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KaVo GENTLEmini LUX 4500 BR, Instructions For Use Manual

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KaVo GENTLEmini LUX 4500 BR Instructions For Use Manual Download Page 21

▪ 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.

▪ A medical device according to relevant national statutory regulations.

Proper use:

According to these provisions, this medical device may only be used for the

described application by a knowledgeable user. The following must be ob‐

served:

▪ the applicable health and safety regulations
▪ the applicable accident prevention regulations
▪ these instructions for use

3 Description of the device

21 / 78

Summary of Contents for GENTLEmini LUX 4500 BR

Page 1: ...Instructions for use MASTERtorque Mini LUX M4500 L 1 007 1700 GENTLEmini LUX 4500 BR 1 007 1700 ...

Page 2: ...Distributed by KaVo Dental Corporation 11729 Fruehauf Drive Charlotte NC 28273 USA Tel 847 550 6800 Fax 847 550 6825 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com ...

Page 3: ...12 3 Description of the device 19 3 1 Intended use 20 3 2 Technical Specifications 23 3 3 Transportation and storage conditions 23 4 Start up and shut down 26 4 1 Mounting the MULTIflex LUX MULTIflex LED coupling 28 4 2 Check the amount of water 30 4 3 Check the pressure 32 4 4 Check O rings 33 Contents 3 78 ...

Page 4: ... grinder 41 6 Troubleshooting 43 6 1 Changing the O rings on the coupling of the supply hose 43 6 2 Cleaning the spray nozzle 45 6 3 Change the water filter 46 7 Preparation methods according to ISO 17664 49 7 1 Preparations at the site of use 49 7 2 Cleaning 50 7 2 1 Manual cleaning external 51 7 2 2 Automated external cleaning 52 Contents 4 78 ...

Page 5: ... external 55 7 3 2 Manual disinfection internal 56 7 3 3 Machine disinfection external and internal 56 7 4 Drying 57 7 5 Care products and systems Servicing 58 7 5 1 Servicing with KaVo Spray 60 7 5 2 Servicing with KaVo QUATTROcare 2104 2104A 62 7 5 3 Servicing with KaVo QUATTROcare Plus 64 7 6 Packaging 68 Contents 5 78 ...

Page 6: ...7 7 Sterilisation 69 7 8 Storage 71 8 Tools 72 9 Warranty terms and conditions 74 Contents 6 78 ...

Page 7: ...ew high quality product Following the in structions below will allow you to work smoothly economically and safely Copyright by KaVo Dental GmbH Symbols See the section Safety Warning Symbols Important information for users and technicians 1 User instructions 7 78 ...

Page 8: ...t Sterilizable in steam up to 135o C 275o F Action request Target group This document is intended for dentists and their assistants The section on starting up is also intended for service technicians 1 User instructions 8 78 ...

Page 9: ...uctions Warning symbol Structure DANGER The introduction describes the type and source of the dan ger This section describes the possible consequences of misuse The optional step contains necessary measures for avoiding hazards 2 Safety 9 78 ...

Page 10: ...he safety instructions cited herein with the three levels of danger will help avert property damage and injury CAUTION CAUTION indicates a hazardous situation that can lead to property damage or minor to moderate injury 2 Safety 10 78 ...

Page 11: ...RNING WARNING indicates a hazardous situation that can lead to serious injury or death DANGER DANGER indicates a maximum hazardous situation that can directly cause serious injury or death 2 Safety 11 78 ...

Page 12: ...NING Hazard to the care provider and patient Damage irregular noise during operation excessive vibration unusual build up of heat or if the cutter or grinder cannot be firmly held Stop work and seek service support 2 Safety 12 78 ...

Page 13: ... If the soft tissue in the oral cavity becomes damaged septic substance may enter the tissue from compressed air If soft tissue in the oral cavity becomes damages treatment with pneu matically operated instruments must stop 2 Safety 13 78 ...

Page 14: ...ure wear and malfunctioning from improper storage during long periods of nonuse Reduced production time The instrument must be cleaned serviced and stored dry if it has not been used for a long period 2 Safety 14 78 ...

Page 15: ...ting away instruments Injury and infection caused by chucked cutters or grinders Damage to the chucking system when the instrument fails After treatment place the cutter or grinder properly in the cradle with out the tool 2 Safety 15 78 ...

Page 16: ...CAUTION Burning 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 2 Safety 16 78 ...

Page 17: ...ating cutter grinder can cause injury For additional illumination of the oral cavity or preparation site use a suitable light probe such as the KaVo DIAlux 2300L Note For safety reasons we recommend that the tool holder system be checked annually after the warranty period expires 2 Safety 17 78 ...

Page 18: ...ed in the KaVo instructions for use and the care prod ucts 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 interval should take into account the frequency of use Service may only be provided by repair shops that have undergone training by K...

Page 19: ...3 Description of the device MASTERtorque Mini LUX M4500 L Mat no 1 007 1700 3 Description of the device 19 78 ...

Page 20: ...GENTLEmini LUX 4500 BR Mat no 1 007 1700 3 1 Intended use Purpose This medical device is 3 Description of the device 20 78 ...

Page 21: ...l of fillings processing of tooth and restoration surfaces A medical device according to relevant national statutory regulations Proper use According to these provisions this medical device may only be used for the described application by a knowledgeable user The following must be ob served the applicable health and safety regulations the applicable accident prevention regulations these instructi...

Page 22: ...e user is required to 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 3 Description of the device 22 78 ...

Page 23: ...60 bar psi Recommendation 2 8 40 bar psi Air consumption 49 to 55 Nl min Idle speed 380 000 to 450 000 rpm Recommended operating pressure 2 to 3 N Return air 0 5 bar 7 psi Can be placed on all MULTIflex LUX couplings 3 3 Transportation and storage conditions 3 Description of the device 23 78 ...

Page 24: ...tored refrigerated This can cause the medical device to malfunction The temperature of very cold products must be raised to a range of 20o C 68o F to 25o C 77o F Temperature 20 C to 50 C 4 F to 122 F Relative humidity Non condensing 3 Description of the device 24 78 ...

Page 25: ...Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture 3 Description of the device 25 78 ...

Page 26: ... and patient Before first use and after each use reprocess and sterilise the medical device properly WARNING Disposal of the product in the appropriate manner Prior to disposal the product and accessories must be appropriately pre pared or sterilised if this is necessary 4 Start up and shut down 26 78 ...

Page 27: ...d to premature bearing wear Always make sure that the supply of cooling air is dry clean and un contaminated according to ISO 7494 2 Note After each treatment KaVo recommends turning on the spray for at least 20 seconds with the instrument attached to rinse the air and water chan nels 4 Start up and shut down 27 78 ...

Page 28: ... is not properly locked in place it can release from the MULTIflex LUX coupling during treatment Pull on it before each treatment to ensure that the medical device is securely locked in the MULTIflex LUX coupling Screw the MULTIflex LUX coupling onto the turbine hose and tight en with the wrench 4 Start up and shut down 28 78 ...

Page 29: ... Rotate the spray ring on the MULTIflex LUX MULTIflex LED cou pling in order to regulate the fraction of water 4 Start up and shut down 29 78 ...

Page 30: ... 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 cm3 min 3 1 inch3 Check spray water channels and if necessary clean spray nozzles with the nozzle needle Mat no 0 410 0921 Check water filter and replace if necessary 4 Start up and shut down 30 78 ...

Page 31: ...3 Adjust the water amount for the spray cooling to a minimum of 50 cm3 min 3 1 inch3 4 Start up and shut down 31 78 ...

Page 32: ...Supply dry clean and uncontaminated compressed air according to ISO 7494 2 only Insert the test gauge Mat no 04118731 between the MULTIflex LUX Kupplung MULTIflex LED Kupplung couplings and the medi cal device and check the following pressures ð Drive air 2 1 to 3 5 bar 30 to 51 psi recommended 2 8 bar 41 psi 4 Start up and shut down 32 78 ...

Page 33: ...Missing or damaged O rings If the O rings are missing and damaged malfunctions and premature fail ure can occur Check if all O rings are on the coupling and undamaged Number of available O rings 5 4 Start up and shut down 33 78 ...

Page 34: ...h workday the water conducting systems should be rinsed for at least 2 min without the instruments being attached If there is a risk of contamination from reflux or back suction the systems should be rinsed for 20 30 seconds 5 Operation 34 78 ...

Page 35: ...ring treatment If the medical device is not properly locked in place it can release from the MULTIflex LUX coupling during treatment Pull on it before each treatment to ensure that the medical device is securely locked in the MULTIflex LUX coupling 5 Operation 35 78 ...

Page 36: ... reduce its life Check if the turbine seat on the coupling is secure by pulling on it Precisely mount the medical device on the MULTIflex LUX coupling and push it to the rear until the coupling audibly locks on the medical device Check if the seat of the medical device on the coupling is secure by pulling on it 5 Operation 36 78 ...

Page 37: ... 3 Inserting the cutter or grinder Note Only use carbide cutters or diamond grinders that comply with 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 19 mm Shaft clamping length at least 9 mm Blade diameter max 2 mm 5 Operation 37 78 ...

Page 38: ...uctions for use and use the cutter or grinder properly Only use cutters or grinders that do not deviate from the indicated da ta CAUTION Injury from using worn cutters or grinders Cutters or grinders can fall out during treatment and injure the patient Never use cutters or grinders with worn shafts 5 Operation 38 78 ...

Page 39: ...CAUTION Injury hazard from cutters or grinders Infections or cuts Wear gloves or fingerstalls 5 Operation 39 78 ...

Page 40: ...rips abrasives to check if the clamping sys tem is functioning properly and that the tool is firmly clamped Wear gloves or a thimble to check insert or remove the bits to prevent injury and infection Forcefully press the push button with your thumb and simultaneously insert the cutter or grinder all the way 5 Operation 40 78 ...

Page 41: ...he pushbutton when the cutter or 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 grinder from the contra angle handpiece since injury and infection may result from putting it away when the cutter or grinder are inserted 5 Operation 41 78 ...

Page 42: ... cutters or grinders Lacerations Avoid inadvertently touching rotating cutters or grinders After the cutter or grinder has stopped rotating press the push button with your thumb and pull out the cutter or grinder 5 Operation 42 78 ...

Page 43: ...n the coupling of the supply hose CAUTION Hazard from improper care of O rings The medical device can malfunction and completely fail if the O rings do not receive proper care Do not use Vaseline or any other grease or oil 6 Troubleshooting 43 78 ...

Page 44: ...coupling may only be lubricated with cotton ball wet with KAVOspray Press the O ring between your fingers to form a loop Shove the O ring to the front and remove it Insert new O rings into the grooves 6 Troubleshooting 44 78 ...

Page 45: ...device and damage to the tooth Check the spray water channels and clean the spray nozzles with the nozzle needle Mat no 0 410 0921 if necessary Check the water filter and exchange if necessary Use the nozzle needle Mat no 0 410 0921 to free the water passage in the spray nozzles 6 Troubleshooting 45 78 ...

Page 46: ...nger to the care provider and patient Reprocess and sterilise the medical device properly before the next use 6 3 Change the water filter Unscrew the sleeve anticlockwise from the insert and pull off Pull back the insert slightly 6 Troubleshooting 46 78 ...

Page 47: ... Use tweezers to remove the water filter from the insert Insert a new water filter Pull back the insert slightly Place the sleeve on the insert and screw it tight clockwise 6 Troubleshooting 47 78 ...

Page 48: ...WARNING Hazard from nonsterile products Infection danger to the care provider and patient Reprocess and sterilise the medical device properly before the next use 6 Troubleshooting 48 78 ...

Page 49: ... infection hazard exists from contaminated medical 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 in a solution or the like 7 Preparation methods according to ISO 17664 49 78 ...

Page 50: ...as possible Remove the hard metal cutter or diamond bur from the medical de vice 7 2 Cleaning CAUTION Malfunctions from cleaning in the ultrasonic unit Defects in the product Only clean in a thermodisinfector or manually 7 Preparation methods according to ISO 17664 50 78 ...

Page 51: ...ries Tap water 30o C 5 o C 86o F 41o 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 alcohol solution 7 Preparation methods according to ISO 17664 51 78 ...

Page 52: ...er mielclear and only applies to the compatibility of materials 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 complying with max pH value of 10 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 comple...

Page 53: ...ion was carried out with pro gramme VARIO TD cleaning agent neodisher mediclean neutralisa tion agent neodisher Z and rinsing agent neodisher mielclear and only applies to the compatibility of materials 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 complying with max pH value of 10 7 Prepa...

Page 54: ...fter completion of the cycle and then grease it immediately with servicing agents from the KaVo care system 7 3 Disinfection CAUTION Malfunctioning from using a disinfectant bath or chlorine containing disinfectant Defects in the product Only disinfect in a thermodisinfector or manually 7 Preparation methods according to ISO 17664 54 78 ...

Page 55: ...isinfectant manufac turer CaviCide by Metrex Required tools Cloths for wiping down the medical device Spray the disinfectant on a cloth then thoroughly wipe down the medical device and leave the disinfectant to soak in according to the instructions from the disinfectant manufacturer disinfectant manufacturer 7 Preparation methods according to ISO 17664 55 78 ...

Page 56: ...hermodisinfectors in accordance with ISO 15883 1 which are operated with alkaline cleaning agents with a pH value of max 10 e g Miele G 7781 G 7881 Validation was carried out with pro gramme VARIO TD cleaning agent neodisher mediclean neutralisa tion agent neodisher Z and rinsing agent neodisher mielclear and only applies to the compatibility of materials with KaVo products 7 Preparation methods a...

Page 57: ...vent 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 4 Drying Manual drying Blow off the outside and inside with compressed air until no water drops are visible 7 Preparation methods according to ISO 17664 57 78 ...

Page 58: ...ector 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 and or pointed cutters or grinders Remove cutter or grinder 7 Preparation methods according to ISO 17664 58 78 ...

Page 59: ... production time Regularly perform proper care Note KaVo only guarantees that its products will function properly when the care products are used that are listed as accessories since they were test ed for proper use on our products 7 Preparation methods according to ISO 17664 59 78 ...

Page 60: ...evening after hours after each time the machine is cleaned and before each sterilization Remove the cutter or grinder and close the chuck Cover the product with the Cleanpac bag Place the product on the cannula and press the spray button for one second 7 Preparation methods according to ISO 17664 60 78 ...

Page 61: ...ining the chucking system once a week Remove the cutter or grinder place the spray nipple tip in the open ing and spray Carry out the servicing according to the instructions in the section Care with KaVo Spray 7 Preparation methods according to ISO 17664 61 78 ...

Page 62: ...ngs May reduce the service life of the product Cleaning and care unit with expansion pressure for thorough cleaning and care KaVo recommends servicing the product after each time it is used i e af ter each automatic cleaning and before each sterilisation 7 Preparation methods according to ISO 17664 62 78 ...

Page 63: ...and maintaining the chucking system once a week See also 2 Instructions for use KaVo QUATTROcare 2104 2104A Remove the cutter or grinder place the spray nipple tip in the open ing and spray Subsequently treat with the care products and systems listed below 7 Preparation methods according to ISO 17664 63 78 ...

Page 64: ...e Defective or missing O rings on the service couplings May reduce the service life of the product KaVo recommends servicing the product after each time it is used i e af ter each automatic cleaning and before each sterilisation Remove the cutter or grinder 7 Preparation methods according to ISO 17664 64 78 ...

Page 65: ...ructions for Use KaVo QUATTROcare PLUS 2124 A Servicing the clamping chuck KaVo recommends cleaning and maintaining the chucking system once a week See also 2 Instructions for Use KaVo QUATTROcare PLUS 2124 A 7 Preparation methods according to ISO 17664 65 78 ...

Page 66: ...coupling chuck from the side hatch of the QUAT TROcare PLUS and attach it to coupling service point four on the far right A MULTIflex adaptor must be mounted there Press the handpiece together with the guide bush of the chuck to be serviced against the tip of the service coupling 7 Preparation methods according to ISO 17664 66 78 ...

Page 67: ...andpieces in the QUATTROcare PLUS 2124 A close the front door and start theservice procedure Option 2 After three minutes with no service procedure running the de vice automatically switches back to normal service mode See also 2 Servicing with KaVo QUATTROcare PLUS 7 Preparation methods according to ISO 17664 67 78 ...

Page 68: ...that the bag is not stretched The quality and use of the sterilized product packaging must satisfy appli cable standards and be suitable for the sterilization procedure Weld each medical device individually in a sterilised item package 7 Preparation methods according to ISO 17664 68 78 ...

Page 69: ...ve in accordance with ISO 17665 1 CAUTION Premature weary and malfunctions from improper servicing and care Reduced production time Before each sterilization cycle treat the medical device with KaVo care products 7 Preparation methods according to ISO 17664 69 78 ...

Page 70: ...eam sterilizer The KaVo medical device has a maximum temperature resistance up to 138 280 4 F Select a suitable procedure depending on the available autoclave from the following sterilisation processes Autoclave with pre vacuum at least 3 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F 7 Preparation methods according to ISO 17664 70 78 ...

Page 71: ...F Drying time 30 min Use according to the manufacturer s Instructions for Use 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 7 Preparation methods according to ISO 17664 71 78 ...

Page 72: ...bine with key 1 006 5535 Replacement turbine without key 1 006 4564 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 MULTIflex spray head nozzle 0 411 9921 QUATTROcare coupling 0 411 7991 8 Tools 72 78 ...

Page 73: ...Only for the USA Material summary Mat no KAVOspray America 2113 A 0 411 9660 QUATTROcare plus Spray America 2141 P 1 005 4524 8 Tools 73 78 ...

Page 74: ...ims of any nature whatsoever in particular with respect to compensation are excluded In the event of default gross negli gence or intent this shall only apply in the absence of mandatory legal reg ulations to the contrary KaVo cannot be held liable for defects and their consequences that are or may be due to natural wear improper handling cleaning or maintenance non compliance with operating or co...

Page 75: ...med when defects or their consequences are derived from manipulations 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 The dealer purchase date unit number or type and serial number must be clearly visible on this document 9 Warranty te...

Page 76: ...9 Warranty terms and conditions 76 78 ...

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