Goldspeed EVO S1 / S1-L / M5-L /

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1 Rev Goldspeed EVO S1 / S1-L / M5-L / D1 / D1-L / R20-L / E16 ENGLISH..2 EN

2 ENGLISH 1. INTENDED USE IMPORTANT WARNINGS SYMBOLS TECHNICAL SPECIFICATIONS CONNECTION AND DISCONNECTION OF THE HANDPIECE DRILL ASSEMBLY SETTING OPERATIONAL PARAMETERS ILLUMINATION DEVICE MAINTENANCE CLEANING, DISINFECTION AND STERILISATION REPAIRS AND OVERHAULS MODE OF USE ENVIRONMENTAL CONDITIONS FOR USE ENVIRONMENTAL CONDITIONS PERMITTED FOR TRANSPORT AND WAREHOUSING TROUBLESHOOTING SCRAPPING GUARANTEE CONDITIONS MANUFACTURER OPERATOR'S MANUAL EN

3 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 standard (III 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 standard. 2. IMPORTANT WARNINGS Before using the device, it is necessary to carefully read the instructions on this manual. The device must be used following the given instructions. For the correct interpretation of the instructions contained in this manual, the Italian version shall be valid as original text. - The instrument is provided in a non-sterile state. Before use, clean and disinfect properly. If the device can be sterilised, lubricate it before sterilising it in an autoclave. - Instrument rotating at high speed! An excessive pressure could damage the tooth! - Do not connect or disconnect the handpiece from the micromotor until this is completely still! - Cool operating field during use! If the cooling flow stops, turn handpiece off immediately! - Always start the handpiece with a drill fitted! - Use only drills (or other similar instruments) with CE Mark in compliance with Directive 93/42/EEC and subsequent additions and amendments, made with biocompatible materials complying with ISO and whose dimensions comply with EN ISO standards. - Do not use worn or damaged drills! Handle drills with care and wearing protective gloves! - Before every use, check the correct locking of the handpiece on the micromotor and of the drill on the handpiece. - Do not exceed the speed indicated by drill manufacturer! - Drill locking button overheats if pressed during handpiece operation. Pay the utmost care not to press it against Patient oral cavity by accident. - In case of visible damage, emission of unusual noises and/or vibrations, anomalous heating or if the drill is not well fixed, do not use the instrument: immediately stop working and contact the authorised Technical Service. - During the use of the device dust and fragments from the patient s oral cavity or from the device may be projected into the environment (organic and inorganic 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 when the dam is not applicable. - Medical personnel must wear suitable personal protective equipment. - GOLDSPEED EVO R20-L: Contra-angle can be activated with a max. torque of 7.5Ncm (risk of damage of mechanical parts of the instrument)! According to IEC / UL , contra-angle is not suitable for use in environments with risk of explosion or for explosive mixtures of anaesthetics with oxygen or laughing gas. 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. - GOLDSPEED M5-L: Do not exceed a drill speed of 200,000 rpm. If such limit is exceeded, the handpiece could overheat and hurt the patient. - GOLDSPEED EVO E16: Contra-angle has a degree of efficiency undoubtedly higher than that of the previous model GOLDSPEED E16. WARNING: If this handpiece is used with micromotors applied to dental units in which EVO E16 model is not present in the endodontics menu database, it is necessary to select contra-angle E16 and reduce torque. This means that to reach 5Ncm on the rotary instrument, it is necessary to set a 3.5 Ncm torque on the display. The Manufacturer will not be responsible for safety, reliability and performance if the device: - The essential environmental requirements described in the unit user manual are not met. - Assembly, addition, adjustment, calibration and repair processes are not carried out by authorised technical personnel. - The device is modified, tampered with, not correctly serviced, incompatible spare parts and/or non-original components are used. - The device is not used in compliance with use instructions and for product intended use. EN OPERATOR'S MANUAL 3

4 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 Indicates a protection grade against direct and indirect contacts. Part that may be sterilised in an autoclave. Thermo-disinfectable part. Mark of compliance with the 93/42/EEC Directive MEDICAL DEVICES and subsequent additions and amendments. Disposal symbol in accordance with Directives 2002/95/EC, 2002/96/EC and 2003/108/EC. 4. TECHNICAL SPECIFICATIONS Model EVO S1 EVO S1-L EVO M5-L EVO R20-L EVO E16 EVO D1 EVO D1-L Transmission ratio 1:1 1:1 1:5 20:1 16:1 1:1 1:1 Union on engine side ISO 3964 ISO 3964 ISO 3964 ISO 3964 ISO 3964 ISO 3964 ISO 3964 Drills EN ISO Ø 2.35 Ø 2.35 Ø 1.6 Ø 2.35** Ø 2.35 Ø 2.35 Ø Drill max. length (mm) *** 22 50* 50* Drill max. 3,125 rotation 40,000 40, ,000 2, (endo) speed 40,000 40,000 No Fiber optic No Yes Yes LED with internal generator No No Yes Max. torque 70** to drill (Ncm) 105**** Classification IEC IEC IEC ISO ISO * see straight handpiece DRILL ASSEMBLY. ** with torque to drill >30 Ncm instruments with reinforced shank must be used (>50 HRC, >520 HV) (danger of deformation). *** if longer drills are used, the user must pay attention not to put himself/herself, the patient or third parties in danger. **** if drills with hexagon driver are used. The Manufacturer will supply, if requested, circuit diagrams, part lists, instructions for calibration or other information that might be useful to the authorised technical personnel. The Manufacturer reserves the right to make changes at any time and without prior notice. 4 OPERATOR'S MANUAL EN

5. CONNECTION AND DISCONNECTION OF THE HANDPIECE Handpieces without fiber optic. Fit the handpiece and push it fully home until hearing the engagement click. To remove the handpiece pull it axially.

To remove the handpiece, pull it axially. WARNING! Do not connect or disconnect the handpiece from the micromotor until the latter is completely still! 6. DRILL ASSEMBLY Straight handpiece.

5 5. CONNECTION AND DISCONNECTION OF THE HANDPIECE Handpieces without fiber optic. Fit the handpiece and push it fully home until hearing the engagement click. To remove the handpiece pull it axially. Handpieces with fiber optic. Fit the handpiece, align the part protruding from the handpiece with the corresponding slot on the micromotor and push fully home until hearing the engagement click. To remove the handpiece, pull it axially. WARNING! Do not connect or disconnect the handpiece from the micromotor until the latter is completely still! 6. DRILL ASSEMBLY Straight handpiece. Rotate the ring nut until it clicks to remove drill (O), fit the new drill, and bring the ring nut back to close position ( ). Do not start the motor if the ring nut is in open position (O). * Ø 2.35 contra-angle drills can be fitted on straight handpiece. Fit drill connection (not supplied) inside handpiece then fit the rotating instrument until it locks in position. Drill connection compensates length difference. Contra-angles. Pressing with the thumb on the centre of the button on the head is enough to slide drill out and fit a new one. Inserting the drill. Ø 2.35 drills: pressing and holding the button, fit the drill fully home and slightly rotate it keeping it pressed until it clicks; then release the button. Ø 1.6 drills: fit the drill fully home pressing and holding the button, then release it. The GOLDSPEED EVO R20-L handpiece can fit drills with 2.35 mm hexagon driver. WARNING! Make sure drill shank is clean. Wear protective gloves and, before using the handpiece, check that the drill is correctly fitted by pulling it by hand. Do not use drills longer than what specified (see technical data table)! For a correct locking, it is mandatory to fit the drill fully home. Do not start drill unlocking mechanism until the drill is completely still in order to avoid severe damage! 7. 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. 8. 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. EN OPERATOR'S MANUAL 5

9. MAINTENANCE The handpiece must be lubricated at least once a day and before every sterilisation in an autoclave, using the suitable "DAILY OIL" spray and adapters.

After lubrication, refit handpiece on micromotor and activate it so as to expel the excess of lubricant (carry out such procedure with a drill fitted in order to avoid mechanical damage to the

6 9. MAINTENANCE The handpiece must be lubricated at least once a day and before every sterilisation in an autoclave, using the suitable "DAILY OIL" spray and adapters. Follow the instructions on the spray can paying attention to apply the spray in two short jets. After lubrication, refit handpiece on micromotor and activate it so as to expel the excess of lubricant (carry out such procedure with a drill fitted in order to avoid mechanical damage to the instrument), then dry the outer part of the device with gauze or cotton. A regular use of the lubricant spray ensures instrument top operating conditions. Lubricate the O-rings on quick coupling with S1 silicone lubricant grease at least once a week. Wear disposable gloves, apply a thin layer of grease on fingertips and lubricate by hand. In the event that liquids that potentially leave incrustations supply the sprayer, it is recommended that the fluid 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 technical service personnel. After 3 years from handpiece installation, a general overhaul at manufacturer's premises is required. For GOLDSPEED EVO R20-L model only Contra-angle disassembly. 1 Remove drill internal cooling duct. 2 Remove spray clip. 3 Grab contra-angle head with one hand. 4 Slightly press the sheath towards the elbow. At the same time, rotate the sheath to separate it from the elbow. 5 Remove elbow from contra-angle head. 6 Slide intermediate gear out of elbow. Contra-angle reassembly. 1 Fit intermediate gear inside elbow. 2 Have golden contacts on elbow and contraangle head coincide. 3 Fit elbow on contra-angle head. Check that tightening system (a) and shaft (b) rotate freely. 4 Fit sheath on contra-angle head. Pay attention to the symbols and rotate until it locks. 6 OPERATOR'S MANUAL EN

10. CLEANING, DISINFECTION AND STERILISATION Wear protective gloves! Remove the burr before sanitisation operations! Remove the handpiece from micro-motor.

For cleaning and/or disinfection of the outside of the handpiece, use gauze or cotton soaked in ethyl alcohol 70% V. Do not use pointed or sharp instruments to clean terminals of fibre optics.

7 10. CLEANING, DISINFECTION AND STERILISATION Wear protective gloves! Remove the burr before sanitisation operations! Remove the handpiece from micro-motor. To maintain a level of hygienic security, at the end of each use and within a short time, clean, disinfect and sterilise the handpiece. For cleaning and/or disinfection of the outside of the handpiece, use gauze or cotton soaked in ethyl alcohol 70% V. Do not use pointed or sharp instruments to clean terminals of fibre optics. Clean regularly, using the suitable tool, spray outlet holes. The handpiece can be cleaned and disinfected with a thermodisinfector (respect indications of the manufacturer concerning equipment, detergents and cleaners). Before each autoclave cycle it is essential to lubricate the handpiece using the specific spray lubricant DAILY OIL, and clean terminals of fibre optics Before sterilisation, reassemble the handpiece on the motor and activate it so as to expel the excess of lubricant. Wipe the outer part of the handpiece with gauze or cotton. To maintain a level of hygienic security, the handpiece must be sterilised in a steam autoclave max. 135 C 220 kpa (2.2 bar) for 5 minutes (250 cycles tested - UNI-EN-ISO-14457) after its use on each patient. - Do not use ultrasonic cleaners. - Never sterilise the device in a dry heat steriliser. - Do not leave the handpiece in the autoclave at the end of the cycle. - Periodically check the autoclave according to the requirements of the manufacturer. Sterilisation temperatures higher than the limit indicated on the device may damage the handpiece. Manual internal and external cleaning. 1 Rinse and brush with demineralised water (<38 C). 2 Remove any liquid residues (absorbent cloth, dry with a jet of air). WARNING! Do not soak handpiece / contra-angle in disinfectant or ultrasonic cleaning). Manual disinfection. 1 Disinfection with disinfectant, the use of disinfectant tissues is recommended. Use chlorine free disinfectants, certified by officially acknowledged institutes. Follow the instructions of disinfectant manufacturer. WARNING! After cleaning, disinfection and manual lubrication, always sterilise (packed instrument) in class B or S steam sterilizers (according to EN 13060). 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. EN OPERATOR'S MANUAL 7

8 12. MODE OF USE A continuous operating mode is possible for all the handpieces, except for GOLDSPEED EVO R20-L, for which the following intermittent mode is foreseen: Type of Instrument Operation (minutes) Pause (minutes) GOLDSPEED EVO R20-L ENVIRONMENTAL CONDITIONS FOR USE - Ambient temperature C - Relative humidity % (non-condensing at +30 C) - Atmospheric pressure hpa ( mbar) 14. ENVIRONMENTAL CONDITIONS PERMITTED FOR TRANSPORT AND WAREHOUSING - Ambient temperature between C - Relative humidity 8 80 % (non-condensing at +40 C) - Atmospheric pressure hpa ( mbar) 15. TROUBLESHOOTING FAULTS POSSIBLE CAUSES RECOMMENDED INTERVENTION Handpiece with low power, sudden speed decrease Extremely handpiece noisy Faulty drill enabling or disabling Spray supply faults Lack of lighting Water leakage 16. SCRAPPING Lack of lubrication Worn rotating parts Curved or very worn drill Lack of lubrication Worn rotating parts Lubricate in steps, after short rotation in between Contact technical assistance Insert a new drill Lubricate in steps, after short rotation in between Contact technical assistance Drill with not calibrated diameter Use high quality drills only (ISO ) Worn drill Button not pressed all the way down Worn pliers Clogged nozzles Damaged micromotor light source Handpiece not correctly fitted on micromotor Brightness regulator at minimum Worn O-rings of the connection on micromotor Use a new drill Press the button centre all the way down Contact technical assistance Remove handpiece, direct cord towards the bowl and check that air and water come out. NOTE: water regulator must be open. Clean the handpiece and use the suitable steel wire paying attention not to make nozzles out of round. Replace the light source if possible or contact technical service Correctly fit the handpiece Adjust control on board Replace the O-rings and lubricate them 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. 8 OPERATOR'S MANUAL EN

9 17. GUARANTEE CONDITIONS The manufacturer provides the end user with a 24-month warranty, starting from the date of installation, 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 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. 18. MANUFACTURER Manufactured by Sede Legale ed Amministrativa / Head Quarter CEFLA sc - Via Selice Provinciale, 23/a Imola (BO) Italy Tel. +39/ Fax Stabilimento / Plant CEFLA DENTAL GROUP - Via Bicocca, 14/c Imola (BO) Italy Tel Fax EN OPERATOR'S MANUAL 9

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