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1. 9 JUBIJOZIIA Y 119ISOZ3IA ENG less beacon senor ace acne sequoia os CE 0051 CASTELLINI CASTELLINI 1 INTENDED USE ans 3 2 IMPORTANT WARNINGS anna 3 4 4 TECHNICAL SPECIFICATIONS cnn ranma 4 5 CONNECTION TO THE POWER SUPPLY INSTRUMENT TUBING ccccsssecsessesecsesecsesscssesesscsesesscseseesecsesseeseeess 4 6 MOUNTING THE INSERTS narra 5 A N a e acia 6 8 USING INSTRUMENTS FOR ENDODONTIC THERAPY NOT AVAILABLE FOR HANDPIECE FOR S TYPE TIPS AA 7 9 SETTING OPERATIONAL PARAMETERS ccccscsccssssssessesecsesucsesscsucsesusssesesscsuesessesesstsusstsstsrestsatsesesssstsstsisetssteteees 7 10 ILLUMINATION DEVICE aan 7 11 MAINTENANCE cccccecsesscsecsesscsessesecsecsesecsessesecscsucsusscsucsussesucsesucsssaesussussesucsesacsusaesussessesucatsuesecsesassusatsasaesatsaeatsseaeeaes 7 12 CLEANING DISINFECTION AND STERILISATION ccccccscccssecsessssessesucsesecsucsesscsvesestesessessesesatsestsisatsstsveseeseseeees 7 13 REPAIRS AND OVERHAULS in nano 8 14 MODE OF USE as 8 15 ENVIRONMENTAL CONDITIONS FOR USE 8 16 ENVIRONMENTAL CONDITIONS PERMITTED FOR TRANSPORT AND WAREHOUSING una 8 17 TROUBLESHOOTING iii 8 o A 9 19 GUARANTEE CONDITIONS cccccccsesscsessessecessesecsessesecsessesecsesucsucsesussussesucsesuesecausussessesucsessesucsesasssatsacaesatsucaessesecees 9 MANU EACTURER ANA GAI KAANAK AAKALA LLANA MAALAB LANGAN LALALALA mamamana 9 CASTELLINI 1 INTENDED USE This is a Medical device or a medic
2. ICATIONS gt gt piezostel6 7 3D piezolight6 Rated power 32 VDC Working frequency Intermittent Operation Water Supply 90 140 kPa 0 9 1 4 bar Class lla Directive 93 42 EEC and subsequent additions and Classification amendments Class II type B IEC 60601 1 3500 K 20000 mim LED Illumination A 400 600 nm Pma lt 1 mw IEC 60601 1 IEC 60601 2 ISO 10993 1 IEC 62471 ISO 22374 Applicable regulations For the correct operation of the device it must be connected to the specific power supply and electronic control circuits designed by the manufacturer by way of suitable connection supply tubing The manufacturer promises to provide upon request wiring diagrams component parts lists calibration instructions or any other information that may be needed by authorised technical service assistance personnel The manufacturer reserves the right to bring about modifications at any moment without notice 5 CONNECTION TO THE POWER SUPPLY INSTRUMENT TUBING The scaler must be fully engaged on its power cord This can be achieved by pushing it in Ensure that the coupling surfaces are clean and dry Do not unplug the scaler from the cord while it is operating CASTELLINI 6 MOUNTING THE INSERTS The scalers must be used exclusively with the inserts supplied with original spare parts or with inserts approved by the manufacturer They must be screwed and tightened using the appropriate torque wrench only In the
3. al device accessory for professional use by Dentists assisted by authorised office personnel The device is intended for use on Dental Units complying with the 93 42 EEC Directive and subsequent additions and amendments complying with the IEC 60601 1 standard Ill ed and installed in locations meeting the standards in force for locations for medical purposes and with an electrical plant system that complies with the IEC 60364 7 710 standard 2 IMPORTANT WARNINGS Before using the device read the instructions in this manual carefully The use of the device must respect the instructions provided For the correct interpretation of the indications in this manual the Italian text is binding The device is not suitable for use with blends of inflammable anaesthetics and oxygen or nitrous oxide The instrument is provided in a non sterile state Before use see to its suitable cleaning and disinfection Use of electrically powered devices may interfere with the operation of active implantable devices such as pacemakers or other active devices In case of doubt regarding the treatment of patients with such devices consult a cardiology expert or another competent medical institute During use of the device dust and fragments from the patient s oral cavity or from the same device may be projected into the environment organic and inorganic powders fragments of the inserts potentially infectious biological materials Protect the patient wh
4. and contact the authorized technical support service If saline is used as a coolant before removing the handpiece it is necessary to drain the water for at least 20 seconds in order to rinse the ducts of the handpiece and the water circuit LED radiation do not stare into beam or view directly with optical instruments The manufacturer will not be held responsible regarding safety reliability or performance of the device if The essential requirements for the location detailed in the Dental Unit User Manual are not respected The assembly the additions the adjustments the calibrations and or the repairs are not performed by authorised technical service personnel If modifications tampering incorrect maintenance have been performed or incompatible and or non original spare parts have been used on the device The device is not used in compliance with the use instructions and its intended use CASTELLINI 3 SYMBOLS Symbol to call the attention to other information found in the equipment User Manual Symbol corresponding to TYPE B PART APPLIED according to IEC 60601 1 R Indicates a protection grade against direct and indirect contacts Part that may be sterilised in an autoclave Mark of Compliance with the 93 42 EEC Directive MEDICAL DEVICES and subsequent additions and 0051 amendments Symbol for disposal pursuant to the 2002 95 EC 2002 96 EC 2003 108 EC Directives E 4 TECHNICAL SPECIF
5. and or their consequences may be attributed to unsuitable procedures or modifications of the product performed by third parties not authorised by the manufacturer that is if non original Spare parts or components are used The recognition of any other claims from any origin whatsoever in particular any requests for indemnification for damages or interest are excluded The manufacturer may not be held responsible for damages or injuries and their respective consequences derived From excessive wear From connection of the instrument not compliant with the CE regulations From improper tampering or maintenance performed by unauthorised personnel From use of non original accessories or spare parts From the lack of observance of the instructions for use for assembly or maintenance or from improper use of the product From unusual chemical electrical or electronic influxes From faulty connections air water electricity The guarantee does not cover the conductors such as the flexible fibre optics nor any other elements made of synthetic materials 20 MANUFACTURER Manufactured by Sede Legale ed Amministrativa Head Quarter CEFLA sc Via Selice Provinciale 23 a 40026 Imola BO Italy Tel 39 0542 653111 Fax 39 0542 653344 Stabilimento Plant CEFLA DENTAL GROUP Via Bicocca 14 c 40026 Imola BO Italy Tel 39 0542 653441 Fax 39 0542 653555 EN OPERATORS MANUAL Ipon
6. ater duct blocked ae using the syringe if necessary Cord blocked Request technical support Water circuit not working Request technical support element Lighting element with reverse polarity element oxidized Lighting element damaged Replace the lighting element Cord damaged Request technical support Control panel damaged Request technical support CASTELLINI 18 SCRAPPING Scrapping the device must be carried out with respect for the laws in force for electrical and electronic equipment according to the individual national laws The materials used for the manufacture are not harmful for human beings or animals that come into contact with or are exposed to them 19 GUARANTEE CONDITIONS The manufacturer provides the end user with a 12 month warranty starting from the date of installation and in any case not exceeding 18 months from the invoice date covering all operational faults defects of materials or manufacture In case of justified complaints the manufacturer or the Authorised Repair Centre will proceed with the repair or substitution of the product free of charge To be able to make use of the free repair or substitution it is an indispensable condition that shipped together with the device there is a proof of user s purchase document for the same device which must include clearly legible references to the product its serial number and date of purchase The guarantee expires when any damages
7. en possible using a dental dam Instruct the patient to breathe through the nose in cases where the dam is not applicable Medical personnel must put on suitable personal protection equipment Suitably cool the surgical field during use In case of visible damage the emission of unusual noises and or vibrations or if overheating is noticed do not use the device and call authorised technical service assistance The scalers must be used exclusively with the inserts supplied with original spare parts or with inserts approved by the manufacturer Before use check that the inserts are secured in place Donot use worn or damaged inserts Handle the inserts carefully wearing protective gloves Use only inserts bearing the CE marking under Directive 93 42 EEC and subsequent additions and amendments made of biocompatible materials in accordance with the ISO 10993 1 standard Use only original spare parts and accessories or those authorised by the manufacturer Donot change the structure of the inserts by bending or filing them Donot use the handpiece on metal or ceramic articles The high frequency oscillations can damage them The inserts can be particularly pointed and sharp To avoid accidental cuts or injuries take care when the inserts are mounted on the handpiece and remove them after use Make sure that the surgical area cooling flow is present during operation In the absence of cooling suspend use of the device
8. er after use To prevent it from becoming blocked the insert must be removed after each treatment and before sterilization in an autoclave The manufacturer requires an annual check or overhaul of the device by authorised service assistance personnel 12 CLEANING DISINFECTION AND STERILISATION Before disinfection remove the inserts from the handpiece and the handpiece from the cord To maintain the level of hygiene after each use and within a short time clean disinfect and sterilize the scaler Clean the coolant ducts by blowing air through using a syringe For external cleaning and or disinfection use gauze or cotton soaked in 7096 v v ethyl alcohol The inserts can be disinfected by immersing them in 70 v v ethyl alcohol Sterilize the handpiece the wrench the inserts and the insert holder in a steam autoclave max 135 C 220 kPa 2 2 bar for 5 minutes 250 cycles tested EN ISO 22374 Donot use ultrasound cleaners Donot immerse the device in disinfectant or sterilizing liquids Never sterilise the handpiece in a dry heat steriliser Do not leave the device in the autoclave at the end of the cycle Periodically check the autoclave according to the requirements of the manufacturer Sterilization temperatures above the limit may damage the device CASTELLINI 13 REPAIRS AND OVERHAULS Installation overhaul calibration and repair of the device must be performed exclusively by technical service assistance p
9. ersonnel authorised by the manufacturer 14 MODE OF USE The method of application of the device is intermittent The operational cycle indicated respects the following times Type of Instrument Operation minutes Pause minutes piezosteril 6 piezolight 6 15 ENVIRONMENTAL CONDITIONS FOR USE Ambient Temperature 10 40 C Relative Humidity 30 75 Atmospheric Pressure 700 1060 hPa 700 1060 mBar 16 ENVIRONMENTAL CONDITIONS PERMITTED FOR TRANSPORT AND WAREHOUSING Ambient Temperature between 20 70 C Relative Humidity 10 100 Atmospheric Pressure 500 1060 hPa 500 1060 mBar 17 TROUBLESHOOTING FAULTS PROBABLE CAUSES INTERVENTION SUGGESTED The handpiece is not correctly Checkconneciion inserted onto the cord The power setting is at minimum Check the power setting on the unit ENDO mode has been selected Check the operating mode setting The insert is not properly tightened nen USA ie ep plepiale wrench MELONES O platen The insert is worn or deformed Replace the insert The insert has micro fractures in the Replace the insert threaded area The scaler is damaged Replace the handpiece The cord is damaged Request technical support The control panel is damaged Request technical support Check the position of the flow Water flow regulator closed regulator on the table or on the cord connector Make sure the hole in the insert is Insufficient water supply W
10. ert Not available for handpiece for S type tips ENU P1 Code F680C4400 P1S Code 99926378 Scaler Tip Prophylaxis Supra and subgingival application interproximal spaces and grooves Fr P3 Code F680C8300 Subgingival and root surface application periodontal pocket irrigation with antibacterials Not available for handpiece for S type tips R1 Code F680C8100 R2 Code F680C8200 R3 Code F680C 7900 RR Cod F680C7700 RL Cod F680C 7800 Cavity preparation small scale interventions particularly suitable for interdental cavities in front teeth and molars Not available for handpiece for S type tips i E1 Code F680C6800 DA 120 chuck for clamping endodontic files Not available for handpiece for S type tips aha E2 Code F680C6700 95 chuck for clamping endodontic files A Not available for handpiece for S type tips Endo wrench Code FR300R009 er Wrench for clamping the chuck to the handpiece and the files to the chuck Not available for handpiece for S type tips Oe ERATORS MANUAL EN CASTELLINI 8 USING INSTRUMENTS FOR ENDODONTIC THERAPY NOT AVAILABLE FOR HANDPIECE FOR S TYPE TIPS In units with the ENDO function it is possible to use special inserts for endodontic therapy Set the ENDO functions using the control on the table Tighten the E1 or E2 file support chuck fully onto the handpiece using the corresponding wrench Always use a co
11. handpiece marked with use exclusively the inserts C1S C2S C4S P1S or inserts approved by manufacturer After connecting the handpiece to the cord operate it for a few seconds until a constant spray of coolant is produced The spray of water varies according to the power level and type of insert The insert mounted on the scaler handpiece reaches the correct operating frequency within a few tenths of a second after the device is activated In order to allow proper syntonization do not apply the tip to the tooth surface during this phase Handpieces with tips P1 P1S C1 C1S and C4 C4S must not operate perpendicularly or head on to the tooth but tangentially with slight lateral pressure while the C2 C2S inserts can also work perpendicularly to the tooth surface The P1 P1S insert must be used at a medium low power level With any specific inserts for dry machining operate at intervals of no more than 3 seconds CASTELLINI 7 INSERTS C1 Code F680C2700 C1S Code 99926376 Scaler Tip Supragingival application C2 Code F680C2800 C2S Code 99926377 Scaler Tip Supragingival application C4 Code F680C9900 CAS Code 99926379 Scaler Tip Supragingival incisors and neck of molars application E3 Code F680C6900 Insert for the lateral thermal condensation of the gutta percha Not available for handpiece for S type tips Aas E4 Code F680C6600 Canal widening diamond coated ins
12. olant to prevent the chuck from overheating Tighten the file in the chuck making sure that the coloured notch remains visible with the exception of the ISO 25 file colour code red which must be inserted fully Adjust the power to a minimum and increase it gradually as needed in any case not exceeding the limits specified in the table below ISO 15 file colour code white ISO 20 file colour code yellow ISO 25 file colour code red ISO 30 file colour code blue max 100 ISO 35 file colour code green max 100 Endosonore files manufacturer Dentsply Maillefer Ref A 012U 9 SETTING OPERATIONAL PARAMETERS It is possible to adjust the speed activate and adjust the spray or the lighting if any using the commands on the unit Refer to the unit instruction manual for operating parameter settings 10 ILLUMINATION DEVICE In models with the feature the lighting in the surgical area operates in accordance with the provisions of the unit on which it is installed Refer to the unit user manual for information about the lighting device In order to replace the lighting element unscrew the front part of the instrument and remove the tapered lighting element When repositioning the new lighting element be careful to respect the polarity If the polarity is inverted the light does not come on 11 MAINTENANCE If the handpiece is fed with liquid which might create encrustations it is necessary to rinse the circuit with wat

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