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1. Instrument tubing broken Request technical service assistance Blocked handpiece The motor does not turn Request technical service Adjustment command broken l The motor runs but its speed is not assistance adjustable Electronic control board Request technical service malfunction assistance Instrument tubing defective Substitute the instrument tubing The motor functions sporadically Bearings damaged Request technical service assistance Torque set to its minimum Recover the proper adjustment The motor does not provide Endodontics mode selected Recover the proper adjustment sufficient torque Request technical service Power supply motor malfunction l assistance Request technical service assistance Lubricate the handpiece Send the handpiece to technical service assistance Slide the handpiece out and reinsert it properly Send the handpiece to technical Handpiece broken l l service assistance l D Request technical service Defective transmission coupling assistance The handpiece rotates on its send the handpiece to technical Blocked handpiece l coupling service assistance Handpiece damaged Substitute the handpiece The handpiece does not remain l Request technical service inserted on the micro motor Motor hook ring damaged as ee Water leakage at the handpiece O ring seals worn or damaged Substitute the O rings aal Parage SE DESEN O ring seals worn or2. 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 Sr Symbol corresponding to TYPE B PART APPLIED according to IEC 60601 1 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 SPECIFICATIONS handy power O 1 men 1 weie 100 10 revs min 3 3 Nem Water Supply Cooling air 25 Ni min Consumption Air Spray 5 NI min Water Spray 35 cc min Class Ila Directive 93 42 EEC and subsequent additions and Classification amendments Class II type B IEC 60601 1 Handpiece Connection Compliant with ISO 3964 and compatible with INTRAmatic Lux LED Illumination 5000 K 20000 mlm Applicable reaulations IEC 60601 1 IEC 60601 1 2 IEC 60825 1 ii i ISO 10993 1 EN ISO 14457 Dimensions mm mM Weight 66 5 g 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 reque
3. At least once a week lubricate the O Ring seals found in the handpiece coupling with silicone lubricating grease Wearing disposable gloves apply a film of grease on the fingertips and lubricate with the fingers If liquids that potentially leave incrustations are used to supply the spray it is recommended that the circuit be flushed well with water at the end of each use The manufacturer requires an annual check or overhaul of the device by authorised service assistance personnel 10 CLEANING DISINFECTION AND STERILISATION Before sanitisation operations detach the handpiece from the micro motor and the motor from the instrument tubing To maintain a level of hygienic security at the end of each use and within a short time clean disinfect and if applicable sterilise the micro motor Micro motors that may be sterilised are identified by the specific symbol found in the Symbols paragraph For cleaning and or disinfection of the outside of the micro motor use gauze or cotton soaked in ethyl alcohol 70 viv Sterilise in a steam autoclave max 135 C 220 kPa 2 2 bar for 5 minutes 250 cycles tested EN ISO 14457 Before each autoclave cycle lubricate the micro motor using the specific spray lubricant DAILY OIL applying a quick squirt Reconnect the motor onto the instrument tubing and activate it so as to expel the excess lubricant Dry the outside of the micro motor with gauze or cotton wool before proceeding on with sterilis
4. QJ JeMod ApueU 19M0d puey G37 Jo uejdwi Z J Wht ve N U LJ CASTELLINI t INTENDE DNU SE aasia eee ee EEAS EEA 3 Ze IMPORTANT WV Ell E 3 a MBO saree einen eee erie re ee err eres eet er er ee ee ee 4 A TECHNICAL OGPECIFRICA HONG E 4 5 CONNECTION TO THE POWER SUPPLY INSTRUMENT TUBING 4 D CONNECTION AND DISCONNECTION OF THE HANDPIECE nsssssssssssnsssssnnssssnnnssssrrrrrssrrrrrrssrrrressrnrrresrnrrrnsnrnnnne 4 7 SETTING OPERATIONAL PARAMETERS E 5 os ECUMINA Eeer 5 d MAINTENANCE ee ee e ee ee eee 5 10 CLEANING DISINFECTION AND STERILISATION ossssossssnssssnnnssssnnnssssnnnssssrnrrrnsrrnnrrssrrnnnesrrrrrnsrrrrrresnnrnntsnrrrrtenn n 5 NK REFAIRS AND OVERRAULG EE 5 UZ MODE OFU E 5 13 ENVIRONMENTAL CONDITIONS FOR UE AAA 5 14 ENVIRONMENTAL CONDITIONS PERMITTED FOR TRANSPORT AND WAREHOUSING nsee 6 OR e Eeleren EE 6 NG eerie etre cere eres seen tee vec rere cu acted EES E a EOE aE 6 17 GUARANTEE CONDITION E 7 MS EE eg TOR ee cre sec a cette ease eed ee ees eee AEA E AEE A EEE E Ea A E 7 CASTELLINI 1 INTENDED USE This is a Medical device or a medical 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 IIl ed and installed in locations meeting the standards in force for locations for medical purposes and wi
5. arties 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 18 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
6. ation Donot use ultrasound cleaners Do not immerse the handpiece in disinfectant or sanitizing solution Never sterilise the handpiece in a dry heat steriliser Do not leave the handpiece in the autoclave but remove it immediately after the cycle Periodically check the autoclave according to the requirements of the manufacturer Temperatures higher than the indicated limit may damage the micro motor 11 REPAIRS AND OVERHAULS Installation overhaul calibration and repair of the device must be performed exclusively by technical service assistance personnel authorised by the manufacturer 12 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 implantor LED handy power handy power LED 13 ENVIRONMENTAL CONDITIONS FOR USE Ambient Temperature 10 40 C Relative Humidity 30 75 Atmospheric Pressure 700 1060 hPa 700 1060 mBar CASTELLINI 14 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 15 TROUBLESHOOTING Motor blocked Request technical service assistance Lubricate the handpiece Send the handpiece to technical service assistance Electronic control board broken Request technical service assistance
7. damaged Substitute the O rings tubing coupling 16 SCRAPPING Insufficient cooling air The motor overheats Handpiece with strong friction Handpiece not connected properly The motor turns regularly The burr does not turn 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 gen ERATORS WANUAL e CASTELLINI 17 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 and or their consequences may be attributed to unsuitable procedures or modifications of the product performed by third p
8. e only handpieces and counter angles with the CE mark of compliance with the 93 42 EEC Directive and subsequent additions and amendments Use only burrs or other similar tools with CE Mark of compliance with Directive 93 42 EEC and subsequent additions and amendments made with biocompatible materials complying with ISO 10993 1 and whose dimensions comply with EN ISO 1797 1 standards Before each use verify the proper locking of the handpiece onto the micro motor and of the burr onto the handpiece chuck Do not use damaged or worn handpieces Make sure that during operation of the motor there is full flow of cooling air In the absence of cooling stop using the device and call authorised technical service assistance 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 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 lf modifications tampering incorrect maintenance have been performed or incompatible and or non original
9. st 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 Bring the motor next to the instrument tubing and rotate it on the connector itself until the coupling point is found Insert the motor completely and then fully tighten the ring nut 6 CONNECTION AND DISCONNECTION OF THE HANDPIECE Handpieces complying with ISO 3964 and with the INTRAmatic Lux type may be used Insert the handpiece on the coupling until the connection click is heard Never mount a handpiece onto a motor that is running To detach the handpiece from the motor pull lightly CASTELLINI 7 SETTING OPERATIONAL PARAMETERS Operational modes speed adjustment inversion of the rotation direction torque adjustment spray and LED lighting activation if available are to be made through the Dental Unit command panel Refer to the Dental Unit instruction manual for the setting of the operational parameters 8 ILLUMINATION DEVICE In the micro motors set up with LEDs for lighting of the surgical field these light up automatically when the micro motor is running After the motor stops the LED remains lighted for a pre set time Lighting depends on settings made on the Dental Unit 9 MAINTENANCE
10. th 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 If the device may be sterilised lubricate it before performing the autoclave sterilisation 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 dust and metal dust fragments of the device or its tips and potentially infected biological material Protect the patient when 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 Us
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