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6.6 Packaging

Note
The sterilisation bag must be large enough for the handpiece so that the

bag is not stretched.

The quality and use of the sterilisation packaging must satisfy applicable

standards and be suitable for the sterilisation procedure!

▶

Individually seal the medical device in the sterilised item packaging.

Preparation methods according to ISO 17664

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Содержание 1.001.5660

Страница 1: ...Instructions for use GENTLEpower LUX handpiece 10 LP 1 001 5660 ...

Страница 2: ...Distributed by KaVo Dental GmbH Bismarckring 39 D 88400 Biberach Phone 49 7351 56 0 Fax 49 7351 56 1488 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com ...

Страница 3: ...ns 7 2 2 Safety instructions 9 3 Product description 13 3 1 Purpose Intended use 14 3 2 Technical Specifications 16 3 3 Transportation and storage conditions 17 4 Start up and shut down 19 4 1 Check the amount of water 20 5 Operation 23 5 1 Attach the medical device 23 Table of contents 1 ...

Страница 4: ...Preparation methods according to ISO 17664 32 6 1 Preparations at the site of use 32 6 2 Cleaning 33 6 2 1 Cleaning Manual cleaning external 33 6 2 2 Cleaning Automated external cleaning 34 6 2 3 Cleaning Manual cleaning internal 35 6 2 4 Cleaning Automated internal cleaning 36 6 3 Disinfection 38 6 3 1 Disinfection Manual disinfection external 39 6 3 2 Disinfection Manual disinfection internal 40...

Страница 5: ...roducts and systems Servicing Care with the KaVo SPRAYrotor 47 6 5 3 Care products and systems Servicing Servicing with KaVo QUATTROcare 2104 2104A 48 6 5 4 Care products and systems Servicing Servicing with KaVo QUATTROcare PLUS 2124 A 51 6 5 5 Care products and systems Servicing Servicing with KaVo QUATTROcare CLEAN 2140 A 54 6 6 Packaging 56 6 7 Sterilisation 57 6 8 Storage 59 Table of contents...

Страница 6: ...7 Tools and consumables 61 8 Warranty terms and conditions 63 Table of contents 4 ...

Страница 7: ... 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 Important information for users and service technicians User instructions 5 ...

Страница 8: ... mark European Community A product bearing 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 User instructions 6 ...

Страница 9: ...uctions Warning symbol Structure DANGER The introduction describes the type and source of the hazard This section describes potential consequences of non compliance The optional step includes necessary measures for hazard preven tion Safety 7 ...

Страница 10: ... 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 lead to serious or fatal injury Safety 8 ...

Страница 11: ...ause death or fatal 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 Do not use further and notify Service Safety 9 ...

Страница 12: ...he instrument After treatment place the instrument properly in the cradle without the cutter or grinder CAUTION Hazard from use as a light probe Do not use the device as a light probe since the rotating cutters or grind ers can cause injury Use an appropriate light probe for additional illumination of the oral cavity or site of preparation Safety 10 ...

Страница 13: ...nonuse Reduced product life The medical device should be cleaned serviced and stored in a dry location according to instructions before long periods of non use Note For safety reasons we recommend that the tool holder system be checked annually after the warranty period expires Safety 11 ...

Страница 14: ... described in the KaVo Instructions for Use 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 Service may only be carried out by KaVo train...

Страница 15: ...3 Product description GENTLEpower LUX Handpiece 10 LP Mat no 1 001 5660 Product description 13 ...

Страница 16: ...duct is impermissible and can be hazardous The med ical device is intended for the following uses Removal of carious ma terial cavity preparation removal of fillings processing of surfaces and polishing and smoothing tooth and restoration surfaces A medical device according to relevant national statutory regulations Product description 14 ...

Страница 17: ...h and safety regulations the applicable accident prevention regulations these instructions for use According 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 description 15 ...

Страница 18: ... Drive speed max 40 000 rpm identification 1 blue ring Transmission 1 1 Maximum speed max 40 000 rpm Handpiece cutters or grinders can be used Short handpiece cutters or grinders can be used after conversion Product description 16 ...

Страница 19: ...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 Temperature 20 C to 70 C 4 F to 158 F Relative humidity 5 RH to 95 RH absence of condensation Product description 17 ...

Страница 20: ...Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 18 ...

Страница 21: ...re 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 Prior to disposal the product must be appropriately prepared or steri lised if this is necessary Start up and shut down 19 ...

Страница 22: ...he amount of water CAUTION Overheating of the tooth due to lack of cooling water Thermal damage to the dental pulp Adjust the water amount for the spray cooling to a minimum of 50 cm3 min Start up and shut down 20 ...

Страница 23: ...3 Start up and shut down 21 ...

Страница 24: ...pray water Insufficient spray water can cause the medical device to overheat and damage the tooth Check the spray water channels and clean the spray nozzles with the nozzle needle Mat no 0 410 0921 if necessary Start up and shut down 22 ...

Страница 25: ... medical device during treatment A medical device that is not properly locked in place can release from the motor coupling and fall off Carefully pull on it before each treatment to ensure that the medical device is securely locked on the motor coupling Operation 23 ...

Страница 26: ...piece blocked Only start the handpiece when the chuck is closed CAUTION Removing and attaching the handpiece while the drive motor is rotating Damage to the catch Never attach or remove the handpiece while the device is rotating Operation 24 ...

Страница 27: ... latch audibly snaps into place Pull on the medical device to make sure that it is securely affixed to the coupling 5 2 Remove the medical device Unlock the medical device from the motor coupling by twisting it slightly and then pulling it along its axis Operation 25 ...

Страница 28: ...spond to ISO 1797 1 type 1 and type 2 are made of steel or hard metal and meet the following criteria Shaft diameter 2 334 to 2 35 mm with a drill bit stop Shaft clamping length min 12 mm Shaft clamping length max 22 mm without a drill bit stop Shaft clamping length min 30 mm Shaft clamping length max 44 5 mm Operation 26 ...

Страница 29: ...instructions for use and use the cutter or grinder prop erly Only use cutters or grinders that do not deviate from the specified data CAUTION Injury 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 Operation 27 ...

Страница 30: ...rom 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 When checking in serting and removing use gloves or a fingerstall to prevent an in jury or infection Operation 28 ...

Страница 31: ... all the way in the direction of the arrow and insert the handpiece cutter or grinder into the chuck Turn the clamping ring back into its initial position Check that the cutter or grinder is seated by pulling on it Operation 29 ...

Страница 32: ... not touch the cutter or grinder when it is rotating Remove the cutter grinder from the contra angle handpiece after treatment to avoid injury and infection when putting it away After the cutter or grinder has stopped rotating turn the clamping ring in the direction of the arrow to the stop Turn the clamping ring back into its initial position Operation 30 ...

Страница 33: ...nverted to use contra angle handpiece drill bits Open the handpiece chuck Insert the enclosed drill stop in the chuck Press the contra angle drill bit onto the stop close the clamping ring and check for firm seating To remove the drill bit stop use the accompanying hook Operation 31 ...

Страница 34: ...ices Take suitable personal protective measures Remove all residual cement composite or blood without delay Recondition the medical device as soon as possible after treatment Remove the cutter or grinder from the medical device The medical device must be dry when transported for reconditioning Do not place it in a solution or similar Preparation methods according to ISO 17664 32 ...

Страница 35: ... Defects in the product Clean manually or in a thermodisinfector only 6 2 1 Cleaning Manual cleaning external Accessories required Tap water 30 C 5 C 86 F 10 F Brush e g medium hard toothbrush Brush off under flowing tap water Preparation methods according to ISO 17664 33 ...

Страница 36: ... agent neodisher mediclean neutralisation agent neodisher Z and rinsing agent neodisher miel clear and only applies to the material compatibility with KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfec tor Directly after automated cleaning disinfection treat the medical de vice with the care products a...

Страница 37: ...e 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 spray attachment and let the cleaner work for one minute Afterwards rinse for 3 5 seconds with KaVo DRYspray See also KaVo CLEANspray KaVo DRYspray Instructions for Use Preparation methods according to ISO 17664 35 ...

Страница 38: ...y be carried out with thermodi sinfectors in accordance with EN ISO 15883 1 6 2 4 Cleaning Automated internal cleaning For the alternative i e internal cleaning in thermodisinfectors KaVo rec ommends devices in accordance with EN ISO 15883 1 which are operat ed with alkaline cleaning agents with a pH value of max 10 e g Miele G 7781 G 7881 validation was performed using the VARIO TD pro gramme neo...

Страница 39: ...ed 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 completion of the cycle and then grease it immediately with servicing agents from the KaVo care system Preparation methods according to ISO 17664 37 ...

Страница 40: ...ctioning from using a disinfectant bath or disinfectant containing chlorine Defects in the product Disinfect in a thermodisinfector or without packaging in an auto clave or manually only Preparation methods according to ISO 17664 38 ...

Страница 41: ... The microbiological efficacy must be ensured and demonstra ted by means of an expert report by the disinfectant manufacturer Mikrozid AF made by Schülke Mayr liquid or cloths FD 322 made by Dürr CaviCide made by Metrex Consumables required Cloths for wiping off the medical device Preparation methods according to ISO 17664 39 ...

Страница 42: ...tion 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 Immediately after internal disinfection lubricate the KaVo medical device immediately with care agents from the KaVo care...

Страница 43: ...n can be carried out using thermodisinfectors in accordance with EN 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 using the VARIO TD programme neodisher mediclean cleaning agent neodisher Z neutralisation agent and neodisher mielclear rinsing agent and applies only to the compatibility of materials with KaV...

Страница 44: ...ent 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 6 4 Drying Manual Drying Blow off the outside and inside with compressed air until water drops are no longer visible Preparation methods according to ISO 17664 42 ...

Страница 45: ...odisinfector Follow the instructions for use of the thermodisinfector 6 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 Remove cutter or grinder Preparation methods according to ISO 17664 43 ...

Страница 46: ...Reduced product life Perform proper care regularly Note KaVo only guarantees that its products will function properly when the care products used are those listed as accessories as they were tested for proper use on our products Preparation methods according to ISO 17664 44 ...

Страница 47: ... as part of the reprocessing after each use i e after each cleaning disinfection and before each sterilisa tion Remove the cutter or grinder Cover the product with the Cleanpac bag Plug the product onto the cannula and press the spray button for one second Preparation methods according to ISO 17664 45 ...

Страница 48: ...nd servicing the chuck 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 Preparation methods according to ISO 17664 46 ...

Страница 49: ... of the reprocessing after each use i e after each cleaning disinfection and before each sterilisa tion Place the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a Cleanpac bag Servicing the product See also Instructions for use KaVo SPRAYrotor Preparation methods according to ISO 17664 47 ...

Страница 50: ...vailable for delivery Successor products QUATTROcare PLUS 2124 A QUATTROcare CLEAN 2140 A Cleaning and servicing device with expansion pressure for internal clean ing of inorganic residues and optimum care not a validated internal cleaning in accordance with German RKI require ments Preparation methods according to ISO 17664 48 ...

Страница 51: ...ach sterilisa tion Remove the cutter or grinder Servicing the product See also Instructions for use KaVo QUATTROcare 2104 2104A Servicing of the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week See also Instructions for use KaVo QUATTROcare 2104 2104A Preparation methods according to ISO 17664 49 ...

Страница 52: ...inder place the spray nipple tip in the open ing and spray Subsequently treat with the care products and care systems speci fied See also Servicing with KaVo QUATTROcare 2104 2104A Preparation methods according to ISO 17664 50 ...

Страница 53: ... not a validated internal cleaning in accordance with German RKI require ments KaVo recommends servicing the product as part of the reprocessing after each use i e after each cleaning disinfection and before each sterilisa tion Remove the cutter or grinder Servicing the product in QUATTROcare PLUS See also Instructions for Use KaVo QUATTROcare PLUS 2124 A Preparation methods according to ISO 17664...

Страница 54: ...ns for Use KaVo QUATTROcare PLUS 2124 A Note Handpieces must be taken off the service couplings before the chuck service can be started and performed Remove the service coupling chuck from the side hatch of the QUATTROcare PLUS and attach it to coupling service point four on the far right A MULTIflex adapter must be mounted there Preparation methods according to ISO 17664 52 ...

Страница 55: ...e handpiece together with the guide bush of the chuck to be serviced against the tip of the service coupling chuck Press the button showing the chuck service symbol Preparation methods according to ISO 17664 53 ...

Страница 56: ...ee minutes with no service procedure running the de vice automatically switches back to normal service mode See also Care with KaVo QUATTROcare PLUS 6 5 5 Care products and systems Servicing Servicing with KaVo QUATTROcare CLEAN 2140 A Programme controlled cleaning and servicing device for perfect instru ment and turbine care Preparation methods according to ISO 17664 54 ...

Страница 57: ... grinder Service the product in QUATTROcare PLUS See also Instructions for use KaVo QUATTROcare CLEAN 2140 A Servicing the clamping chuck KaVo recommends cleaning and servicing the chuck system once a week using the collet servicing program integrated in the device See also Instructions for use KaVo QUATTROcare CLEAN 2140 A Preparation methods according to ISO 17664 55 ...

Страница 58: ...so that the bag is not stretched The quality and use of the sterilisation packaging must satisfy applicable standards and be suitable for the sterilisation procedure Individually seal the medical device in the sterilised item packaging Preparation methods according to ISO 17664 56 ...

Страница 59: ... in accordance with EN 13060 ISO 17665 1 CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Before each sterilisation cycle service the medical device with Ka Vo care products Preparation methods according to ISO 17664 57 ...

Страница 60: ...isture 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 Preparation methods according to ISO 17664 58 ...

Страница 61: ...6 F 7 4 F Autoclave using the gravitation method at least 10 minutes at 134 C 1 C 4 C 273 F 1 6 F 7 4 F or alternatively at least 60 minutes at 121 C 1 C 4 C 250 F 1 6 F 7 4 F Use according to the manufacturer s Instructions for Use 6 8 Storage Prepared products must be stored protected from germs as far as pos sible and dust in a dry dark cool room Preparation methods according to ISO 17664 59 ...

Страница 62: ...Note Comply with the expiry date of the sterilised items Preparation methods according to ISO 17664 60 ...

Страница 63: ...pliers Material summary Mat no Instrument stand 2151 0 411 9501 Cleanpac 10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 Nozzle needle 0 410 0921 Spray hose sterilisable 0 065 5188 Drill stop 0 524 0892 Hook 0 410 1963 Tools and consumables 61 ...

Страница 64: ...NTRAmatic CLEANspray and DRYspray 1 007 1776 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 Tools and consumables 62 ...

Страница 65: ...er claims of any nature whatsoever in particu lar with respect to compensation are excluded In the event of default gross negligence or intent this shall only apply in the absence of manda tory legal regulations to the contrary KaVo cannot be held liable for defects and their consequences that have arisen or may arise from to natural wear improper handling cleaning or maintenance non compliance wi...

Страница 66: ...ences that can be attributed to interventions on or changes made to the product by the customer or a third party not au thorised by KaVo are excluded from the warranty 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...

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