Related Manuals for KaVo SMARTtorque LUX S619 L
Summary of Contents for KaVo SMARTtorque LUX S619 L
- Page 1 Instructions for use SMARTtorque LUX S619 L - REF 1.008.1641 SMARTtorque Mini LUX S615 L - REF 1.008.1643 SMARTtorque S619 C - REF 1.008.1642...
- Page 2 Distributed by: Manufacturer: KaVo Dental GmbH Kaltenbach & Voigt GmbH Bismarckring 39 Bismarckring 39 D-88400 Biberach D-88400 Biberach Phone +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...
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Page 3: Table Of Contents
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 .......................... 16 Technical Specifications ........................18 Transportation and storage conditions .................... - Page 4 Table of contents Checking the O-rings ..........................27 5 Operation ................................ 28 Attaching the medical device ........................ 29 Removing the medical device ......................31 Insert the milling cutter or diamond grinder ..................32 Removing the milling tool or diamond grinder..................36 6 Troubleshooting ..............................
- Page 5 Care products and systems - Servicing: Servicing with KaVo Spray ........53 7.5.2 Care products and systems - Servicing: Care with KaVo SPRAYrotor ........55 7.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS ..... 56 Packaging ............................. 60 Sterilisation ............................61 Storage ..............................64...
- Page 6 Table of contents 8 Tools ................................65 9 Warranty terms and conditions ........................67...
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Page 7: User Instructions
User instructions 1 User instructions Dear User Congratulations on purchasing this KaVo quality product. By following the instructions below you will be able to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH Symbols Refer to the chapter on Safety/Warning symbol... - Page 8 User instructions Action request CE mark (European Community). A product bearing this mark meets the requirements of the applicable EC directive. Can be steam-sterilised at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) Thermodisinfectable Target group This document is intended for dentists and their assistants.
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Page 9: Safety
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 the potential consequences of non-observance. ▶ The optional step includes necessary measures for hazard preven‐ tion. - Page 10 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 cause death or serious injury.
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Page 11: Safety Instructions
Safety DANGER DANGER indicates a hazardous situation that can directly cause death or serious 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. ▶... - Page 12 Safety WARNING Hazard from contraindication. If the soft tissue in the oral cavity is injured, the compressed air may en‐ able septic substances to enter the tissue. ▶ Treatment must be discontinued with instruments operated by com‐ pressed air when soft tissue is damaged in the oral cavity. CAUTION Burning hazard from hot instrument head and instruments cover.
- Page 13 Safety CAUTION Hazard from use as a light probe. Do not use the device as a light probe since the rotating cutter grinder can cause injury. ▶ Use an appropriate light probe for additional illumination of the oral cavity or site of preparation. CAUTION Risk due to incorrectly stored instrument.
- Page 14 For safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires. To ensure proper function, the medical device must be set up according to the reprocessing methods described in the KaVo Instructions for Use,...
- Page 15 Safety 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. This service interval depends on the frequency of use and should be adjusted accordingly.
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Page 16: Product Description
Product description 3 Product description SMARTtorque LUX S619 L (Mat. no. 1.008.1641) SMARTtorque Mini LUX S615 L (Mat. no. 1.008.1643) - Page 17 Product description SMARTtorque S619 C (Mat. no. 1.008.1642)
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Page 18: Purpose - Proper Use
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: Removal of carious ma‐ terial, cavities and crown preparations, removal of fillings, processing of tooth and restoration surfaces. - Page 19 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 ▪...
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Page 20: Technical Specifications
Product description 3.2 Technical Specifications SMARTtorque SMARTtorque SMARTtorque LUX S619 L Mini LUX S619 C S615 L Minimal drive pressure 2.1 bar (30 2.1 bar (30 2.1 bar (30 psi) psi) psi) Drive pressure 2.1 to 4.2 bar 2.1 to 4.2 bar 2.1 to 4.2 bar (30 to 61 psi) (30 to 61 psi) - Page 21 Product description Note The air consumption, idle speed, and power values were determined at a drive pressure of 2.8 bar (40 psi). Can be attached to all MULTIflex (LUX) / MULTIflex LED couplings.
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Page 22: Transportation And Storage Conditions
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). - Page 23 Product description Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi) Protect from moisture...
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Page 24: Start Up And Shut Down
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. -
Page 25: Mount The Multiflex (Lux) / Multiflex Led Coupling
Start up and shut down CAUTION Damage from soiled and moist cooling air. Contaminated and moist cooling air can cause malfunctions and lead to premature bearing wear. ▶ Make sure that the supply of cooling air is dry, clean and unconta‐ minated according to ISO 7494-2. - Page 26 Start up and shut down ▶ Rotate the spray ring on the MULTIflex (LUX) / MULTIflex LED coupling in order to regulate the fraction of water.
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Page 27: Checking The Amount Of Water
Start up and shut down 4.2 Checking the amount of water CAUTION Overheating of the tooth due to insufficient amount of cooling water. Insufficient spray water can cause the medical device to overheat and damage the pulp and tooth. ▶ Adjust the water amount for the spray cooling to a minimum of 50 /min! ▶... -
Page 28: Checking The Pressures
Start up and shut down 4.3 Checking the pressures CAUTION Compressed air connections on device. Dirty and moist compressed air causes premature bearing wear. ▶ Ensure dry, clean and uncontaminated compressed air according to ISO 7494-2. ▶ Insert the test gauge (Mat. no. 0.411.8731) between the MULTIflex (LUX) / MULTIflex LED coupling and the medical device, and check the following pressures: - Drive pressure: 2.8 bar (40 psi) -
Page 29: Checking The O-Rings
Start up and shut down - Spray air: 1.0 to 4.0 bar (15 to 58 psi) 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... -
Page 30: Operation
Operation 5 Operation Note At the beginning of each workday, the water-conducting systems should be rinsed for at least 2 min. without the instrument being attached; if there is a risk of contamination from reflux or back suction, the system must be rinsed for 20-30 seconds. -
Page 31: Attaching The Medical Device
Operation 5.1 Attaching the medical device 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. ▶ Check the seat of the turbine on the coupling by pulling on it. - Page 32 Operation 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. ▶ Before each use, check if the medical device is securely locked on‐ to the MULTIflex (LUX) / MULTIflex LED coupling by pulling on it.
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Page 33: Removing The Medical Device
Operation 5.2 Removing the medical device ▶ Hold the coupling tight, and pull the medical device off while twisting slightly. -
Page 34: Insert The Milling Cutter Or Diamond Grinder
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 SMARTtorque LUX S619 L and SMARTtorque S619 C: max. 25 mm - Overall length SMARTtorque Mini LUX S615 L: max. 21 mm... - Page 35 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.
- Page 36 Operation CAUTION Danger of injury 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.
- Page 37 Operation ▶ Forcefully press the push button with your thumb and simultaneously insert the cutter or grinder all the way. ▶ Check that the cutter or grinder is seated by pulling on it.
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Page 38: Removing The Milling Tool Or Diamond Grinder
Operation 5.4 Removing the milling 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! ▶... - Page 39 Operation ▶ 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.
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Page 40: Troubleshooting
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. ▶ Press the O-ring between your fingers to form a loop. -
Page 41: Cleaning The Spray Nozzle
Troubleshooting ▶ 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 spray water. Overheating of the medical device and damage to the tooth. ▶ Check the spray water channels and clean the spray nozzles with nozzle needleMat. - Page 42 Troubleshooting ▶ Clean the water passage in the spray nozzles by using the nozzle needle Mat. no. 1.003.8150.
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Page 43: Reprocessing Methods According To Iso 17664
Reprocessing methods according to ISO 17664 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. ▶... -
Page 44: Cleaning
Reprocessing methods according to ISO 17664 7.2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit. Defects in the product. ▶ Only clean manually or in a thermodisinfector. 7.2.1 Cleaning: Manual external cleaning Accessories required: ▪ Tap water 30 °C ± 5 °C (86 °F ± 10 °F) ▪... -
Page 45: Cleaning: Automated External Cleaning
Brush off under flowing tap water. 7.2.2 Cleaning: Automated external cleaning KaVo recommends thermodesinfectors in accordance with EN ISO 15883-1 that are operated with alkaline cleaning agents at a pH value of max. 10 (e. g. Miele G 7781 / G 7881 – validation was performed with the "VARIO-TD"... -
Page 46: Cleaning: Manual Internal Cleaning
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... - Page 47 Reprocessing methods according to ISO 17664 ▶ Afterwards, rinse for 3-5 seconds with KaVo DRYspray. See also: KaVo CLEANspray / KaVo DRYspray Instructions for Use Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the following countries: Germany, Austria, Switzerland, Italy, Spain, Portugal, France, Luxem‐...
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Page 48: Cleaning: Automated Internal Cleaning
Reprocessing methods according to ISO 17664 7.2.4 Cleaning: Automated internal cleaning KaVo recommends thermodesinfectors in accordance with EN ISO 15883-1 that are operated with alkaline cleaning agents at a pH value of max. 10 (e. g. Miele G 7781 / G 7881 – validation was performed with the "VARIO-TD"... -
Page 49: Disinfection
▶ In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry, and then lubricate immediately with care agents from the KaVo care system. 7.3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine. -
Page 50: Disinfection: Manual External Disinfection
Reprocessing methods according to ISO 17664 7.3.1 Disinfection: Manual external disinfection KaVo recommends the following products based on material compatibili‐ ty. The microbiological efficacy must be ensured by the disinfectant man‐ ufacturer. ▪ Mikrozid AF Liquid made by Schülke & Mayr ▪... -
Page 51: Disinfection: Manual Disinfection - Internal
The efficacy of manual internal disinfection must be demonstrated by the manufacturer of the disinfection agent. With KaVo products, use only dis‐ infection agents that have been released by KaVo with respect to the compatibility of materials (e.g. WL-cid / made by ALPRO). -
Page 52: Disinfection: Machine Disinfection - External And Internal
Follow the instructions for use of the disinfectant. 7.3.3 Disinfection: Machine disinfection - external and internal KaVo recommends thermodesinfectors in accordance with EN ISO 15883-1 that are operated with alkaline cleaning agents at a pH value of max. 10 (e. g. Miele G 7781 / G 7881 – validation was performed with the "VARIO-TD"... -
Page 53: Drying
▶ In order to prevent negative effects on the medical device, make sure that the interior and the exterior of the medical device are dry, and then lubricate immediately with care agents from the KaVo care system. 7.4 Drying Manual Drying ▶... -
Page 54: Care Products And Systems - Servicing
Reprocessing methods according to ISO 17664 ▶ Follow the instructions for use of the thermodisinfector. 7.5 Care products and systems - Servicing WARNING Sharp cutters or grinders in the medical device. Risk of injury from sharp or pointed cutters or grinders. ▶... -
Page 55: Care Products And Systems - Servicing: Servicing With Kavo Spray
7.5.1 Care products and systems - Servicing: Servicing 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. ▶ Remove cutter or grinder. - Page 56 Place the product on the cannula and press the spray button for one second. Chuck care KaVo recommends cleaning and servicing the chuck system once a week. ▶ Remove the cutter or grinder, place the INTRA spray nipple tip in the...
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Page 57: Care Products And Systems - Servicing: Care With Kavo Sprayrotor
Subsequently treat with the specified care agents and systems. 7.5.2 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. ▶... -
Page 58: Care Products And Systems - Servicing: Servicing With Kavo Quattrocare Plus
Reprocessing methods according to ISO 17664 7.5.3 Care products and systems - Servicing: Servicing with KaVo QUATTROcare PLUS KaVo recommends servicing the product after each time it is used, i.e. af‐ ter each automatic cleaning and before each sterilisation. ▶... - Page 59 Reprocessing methods according to ISO 17664 Servicing of the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week. See also: Instructions for use KaVo QUATTROcare PLUS Note Switch on the chuck service mode. No handpieces may be on the treatment coupling at the start of and dur‐...
- Page 60 Reprocessing methods according to ISO 17664 ▶ Remove the adaptor from the side door of the QUATTROcare PLUS and plug it into service coupling four, on the far right. A MULTIflex adapter must be mounted there. ▶ Press the handpiece together with the bush of the chuck to be serv‐ iced against the tip of the adapter.
- Page 61 Completing the chuck service mode. Option 1: Equipping the QUATTROcare with handpieces and closing the front panel. Option 2: after three minutes without a service procedure, the device switches automatically to normal service mode. See also: Care with KaVo QUATTROcare PLUS...
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Page 62: Packaging
The quality and use of the sterilisation packaging must satisfy applicable standards and be suitable for the sterilisation procedure! ▶ Individually weld the medical device in the sterilised item packaging (such as KaVo STERIclave bags Mat. no. 0.411.9912)! -
Page 63: Sterilisation
Reprocessing methods according to ISO 17664 7.7 Sterilisation Sterilisation in a steam steriliser (autoclave) in accordance with EN 13060 / ISO 17665-1 (z. B. KaVo STERIclave B 2200 / 2200 P) CAUTION Premature wear and malfunctions from improper servicing and care. - Page 64 Reprocessing 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! The KaVo medical device has a maximum temperature resistance up to 138 ℃ (280.4 °F).
- Page 65 Reprocessing methods according to ISO 17664 (Depending on the available autoclave,) select a suitable procedure from the following sterilisation processes: ▪ Autoclave with three times initial vacuum: – at least 3 minutes at 134 °C -1 °C / +4 °C (273 °F -1.6 °F / +7.4 °F) ▪...
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Page 66: Storage
Reprocessing methods according to ISO 17664 7.8 Storage ▶ Reprocessed products should be stored protected from dust with minimum exposure to germs in a dry, dark and cool space. ▶ Comply with the expiry date of the sterilised items. - Page 67 Tools 8 Tools Available from dental suppliers. Material summary Mat. no. Replacement rotor Standard 1.008.4163 Replacement rotor Mini 1.008.4164 Wrench Standard 0.411.3053 Wrench Mini 1.006.3384 Instrument stand 2151 0.411.9501 Nozzle needle 1.003.8150 MULTIflex spray head (nozzle) 0.411.9921 Spray head INTRA 0.411.9911 Cleanpac 10 units 0.411.9691...
- Page 68 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 STERIclave bags 0.411.9912...
- Page 69 The KaVo service offices listed in the appendix shall not be liable for de‐ fects and their consequences that have or may have arisen from natural wear, improper handling, improper cleaning, maintenance or care, non- compliance with operating or connection instructions, calcification or cor‐...
- Page 70 The dealer, purchase date, type, and serial number must be clearly evident from this document. Only the following KaVo service offices grant a warranty and conduct re‐ pairs under the warranty granted:...
- Page 71 Phone: +44 1 494 733 000 vo.com Fax: +44 1 494 431 168 Internet: www.kavo.com Email: sales@kavo.com Internet: www.kavo.co.uk Spain KaVo Dental S.L. Italy Joaquín María López, 41 dpdo. KaVo Italia SrL E - 28015 Madrid Via del Commercio 35...
- Page 72 Warranty terms and conditions Poland Czech KaVo Polska Sp.z.o.o. Republic KaVo CZ spol. s.r.o. UL. Pomorska 251 p.405 Lesanska 2a/1176 PL - 92-213 Lodz CZ - 141 00 Praha 4 Phone: +48 42 675 75 36 Phone: +420 272 654 566...
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