User s manual Manuel d utilisation Manual de uso Benutzerhandbuch Manuale d uso Handleiding voor de gebruiker Manual de utilizaçăo Användningshandbok

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1 User s manual Manuel d utilisation Manual de uso Benutzerhandbuch Manuale d uso Handleiding voor de gebruiker Manual de utilizaçăo Användningshandbok

2 2

3 English 4 Francais 24 Espanol 44 Deutsch 64 Italiano 84 Nederlands 104 Portugues 124 Svenska

4 English CONTENTS 1 SAFETY INFORMATION 6 2 SAFETY INSTRUCTIONS 7 3 WARNING TO THE END USER 7 4 INSTALLATION Description 9 Installation 9 5 STEP-BY-STEP INSTRUCTIONS First use 10 Setting in rotating mode 10 Use in rotating mode 12 Setting in reciprocating mode 13 Use in reciprocating mode 14 Ultrasonic mode setting 14 Use in ultrasonic mode 15 6 STERILIZATION AND SPARE PARTS Autoclavable components 16 Non-autoclavable components 17 Replacement instruments 17 7 MAINTENANCE Ultrasonic handpiece 17 Tip maintenance 17 Motor maintenance 17 Control unit maintenance 18 8 TROUBLESHOOTING 18 9 TECHNICAL / PERFORMANCE DATA DISPOSAL AND RECYCLING WARRANTY ELECTROMAGNETIC COMPATIBILITY Electromagnetic emissions 20 Electromagnetic immunity 21 Electromagnetic immunity / Radiofrequency mobile equipment 21 Recommended separation distances 22 Cable lengths MANUFACTURER S LIABILITY REGULATIONS CUSTOMER RELATIONS 184 4

5 Thank you for purchasing the ENDOCENTER The ENDOCENTER is a unique product combining a piezo-electrical ultrasonic generator and a Digital electrical endodontic micromotor The ultrasonic generator, using the NEWTRON ź technology, offers the unique following features: - Automatic real-time frequency adjustment for a perfect vibration of the instruments (auto-tuning) - Full control of oscillation amplitude (push-pull) - Feedback control of the power to avoid breaking the instruments The micromotor is compatible with all major file manufacturers It integrates an encoder to ensure an accurate angular positi on The SATELEC ź technology enables to drives the files: - As a traditionnal rotating motion - With a Reverse/Forward angular motion, called reciprocating movement Indications for use The ENDOCENTER is designed to carry out dental procedures, especially for root canal treatments In order to receive the most out of this high technology product, and prolong its life, we ask you to read these instructions carefully before using the device for the first time Refer to the separate manuals or operating instructions to cover the operation and maintenance of handpieces or other accessories used with the unit The User Manual is supplied for safety reasons and must be considered as an integral part of the system We recommend always keeping it close at hand It is of the utmost importance that this manual be retained for future consultation The manual must accompany the system in all cases of sale or other transfer in order that you as the new owner can be aware of its operational characteristics, the relative preca utions and warnings and the intended use Please do not hesitate to contact SATELEC ź for help with any doubt or problem that may arise during consultation of this User Manual These symbols found on labels of the unit and accessories remind you to consult this User Manual Notes These instructions for use are available in several languages upon request Changes to the content of these instructions are reserved without prior notice Manufacturer: By Dental, a company of ACTEON ź group Via Vecchia Provinciale Lucchese, Serravalle Pistoiese Italy Distributor: SATELEC ź, a company of ACTEON ź group 17 AveGustave Eiffel, BP Merignac Cedex France wwwacteongroupcom 5

6 1 SAFETY INFORMATION Note the meaning of the following symbols: Protection class II Type B device See Directions of Use; if the instructions are not being followed properly, operation may result in hazards for the product or the user/patient Warning or Precaution Do not dispose of as normal household waste; special disposal according to the Directive 2002/96/EEC of concerning waste of electrical/electronic equipment CE marking Can be placed in Washer disinfector Potential risk with patient having ICDs United States Federal Law restricts the use of this unit exclusively to trained, competent and licensed dental healthcare professionals, or under their control Read this instruction booklet carefully before installing and using the machine to obtain the best possible results and maxim um operating safety SATELEC ź liability is applicable only if it used as directed, and if the safety instructions are properly followed SATELEC ź is not liable for uses other than those specified in this manual Most problems and accidents result form insufficient attention being paid to the manufactureržs recommendations Contraindication Interference may occur when used on patients with cardiac pacemakers This system emits electromagnetic fields, which means t here are some potential risks The malfunctioning of implantable devices such as cardiac pacemakers and ICDs - implantable cardioverter defibrillator (in general, any type of active implant) is possible: Ask patients and users if they have an implanted device before using this product Explain the circumstances to them Weigh the risks and benefits and contact your patient s cardiologist or appropriate qualified healthcare professional prior to performing the treatment Keep this product away from implanted devices Make appropriate emergency provisions and take immediate action if patients become ill Symptom including a raised heartbeat, irregular pulse, and dizziness may signal problems with a cardiac pacemaker or ICD The device is no designed to withstand shocks delivered by an electrical defibrillator 6

7 2 SAFETY INSTRUCTIONS Take the following precautions to reduce the risk of any accident: Environment Determine a suitable location within the following precautions: Do not immerse the device in liquid, and do not use it outdoors Do not expose the device to water vapor, or splashes The device is not designed for use in the presence of anesthetic gases or any other flammable gas The device is not designed to work near ionizing radiation Do not install near a source of heat or humidity (piping, valves, and tanks) In order to maximize air flow, install the device in a ventilated area Do not cover the device or obstruct the air vents Make sure that the cords do not hinder the free passage of people Accessories The device has been developed to be used with SATELEC ź ultrasonic tips For hygienic and prophylactic purposes SATELEC ź periodontic and scaling tips can also be used Using non SATELEC ź tips may damage the handpiece and even the tips themselves The device can only accept accessories designed by SATELEC ź for the particular use for which they are intended Use of accessories from other manufacturers is a potential hazard for you or your patients and the operator assumes all risk for their use Maintenance Before maintenance, switch the device off and unplug the power cord After use, turn-off the the power, and remove the irrigation bottle and its hanger When unplugging the power cord, hold both the power supply and the power socket in the wall Do not carry out repairs or modifications to the device without prior authorization by SATELEC ź Do not disassemble or alter the console, the motor, handpiece or footswitch If any fault occurs, contact your local supplier rather than have it repaired by an unauthorized person or contact the After Sales Service of SATELEC ź Installation The device must not be connected to or used in combination with any other apparatus or system It must not be used as an inte gral component of any other apparatus or system The device complies with the Electromagnetic compatibility standards (CEI ), however, make sure that any possible electromagnetic interference does not present any additional risk The electric supply to which the device is connected must comply with the standards in force in your country Adverse reactions Unknown 3 WARNING TO THE END USER The ENDOCENTER should be used only with handpieces, Motor & ultrasonic tips from SATELEC ź Refer to their manuals for specific operating conditions User population The use of the ENDOCENTER is exclusively limited to trained, competent and qualified dental healthcare professionals in the ordinary course of their activities The user must have the mandatory skills related to the principles of dental and medical hygiene such as cleaning, disinfectio n, and sterilization of medical devices The ultrasonic and electric motor functions can be used without taking in consideration the adult user s characteristics such as weight, age, size, sex and nationality The user must wear gloves The user is not the patient Users must not - Have memory or concentration problems preventing them to remind properly the setting, the sequences or treatment protocols - Suffer from a disability of upper or lower limbs preventing them to use the handpiece as well as the footswitch - Have visual disturbances If so, they should be equipped with means of vision corrections Training of the users No specific training other than the initial vocational training is required when using the ultrasonic function 7

8 Patient Population The ultrasonic and electric motor functions can be used with the following patients without consideration of physical characteristics such a s weight (except for children), age, size, sex and nationality: - Children - Teengers - Adults - Seniors The ultrasonic and electric motor functions are prohibited to the following population: - Infant - Pregnant and lactating women - Patients with medical complications - Allergic patients - Patients located on a clinical site which does not enable to carry out the treatment The patient must be calm, relaxed, motionless, ideally lying on a dental chair Body parts or tissue types covered The clinical use of the ultrasonic and motor functions has to be limited to the buccal cavity of the patient Principle of operation of Device Ultrasonic: An electrical signal issued by the ultrasonic generator is supplied to a ultrasonic dental handpiece which is connected to the module located inside the dental unit through a cord The handpiece includes a piezoelectric ceramic transducer that transforms the electrical signal into ultrasonic vibrations The mechanical vibrations are transmitted to a dental instrument screwed onto the end of the transducer Motor: A rotating motor coupled with a dental contra-angle enables to drive dental rotating and reciprocating files Significant performance characteristics Ultrasonic: Ultrasonic vibration of the instrument fixed at the end of the dental handpiece: - Vibration frequency 28 khz - Amplitude of motion: 200 m Motor: Rotation speed of the instrument fixed at the end of the contra-angle: - Maximum speed rpm - Maximum torque 10 Ncm Applied parts Dental ultrasonic handpiece Dental ultrasonic instruments, tips Dental contra-angle handpiece Endodontic files Use The medical device is not restricted to a number of uses Depending on the number of repeated use, the pressure and the selected power, the tips and files may exceptionally break It is recommended to use a succion system during use of the medical device 4 INSTALLATION Carefully remove the unit and the accessories from their packaging and place them properly on a flat surface in the desired location Before set-up, check that all parts are present in the box: Central unit Footswitch (Fig 4) Wallplug power supply Ultrasonic handpiece Sterijoint Endo MicroMotor / Cord Irrigation clips Irrigation bracket Irrigation line Handpiece holder Tip wrench Set of tips User manual 8

9 Notes None of the components are delivered disinfected or sterilized! Prior to installation, check the device for any damage Report any damage sustained during shipment to your local supplier within 24 hours of receipt of the device 41 DESCRIPTION The Front panel includes: The LCD screen and the keyboard to display and select the required clinical mode and set the parameters (See Fig 3 for keyboard description) The Ultrasonic handpiece cord connection fixed on the left side (Fig 11) The Micromotor cord connection on the right side (Fig 12) A receptacle for the irririgation hanger (Fig 13) The Rear panel includes (see Fig 2): The On / Off switch (Fig 24) The footswitch cord connection (Fig 25) The external power supply connection (Fig 26) The peristaltic pump system (Fig 27) Multifunction footswitch Mode (Fig 41) Purge (Fig 42) On/Off irrigation (Fig 43) On/Off motor or ultrasonics (Fig 44) 42 INSTALLATION Notes: The ENDOCENTER should be connected to the electrical supply in accordance with current standards 1 Check that the power adjustment knob is set to position OFF 2 Check the voltage present on your power line (100V to 240V) 3 Slot the plug (in compliance with the standards applicable in your country) onto the transformer and connect it to the main 4 Connect the power cord to the ENDOCENTER by inserting the connector into the receptacle on the back of the unit 5 Place the 4 grey silicone holders to the 4 metallic parts 6 Place the footswitch properly to make operation easy 7 Connect the footswitch into its receptacle at the back of the unit 8 Plug the micromotor cord to the device being careful to align the plugs and their receptacles 9 Plug the ultrasonic handpiece on its cord (to work without irrigation) and align the electrical contacts (see Fig 5 below) Plug the Sterijoint in between the ultrasonic handpiece and its cord (to work with irrigation) and align the electrical contacts 10 Plug the contra-angle onto the Micromotor 11 Insert the bracket on its holder, and hang the bottle or bag of solution on the bracket 12 Pull out the pump tray, insert the irrigation cassette inside the tray and close it 13 Insert the irrigation line perforating pin into the bottle or bag and open the irrigation line by pulling back its cap 14 Fasten the irrigation line to the cord using line clips and connect it to the sterijoint Notes: The Irrigation solution should satisfy the quality criteria required for dental treatment Never use a bottle with a capacity higher than 1000 ml Fig 5 Handpiece Connection 9

10 5 STEP-BY-STEP INSTRUCTIONS Notes Before and after each use, your device must be disinfected with appropriate products Before each procedure, it is essential to make sure that the accessories to be used have been cleaned, disinfected and sterilized Before turning on the unit, check if you have completed the installation of all components 51 FIRST USE When first switched on, the current software version appears on the screen for few seconds: ACTEON ENDOCENTER V10 And the values set by manufacturer are displayed: ULTRASONIC Power range: Soft Setting: 3 Pump: 2 According to the expected use, press the MODE key to toggle from Rotating Mode to Reciprocating Mode or Ultrasonic mode or press on the multifunctional footswitch (Fig 41) Notes The ENDOCENTER will store the operative parameters for each program as soon as they are set by the user and they will be maintained in the memory even if the central unit is switched off To reset the parameters to the manufacturer presets (Software unit reset), press the MODE key while the unit is switched on The LCD screen will display the message: SOFTWARE RESET 52 SETTING IN ROTATING MODE Torque Calibration: 1 Select Rotating using the MODE key or the multifunctional footswitch (Fig 41) 2 Plug the E-Type contra-angle onto the micromotor: use only contra-angle that conforms to ISO Press Ratio, and with the + and - keys, set the reduction ratio according to the contra-angle you selected Press again Ratio to valid your choice 4 Perform a torque calibration, using the Calib key on the front panel while holding the micromotor This function chec ks the handpiece mechanical inertia, in order to off-set this value This operation will take a few seconds, the motor will run at a different speed, and the LCD screen will display the following message: Calibrating Please wait Notes Wether in rotating or reciprocating mode, the calibration should be performed at each change or lubrication of the contra-angle Time of Calibration: about 8 sec Do not perform the calibration if the motor cord is not connected the unit In case of error, perform a System Reset as described in 51 Do not perform any operation during calibration The file must not be engaged in any operation when the calibration is performed Programs: The library of the ENDOCENTER enables to store 5 programs in rotating mode Once you have selected ROTATING using the MODE key or the multifunctional footswitch (Fig 41), use the + and - keys to toggle from P1 to P5 For each program it is possible to set: Ratio, speed, torque, type of auto-reverse, direction FWD or REV and Flow rate 10

11 Every program has been preset with the same information - Ratio: 16:1 - Direction: FWD - Speed: 300 Rpm - Special autoreverse: ON - Torque: 05Ncm - Flow rate: 0 ROTATING - P1 Ratio: 16:1 FWD Rpm: 300 A/R: SAR Torque: 05 Ncm Pump: 0 Notes The listed parameters are only examples To prevent unnecessary risk, observe the guideline speeds given by the manufacturer of the rotating instruments and the guideline given by the manufacturer of the Contra-Angle in use The first row shows the: MODE and Program in use The second row shows the: Contra-angle reduction rate (left) Direction FWD or REV (right) The third row shows the: Speed in use in Rpm (left) Type of Autoreverse SAR/AR/STP (right) The fourth row shows the: Torque in Ncm (left) Flow rate (right) To adjust a parameter (Ratio, Rpm, Torque, Pump): Press its related key (see Fig3) Adjust the value with + and - keys Press again its related key for validation Torque adjustment The Torque values are expressed in Ncm and depend on contra-angle reduction rate, See the following table for 16:1: Ncm MAX Rotation Switch between forward and reverse motor rotation by pressing directly on FWD/REV key (in reverse, console emits a beeping tone) 11

12 Speed Sets motor rotation speed in Rpm See the available values in the following table: Speed vs Contra-angle Ratio 1:1 6:1 8:1 16:1 20:1 32: A/R mode Set the type of Auto reverse mode by pressing directly on AR MODE key: STP: Autoreverse OFF When set the torque value is reached, the motor stops without rotation AR: Autoreverse standard When the file reaches the set torque value, the motor runs reverse until the motor has been stopped Next start will be in Fo rward SAR: Autoreverse special When file reaches the set torque value, the motor runs reverse until it has freed the file Then the motor runs again automatically in forward Notes AR and SAR modes are in use only if the torque is not set on Max Beeping sound notifies user when 75% of the preset torque has been reached and when preset torque limit has been exceeded Flow: Set the value of the irrigation flow from 0 to 9 53 USE IN ROTATING MODE Once the parameters have been set: 1 Fit an instrument (file) to the contra-angle 2 Check the integrity of the device and its accessories before use in order to detect any problem Do not use the device if it appears to be damaged or faulty 3 Press the footswitch (Fig 44) 4 The motor starts running 12

13 Notes Settings: Refer to the file manufacturer instruction to set the related speed and torque (wwwsateleccom/documents) Precautions during use Do not move the device during use Handpiece should only be attached when the motor has stopped running Never touch files or other handpiece tips when they are still rotating Do not disconnect the micromotor cord when the device is switched on and the footswitch is pressed Do not engage the instrument to or disengage it from the contra-angle when the micromotor is running Upon completion of the clinical procedure 1 Switch off the device 2 Remove the instrument fastened to the contra-angle 3 Disconnect the contra-angle from the micromotor 4 Disinfect and sterilize the accessories (as mentioned by the manufacturer) Clean and desinfect the device and its accessories 54 SETTING IN RECIPROCATING MODE Torque Calibration: 1 Select Reciprocating using the MODE key or the multifunctional footswitch (Fig 41) 2 Plug the contra-angle onto the micromotor 3 Set the reduction ratio according to the contra-angle, and perform a torque calibration by pressing Calib key Programs: As for the rotating, in reciprocating, the library of the ENDOCENTER includes 5 programs preset as following: - Ratio: 16:1 - Speed: 250 Rpm - FWD angle: 30 - REV angle: Flow rate: 0 RECIPROCATING - P1 Ratio: 16:1 FWD : 30 Rpm: 250 REV : 150 Pump: 0 Notes Again, the listed parameters are only examples To prevent unnecessary risk, observe the guideline speeds given by the manufa cturer of the rotating instruments and the guideline given by the manufacturer of the Contra-Angle in use (wwwsateleccom/documents) The first row shows the: MODE and Program in use The second row shows the: Contra-angle reduction rate (left) FWD angle in degree (right) The third row shows the: Speed in use in Rpm (left) REV angle in degree (right) The fourth row shows the: Flow rate (right) To adjust a parameter such as Ratio, Rpm, FWD, REV and Pump: Press its related key (see Fig3) Adjsut the value with + and - keys Press again its related key for validation The angle parameters go from 10 to 360 with 5 steps 13

14 55 USE IN RECIPROCATING MODE Once the parameters have been set: 1 Fit an instrument (file) to the contra-angle 2 Check the integrity of the device and its accessories before use in order to detect any problem Do not use the device if it appears to be damaged or faulty 3 Press the footswitch (Fig 44) 4 The motor starts running 5 Use the same note (53) and observe precautions than those descibed in rotating mode 56 ULTRASONIC MODE SETTING Before operating the unit: 1 Select Ultrasonic using the MODE key or the multifunctional footswitch (Fig 41) 2 Sterilize the handpiece, the Sterijoint (if used) and tips (see section Sterilization ) 3 Select the appropriate tip, and connect it by screwing it on with the supplied wrench Tighten it moderately (see Fig 6 below) Fig 6 Tip tightening with wrench 4 Make sure there is no trace of moisture in the handpiece connection, if this is the case then wipe it and dry it with the air blower Then connect the handpiece carefully to the handpiece connection without twisting or rotating If irrigation is needed, connect the Sterijoint in between the handpiece and its cord Warning Neither rotate the handpiece nor twist the handpiece connector on its cord Correct tip vibration requires a tight fit, but without over-tightening it Over-tightening the tip with force may damage tip and/or handpiece Do not rotate the handpiece during installation of the tip when the handpiece is already connected to the cord Program: The program preset is as following: - Power range: Soft - Setting: 3 - Pump: 2 ULTRASONIC Power range: Soft Setting: 3 Pump: 2 The first row shows the: MODE The second row shows the: Power range The third row shows the: The power setting The fourth row shows the: Flow rate 14

15 Power range SATELEC ź developed and patented a system of identification and selection of ultrasonics instruments according to their ideal power range The tips are color coded to show their recommended power range and the same color coding is used on the ENDOCENTER front panel Soft power and amplitude, Green Especially dedicated to Periodontics and implant maintenance Medium power and amplitude, Yellow Mainly used for Endodontics High power and amplitude, Blue Even if the ENDOCENTER is focused toward endodontics application, the high power delivered enables to carry out Prophylaxis and conservative clinical procedures Boost power and maximum amplitude, Orange For specific applications requiring high power such as crown loosening Setting Once you have selected the power range use the + and - keys to select the power setting from inside the following ranges: Soft: from 1 to 5 Medium: from 6 to 10 High: from 11 to 15 Boost: from 16 to USE IN ULTRASONIC MODE Endodontic application Notes Prior to the endodontic treatment place a rubber dam to avoid inhaling any foreign objects Sufficient optical magnification is recommended The indicated power ranges and setting are only relevant for operating the ENDOCENTER with SATELEC ź tips These recommended ranges may not be appropriate for other ultrasonic generators and tips The recommended settings are determined both by the clinicianžs experience with ultrasonics and SATELEC ź tips 1 Choose the tip in accordance to coronal access, root anatomy, procedural application and general visibility 2 After selection of the appropriate tip, screw it on the handpiece 3 Check the color coding ring of the tip, and select the related power range key on the front panel 4 Refer to the tip book and note the appropriate minimum power setting for the tip that is being used 5 Adjust the power setting with the + and - keys 6 Irrigate with an appropriate solution, directly through the tip or with a syringe 7 Check and adjust the irrigation flow by pressing on Pump key and adjsut the flow with + and - keys 8 Press the footswitch (Fig 44) 9 If needed, increase the power gradually Observe whether this setting allows safe procedure If not efficient enough, increas e the power gradually up to the maximum power setting for that tip, to maximize clinical performances 10 Use irrigation whenever the clinical situation is appropriate Precautions regarding breakage Do not switch quickly to the maximum level for each indication in order to avoid tip breakages Too much vibration will damage the tip Never activate an irrigation file by pressing the footswitch as long as it is still in the air and has not yet got in touch with the root canal Even if used according to the instructions, within the recommended power range, the tip can break in some case The ultrasounic tips are equipped with an irrigation port Check and adjust the irrigation during procedure Other applications The ENDOCENTER allows to carry out scaling and periodontic treatments with SATELEC ź tips which are compatible with the device In general, the scaling tips are used at high power, whereas the perio tips are used at low power 15

16 Dry operation and Irrigation It is mandatory to always use the water spray during scaling and perio treatments Dry operation without cooling can lead to overheating of the handpiece and might cause a necrosis To avoid this from happeni ng, work intermittently, ie take breaks (2 min operation/5 min pause) when using the tip For cooling external irrigation with a syringe is recommended For high-power applications, eg dislodging a metal post, it is mandatory to use water for cooling by adjusting the water spray knob Other medium-power applications, eg during retreatment, can be carefully carried out in dry procedure for a short time 6 STERILIZATION AND SPARE PARTS Notes Follow the maintenance and/or sterilization instructions before using the accessories supplied for the first time Avoid using cleaning agents and disinfectants containing inflammable substances If unavoidable, ensure that the product has evaporated and that there is no combustible product on the device and accessories before operation Consider concentration and contact time recommended by the manufacturer of the disinfectant Use a disinfectant with tested effectiveness (eg DGHM certification or CE mark) or which is in compliance with any standard required by the national regulations 61 AUTOCLAVABLE COMPONENTS 611 Ultrasonic handpiece and Sterijoint 1 After each use, flush the irrigation circuits of the ultrasonic handpiece with distilled water (with the footswitch button Fig 42) and tip at low power level for around sec 2 Disconnect the tip, the sterijoint and the handpiece 3 Disassemble the nozzle from the handpiece 4 Clean the handpiece and sterijoint with an alcohol wipe before sterilization 5 The handpiece can also be placed in a washer disinfector if available 6 Put the handpiece and sterijoint in a sterilization pouch for autoclaving 7 Autoclave at 134 C for 18 minutes, or 132 C for 4 minutes according to the instructions given by the autoclave manufacturer 8 After sterilization thoroughly dry the electrical contacts of the handpiece 612 Ultrasonic tips Prior to sterilization carry out pre-disinfection, mechanical cleaning and drying 1 Put on thick gloves when cleaning the tips with alcohol wipes or immerse the tips in an ultrasonic tank (enzymatic, quaternar y ammonium base detergent/disinfectant solution) 2 Place under running water for at least 30 seconds 3 Scrub the tips in a new disinfectant bath (enzymatic, quaternary ammonium base detergent/disinfectant solution) for at least 30 seconds, and in any case until all remaining traces of contamination have been removed 4 Rinse again under running water for at least 30 seconds 5 Finally, dry with clean, non-woven single-use cloth to remove any traces of liquid 6 Put it in a sterilization pouch for autoclaving 7 Autoclave at 134 C for 18 minutes or 132 C for 4 minutes according to the instructions given by the autoclave manufacturer Notes Irrigation clips and silicone handpiece holders can be sterilized Autoclave at 134 C for 18 minutes, or 132 C for 4 minutes according to the instructions given by the autoclave manufacturer Autoclave in a standard autoclave (type B; compliant with standard EN 13060) with a cycle of 134 C for 18 minutes at a pressure of 2 bar minimum As not all autoclaves can reach 134 C and draw a pre-vacuum Some use cycle of 132 C for 4 minutes Please refer to your autoclave manufacturer for specific sterilization instructions Autoclave and dry temperatures must not exceed 135 C Thoroughly clean the components before autoclaving as described above If chemical solutions or foreign debris are not removed, autoclaving could damage or deform the components Autoclave handpiece and tips after each patient A second handpiece can be purchased to ease the procedure Do not sterilize in another way than in an autoclave During sterilization, metal parts of different types must not touch each other Any contact will lead to the formation of electrolytic coupling causing localized deterioration 613 Contra-angle and files Read carefully the instructions given by their manufacturers 16

17 62 NON-AUTOCLAVABLE COMPONENTS The ENDO micromotor / cord, the ultrasonic handpiece cord, the footswitch and the control unit are not sterilizable Wipe the micromotor/cord, the handpiece cord, the footswitch and the control unit with an appropriate dental disinfectant sol ution (eg Septol wipes) Ensure that the product has evaporated and that there is no combustible product on the device and accessories before operation 63 REPLACEMENT INSTRUMENTS After certain time of use the tips and files will change due to average wear Refer to the tip card of SATELEC ź and the instructions given by the files manufacturers Follow the instructions and precautions in the Tip Book from SATELEC ź Replace the instruments if necessary depending on degree of wear and duration of usage Reorder replacement parts from your local supplier 7 MAINTENANCE Upon completion of the dental procedure and before maintenance, disconnect the handpieces, the cords and remove the instrumen t from the handpieces 71 ULTRASONIC HANDPIECE As a routine : after treatment with irrigation flow, flush the water circuits of the handpiece and tip with distilled water at low power level for around seconds by pressing down the footswitch button (Fig 42) In case of damage, excessive wear at least once a year: replace the watertight O-ring which is located in the rear part by using the fitting tool (for details see Fig 7 below) Fig 7 O ring replacement Note Lubricate the water-tight O-ring with appropriate dental lubricant in order to prolong its efficacy and prevent internal leaks 72 TIP MAINTENANCE Basically, shape and mass of a tip are the determining factors to obtain consistent performance of the ultrasonic generator The thinner the diameter of a tip, the less the tip should be re-used After a certain time of usage the shape of a tip will gradually be modified, ie the tip will become shorter Operation with a worn tip will lead to longer preparation time and may increase temperature in the cavity or root canal It m ay also lead to tip breakage 73 MOTOR MAINTENANCE Do not sterilize or lubricate the micromotor and do not disassemble the motor or motor connector External surface of the micromotor may be cleaned with a damp cloth or disinfectant wipe Do not place micromotor in ultrason ic sterilizers Do not bend motor cord sharply Do not drop or impact the micromotor against a hard surface as the micromotor is sensitive to shock 17

18 74 CONTROL UNIT MAINTENANCE 1 Regularly inspect accessories and cords for insulation defects and replace if necessary 2 Regularly check whether the air vents of the control unit are clean to avoid overheating 3 It is necessary to remove any traces of moisture in the handpiece connections; if yes dry it by wiping and airblowing Warning Do not use the device if it appears to be damaged or faulty Use only power adaptor provided by SATELEC ź Do not insert metal objects into the device (risk of electric shock, short-circuit or emission of hazardous substances) 8 TROUBLESHOOTING If the device does not operate correctly review the checklist below in order to exclude any user error before contacting your local supplier or SATELEC ź directly Problem Possible cause Solution Defective Power supply or Check mains socket Power cord connection Check if the cord is correctly plugged Return to After Sales Service No operation Unit has not been switched Check the On / Off switch on Defective Footswitch Check that the footswitch is correctly plugged, return to to After Sales Service Motor doesn t work Connection damaged Check that the motor cord is correctly plugged, return to to After Sales Service Motor Damaged Return to After Sales Service Unit damaged Return to After Sales Service Damaged pump system Return to After Sales Service Bad irrigation line insertion Remove the irrigation line Damaged irrigation line Change the irrigation line No irrigation Obstructed tip or irrigation file Remove obstruction Wrong tip selection Check tip Incorrect spray adjustment Re-adjust water flow Insufficient power Low vibration Bad tightening Worn or deformed tip Check the tip is corectly tightened Replace tip Presence of fluid or moisture Thoroughly dry electrical between handpiece and cord contacts with air Incorrect tip tightening Re-tighten with wrench Clean cord contacts Defective connector contact No ultrasonic output Check that the cord is correctly plugged Return to After Sales Service Cut wire in handpiece cord for cord replacement Water leak between handpiece and its base Worn O-ring in handpiece Replace the O-ring or at junction between handpiece or cord Note Find additional information in the SATELEC ź Tip Book giving specific recommendations on how to properly use the SATELEC ź endodontic tips 18

19 9 TECHNICAL / PERFORMANCE DATA ENDOCENTER Model/Type ENDOCENTER device Manufacturer By Dental - Via Vecchia Provinciale Lucchese, 49 F/G Serravalle Pistoiese - Italy Distributor SATELEC ź - 17 av Gustave Eiffel - BP Mérignac Cedex - France Dimension - Weight Control unit:255 x 100 x 195 mm - 14kg Foot pedal: 173 x 43 x 177mm 610g Device protection class Protection Class II Applied component type BF Intermittent operation 5 min Operation / 10 min Pause Conformity IEC , IEC , OC certified following CB scheme Ultrasonics Maximum frequency 28 khz Maximum amplitude 200 m Handpiece dimension & weight Ű 21 x100 mm - 52 g Micromotor Minimum speed rpm with 1:1 Contra-angle Maximum Torque 10 Ncm Handpiece dimension & weight Ű 20 x120 mm g Power supply Model PowerBox - Medline EXM Imput voltage 100 to 240 VAC Output 24 VDC - 29 Amps Ambient conditions Operating temperature +10 to +40 C at a maximum of 95% relative humidity without condensation Storage temperature -20 to +70 C at a maximum of 95% relative humidity non condensing Atmospheric pressure 500 to 1060 hpa Altitude 2000 meters (6500 feet) Note Not suitable for use in presence of flammable anesthetics or oxygen 10 DISPOSAL AND RECYCLING As The ENDOCENTER falls under the category of electric/electronic equipment, the unit must be disposed of according to a spezialized procedure for collection, pick-up and recycling or destruction (especially on the European market, with reference to the Directive 2002/96/EEC of ) As soon as the unit reaches the end of its life cycle, it is strongly recommended to contact the local dealer to obtain information on how to proceed 11 WARRANTY Important please read this limited warranty carefully to understand your rights and obligations The manufacturer hereby certifies the correct construction of the product, use of top-quality materials, performance of all the required testing, and product compliance to pertinent laws and regulations in force The product is covered by warranty for a period of 12 months (excluding tips) beginning on the date of delivery to the end user as attested by the billing documents, containing the serial number of the unit, issued by the seller at the moment of purchase The user has the right to request assistance under warranty only during the warranty period and only on condition that he notifies the manufacturer of the defect in writing within 2 months from the date the defect is noticed 1 This warranty covers only replacement or repair of single components or pieces affected by manufacturing defects, excluding all expenses for visits by technical personnel and packing expenses 2 This warranty does not extend to damage or breakdowns attributable to incorrect maintenance, incorrect power supply, negligence, and/or unskilled handling The warranty does not cover trouble attributable to the user s negligent failure to perform ordinary maintenance (see instruction manual) 3 This warranty does not provide for any compensation for direct or indirect damages of any kind to persons and/or things attributable to the inefficient operation of the unit 19

20 4 This warranty shall automatically be void if the unit is repaired, modified, or in any manner tampered by the user or by unauthorized third parties 5 For repairs under warranty, the user must contact only the dealer or the manufacturer s authorized service centers, or the manufacturer themselves It is the responsibility of the user to ensure that the packing is in perfect condition or in any ca se suitable for safely shipping the unit 6 Controversies regarding application of the warranty or the quality or condition of the devices supplied shall not grant the purchaser the faculty to suspend payment for the devices, in full or in part by installment 7 The purchaser shall have no right to request compensation for device down-time 8 This warranty expressly excludes defects: - caused by damage during shipping - which are not attributable to manufacturing defects but rather to normal wear caused by proper use of the device (and in particular, calcification and wear of the parts subject to wear) - caused by atmospheric events such as (for example) lightning, by fires, and by humidity and in general by any other situation or event not directly attributable to the manufacturer 9 This warranty does not include transportation costs The warranty has validity only if accompanied by the billing document proving date of purchase of the product Note The manufacturer has the right to modify the device and/or the user manual without prior notice Service Form In case your device is defective please return it to SATELEC ź and include the following information: Your address (or stamp): Name: Street: Post code, place, country: Telephone: Fax: Contact person: The device was purchased on (date): at (eg dealer, or sales rep): Please clean and sterilize the device before returning it, and include all accessories SATELEC ź After Sales Service 17 Avenue Gustave Eiffel, BP30216 F , Mérignac Cedex, France 12 ELECTROMAGNETIC COMPATIBILITY Important: The power cord, the ultrasonic handpiece cords and the multifunction footswitch cord must be kept away from each other The device requires special precautions to be taken with regard to electromagnetic compatibility It must be installed and prepared for use as described in chapter 4 Certain types of mobile telecommunication devices such as mobile telephones are likely to interfere with the device The recommended separation distances in this paragraph must therefore be complied with The device must not be used near or on top of another device If this cannot be avoided, its operation under the conditions of use must be checked beforehand The use of accessories other than those specified or sold by SATELEC ź as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the device 121 ELECTROMAGNETIC EMISSIONS The device is intended for use in the electromagnetic environment specified in the table below The user and/or installer must ensure th at the device is used in such an environment 20