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Contents 4 / 88 4.1 Mount the MULTIflex (LUX) / MULTIflex LED coupling..............30 4.2 Checking the amount of water......................31 4.3 Checking the pressures........................33 4.4 Checking the O-rings........................35 5 Operation..............................36 5.1 Attaching the medical device......................36 5.2 Removing the medical device......................
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Automated external and internal disinfection..............62 7.4 Care products and systems - Servicing................... 62 7.4.1 Servicing with KaVo Spray....................64 7.4.2 Care with KaVo SPRAYrotor....................66 7.4.3 Servicing with KaVo QUATTROcare 2104 / 2104A............67 7.4.4 Servicing with KaVo QUATTROcare PLUS 2124 A............70...
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Contents 6 / 88 7.4.5 Servicing with KaVo QUATTROcare 2140 A..............75 7.5 Packaging............................77 7.6 Sterilisation............................78 7.7 Storage............................80 8 Tools and consumables.......................... 81 9 Terms and conditions of warranty......................84...
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1 User instructions 8 / 88 Action request CE mark (European Community). A product bearing this mark meets the requirements of the applicable EC directive. Can be steam sterilizes at 134 C -1 C / +4 C (273 F -1,6 +7,4 Target group This document is intended for dentists and their assistants.
2 Safety 9 / 88 2 Safety 2.1 Description of safety instructions Warning symbol Structure DANGER The introduction describes the type and source of the haz‐ ard. This section describes potential consequences of non-compliance. ▶ The optional step includes necessary measures for hazard prevention.
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2 Safety 10 / 88 Description of hazard levels The safety instructions listed here, together with the three levels of danger will help avert property damage and injury. CAUTION CAUTION indicates a hazardous situation that can cause damage to property or mild to moderate injuries.
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2 Safety 11 / 88 WARNING WARNING indicates a hazardous situation that can lead to serious or fatal injury. DANGER DANGER indicates a maximal hazard due to a situation that can directly cause death or fatal injury.
2 Safety 12 / 88 2.2 Safety instructions WARNING Hazards for the care provider and the patient. In the case of damage, irregular running noise, excessive vibration, un- typical warming or when the cutter or grinder cannot be held. ▶ Do not use further and notify Service.
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2 Safety 13 / 88 WARNING Hazard from incorrectly reconditioned products. An infection hazard exists from contaminated products. ▶ Take suitable personal protective measures. CAUTION Risk of burn injury from hot handpiece head or hot hand‐ piece lid. Burn injuries in the mouth may be caused if the handpiece overheats. ▶...
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2 Safety 14 / 88 CAUTION Hazard from use as a light probe. Do not use the device as a light probe since the rotating cutters or grind‐ ers can cause injury. ▶ Use an appropriate light probe for additional illumination of the oral cavity or site of preparation.
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2 Safety 15 / 88 CAUTION Risk due to incorrectly stored instrument. Injury and infection caused by chucked cutters or grinders. Damage to clamping system from dropping the instrument. ▶ After treatment, place the instrument properly in the cradle, without the cutter or grinder.
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2 Safety 16 / 88 CAUTION Premature wear and malfunctioning from improper storage during long periods of nonuse. Reduced product life. ▶ The medical device should be cleaned, serviced and stored in a dry lo‐ cation, according to instructions, before long periods of nonuse. Note For safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires.
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To ensure proper function, the medical device must be set up according to the reprocessing methods described in the KaVo Instructions for Use, and the care products and care systems described therein must be used. KaVo recommends specifying a service interval at the dental office for a licensed shop to clean, service and check the functioning of the medical device.
3 Product description 20 / 88 INTRAflex LUX contra-angle 2325 LN (Mat. no. 0.535.6210) 3.1 Purpose – Intended use Indications for use: This medical device is ▪ intended for dental treatment only. All other types of use or modifica‐ tions of the product are not permitted and can be hazardous. The medical device is intended for the following applications: Removal of carious material, cavity and crown preparations, removal of fillings, processing of tooth and restoration surfaces.
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3 Product description 21 / 88 ▪ A medical device according to relevant national statutory regulations. Proper use: According to these regulations, this medical device may only be used for the described application by a knowledgeable user. You need to comply with the following: ▪...
3 Product description 22 / 88 ▪ protect him or herself, the patient and third parties from danger, and ▪ avoid contamination from the product. 3.2 Technical Specifications 3.2.1 Reducing shank 2307 LN Identification 1 green ring Transmission ratio 2.7 : 1 Induction air 2.5 to 3.0 bar (29 to 44 psi) Air consumption...
3 Product description 23 / 88 INTRA LUX heads can be used. Attachable to all MULTIflex (LUX) / MULTIflex LED couplings. 3.2.2 Reducing shank 2320 LN Identification 1 blue ring Transmission ratio 1 : 1 Induction air 2.5 to 3.0 bar (29 to 44 psi) Air consumption 50 to 60 Nl/min.
3 Product description 24 / 88 Attachable to all MULTIflex (LUX) / MULTIflex LED couplings. 3.2.3 Reducing shank 2329 LN Identification 2 green rings Transmission ratio 7.4 : 1 Induction air 2.5 to 3.0 bar (29 to 44 psi) Air consumption 50 to 60 Nl/min.
3 Product description 25 / 88 3.2.4 Handpiece 2313 LN Identification 1 green ring Transmission ratio 2.7 : 1 Induction air 2.5 to 3.0 bar (29 to 44 psi) Air consumption 50 to 60 Nl/min. Speed range 5,000 to 12,000 min Idle torque at 3.0 bar (44 psi) = 3.2 Ncm Handpiece drills can be used.
3 Product description 26 / 88 3.2.5 Contra-angle handpiece 2325 LN Identification 1 red ring Transmission ratio 1 : 4 Drive air 2.5 to 3.0 bar (29 to 44 psi) Air consumption 50 to 60 Nl/min Speed range 60,000 to 140,000 min Idle torque at 3.0 bar (44 psi) = 0.32 Ncm Handpiece cutters or grinders can be used.
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3 Product description 27 / 88 CAUTION It is hazardous to start up the medical device after it has been stored strongly refrigerated. This can cause the medical device to malfunction. ▶ Prior to start-up, very cold products must be heated to a temperature of 20 C to 25 C (68...
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3 Product description 28 / 88 Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture...
4 Start up and shut down 29 / 88 4 Start up and shut down WARNING Hazard from non-sterile products. Infection hazard for care provider and patient. ▶ Before first use and after each use, prepare and sterilise the medical device and accessories accordingly.
4 Start up and shut down 30 / 88 CAUTION Damage from contaminated and moist cooling air. Contaminated and moist cooling air can cause malfunctions. ▶ Make sure that the supply of cooling air is dry, clean, and uncontami‐ nated according to EN ISO 7494-2. 4.1 Mount the MULTIflex (LUX) / MULTIflex LED coupling ▶...
4 Start up and shut down 31 / 88 ▶ Rotate the spray ring on the MULTIflex (LUX) / MULTIflex LED cou‐ pling in order to regulate the fraction of water. 4.2 Checking the amount of water CAUTION Overheating of the tooth due to lack of cooling water. Thermal damage to the dental pulp.
4 Start up and shut down 33 / 88 4.3 Checking the pressures CAUTION Compressed air connection on devices. Contaminated and humid compressed air leads to premature wear and tear. ▶ Ensure that the cooling air is dry, clean and uncontaminated in accord‐ ance with EN ISO 7494-2.
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4 Start up and shut down 34 / 88 ▶ Insert the test gauge (Mat. no. 04118731) between the hose and the MULTIflex (LUX) / MULTIflex LED coupling and check the following pressures: ð - Drive air: 2.5 to 3.0 bar (29 to 44 psi), recommended: 3.0 (44 bar psi) ð...
4 Start up and shut down 35 / 88 4.4 Checking the O-rings CAUTION Missing or damaged O-rings. Malfunctions and premature failure. ▶ Make sure that all O-rings are on the coupling and undamaged. Number of available O-rings: 5...
5 Operation 36 / 88 5 Operation 5.1 Attaching the medical device WARNING Release of the medical device during treatment. A medical device that is not properly locked in place can release from the MULTIflex (LUX) / MULTIflex LED coupling during treatment. ▶...
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5 Operation 37 / 88 CAUTION Damage from inaccurate coupling. Inaccurate coupling (especially during the afterglow period) can destroy the high-pressure lamp or the LED of a MULTIflex (LUX) / MULTIflex LED coupling or reduce its service life. ▶ Pull on the medical device to make sure that it is securely affixed to the coupling.
5 Operation 38 / 88 ▶ Pull on the medical device to make sure that it is securely affixed to the coupling. 5.2 Removing the medical device Hold the coupling tight, and pull the medical device off while twisting slight‐...
5 Operation 39 / 88 5.3 Insert INTRA LUX head in bases 2307 LN, 2320 LN or 2329 LN CAUTION Loosening of the medical device during treatment. If the head is not properly locked in place, it can fall out during treatment. ▶...
5 Operation 40 / 88 ▶ Insert the head to the stop. Make sure that the catches are properly seated. ▶ Rotate the clamping ring in the opposite direction (-> close) and tight‐ en it. 5.4 Remove INTRA LUX head from bases 2307 LN, 2320 LN or 2329 LN ▶...
5 Operation 41 / 88 5.5 Insert handpiece or contra-angle drill in handpiece 2313 Note Only use handpiece or contra-angle handpieces that correspond to ISO 1797-1 type 1 and type 2, are made of steel or hard metal and meet the following criteria: - Shaft diameter: 2.334 to 2.35 mm In contra-angle drills with drill bur stop:...
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5 Operation 42 / 88 - Overall length: max. 44.5 mm WARNING Use of impermissible cutters or grinders. Injury to the patient or damage to the medical device. ▶ Observe the instructions for use, and use the cutter or grinder proper‐ ▶...
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5 Operation 43 / 88 CAUTION Injury from using worn drill bits or burs. Drill bits or burs could fall out during treatment and injure the patient. ▶ Never use drill bits or burs with worn shafts. CAUTION Injury hazard from cutters or grinders. Infections or cuts.
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5 Operation 44 / 88 CAUTION Hazard from defective chucking system. The cutter or grinder could fall out and cause injury. ▶ Pull on the cutter or grinder to check that the chucking system is okay and the cutter or grinder is securely held. When checking, inserting and removing, use gloves or a fingerstall to prevent an injury or infec‐...
5 Operation 45 / 88 5.6 Remove handpiece or contra-angle drill from handpiece 2313 LN WARNING Hazard from rotating cutter or grinder. Lacerations and damage to the chucking system. ▶ Do not touch the cutter or grinder when it is rotating! ▶...
5 Operation 46 / 88 ▶ Turn the clamping ring back into its initial position. 5.7 Modification of the handpiece 2313 LN for contra-angle drills Note The handpiece must be converted to use contra-angle handpiece drill bits. ▶ Open the handpiece chuck. ▶...
5 Operation 47 / 88 ▶ To remove the drill bit stop, use the accompanying hook. 5.8 Insert the milling cutters or diamond grinders in contra- angle 2325 L Note Only use dental burs or diamond drill bits that correspond to ISO 1797-1 type 3, are made of steel or hard metal and meet the following criteria: - Shaft diameter: 1.59 to 1.60 mm - Overall length: max.
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5 Operation 48 / 88 CAUTION Use of unauthorised cutters or grinders. Injury to the patient or damage to the medical device. ▶ Observe the instructions for use and use the cutter or grinder properly. ▶ Only use cutters or grinders that do not deviate from the specified da‐ CAUTION Injury from using worn cutters or grinders.
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5 Operation 49 / 88 CAUTION Danger of injury from cutters or grinders. Infections or cuts. ▶ Wear gloves or fingerstalls.
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5 Operation 50 / 88 CAUTION Hazard from defective chucking system. The cutter or grinder could fall out and cause injury. ▶ Pull on the cutter or grinder to check that the chucking system is okay and the cutter or grinder is securely held. When checking, inserting and removing, use gloves or a fingerstall to prevent an injury or infec‐...
5 Operation 51 / 88 ▶ Check that the cutter or grinder is seated by pulling on it. 5.9 Removing the cutting tools or diamond grinder from the contra-angle 2325 LN WARNING Hazard from rotating cutter or grinder. Lacerations and damage to the chucking system. ▶...
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5 Operation 52 / 88 ▶ After the cutter or grinder has stopped rotating, press the press-but‐ ton with your thumb and simultaneously pull out the drill bit or bur.
Hazard from improper care of the O-rings. Malfunctions or complete failure of the medical device. ▶ Do not use Vaseline or other grease or oil. Note The O-ring on the coupling may only be lubricated with a cotton ball wet with KAVO spray.
6 Troubleshooting 54 / 88 ▶ Press the O-ring between your fingers to form a loop. ▶ Shove the O-ring to the front, and remove it. ▶ Insert new O-rings into the grooves. 6.2 Cleaning the spray nozzle CAUTION Hazard from insufficient amount of spray water. Overheating of the medical device and damage to the tooth.
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6 Troubleshooting 55 / 88 ▶ Clean and free the water passage in the spray nozzles by using the nozzle needle Mat. no. 0.410.0931.
7 Reprocessing methods according to ISO 17664 56 / 88 7 Reprocessing methods according to ISO 17664 7.1 Preparations at the site of use WARNING Hazard from nonsterile products. There is a risk of infection from contaminated medical devices. ▶ Take suitable personal protective measures. ▶...
7 Reprocessing methods according to ISO 17664 57 / 88 ▶ The medical device must be dry when transported for reprocessing. ▶ Do not place it in solutions or the like. 7.2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product.
7 Reprocessing methods according to ISO 17664 58 / 88 ▪ Brush, e.g. medium-hard toothbrush ▶ Brush off under flowing tap water. 7.2.2 Automated external cleaning Not applicable. Do not wash the product in thermodisinfectants. 7.2.3 Manual internal cleaning Not applicable. 7.2.4 Automated internal cleaning Not applicable.
7 Reprocessing methods according to ISO 17664 59 / 88 7.3 Disinfection WARNING Hazard due to incomplete disinfection. Principally, KaVo recommends carrying out an final disinfection of the un‐ packaged item if complete disinfection cannot be guaranteed without this measure.
Defects in the product. ▶ Disinfect manually only! 7.3.1 Manual external disinfection KaVo recommends the following products based on compatibility of the materials. The microbiological efficacy must be ensured by the disinfec‐ tant manufacturer and proven by an expert opinion.
7 Reprocessing methods according to ISO 17664 61 / 88 ▪ FD 322 made by Dürr ▪ CaviCide made by Metrex Consumables required: ▪ Cloths for wiping off the medical device. ▶ Spray the disinfectant on a cloth, then thoroughly wipe down the medical device and leave the disinfectant to soak in according to the instructions from the disinfectant manufacturer.
7 Reprocessing methods according to ISO 17664 62 / 88 7.3.3 Automated external and internal disinfection Not applicable. Do not wash the product in thermodisinfectants. 7.4 Care products and systems - Servicing WARNING Sharp cutters or grinders in the medical device. Risk of injury from sharp and/or pointed cutters or grinders.
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Reduced product life. ▶ Perform regular proper care and maintenance! Note KaVo only guarantees that its products will function properly when the care products are used that are listed as accessories since they were tes‐ ted for proper use on our products.
7 Reprocessing methods according to ISO 17664 64 / 88 7.4.1 Servicing with KaVo Spray KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion. ▶ Remove drill or grinder and close the clamping rings on handpiece 2313 LN.
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Servicing of the clamping chuck Note Only possible for the INTRAflex contra-angle. KaVo recommends cleaning and servicing the chuck system once a week. ▶ Remove the cutter or grinder, place the spray nipple tip in the open‐ ing and spray.
▶ Remove drill or grinder and close the clamping rings on handpiece 2313 LN. ▶ Place the product on the appropriate coupling of the KaVo SPRAYro‐ tor and cover it with a Cleanpac bag. ▶ Servicing the product. See also:...
7 Reprocessing methods according to ISO 17664 67 / 88 2 Instructions for use KaVo SPRAYrotor 7.4.3 Servicing with KaVo QUATTROcare 2104 / 2104A Note QUATTROcare 2104 / 2104 A is no longer included in the current delivery programme. Follow-up products: ▶...
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68 / 88 (no validated cleaning of the interior in accordance with German RKI re‐ quirements) KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion. ▶ Remove drill or grinder and close the clamping rings on handpiece 2313 LN.
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7 Reprocessing methods according to ISO 17664 69 / 88 Servicing of the clamping chuck Note Only possible for the INTRAflex contra-angle. KaVo recommends cleaning and servicing the chuck system once a week. See also: 2 Instructions for use KaVo QUATTROcare 2104 / 2104A...
▶ Subsequently treat with the specified care products and systems. See also: 2 Servicing with KaVo QUATTROcare 2104 / 2104A 7.4.4 Servicing with KaVo QUATTROcare PLUS 2124 A Servicing and cleaning device with expansion pressure for the interior...
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71 / 88 (no validated cleaning of the interior in accordance with German RKI re‐ quirements) KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion. ▶ Remove the milling tool or grinder, and close the chuck in the case of handpiece 2313 LN.
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Servicing the clamping chuck Note Only possible for the INTRAflex contra-angle. KaVo recommends cleaning and servicing the chuck system once a week using the collet servicing program integrated in the device. See also: 2 Instructions for Use KaVo QUATTROcare PLUS 2124 A...
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7 Reprocessing methods according to ISO 17664 73 / 88 Note Handpieces must be taken off the service couplings before the chuck service can be started and performed. ▶ Remove the service coupling chuck from the side hatch of the QUAT‐ TROcare PLUS and attach it to coupling service point four, on the far right.
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Option 1: Place the dental handpieces in the QUATTROcare PLUS 2124 A, close the front door and start theservice procedure. Option 2: After three minutes with no service procedure running, the de‐ vice automatically switches back to normal service mode. See also: 2 Servicing with KaVo QUATTROcare PLUS...
7.4.5 Servicing with KaVo QUATTROcare 2140 A Programme-controlled cleaning and servicing device for perfect servicing of handpieces and turbines. KaVo recommends servicing the product as part of the reprocessing after each use, i.e. after each cleaning, disinfection, and before each sterilisa‐ tion.
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Servicing the chuck Note Only possible for the INTRAflex contra-angle. KaVo recommends cleaning and servicing the chuck system once a week using the collet servicing program integrated in the device. See also: 2 Instructions for use KaVo QUATTROcare CLEAN 2140 A...
7 Reprocessing methods according to ISO 17664 77 / 88 7.5 Packaging Note The sterilisation bag must be large enough for the handpiece so that the bag is not stretched. The quality and use of the sterilisation packaging must satisfy applicable standards and be suitable for the sterilisation procedure! ▶...
Sterilisation in a steam steriliser (autoclave) in accordance with EN 13060 / ISO 17665-1 CAUTION Premature wear and malfunctions from improper servicing and care. Reduced product life. ▶ Before each sterilisation cycle, service the medical device with KaVo care products.
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Damage to product. ▶ Immediately remove the product from the steam steriliser after the sterilisation cycle! The KaVo medical device has a maximum temperature resistance of up to 138 ℃ (280.4 °F). Select a suitable procedure (depending on the available autoclave) from the following sterilisation processes: ▪...
7 Reprocessing methods according to ISO 17664 80 / 88 ▪ Autoclave using the gravity method: - at least 10 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) ▶ Use according to the manufacturer's Instructions for Use. 7.7 Storage Prepared products must be stored, protected from germs (as far as possi‐...
12 months from the date of the invoice, subject to the following condi‐ tions: In case of justified complaints, KaVo will honour its warranty with a free re‐ placement or repair. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded.
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85 / 88 cal or electrical factors deemed abnormal or impermissible in accordance with KaVo's instructions for use or other manufacturer's instructions. The warranty granted does not usually extend to lamps, light conductors made of glass and glass fibres, glassware, rubber parts, and the colourfastness of plastic parts.
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9 Terms and conditions of warranty 86 / 88...
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