User Manual Newtron P5XS - Support-acteon
Contents
1. 13 4 17 Mains Connector 13 4 18 I es nis ay D 13 4 I9 FUSE FCCESS RU Per ls DUI cR Mate E LL EU ri 13 A the talk uso eee ttu Ea sa 0 13 AD PUNO u L 13 4 23 Cleaning the irrigation system 14 5 Cleaning disinfecting and sterilizing 15 5 1 medical device cleaning and disinfection 15 5 2 Cleaning and disinfecting accessories 16 6 Monitoring and maintenance of the medical device 17 7 Maintenance 19 7 1 Identifying incorrect operation 19 TO 19 7 27 NO Spray ui ca a 19 7 1 3 The power is not as expected 19 7 1 4 Ultrasounds not working 20 5 20050000 20 7 2 Corrective Maintenance 202. 10 4 Description of the medical device 11 ZR Mao nido BUM EM 11 4 2 Power configuration button 11 4 2 1 Remote configuration via Bluetooth depending on option 11 4 3 Adjusting ultrasound power 11 AA nandplecen css cot tg aoc 00 11 ADAAN A oes RU perse ia clas Bos Es E CE UE 11 4 6 Connecting and disconnecting accessories during use 12 4 7 Connecting the handpiece 12 4 8 Handpiece support 2 2 12 49 handpiece bee aed cue he eels 12 0 ALOR 12 4 11 Irrigation flow configuration button 12 4 17 AdJustire Ele JE EIS ACION 2 2 Ide saa masa Sm skua Eam nhe 12 4 13 Initiating irrigation 13 4 14 AMNES os on Sok gt ale titia UE EE 13 4 15Gontrol pedal i 0 t SS masa PL 13 4 16 Activating ultrasounds using the pedal
3. detailed manual and automatic protocols information concerning conditioning for sterilization recommendations for the inspection of parts 1 Documentation This document contains the following information indications for use description of the medical device installation of the medical device use of the medical device preparation for cleaning and disinfection of the medical device monitoring and general maintenance of the medical device maintenance to be performed by the user 1 1 Associated documentation This document must be used in association with the following documents Quick Start Newtron P5XS User Manual for Newtron 5 5 Software User Manual Newtron 5 5 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 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
4. Le support permet de poser la piece a main 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 indicators colour cor responds to the power level 4 11 Irrigation flow configuration button The irrigation flow configuration button stops the irrigation function at the minimum stop marked by and sets the irrigation flow from mark to The irrigation flow configuration button can be removed to clean the medical device The button cannot be ste rilised The purge function is activated by pressing the pedal for 4 minutes it can be stopped by pressing the pedal again The pump operates at its maximum flow rate gt in purge position 4 1
5. a oh d E 30 9 6 Disposal and recycling 32 MOINS Xo ois os hes ay se SoU hes Banaue hee ect eon Anat au eee ree 33 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 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 preparation of parts for sterilization
6. connectable mains cord 4 18 Switch The mains switch is used to switch on position or to stop position O the medical device 4 19 Fuse recess The recess holds two mains fuses designed to protect the medical device in the event of overvoltage or an inter nal fault 4 20 Irrigation solution tank The medical device is equipped with a tank designed to hold 300ml or 500ml of irrigation solution depending on the option chosen The maximum capacity is shown by the MAX mark on the tank The irrigation solution tank is fitted with a cover Neither the tank nor the cover can be sterilised 4 21 Filling the tank Remove the tank from the medical device by pulling it upwards Fill the irrigation solution tank up to the MAX mark with an irrigation solution that is approved for the medical device The following solutions are approved for use e Hydrogen peroxide lt 3 Chlorexidine lt 3 EDTA Ethylenediaminetetraacetic acid lt 15 Sodium Hypochlorite lt 0 9 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 22 Pump The medical device is fitted with a peristaltic pump This pump must be replaced yearly by the practitioner using the F62202 kit or by the After Sales Department SATELEC User Manual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 13 36 4 23 Cleaning the
7. remove the various parts of Newtron P5XS 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 16 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENOAOB 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 P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 17 36 Page 18 36 User Manual e Newtron P5XS J62151 V1 13 04 2013 NBADENO40B 7 Maintenance The only preventive maintenance the medical device requires is e checking of accessories e everyday cleaning disinfection and sterilisation procedures e cleaning 7 1 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 th
8. 72 4 Replacing THE fUses u u Lu d eM S PLI a aQ u Ga 20 7 2 2 Replacing the irrigation cassette 21 8 Technical specifications for the medical device 25 51 16 SMEMCALION de ee E C RE SEDEM 25 8 2 otek ho Een LI PEE d IL M E E EE ae 25 95 3 Ultrasonic generator 0 25 5 4 Leneth of CONES 25 eni atO 5 25 8 6 Controt Dedal uuu cee ae eet ees Ml is ede ah Se hee ee 25 8 7 Environmental characteristics 26 5 8 Environmental TestricEIOns 22222 ullu usu OI gee eee ee ot spa heehee ied E 26 8 9 Main performance characteristics 2 26 9 Regulations and standards 27 tat Dusun cee ps e E Seta 27 9 2 Medical class of the device 27 9 3 Standardised u uuu uu eee Paes tena teins 28 9 4 Manufacturer identification 28 0 5 osten
9. 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 2 1 Remote configuration via Bluetooth depending on option The Newtron 5 5 depending on the option allows you to use a tablet or a smartphone to remotely pre configure the power and irrigation settings Refer to the P5XS application instructions J62111 for more information Only the Newtron P5XS with Bluetooth option is compatible with remote configuration 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 satelec com documents and on the treatment sheets 4 4 SLIM handpiece Only handpieces with SLIM connector SATELEC can be connected to the medical device Ther
10. 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 1 fill the tank with hypochlorite diluted at less than 3 2 position the irrigation flow configuration button on purge 3 operate the irrigation spray for two minutes to rinse the medical device s internal water system 4 refill the tank with demineralised or distilled water or even drinking water 5 rinse the system 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 device cleaning and disin fection page 15 3 follow the instructions for accessory cleaning disinfection and sterilization protocols SATELEC J81000 and J02000 Page 14 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENOAOB 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 loc
11. 2 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 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 Page 12 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADEN040B 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 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 O 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 16 Activating ultrasounds using the pedal To activate the ultrasounds on your medical device press the control pedal 4 1 7 Mains Connector The mains connector with its earthing pin is used to connect the device to the electrical network via a dis
12. 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 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 User Manual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 9 36 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 5 Installing the cont
13. ORDAN Tel 962 6 553 4401 Fax 962 6 553 7833 e mail info me acteongroup com CHINA ACTEON CHINA Page 30 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENOAOB 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 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 M
14. SATELEC Page 28 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENO40B 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 2 E mail satelec acteongroup com www acteongroup com User Manual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 29 36 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 4726 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 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 J
15. User Manual Newtron P5XS SATELEC Contents 1 Documentation 5 1 1 Associated documentation nus sini tet hohe m lela bus 5 1 2 Electronic documentation 5 2 Required information 7 GON 0 7 2 2 Operatine principle 22 20 7 2 3 Date of inclusion of EC marking 7 2 4 Latest document update 7 2 5 Repairing or modifying the device 7 DOV Mp UM BERNER ICE eink LIT u cece 8 2 7 Accessory usasee CONGILIONS na dos s dip A Rt ede unie 8 3 Removal from packaging installation connections 9 3 1 Unpacking your medical device 9 3 2 Positioning the medical device 9 tea 9 3 4 Connecting the medical device to the electrical network 9 3 5 Installing the control pedal 10 3 6 Fix the medical device to a non removable support
16. al 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 14 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 device 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 Schulke Cyberclean by Cybertech SEPTOL wipes by Anios SEPTOL spray by Anios Dentasept spray 41 by Anios Anionyxspray WS by Anios User Manual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 15 36 To prepare for cleaning
17. anual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 31 36 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 given in the chapitre Branch addresses page 30 Page 32 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADEN040B 10 Index 300 ml 13 500 ml 3 After installation 14 air circulation 13 air inlets 17 Air inlets 13 Altitude 26 Amplitude 26 approved dealers 7 attachments 9 B LED 11 Bleach 13 Bluetooth 11 C Chlorexidine 13 clean and disinfect the device 14 clean irrigation system 14 cleaned 8 color coding system 11 control pedal 10 13 control unit 11 cover 13 Index 300 ml gas filled atmosphere Cruise Control 11 damage 17 deionised water 13 demineralised water 14 dental file 7 dental ultrasonic
18. at it cannot be used 7 1 1 No operation Symptoms the indicator light on the medical device is off and the medical device is not working No electrical current Contact your electrician Internal fuse not working Return to After Sales team SATELEC Mains switch in position O Set the mains switch to position Faulty connection between the mains cord and the mains I connector Connect the mains cord to the mains connector Faulty connection between the mains cord and the electrical wall socket Mains fuses in the mains connector not working rating medical device also has internal fuse ref F1 on the printed circuit board that cannot be acces sed by the user 7 1 2 No spray Symptoms There is no water spray at the tip Pesbecases _ Flow configuration button on minimum Adjust the flow configuration button Tip or file blocked Unblock the tip or file Incorrect choice of tip Check the tip Inadequate amount of spray Adjust the spray No irrigation solution in the tank Fill the irrigation solution tank 7 1 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 User Manual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 19 36 esbecue _ Wor
19. e end of the conventional dental ultrasonic handpiece e Vibration frequency 2 28 kHz e Tip amplitude lt 200 um Page 26 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENOAOB 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 lla device according to European Directive 93 42 EEC User Manual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 27 36 9 3 Standardised Symbols Refer to the accompanying documentation Consult the User Manual Accompanying documentation in electronic format Electronic user informations Alternating voltage Sterilisation at 134 C in an autoclave Sterilisation at 132 C in an autoclave Washer disinfector for thermal disinfection EC marking Do not dispose of as household waste Year of manufacture Control pedal Device OFF IP ingress protection ratings procured by arange IPX1 X no ingress of protection rating claim against the penetration of solids 1 protects against the vertical falls of drops of water 9 4 Manufacturer identification
20. e is a handpiece with SLIM connector 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 User Manual Newtron P5XS J62151 V1 13 04 2013 gt NBADENO4OB Page 11 36 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 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
21. ece 150 VAC Output frequency Minimum 28 kHz Intermittent 10 minutes ON 5 minutes OFF BF Internal fuse not accessible to the user Ref FU1 1 5 AT 125 V SMD Breaking capacity 50 A 2 x 1 AT 230 VAC fuses 5mm x 20mm Breaking capacity 35 A 8 4 Length of cords Scaler handpiece cord in mm 22040 Control pedal cord in mm 22000 8 5 Irrigation Tank capacity in ml 300 or 500 Nominal water output flow at the end of the handpiece in ml min Nominal water output flow at purge in ml min 8 6 Control pedal With Height n mm Depth nmm User Manual Newtron P5XS 62151 V1 13 gt 04 2013 gt NBADENO4OB Page 25 36 Ingress protection rating IPX1 8 Environmental characteristics Operating temperature 10 C to 30 C Storage temperature 20 C to 70 C Operating humidity 10 a 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 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 th
22. elease it remove the used fuses Page 20 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENOAOB e replace the used fuses with fuses of the same type and same rating e place the fuse holder in its recess by pushing it until you hear a click that confirms it is in the correct position e connect the mains cord to the connector e connect the mains cord to the electrical network The medical device also has an internal fuse P N FU1 on the printed circuit board that cannot be accessed by the user 7 2 2 Replacing the irrigation cassette Cy User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENO4OB Page 21 36 e 04 2013 NBADENO40B 13 Page 22 36 User Manual e Newtron P5XS gt J62151 e V1 e 04 2013 gt NBADENO4OB Page 23 36 13 User Manual gt Newtron P5XS J62151 V1 e 04 2013 NBADENO40B 13 Page 24 36 User Manual e Newtron P5XS gt J62151 e V1 8 Technical specifications for the medical device 8 1 Identification Nom du medical device NEwTRoN P5XS 8 2 Control unit 110 145 with 300ml tank 182 with 500ml tank Weight in g SLIM cord 1674 with pedal SLIM cord and 300ml tank 1712 with pedal and 500 ml tank Ingress protection rating IPXO 8 3 Ultrasonic generator Supply voltage 100 VAC 240 VAC Voltage supplied to handpi
23. generators 5 dimineralised water 13 disinfected 8 disposal 32 distilled water 13 drinking water 14 earthing pin 13 EDTA Ethylenediaminetetraacetic acid 13 Electrical Safety 27 electronic user instructions 5 end of the day 14 endodontics 7 European Directive 27 F61001 10 fall risk 10 fault 17 first inclusion of EC marking 7 first use 14 fuse 19 fuses 20 G gas filled atmosphere 26 Newtron P5XS gt J62151 V1 13 04 2013 gt NBADENO4OB Page 33 36 Index Handpiece support Tip H Handpiece support 12 Handpieces 5 Hextril Hexedrin 13 humidity 12 Hydrogen peroxide 13 hypochlorite 14 incorrect operation 19 indexing points 12 indicator light 19 instructions relating to the comprehensive range of dental ultrasonic generators 3 irrigation flow 12 irrigation flow settings 11 K kit F12304 20 kit F62202 13 20 LED 11 light function 13 light indicator 12 M mains connector 13 20 mains fuses 13 mains switch 13 Mains switch 19 Manufacturer 25 Medical class 27 non use 14 pedal 13 periodontics 7 peristaltic pump 13 power settings 11 preservation and restoration dentistry 7 Pressure 26 printed copy 5 prophylaxis 7 purge function 11 12 Q Quick Clean 5 Quick Start 5 R recycling 32 removal of the button 11 repair 7 repairer 7 Saline solution 13 seal 20 silicone supports 12 SLIM cord 12 25 smartphone 11 Sodium Hypochlorite 13 Softwa
24. ing 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 wWwww acteongroup com satelec acteongroup com 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 User Manual Newtron P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 7 36 N YW The screws marked A B and C must not under any circumstances be unscrewed by the user as this may void the warranty for the medical device LLLA 2 Accessory usage conditions Accessories and SLIM handpiece must be cleaned disinfected and sterilized prior to use Page 8 36 User Manual e Newtron P5XS J62151 V1 13 04 2013 NBADENO40B 3 Removal from packaging ins tallation connections 3 1 Unpacking your medical device When you receive yo
25. n 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 Thoredshbvdrytheelsctricsleon tact piece and cord 7 1 4 Ultrasounds not working Symptoms the tip does not vibrate vibration cannot be heard 7 1 5 Water leakage Symptoms Water is leaking from one of the following places e between the base of the SLIM handpiece and its cord e under the tank e under the medical device Wear S EUM Replace the seal using F12304 kit Refer to the instructions in document J12921 handpiece seal Wear of the tank seal Contact the After Sales Department SATELEC to replace the tank T Replace the irrigation cassette using kit F62202 as detailed in the chapitre Replacing Worn irrigation cassette the irrigation cassette page 21 7 2 Corrective Maintenance In the event of faulty operation the following corrective maintenance actions may be performed by the user 7 2 1 Replacing the fuses The medical device is protected by two fuses in the mains connector To replace the fuses perform the following operations e stop the medical device position O disconnect the mains cord from the electrical network disconnect the mains cord from the mains connector insert the tip of a flathead screwdriver into the notch on top of the fuse holder to r
26. re User Manual 5 spray 13 19 Spray 15 Sterile water 13 sterilized 8 tablet 11 tank 13 Temperature 26 tip 7 20 Tip 19 Page 34 36 Newtron P5XS gt 62151 V1 13 04 2013 NBADENO40B Index Tips Wrenches Tips 5 treatment 11 12 ultrasonic vibrations 7 ultrasound instrument 7 ultrasound power 11 update 7 user instructions 5 User Manual 5 V Vibration frequency 26 W water leak 20 Wipes 15 Wrenches 5 Newtron P5XS J62151 V1 e 13 e 04 201304 2013 gt NBADEN040BJ12921 Page 35 36 Ref 62151 V1 13 04 2013 NBADENO40B C 2 SATELEC A Company of ACTEON Group 17 av Gustave Eiffel gt BP 30216 33708 cedex France Tel 33 0 556 340607 Fax 33 0 556 349292 E mail satelec acteongroup com www acteongroup com
27. rol pedal The control pedal must be positioned near the feet of the operator and must be readily accessible 3 6 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 clamp F61001 supplied in the packaging box to ensure that it cannot be dismantled or moved without nee ding a tool Page 10 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADEN040B 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 ultrasound 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
28. 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 P5XS J62151 V1 13 gt 04 2013 gt NBADENO4OB Page 5 36 Page 6 36 User Manual Newtron P5XS J62151 V1 13 04 2013 NBADENO40B 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 is 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 Repair
29. ur 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 P5XS includes the following items e aNewtron P5XS unit with non detachable pedal cord a non detachable SLIM cord a 300 or 500ml tank and a SLIM handpiece support a Newtron SLIM handpiece a Quick Start J12900 and a Quick Clean J12930 tips and wrenches depending on selected options an attachment kit a box containing FLAG disclosing liquid a Quick Start Newtron P5xs J62100 a Quick Clean Newtron 5 5 062101 3 2 Positioning the medical device Place the control unit in the position that is suitable for your activity Check 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
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