instructions of parameters adjustment during the treatment e Refer to the treatment procedures below for instructions regarding the different treatment protocols e Recommended starting level for TriLipo muscle power indicated in treatment protocols 5 7 Treatment programs There are 3 treatment programs available For each treatment area certain program is available by default Treatment protocols are follow
12. Version 7 Proprietary Information of Po Applicator does not heat the treatment area Applicator No 1 2 or 3 Applicator does not heat the treatment area Applicator No 1 2 or 3 No text on the LCD No backlight on the LCD Display failure oystem does not stop treatment when Foot Switch is released No AC power the supply to unit oystem can not be switched off Mix up between Applicator connections Bio Feedback Control is not connected Communicati on problem AC DC Power supply failure LCD fault Foot Switch failure One of the inlet fuses is burned ON OFF switch failure lo oen 5 ooftware warning when switching ON the system APPLICATOR NO 1 ERROR APPLICATOR NO 2 ERROR APPLICATOR NO 3 ERROR CONNECT APPLICATOR No indication on either Applicator Software warning BIO FEEDBACK CONTROL DISCONNECTED Back light only on LCD ON OFF power switch is lit No backlight on the LCD ON OFF power switch is lit No indication on either Applicator Partial data displayed on the LCD Screen display still operating when Foot Switch is released No display on the LCD ON OFF switch is not illuminated in ON position System can not be switched off Ensure that Applicators are connected to their correct connector see Figure 3 If System still does not operate properly contact local Pollogen representative for service
13. of the Applicators is properly connected the System will display the status of all 3 Applicators and will remain in this status until Bio Feedback Control is pressed APPLICATOR 1 APPLICATOR 2 APPLICATOR 3 Ok NOTE By pressing the Bio Feedback Control system PRESS BIO FEEDBACK CONTROL verifies it s ready for proper operation Any disconnected Applicator may be connected at this stage and the System will indicate it on this screen e The System will allow operation if at least one of the Applicators is connected e Incase the Applicator chosen is not connected the system will sound an alarm with Error message and direct you to connect the chosen Applicator During the preliminary System check if the Bio Feedback Control is pressed the System check will stop and will not move on to next screen until released Once the Bio BIO FEEDBACK PRESSED Feedback Control is released the System will continue ac automatically after check is successful Once the preliminary System check is completed SYSTEM IS READY FOR USE screen will appear and the System will automatically go to the Choose Applicator Screen SYSTEM 15 READY FOH USE NOTE It is recommended to verify keys functioning before starting the treatment 4 2 Choosing an Applicator and a Treatment Area 4 2 1 Choosing the Applicator Select Applicator by pressing the UP DOWN key Press the OK key to confirm Press BACK Key to return to the previ
14. procedures AL BUTTOCKS 4 3 1 Changing TIME 25 way CECI RF POWER RF POWER 50 PULSE WIDTH 200 US S o PULSE HIDTH 27800 US Highlight the TIME option FREQUENCY 8 78 Hz FREQUENCY 8 78 HZ and press the OK key 6 E CN Adjust treatment duration SWITCH ise ERED To CHANGE time using the UP DOWN v keys Press OK to confirm 20 MIN TIME RF POWER RF POWER 50 PULSE WIDTH 200 US PULSE WIDTH 200 US FREQUENCY 6 78 HZ FREQUENCY 5 78 HZ PROGRAM TLP PROGRAM TLP READY PRESS OK TO CONFIRM ras FOOT SHITCHBEEESTTS TUIS Tia UP DOWN Beier ic Proprietary Information of Po O g en 25 Maximus Non invasive body shaping System User Manual Version 7 4 3 2 Changing POWER of Applicator 1 Highlight the RF POWER option by using the UP DOWN keys and press the OK key Adjust the power level using the UP DOWN keys Press OK to confirm Note PL mi PULSE WIDTH 208 US FREQUENCY a 78 He PROGRAM TLP READY PULSE WIDTH 200 FREQUENCY 48 78 HZ PROGRAM TLP READY xU FOOT 25 MIN RF POWER Y PULSE WIDTH 00 US FREQUENCY 0 78 HZ PROGRAM TLP PRESS D CONFI USE TO CHANGE RF POWER SET TIME 25 MIM RF POWER amp B d PULSE WIDTH 20 US FREQUENCY 8 78 HZ PROGRAM TLP PRESS Dk TO CONFIRA USE DTI TO CHANGE e Power level may be changed from 0 to 95 The number reflects relativ
15. the applicator connector with positioning grooves on its receptacle marked with label e Push the connector inside and fasten the connector nut properly e Make sure the red mark on the connector receptacle is totally covered with the nut Proprietary Information of P lo g en Maximus Non invasive body shaping System User Manual Version 7 3 3 7 Power supply cord connection Reminder Before connecting the power supply cable make sure that the ON OFF switch is in the OFF position 0 and the cable has a grounding wire 3 pin plug Proprietary Information of lo g e n 21 Maximus Non invasive body shaping System User Manual Version 7 4 User Interface 4 1 Turning System On Before turning the System on verify that the System power supply cord is connected to the System inlet on the back panel and to the power outlet The System must be connected to grounded power outlet 3 pin and must be used only with the cable supplied Cable 10A 250V 1 8m length Warnings e High voltage is present inside the System e Delivering excessive energy to the treatment area can damage the skin resulting in burns e Lock the front wheels during operation of the System see Fig 1 e Check all connections before plugging in the System s power supply cord e Verify that fan is functioning when operating the System In case of fan failure do not operate the device call your Pollogen representat
16. using a non contact infra red thermometer placed a few centimeters above the skin e Continue checking patient s skin temperature periodically every 2 minutes Make sure temperature does not exceed 45 throughout the treatment During the treatment some skin erythema redness and or edema swelling may develop to a different extent These signs are indications of the heating process e During treatment the TriLipo RF power should be adjusted increased or decreased to the maximum level pleasantly tolerated by the patient Do not increase TriLipo RF power level at once by more than 5 points e After finishing the treatment with TriLipo RF energy it is recommended to complete the treatment of the face cheeks area only and hands with a short session 5 minutes of TriLipo Muscle energy see Step 2 below Proprietary Information of Po lo g an 38 2 Maximus Non invasive body shaping System User Manual Version 7 Step 2 TriLipo Muscle energy minimum TriLipo RF ener Choose Muscle option on treatment 8 TREATMENT AREA areas menu This will enable the use of TriLipo muscle energy with a low level RF energy meant to maintain warmth feeling with default GO CONFIRM parameters appropriate for face cheeks area and hands areas Inorder to set the TriLipo muscle amplitude TriLipo power as shown on screen press on FS shortly and release
17. 2 Maximus Non invasive body shaping System User Manual Version 7 2 1 2 Control Panel The Control Panel serves as the user interface and is located on the top of the Main Unit The Control Panel includes Graphic LCD 4 function keys and regulation Jog button Buttocks 24 min Graphic LCD POWER TriLipo signal LED indication Trilipo power regulation Jog BACK key DOWN key UP key OK key Figure 2 User Interface Control panel Function Keys BACK BACK key returns to previous screen AA Scroll DOWN key chooses a parameter on the screen Scroll UP key chooses a parameter on the screen OK OK key activates selected function parameter Regulation Jog Button change TriLipo Power User Interface Options The MENU allows the following operations e Choose Applicator Applicator No 1 2 or 3 e Choose Treatment Area face neck arms tummy buttocks thighs or hands e Change RF Treatment Parameters of TriLipo RF energy Time and power setting e Change Treatment Parameters of TriLipo Muscle energy frequency pulse width settings Proprietary Information of Po lo g 7 Maximus Non invasive body shaping System User Manual Version 7 2 1 3 Back Panel Applicator holder Program Plug ON OFF Switch Fan Bio feedback connector Applicator 1 connector Applicator 2 connector Applicator 3 connector Device S N label Foot switch connector
18. F Output power control RF TriLipo pulse duration TriLipo pulse frequency TriLipo pulse amplitude Programs Weight Dimensions L57xW49xH127 cm with Applicators Holders assembled Table 1 Technical Specifications Wave form biphasic output specified to peak not peak to peak e 60601 1 Classification Class 10 Proprietary Information of Pi llogen 5 Maximus Non invasive body shaping System User Manual Version 7 2 3 Safety Features During the design phase of the system considerable thought was given to the user s safety This chapter describes safety issues regarding the use and maintenance of the system 2 3 1 Introduction The System is designed for safe and reliable treatment when used in accordance with proper operation and maintenance procedures The operator and all other personnel operating or maintaining the System should be familiar with the safety information provided in this chapter IN ORDER TO PREVENT THE MAXIMUS SYSTEM FROM USE BY UNQUALIFIED PERSONNEL TURN THE SYSTEM OFF WHEN SYSTEM IS NOT IN USE WARNING BEFORE ATTEMPTING TO OPERATE THE MAXIMUS SYSTEM BE SURE TO READ THIS MANUAL TO BECOME FAMILIAR WITH ALL SAFETY REQUIREMENTS AND OPERATING PROCEDURES WARNING HIGH VOLTAGE IS PRESENT INSIDE THE MAXIMUS SYSTEM ALWAYS TAKE PROPER PRECAUTIONS AS DESCRIBED IN THIS MANUAL WARNING ONLY QUALIFIED PERSONNEL WHO HAVE BEEN TRAINED BY POLLOGEN LTD
19. H SYSTEM OK After language is selected the System will move on to check proper connections 4 1 3 During the accessories check of the system the following warning messages may Appear During preliminary System check an alarm will sound if Foot Switch is not connected Once Foot Switch is connected properly the system will continue automatically after check FOOT SMITCH DISCONNECTED CONNECT FOOT SWITCH is successful During preliminary System check an alarm will sound if Foot Switch is pressed Once Foot Switch is released the FOOT SWITCH PRESSED System will continue automatically after check is successful RELEASE FOOT SWITCH During preliminary System check an alarm will sound if the Bio Feedback Control is not connected In case of disconnection the System check will stop Once the Bio BIU FEEDBACK DISCONNECTED Feedback Control is connected properly the System will Sita continue automatically after check is successful During the preliminary System check if any Applicator is disconnected or if any Applicator is connected to the wrong connector an alarm will sound and stop at this screen until 20228 ERROR APPLICATOR 2 ERROR at least one of the Applicators is properly connected Rec a Ee E CONNECT APPLICATOR Proprietary Information of Po O g en 23 Maximus Non invasive body shaping System User Manual Version 7 During the preliminary System check if at least one
20. HE CHEST BREASTS OR UNDERARMS DO NOT USE WITHOUT GLYCERIN OIL DO NOT USE OILS BASED ON MINERAL OIL FOR TREATMENT DO NOT HEAT THE SKIN OVER 45 5 8 2 Body treatment protocol Once the treatment area is selected and the treatment plan has been discussed with the patient it is recommended to take a picture and measurements of the treatment area for recording the pre treatment condition in the patient s file Prepare the treatment area e Clean with soap and water e Dry completely after cleaning e Lubricate the treatment area thoroughly using medical grade Glycerin 87 or higher purity THEN e Select the appropriate applicator and the treatment area For optimal results use the default program TLP for body treatment This protocol incorporates the combined energy of TriLipo RF and TriLipo Muscle e Provide the patient with the Bio Feedback Control and show them how to strap the Velcro band around the fingers with the push button in range of their thumb for easy access Then explain that they can stop the treatment at any time by pressing the button in case of discomfort e Maneuver the patient into a comfortable position for treatment e Please note that TriLipo muscle amplitude is set to zero by default e In order to set the TriLipo muscle amplitude TriLipo power as shown on screen press on FS shortly and release Proprietary Information of Po y 35 Maximus Non invasive body sha
21. LCD when Foot Switch is pressed Warning on the screen BIOFEEDBACK IS PRESSED Applicator does not heat the treatment area Warning on the screen APPLICATOR 1 ERROR No indication on the Applicator No 1 Beeps when Foot Switch is pressed Warning on the screen APPLICATOR 2 ERROR No indication on the Applicator No 2 Beeps when Foot Switch is pressed Warning on the screen APPLICATOR 3 ERROR No indication on the Applicator No 3 Beeps when Foot Switch is pressed If System still does not operate properly contact local Pollogen representative for service Release Bio Feedback Control release Foot Switch and press Foot Switch If System still does not operate properly contact local Pollogen representative for service Check that Applicator No 1 is properly connected with locking mechanism Replace Applicator No 1 If Applicator still does not operate properly contact local Pollogen representative for service Check that Applicator No 2 is properly connected with locking mechanism Replace Applicator No 2 If Applicator still does not operate properly contact local Pollogen representative for service Check that Applicator No 3 is properly connected with locking mechanism Replace Applicator No 3 If Applicator still does not operate properly contact local Pollogen representative for service 4 Maximus Non invasive body shaping System User Manual
22. Lipo Muscle Energy cannot be adjusted Machine in Ready Mode No TriLipo Muscle Energy output No TriLipo Muscle Energy output Applicator failure TriLipo Energy output is intermitted 20 Temp End point is not reached Temp End point is not reached Thermometer Failure Temperature reading inaccurate 14 15 16 17 18 19 21 22 Proprietary Information of Po lo p en J Contact local Pollogen representative for service Contact local Pollogen representative for service Contact local Pollogen representative for service Press shortly on FS to enable TriLipo Mode calibration Contact local Pollogen representative for service No TriLipo RF PPB Failure No TriLipo RF Energy Contact local Pollogen Energy output output representative for service Replace Applicator Replace Thermometer a Results are not Pure glycerin is not used Use high grade glycerin oil seeing 43 Maximus Non invasive body shaping System User Manual Version 7 9 Warranty Terms This product is powered by TriLipo technology the most advanced technology in the market and has been subjected to strict quality control performed by the manufacturer For this reason the TriLipo distributor in your country guarantees proper function of your product for 12 months from date of actual purchase If you use the device properly follow all instructions outlined in the user manual you can enjoy the product
23. Non Contact Infrared Thermometer 10 Figure 10 Unpacking the System 17 Tables Table 1 Technical Specifications Table 2 Explanation of User Manual Symbols Table 3 Labels Affixed To The Device Table 4 1 Treatment Parameters Applicator 1 Table 4 2 Treatment Parameters Applicator 2 Table 4 3 Treatment Parameters Applicator 3 Proprietary Information of Pe J lo E enn d Maximus Non invasive body shaping System User Manual Version 7 1 INTRODUCTION The Maximus system is intended for use in general dermatologic procedures The Maximus system is indicated for use in dermatologic procedures for non invasive body shaping skin tightening reduction of cellulite and treatment of wrinkles using the Combination of TriLipo RF energy and TriLipo Muscle energy Intended place of the device Clinics amp Hospitals Intended users Healthcare professionals I E Doctors amp Nurses and subject to the local regulations Maximus consists of 6 main parts Main Unit Applicator No 1 for the treatment of large body areas Applicator No 2 for the treatment of medium size body areas and face Applicator No 3 for the treatment of very small facial areas and hands Foot Switch and Bio Feedback Control The operator can adjust all system parameters from the user interface screen on the front panel 2 SYSTEM DESCRIPTION This chapter provides a detailed description of the Maximus system including its main components
24. SE PROTECTIVE EARTH GROUND TYPE BF APPLIED PART ATTENTION CONSULT ACCOMPANYING DOCUMENTS Table 2 Symbols used throughout this User Manual 2 5 2 Labels affixed to the System and its accessories The labels shown in the following table Table 3 are affixed to the back of the Main Unit as well as accessories These include serial numbers of system parts and a few usage warnings z EAM s Device serial Pollo Or Lm 68012 Tel Aviv israel number label MAXIMUS 100V 240V MAX 2 2 A 50 60 Hz MX1000001 TERR LIA Made in Israel f Patent pending 0344 F 7 218 TA APPLICATOR 2 Label on Applicator No 2 connector L3 APPLICATOR 3 Label on Applicator No 3 connector L abel on Bio BIO FEEDBACK Feedback Control connector FOOT SWITCH Label on Foot Switch connector 15 Proprietary Information of Po logen 5 Maximus Non invasive body shaping System User Manual Version 7 nt Applicator 4 Applicator No 1 20900230 serial number label ARC m er Applicator No 2 21400230 serial number label 0344 MA2100 Anni itor 3 Applicator No 3 21401590 serial number label AIRC P TT ARP Bio Fee Feedback Bio Feedback PEF 21000020 Control serial KC number label BF 12001 01 X zm Foot Swen Foot Switch serial 21110000 number label RC Enu 5 PFS0800011 ANN Ly Table 3
25. bally amp regularly throughout treatment The patient may feel a mild tingling sensation Treatment thermal endpoint is reaching skin temperature of 40 42 and maintaining it for a few minutes at least the recommended exposure time Monitor the skin temperature using a non contact infra red thermometer placed a few centimeters above the skin e After reaching skin temperature end point adjust the TriLipo Muscle amplitude to the maximum value tolerated by the patient The patient should feel local pleasant muscle activation e Continue checking patient s skin temperature periodically every 2 3 minutes Make sure temperature does not exceed 45 throughout treatment During the treatment some skin erythema redness and or edema swelling may develop to a different extent These signs are indications of the heating process e During treatment the TriLipo Muscle amplitude and the TriLipo RF power should be adjusted increased or decreased to the maximum level pleasantly tolerated by the patient e In case muscle activation is too subtle TriLipo Muscle parameters pulse width pulse amplitude and frequency may be increased gradually Do not increase TriLipo RF power level or TriLipo muscle amplitude at once by more than 5 points Proprietary Information of Po lo g en 36 Maximus Non invasive body shaping System User Manual Version 7 e Inthe case of patients with sensitive skin it is recomm
26. e of treatment typical treatment results realistic expectations and possible side effects and discomfort Instruct the patient as to the safety warnings Prior to beginning treatment the patient should sign an informed consent form 5 5 Possible Side Effects Improper use of the System could result in possible side effects Although these effects are rare and expected to be temporary any adverse reactions should be reported to a physician immediately Side effects may appear either at the time of treatment or shortly after Side effects may include any of the conditions listed below Prolonged Pain Excessive skin redness Erythema Damage to natural skin texture crust blister burn Excessive Swelling Edema Excessive tingling sensation Fragile skin Bruising 32 Proprietary Information of Pe lo g en Maximus Non invasive body shaping System User Manual Version 7 5 6 Treatment Parameters The default parameters recommended for treatment are based on physician s experience the Maximus System are indicated in the below tables 5 6 1 Applicator 1 parameters Thighs e Level RF Maximum 5 width usec Maximum 40 _ 278 0 78 Frequency Default 0 78 0 78 Hz LP Te HP TLP TLP TLP PULSE PULSE PULSE 99 99 Table 4 1 Parameters for A1 5 6 2 Applicator 2 parameters Parameter Arms Time Default min
27. e power levels in percentage from minimum to maximum e For safety reasons Power level for different treatment areas is limited See Table 4 TriLipo Muscle energy 4 3 3 Changing PULSE WIDTH Highlight the PULSE WIDTH option using the UP DOWN keys and press the OK key Adjust the PULSE WIDTH using the UP DOWN keys Press OK to confirm 4 3 4 Changing the FREQUENCY Highlight the FREQUENCY option using the UP DOWN keys and press the OK key Adjust the FREQUENCY using the UP DOWN keys Press OK to confirm TIME 2 EF wi AL BUTTOCKS PULSE WIDTH FRERUENCY 0 78 HZ PROGRAM POHER PULSE HIDTH FREQUENCY PROGRAM READY east FOOT SHITCH BRE 2375113 Al BUTTOCKS TIME 2 MIN PUREE 2 Y d PULSE WIBTH 200 US FREQUENCY 0 78 HZ PROGRAM BUTTOCKS 45 MIN RF POHER PULSE HIDTH 120 US FREQUENCY PROGRAM TLP cia FOOT SHI TCHECA 23 5 112 Proprietary Information of Po O g en PULSE HIDTH SET TIME 25 MIN RF POMER y PULSE HIDTH OE LIS FREQUENCY 68 78 HZ PROGRAM TLP PRESS OK TO CONFIRM USE TO CHANGE E TIME RF POHER Ea LL son us FREQUENCY a He PROGRAM TLP PRESS OC TO CONF IRA USE TO CHANGE TIME 25 HIN RF POHER So y PULSE zo US FREQUENCY PROGRAM TLP PRESS OK TO CONFIRH USE TO CHANGE RF POHER PULSE HIDIH 120 US FREQUENCY PROGRAM TLP PRESS TO CONFIRM Ex
28. ed TLP program which combines TriLipo RF and TriLipo Muscle energy RF program applying TriLipo RF energy only PULSE program applying TriLipo Muscle energy only 5 8 Treatment Procedure There are 2 treatment protocols to be followed by the user Each one of them is designated for different areas in the body e Treatment protocol for body areas includes buttocks thighs tummy and arms see Section 5 8 2 e Treatment protocol for face and hands This protocol is comprised from 2 separate steps first step is applying TriLipo RF energy only and second step which is optional and restricted to specific area is applying TriLipo Muscle energy see Section 5 8 3 34 Proprietary Information of Pe J lo p ern D Maximus Non invasive body shaping System User Manual Version 7 5 8 1 General guidelines and warnings e When starting with a new patient at the beginning of the first treatment the pre programmed default parameters should be used e Please note the default parameters are the typical starting point and should be adjusted according to each patient individually e Exact treatment parameters are individual and should be adjusted increased or decreased according to patient feedback and skin tolerance e After each Maximus treatment the applicator should be cleaned by wiping all plastic parts and the electrodes with a soft non abrasive cloth moistened with medical grade alcohol 7096 DO NOT TREAT T
29. elow Proprietary Information of Pe J lo E ern d 37 Maximus Non invasive body shaping System User Manual Version 7 e Provide the patient with the Bio Feedback Control and show them how to strap the Velcro band around the fingers with the push button in range of their thumb for easy access Then explain that they can stop the treatment at any time by pressing the button in case of discomfort e Maneuver the patient into a comfortable position for treatment Protocol is comprised of two consecutive steps Step 1 TriLipo RF energy enabled onl e Position the clean Applicator onto the skin of the patient and start moving it Then press the Foot Switch for treatment to begin FACE TINE H HIN press BF POWER I5 PULSE WIDTH e FREQUENCY PRDGRA RF READY i m T TREAT MENT rim FOOT SHITCHRI NI ar iS nu COUNTER 05 e Apply the applicator with mild pressure and use a rubbing massaging technique linear circular etc depending on the area All electrodes should be in full contact contact with the skin When administrating the treatment the applicator should move at all time on the skin e Monitor heat sensation verbally amp regularly throughout treatment Treatment thermal endpoint is reaching skin temperature of 40 42 and maintaining it for a few minutes at least the recommended exposure time Monitor the skin temperature
30. ended to reduce TriLipo RF power level and TriLipo Muscle amplitude gradually 5 8 3 Face amp Hands treatment protocol NEVER TREAT OVER THE EYE SOCKET NEVER APPLY TRILIPO MUSCLE ENERGY ON THE NECK NEVER APPLY TRILIPO MUSCLE ENERGY ON THE TEMPLE AREA Default treatment program for sensitive area uses TriLipo RF energy only Maximum TriLipo RF power level for face is restricted to 30 When treating face and hands areas TriLipo Muscle energy can be applied after treatment with TriLipo RF TriLipo Muscle energy should never be applied on the neck area since the carotid sinuses the anterior neck and the vagus areas should be strictly avoided When treating the face use TriLipo Muscle energy only on the cheeks area Once treatment area is selected and treatment plan has been discussed with the patient it is recommended to take a picture and measurements of the treatment area for recording the pre treatment condition in the patient s file Prepare the treatment area e Clean with soap and water e Dry completely after cleaning e Lubricate the treatment area thoroughly using medical grade Glycerin 87 or higher purity e DO NOT USE OILS BASED ON MINERAL OIL FOR TREATMENT DO NOT HEAT THE SKIN OVER 45 THEN e Select the appropriate applicator and the treatment area e For optimal results select default program RF for face amp hands protocol which uses only the TriLipo RF energy see Step 1 b
31. ensured only when well trained personnel operate the system A patient s medical history should be completed prior to scheduling a treatment Patient s should be fully informed of the treatment protocols including inclusion and exclusion criteria clear expectations realistic results and if there are any risks associated with the treatment 2 4 1 Cautions The following cautions should be taken for safe System use e Do not touch the inner parts of the System SERVICE IS PROVIDED ONLY BY COMPANY AUTHORIZED PERSONNEL e Keep the Applicators clean See cleaning instructions in section 6 2 of this user manual Do notallow the Applicator to come in contact with hard objects that can damage the RF electrodes Do not connect a patient to a HF surgical equipment during treatment Do not use Maximus device in close proximity to a short wave or microwave therapy equipment Donottreat the area near the thorax which may increase the risk of cardiac fibrillation 2 4 2 Electrical and Mechanical Safety e Keep all covers and panels of the System securely closed at all times when in use Removal of the covers or panels can create a safety hazard e Perform maintenance procedures when the System is shut down and disconnected from power outlets e Always keep the System s wheel breaks locked to avoid uncontrolled movement When movement is necessary unlock the breaks before doing so Always move the System slowly and carefully The System ma
32. et Contact Information Customer satisfaction is a Pollogen priority To help us in providing you with the best possible product and support please send us your comments and suggestions Contact us at the details below Pollogen Ltd 6 Kaufman St Gibor House PO Box 50320 Tel Aviv Israel 68012 Telephone 972 3 510 4110 Facsimile 972 3 510 4112 Web Site www pollogen com www tripollar com Email info pollogen com Proprietary Information of Pe llogen Maximus Non invasive body shaping System User Manual Version 7 Table of Contents ao INTRODUCTION TO THE SYSTEM 5 SYSTEM DESCRIPTION 5 SYSTEM COMPONENTS AND CONTROLS MAJOR PRECAUTIONS amp WARNINGS 14 ain INITIAL SET UP 17 UNPACKING THE SYSTEM GENERAL INSTALLATION REQUIREMENTS 17 PREPARATION FOR OPERATION USER INTERFACE 22 TURNING SYSTEM ON 22 42 CHOOSING APPLICATOR TREATMENT AREA 24 PROGRAM UPDATE PROGRAM UPDATE TURNING SYSTEM OFF 30 MAXIMUS TREATMENT 1 POSSIBLE SIDE EFFECTS 32 TREATMENT PARAMETERS TREATMENT PARAMETERS 6 TREATMENT PROTOCOL AND CONCLUSION 40 MAINTENANCE 40 SYSTEM CLEANING APPLICATOR CLEANING ORANGE CUPS CLEANING TROUBLESHOOTING 41 9e WARRANTY TERMS 44 Proprietary Information of ollogen 2 Maximus Non invasive body shaping System User Manual Version 7 Figures Figure 6 Applicator No 3 9 Figure 7 Foot Switch 9 Figure 8 Bio Feedback Control 9 Figure 9
33. etary Information of Pe J lo E er A Maximus Non invasive body shaping System User Manual Version 7 e Any surgical invasive ablative procedure in the treatment area before complete healing e As per practitioner s discretion refrain from treating any condition which might make it unsafe for the patient 5 3 Precautions opecial caution should be taken in the following cases e Patients taking medications herbal preparations food supplements or vitamins that might cause fragile skin or impaired skin healing such as prolonged steroid regime Isotretinoin Accutane tetracyclines or St John s Wort e Patient having any medical condition that might impair skin healing e Aesthetic procedures in the treatment area such as fillers gold plastic threads fat implants Note In case of uncertainty regarding potential side effects have the patients consult their physician and bring consent for treatment 5 4 Pre Treatment Preparation During the first visit the operator or an authorized staff member should assess the areas intended for treatment and take the following actions Take a detailed patient medical and physical history including previous treatment methods Determine if the patient is suitable for treatment do not treat patients with any of the contraindications outlined in this User Manual Determine why the patient is seeking treatment and what his her expectations are Inform the patient as to the cours
34. g 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 the system 7 2 Cleaning the Applicators After every treatment clean the Applicator by wiping all plastic parts and the electrodes with a soft non abrasive cloth moistened with medical grade alcohol 70 The patient contact part of the applicators must be cleaned between patients using standard disinfection methods for skin contact devices 7 3 Cleaning the orange rings For cleaning the orange rings inside the applicators holder may be pulled out Gently press the bottom part of the orange ring towards the inside until it releases from the holder 40 Proprietary Information of Pe llogen Maximus Non invasive body shaping System User Manual Version 7 8 ES Proprietary Information of Pe lo gen 5 Troubleshooting Applicator does not heat the treatment area Applicator does not heat the treatment area Applicator does not heat the treatment area Applicator No 1 Applicator does not heat the treatment area Applicator No 2 Applicator does not heat the treatment area Applicator No 3 Cause of Failure Foot Switch failure Bio Feedback control is pressed Applicator No 1 connection problem Applicator No 2 connection problem Applicator No 3 connection problem Description No feedback on
35. ive for service e Do not operate the unit in the presence of electromagnetic interference Electromagnetic interference may be caused by electro surgery diathermy magnetic resonance imaging or other type equipment e Portable and mobile are RF communication equipment amp may affect operation of this device 4 1 1 To turn on the system switch the ON OFF control to the ON position on the back panel The button will turn green ON OFF switch on the back panel 0 position pressed OFF 1 position pressed ON A Pay attention to the screen quality that it is OK during the first few seconds of the system check LCD will become blue and then turn white At this time the Applicators LED will flash first Green then Orange as part of the System s self system check In the following cases please consult your Pollogen Service representative Residual blue pixels while the screen turns white No applicator indications appear e LCD becomes blue and then turns white While the LCD is Proprietary Information of Po lo g 2 Maximus Non invasive body shaping System User Manual Version 7 white Led Indicator on the applicators flashes green and then orange 4 1 2 Following a screen quality check appears yielding a SYSTEM message if self test is successful Then the System will automatically move to the Choose Language screen Tri Lipo E PROGRAM VERSION TIN K
36. nector It s also consists of a plastic body with an integrated electronic system 3 electrodes and indication light guide ring When not in use the applicator should be stored in its cradle Figure 6 Applicator No 3 2 1 7 Foot Switch The Foot Switch is used for system activation upon press The Foot Switch is supplied with cable and connector IE Figure 7 Foot Switch 2 1 8 Bio Feedback Control The Bio Feedback Control is used as a patient control in the case of discomfort It consists of a plastic body with button Velcro strip and cable with connector Figure 8 Bio Feedback Control Proprietary Information of Po lo g 9 Maximus Non invasive body shaping System User Manual Version 7 2 1 9 Non Contact Infrared Thermometer Infrared thermometer Figure 9 measures the surface temperature of the skin An optical component of the unit collects energy emitted reflected and transmitted and focuses it onto a detector Then an electronic component translates the Figure 9 Non Contact Infrared Thermometer information into a temperature reading which is displayed on the thermometer The laser is used for aiming purpose only Please note that calibration is required yearly and is within your responsibilities Pollogen do not calibrate or follow up thermometers calibration 2 2 Technical Specifications Parameter Input voltage Mode of operation Maximum output power RF Output frequency R
37. nge 4 5 2 Indication on Operation panel and LCD e Yellow LED blinks when the TriLipo Muscle energy is transmitted to the applicator electrodes Blinking frequency corresponds with transmitted pulse frequency During normal operation procedure on LCD presented chosen applicator number treatment area and current treatment parameters Proprietary Information of Po lo g 28 Maximus Non invasive body shaping System User Manual Version 7 Operation status READY TREATMENT AL BUTTOCKS T IME 25 MIN TRILIPO e Frame icon appears if Trilipo muscle energy is transmitted RF POWER 50 In case of events or errors the relevant PULSE WIDTH 2808 US messages will appear on the LCD FREQUENCY 0 78 HZ PROGRAM TLP TREATMENT eS 4 6 Program Update The System is equipped with the possibility of an external program plug located on the device back panel see figure 3 In the case where program update will be required you will be provided with an external program plug Each time System is turned on the System will check if new version program plug is connected To perform software update do the following 1 Switch OFF the System 2 Unscrew the 2 plug screws and release the plug window cover in new unit or the existing plug In case of it not being your first update Plug screw 3 Connect the new plug and screw the screws back into their places 4 Note Program version is marked
38. on the plug supplied 5 Switch ON the System 6 Once program plug with updated version of program is connected the System will sound an alarm and ask you to confirm the new program installation Proprietary Information of Po lo g 29 Maximus Non invasive body shaping System User Manual Version 7 7 Press OK to confirm new program installation procedure By pressing BACK system will ignore new program installation procedure The System will indicate the installation progress by a bar of stars asterisks 8 Once installation is successfully completed the system will automatically restart Note The new program version Version appears on the System OK screen Verify that the new program installed matches the program marked on the supplied plug PROGRAM VERSION X E SYSTEM OK 9 In case the program was not successfully installed the System will sound an alarm and indicate by a warning message on the screen Try to repeat installation by restarting the system Switch ON OFF If the device does not operate please contact you Service representative 10 Leave the new used plug inside the connector for connector protection 4 7 Turning the System OFF To turn off the system switch the ON OFF control to the OFF position on the back panel The green light will switch off Disconnect power supply cord Warning Before disconnecting the power supply cord make sure that the ON OFF s
39. or light guide ring will turn orange TriLipo Muscle energy After each press and release of the Foot Switch a yellow indicator LED is lit on the machine parallel to an indication on screen e Buttocks FRAME icon OK F _ TriLipo signal CUM DO E TRILIPO appears woen i LED indication ce wer 50 output signal is PULSE width 200 US i presence fe owen ey 0 78 hz sail PROGRAM TLP Trilipo power treat ment regulation Jog Counter 00 05 D Operation The following features are implemented for safety operation procedure Tostart the treatment the Foot Switch must be pressed down by the operator e If the Foot Switch is released treatment is stopped and counter on LCD stops as well e With starting the treatment Trilipo Power always is set to 0 E BUTTOCKS press I ME 45 MIN TRILIPO RF POWER 85 POWER MQ PULSE WIDTH 150 US FREQUENCY 78 2 HH PROGRAM TLP1 TREATMENT COUNTER Baas e Counter indication of cumulative time of machine use is located at the bottom of the Choose Applicator screen It enables track of the total cumulative RF hours output CHOOSE APPLICATOR ADEL TcAroe 1 APPLICATOR z APPLICATOR amp PRESS TO CONFIRM HES Gia Proprietary Information of Po lo g en 13 Maximus Non invasive body shaping System User Manual Version 7 2 4 Major Precautions amp Warnings Patient safety can be
40. ous screen 4 2 2 Choosing the Treatment Area Select the treatment area by highlighting it using the UP DOWN key Press OK key to confirm Press the BACK key to return to the previous screen Proprietary Information of Po lo g en 24 Maximus Non invasive body shaping System User Manual Version 7 CHOOSE APPLICATOR HO USE APPLICATOR CHOOSE APPLICATOR APPLICATOR 1 APPLICATOR 1 APPLICATOR 1 APPLICATOR 2 W APPLICATOR z W APPLICATOR 2 APPLICATOR 3J APPLICATOR 3 m APPLICATOR 3 e PRESS TO CONFIRN HES i8 oh PRESS OK T CONF IRA PRESS UK FO CONF IRA HHS 18 38 HRS 10 28 EE CHOOSE TREATMENT AREA CHOOSE TREATMENT AREA FACE HANDS MUSCLE NECK FACE ALISCLE TUH HY MUSCLE Press PRESS TO CONFIRM PREBB TU CONFI Note When the treatment area has been chosen default treatment parameters will appear on the screen 4 3 Changing System s Default Parameters For safety reasons each time you switch OFF the System all parameters return back to the default values Each one of the treatment parameters may be easily changed using the simple user interface e Select a parameter to be changed by highlighting it using the UP DOWN key Press OK to select parameter and then follow instructions below for that parameter mode exposure or power TriLipo RF energy Applicator 1 is used as an example in below
41. ping System User Manual Version 7 TIME SU MIN f 7 MIM TRILIPO BF POHER 2 POWER sA POHER PULSE HIDTH 230 US i I PULSE WIDTH 209 UB FREQUENCY HZ Frequency 8 78 uz HA i PROGRAM TLP i i PROGRAM TLF EERDY am TREATHEHT FOOT S COUNTER 7 It is recommended to increase the amplitude to 20 using the TriLipo power Jog on the front panel BUTTOCKS MIN ITEILIPU 75 HIN TRILIPO RF POKER IE PULSE HIDIH 266 US FREQUENCY 5 78 HZ PROGRAM TREATMENT A TREATRENT COUNTER 86 05 MMC COUNTER 08 65 POHER HA HEHE HR PULSE WIDTH 200 US FREQUENCY 8 78 HZ PROGHEA M TLP e Position the clean Applicator onto the skin of the patient and start moving it Then press the Foot Switch for treatment to begin En BUTTOCKS press T 1 ME 75 MIH TRILIPO RF POHER MEJ POHER __ PULSE WIDTH 268 US FREQUENCY 0 78 HZ 2L PROGRAM TLP TREATMENT COUNTER T _ e Apply the applicator with mild pressure and use a rubbing massaging technique linear circular etc depending on the area Make sure all electrodes should be in full contact with the skin When administrating the treatment the applicator should move at all time on the skin It is recommended to do the treatment in the direction of the lymphatic drainage e Monitor heat and muscle activation sensation ver
42. r foot switch is pressed or released Note TIME FREQUERCY PROGRAM TLP FREQUENCY TRILIPO POHER add 2 MIN HF 3 PULSE WIDTH 266 US 68 78 HZ TREAT AEA COUNTER DOI GS FAIA RF POHER au PULSE WIDIH 288 US ERU Mer TI THEI LIPO POHER PROGRAM TREATMENT COUNTER If the Foot Switch is released and pressed again the counter will stop and then continue to count remaining time For safety reasons always verify Operation stopped once Foot Switch is released Proprietary Information of Po g 21 Maximus Non invasive body shaping System User Manual Version 7 Bio feedback control System will immediately stop the treatment once bio Y BIO FEEDBACK PRESSED feedback control is pressed MERETUR press During treatment the System is continuously checking proper connection of chosen Applicator Foot Switch and Bio Feedback Control In case of connection failure the System DUC will sound an alarm and display a warning message see Foot porre ee Switch connection error as an example 4 5 Indications 4 5 1 Applicator Indication After press and release of the Foot Switch the indicator light guide ring on the chosen applicator will turn green e When the Foot Switch is pressed and TriLipo Energy is transmitted to the electrodes the indicator light guide ring will turn ora
43. rthquakes floods fire lightening etc force majeure or accident 7 Damage to the device after being subjected to high dust environments humidity or application of excessive voltage from the power inlet 8 If the product s serial number has been amended or erased 9 o cosmetic damage including but not limited to scratches and dents 44 Proprietary Information of Pe J lo E en 2
44. tain room temperature between 15 30 C keep relative humidity at less than 80 and maintain Atmospheric pressure of 0O0hPa to 1060hPa Moving the System Turn the System off Disconnect the power cord Foot Switch and Bio Feedback Control Place the Applicators into their cradles Release the wheel brakes With one hand securing the Applicators slowly push or pull the System using its handle gt NS Proprietary Information of Po lo g 17 2 Maximus Non invasive body shaping System User Manual Version 7 ONLY MOVE THE SYSTEM BY USING ITS HANDLE PUSHING OR PULLING THE SYSTEM WITHOUT USING ITS HANDLE MAY TURN THE SYSTEM OVER AND RESULT IN DAMAGE TO THE SYSTEM 3 3 Preparation for Operation 3 3 1 Applicator and cable holders assembly procedure e out holder s base out of box Assemble applicator holder base on machine chassis using supplied 4 screws Make sure to tighten screws properly out cable holders out of the box Place each cable holder inside the available holes e Superpose screw hole in cable holder with the corresponding place of applicator holder Fasten with supplied screws Make sure to tighten screws properly Proprietary Information of Po O g en 18 Maximus Non invasive body shaping System User Manual Version 7 Place each applicator in its cradle and arrange its cable along the designated pathway on the arc
45. to your ultimate satisfaction This policy warrants the support that the distributor provides for the TriLipo device should it happen that failures attributable to manufacturing defects be found In such case you shall be entitled to make full use of the benefits of this warranty This implies the reason and replacement of parts free of charge regarding both service and parts at any Authorized Service Center Within its validity term you are entitled to make use of the warranty if necessary to have a fully enjoyable product provided the above indicated conditions are fully met This warranty is valid for the TriLipo device marketed by the distributor in your country The warranty is not valid when 1 Amendments in the warranty policy sales receipt or invoice or the absence of any of these original documents 2 Damage or deterioration of the device due to improper use or if the device has been modified or repaired by an unauthorized third party 3 Damage of the product due to defects incurred during transportation such as bumps bangs or improper handling 4 Damage due to humidity or any kind of liquids foreign bodies inside the device or the use of unapproved unadvised accessories with the device contradictory to the user manual 5 When the device is not used in accordance with the respective user manual or with its supplied accessories 6 Partial or total damage or loss of the device due to natural disasters such as ea
46. uld not be treated e Under 18 years of age e Pacemaker or internal defibrillator implanted neurostimulators or any other internal electric device Do not use on patients who have had an implant in the past unless you are absolutely certain that the implant and all leads in their entirety have been removed e Metal implants or other implants in the treatment area e Pregnancy or nursing or on abdomen during the menstruation Current or history of cancer especially skin cancer or pre malignant moles Impaired immune system due to immunosuppressive diseases such as AIDS and HIV or use of immunosuppressive medications e Sever concurrent conditions such as cardiac disorders or epilepsy e Patients whose condition could be negatively affected by heat Patients with a history of diseases stimulated by heat such as recurrent Herpes Simplex in the treatment area may be treated only following a prophylactic regime e Patients having diminished or exaggerated perception of temperature changes e Patients having areas of sensory impairment such as in cases of nerve lesions and neuropathies e Any active condition in the treatment area such as sores hemorrhages or risk of hemorrhages septic conditions psoriasis eczema and rash as well as excessively freshly tanned skin e Varicose veins in the treatment area e History of skin disorders such as keloid scarring abnormal wound healing as well as very dry and fragile skin 3 Propri
47. witch is in the OFF position 0 Proprietary Information of Po o g en 30 Maximus Non invasive body shaping System User Manual Version 7 5 Maximus TREATMENT The following are safe start guidelines for treatments on body and face with the Maximus oystem This information is based on the observations and clinical experience of doctors and clinicians experienced with the TriLipo Technology This is intended as a guide and it is not a replacement for clinical training certification or supervised experience Please follow the instructions in this User Manual Maximus is a precise and effective tool for body shaping procedures Using higher parameters than needed or longer treatment sessions can cause over treatment and lead to undesired over heating or over sensitization of the skin e NEVER TREAT OVER THE EYE SOCKET e DO NOT TREAT THE CHEST BREASTS OR UNDERARMS e NEVER APPLY TRILIPO MUSCLE ENERGY ON THE NECK 5 1 Indications for use The Maximus system is intended for use in general dermatologic procedures The Maximus system is indicated for use in dermatologic procedures for non invasive body shaping skin tightening reduction of cellulite and treatment of wrinkles using the Combination of TriLipo RF energy and TriLipo Muscle energy The Maximus treatment is suitable for various body areas on all skin types 5 2 Contraindications Patients having the following conditions sho
48. ximum level pleasantly tolerated by the patient Do not increase TriLipo Muscle amplitude at once by more than 5 points e In case muscle activation is too subtle TriLipo Muscle parameters pulse width pulse amplitude and frequency may be increased gradually e Incase of patients with sensitive skin it is recommended to reduce TriLipo Muscle amplitude gradually Proprietary Information of Po le g en 39 Maximus Non invasive body shaping System User Manual Version 7 Treatment of face and hands can be completed with Applicator 3 using TriLipo RF program on perioral and periorbital areas or on the fingers respectively 5 9 Post Treatment Care Refer to the following recommendations to determine your own suitable course of action for post treatment care In case of excessive edema or erythema cool the area well for at least 15 minutes until heat sensation fades Typically there will be a slight edema or slight erythema which may last for 1 3 days If side effect persists beyond the above indicated period the patient should seek medical advice 6 Treatment Protocol and Conclusion Normally treatment should be administrated once a week for at least 4 6 successive weeks Few maintenance treatments are recommended every 4 8 weeks according to individual needs to sustain long term results Treatment should be concluded when operator and patient are satisfied with the results 7 MAINTENANCE 7 1 Cleanin
49. y cause injury if proper care is not taken when moving it System is grounded through the grounding conductor inside the power cable This protective grounding is essential for safe operation e Verify fan operation when operating the device and stop device operation when fan is not operating e Verify that once the Foot Switch is released the treatment will stop and the counter on LCD will stop as well 2 4 3 Fire Hazards use the System in the presence of explosive or highly flammable materials like Alcohol Methanol Acetone etc The suggested use of the Glycerin oil is in no way an explosive or highly flammable material and is approved for usage e f alcohol is used for cleaning and disinfecting it must be allowed to dry thoroughly before the oystem is used and then set a distance from the System 2 5 Symbols amp Labels This section describes the symbols used throughout this user manual Table 2 and the labels affixed to the Maximus System It is recommended that users review the meaning of these labels for everyday usage and in case any details are needed for service purpose The table Table 2 below briefly reviews a number of internationally recognized symbols that are found on the Maximus main unit 14 Proprietary Information of Pe lo g en Maximus Non invasive body shaping System User Manual Version 7 2 5 1 Symbols Used in this User Manual SEE INSTRUCTIONS FOR U
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