Table of contents Table of contents User instructions ..................................6 Warranty terms and conditions ............................. 9 Safety ....................................12 Description of safety instructions ............................12 Purpose – Intended use ..............................16 Safety instructions ................................18 Product Description ................................. 23 Technical Data ................................24...
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Table of contents Transportation and Storage Conditions ..........................25 First Use ....................................27 Cooling medium supply ..............................28 Operation ....................................29 Attaching the medical device ............................. 29 Removing the medical device ............................32 Insert the milling cutters or diamond grinders ........................33 Removing the cutting tool or diamond grinder ........................
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Table of contents Troubleshooting ..................................42 Cleaning the spray nozzle..............................42 Preparation methods according to ISO 17664 ..........................44 Preparations at the site of use ............................44 Cleaning ..................................46 7.2.1 Cleaning: Manual cleaning - external ........................47 7.2.2 Cleaning: Automated external cleaning ........................
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Disinfection:: Automated disinfection - external and internal ..................57 Drying ................................... 58 Care products and systems - Servicing ..........................60 7.5.1 Care products and systems - Servicing: Care with KaVo Spray ................... 62 7.5.2 Care products and systems - Servicing: Care with KaVo SPRAYrotor ................66 7.5.3...
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User instructions Symbols See the Safety/Warning Symbols chapter Important information for users and technicians Disinfectable by heat...
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User instructions Steriliseable in steam up to 135°C (275°F) CE mark (European Community). A product with this mark meets the requirements of the applicable EC directive. Call to Action...
The following warranty conditions apply to this KaVo medical device: KaVo provides the end customer with a warranty of proper function and guarantees zero defects in respect of material and processing for a period of 12 months from date of invoice, subject to the...
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User instructions In case of justified complaints, KaVo will honour its warranty with a free replacement or repair. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded. In the event of default, gross negligence or intent, this shall only apply in the absence of mandatory legal regulations to the contrary.
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User instructions Service warranty claims will only be accepted if the product is submitted along with proof of purchase in the form of a copy of the invoice/delivery note. The dealer, purchase date, type and serial number must be clearly visible on this document.
Safety 2 Safety 2.1 Description of safety instructions Warning symbol...
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Safety Structure DANGER The introduction describes the type and source of the danger. This section describes the potential consequences of non-observance. ▶ The optional step covers measures necessary for avoiding hazards.
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Safety Description of danger 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 or moderate physical harm.
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Safety WARNING WARNING indicates a hazardous situation that can cause death or serious injury. DANGER DANGER indicates a maximum hazardous situation that can directly cause serious injury or death.
Safety 2.2 Purpose – Intended use This medical device is ▪ Only intended for dental treatment. Any other type of use or alteration to the product is im‐ permissible and can be hazardous. The medical device is intended for the following uses: , cavity preparation, caries excavation, endodontics.
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Safety According to these regulations, this medical device may only be used for the described application by a knowledgeable user. The following must be observed: ▪ the applicable health and safety regulations ▪ the applicable accident prevention regulations ▪ these Instructions for use According to these regulations, the user is required to: ▪...
Safety 2.3 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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▶ A note is to be included in the documents accompanying the dental treatment unit, referring to responsibilities arising from safety, reliability and performance. ▶ The medical device may only be combined with a treatment unit released by KaVo.
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Safety 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 location, according to instructions, before long periods of nonuse.
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Safety 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. Note For safety reasons, we recommend that the tool holder system be checked annually after the war‐...
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To ensure proper function, the medical device must be set up according to the methods described in the KaVo instructions for use, and the care products and methods 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.
Product Description The contra-angle handpiece can be mounted on all INTRAmatic (LUX) motors, and motors with a connection in accordance with ISO 3964 / DIN 13940. 3.2 Transportation and Storage Conditions CAUTION Starting up the medical device can be hazardous after it has been stored in an excessively cold location.
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Product Description Temperature: -20°C to +70°C (-4°F to +158°F) Relative humidity 5% RH to 95% RH Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture.
First Use 4 First Use WARNING Hazard from non-sterile products. Infection danger to the care provider and patient. ▶ Before first use and after each use, sterilise the medical device.
First Use 4.1 Cooling medium supply CAUTION Overheating of the tooth due to lack of cooling water. Thermal damage to the dental pulp. ▶ Adjust the water amount for the spray cooling to a minimum of 50 cm /min...
Operation 5 Operation 5.1 Attaching the medical device WARNING Loosening of the medical device during treatment. A medical device that is not properly locked in place can become disconnected from the motor coupling and fall off. ▶ Carefully pull on the medical device before each treatment to ensure that it is securely locked onto the motor coupling.
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Operation CAUTION Removing and attaching the contra-angle handpiece while the drive motor is rotating. Damage to the drive. ▶ Never attach or remove the contra-angle handpiece while the drive motor is rotating!
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Operation ▶ Connect the medical device to the (LUX) motor coupling until it locks into place, and twist it until the catch audibly locks.
Operation ▶ Pull on it to make sure that the medical device is securely attached to the coupling. 5.2 Removing the medical device ▶ Unlock the medical device from the (LUX) motor coupling by twisting it slightly and then pulling it along its axis.
Operation 5.3 Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond burs that correspond to ISO 1797-1 type 1, are made of steel or tungsten carbide and meet the following criteria: - shaft diameter: 2.334 to 2.35 mm - overall length: max.
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Operation WARNING 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 data.
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Operation CAUTION Injury from using worn cutters or grinders. Cutters or grinders could fall out during treatment and injure the patient. ▶ Never use cutters or grinders with worn shafts.
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Operation CAUTION Danger of injury from cutters or grinders. Infections or cuts. ▶ Wear gloves or fingerstalls.
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Operation 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 infection.
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Operation ▶ Insert the cutter or grinder into the segment of the head drive by twisting the tool slightly, and push to the stop.
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Operation ▶ Check that the tool is seated by pulling on it.
Operation 5.4 Removing the cutting tool or diamond grinder WARNING Hazard from rotating cutter or grinder. Lacerations and damage to the chucking system. ▶ Do not touch rotating cutter or grinder.! ▶ Never press the press-button while the cutter or grinder is rotating! ▶...
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Operation ▶ After the cutter or grinder has stopped rotating, press the press-button with your thumb and simultaneously pull out the drill bit or bur.
Troubleshooting 6 Troubleshooting 6.1 Cleaning the spray nozzle. CAUTION Hazard from insufficient spray water. Insufficient spray water can cause the medical device to overheat and damage the tooth. ▶ If the amount of spray water is insufficient, unblock the spray nozzles.
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Troubleshooting ▶ Use the nozzle needle (Mat. no. 0.410.0921) to free the water passage in the spray nozzles.
Preparation methods according to ISO 17664 7 Preparation methods according to ISO 17664 7.1 Preparations at the site of use WARNING Hazard from non-sterile products. There is a risk of infection from contaminated medical devices. ▶ Observe suitable personal protective measures. ▶...
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Preparation methods according to ISO 17664 ▶ - The medical device must be dry when transporting it to be prepared. Do not place it in a solution or the like. ▶ Prepare the medical device directly after treatment. ▶ Remove the cutter or grinder from the medical device.
Preparation methods according to ISO 17664 7.2 Cleaning CAUTION Malfunctions from cleaning in an ultrasonic unit. Defects in the product. ▶ Only clean manually or in a thermodisinfector.
Preparation methods according to ISO 17664 7.2.1 Cleaning: Manual cleaning - external Accessories required: ▪ Tap water 30 °C ± 5 °C (86 °F ± 10 °F) ▪ Brush, e.g. medium-hard toothbrush...
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Preparation methods according to ISO 17664 ▶ Brush off under flowing tap water.
Preparation methods according to ISO 17664 7.2.2 Cleaning: Automated external cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883-1, e.g.. Miele G 7781 / G 7881. (Validation was performed with the program "VARIO-TD", the detergent "neodisher mediclean", the ® neutraliser "neodisher Z"...
Can only be done with KaVo CLEANspray or KaVo DRYspray. ▶ Cover the medical device with the KaVo CLEANpac bag, and place it on the corresponding care adapter. Press the spray button three times for 2 seconds each time. Remove the medical device from the spray attachment and let the cleaner work for one minute.
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Preparation methods according to ISO 17664 Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the fol‐ lowing countries: Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxembourg, Belgium, Netherlands, United Kingdom, Denmark, Sweden, Finland and Norway.
Preparation methods according to ISO 17664 7.2.4 Cleaning: Automated internal cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883-1, e.g.. Miele G 7781 / G 7881. (Validation was performed with the program "VARIO-TD", the detergent "neodisher mediclean", the ® neutraliser "neodisher Z"...
Preparation methods according to ISO 17664 ▶ Directly after automated cleaning, treat the medical device with the care products and systems provided by KaVo. 7.3 Disinfection: CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. Defects in the product.
Preparation methods according to ISO 17664 7.3.1 Disinfection:: Manual disinfection - external KaVo recommends the following products based on material compatibility. The microbiological ef‐ ficacy must be ensured by the disinfectant manufacturer.
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Preparation methods according to ISO 17664 ▪ Microcide AF from Schülke&Mayr (liquid or cloths) ▪ FD 322 from Dürr ▪ CaviCide from Metrex Tools required: ▪ Cloths for wiping down 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 of the disinfectant manufacturer.
Preparation methods according to ISO 17664 Note Observe the instructions for use for the disinfectant. 7.3.2 Disinfection:: Manual disinfection - internal For the effective re-preparation, the inside of the device must be cleaned automatically in a cleaning and disinfection unit in accordance with ISO 15883-1. The interior of this product is not designed for manual disinfection.
Preparation methods according to ISO 17664 7.3.3 Disinfection:: Automated disinfection - external and internal KaVo recommends thermodisinfectors in accordance with ISO 15883-1, e.g.. Miele G 7781 / G 7881. (Validation was performed with the program "VARIO-TD", the detergent "neodisher mediclean", the ®...
Preparation methods according to ISO 17664 ▶ Directly after automated cleaning, treat the medical device with the care products and systems provided by KaVo. 7.4 Drying Manual drying ▶ Blow off the outside and inside with compressed air until water drops are no longer visible.
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Preparation methods according to ISO 17664 Note Please observe the instructions for use of the thermodisinfector.
Preparation methods according to ISO 17664 7.5 Care products and systems - Servicing CAUTION Sharp cutters or grinders in the medical device. Injury hazard from sharp or pointed cutters or grinders. ▶ Remove cutter or grinder.
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Premature wear and malfunctions from improper servicing and care. Reduced product life. ▶ Perform proper care regularly! Note KaVo only guarantees that its products will function properly when the care products used are those listed as accessories, as they were tested for proper use on our products.
Preparation methods according to ISO 17664 7.5.1 Care products and systems - Servicing: Care with KaVo Spray KaVo recommends servicing the project after each time it used, i.e. after each automatic cleaning and before each sterilisation. ▶ Remove cutter or grinder.
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Preparation methods according to ISO 17664 Chuck care KaVo recommends cleaning and servicing the chuck system once a week.
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Preparation methods according to ISO 17664 ▶ Remove the cutter or grinder, place the spray nipple tip in the opening and spray.
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Preparation methods according to ISO 17664 Note Carry out servicing according to instructions in the section "Care with KaVo Spray".
7.5.2 Care products and systems - Servicing: Care with KaVo SPRAYrotor KaVo recommends servicing the project after each time it used, i.e. after each automatic cleaning and before each sterilisation. ▶ Place the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a CLEANpac bag.
Preparation methods according to ISO 17664 ▶ Service the product. See also: Instructions for use KaVo SPRAYrotor 7.5.3 Care products and systems - Servicing: Care with KaVo QUATTROcare Cleaning and care unit with expansion pressure for effective cleaning and care.
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Preparation methods according to ISO 17664 KaVo recommends servicing the project after each time it used, i.e. after each automatic cleaning and before each sterilisation. ▶ Remove cutter or grinder.
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Preparation methods according to ISO 17664 ▶ Service the product. Chuck care KaVo recommends cleaning and servicing the chuck system once a week. See also: Instructions for use KaVo QUATTROcare...
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Preparation methods according to ISO 17664 ▶ Remove the cutter or grinder, place the spray nipple tip in the opening and spray.
Preparation methods according to ISO 17664 ▶ Subsequently treat with the care products and care systems specified. See also: Care with KaVo QUATTROcare 7.6 Packaging Note The sterilisation bag must be large enough for the instrument so that the bag is not stretched.
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Preparation methods according to ISO 17664 ▶ Individually weld the medical device in the sterilised item packaging (such as KaVo STERI‐ clave bags Mat. no. 0.411.9912)!
Preparation methods according to ISO 17664 7.7 Sterilisation Sterilisation in a steam steriliser (Autoclave) 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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Preparation methods according to ISO 17664 CAUTION Contact corrosion due to moisture. Damage to product. ▶ Immediately remove the product from the steam steriliser after the sterilisation cycle!
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The medical device is resistant to temperatures up to 138℃ (280.4°F). KaVo recommends e.g. - STERIclave B 2200/ 2200P from KaVo Citomat / K series from Getinge Depending on the device, select a suitable process from the following sterilisation processes.
Preparation methods according to ISO 17664 Autoclave with a triple pre-vacuum for least four minutes at 134°C ± 1°C (273°F ± 1.8°F) Autoclave with gravitation process for least ten minutes at 134°C ± 1°C (273°F ± 1.8°F) Autoclave with gravitation process for at least 60 minutes at 121°C ± 1°C (250°F ± 1.8°F) Follow the manufacturer's instructions for use.
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Preparation methods according to ISO 17664 Note Observe the expiration date of the sterilised item.
Tools 8 Tools Obtainable from dental and medical suppliers Material summary Mat. no. Instrument stands 2151 0.411.9501 CLEANpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 Nozzle needle 0.410.0921...
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Tools Material summary Mat. no. KaVo CLEANspray 1.007.0579 KaVo DRYspray 1.007.0580 KaVo Spray 2112 A 0.411.9640 ROTAspray 2142 A 0.411.7520 QUATTROcare plus Spray 2108 P 1.005.4525...
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