User Manual Newtron P5 - Support-acteon
Contents
1. User Manual Newtron P5 J61101 V1 13 04 2013 e NBACENO40B Page 25 34 9 3 Standardised Symbols L mbas Meaning Refer to the accompanying documentation Consult the User Manual Accompanying documentation in electronic format HH Electronic user informations cT LF type Sterilisation at 134 C in an autoclave Sterilisation at 132 C in an autoclave Washer disinfector for thermal disinfection Do not dispose of as household waste Device OFF IP ingress protection ratings procured by a range X no ingress of protection rating claim against the penetration of solids 1 protects against the vertical falls of drops of water Page 26 34 User Manual lt Newtron P5 J61101 V1 13 04 2013 e NBACENO40B 9 4 Manufacturer identification SATELEC A Company of ACTEON Group 17 avenue 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 User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Page 27 34 9 5 Branch addresses FRANCE SATELEC ACTEON GROUP 17 av Gustave Eiffel Zone industrielle du phare 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 Inc 124 Gaither Drive Suite 140 Mount Laurel NJ 08054 USA Tel 1 856 222 9988 Fax 1 856 222 4722. feedback and professional training differ from one professional to another the user must make sure that the irrigation flow is perfectly adapted to the treatment to be carried out to avoid burning the treat ment area 4 13 Initiating irrigation The medical device must be set to minimum power depending on the required irrigation flow rate Press the pedal until a spray appears 4 14 Air inlets Air inlets ensure correct ventilation of the control unit Leave them uncovered to allow air to circulate 4 15 Connection to water system The supply pipe connector is used to connect the medical device device to the domestic water distribution sys tem The connector is extended by a pipe to which a filter is attached The filter needs to be cleaned and or Page 14 34 User Manual e Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B replaced regularly as specified in the chapitre Replacing the water filter page 21 The water quality must meet the criteria required to perform dental treatments 4 16 Control pedal The ON OFF type pedal is used by the practitioner to operate the medical device Pressing the pedal automatically activates the handpiece ultrasounds and the irrigation function if it is not in 0 position The control pedal equipped with its cord cannot be disconnected Its weight and antislip pad ensure good sta bility The light function remains active for approx 9 seconds after the pedal is released 4 17 Activ
3. SATELEC at the request of technical personnel working for the network of dealers approved by SATELEC provide all information required to repair the faulty parts on which they may perform repairs 2 6 Accessory usage conditions Accessories and SLIM handpiece must be cleaned disinfected and sterilized prior to use User Manual Newtron P5 J61101 V1 13 04 2013 e NBACENO4OB Page 7 34 Page 8 34 User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B 3 Removal from packaging ins tallation connections 3 1 Unpacking your medical device When you receive your medical device check for any damage that may have occurred during transportation If you have received this medical device by mistake please contact the supplier to arrange for it to be col lected If you have any questions or requirements contact your supplier The Newtron P5 includes the following items e aNewtron P5 unit with non detachable pedal cord a non detachable SLIM cord and a SLIM handpiece support e a Newtron SLIM handpiece depending on configuration a Quick Start J12900 and a Quick Clean J12930 e tips and wrenches depending on selected options e anattachment kit e a box containing FLAG disclosing liquid e a Quick Start Newtron P5 J61000 e a Quick Clean Newtron P5 J61000 3 2 Positioning the medical device Place the control unit in the position that is suitable for your activity Che
4. ceeeceeeeeee 14 4 16 Control pedal 2 00 2 ccc ccc cece cece cee cece eee bene SENER TE Rn es s 15 4 17 Activating ultrasounds using the pedal eee eee cece cee a SK SK KK KK KK KK KK KK KS 15 4 18 Mains Connector 1 e wa a PATE De El Ug av hee Te Y ees Ro 15 AAD SWIEGH ce An ar eue See e har Etuis SAI mue A AA Za ea de WA WA DSE c Ko tede 15 4 20 Fuse recess 15 4 21 Cleaning the irrigation system sas sas sas aS A cee cee cee cece eee sense 15 5 Cleaning disinfecting and sterilizing css asas saa sesa a SK SK RR KK SK KK KK KK KK RR 17 5 1 medical device cleaning and disinfection 000002 c eee eee KK RR KK KK 17 5 2 Cleaning and disinfecting accessories 2 sk a ns nS SS SK KK KK KK KK KK KK KK K KK KK KK 18 6 Monitoring and maintenance of the medical device KK 19 ZiMaintenance osx nete R A bu WE e E Lear vete ese Y RC Sees 21 7 1 Replacing the water iter 21 7 2 Identifying incorrect operation saa sa aa as cee cee KS cee cee SK serrer es 21 7 2 1 NO Operation cede tote sala Pi es de tate eA te sse iuter sy len andet cac Cakes SUA 21 7 2 2 NoSptay i m suc HHR sd Lads HRH HHHH 21 7 2 3 The power is not as expected J J eee ee cee cee eee cece cece KAK sn 22 7 2 4 Ultrasounds not working 0 asa cee cece cee cee cee eee cece KAK KK KK KK KK KRA 22 7 2 5 Water leakage 5252 2550 DON DA y ka uu gases E RIRs e DIE AE E Dan Hi 22 8 Technical specifications for the medical devi
5. is not working Internal fuse not working Mains switch in position O Faulty connection between the mains cord and the mains Connect the mains cord to the mains connector connector Faulty connection between the mains cord and the electrical wall AER Connect the mains cord to the electrical wall socket Replace the mains fuses with fuses of the same type and rating Mains fuses in the mains connector not working The medical device also has an internal fuse ref F1 on the printed circuit board that cannot be acces sed by the user 7 2 2 No spray Symptoms There is no water spray at the tip User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Page 21 34 SC Passibieceuses TT uan TT Dental cabinet water inlet in shut off position Open the water inlet Flow configuration button on minimum Adjust the flow configuration button 7 2 3 The power is not as expected Symptoms the tip does not vibrate at the expected frequency the treatment is not progressing as normal and is taking longer or at a standstill Worn or distorted tip Replace the tip Incorrect use incorrect approach angle or inadequate Refer to the configuration table available at www pressure on the tooth satelec com documents Presence of liquid or humidity between the hand Thoroughly dry the electrical contacts piece and cord 7 2 4 Ultrasounds not working Symptoms the tip does not vibrate vibration cannot be h
6. performed by the user 1 1 Associated documentation This document must be used in association with the following documents Quick Clean Newtron P5 Quick Start Newtron P5 User Manual for Newtron P5 User Manual for SLIM handpiece 1 2 Electronic documentation The user instructions for your device are provided in electronic format and not in printed format However you can request a free printed copy of the user instructions within 7 days via our website by telephone or in wri ting The electronic user instructions are available in PDF format Portable Document Format and you will need to have a PDF file read software installed to read the instructions The device user instructions can be consulted at the following address www satelec com documents HH Electronic user informations It is important for you to have read and understood the content of the user instructions relating to the use of your device and its accessories prior to use We recommend that you visit the website regularly to consult and or to download the latest version of your device s user instructions User Manual Newtron P5 J61101 V1 13 04 2013 e NBACENO4OB Page 5 34 Page 6 34 User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B 2 Required information 2 1 Indication for use This medical device is used in association with a dental utrasound handpiece to which an ultrasound instrument is attached It i
7. your patients comfort in your daily practice and to benefit fully from the technology of your medical device please read the documentation provided carefully If you have received this medical device by mistake please contact the supplier to arrange for it to be collected Please refer to the instructions relating to the comprehensive range of dental ultrasonic gene rators SATELEC for information about the following documentation format the documentation archiving period warnings concerning user and patient populations the treatment area the medical device usage interactions contraindications and prohibitions electromagnetic compatibility disposal and recycling of the medical device manufacturer responsibility Please refer to the accessory cleaning disinfection and sterilization protocols and the hand piece predisinfection cleaning and sterilisation protocols for information about the fol lowing e preparation of parts for sterilization e detailed manual and automatic protocols e information concerning conditioning for sterilization e recommendations for the inspection of parts 1 Documentation This document contains the following information e indications for use e description of the medical device e installation of the medical device e use of the medical device e preparation for cleaning and disinfection of the medical device e monitoring and general maintenance of the medical device e maintenance to be
8. 4 User Manual e Newtron P5 J61101 V1 13 lt 04 2013 e NBACEN040B 7 Maintenance The only preventive maintenance the medical device requires is checking of accessories everyday cleaning disinfection and sterilisation procedures cleaning replacement of the water filter cartridge 7 1 Replacing the water filter The water filter must be cleaned regularly and must be replaced every 6 months Proceed as follows shut off the water supply stop the medical device position O unplug the network plug unscrew the two filter sections using the two 10mm open ended wrenches remove the filter cartridge to be replaced kit F10389 or clean it with water spray repeat the same process for the seal e perform the same operations in the reverse order for reassembly e check that the spray works correctly and that there is no leakage A damaged or blocked cartridge must be replaced 7 2 Identifying incorrect operation In the event of incorrect operation refer to the tables below to quickly identify and repair the non complex parts of the medical device If the incorrect operation is not described in the tables below please contact your supplier or the After Sales team at SATELEC Do not use the medical device if it appears to be damaged or faulty Isolate the medical device and make sure that it cannot be used 7 2 1 No operation Symptoms the indicator light on the medical device is off and the medical device
9. 4 2013 e NBACENO4O0B Page 23 34 Ingress protection rating IPX1 8 7 Environmental characteristics Operating temperature 10 C to 30 C Storage temperature 20 C to 70 C Operating humidity 10 100 Atmospheric pressure Between 800 hPa and 1060 hPa Altitude Less than or equal to 2000 metres 8 8 Environmental restrictions Can be used at all medical premises The medical device must not be used in an operating Usage premises 2 theatre or outside Use in gas filled The medical device is not designed for use in a type AP or APG gas filled atmosphere or in the atmosphere presence of anaesthetic gases Immersion The SLIM handpiece must not be immersed 8 9 Main performance characteristics Ultrasonic vibrations of the tip or file fitted to the end of the conventional dental ultrasonic handpiece e Vibration frequency gt 28 kHz e Tip amplitude lt 200 um Page 24 34 User Manual e Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B 9 Regulations and standards 9 1 Official Texts This medical device complies with the essential requirements of European Directive 93 42 EEC This equip ment is designed and developed in compliance with Electrical Safety standard IEC60601 1 in force It was desi gned and manufactured in accordance with an EN ISO 13485 certified quality assurance system 9 2 Medical class of the device This medical device is a class Ila device according to European Directive 93 42 EEC
10. 6 e mail info us acteongroup com GERMANY ACTEON GERMANY GmbH 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 MEDICO DENTAL IBERICA S A U 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 ACTEON UK 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 2nd Floor N 205 Gardens Street PO Box 5746 11953 AMMAN JORDAN Tel 962 6 553 4401 Fax 962 6 553 7833 e mail info me acteongroup com CHINA ACTEON CHINA Page 28 34 User Manual e Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B 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 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 Corp 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
11. INDIA ACTEON INDIA B 94 GIDC Electronic Estate Sector 25 GANDHINAGAR 382028 Gujarat INDIA Tel 91 79 2328 7473 Fax 91 79 2328 7480 e mail info in acteongroup com LATIN AMERICA ACTEON LATIN AMERICA Bogota COLOMBIA Celular 57 312 377 8209 e mail carlosandres vera es acteongroup com RUSSIA ACTEON RUSSIA Valdajski Proezd 16 office 253 125445 Moscow RUSSIA Tel Fax 7 499 76 71 316 e mail sergey koblov ru acteongroup com AUSTRALIA NEW ZEALAND ACTEON AUSTRALIA NEW ZEALAND Suite 119 30 40 Harcourt Parade Rosebery NSW 2018 Australia Tel 612 9669 2292 Fax 612 9662 2204 e mail sandy junior au acteongroup com TAIWAN User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Page 29 34 ACTEON TAIWAN 14F 1 N 433 Jinping Rd Jhonghe Dist New Taipei City 23563 TAIWAN R O C Tel 886 926 704 505 e mail tina chu tw acteongroup com 9 6 Disposal and recycling As an item of Electrical and Electronic Equipment the must be medical devicedisposed of via a specialist col lection removal recycling or destruction channel This applies in particular to the European market in refe rence to Directive 2002 96 EC dated 27 01 2003 When your medical device has reached the end of its service life contact your nearest dental equipment dea ler or ACTEON GROUP head office or one of the company branches to find out how to proceed The relevant contact details are gi
12. User Manual N WwTRON P25 Newtron P5 Contents 1 Documentation 12 2 2 ss asas ss sS SK KK SK ee KK KK KK KK KK KK KK KRG 5 1 1 Associated documentation 5 1 2 Electronic documentation 2 lk sk a a a sS ks a SK KK KK SK SK KK KK KK KK KK KK KK KK KK KK KK KG 5 2 Required information 2 moti chcci A iei das aZ IAS 355 imc debct anit kaz 7 2 4 lfidication for Use euro kerl nr ht hd nn i ea ense dal uoi ed Remove Ke ERNA i ule shad 7 2 2 Operating Principle ches orci mue o e a ha ben l a E wee FEE rear nele kef 7 2 3 Date of inclusion of EC marking s cee KAK KK KRA KK K6 7 2 4 Latest document update cee eee cee cee cece KS KK KK KK KK K8 7 2 5 Repairing or modifying the device eee eee 7 2 6 Accessory usage conditions 02202 cece ccc ce cee cee eee ssl ls erre 7 3 Removal from packaging installation connections L L L L RR ee ee 9 3 1 Unpacking your medical device 2 00 20 nasa sa aa cee cee cece eee cee KK SK ss KK KK KK RR 9 3 2 Positioning the medical device JJ J sas ee asas aa aa Sa Ka SK SK esses KK KK KK KK KK KK KK 9 3 3 Installarig Cords s o i SEER eRe Ke eke tet eU Ao PURO EE fates Te aa Wwe a relais 9 3 4 Connecting the medical device to the water system KK ee 9 3 5 Connecting the medical device to the electrical network 10 3 6 Plugging the medical device to the electrical network 10 3 7 Installing the control pedal 0 0 0 000 asas aa aS cece cece
13. ating ultrasounds using the pedal To activate the ultrasounds on your medical device press the control pedal 4 18 Mains Connector The mains connector with its earthing pin is used to connect the device to the electrical network via a dis connectable mains cord 4 19 Switch The mains switch is used to switch on position or to stop position O the medical device 4 20 Fuse recess The recess holds two mains fuses designed to protect the medical device in the event of overvoltage or an inter nal fault The following solutions are approved for use e Hydrogen peroxide lt 3 e Chlorexidine lt 3 e EDTA Ethylenediaminetetraacetic acid lt 15 e Sodium Hypochlorite lt 0 9 e Sterile water distilled water deionised water dimineralised water e Saline solution at 0 9 The following solutions must not be used e Hextril Hexedrin e Bleach 4 21 Cleaning the irrigation system After installation and before first use at the end of the day and following a period of prolonged non use of the medical device it is important to clean the irrigation system Operate the device at minimum power at maximum irrigation flow rate for two minutes When the irrigation system has been cleaned perform the following operations 1 disconnect the handpiece and refer to handpiece predisinfection cleaning and sterilisation protocols SATELEC J12910 2 clean and disinfect the medical device as indicated in the chapitre medical devic
14. ce 23 Sil Mdentificatione MEN ate N A Ree DD N R a NN 23 EA GONCHOUUNIC 5 57 55 e EDEL ges ORL OCIO Sa UE EOS 1525555222 23 8 3 Ultrasonic generator lt 253a sa dezan da wa se sal cece ec cee cee cece cece cece cece e Ba ee Ee k ra 4 23 8 4 Length of cords 1 2 0 E EEE E HH HH HH H HHH HHHH HHHH HH HH HH ee 23 8 5 irrigation ASTE es eae a SENSE kK 23 8 6 Control pedals eos co ace cree Erden HE de z aU azz z gt i 23 8 7 Environmental characteristics lcs sa saa aa a asa a cee eee eee cee KA SK KS KK SK KK KK KK RR 24 8 8 Environmental restrictions lsa asa sas cee cee cee eee eee KS SK KS KK AK elles 24 8 9 Main performance characteristics _ 2 2 2 022 022 lee cee 24 9 Regulations and standards 25 OAO o GT 25 9 2 Medical class of the device 20 2 2 sese same ss cece ee eee sese s cence KK KK KK 8R 25 9 3 Standardised Symbols risieda a a n N eaa es me ee QE DOK AT RS 26 9 4 Manufacturer identification l l css asas aa SAS A ASA s KS KAK KK KK KK K6 27 9 5 Branchiaddresses tien sa ne hb td bima l De M bi oe io a d Oed 28 9 6 Disposal and recycling Jl sa eee cece cee eee KS ss KS KS KK SK KS KK KK KK KK K8 30 10 Index 31 Foreword The medical device SATELEC that you are about to install and use in your practice is a medi cal device designed for professional use It comprises the chosen tool with which you will pro vide treatment within the context of your work To ensure optimum safety for yourself and
15. ck that the cords do not hinder the movement or free circulation of anyone The medical device must be placed on a secure and flat surface or a surface with a maximum slope of 5 degrees Fix your medical device using the attachments provided to ensure that the device cannot be removed without the use of a tool Adjust the position of your medical device to correspond to your angle of vision and the characteristics of your workstation e g lighting or distance between the user and the medical device Ensure that you can access your medical device quickly Do not install your medical device near or on another device 3 3 Installing cords Check that the cords do not hinder the movement or free circulation of anyone Never rotate the handpiece connector on its cord as this can damage your medical device Never wrap the handpiece cord around the medical device Make sure that it is not possible to wheel over or walk on the different cords The cord attached to its handpiece must be easily accessible Make sure that the cord is slack during use Do not put the medical device cords in a cable cover or a cable tray 3 4 Connecting the medical device to the water system The information below only applies to medical device that need to be connected to the water system to operate Ask an approved dental installation technician to connect your medical device to the water system The water supply system pressure may vary throughout the day Th
16. e cleaning and disin fection page 17 3 follow the instructions for accessory cleaning disinfection and sterilization protocols SATELEC J81000 and J02000 User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Page 15 34 Page 16 34 User Manual e Newtron9 P5 J61101 V1 13 lt 04 2013 e NBACENO40B 5 Cleaning disinfecting and ste The instructions relating to accessory cleaning disinfection and sterilization protocols provided by SATELEC have been approved for each medical device and accessory The applicable guides are listed in chapitre Asso ciated documentation page 5 They can be downloaded at the following address www satelec com documents In all cases the local regulations in force relating to the accessory cleaning disinfection and sterilization pro tocols take precedence over the information provided by SATELEC 5 1 medical device cleaning and disinfection The medical device must be in OFF or O stop position during cleaning and disinfecting procedures Refer to the instructions detailed in the chapitre Cleaning the irrigation system page 15 Avoid using cleaning and disinfection products that contain flammable agents Otherwise ensure that the product has completely evaporated from or that there is not fuel left on the medical device and its accessories before switching it on Do not use abrasive product to clean the medical device Never apply sprays directly to the medical de
17. e water supply system pressure must be adap ted to the values recommended for your medical device It is very important to make sure that the maximum User Manual Newtron P5 J61101 V1 13 04 2013 e NBACENO4OB Page 9 34 pressure permitted for the medical device is never reached or exceeded If in doubt you are strongly advised to install or arrange for installation of a water pressure limiting system The water supply system must comply with the quality criteria compatible with the practice of dental treatments 3 5 Connecting the medical device to the electrical network Set the medical device to OFF position O and check that the mains voltage is compatible with that indicated on the medical device or its mains adapter Next connect the cord to the wall socket in compliance with the stan dards in force in the country of use A different voltage would cause damage to the medical device and could injure the patient and or user Any variation in the electrical network voltage or electromagnetic field that is non compliant with the limits in force could interfere with the medical device s operation medical devices equipped with a protective earth must be connected to a supply network equipped with a pro tective earth Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or cable tray 3 6 Plugging the medical device to the electrical network 1 Set the medical device s mains
18. eard Return to After Sales Department SATELEC to replace the cord 7 2 5 Water leakage Symptoms Water is leaking from one of the following places e between the base of the SLIM handpiece and its cord Wear of 1 15mm x1mm SLIM handpiece Replace the seal using F12304 kit Refer to the instructions in document seal J12921 Page 22 34 User Manual lt Newtron P5 J61101 V1 13 04 2013 e NBACENO40B 8 Technical specifications for the medical device 8 1 Identification Nom du medical device NEwTRON P5 8 2 Control unit Height in mm 102 1650 with mains cord SLIM cord 1674 with pedal SLIM cord and 300ml tank 1712 with pedal Weight in g Ingress protection rating IPXO 8 3 Ultrasonic generator Type of leakage currents BF 1 Internal fuse not accessible to the user Ref FU1 1 5 AT 125 V SMD Breaking capacity 50 A Fuse mains connector 2 x 1 AT 230 VAC fuses 5mm x 20mm Breaking capacity 35 A 8 4 Length of cords Scaler handpiece cord in mm 2040 o o ue 5 c c D ct Uu E 5 o DERE lt lt i E D ct 3 a ra o c va a D b 6 5 a lt Control pedal cord in mm gt 2000 8 5 Irrigation Water pressure at inlet 1 to 5 bars Maximum water output flow at the end of the handpiece 8 6 Control pedal Width in mm Height in mm i 80ml min to 100ml min at 5 input bars weight ing User Manual Newtron P5 J61101 V1 13 0
19. in ou la douille du cordon The handpiece support can be fixed to the front face or the right side face of the medical device To change the position of this support unscrew the two screws located under the support position the support over the two holes located on the right side face and insert and tighten the two fastening screws The two silicone supports can be removed by sliding them along the metal rod They can be sterilised 4 9 handpiece cord The SLIM cord is only compatible with handpieces SATELEC with SLIM connector The SLIM cord ensures irrigation circulation and electrical connection between the medical device and the SLIM handpiece 4 10 Light indicator The light indicator is designed to provide information about the status of the device When the light indicator is illuminated the medical device is on and ready to use The indicator s colour cor responds to the power level 4 11 Irrigation flow configuration button The irrigation flow configuration button stops the irrigation function at the stop at least and sets the irrigation flow from min to max The irrigation flow configuration button is not designed to be removed The purge function is activated by pressing the pedal for 4 minutes it can be stopped by pressing the pedal again 4 12 Adjusting the irrigation Adjust the irrigation flow using the irrigation flow configuration button This adjustment depends on the tip and the treatment As work habits
20. nnector without LED and a handpiece with SLIM connector B LED with white or blue LED Refer to the handpiece user manual Newtron J12921 for more information 4 5 Attach a tip or a file A tip or a file vibrates correctly when it is perfectly tightened without being forced beyond its stop point Tigh ten it moderately using the wrench provided to ensure optimum ultrasound operation Over tightening of the tip or file can result in breakage of the tip file or handpiece To prevent self locking of the tip or the file the latter must be removed after each use 4 6 Connecting and disconnecting accessories during use Do not connect disconnect the cord s or the handpiece when the medical device is switched on and your foot is on the pedal Do not tighten or loosen the tips when the handpiece is activated User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Page 13 34 4 7 Connecting the handpiece Check for the absence of signs of humidity at the SLIM handpiece connections and eliminate them if necessary wipe and blow using a multipurpose syringe Lubricate the irrigation system seal located behind the SLIM handpiece with dental instrument lubricant to extend its effectiveness and prevent leaks Connect the SLIM handpiece to the sleeve by aligning the indexing points and by avoiding rotation movement Install the SLIM handpiece on the support 4 8 Handpiece support Le support permet de poser la pi ce a ma
21. ns connector 10 15 mains fuses 15 mains switch 15 Mains switch 21 Manufacturer 23 Medical class 25 non use 15 pedal 15 periodontics 7 power settings 13 preservation and restoration dentistry 7 Pressure 24 printed copy 5 prophylaxis 7 purge function 13 14 Q Quick Clean 5 Quick Start 5 Index instructions relating to the comprehensive range of dental ultrasonic generators water filter R recycling 30 removal of the button 13 repair 7 repairer 7 Saline solution 15 seal 22 silicone supports 14 SLIM cord 14 23 Sodium Hypochlorite 15 spray 14 21 Spray 17 Sterile water 15 sterilized 7 supply pipe 14 Temperature 24 tip 7 22 Tip 22 Tips 5 treatment 13 14 ultrasonic vibrations 7 ultrasound instrument 7 ultrasound power 13 update 7 user instructions 5 User Manual 5 V Vibration frequency 24 W water filter 21 Page 32 34 Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Index water leak Wrenches water leak 22 water system 9 Wipes 17 Wrenches 5 Newtron P5 J61101 V1 13 e 04 201304 2013 e NBACENO40BJ12921 Page 33 34 C Ref J61101 e V1 13 04 2013 e NBACENO40B SATELEC A Company of ACTEON Group 17 av Gustave Eiffel e BP 30216 33708 MERIGNAC cedex France Tel 33 0 556 340607 Fax 33 0 556 349292 E mail satelec acteongroup com www acteongroup com
22. ound power configuration button ensures e Configuration of the operating power 1 to 20 The configuration button has 4 colour sectors each with 5 positions e Green 1 to 6 very low to low power used mainly for periodontics e Yellow 6 to 11 medium power used mainly for endodontics e Blue 11 to 16 high power used mainly for scale removal e Orange 16 to 20 very high power used mainly for implant loosening The ultrasound power configuration button can be removed by the user to facilitate the cleaning and disin fection of the control unit The button cannot be sterilised The removal of the button inhibits the activation of ultrasounds The top surface of the control unit lights up white and the control pedal can be pressed to activate the purge function The purge function can be stopped at any time by pressing the control pedal again 4 3 Adjusting ultrasound power Adjust the ultrasound power using the ultrasound power configuration button The ultrasound power must be adjusted in accordance with the tip used and the required treatment The operating power of the tips must be selected in compliance with the Satelec tips color coding system CCS tips Details of these indications are given in the adjustment table available at the address www Sate lec com documents and on the treatment sheets 4 4 SLIM handpiece Only handpieces with SLIM connector SATELEC can be connected to the medical device There is a handpiece with SLIM co
23. s designed for the treatment of prophylaxis periodontics endodontics and preservation and res toration dentistry 2 2 Operating principle An electrical signal emitted by the medical device is supplied to the dental ultrasonic handpiece This is connected to the medical device via a cord The handpiece comprises a piezoelectric ceramic transducer which transforms the electrical signal into ultrasonic vibrations Mechanical vibrations are transmitted to a tip or a dental file attached to the end of the ultrasonic handpiece The Newtron SLIM B LED fitted with its Blue LED ring and used in conjunction with the F L A G disclosing liquid shows up dental plaque during the scale removal or dental prophylaxis phase Fitted with a white LED ring the handpiece emits a white light providing the user with optimum visibility of the treatment area 2 3 Date of inclusion of EC marking 2013 2 4 Latest document update 04 2013 2 5 Repairing or modifying the device Contact the supplier of your device Using the services of an unapproved repairer could render your device dan gerous for you and your patients Do not repair or modify the SATELEC without seeking the prior permission of If the device is modified or repaired specific checks and tests must be carried out to ensure that the device is still safe to use In the event of doubt contact an approved dealer or the SATELEC customer service team www acteongroup com satelec acteongroup com
24. sess nnne 10 3 8 Fix the medical device to a non removable support 022 e ee KK 10 4 Description of the medical device _ 2 202 222 eee 13 AA Con COL UE xuma Sk Anna DE A SE tee eni hie eo ee tte ate Ne li hede 13 4 2 Power configuration button 0 0000000 a ass aS ennen ee cee cece cece ceeeceeeeee 13 4 3 Adjusting ultrasound power 2 22 c cece ee cee cee cee eee SK SK SK eee KK KA KK KK KK KK 13 A A SLIM hiandplece eerie bb e wel ll dts ER VM ELA ead 13 4 5 Attach atip orafile 00 0 eT la a hb nay nd de kis SK cece ee ee cece cece kala Ka nake 13 4 6 Connecting and disconnecting accessories during use a KK KS 13 4 7 Connecting the handpiece 2 2 2 o cece cece cee cee cee cece KK KS KK KK KK KK R8 14 4 8 Handpiece support o les 2 24 sa Sess seid leva ew nile ed vcil duin E W n AE rcc kin DE Besant Sick 14 Z 9 hahndpiGGe COFQ lt a Ax ae 23 620 2 0 R sela nen dekh ae ne Tala neat AO Aa DN ed nO ea dae da a a Eb ben 14 4 10 Light tnidicator soc etr Sut Get SNN yy ed b gale ie a r 14 4 11 Irrigation flow configuration button J J ks 0222 sS E SK KK KK KK KK SK KK KK KK KK KK KK 14 4 12 Adjusting the irrigation lt A 4 passer k a a a de A AE se cee cece see R RA SRG 14 4 13 Initiating irrigation lt Ai XA sh cece ccc cee We RR I RII eller rell 14 AAI inl ts 7222 eea b ire a e ae UO PONI S GERI eS oe heh eas 14 4 15 Connection to water system l lee cece cee cee cee es re
25. switch to stop position O 2 connect the mains cord to the control unit mains connector 3 connect the mains cord to the electrical fixture wall socket 3 7 Installing the control pedal The control pedal must be positioned near the feet of the operator and must be readily accessible 3 8 Fix the medical device to a non removable support The medical device that you have just acquired is not designed for mobile use To avoid accidently dropping the device we recommend that you fix it in a precise place in your treatment room using the screw and Page 10 34 User Manual e Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B clamp F61001 supplied in the packaging box to ensure that it cannot be dismantled or moved without nee ding a tool User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Page 11 34 Page 12 34 User Manual e Newtron9 P5 J61101 V1 13 lt 04 2013 e NBACENO40B 4 Description of the medical device 4 1 Control unit The control unit incorporates technology Newtron patented by SATELEC The patented technology Newtron controls the tips by Cruise Control an automatic system for setting the frequency and power in real time This ensures that Satelec tip vibration is gentle regular and controlled 4 2 Power configuration button To ensure a quality treatment you will need to use the tips at the power and irrigation flow settings recom mended by SATELEC The ultras
26. ven in the chapitre Branch addresses page 28 Page 30 34 User Manual lt Newtron P5 J61101 V1 13 04 2013 e NBACENO40B 10 Index After installation 15 air circulation 14 air inlets 19 Air inlets 14 Altitude 24 Amplitude 24 approved dealers 7 attachments 9 B LED 13 Bleach 15 C Chlorexidine 15 clean and disinfect the device 15 clean irrigation system 15 cleaned 7 color coding system 13 control pedal 10 15 control unit 13 Cruise Control 13 damage 19 deionised water 15 dental file 7 dental ultrasonic generators 5 dimineralised water 15 disinfected 7 disposal 30 Index After installation indicator light distilled water 15 earthing pin 15 EDTA Ethylenediaminetetraacetic acid 15 Electrical Safety 25 electronic user instructions 5 end of the day 15 endodontics 7 European Directive 25 F61001 11 fall risk 10 fault 19 Filter 22 first inclusion of EC marking 7 first use 15 fuse 21 G gas filled atmosphere 24 H Handpiece support 14 Handpieces 5 Hextril Hexedrin 15 humidity 14 Hydrogen peroxide 15 incorrect operation 21 indexing points 14 indicator light 21 Newtron P5 J61101 V1 13 e 04 2013 e NBACENO40B Page 31 34 instructions relating to the comprehensive range of dental ultrasonic generators 3 irrigation flow 14 irrigation flow settings 13 K kit F10389 21 kit F12304 22 LED 13 light function 15 light indicator 14 M mai
27. vice to clean it Always spray the product onto a wipe then clean the medical device The medical device control unit handpiece cord and control pedal must be cleaned and disinfected daily The following cleaning and disinfection products can be used e Unowipes wipes by Unodent Alcohol free hard surface disinfectant wipes by Classic Spray alcohol free hard surface disinfectant by Classic Hard surface disinfectant wipes by Classic Microzid wipes by Schilke Cyberclean by Cybertech SEPTOL wipes by Anios SEPTOL spray by Anios Dentasept spray 41 by Anios Anionyxspray WS by Anios User Manual Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B Page 17 34 To prepare for cleaning remove the various parts of Newtron P5 as shown here 5 2 Cleaning and disinfecting accessories Refer to the accessory cleaning disinfection and sterilization protocols listed in the chapitre Associated docu mentation page 5 Page 18 34 User Manual e Newtron P5 J61101 V1 13 lt 04 2013 e NBACENO40B 6 Monitoring and maintenance of the medical device Before and after each use check that the device and its accessories are not faulty in any way This is neces sary to detect any isolation fault or damage If necessary replace damaged parts Monitor the cleanliness of the air inlets on the control unit to prevent any heating User Manual Newtron P5 J61101 V1 13 04 2013 e NBACENOAOB Page 19 34 Page 20 3
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