Instructions For Use

Instructions for useGENTLEsilence 6500B - REF 1.000.0600

Distributed by:KaVo Dental Corporation11729 Fruehauf DriveCharlotte, NC 28273 USATel. 847-550-6800Fax 847-550-6825Manufacturer:Kaltenbach & Voigt GmbHBismarckring 39D-88400 Biberachwww.kavo.com

Table of contents1Table of contents1 User instructions . 52 Safety . 72.1 Description of safety instructions . 72.2 Safety instructions . 93 Product description . 143.1 Purpose – Proper use . 153.2 Technical Specification . 173.3 Transportation and storage conditions . 184 First use . 204.1 Attach the MULTIflex coupling . 214.2 Check the amount of water . 234.3 Check the pressure . 24

Table of contents4.4 Check O-rings .5 Operation .5.1 Attach the medical device .5.2 Remove the medical device .5.3 Insert the milling cutters or diamond grinders .5.4 Removing the milling tool or diamond grinder .6 Troubleshooting .6.1 Exchanging the O-rings on the coupling on the supply hose .6.2 Cleaning the spray nozzle. .6.3 Change the water filter .7 Preparation methods according to ISO 17664 .7.1 Preparations at the site of use .7.2 Cleaning .7.2.1 Cleaning: Manual cleaning - external .22527283030343636373840404141

Table of contents7.37.47.57.67.77.87.2.2 Cleaning: Automated external cleaning .7.2.3 Cleaning: Manual cleaning of the inside .7.2.4 Cleaning: Automated internal cleaning .Disinfection .7.3.1 Disinfection: Manual disinfection - external .7.3.2 Disinfection: Manual disinfection - internal .7.3.3 Disinfection: Machine disinfection - external and internal .Drying .Care products and systems - Servicing .7.5.1 Care products and systems - Servicing: Care with KaVo Spray .7.5.2 Care products and systems - Servicing: Care with KaVo QUATTROcare .Packaging .Sterilisation .Storage .34243434546474849505153555658

Table of contents48 Tools . 599 Warranty terms and conditions . 61

User instructions51 User instructionsDear UserCongratulations on purchasing this KaVo quality product. By following theinstructions below you will be able to work smoothly, economically andsafely. Copyright by KaVo Dental GmbHSymbolsRefer to the Chapter on Safety/Warning symbolImportant information for users and service technicians

User instructions6Action requestCan be sterilized with steam up to 135 C (275 F)ThermodisinfectableTarget groupThis document is intended for dentists and their assistants. The section onstarting up is also intended for service technicians.

Safety72 Safety2.1 Description of safety instructionsWarning symbolStructureDANGERThe 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.

Safety8Description of hazard levelsThe safety instructions listed here, together with the three levels ofdanger will help avert property damage and injury.CAUTIONCAUTIONindicates a hazardous situation that can cause damage to property or mildto moderate injuries.WARNINGWARNINGindicates a hazardous situation that can cause death or serious injury.

Safety9DANGERDANGERindicates a hazardous situation that can directly cause death or seriousinjury.2.2 Safety instructionsWARNINGHazards for the care provider and the patient.In the case of damage, irregular running noise, excessive vibration, untypical warming or when the cutter or grinder cannot be held. Do not use further and notify Service.

Safety10WARNINGHazard from contraindication.If the soft tissue in the oral cavity is injured, the compressed air may enableseptic 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.CAUTIONPremature wear and malfunctioning from improper storage during longperiods of nonuse.Reduced product life. The medical device should be cleaned, serviced and stored in a drylocation, according to instructions, before long periods of nonuse.

Safety11CAUTIONRisk 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, withoutthe cutter or grinder.CAUTIONBurning hazard from hot instrument head and instruments cover.If the instrument overheats, burns may arise in the oral area. Never contact soft tissue with the instrument head.

Safety12CAUTIONHazard from use as a light probe.Do not use the device as a light probe since the rotating cutter grinder cancause injury. For additional illumination of the oral cavity or preparation site, use asuitable light probe such as the KaVo DIAlux 2300L.NoteFor safety reasons, we recommend that the tool holder system be checkedannually after the warranty period expires.

Safety13The following individuals are authorized to repair and service KaVo prod‐ucts: Technicians at KaVo branches throughout the world Technicians specially trained by KaVoTo ensure proper function, the medical device must be set up according tothe reprocessing methods described in the KaVo Instructions for Use, andthe care products and care systems described therein must be used. KaVorecommends specifying a service interval at the dental office for a licensedshop to clean, service and check the functioning of the medical device. Thisservice interval depends on the frequency of use and should be adjustedaccordingly.Service may only be carried out by KaVo-trained repair shops using originalKaVo replacement parts.

Product description143 Product descriptionGENTLEsilence LUX 6500 B (Mat. no. 1.000.0600)

Product description153.1 Purpose – Proper usePurpose:This medical device is Only intended for dental treatment. Any other type of use or alterationto the product is impermissible and can be hazardous. The medicaldevice is intended for the following uses: Removal of carious material,cavities and crown preparations, removal of fillings, processing of toothand restoration surfaces. A medical device according to relevant national statutory regulations.

Product description16Proper use:According to these regulations, this medical device may only be used forthe described application by a knowledgeable user. The following must beobserved: the applicable health and safety regulations the applicable accident prevention regulations these instructions for useAccording to these regulations, it is the responsibility of the user to: only use equipment that is operating correctly, use the equipment for the proper purpose, protect him or herself, the patient and third parties from danger, and avoid contamination from the product.

Product description173.2 Technical SpecificationMinimum pressure2.1 bar (30 psi)Drive pressure2.1 to 3.5 bar (30 to 51 psi)Recommendation 2.8 bar (40 psi)Air consumption49 to 55 Nl/min. (1.7 to 1.9 cfm)Idle speedRecommended operating pressure 2 to 3 N (0.45 to 0.68 lbs)Can be attached to all MULTIflex (LUX) / MULTIflex LED couplings.

Product description183.3 Transportation and storage conditionsCAUTIONIt is hazardous to start up the medical device after it has been storedstrongly refrigerated.This can cause the medical device to malfunction. Prior to start-up, very cold products must be heated to a temperatureof 20 C to 25 C (68 F to 77 F).Temperature: -20 C to 70 C (-4 F to 158 F)Relative humidity: 5% RH to 95% RH absence of condensation

Product description19Air pressure: 700 hPa to 1060 hPa (10 psi to 15 psi)Protect from moisture

First use204 First useWARNINGHazard from nonsterile products.Infection danger to the care provider and patient. Before first use and after each use, prepare and sterilise the medicaldevice if needed.

First use21CAUTIONDamage from soiled and moist cooling air.Contaminated and moist cooling air can cause malfunctions and lead topremature bearing wear. Make sure that the supply of cooling air is dry, clean and unconta‐minated according to ISO 7494-2.4.1 Attach the MULTIflex coupling Screw the MULTIflex (LUX) / MULTIflex LED coupling onto the turbinehose and tighten with the wrench.

First use22 Rotate the spray ring on theMULTIflex (LUX) / MULTIflex LED coupling in order to regulate thefraction of water.

First use234.2 Check the amount of waterCAUTIONOverheating of the tooth due to insufficient amount of cooling water.Insufficient spray water can cause the medical device to overheat anddamage the pulp and tooth. Adjust the water amount for the spray cooling to a minimum of 50cm3/min (3.1 inch3). Check spray water channels and if necessary clean spray nozzleswith the nozzle needle (Mat. no. 0.410.0921). Check water filter and replace, if necessary.

First use244.3 Check the pressureCAUTIONCompressed air connections on device.Dirty and moist compressed air causes premature bearing wear. Ensure dry, clean and uncontaminated compressed air according toISO 7494-2.A minimum drive pressure of 2.1 to 3.5 bar (30 to 51 psi) is required tooperate the medical device.A higher drive pressure will be reduced automatically by the medical device.The air consumption is 49 to 55 Nl/min. (1.7 to 1.9 cfm/min).2.8 bar (40 psi) is ideal.

First use25 Insert the test manometer (Mat. no. 0.411.8731) between theMULTIflex LUX coupling and the turbine and check the following pres‐sures:- Drive air: 2.1 to 3.5 bar (30 to 51 psi) (recommended: 2.8 (40 bar psi))Return air: 0.5 bar (7 psi)- Water: 0.8 to 2.5 bar (11 to 36 psi)- Spray air: 1.0 to 4.0 bar (14 to 57 psi)4.4 Check O-ringsCAUTIONMissing or damaged O-rings.Malfunctions and premature failure. Make sure that all O-rings are on the coupling and undamaged.

First use26Number of available O-rings: 5

Operation275 OperationNoteAt the beginning of each workday, the water-conducting systems shouldbe rinsed for at least 2 min. without the instrument being attached; if thereis a risk of contamination from reflux or back suction, the system must berinsed for 20-30 seconds.

Operation285.1 Attach the medical deviceWARNINGRelease of the medical device during treatment.A medical device that is not properly locked in place can release from theMULTIflex (LUX) / MULTIflex LED coupling during treatment. Before each use, check if the medical device is securely locked ontothe MULTIflex (LUX) / MULTIflex LED coupling by pulling on it.

Operation29CAUTIONDamage from inaccurate coupling.Inaccurate coupling (especially during the afterglow period) can destroythe high-pressure lamp or the LED of a MULTIflex (LUX) / MULTIflex LEDcoupling or reduce its service life. Check the seat of the turbine on the coupling by pulling on it. Mount the medical device accurately on theMULTIflex (LUX) / MULTIflex LED coupling and push it backward untilthe coupling audibly locks in the medical device. Pull on it to make sure that the medical device is securely affixed to thecoupling.

Operation305.2 Remove the medical device Hold the coupling tight, and pull the medical device off while twistingslightly.5.3 Insert the milling cutters or diamond grindersNoteOnly use carbide cutters or diamond grinders that correspond to ISO1797-1 type 3, are made of steel or hard metal and meet the followingcriteria:- Shaft diameter: 1.59 to 1.60 mm- Overall length: max. 25 mm- Shaft clamping length: 11 mm- Edge diameter: max. 2 mm

Operation31WARNINGUse 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 prop‐erly. Only use cutters or grinders that do not deviate from the indicateddata.CAUTIONInjury 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.