KaVo GENTLEsilence LUX gold 8000B Instructions For Use Manual
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KaVo GENTLEsilence LUX gold 8000B Instructions For Use Manual

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Instructions for use
GENTLEsilence LUX gold 8000B - REF
1.006.5500

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Summary of Contents for KaVo GENTLEsilence LUX gold 8000B

  • Page 1 Instructions for use GENTLEsilence LUX gold 8000B - REF 1.006.5500...
  • Page 2 Sales: Manufacturer: KaVo Dental GmbH Kaltenbach & Voigt GmbH Bismarckring 39 Bismarckring 39 D-88400 Biberach D-88400 Biberach Tel. +49 7351 56-0 www.kavo.com Fax +49 7351 56-1488...

  • Page 3: Table Of Contents

    Contents Contents Contents ................................. 1 User instructions ..............................5 Warranty terms and conditions ..........................7 Safety ..................................9 Description of safety instructions ......................... 9 Purpose – Proper use ............................11 Safety instructions ............................. 13 Product description ............................... 17 Technical data ..............................18 Transportation and storage conditions ......................
  • Page 4 Contents Check the amount of water ..........................22 Check the pressure ............................23 Check O-rings ..............................25 Operation ................................26 Mount the medical device ..........................27 Remove the medical device ..........................29 Insert the milling cutters or diamond grinders ....................30 Removing the milling tool or diamond grinder ....................
  • Page 5 Care products and systems - Servicing ......................51 Care products and systems - Servicing: Care with KAVOspray ..............52 Care products and systems - Servicing: Care of the KaVo SPRAYrotor ............ 54 Care products and systems - Servicing: Care with KaVo QUATTROcare ..........55 Packaging ................................
  • Page 6 Contents...

  • Page 7: User Instructions

    User instructions User instructions Dear user, KaVo hopes that you enjoy your new high-quality product. Following the instructions below will allow you to work smoothly, economically and safely. © Copyright by KaVo Dental GmbH Symbols See the section Safety/Warning Symbols...
  • Page 8 User instructions Disinfectable with heat Sterilizable in steam up to 135°C (275°F) CE mark (Communauté Européenne). A product with this mark meets the requirements of the applicable EC directive. Action request Target group This document is intended for dentists and their assistants. The section on starting up is also intended for service technicians.

  • Page 9: Warranty Terms And Conditions

    24 months from data of invoice, subject to the following conditions: In case of justified complaints, KaVo will honour its warranty with a repair or free replacement. Other claims of any nature whatsoever, in particular with respect to compensation, are excluded.
  • Page 10 User instructions usually cover lamps, light conductors made of glass and glass fibres, glas‐ sware, rubber parts and the colourfastness of plastic parts. No liability is assumed when defects or their consequences arise from ma‐ nipulations or changes to the product by the customer or a third party. 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.

  • Page 11: Safety

    Safety Description of safety instructions Warning symbol Structure The introduction describes the type and source of the hazard. This section describes the potential consequences of non-observance. ▶ The optional step contains necessary measures for avoiding hazards. DANGER Description of hazardous steps The safety instructions cited herein with the three levels of danger will help avert property damage and injury.
  • Page 12 Safety CAUTION indicates a hazardous situation that can lead to property damage or minor to moderate injury. CAUTION WARNING indicates a hazardous situation that can lead to serious injury or death. WARNING DANGER indicates a maximum hazardous situation that can directly cause serious injury or death.

  • Page 13: Purpose - Proper Use

    Safety Purpose – Proper use This medical device is: ▪ Only intended for dental treatment. Any other type of use or alteration to the product is impermissible and can be hazardous. The medical device is intended for the following use: Removal of carious material, cavities and crown preparations, removal of fillings, processing of tooth and restoration surfaces.
  • Page 14 Safety ▪ only use properly operating equipment, ▪ use the equipment for the proper purpose, ▪ to protect himself, the patient and third parties from danger. ▪ to avoid contamination from the product.

  • Page 15: Safety Instructions

    Safety Safety instructions Premature wear and malfunction due to improper storage or longer peri‐ ods of nonuse. Reduced product life. CAUTION ▶ The medical device should be cleaned, serviced and placed in a dry stored location according to instructions before long periods of non‐ use.
  • Page 16 Safety Note For safety reasons, we recommend that the tool holder system be checked annually after the warranty period expires. Hazard from improperly putting away instruments. Injury and infection caused by chucked cutters or grinders. Damage to the chucking system when the instrument fails. CAUTION ▶...
  • Page 17 For additional illumination of the oral cavity or preparation site, use a suitable light probe such as the KaVo DIAlux 2300L. 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 pro‐...
  • Page 18 Safety ducts 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. This service in‐ terval should take into account the frequency of use.

  • Page 19: Product Description

    Product description Product description GENTLEsilence LUX gold 8000B (Mat. no. 1.006.5500)

  • Page 20: Technical Data

    Product description Technical data Minimum pressure 2,1 bar Drive pressure 2.1 to 4.2 bar recommendation 2.8 bar Air consumption 39 to 51 Nl/min. Idle speed 330,000 to 380,000 rpm Recommended operating pressure 2 to 3 N Attachable to all MULTIflex (LUX) couplings.

  • Page 21: Transportation And Storage Conditions

    Product description Transportation and storage conditions Starting up the medical device can be hazardous after it has been stored in an excessively cold location. The medical device can malfunction. CAUTION ▶ Products that are very cold must be warmed to 20°C (68°F) to 25°C (77°F) before use.

  • Page 22: First Use

    First use First use Hazard from nonsterile products. Infection danger to the care provider and patient. ▶ Before first use and after each use, sterilise the medical device. WARNING Damage from soiled and moist cooling air. Contaminated and moist cooling air can cause malfunctions and lead to premature bearing wear.

  • Page 23: Attach The Multiflex Coupling

    First use Attach the MULTIflex coupling ▶ Screw the MULTIflex (LUX) coupling to the turbine hose and tighten with the key. The amount of water in the spray can be regulated by turning the spray ring at the MULTIflex (LUX) coupling.

  • Page 24: Check The Amount Of Water

    First use Check the amount of water The tooth may overheat from insufficient water. Thermal damage to the pulp. ▶ Set the amount of water for spray cooling to at least 50 cm /min.! CAUTION Hazard from insufficient amount of spray water. Insufficient spray water can cause the medical device to overheat and damage the tooth.

  • Page 25: Check The Pressure

    First use Check the pressure Connecting to devices Dirty and moist compressed air causes premature bearing wear. ▶ Ensure dry, clean and uncontaminated compressed air according to CAUTION ISO 7494-2. A minimum drive pressure of 2.1 bar is required for operating the medical device.
  • Page 26 First use ▶ Insert the test manometer (Mat. no. 0.411.8731) between the hose and MULTIflex LUX coupling and check the following pressures: - Drive air: 2.1 to 4.2 bar (recommended: 2.8 bar) - Return air: < 0.5 bar - Water: 0.8 to 2.5 bar - Spray air: 1.0 to 4.0 bar...

  • Page 27: Check O-Rings

    First use Check O-rings Missing or damaged O-rings If the O-rings are missing or damaged, malfunctions and premature failure can occur. CAUTION ▶ Check that all O-rings are present and undamaged on the coupling. Number of available O-rings: 5...

  • Page 28: Operation

    Operation 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. there is a risk of contamination from reflux or back suction, the systems should be rinsed for 20-30 seconds.

  • Page 29: Mount The Medical Device

    Operation Mount the medical device Damage from inexact coupling Improper coupling, especially during the afterglow period, can destroy the high-pressure lamp of a MULTIflex LUX or reduce its life. CAUTION ▶ Check the seat of the turbine on the coupling by pulling it. ▶...
  • Page 30 Operation Release of the medical device during treatment. A medical device that is not properly locked can release from the MULTI‐ flex (LUX) during treatment. WARNING ▶ Before each use, check if the medical device is securely locked onto the MULTIflex (LUX).

  • Page 31: Remove The Medical Device

    Operation Remove the medical device ▶ Hold the coupling tight, and pull the medical device off while twisting slightly.

  • Page 32: Insert The Milling Cutters Or Diamond Grinders

    Operation Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond grinders 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.
  • Page 33 Operation Use of impermissible carbide cutters or diamond grinders. Injury to the patient or damage to the medical device. ▶ Observe manufacturer instructions, and use the cutter or grinder pro‐ WARNING perly. ▶ Only use carbide cutters or diamond grinders that do not deviate from the indicated data.
  • Page 34 Operation Injury from improper use of carbide cutters or diamond grinders. Never use metal cutters or grinders with worn shafts can fall out during treatment and injure the patient. DANGER ▶ Never use cutters or burrs with worn shafts. Do not use tools that deviate from the indicated data.
  • Page 35 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. Hazard from defective chucking system. The tool can fall out and cause injury. ▶...

  • Page 36: Removing The Milling Tool Or Diamond Grinder

    Operation Removing the milling tool or diamond grinder Hazard from rotating tools. Lacerations. ▶ Avoid unintentionally touching rotating tools. CAUTION ▶ After the cutter or grinder has stopped rotating, press the push button with your thumb and pull out the cutter or grinder.
  • Page 37 Operation Do not press the pushbutton while the drill bit or burr is rotating. If you press the pushbutton when the cutter or grinder is rotating, it can damage the chucking system and cause injury. WARNING ▶ Never touch soft tissue with the head or tip since it may be hot and cause a burn.

  • Page 38: Troubleshooting

    Troubleshooting Exchanging the O-rings on the coupling on the supply hose Hazard from improper care of the O-rings. Improper care of the O-ring can cause the medical device to partially or completely malfunction. CAUTION ▶ Do not use Vaseline or other grease or oil. Note The O-rings on the coupling may only be lubricated with a cotton ball wet with KAVOspray.

  • Page 39: Cleaning The Spray Nozzle

    Troubleshooting Cleaning the spray nozzle. Hazard from insufficient amount of spray water. Insufficient spray water can cause the medical device to overheat and damage the tooth. CAUTION ▶ If the spray water is insufficient, unplug the spray nozzles or check or exchange the water filter.
  • Page 40 Troubleshooting ▶ Clean the water passage in the spray nozzles by using the nozzle needle Mat. no. 0.410.0921.

  • Page 41: Change The Water Filter

    Troubleshooting Change the water filter ▶ Rotating to the left, unscrew the sleeve ① from the insert ② and re‐ move. ▶ Pull the insert ② back slightly. ▶ Remove the water filter ③ from the insert ② with a tweezers. ▶...

  • Page 42: Preparation Methods According To Iso 17664

    Preparation methods according to ISO 17664 Preparation at the site of use Hazard from nonsterile products. An infection hazard exists from contaminated medical devices. ▶ Observe suitable personal protective measures. CAUTION ▶ Remove residual cement, composite or blood at the site of use. ▶...

  • Page 43: Cleaning

    Preparation methods according to ISO 17664 Cleaning Malfunctions from cleaning in the ultrasonic unit. Defects to the product. ▶ Only clean manually or in the thermodesinfector! CAUTION...

  • Page 44: Cleaning: Manual Cleaning Of The Exterior

    Preparation methods according to ISO 17664 Cleaning: Manual cleaning of the exterior Required accessories: ▪ Tap water 30°C ± 5 °C (86°F ± 10°F) or a 60 to 70% alcohol solution ▪ Brush such as a medium hard toothbrush ▶ Brush off under flowing tap water, or clean with a 60-70% alcohol solution.

  • Page 45: Cleaning: Manual Cleaning Of The Inside

    Preparation methods according to ISO 17664 Cleaning: Manual cleaning of the inside To effectively set up, the inside of the machine must be cleaned automati‐ cally in a cleaning and disinfection unit in accordance with ISO 15883-1. (The interior of this product is not to be cleaned manually).

  • Page 46: Cleaning: Machine Cleaning Of The Exterior And Interior

    Preparation methods according to ISO 17664 Cleaning: Machine cleaning of the exterior and interior KaVo recommends thermodesinfectors according to ISO 15883 such as the Miele G 7781/ G 7881. (Validation was performed with the program "VARIO-TD", the cleaner "ne‐ odisher mediclean", the neutraliser "neodisher...

  • Page 47: Disinfection

    Preparation methods according to ISO 17664 Disinfection Malfunctions from using a disinfectant bath or chlorine-containing disin‐ fectant. Defects to the product. CAUTION ▶ Only clean manually or in the thermodesinfector!

  • Page 48: Disinfection: Manual Disinfection Of The The Exterior

    Preparation methods according to ISO 17664 Disinfection: Manual disinfection of the the exterior KaVo recommends the following products based on material compatibility. The microbiological efficacy must be ensured by the disinfectant manufac‐ turer. ▶ Microcide AF by Schülke&Mayr (liquid or cloths) ▶...
  • Page 49 Preparation methods according to ISO 17664 Spray the disinfectant on a cloth then wipe the medical device and let it work according to the disinfectant manufacturer. Note Observe the instruction for use for the disinfectant.

  • Page 50: Disinfection: Manual Disinfection Of The Interior

    Preparation methods according to ISO 17664 Disinfection: Manual disinfection of the interior To effectively set up, the inside of the machine must be cleaned automati‐ cally in a cleaning and disinfection unit in accordance with ISO 15883-1. (The inside of this product should not be disinfected manually.)

  • Page 51: Disinfection: Machine Disinfection Of The Exterior And Interior

    Preparation methods according to ISO 17664 Disinfection: Machine disinfection of the exterior and interior KaVo recommends thermodesinfectors according to ISO 15883 such as the Miele G 7781/ G 7881. (Validation was performed with the program "VARIO-TD", the cleaner "ne‐ odisher mediclean", the neutraliser "neodisher...

  • Page 52: Drying

    Preparation methods according to ISO 17664 Drying Manual drying ▶ Blow off the outside and inside the compressed air until no water drops are visible. Machine drying The drying procedure is normally part of the cleaning program of the ther‐ modisinfector.

  • Page 53: Care Products And Systems - Servicing

    ▶ Regularly service the device properly! CAUTION Note KaVo only guarantees that its products will function properly when care products are used that are listed by KaVo in the accessories since they were tested for proper use on KaVo products.

  • Page 54: Care Products And Systems - Servicing: Care With Kavospray

    Preparation methods according to ISO 17664 Care products and systems - Servicing: Care with KAVOspray KaVo recommends servicing the project twice daily (at noon and in the evening after hours), after each time the machine is cleaned, and before each sterilisation.
  • Page 55 Preparation methods according to ISO 17664 Care for the chuck of the KAVOspray KaVo recommends cleaning and maintaining the chucking system once a week. ▶ Remove tool, place the spray nipple tip in the opening and spray. Note For the care procedure, see the section "Care with KAVOspray."...

  • Page 56: Care Products And Systems - Servicing: Care Of The Kavo Sprayrotor

    Preparation methods according to ISO 17664 Care products and systems - Servicing: Care of the KaVo SPRAYrotor KaVo recommends servicing the project twice daily (at noon and in the evening after hours), after each time the machine is cleaned, and before each sterilisation.

  • Page 57: Care Products And Systems - Servicing: Care With Kavo Quattrocare

    Care products and systems - Servicing: Care with KaVo QUATTROcare Cleaning and care unit with expansion pressure for thorough cleaning and care KaVo recommends servicing the project twice daily (at noon and in the evening after hours), after each time the machine is cleaned, and before each sterilisation.
  • Page 58 Preparation methods according to ISO 17664 KaVo QUATTROcare plus spray can KaVo recommends cleaning and maintaining the chucking system once a week. See also: Instructions for use KaVo QUATTROcare. ▶ Remove tool, place the spray nipple tip in the opening and spray.

  • Page 59: Packaging

    The quality and use of the packaging of the items to be sterilised must satisfy the applicable standards and be appropriate for sterilising. ▶ Individually weld the medical device in the sterilised item packaging (such as KaVo STERIclave bagsMat. no. 0.411.9912)!

  • Page 60: Sterilisation

    Premature wear and malfunctions from improperly care and service shor‐ tens the service life of the product. Shortened product life. CAUTION ▶ The medical device must be serviced with KaVo care products before each sterilisation cycle. Contact corrosion from moisture. Damage to the product. ▶...
  • Page 61 The medical device has a max. temperature resistance of 138℃. KaVo recommends for example - STERIclave B 2200/ 2200P by KaVo - Citomat/ K-series by Getinge Autoclave with a triple prevacuum for at least 4 minutes at 134°C ± 1 (273 °F ±...

  • Page 62: Storage

    Preparation methods according to ISO 17664 Storage Prepared products should be stored protected germ-free from dust in a dry, dark and cool room. Note Observe the expiration date of the sterilised item.

  • Page 63: Auxiliary Equipment

    Auxiliary equipment Auxiliary equipment Available from dental and medical suppliers Material summary Mat. No. Replacement turbine with key 1.003.6883 Replacement turbine without key 1.003.6884 Water filter with nipple 1.000.4823 Instrument stand 2151 0.411.9501 Insert for turbines 0.411.9902 Cleanpac 10 units 0.411.9691 KAVOspray 2112 A 0.411.9640...

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1.006.5500

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