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1 book Seite 1 Freitag, 21. April :54 15 fjmi^kq=omwn Operating instructions båöäáëü lééê~íáåö=fåëíêìåíáçåë

2 book Seite 2 Freitag, 21. April :54 15 Table of contents Operating Instructions IMPLANT 20:1 Table of contents 1 Before you begin Structure of the document Service life of Sirona instruments Safety information Technical description Task Structure of IMPLANT 20: Technical data Preparation Initial start-up and longer breaks in use Operation D

3 book Seite 3 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 Table of contents 5.1 Replacing the instrument Inserting and removing burs Connecting and detaching hoses for NaCl solution Disassembling and assembling instrument Follow-up After each treatment session At the end of the work day Conditioning Conduct pre-disinfection Automated cleaning and disinfecting Manual cleaning and disinfection Manual maintenance Sterilizing D

4 book Seite 4 Freitag, 21. April :54 15 Table of contents Operating Instructions IMPLANT 20:1 8 Spare parts and consumables Storage and transport conditions Disposal D

5 book Seite 5 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 1 Before you begin 1 Before you begin IMPLANT 20:1 complies with state-of-the-art technical regulations. IMPLANT 20:1 complies with the ISO standard. 1. Read the operating instructions prior to using IMPLANT 20:1. 2. Only use IMPLANT 20:1 for the applications described in the operating instructions. 3. Observe the applicable hygiene standards, occupational safety regulations and accident prevention measures for IMPLANT 20:1. Holding and driving burs _ rotary processing_product name Intended use IMPLANT 20:1 is used to hold and drive burr instruments for the purposes of rotary processing and is intended for the following uses in dentistry: Implantology and surgery _ Implantology, surgery, processing of bones Contraindications None Target group This product is intended only for use by trained dental personnel in dental practices and laboratories D

6 book Seite 6 Freitag, 21. April : Before you begin Operating Instructions IMPLANT 20:1 Warnings Instructions for use 1.1 Structure of the document Labeling of information To prevent injuries, please observe the warnings. Warnings are labeled as follows: DANGER! indicates a danger leading to death or serious injury if not avoided. WARNING! indicates a danger that may lead to death or serious injury if not avoided. CAUTION! indicates a danger that may lead to injury if not avoided. To prevent material damage and additional expenses, please observe all instructions for use. Instructions for use are labeled as follows: NOTICE! indicates measures for the prevention of material damage D

7 book Seite 7 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 1 Before you begin IMPORTANT: indicates information on the avoidance of additional expenses and other important information. Tip: indicates information for facilitating work D

8 book Seite 8 Freitag, 21. April : Before you begin Operating Instructions IMPLANT 20: Formats and symbols The formats and symbols used in this document have the following meaning: Prerequisite 1. First action step 2. Second action step or Alternative action Result Individual action step Use of formats and symbols [ 8]. List Requests you to do something. Identifies a reference to another text passage and specifies its page number. Identifies a list D

9 book Seite 9 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 1 Before you begin 1.2 Service life of Sirona instruments When used as intended: Standard_Sirona Non-moving parts of Sirona instruments have a typical service life of approx. 5 years Moving parts of Sirona instruments have a typical service life of approx. 3 years No warranty claim can be inferred here, as wear may occur earlier or later than indicated above depending on use, frequency of sterilization, and frequency of maintenance D

10 book Seite 10 Freitag, 21. April : Safety information Operating Instructions IMPLANT 20:1 Obligations of the user Preventing the spread of infections and cross contamination Requirements for the drive assembly 2 Safety information Use only fault-free materials that do not deviate from the specified data [ 13]. Protect yourself, patients, and others against any foreseeable dangers. To do this, follow the safety information. Comply with the Intended use of the equipment. You should always keep these operating instructions within reach for further reference. Sterilization Prevent the spread of infections and cross contamination between patients, users, and third parties. Sterilize equipment after each patient. Take the appropriate hygiene measures, e.g. wear protective gloves. The instrument may be operated only on drive assemblies that comply with the EU Medicinal Product Directive and are intended for use in implantology and surgery D

11 book Seite 11 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 Malfunction or damage Repair Spare and accessory parts 2 Safety information Discontinue use immediately in case of malfunction, unusual or different sounds or damage. Damaged instruments may cause injury. Notify the dental dealer or the manufacturer. Do not repair the instrument yourself. Use only original Sirona parts or parts approved by Sirona. Safe operation is not guaranteed for parts that have not been approved by Sirona. If you have any questions, please contact your dental dealer or the manufacturer D

12 book Seite 12 Freitag, 21. April : Technical description Operating Instructions IMPLANT 20:1 3 Technical description 3.1 Task The instrument transmits the drive power and speed of the Implant motor to the preparation tool. 3.2 Structure of IMPLANT 20:1 A B Instrument head Push button Lateral spray connector tube D E Spray tube for NaCl solution Opening for the clamping system D

13 book Seite 13 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 3.3 Technical data Instrument 3 Technical description IMPLANT 20:1 Gear ratio ~ 20:1 Maximum motor speed in rpm ~ Maximum operating speed in rpm ~ 2000 Maximum drive torque in Ncm ~ 6 Clamping system CA Internal cooling media D

14 book Seite 14 Freitag, 21. April : Technical description Operating Instructions IMPLANT 20:1 IMPLANT 20:1 Light function - Instrument coupling INTRAmatic Burs CA Shank diameter in mm Maximum total length in mm 45 Maximum working diameter in mm - Gripping length in mm 11 Standard ISO D

15 book Seite 15 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20: Technical description This product bears the CE mark in accordance with the provisions of the Council Directive 93/42/EEC of June 14, 1993 concerning medical devices (MDD) D

16 book Seite 16 Freitag, 21. April : Preparation Operating Instructions IMPLANT 20:1 4 Preparation 4.1 Initial start-up and longer breaks in use Sterilize the instrument and accessories prior to startup. Clean and maintain the instrument after longer breaks in use D

17 book Seite 17 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 5 Operation 5 Operation NOTICE! Use only burs and diamond polishers that are sharp and undamaged. Use clean burs and diamond polishers to avoid dirt in the clamping system. CAUTION! A loose or partially removed bur instrument can come loose from the head or break off. Risk of injury! Therefore the instrument must only be used when the bur instrument is securely clamped at least 10 mm deep. CAUTION! Insufficient cooling leads to overheating of the preparation site and damage to the tooth substance. Ensure that the flow rate is > 30 ml/min. CAUTION! Do not pull the patient's cheek back with the contra-angle handpiece while the motor is running. This would actuate the pushbutton, thus creating a risk of burning the patient's oral mucosa D

18 book Seite 18 Freitag, 21. April : Operation Operating Instructions IMPLANT 20:1 NOTICE! Always make sure that the correct reduction ratio is set on the display of the drive assembly or treatment center, otherwise the torque and rpm can deviate from the set values. IMPORTANT: For implantology applications, use the Implant 20:1 contra-angle handpiece only with an Implant motor. IMPORTANT: For application details and operating data of the different preparation tools, please refer to the information provided by the manufacturer D

19 book Seite 19 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 5.1 Replacing the instrument 5 Operation CAUTION! The instrument should only be fitted or removed when the motor is at standstill. product name Attaching the IMPLANT 20:1 without light nut The motor is at a standstill. Insert the instrument until it snaps into place. Product name _ Remove Removing the IMPLANT 20:1 The motor is at a standstill. Detach the instrument. Do not pull on the supply hose while doing this D

20 book Seite 20 Freitag, 21. April : Operation Operating Instructions IMPLANT 20:1 5.2 Inserting and removing burs IMPORTANT: Check the push button to make sure it moves freely! NOTICE! Use only burs and diamond polishers that are sharp and undamaged. Use clean burs and diamond polishers to avoid dirt in the clamping system. CAUTION! A loose or partially removed bur instrument can come loose from the head or break off. Risk of injury! Therefore the instrument must only be used when the bur instrument is securely clamped at least 10 mm deep. CAUTION! Avoid endangering the user, patient, or other persons by selecting the proper operating conditions when using long rotating instruments. NOTICE! If the torque of a rotating instrument is more than 30 Ncm, tempered drill shanks (> 50 HRC, > 520 HV) must be used. There is a risk of deformation D

21 book Seite 21 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 5 Operation Inserting the bur The motor is at a standstill. 1. Slide the deflection disk onto the shaft of the bur. 2. Press the button and insert the bur up to the stop. 3. Turn the bur back and forth gently until it snaps into place. 4. Slide the deflection disk up to the opening of the clamping system. The deflection disk prevents the air emitted from the head from entering the wound. 5. Pull and turn the bur to check that it is firmly in place. Removing the bur The bur must not be moving. Press the button and remove the bur D

22 book Seite 22 Freitag, 21. April : Operation Operating Instructions IMPLANT 20:1 5.3 Connecting and detaching hoses for NaCl solution CAUTION! Insufficient cooling leads to overheating of the preparation site and damage to the tooth substance. Ensure that the flow rate is > 30 ml/min D

23 book Seite 23 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 5 Operation Connecting hoses 1. Push the spray tube (A) for the bur into the instrument head and snap the spray tube into the holder (C). 2. Attach a silicone hose (D) to the spray tube for the bur. 3. If you also want to cool the bur externally with NaCl solution, attach a silicone hose (D) to the lateral spray connector tube (B) and connect the silicone hoses with the distributor (E). Removing hoses NOTICE! The silicone hoses, the spray tube, and the distributor are intended for a single use. Replace the silicone hoses, the spray tube, and the distributor after every patient. 1. Disconnect the silicone hoses from the spray tubes. 2. Detach the silicone hoses from the distributor. 3. Remove the spray tube for the bur from the holder D

24 book Seite 24 Freitag, 21. April : Operation Operating Instructions IMPLANT 20:1 4. Detach the spray tube from the instrument head. 5. Dispose of the silicone hoses, the distributor, and the spray tube. 5.4 Disassembling and assembling instrument No liquid may enter the instrument during surgical treatment. Prevent jamming of the inner parts by disassembling the instrument immediately after treatment and removing residues of blood, saliva, or NaCl solution. Disassembling the instrument 1. Unscrew the head housing (A) from the coupling housing (C). 2. Remove the drive (B). 3. Blow out the spray lines with compressed air. 4. Conduct complete reprocessing [ 28] D

25 book Seite 25 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 5 Operation Assembling the instrument The identification numbers of the head housing (A), drive (B), and coupling housing (C) match. Exception: If parts have been replaced due to repair, these parts may have a new identification number. 1. Place the gear unit on the head housing. 2. Screw the head housing to the coupling housing D

26 book Seite 26 Freitag, 21. April : Follow-up Operating Instructions IMPLANT 20:1 6 Follow-up 6.1 After each treatment session NOTICE! Condition immediately, or at the latest, one hour after treatment. NOTICE! Only use Sirona T1 Spray. Wear appropriate protective clothing. 1. Purge the water and air channels on the treatment center for 30 seconds. 2. Remove the bur with tweezers. 3. Pre-disinfect directly at the treatment center/tabletop unit [ 28]. 4. Detach the instrument from the drive. 5. Transport the instrument to the hygiene room in a suitable transport container D

27 book Seite 27 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 6 Follow-up 6. Conduct automatic reprocessing [ 29]. Manual conditioning [ 34] is possible in exceptional cases if the national/local regulations are followed. 7. Apply spray to the instrument [ 37]. 8. Sterilize the instrument and accessories [ 42]. 6.2 At the end of the work day Apply spray to the instrument [ 37]. NOTICE! Do not leave any instruments on the motor overnight, in order to prevent oil from leaking into the electric motor. Never lubricate the electric motor D

28 book Seite 28 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 7 Conditioning 7.1 Conduct pre-disinfection Wear appropriate protective clothing. All disinfectants must be approved in your country and have proven bactericidal, fungicidal and virucidal properties. Only use disinfectants with no protein-fixing properties. 1. Spray the surface with disinfectant. 2. Wipe the disinfectant off with a cloth. For further conditioning, the instrument should be dry and free of residue. Please observe the manufacturer's instructions for using instrument disinfectants D

29 book Seite 29 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 DAC Universal 7.2 Automated cleaning and disinfecting... 7 Conditioning with a DAC UNIVERSAL We recommend using Sirona DAC UNIVERSAL for automated cleaning, disinfection, care, and unwrapped sterilization. For further details, refer to the operating instructions supplied with the unit. 1. Clean the lateral spray connector tube on the head housing using the corresponding adapter and an agent recommended by the manufacturer, e.g. WL Clean by ALPRO. 2. Blow out the lateral spray connector tube on the head housing with bar until no more moisture escapes, at least 10 seconds. 3. Disassemble the instrument [ 24]. 4. Place the disassembled instrument in the basket of the DAC Universal D

30 book Seite 30 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 5. Switch the oil function off and conduct an automatic cleaning and disinfection. 6. Check whether the instrument is clean after reprocessing under good lighting (min. 500 lux) and color rendering index (min. 80 Ra). If it is still dirty, repeat the process. 7. Assemble the instrument [ 24]. 8. Maintain the push button chuck manually [ 39]. 9. Conduct automatic cleaning, disinfection, and maintenance in the DAC Universal with the appropriate adapter. 10.Check whether the instrument is clean after reprocessing under good lighting (min. 500 lux) and color rendering index (min. 80 Ra). If they are still dirty, repeat the process. For further reprocessing, the instrument should be dry and free of residue D

31 book Seite 31 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 7 Conditioning 11.Pack the instrument in packaging material suitable for sterilization and storage. e.g. paper/plastic composite packaging. 12.Conduct sterilization [ 42] with cleaning and disinfection equipment The instrument can also be cleaned and disinfected in a suitable piece of cleaning and disinfection equipment. The cleaning and disinfection equipment used must be approved by its manufacturer for the cleaning and disinfection of dental instruments and comply with EN ISO (e.g. 95 C (203 F) and 10 min. holding time). For further details, refer to the operating instructions supplied with the unit. 1. Clean the lateral spray connector tube on the head housing using the corresponding adapter and an agent recommended by the manufacturer, e.g. WL Clean by ALPRO D

32 book Seite 32 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 2. Blow out the lateral spray connector tube on the head housing with bar until no more moisture escapes, at least 10 seconds. 3. Disassemble the instrument [ 24]. 4. Reprocess the disassembled instrument with a cleaning and disinfecting unit. 5. Check whether the instrument is clean after reprocessing under good lighting (min. 500 lux) and color rendering index (min. 80 Ra). If it is still dirty, repeat the process. 6. Assemble the instrument [ 24]. 7. Reprocess the assembled instrument with a cleaning and disinfection unit. 8. Check whether the instrument is clean after reprocessing under good lighting (min. 500 lux) and color rendering index (min. 80 Ra). If they are still dirty, repeat the process D

33 book Seite 33 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 7 Conditioning For further reprocessing, the instrument should be dry and free of residue. 9. Blow the instrument out with max. 3 bar. 10.Maintain mechanical parts manually. [ 37] 11.Maintain the push button chuck manually [ 39]. 12.Pack the instrument in packaging material suitable for sterilization and storage. e.g. paper/plastic composite packaging. 13.Conduct sterilization [ 42] D

34 book Seite 34 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 7.3 Manual cleaning and disinfection IMPORTANT: Manual conditioning is possible in exceptional cases if the national/regional regulations are followed. The national/regional regulations are to be checked before. NOTICE! Condition immediately, or at the latest, one hour after treatment. NOTICE! Never clean in an ultrasound bath! NOTICE! Never immerse in disinfectant solution! NOTICE! Only use Sirona T1 Spray. IMPORTANT: Use a soft, clean, and disinfected brush for cleaning. Wear appropriate protective clothing. All disinfectants must be approved in your country and have proven bactericidal, fungicidal and virucidal properties. Only use disinfectants with no protein-fixing properties D

35 book Seite 35 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 7 Conditioning 1. Disassemble the instrument [ 24]. 2. Brush the disassembled instrument under running water (< 38 C, < 100 F, at least drinking water quality) and good lighting (min. 500 lux) and color rendering index (min. 80 Ra) until no more dirt can be seen, for at least 10 seconds. 3. Clean the lateral spray connector tube on the head housing using the corresponding adapter and an agent recommended by the manufacturer, e.g. WL Clean by ALPRO. 4. Blow out the lateral spray connector tube on the head housing with bar until no more moisture escapes, at least 10 seconds. 5. Assemble the instrument [ 24]. 6. Brush the assembled instrument under running water (< 38 C, < 100 F, at least drinking water quality) and good lighting (min. 500 lux) and color rendering index (min. 80 Ra) until no more dirt can be seen, for at least 10 seconds. 7. Maintain mechanical parts manually [ 37] D

36 book Seite 36 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 8. Maintain the push button chuck manually [ 39]. 9. Conduct unwrapped steam sterilization. 10.Maintain mechanical parts manually [ 37]. 11.Maintain the push button chuck manually [ 39]. 12.Pack the instrument in packaging material suitable for sterilization and storage. e.g. paper/plastic composite packaging. 13.Conduct sterilization [ 42] D

37 book Seite 37 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 7.4 Manual maintenance 7 Conditioning Maintenance of mechanical parts Intervals At least every noon and evening Prior to each sterilization After every thermal disinfection without integrated maintenance Required accessories B A B C Spray adapter O-ring for spray adapter T1 Spray A C NOTICE! Only use Sirona T1 Spray D

38 book Seite 38 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 Process The spray adapter is disinfected. The O-ring on the spray adapter is intact. 1. Fit the spray adapter onto the nozzle of the spray can. 2. Insert the instrument until it snaps into place and hold it. 3. Spray the instrument for 1-2 seconds. IMPORTANT: Hold the spray can upright. 4. Wipe any spray that comes out with a disinfection cloth. 5. Repeat the process until the spray is clear D

39 book Seite 39 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 7 Conditioning Care of the push button chuck New Use Sirona T1 Spray on the push button chuck to remove deposits and ensure proper functioning of the clamping system. Interval At least once a week Required accessories A B A B Black nozzle insert Sirona T1 Spray NOTICE! Only use Sirona T1 Spray D

40 book Seite 40 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 Procedure The instrument is clean and disinfected. 1. Press the contra-angle handpiece head with the chuck firmly against the spray can nozzle. 2. Spray the chuck for 1-2 seconds. IMPORTANT: Hold the spray can upright. 3. Wipe any spray that comes out with a disinfection cloth D

41 book Seite 41 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 7 Conditioning Maintenance of cooling spray nozzles If your tap water is very hard, lime deposits may constrict or completely block the cooling spray nozzles. 1. Carefully insert the disinfected cleaning wire into the openings of the lateral spray connector tube at regular intervals. 2. Blow cold air into the openings of the lateral spray connector tube with a syringe to clear them D

42 book Seite 42 Freitag, 21. April : Conditioning Operating Instructions IMPLANT 20:1 134 C 274 F 7.5 Sterilizing The instrument is clean and disinfected. Instrument maintenance is complete. The instrument can be sterilized in packaging suitable for sterilization and storage: paper/plastic composite packaging according to ISO Sterilize the instrument in the steam sterilizer with saturated water vapor. Overpressure: 2.04 bar (29.59 psi) Temperature: 134 C (274 F) Holding time: 3 min D

43 book Seite 43 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 7 Conditioning Steam sterilizers that comply with either EN class B (for example, DAC PREMIUM / DAC PROFESSIONAL) or EN class S and are also suitable for the sterilization of straight/contra-angle handpieces are approved. NOTICE! Do not exceed 140 C (284 F), even during the drying phase. After sterilizing 1. Remove the instrument from the steam sterilizer immediately. CAUTION! The instrument is hot. Risk of burns! NOTICE! Do not attempt to accelerate the cooling process by immersing the instrument in cold water. This can damage your instrument. 2. Store all instruments so that they are protected from contamination. 3. Sterilize again once the storage period has elapsed D

44 book Seite 44 Freitag, 21. April : Spare parts and consumables Operating Instructions IMPLANT 20:1 8 Spare parts and consumables Use only original Sirona parts or parts approved by Sirona. REF REF NaCl silicone hose, thin, 200 mm long, 6 pcs NaCl spray tube Cleaning wire for spray nozzles NaCl distributor T1 spray (6 x 250 ml cans) Silicone disks for contra-angle handpiece, dia mm Spray adapter O-ring for spray adapter D

45 book Seite 45 Freitag, 21. April :54 15 Operating Instructions IMPLANT 20:1 9 Storage and transport conditions 9 Storage and transport conditions Protect from moisture Sensitive contents Relative humidity Air pressure kpa Temperature After a severe change in temperature, allow sufficient time for acclimation D

46 book Seite 46 Freitag, 21. April : Disposal Operating Instructions IMPLANT 20:1 10 Disposal According to current information, the product does not contain any substances that are hazardous to the environment. Disinfect the product prior to disposal. Observe the applicable disposal regulations for your area D

47 book Seite 47 Freitag, 21. April :54 15

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