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KaVo GENTLEsilence LUX gold 8000B, Instructions For Use Manual, Page: 59 / 68

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KaVo GENTLEsilence LUX gold 8000B Instructions For Use Manual Download Page 59

Preparation methods according to ISO 17664

57

Packaging

Note

The sterilisation bag must be large enough for the instrument so that the

bag is not stretched.

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)!

Summary of Contents for GENTLEsilence LUX gold 8000B

Page 1: ...Instructions for use GENTLEsilence LUX gold 8000B REF 1 006 5500...

Page 2: ...Sales KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Tel 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com...

Page 3: ...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 condition...

Page 4: ...medical device 29 Insert the milling cutters or diamond grinders 30 Removing the milling tool or diamond grinder 34 Troubleshooting 36 Exchanging the O rings on the coupling on the supply hose 36 Clea...

Page 5: ...rior 46 Disinfection Manual disinfection of the interior 48 Disinfection Machine disinfection of the exterior and interior 49 Drying 50 Care products and systems Servicing 51 Care products and systems...

Page 6: ...Contents 4...

Page 7: ...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 Warni...

Page 8: ...5 C 275 F CE mark Communaut Europ enne 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 assis...

Page 9: ...ny 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 t...

Page 10: ...hen 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 w...

Page 11: ...type and source of the hazard This section describes the potential consequences of non observance The optional step contains necessary measures for avoiding hazards Description of hazardous steps The...

Page 12: ...on that can lead to property damage or minor to moderate injury WARNING WARNING indicates a hazardous situation that can lead to serious injury or death DANGER DANGER indicates a maximum hazardous sit...

Page 13: ...preparations removal of fillings processing of tooth and restoration surfaces A medical device according to relevant national statutory regulations According to these provisions this medical device m...

Page 14: ...Safety 12 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: ...Reduced product life The medical device should be cleaned serviced and placed in a dry stored location according to instructions before long periods of non use CAUTION Injury or damage due to wear Ir...

Page 16: ...or grinders Damage to the chucking system when the instrument fails After treatment place the cutter or grinder properly in the cradle wi thout the tool WARNING Hazard from contraindication If the so...

Page 17: ...nches throughout the world Special technicians especially trained by KaVo CAUTION Hazard from use as a light probe Do not use the device as a light probe since the rotating cutter or grinder can cause...

Page 18: ...l 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 Service may only be pro...

Page 19: ...Product description 17 Product description GENTLEsilence LUX gold 8000B Mat no 1 006 5500...

Page 20: ...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...

Page 21: ...ous after it has been stored in an excessively cold location The medical device can malfunction Products that are very cold must be warmed to 20 C 68 F to 25 C 77 F before use Temperature 50 C 58 F to...

Page 22: ...Before first use and after each use sterilise the medical device CAUTION Damage from soiled and moist cooling air Contaminated and moist cooling air can cause malfunctions and lead to premature beari...

Page 23: ...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...

Page 24: ...Set the amount of water for spray cooling to at least 50 cm3 min CAUTION Hazard from insufficient amount of spray water Insufficient spray water can cause the medical device to overheat and damage th...

Page 25: ...ture bearing wear Ensure dry clean and uncontaminated compressed air according to ISO 7494 2 A minimum drive pressure of 2 1 bar is required for operating the medical device A higher drive pressure wi...

Page 26: ...e 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 Sp...

Page 27: ...rings CAUTION Missing or damaged O rings If the O rings are missing or damaged malfunctions and premature failure can occur Check that all O rings are present and undamaged on the coupling Number of...

Page 28: ...eginning 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...

Page 29: ...high pressure lamp of a MULTIflex LUX or reduce its life Check the seat of the turbine on the coupling by pulling it Precisely attach the medical device to the MULTIflex LUX coupling and push is to t...

Page 30: ...se of the medical device during treatment A medical device that is not properly locked can release from the MULTI flex LUX during treatment Before each use check if the medical device is securely lock...

Page 31: ...Operation 29 Remove the medical device Hold the coupling tight and pull the medical device off while twisting slightly...

Page 32: ...ote 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: ...ter or grinder pro perly Only use carbide cutters or diamond grinders that do not deviate from the indicated data CAUTION Injury from using worn carbide cutters or diamond grinders Cutters or grinders...

Page 34: ...n fall out during treatment and injure the patient Never use cutters or burrs with worn shafts Do not use tools that deviate from the indicated data Follow the manufacturer s instructions only use the...

Page 35: ...he cutter or grinder is seated by pulling on it CAUTION Hazard from defective chucking system The tool can fall out and cause injury Pull on the tool to check if the chucking system is functioning pro...

Page 36: ...ol or diamond grinder CAUTION Hazard from rotating tools Lacerations Avoid unintentionally touching rotating tools After the cutter or grinder has stopped rotating press the push button with your thum...

Page 37: ...grinder is rotating it can damage the chucking system and cause injury Never touch soft tissue with the head or tip since it may be hot and cause a burn After treatment is over remove the cutter or gr...

Page 38: ...O ring can cause the medical device to partially or completely malfunction 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 wi...

Page 39: ...le CAUTION Hazard from insufficient amount of spray water Insufficient spray water can cause the medical device to overheat and damage the tooth If the spray water is insufficient unplug the spray noz...

Page 40: ...Troubleshooting 38 Clean the water passage in the spray nozzles by using the nozzle needle Mat no 0 410 0921...

Page 41: ...ing to the left unscrew the sleeve from the insert and re move Pull the insert back slightly Remove the water filter from the insert with a tweezers Insert new water filter Reinsert the insert Mount t...

Page 42: ...devices Observe suitable personal protective measures Remove residual cement composite or blood at the site of use The medical device must be dry when transporting it to be prepared Do not place it i...

Page 43: ...Preparation methods according to ISO 17664 41 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit Defects to the product Only clean manually or in the thermodesinfector...

Page 44: ...64 42 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...

Page 45: ...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 o...

Page 46: ...Validation was performed with the program VARIO TD the cleaner ne odisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear The program settings and cleansers and disinfectants that...

Page 47: ...on methods according to ISO 17664 45 Disinfection CAUTION Malfunctions from using a disinfectant bath or chlorine containing disin fectant Defects to the product Only clean manually or in the thermode...

Page 48: ...terior KaVo recommends the following products based on material compatibility The microbiological efficacy must be ensured by the disinfectant manufac turer Microcide AF by Sch lke Mayr liquid or clot...

Page 49: ...ethods according to ISO 17664 47 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...

Page 50: ...fection 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...

Page 51: ...7881 Validation was performed with the program VARIO TD the cleaner ne odisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear The program settings and cleansers and disinfectants...

Page 52: ...nd 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 Note Please follow the instructions...

Page 53: ...nted tool Remove the tool CAUTION Premature wear and malfunction from improper service and care Shortened product service life Regularly service the device properly Note KaVo only guarantees that its...

Page 54: ...spray 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 Removing the tool Cover the product...

Page 55: ...4 53 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 proc...

Page 56: ...s servicing the project twice daily at noon and in the evening after hours after each time the machine is cleaned and before each sterilisation Place the product on the appropriate coupling on the KaV...

Page 57: ...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...

Page 58: ...lus 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 Su...

Page 59: ...r the instrument so that the bag is not stretched The quality and use of the packaging of the items to be sterilised must satisfy the applicable standards and be appropriate for sterilising Individual...

Page 60: ...malfunctions from improperly care and service shor tens the service life of the product Shortened product life The medical device must be serviced with KaVo care products before each sterilisation cyc...

Page 61: ...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 1 8 Autoclave using the gravitation method for at least 10 minutes at 134 C...

Page 62: ...reparation methods according to ISO 17664 60 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 ite...

Page 63: ...03 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 4...

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