Table of contents Table of contents 1 User instructions ............................... 5 2 Safety ................................7 Description of safety instructions ......................7 Safety instructions ..........................9 3 Product description ............................14 Purpose – Proper use ........................... 15 Technical Specification ......................... 17 Transportation and storage conditions ....................
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Table of contents Remove the medical device ......................... 26 Insert the handpiece or contra-angle handpiece drill bit............... 27 Remove the handpiece or contra-angle drill bit ..................30 Conversion for contra-angle handpiece drill bit ..................31 6 Troubleshooting .............................. 33 Check for malfunctions .........................
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Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A ............................50 7.6.4 Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS ..... 51 7.6.5 Care products and systems - Servicing: Servicing with KaVo QUATTROcare CLEAN 2140 A .............................
Table of contents Storage ..............................59 8 Tools ................................61 9 Terms and conditions of warranty ........................63...
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User instructions Can be steam-sterilised at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) Thermodisinfectable CE mark (European Community). A product bearing this mark meets the requirements of the applicable EC directive. Action request Target group This document is intended for dentists and their assistants.
Safety 2 Safety 2.1 Description of safety instructions Warning symbol Structure DANGER The introduction describes the type and source of the hazard. This section describes potential consequences of non-compliance. ▶ The optional step includes necessary measures for hazard preven‐ tion.
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Safety 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. WARNING WARNING indicates a hazardous situation that can lead to serious or fatal injury.
Safety DANGER DANGER indicates a maximal hazard due to a situation that can directly cause death or fatal injury. 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.
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▶ A note is to be included in the documents accompanying the dental treatment unit, referring to responsibilities arising from safety, relia‐ bility and performance. ▶ The medical device may only be combined with a treatment centre released by KaVo.
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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.
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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 non‐ use. Note For safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires.
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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.
Product description 3 Product description SURGmatic S 11 L SURGmatic S11 L (Mat. no. 1.009.1010) SURGmatic S 11 C SURGmatic S11 C (Mat. no. 1.009.1005)
Product description 3.1 Purpose – Proper use Purpose: This medical device is ▪ Only intended for dental treatment. Any other type of use or altera‐ tion to the product is impermissible and can be hazardous. The med‐ ical device is intended for the following uses: Surgery such as setting an implant, bone augmentation, sinus lift, tooth extraction, implantol‐...
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Product description Proper use: 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 ▪...
Product description 3.2 Technical Specification Drive speed max. 40,000 rpm identification 1 blue ring Transmission 1 : 1 Maximum speed max. 40,000 rpm Handpiece cutters or grinders can be used. Short handpiece cutters or grinders can be used after conversion. The handpiece can be mounted on all INTRAmatic (LUX) motors, and motors with a connection in accordance with ISO 3964 / DIN 13940.
Product description 3.3 Transportation and storage conditions 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 tempera‐ ture of 20°C to 25°C (68°F to 77°F).
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Product description Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture...
Start up and shut down 4 Start up and shut down WARNING Hazard from nonsterile products. Infection danger to the care provider and patient. ▶ Before first use and after each use, prepare and sterilise the medi‐ cal device if needed. WARNING Disposal of the product in the appropriate manner.
Start up and shut down 4.1 Checking the amount of water 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 /min...
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Start up and shut down CAUTION Hazard from insufficient amount of spray water. Insufficient spray water can cause the medical device to overheat and damage the tooth. ▶ Check spray water channels and if necessary clean spray nozzles with the nozzle needle (Mat. no. 0.410.0931). ▶...
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Start up and shut down ▶ Use physiological, sterile cooling fluid.
Operation 5 Operation 5.1 Attach the medical device WARNING Detachment of the medical device during treatment. A medical device that is not properly locked in place can become dis‐ connected from the motor coupling and fall off. ▶ Carefully pull on the medical device before each treatment to en‐ sure that it is securely locked onto the motor coupling.
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▶ Only start the handpiece when the chuck is closed. CAUTION Removing and attaching the handpiece while the drive motor is rotating. Damage to the catch. ▶ Never attach or remove the handpiece while the device is rotating! ▶ Lightly spray O-rings on motor coupling with KaVo Spray.
▶ Place the medical device on the motor clutch and lock it into place. With the SURGmatic S11 L, the latch must lock into place audibly. ▶ Pull on the medical device to make sure that it is securely affixed to the coupling.
Operation 5.3 Insert the handpiece or contra-angle handpiece drill bit. 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: - Shaft clamping length: at least 12 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 prop‐ erly. ▶ Only use cutters or grinders that do not deviate from the specified data.
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Operation CAUTION Injury hazard from cutters or grinders. Infections or cuts. ▶ Wear gloves or fingerstalls. 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.
Operation ▶ Rotate the clamping ring in the direction of the arrow to the backstop and insert the handpiece cutter or polisher into the chuck. ▶ Turn the clamping ring back into its initial position. ▶ Check that the cutter or grinder is securely attached by pulling on it. 5.4 Remove the handpiece or contra-angle drill bit WARNING Hazard from rotating cutter or grinder.
Operation ▶ After the milling or grinding tool has come to a standstill, turn the clamping ring as far as it will go and remove the milling or grinding tool. ▶ Turn the clamping ring back into its initial position. 5.5 Conversion for contra-angle handpiece drill bit Note The handpiece must be converted to use contra-angle handpiece drill...
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Operation ▶ To remove the drill bit stop, use the accompanying hook.
Troubleshooting 6 Troubleshooting 6.1 Check for malfunctions CAUTION Heating of the product. Burns or product damage from overheating. ▶ Do not use the product if it is irregularly heated. ▶ The medical device is too hot while working: Service the medical device. ▶...
Troubleshooting ▶ An O-ring is missing on the motor coupling: Replace O-ring. See also: Instructions for use of motor 6.2.1 Troubleshooting: Cleaning the spray tube CAUTION Hazard from insufficient amount of spray water. Insufficient spray water can cause the medical device to overheat and damage the tooth.
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Troubleshooting ▶ Use the nozzle needle (Mat. no. 0.410.0931) to free the water pas‐ sage at the spray tubes.
Reprocessing steps in accordance with ISO 17664 7 Reprocessing steps in accordance with ISO 17664 7.1 Preparation at the site of use WARNING Hazard from inappropriately reprocessed products. There is a risk of infection from contaminated medical devices. ▶ Take suitable personal protective measures. ▶...
Reprocessing steps in accordance with ISO 17664 7.2 Non-fixing preliminary cleaning of the spray tube Accessories required: ▪ Demineralised water 30 °C ± 2 °C (86 °F ± 3.6 °F) ▪ Nozzle pin ▪ Brush, e.g. medium-hard toothbrush ▪ Disposable syringe ▶...
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The non-fixing preliminary cleaning is a central constituent and must be carried out prior to the automatic reconditioning. In the KaVo QUATTROcare CLEAN, a validated interior cleaning of the spray tube can be achieved by using the surgical adapter coupling.
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Reprocessing steps in accordance with ISO 17664 In the cleaning and disinfecting device, validated internal cleaning of the spray tube necessitates preliminary non-fixing cleaning.
Reprocessing steps in accordance with ISO 17664 7.3 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. ▶ The instrument must not be cleaned in ultrasonic devices! 7.3.1 Cleaning: Manual external and internal cleaning Not applicable.
Z" and rinsing agent "neodisher miel‐ ® ® clear" and only applies to the material compatibility with KaVo products). ▶ For program settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the thermodisinfector...
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Manual external and internal cleaning cannot be performed. Follow‐ ing the non-fixing preliminary cleaning (item 7.2), the reprocessing must be continued in the thermodisinfector. In the KaVo QUATTROcare CLEAN, validated interior cleaning of the spray tube using the surgical adapter coupling is permissible.
Reprocessing steps in accordance with ISO 17664 7.4 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. Defects in the device. ▶ Only disinfect in the thermodisinfector. 7.4.1 Disinfection: Manual external and internal disinfection Not applicable.
Z" and rinsing agent "neodisher miel‐ ® ® clear" and only applies to the material compatibility with KaVo products). ▶ For program settings as well as cleansers and disinfectants to be used, please refer to the Instructions for Use of the thermodisinfector...
In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry after completion of the cycle, and then grease it immediately with servicing agents from the KaVo care system. 7.5 Drying Manual Drying ▶...
Reprocessing steps in accordance with ISO 17664 ▶ Follow the instructions for use of the thermodisinfector. 7.6 Care products and systems - Servicing WARNING Sharp cutters or grinders in the medical device. Risk of injury from sharp or pointed cutters or grinders. ▶...
7.6.1 Care products and systems - Servicing: Care with KaVo Spray KaVo recommends servicing the product after each time it is used, i.e. af‐ ter each automatic cleaning and before each sterilisation. ▶...
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Plug the product onto the cannula, and press the spray button for one second. Servicing of the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week. ▶ Remove the cutter or grinder, place the spray nipple tip in the open‐...
KaVo Spray". 7.6.2 Care products and systems - Servicing: Care with KaVo SPRAYr‐ otor KaVo recommends servicing the product after each time it is used, i.e. af‐ ter 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.
Reprocessing steps in accordance with ISO 17664 7.6.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare 2104 / 2104A Servicing device with expansion pressure for the cleaning of inorganic residues and optimum care. KaVo recommends servicing the product after each disinfection, and be‐...
Reprocessing steps in accordance with ISO 17664 7.6.4 Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS KaVo recommends servicing the product after each disinfection, and be‐ fore each sterilisation, in the scope of the reprocessing. ▶ Remove the cutter or grinder.
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Reprocessing steps in accordance with ISO 17664 Servicing the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week. See also: Instructions for Use KaVo QUATTROcare PLUS 2124 A Note Handpieces must be taken off the service couplings before the chuck service can be started and performed.
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Reprocessing steps in accordance with ISO 17664 ▶ Press the handpiece together with the guide bush of the chuck to be serviced against the tip of the service coupling chuck. ▶ Press the button showing the chuck service symbol.
Option 2: After three minutes with no service procedure running, the de‐ vice automatically switches back to normal service mode. See also: Care with KaVo QUATTROcare PLUS 7.6.5 Care products and systems - Servicing: Servicing with KaVo QUATTROcare CLEAN 2140 A Programme-controlled cleaning and servicing device for perfect instru‐...
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Reprocessing steps in accordance with ISO 17664 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 cutter or grinder. ▶ Service the product in QUATTROcare PLUS.
Reprocessing steps in accordance with ISO 17664 7.7 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! ▶...
Reprocessing steps in accordance with ISO 17664 7.8 Sterilisation 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 Ka‐ Vo care products.
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Reprocessing steps in accordance with ISO 17664 CAUTION Contact corrosion due to moisture. Damage to product. ▶ Immediately remove the product from the steam steriliser after the sterilisation cycle! The KaVo medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F).
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Reprocessing steps in accordance with ISO 17664 Select a suitable procedure (depending on the available autoclave) from the following sterilisation processes: ▪ Autoclave with three times pre-vacuum: – at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) ▪...
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Reprocessing steps in accordance with ISO 17664 ▶ Comply with the expiry date of the sterilised items.
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Instrument stand 2151 0.411.9501 Cleanpac 10 units 0.411.9691 Cellulose pad 100 units 0.411.9862 Drill stop 0.524.0892 Hook 0.410.1963 Nozzle needle 0.410.0931 Coupling piece 0.593.0361 Spray head INTRA (KaVo Spray) 0.411.9911 Service coupling for heads (QUAT‐ 0.411.7941 TROcare) Surgery service coupling 1.009.9489...
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Tools Material summary Mat. no. Adaptor INTRAmatic (CLEANspray 1.007.1776 and DRYspray) KaVo CLEANspray 2110 P 1.007.0579 KaVo DRYspray 2117 P 1.007.0580 KaVo Spray 2112 A 0.411.9640 ROTAspray 2 2142 A 0.411.7520 QUATTROcare plus Spray 2140 P 1.005.4525...
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12 months from the date of the invoice, subject to the following con‐ ditions: In case of justified complaints, KaVo will honour its warranty with a free replacement or repair. Other claims of any nature whatsoever, in particu‐...
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Terms and conditions of warranty or chemical or electrical factors deemed abnormal or impermissible in ac‐ cordance with KaVo's instructions for use or other manufacturer's instruc‐ tions. The warranty granted does not usually extend to lamps, light con‐ ductors made of glass and glass fibres, glassware, rubber parts, and the colourfastness of plastic parts.