User's manual • Manuel d'utilisation • Manual de uso
Contents
1. Identification of key areas common to all modes that also display information Fig 3 1 Flush prime 3 Irrigation ON OFF 8 Save store data 10 Select footswitch mode 11 ON OFF of light function on handpiece 12 Select mode according to connected handpiece type Key areas and displays specific to the selected mode PIEZOTOME mode Identification of information display areas Fig 4 13 Selected program power level Identification of key areas that also display information Fig 4 14 Select program 01 02 D3 04 NEWTRON mode Identification of information display areas Fig 5 15 Selected program power level Identification of key areas that also display information Fig 5 16 Select program Soft Medium High Boost I Surge mode Identification of information display areas Fig 6 17 Contra angle ratio 18 Motor speed value 19 Motor delivered torque value Identification of key areas Fig 6 20 Adjust contra angle ratio 21 Adjust motor speed 22 Adjust motor delivered torque Identification of key areas that also display information Fig 6 23 Select micro motor rotation clockwise or counterclockwise 24 Select program P1 P2 P3 P4 Contra angle speed and torque setting adjustment page Identification of common information display areas Fig 7 25 Contra angle ratio 26 Maximum d2. Avoid using cleaning and disinfection agents containing flammable substances If this is not possible make sure that all the agent has evaporated and that there is no combustible matter on the device or its accessories before it is switched on Sterilized items must be allowed to dry and cool to room temperature before they are reused Before sterilization check that your autoclave is clean and that the water used is of adequate quality After each sterilization cycle remove the items from the autoclave immediately in order to minimize the risk of metal corrosion 11 1 IRRIGATION LINE MAINTENANCE Sterile irrigation line The irrigation lines supplied by SATELEC are disposable and must always be discarded after use Re use of an irrigation line may result in contamination of your patients and expose you to de facto liability Do not attempt to resterilize the single use irrigation lines Do not attempt to modify the irrigation lines Sterilizable irrigation line Refer to the user s manual delivered with the equipment 22 11 2 CONTRA ANGLE MAINTENANCE Refer to the manufacturer s instructions for your contra angle 11 3 ROTARY INSTRUMENT MAINTENANCE Please refer to the manufacturer s instructions for your instruments burs drills etc 11 4 DEVICE MAINTENANCE A Important Never use an abrasive cleaning agent on the device Do not use sprays or liquids to clean and disinfect the IMPLANT CENTE
3. Push the fuse drawer back into its housing until it clicks to indicate the correct position Plug the power cord into the receptacle Fig 2 1 Plug the power cord into the electrical supply 25 Note The device also has an internal fuse not accessible to the user Contact SATELEC after sales service see Chapter 2 Repairs All the information necessary for the repair of faulty components is made available by SATELEC to the technical personnel of the SATELEC approved dealer network who carry out the work 12 4 OPERATION FAULTS Refer to the tables on the next page Power cord not plugged in properl check the electric socket puss Return to SATELEC after sales Aucun fonctionnement e PA m Ecran LCD teint Power switch in position O OFF Place the power switch in position ON power voltage Call an electrician Power receptacle fuse s blown Replace the power receptacle fuses Internal fuse blown Return to SATELEC after sales Device does not operate fault Switch the device OFF then ON again LCD screen on Return to SATELEC after sales Check the motor cord connector Check that the cord connector is properly Motor does not operate Motor or motor connections problem plugged into the motor connector of the device Return to SATELEC after sales Wrona EE Change the g 8 Return to SATELEC after sales hermal cut out Allow the micro mo
4. Alternating current Courant alternatif Corriente alterna Wechselstrom Corrente alternata Wisselstroom Corrente alternativa V xelstr m EvaAAaoo nevo pe pa Control footswitch P dale de commande Pedal de mando Fufipedalkabel Pedale di comando Bedieningspedaal Pedal de comando Kontrollpedal EAEYXoU Device power OFF Appareil hors tension Equipo sin tensi n Ger t AUS Apparecchio fuori tensione Apparaat Uit Aparelho fora de tens o Apparat ur spanning Atevepyomonp vn Device power ON Appareil sous tension Equipo con tensi n Ger t EIN Apparecchio sotto tensione Apparaat Aan Aparelho sob tens o Apparat under sp nning Evepyonoinp vn cuokeur Motor ON Partie active moteur Pieza activa motor Aktives Motorteil Parte attiva motore Actieve motordeel Parte activa do motor Aktiv del motor p pog Ultrasound part ON Partie active ultrasons Pieza activa ultrasonido Aktives Ultraschallteil Parte attiva ultrasuoni Actieve ultrasone deel Parte activa ultra sons Aktiv del ultraljud p pog UTEPNXOI XVIII CUSTOMER RELATIONS RELATIONS CLIENTELE RELACI N CON EL CLIENTE ANSCHRIFTEN RELAZIONI CON CLIENTI KLANTENBETREKKINGEN RELAC ES COM OS CLIENTES KUNDRELATIONER 18 1 MANUFACTURER IDENTIFICATION IDENTIFICATION DU FAB
5. Implant Center 2 User s manual Manuel d utilisation Manual de uso Benutzerhandbuch Manuale d uso Handleiding voor de gebruiker Manual de utiliza o Anv ndningshandbok Eyxetpi to xp onc pem ACTEON Equipment English 10 11 INTRODUCTION 5 Ultrasonic handpiece maintenance Tip maintenance WARNINGS 5 7 12 MONITORING MAINTENANCE DESCRIPTION 7 Monitoring Physical description 7 Maintenance Technical description 7 11 Fuse replacement Operation faults INSTALLATION FIRST USE 11 Unpacking the device 11 Recommendations 11 13 ELECTROMAGNETIC COMPATIBILITY Installation 11 12 Electromagnetic emissions First use 12 Electromagnetic immunity Electromagnetic immunity IRRIGATION SOLUTION 12 Radiofrequency mobile equipment Recommended separation distances IRRIGATION LINES 12 Cable lengths ADJUSTMENTS SETTINGS MODES INTERFACE 14 DISPOSAL AND RECYCLING Startup 12 Settings 12 15 MANUFACTURERS LIABILITY Irrigation function 13 Light function 13 16 REGULATIONS I Surge function 13 16 Piezotome function 16 17 17 SYMBOLS NEWTRON function 17 Toolbox 17 19 18 CUSTOMER RELATIONS Manufacturer identification SAFETY 19 Addresses of subsidiaries USING THE DEVICE 19 21 The list of accessories referred to in this manual is non exhaustive Consult your local dealer for further SHUTTING DOWN THE DEVICE 21 details ROUTINE MAINTENANCE STERILIZATION 21 Irrigation line maintenance 22 Contra angle
6. 1 1 5086 motor control ON OFF progressive 2 Rotation direction 3 Change program P1 to P4 4 Irrigation ON OFF 5 Select active handpiece 0 mode Footswitch button definition Fig 11 1 Ultrasonics control ON OFF or progressive 2 Flush prime 3 Change program D1 to D4 4 Irrigation ON OFF 5 Select active handpiece NEWTRON mode Footswitch button definition Fig 11 1 Ultrasonics control ON OFF or progressive 2 Flush prime 3 Change program Soft to Boost 4 Irrigation ON OFF 5 Select active handpiece f Technical characteristics Manufacturer SATELEC Device name IMPLANT CENTER 2 Electrical power supply Voltage 100 VAC to 230 VAC Frequency 50 Hz 60 Hz Rated power 250 VA at 230 VAC I SurcE function Operation Intermittent service 20 sec ON 30 sec OFF at 2 N cm Output characteristics I SURGE micro motor speed 40 000 rpm SuRGE micro motor torque max 6 N cm Irrigation flow rate 10 to 120 ml min nominal value Adjustment in 10 ml min steps Flush prime flow rate 120 ml min 100 rpm to PiEzorowE function Operation Intermittent service 10 min ON 5 min OFF Output characteristics No load voltage 250 volts nominal value without handpiece Min ultrasonic frequency 28 kHz Irrigation flow rate 10 to 120 ml min nominal value Adjustment in 10 ml min steps
7. medical quality filtered air Connect the micro motor cord to the lefthand connector of the device Fig 1 7 Align the micro motor and cord connector electrical contacts then screw the motor onto the connector Connect a contra angle to the 1 5086 micro motor Fit an instrument drill bur etc to the contra angle Fasten the irrigation line to the cord using line clips Connect the end of the irrigation line to the contra angle Run the motor fitted with its contra angle and its instrument without irrigation at moderate speed for 10 to 15 seconds in order to diffuse the lubricant and eliminate excess Prime the irrigation circuit by pressing the control keypad flush prime button Fig 3 1 When the irrigation solution reaches the end of the contra angle release the footswitch Use IMPLANT CENTER 2 in accordance with good dental practice PiEzorowE function Connect the PiEzorowE 2 handpiece cord to the righthand connector of the device Fig 1 9 Screw the selected tip onto the handpiece using a tip wrench according to the recommendations of the clinical booklets Fasten the irrigation line to the cord using line clips Connect the end of the irrigation line to the PiezotoME 2 handpiece Prime the irrigation circuit by pressing the flush prime button on the screen Fig 3 1 or the multifunction footswitch Fig 11 2 When the irrigation solution reaches the end of the ti
8. Important Never use an abrasive cleaning agent on the I SurGE micro motor The I Surce micro motor must not be immersed or disinfected using agents containing acetone chlorine or bleach The I Surce micro motor must not be cleaned in an ultrasonic bath or disassembled The L uper micro motor is high technology device To maintain optimal performance the following recommendations must be complied with a Cleaning and disinfection Use cleaning and disinfection agents compatible with the Surce micro motor such as SPRAYNET When using a spray spray the outside and inside of the I Surce micro motor moderately to expel residues Clean and disinfect the surfaces using a clean lint free cloth impregnated with the agent b Lubrication Lubricate before each sterilization or at least twice a day Use lubricants compatible with the I SuRcE micro motor such as LUBRIFLUID Place a clean cloth over the I SuRcE micro motor ventilation vents to absorb the surplus lubricant Inject the lubricant through the nose of the micro motor using an oilcan of lubricant or a spray for one half to one second C Sterilization The I SuncE micro motor can be sterilized in an autoclave under the following conditions Autoclave Class B Sterilization temperature 134 C Time at sterilization temperature 18 minutes 23 11 7 ULTRASONIC HANDPIECE MAINTENANCE After each use the handpiece irrigation circuit must
9. In the 150 kHz to 80 MHz frequency range the electromagnetic field strengths must be less than 3 V m 13 4 RECOMMENDED SEPARATION DISTANCES IMPLANT CENTER 2 is intended for use in an electromagnetic environment in which radiated radiofrequency disturbances are controlled The lweLANT CENTER 2 user and or installer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile radiofrequency communications equipment emitters and the IMPLANT CENTER 2 according to the maximum output power of the equipment as recommended in the table below Separation distance in metres m according to emitter frequency Rated max power of the emitter W 150 KHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz 4 12 VP 4 12 VP 4 23 VP atm or emitters rated at max power not listed above the recommended separation distance d in meteres m can be estimated using the equation applicable to the frequency of the emitter where P is the max power rating of the emitter in watts W according the manufacturer Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These specifications may not be applicable in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and persons 30 13 5 CABLE LENGTHS Cables and accessories Maximum length Complies with Harmonic current emission IEC61000 3 2 oltage fluctuation IEC61000 3 3 Immun
10. OFF by pressing button Fig 3 11 Confirm the new settings by pressing button Fig 3 8 The saving of the various settings is confirmed by an audible signal and a visual signal button flashing Repeat this sequence if necessary order to adjust all the programs Caution The tips designed for PiezotoME 2 and IMPLANT CENTER 2 are not compatible with PIEZOTOME and IMPLANT CENTER and vice versa 7 7 NEWTRON FUNCTION A Important A scaler cord and its NEWTRON handpiece must be connected to the device in order to be able to configure the various settings NEWTRON function settings customized by the user can be Select the Newrron function by pressing button Fig 3 12 or by pressing the footswitch button Fig 11 5 On the LCD screen the NEWTRON tab must be highlighted Select the program for which settings are to be adjusted by pressing buttons EA C or Les Fig 5 16 or by pressing the footswitch button Fig 11 3 Adjust the power level according to the TipBook recommendations If necessary modify the program power level 1 to 10 using buttons 17 Fig 3 6 and Fig 3 7 The power level of the program concerned is shown as a number and a bar graph Fig 5 15 Modify the footswitch type if necessary by pressing button Fig 3 10 to toggle between ON OFF and progressive If necessary select handpiece light function ON OFF by pres
11. Unit 1B Steel Close Eaton Socon St Neots CAMBS PE19 8TT UK Tel 44 1480 477 307 Fax 44 1480 477 381 e mail info uk acteongroup com MIDDLE EAST ACTEON MIDDLE EAST Numan Center 1st Floor N 111 Gardens Street PO Box 468 AMMAN 11953 JORDAN Tel 962 6 553 4401 Fax 962 6 553 7833 e mail info me acteongroup com CHINA ACTEON CHINA Office 401 12 Xinyuanxili Zhong Street Chaoyang District BEIJING 100027 CHINA Tel 86 10 646 570 11 2 3 Fax 86 10 646 580 15 e mail beijing cn acteongroup com PHILIPPINES ACTEON PHILIPPINES 4th Floor Alco Building No 391 Sen Gil Puyat Avenue Makati City 1200 PHILIPPINES Tel 632 899 78 66 or 67 Fax 632 899 78 43 e mail info ph acteongroup com THAILAND ACTEON THAILAND LTD 23 45 Sorachai Building 16th floor Sukumvit 63 Road Klongton Nua Wattana BANGKOK 10110 THAILAND Tel 66 2 714 3295 Fax 66 2 714 3296 e mail info th acteongroup com KOREA ACTEON KOREA 8F Hanil B D 132 4 1Ga Bongrae dong JOONG GU SEOUL KOREA Tel 82 2 753 41 91 Fax 82 2 753 41 93 e mail info kr acteongroup com INDIA ACTEON INDIA E 145 G I D C Electronic Estate Sector 26 GANDHINAGAR 382028 Gujarat INDIA Tel 91 79 2328 7473 Fax 91 79 2328 7480 e mail info in acteongroup com COSTA RICA ACTEON LATIN AMERICA Apdo Postal 978 2070 Sabanilla COSTA RICA Tel Fax 506 2273 4033 Celular 506 8981
12. are not compatible with PiezotoME and IMPLANT CENTER and vice versa To reduce the risk of accidents the precautions stipulated below must be taken Device users Use of the IMPLANT CENTER 2 is restricted solely to qualified trained and competent dental health practitioners in the normal context of their work If you have received this device by error please contact the supplier so that it can be removed Interactions The IMPLANT CENTER 2 must not be used if the patient and or the operator has a cardiac stimulator pacemaker or any other active implant e g a cochlear implant The device complies with applicable electromagnetic compatibility standards The user should nevertheless ensure that any potential electromagnetic interference does not cause an additional risk presence of radiofrequency emitters electronic devices etc The device is not designed to withstand shocks delivered by an electric defibrillator Do not attempt to connect to the IMPLANT CENTER 2 any other accessories than those supplied by SATELEC Electrical connection Your IMPLANT CENTER 2 must be connected to the electric power supply by a certified dental installation technician Warning To avoid any risk of electric shock this device must be connected to an electrical power supply with a protective ground The electric supply to which the device is connected must comply with the standards in force in your country I
13. connect the IMPLANT CENTER 2 to the power supply using a plug in power cord The footswitch connector Fig 2 2 is used to connect the IMPLANT CENTER 2 to the multifunction control footswitch The fan Fig 2 3 protected by a metal grille keeps the IMPLANT CENTER 2 at its optimal performance level The bracket holders Fig 2 4 are used to install the brackets The power switch Fig 2 5 is used to switch the device ON or OFF c Control unit sides The pump housings Fig 1 8 are designed to accommodate SATELEC irrigation line cassettes The irrigation cassettes are installed by lifting the pump covers and inserting the cassettes horizontally into the cassette housings d Front panel The left connector is designed to accept the connector of the I Surce micro motor cord Only a SATELEC micro motor cord must be used The right hand connector is designed to accept the connector of the NEWTRON NEWTRON LED cord or the connector of the PIEZOTOME 2 PIEZOTOME 2 Leo handpiece cord e Control footswitch Having access to a large number of functions on the control footswitch allows the practitioner to work in a perfectly sterile environment avoiding the risk of cross contamination Once the various settings have been adjusted the user has no further need to touch the keypad Depending on the mode the control footswitch buttons have different functions I SURGE mode Footswitch button definitions Fig 11
14. contacts thoroughly Incorrect tip tightening Retighten the tip with the wrench Faulty connector contact Clean the connector contacts Return to SATELEC after sales to replace the cord light ring absent Install the light ring Faulty light ring Replace the light ring Faulty light ring connector contacts Clean the light ring connector contacts Bee Position the light ring according to the Light ring the wrong way around foolproofing stud Faulty handpiece and or cord connector Clean the handpiece and or cord connector contacts contacts te your installer fitter Handpiece cord wire cut NEWTRON handpiece and Worn handpiece 1 15x1 seal Replace the seal kit F12304 the handpiece cord Liquid leak in the irrigation pump Broken tube in the irrigation line Replace the irrigation line cassette XIII ELECTROMAGNETIC COMPATIBILITY Important The power cord the ultrasonic handpiece cords and the multifunction footswitch cord must be kept away from each other IMPLANT CENTER 2 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 IMPLANT CENTER 2 The recommended separation distances in this paragraph must therefore be complied with IMPLANT CENTER 2 must not b
15. handpiece by running the flush prime function until the vessel and the irrigation lines are completely empty Remove the irrigation line clips Disconnect the single use irrigation lines from the contra angle and from the handpieces and dispose of them in a safety container for soiled medical items Remove the rotary instruments fastened to the contra angle and the tip screwed onto the handpiece Disconnect the contra angle from the l SuRGE micro motor Disconnect the micro motor cord from the SURGE Disconnect the 2 handpiece or the NewTRoN handpiece and the scaler cord Switch the device OFF 0 XI ROUTINE MAINTENANCE STERILIZATION N Important The device must be switched OFF during cleaning and disinfection procedures The only irrigation lines that can be sterilized are those identified as sterilizable During sterilization items made of different metals must not come into contact Any contact would establish galvanic couples and cause localized damage To avoid this happening place the items in individual sterilizable bags or in a sterilization box To maintain the sterility or asepsis of the accessories micromotor micromotor cord cords handpieces etc 21 store them sealed bags containers suitable for medical practice The maintenance and or sterilization instructions below must be applied before each use of the device
16. maintenance 22 Rotary instruments maintenance 22 Device maintenance 22 Micromotor cord and scaler cord maintenance 23 SURGE micromotor maintenance 23 ENGLISH CONTENTS 24 24 225 25 25 25 26 26 27 28 29 29 30 30 31 31 31 31 256 257 260 260 261 INTRODUCTION Congratulations You have just taken possession of your IMPLANT CENTER 2 Designed by SATELEC the IMPLANT CENTER 2 is a multifunction device intended for e dental implantology with its I SuRGE micro motor surgical procedures osteotomy osteoplasty periodontal and implant surgery with its PIEZOTOME or PIEZOTOME handpiece e mechanical ultrasonic treatment prophylaxis periodontics endodontics with its NEWTRON or NEWTRON ultrasonic handpiece The L uper micro motor coupling developed by SATELEC means that the IMPLANT CENTER can be used with most contra angles without internal spray or light found on the market In order to get the most out of this high technology device and ensure it has a long working life please read this manual carefully before installing using or maintaining it Points preceded by the symbol N should be given particular attention Il WARNINGS A CAUTION United States Federal Law restricts the use of this device solely to qualified trained and competent dental health practitioners or under their supervision The tips designed for PigzoToME 2 and IMPLANT CENTER 2
17. settings are displayed The contra angle ss Fig 6 20 value is displayed Fig 6 17 The speed Fig 6 21 value is displayed Fig 6 18 The torque Fig 6 22 value is displayed Fig 6 19 c Selecting a contra angle Selecting a pre programmed contra angle Press button Fig 6 20 the preprogrammed contra angle options are displayed Fig 8 Select a multiplier contra angle using the red buttons Fig 8 35 or a direct contra angle using the blue button Fig 8 36 or a divider contra angle using the green buttons Fig 8 37 The value of the selected contra angle is displayed Fig 8 38 The maximum permitted speed Fig 8 39 and torque Fig 8 40 are displayed for each contra angle Button Fig 8 32 is used to return to the main screen without saving the changes Confirm the selected contra angle by pressing button displayed Fig 8 34 the main screen is Programming a user defined contra angle MPLANT CENTER 2 enables specific contra angles to be used A contra angle value be programmed On the main screen press button EI Fig 6 20 the preprogrammed contra angle options displayed Fig 8 Press button Fig 8 33 the button is highlighted Press button Fig 8 34 the contra angle adjustment screen is displayed Fig 7 Program the contra angle using the numeric keypad Fig 7 31 The progra
18. speed value If a torque or speed value outside the permitted range is entered min or is displayed The maximum or minimum permitted value is then displayed depending on the case e Torque adjustment On the main screen press button E Fig 6 22 the torque adjustment screen is displayed Fig 7 Program the torque using the numeric keypad Fig 7 31 The programmed torque is displayed Fig 7 27 Press button digit Fig 7 29 to delete the last Press button Fig 7 28 to return to the main screen without saving the changes Confirm the torque adjustment by pressins button displayed Fig 7 30 the main screen is Note The instrument torque can be adjusted directly using buttons L or Fig 3 6 and 3 7 for program n even when the multifunction footswitch is switched on f Selecting footswitch type Change the footswitch type if necessary by pressing button Fig 3 10 to toggle between ON OFF and progressive Lal g Completion of setting adjustment Confirm the new settings by pressing button Fig 3 8 The storing of the various settings is confirmed by an audible signal Repeat this sequence if necessary in order to adjust all the programs 7 6 PIEZOTOME FUNCTION N Important The PiEzorowE function settings can be customized by the user The Piezotome function settings can be adjusted when no Piezotome 2 h
19. the following components a control unit Fig 1 a multifunction footswitch Fig 11 a micro motor cord with connectors Fig 1 2 two brackets for irrigation solution Fig 1 3 an I SURGE micro motor Fig 1 4 without contra angle a grounded power cord Fig 1 5 an LCD Liquid Crystal Display touch screen Fig 1 6 a motor cord connector Fig 1 7 two peristaltic pump housings Fig 1 8 a cord connector for the two ultrasonic functions Fig 1 9 a NEWTRON scaler cord or PiEzoroME 2 LED handpiece with cord Fig 1 10 according to option a NEWTRON LED handpiece or PiEzoroME 2 LED handpiece with its cord Fig 1 11 according to option Located at the back of the unit are 1 power cord socket with ground pin Fig 2 1 1 footswitch connector Fig 2 2 1 fan Fig 2 3 2 bracket holders Fig 2 4 1 power switch Fig 2 5 3 2 TECHNICAL DESCRIPTION a LCD touch screen The LCD touch screen Fig 3 is used to define the settings of your IMPLANT CENTER 2 The IMPLANT CENTER 2 is adjusted by applying moderate pressure to the screen keys Identification of key areas common to all modes Fig 3 4 Reduce irrigation flow rate 5 Increase irrigation flow rate 6 Reduce value 7 Increase value Identification of information display areas common to all modes Fig 3 2 Irrigation flow rate value 9 Operating fault indicator
20. the modified settings press button Fig 10 52 The screen shown in Fig 9 reappears e Factory configuration reset Press button d Fig 10 42 to restore the factory configuration settings The factory configurations for the PiEzorowE and NEWTRON functions are effective when button Fig 10 52 is pressed The screen shown in Fig 9 reappears f Software version The version of the software is displayed at the bottom of the screen Fig 10 51 IMPLANT CENTER 2 is configured in the factory with the following settings 1 5 mode Speed at Torque at Contra angle Program instrument instrument Irrigation Functions ratio end end 1200 rpm 80 fmm Implant site marking site marking i 800 rpm 2 ome a 7 mode Very 60 Powerful D2 3 60 ml min Main functions Osteotomy osteoplasty Medium D3 3 60 ml min 60 Soft tissue NEWTRON mode Program Power Irrigation Main functions Green Soft P 5 ud Periodontics ml min Yellow Medium P 5 15 Endodontics ml min Blue High P 5 15 Scalin 5 ml min 8 15 Orange Bonet mimi Loosening SAFETY The IMPLANT CENTER 2 is equipped with a self diagnosis system to detect malfunctions When an excessively high temperature of the Surge micro motor is detected symbol 1 chap XVII Symbol is displayed in the error zone Fig 3 9 and the device beeps four tim
21. to 40 C Storage 20 C to 70 C Humidity Operation 30 to 75 Storage 10 to 100 including condensation Atmospheric pressure Between 500 hPa and 1060 hPa Measuring units displayed and meaning Ncm torque N cm Rpm speed r min IV INSTALLATION FIRST USE 4 1 UNPACKING THE DEVICE Upon receipt of the device check for any damage caused in transit Contact your supplier if necessary 4 2 RECOMMENDATIONS Have your IMPLANT CENTER 2 connected to the power electricity supply by a certified dental installation technician The electrical connection of the IMPLANT CENTER 2 must comply with the applicable standards in your country Warning To avoid any risk of electric shock this device must be connected to an electrical power supply with a protective ground 4 3 INSTALLATION A Important Do not place the IMPLANT CENTER 2 close to or on top of another device Do not place the power cord and the footswitch cord in a wire cover or in a cable gland Place the control unit in position on a fixed surface horizontal or with a slope of no more than 5 Check that the power switch Fig 2 5 is position OFF Connect the power cord to the receptacl of the device Connect the power cord to a power socket with a ground pin Connect the control footswitch to the footswitch connector Fig 2 2 Position the footswitch so that it is easily accessible for your feet Insert t
22. 5815 e mail amlatinages acteongroup com RUSSIA ACTEON RUSSIA Valdajski Proezd 16 Building 1 office 253 125445 Moscow RUSSIA Tel Fax 7 495 451 80 50 e mail info acteongroup ru AUSTRALIA NEW ZEALAND ACTEON AUTRALIA NEW ZEALAND L3 Suite 23 6 8 Crewe Place 2018 Rosebery NSW AUSTRALIA Tel 612 966 24400 Fax 612 966 24600 e mail sandy junior au acteongroup com 261 Fig Afbeelding 1 Fig Afbeelding 2 262 Fig Afbeelding 3 263 Fig Afbeelding 5 DIEFNTOME Fig Afbeelding 6 20 21 22 w NEWTRON 18 19 23 264 Fig Afbeelding 7 28 25 26 27 29 30 Fig Afbeelding 8 32 38 39 40 33 34 265 Fig Afbeelding 9 MPLANTCENTER Piezo Ultrasonic Surgery amp Implantology Unit 41 Fig Afbeelding 10 Ce 42 43 48 44 49 45 50 46 47 51 266 Fig Afbeelding 11 267 ACTEON Equipment A Company of Acteon Group 17 av Gustave Eiffel BP 30216 33708 MERIGNAC cedex France Tel 33 0 556 34 06 07 Fax 33 0 556 34 92 92 E mail satelec acteongroup com www acteongroup com www piezotome com 127160 T8 V4
23. R 2 control unit The device the brackets and the multifunction footswitch are not sterilizable The IMPLANT CENTER 2 control unit the control footswitch and the bracket must always be cleaned and disinfected after each procedure using alcohol disinfectant agents or disinfectant wipes for dental practices such as SEPToL wipes Regular monitoring of the IMPLANT CENTER 2 unit is necessary in order to detect any problem It is important to keep the control unit ventilation vents clean in order to avoid abnormal heating 11 5 MICROMOTOR AND SCALER CORD MAINTENANCE AN Important Never use an abrasive cleaning agent on the cords The cords must not be immersed or disinfected using agents containing acetone chlorine or bleach The cords must not be cleaned in an ultrasonic bath a Cleaning and disinfection The cords must always be cleaned disinfected and sterilized after each procedure using alcohol disinfectant agents or disinfectant wipes for dental practices such as SePTOL wipes b Sterilization The cords can be sterilized in an autoclave under the following conditions Autoclave Class B Sterilization temperature 134 C at 2 Bar Time at sterilization temperature 18 minutes CAUTION Not all autoclaves can reach 134 C Not all autoclaves draw a pre vacuum Please refer to your autoclave manufacturer for specific sterilization instructions 11 6 I SURGE MICRO MOTOR MAINTENANCE A
24. RICANT IDENTIFICACI N DEL FABRICANTE IDENTIFIKATION DES HERSTELLERS IDENTIFICAZIONE DEL PRODUTTORE IDENTIFICATIE VAN DE FABRIKANT IDENTIFICAC O DO FABRICANTE IDENTIFIERING AV TILLVERKAREN ZTOIXEIA TOY KATAZKEYAZTH SATELEC A Company of Acteon Group 17 avenue Gustave Eiffel BP 30216 33708 MERIGNAC cedex FRANCE T l 33 0 556 34 06 07 Fax 33 0 556 34 92 92 E mail satelec acteongroup com www acteongroup com www piezotome com CE us 260 18 2 SUBSIDIARIES ADRESSE FILIALES DIRECCION FILIALES ADRESSEN DER TOCHTERGESELLSCHAFTEN INDIRIZZI DELLE FILIALI ADRESSEN VAN FILIALEN MORADA DAS FILIAIS DOTTERBOLAGSADRESSER AIEYOYNZEIZ FRANCE SATELEC ACTEON GROUP 17 av Gustave Eiffel B P 30216 33708 MERIGNAC cedex FRANCE Tel 33 0 556 34 06 07 Fax 33 0 556 34 92 92 e mail satelec acteongroup com U S A ACTEON NORTH AMERICA 124 Gaither Drive Suite 140 Mt Laurel NJ 08054 USA Tel 1 856 222 9988 Fax 1 856 222 4726 e mail info us acteongroup com GERMANY ACTEON GERMANY Industriestrasse 9 40822 METTMANN GERMANY Tel 49 21 04 95 65 10 Fax 49 21 04 95 65 11 e mail info de acteongroup com SPAIN ACTEON IBERICA Avda Principal n 11 H Poligono Industrial Can Clapers 08181 SENTMENAT BARCELONA SPAIN Tel 34 93 715 45 20 Fax 34 93 715 32 29 e mail info es acteongroup com U K SATELEC UK LIMITED
25. ailable for the NEWTRON and PIEZOTOME functions ON or OFF The light function has a default light off time out of nine seconds Switching off the light function become effective when the time out has elapsed If necessary you can lengthen the time out refer to 7 7 7 5 SURGE FUNCTION a Selecting the rotation direction The rotation direction of the 1 5086 micro motor is controlled by the control footswitch button Fig 11 2 When clockwise rotation is selected the symbol is displayed on the LCD screen Fig 6 23 When counterclockwise rotation is selected an audible signal is emitted and the symbol is displayed on the LCD screen Fig 6 23 b Program setting adjustment A Important When programming the maximum instrument end speed the entered value cannot exceed the pre programmed value Do not go below the minimum motor speed value 100 rpm 1 1 contra angle Do not exceed the maximum pre programmed value of the instrument end torque and do not go below 10 of this value When setting the torque please refer to the contra angle and implant system manufacturers recommendations Select the I Surce function by pressing button Fig 3 12 On the LCD screen the I Surce tab must be highlighted Select the program for which settings are to be P2 adjusted using buttons E or Fig 6 24 or using the footswitch button Fig 11 3 the various programmed parameter
26. andpiece is connected to the device The program giving the highest power is 01 Ga Very powerful EB Powerful ES Osteotomy osteoplasty Soft tissue detachment Select the Piezotome function by pressing button Fig 3 12 or by pressing the footswitch button Fig 11 5 On the LCD screen the Piezorome tab must be highlighted Select the program to be used by pressing button 8 Jor K Fig 4 14 or using the footswitch button Fig 11 3 the selected program is highlighted on the LCD screen 16 Adjust the programs and the power level according to tip data sheet recommendations If necessary modify the irrigation function flow rate value etc refer to 7 3 If necessary modify the program power level 1 to 5 using buttons Fig 3 6 and LH Fig 3 7 The power level of the program concerned is shown as a number and a bar graph Fig 4 13 Modify the footswitch type if necessary by pressing button Fig 3 10 to toggle between ON OFF and progressive Lal A Important progressive mode for programs D1 to D3 the delivered power ranges between power level 1 of program D3 and the configuration defined by the user program and power level progressive mode the power delivered by program D4 ranges only between levels 1 and 5 according to the value defined by the user If necessary select handpiece light function ON
27. be rinsed with distilled or demineralized water for 20 to 30 seconds Disconnect the handpiece from its cord before cleaning disinfection and sterilization Cleaning and disinfection The handpieces must always be cleaned disinfected and sterilized after each procedure using alcohol disinfectant agents or disinfectant wipes for dental practices such as SePToL wipes For handpiece sterilization refer to the manual for each product 11 8 TIP MAINTENANCE a Lifetime Tip shape and weight are the determining characteristics for obtaining maximal efficiency of the ultrasonic generator Careful monitoring of these two characteristics by the user will ensure that optimal performance of the device is maintained Consequently you are strongly advised not to alter the structure of the tips by filing or twisting them or modifying them in any other way Similarly through normal wear tip aging leads to alteration of its characteristics Always replace a tip that has been damaged by wear or by accidental impact dropped bent etc Use the TiPcARD to check scaler tip wear Replace routinely used tips at least once a year 24 b Pre disinfection chemical cleaning To be carried out immediately after treatment wearing thick gloves Immerse in an ultrasonic bath enzymatic quaternary ammonium base detergent disinfectant solution carefully respecting the concentration and contact time recommended by
28. e is potentially dangerous If the device is to be moved from a cold environment to a hot one it must not be used until it has reached room temperature The device is not designed to work near ionizing radiation Do not insert metal objects into the device risk of electric shock short circuit or projection of hazardous substances Maintenance Before and after each use your IMPLANT CENTER 2 must be disinfected with SATELEC approved agents Before each procedure it is essential to make sure that the accessories to be used have been cleaned disinfected and sterilized Accessories The device has been designed and developed for use only with SATELEC accessories to ensure maximum safety and performance Use of accessories from other manufacturers is a potential hazard for you or your patients Repair Warning Do not repair or modify the device without prior authorization from SATELEC Warning If the device is modified or repaired specific checks and tests must be performed to ensure that the device can still be used safely In the case of a fault contact the supplier of your device Do not use unauthorized repairers who might make your device dangerous for you and your patients If in any doubt contact an approved dealer or our customer support department WWW acteongroup com E mail satelec acteongroup com DESCRIPTION 3 1 PHYSICAL DESCRIPTION The IMPLANT CENTER 2 has
29. e product g Disposal of the product Dispose of the product in receptacles for waste materials of healthcare activities involving infectious risks CAUTION Not all autoclaves can reach 134 C Not all autoclaves draw a pre vacuum Please refer to your autoclave manufacturer for specific sterilization instructions MONITORING MAINTENANCE A Important In the case of a fault you are advised to contact the supplier of your device Do not use unauthorized repairers who might make your device dangerous for you and your patients 12 1 MONITORING Regular monitoring of the device and its accessories is necessary in order to detect any insulation fault or damage Replace them if necessary It is important to keep the control unit ventilation vents clean in order to avoid abnormal heating 12 2 MAINTENANCE I SuRGE micro motor inspection overhaul SATELEC recommends inspection or overhaul of the I Surge micro motor at least once a year 12 3 FUSE REPLACEMENT IMPLANT CENTER 2 is protected by two fuses located in the power receptacle Fig 2 1 The replacement procedure is as follows Switch the device OFF position O Unplug the power cord from the electricity supply Unplug the power cord from the receptacle Fig 2 1 Insert the tip of a flat screwdriver into the notch above the fuse drawer to release it Remove the old fuses Replace the old fuses with fuses of the same type and rating
30. e 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 as replacement parts may have the consequence of increasing the emissions or decreasing the immunity of the IMPLANT CENTER 2 13 1 ELECTROMAGNETIC EMISSIONS IMPLANT CENTER 2 is intended for use in the electromagnetic environment specified in the table below The user and or installer must ensure that the IMPLANT CENTER 2 is used in such an environment Emission test Compliance Electromagnetic environment guidance IMPLANT CENTER 2 uses RF energy for internal operation herefore its radiofrequency emissions are very low and are not likely to cause any interference in nearby equipment RF emission CISPR 11 m IMPLANT CENTER 2 is suitable for use in all establishments except Sch EMISSION Homes establishments those directly connected to the public Ee low voltage power supply network that supplies buildings used for Voltage fluctuation and flicker domestic purposes 28 13 2 ELECTROMAGNETIC IMMUNITY IMPLANT CENTER 2 is intended for use in the electromagnetic environment specified in the table below The user and or installer must ensure that the device is used in such an electromagnetic environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Fl
31. elivered speed 27 Maximum delivered torque Identification of common key areas Fig 7 28 Exit from the page without changes 29 Delete last character entered 30 Return to main page and save settings to Screen memory 31 Numeric keypad Preprogrammed contra angle adjustment page Identification of information display areas Fig 8 38 Contra angle ratio 39 Motor speed value 40 Motor delivered torque value Identification of key areas Fig 8 32 Exit from the page without changes 33 Select custom contra angle 34 Return to main page and save settings to screen memory Identification of key areas that also display information Fig 8 35 Select a multiplier contra angle 36 Select direct contra angle 37 Select a divider contra angle Startup page Identification of key areas Fig 9 41 Enter TooLBox mode Toolbox Identification of information display areas Fig 10 43 Audio volume symbol 44 Screen brightness symbol 45 Light off time out symbol 48 Relative audio volume value 49 Relative brightness level value 50 Selected time out value 51 Software version Identification of key areas Fig 10 42 Reset factory configuration 46 Reduce value 47 Increase value 52 Validate the configuration b Control unit back panel The power receptacle Fig 2 1 with its grounding pin is used to
32. es The device switches to degraded mode so that it can complete the dental procedure The available torque value is set at 25 in order to protect the I SuRcE micro motor It is recommended that the 1 5086 micro motor be allowed to cool down until symbol 1 chap XVII Symbol disappears In the case of a motor malfunction symbol 2 chap XVII Symbol is displayed in the error zone and the device beeps four times It is recommended that you check the connections of your motor and your motor cord If the fault persists switch the device off at the power switch Fig 2 5 and switch it back on again In the case of an internal operation malfunction symbol 3 chap XVII Symbol is displayed in the error zone and the device beeps four times It is recommended that the device be switched off Fig 2 5 and switched back on again IX USING THE DEVICE Important Do not disconnect the micro motor cord or the scaler cord when the device is switched on and the footswitch is pressed Do not disconnect the micro motor or the ultrasonic handpieces when the device is switched on and the footswitch is pressed Do not connect the instrument to or disengage it from the contra angle when the micro motor is running Do not screw or unscrew tips when the handpieces are on All accessories must be cleaned disinfected and sterilized before use For your safety that of your patient IMPLANT CENTER 2 mus
33. f loss of electrical power during use is likely to generate an unacceptable risk the device must be connected to a suitable power source e g UPS Using the device Do not use the device if it appears to be damaged or faulty Turn the device off before unplugging the power cord To unplug the power cord grip the cord plug and hold the wall socket Never use any other irrigation solution containers than those intended for suspension from the supplied brackets The device must only be used with bottles or bags of physiological saline or sterile water The capacity of the irrigation solution containers used must not exceed one litre When the device is not to be used for a long period of time unplug the device from the electric supply Do not exert excessive force on the screen Do not move IMPLANT CENTER 2 during use Environment Do not cover the device or obstruct the ventilation vents Do not immerse the device in liquid and do not use it outdoors Do not tilt the device at an angle greater than KR Do not place the device near a heat source Make sure that the cords are not in a traffic path The device must be stored in its original packaging in an appropriate and safe place The device is not designed for use in the presence of anesthetic gases or any other flammable gas Do not expose the device to water vapor or splashes Any condensation inside an electrical devic
34. ferimento alla documentazione allegata Meegeleverde documenten raadplegen Consultar a documenta o de acompanhamento Se medf ljande dokumentation Avatp te ota ouvodeutiKd Eyypapa Class BF Classe BF Clase BF Niederfrequenz Classe BF Klasse BF Classe BF KAdon BF Class 1 Classe 1 Clase 1 Klasse 1 Classe 1 Klasse 1 Classe 1 Klass BF Klass 1 KAdon 1 Sterilization at 134 C in an autoclave Sterilisation 134 C dans un autoclave Esterilizaci n a 134 C en autoclave Sterilisation im Autoklav bei 134 C Sterilizzazione a 134 C in autoclave Sterilisatie op 134 C in een autoclaaf Esterilizac o a 134 C numa autoclave Sterilisering vid 134 C i autoklav Anooteipwon otoug 134 C aut kAetoto EC marking Marquage CE Marca CE CE Kennzeichnung Marcatura CE CE markering CE CE m rkning Z pavon CE Do not dispose of in household waste Ne pas jeter dans les poubelles domestiques No tirar en los contenedores dom sticos Nicht mit Hausm ll entsorgen Non gettare nei cassonetti dei rifiuti domestici Niet bij het huishoudelijke afval zetten deitar no lixo dom stico Ej hush llsavfall Mnv yia OIKIAKA Year of manufacture Ann e de fabrication A o de fabricaci n Baujahr Anno di fabbricazione Bouwjaar Ano de fabrico Tillverknings r Eto Kataokeung
35. he brackets into the bracket holders Fig 2 4 Connect the micro motor cord to the connector Fig 1 7 Align the l SuRcE micro motor and cord connector electrical contacts then screw the motor onto the connector Connect the NEwTRON scaler cord or the PIEZOTOME 2 handpiece cord to the connector Fig 1 9 according to option Connect the Newrron handpiece to the scaler cord delivered according to option Check that the device is close enough to the work area to be used without pulling on the cords If it is not move the device closer Place the I SurGE micro motor on its rest Place the NEWTRON or PIEZOTOME 2 handpiece on the handpiece support Suspend the bottles or bags of physiological saline or sterile water from the brackets Adjust the position of your device to suit your angle of view 4 4 FIRST USE Before using the IMPLANT CENTER 2 for the first time all the equipment must be given routine maintenance and or sterilized according to the procedures defined in chapter 11 V IRRIGATION SOLUTION IMPLANT CENTER 2 is not designed to administer drugs It must be used only with bottles or bags of physiological saline or sterile water with an individual capacity not exceeding one litre VI IRRIGATION LINES IMPLANT CENTER 2 must be used exclusively with SATELEC irrigation lines VII ADJUSTMENTS SETTINGS MODES INTERFACE 7 1 STARTUP Important After stopping the dev
36. ice wait four seconds before restarting it Each time the device is switched on the screen displays program P1 of the I Surce function after displaying the welcome page 7 2 SETTINGS The settings are saved when each program is configured and are retrieved whenever that program is selected 7 3 FUNCTION Flush prime The flush prime function is available on the LCD screen and on the footswitch Press button Fig 3 1 or the footswitch button Fig 11 2 Piezotome and NEWTRON modes to switch on the flush prime function The flush prime function stays on as long as the button is pressed The flush can be switched on while the device is being used b Flow rate adjustment The irrigation flow rate is adjusted using buttons Fig 3 4 and 5 Each time the corresponding button is pressed the flow rate is adjusted The adjusted value is displayed on the LCD screen Fig 3 2 and stored in the current program The flow rate can be adjusted while the device is being used c Irrigation ON OFF The irrigation is switched ON or 0FF by pressing button 2 Fig 3 3 or the footswitch button Fig 11 4 When irrigation is selected the symbol 2 lis highlighted When irrigation is not selected the symbol LA Jis darkened 7 4 LIGHT FUNCTION The light function is displayed on the LCD screen Pressing button Fig 3 11 switches the light function av
37. ion lines etc other than those supplied by SATELEC have been used the instructions in this document have not been followed Note The manufacturer reserves the right to modify the device and or the user s manual without notice XVI REGULATIONS This medical device is classified as class Ila according to European Directive relevant to Medical Devices currently in force This equipment is manufactured in compliance with the current IEC 60601 1 standard This equipment has been designed and manufactured according to an ISO 13485 certified quality assurance system 31 Audio level Niveau sonore Nivel sonoro Lautst rke Livello acustico Geluidsterkte N vel sonoro Ljudniv Evraon xou Brightness Luminosit Luminosidad Kontrast Luminosit Helderheid Luminosidade Ljusstyrka Owteivornta Time out length Dur e de temporisation Duraci n del temporizador Abschaltzeit Durata di temporizzazione Wachttijd Dura o de temporizac o F rdr jningstid Aidpkeia xpovop tpou Factory configuration Configuration usine Configuraci n de fabrica Werksseitige Konfiguration Configurazione di default Fabrieksinstellingen Configura o de f brica Fabriksinst llning Refer to the accompanying documentation Se r f rer la documentation d accompagnement Consultar documentaci n que acompa a Siehe Begleitunterlagen Fare ri
38. ity to electrostatic discharge IEC61000 4 2 Immunity to electrical fast transients bursts IEC61000 4 4 Less than 3m Immunity to surges IEC61000 4 5 Immunity to voltage dips short interruptions and voltage variations 61000 4 11 Immunity to conducted disturbances induced by radiofrequency fields IEC61000 4 6 Immunity to radiated radiofrequency electromagnetic fields IEC61000 4 3 XIV DISPOSAL AND RECYCLING As electrical and electronic equipment the device must be disposed of according to a specialized procedure for collection pick up and recycling or destruction in particular on the European market with reference to Directive 2002 96 EC of 27 01 2003 When your device reaches the end of its life we consequently recommend that you contact your dental equipment dealer or failing this the ACTEON Group website the address of which is given in chapter 18 for information on how to proceed XV MANUFACTURER S LIABILITY The manufacturer is not liable if the manufacturer s installation recommendations have not been followed supply voltage electromagnetic environment etc repairs or other work have been done on the device by persons not authorized by the manufacturer the device has been used connected to an electrical system that does not comply with current regulations the device has been used in ways other than those specified in this manual accessories tips handpiece irrigat
39. mmed contra angle value is displayed Fig 7 25 Press button digit Fig 7 29 to delete the last Press button Fig 7 28 to return to the main screen without saving the changes Confirm your customization of the contra angle by pressing button screen is displayed The maximum permitted speed Fig 6 18 and torque Fig 6 19 are displayed for the programmed contra angle Fig 7 30 the main d Speed adjustment On the main screen press button Fig 6 21 the speed adjustment screen is displayed Fig 7 Program the speed using the numeric keypad Fig 7 31 The programmed speed is displayed Fig 7 26 Press button digit Fig 7 29 to delete the last Press button Fig 7 28 to return to the main screen without saving the changes Confirm the speed adjustment by pressing button BH Fig 7 30 the main screen is displayed Note The instrument speed can be adjusted directly using buttons 7 or Fig 3 6 and 3 P2 7 for programs or even when the multifunction footswitch is switched on To obtain a stable speed adjustment result it is recommended to press the footswitch fully Fig 11 1 Pressing buttons or Fig 3 6 and 3 7 increases or reduces the speed value Pressing and holding buttons or Fig 3 6 3 7 for longer than 3 seconds causes faster increase or reduction of the
40. nominal value Flush flow rate 120 ml min nominal value NEWTRON function Operation Intermittent service 10 min ON 5 min OFF Output characteristics No load voltage 150 volts nominal value without handpiece Min ultrasonic frequency 28 kHz Irrigation flow rate 10 to 40 ml min nominal value Adjustment in 1 ml min steps nominal value Flush flow rate 120 ml min nominal value Protection Electrical equipment class Class 1 Electrical safety class Type BF in I Surce mode Type BF in Piezotome mode Type BF in NEWTRON mode Safety devices Thermal safety shut off to avoid overheating of the I SuRGE micro motor Safety shut off if internal malfunction 2 fuses power cord receptacle 5 mm x 20 mm 2 AT for 100 VAC to 230 VAC 1 internal fuse not accessible to the user reference F1 5 mm x 20 mm 10 AT 250 VAC Overall dimensions Control unit Width 472 9 mm Height 149 5 mm Height with bracket 471 1 mm Depth 339 9 mm Weight 5 kg without accessories Footswitch Width 311 mm Depth 209 mm Height 181 mm Weight approximately 3 5 kg LCD screen Height 86 mm Width 115 mm Micro motor cord 2 000 mm 2 900 mm optional Scaler handpiece cord 2 000 mm 2 900 mm optional Piezotome handpiece cord 2 000 mm 2 900 mm optional I SURGE micro motor Length 99 mm Diameter 21 mm Weight 120 g Coupling type according to standard ISO 3964 Temperatures Operation 10 C
41. ommended separation distance 150 KHz to 80 MHz d 1 2 VP d 1 2 VP 80MHz to 800MHz 3 V m d 2 3 VP 800MHz to 2 5GHz 80 MHz to 2 5 GHz here P is the maximum power rating of the emitter in watts W according to the manufacturer s specifications and d is the recommended minimum separation distance in meters m must be less than the compliance level in each frequency range b 9 Interference may occur near equipment marked with the symbol below 29 Note 1 At 80 MHz and 800 MHz the higher frequency range applies Note 2 These specifications may not be applicable in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and persons a The electromagnetic field strengths of fixed radiofrequency emitters such as base stations for mobile telephones cellular cordless mobile radios amateur radio AM FM radio broadcasts and TV broadcasts cannot be determined exactly by theory To assess the electromagnetic environment due to fixed radiofrequency emitters an electromagnetic environment measurement must be made If the measured radiofrequency field strength in the immediate environment where the product is used exceeds the compliance level specified above the performance of the product must be tested to verify whether it conforms to the specification If abnormal performance is observed additional measures may be necessary such as reorienting or relocating the product b
42. oors must be wood concrete cement or tiled If floors are covered with synthetic material carpet etc the relative humidity must be at least 30 Electrostatic discharge ESD ains power quality should be that of a typical commercial or hospital environment hospital clinic Ur gt 95 dip in Ur for 0 5 Ur gt 95 dip in Ur for 0 5 Bn es ains power quality should be that of a typical commercial or hospital environment If the use of the IMPLANT CENTER 2 requires continued operation during power mains interruption it is recommended that the product be powered from a Separate power supply UPS etc Ur 60 dip in Ur for 5 40 Ur 60 dip in Ur for 5 es Ur 30 dip in Ur for 25 Ur 30 dip in Ur for 25 cycles es lt 5 Ur gt 95 dip in Ur for 250 Ur gt 95 dip in Ur for 250 cycles es 13 3 ELECTROMAGNETIC IMMUNITY RADIOFREQUENCY MOBILE EQUIPMENT The IMPLANT CENTER 2 is intended for use in the electromagnetic environment specified in the table below The user and or installer must ensure that the device is used in such an electromagnetic environment Immunity test IEC 60601 test level Compliance level Electromagnetic environment guidance Portable and mobile radiofrequency communications devices must not be used near the ImPLANT CENTER 2 including its cables at a distance less than that recommended and calculated according to the frequency and power of the emitter 3V m Rec
43. p release the footswitch Use the IMPLANT CENTER 2 in accordance with good dental practice NEWTRON function Check that there are no traces of moisture on the NEWTRON handpiece or the scaler cord connections Remove any moisture by wiping and by drying with the multifunction syringe fed with medical quality filtered air Connect the scaler cord to the righthand connector of the device Fig 1 9 Align the electrical contacts of the NEWTRON handpiece and the scaler cord then plug the handpiece into the cord Screw the selected tip onto the handpiece using a tip wrench according to the recommendations Fasten the irrigation line to the cord using line clips Connect the end of the irrigation line to the scaler cord Prime the irrigation circuit by pressing the flush prime button on the screen Fig 3 1 or the multifunction footswitch Fig 11 2 When the irrigation solution reaches the end of the tip release the footswitch Use the IMPLANT CENTER 2 in accordance with good dental practice X SHUTTING DOWN THE DEVICE Upon completion of the dental procedure Remove the bottles or bags of physiological saline or sterile water from the brackets Remove the irrigation line perforating pins from the bottles or bags Immerse the irrigation line perforating pins in a vessel containing distilled water Rinse each irrigation line alternately along with the contra angle and the
44. sing button L5 Fig 3 11 Confirm the new settings by pressing button is Fig 3 8 The saving of the various settings is confirmed by an audible signal and a visual signal flashing button Repeat this sequence if necessary in order to adjust all the programs 7 8 TOOLBOX A Important IMPLANT CENTER 2 has a function used to make various adjustments including brightness light off time out audio volume and factory configuration reset To access the TootBox function switch OFF the device wait four seconds switch the device ON again then press button DS welcome screen Fig 9 Fig 9 41 on the a Audio volume adjustment Adjust the audio volume value H Fig 10 43 using buttons and Fig 10 46 and 47 The audio volume is adjustable from 0 to 100 relative value of the audio volume is displayed Fig 10 48 b Screen brightness adjustment Adjust the brishtness value Xt Fig 10 44 using buttons L and Fig 10 46 47 brightness is adjustable from 30 to 100 brightness level setting is displayed Fig 10 49 c Light off time out adjustment Adjust the time out length value X Fig 10 45 by pressing buttons L and Fig 10 46 and 47 length of the adjustable time out from seconds to 18 seconds is displayed Fig 10 50 d Storing the settings To store
45. t not be used with accessories other than those supplied or recommended by SATELEC Check the integrity of the device and its accessories before and after each use in order to detect any problem If necessary do not use the device and replace any faulty component The IMPLANT CENTER 2 is prepared for use as follows Make sure that the device is connected correctly and properly insulated Switch the power switch Fig 2 5 to position ON Suspend the bottles or bags of physiological saline or sterile water from the brackets Raise the irrigation pump covers Insert the irrigation line cassettes horizontally into their housings Close the covers Insert the irrigation line perforating pins into the bottles or pouches of physiological saline and open the cap on the pins Make any necessary setting adjustments irrigation flow rate speed torque power power mode program etc refer to chapter 7 Note This sequence must be completed under conditions of controlled asepsis for the safety of your patients An operating assistant may be needed Note The data is saved automatically in order to maintain the display parameters as previously used upon switchover from the various modes I SuncE function Check that there are no traces of moisture on the 1 5086 micro motor or micro motor cord connections If there are remove by wiping and drying with the multifunction syringe fed with 20
46. the manufacturer of the solution Use a solution that bears the EC marking or that is in compliance with any standard required by the national regulations Rinse under running water for at least 30 seconds c Mechanical chemical cleaning To be carried out immediately after pre disinfection chemical cleaning wearing thick gloves Scrub the products in a new bath of 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 Rinse again under running water for at least 30 seconds d Drying Dry with a clean non woven single use cloth so as to remove any traces of liquid Pack in single use sterilization pouches or bags in compliance with the specifications defined in standard EN ISO 11607 1 or in any equivalent standard required by the national regulations Sterilization tips must be sterilized individually autoclave according to the following parameters autoclave type B compliant with standard EN 13060 sterilization temperature 134 C sterilization stabilization time 18 minutes pressure 2 Bars min f Storage Store the sterilized products in a dry place protected from dust Before re use if the integrity of the packaging is not certain repackage then re sterilize in accordance with the defined protocol If contamination is visible inside the bag destroy th
47. tor to cool down Adjust the torque accordance with good orque fault q dental practice Incorrect speed adjustment Adjust the speed in accordance with good dental practice cia Change the contra angle se Return to SATELEC after sales Irrigation solution bag or bottle empty Replace DIE bag ar solution Irrigation off Press the irrigation ON OFF button Irrigation line clogged Change irrigation line ine end piece contra angle clogged Clear the contra angle line end piece Inadequate 5 Incorrect irrigation flow rate adjustment Adjust the irrigation flow rate Micro motor does not Power fault weak tip vibration Leak between the Faulty micro motor cord connector Clean the electrical contacts of the micro electrical contacts motor cord connectors Clean the electrical contacts of the micro Faulty micro motor electrical contacts motor Return to 5 after sales to replace Micro motor cord wires cut the cord Motor damaged Return to SATELEC after sales to replace the motor ip worn or distorted Replace the tip iena Refer to the and the clinical booklet for the necessary information Incorrect use incorrect angle of attack or Refer to the TipBook and the clinical inadequate pressure on the tooth booklet for the necessary information Liquid or moisture present between handpiece and cord Dry the electrical
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