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KaVo INTRAmatic 10 ES, Instructions For Use Manual, Page: 13 / 56

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KaVo INTRAmatic 10 ES Instructions For Use Manual Download Page 13

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

According to these regulations, the user is required to:

▪ Only use equipment that is operating correctly

▪ use the equipment for the proper purpose

▪ to protect himself, the patient and third parties from danger.

▪ to avoid contamination from the product

Safety

11

Summary of Contents for INTRAmatic 10 ES

Page 1: ...Instructions for use INTRAmatic handpiece 10 ES REF 1 003 1111 ...

Page 2: ...Distributed by 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: ...nditions 6 2 Safety 8 2 1 Description of safety instructions 8 2 2 Purpose Intended use 10 2 3 Safety instructions 12 3 Product description 15 3 1 Technical Specification 15 3 2 Transportation and storage conditions 17 4 First use 19 4 1 Check the amount of water 19 Table of contents 1 ...

Page 4: ...drill bit 29 5 5 Conversion for contra angle handpiece drill bit 30 6 Preparation methods according to ISO 17664 31 6 1 Preparations at the site of use 31 6 2 Cleaning 32 6 2 1 Cleaning Manual cleaning external 32 6 2 2 Cleaning Automated external cleaning 33 6 2 3 Cleaning Manual cleaning internal 34 6 2 4 Cleaning Automated internal cleaning 36 6 3 Disinfection 37 Table of contents 2 ...

Page 5: ...rnal 40 6 4 Drying 41 6 5 Care products and systems Servicing 42 6 5 1 Care products and systems Servicing Care with KaVo Spray 43 6 5 2 Care products and systems Servicing Care with the KaVo SPRAYrotor 44 6 5 3 Care products and systems Servicing Care with KaVo QUATTROcare 45 6 6 Packaging 46 6 7 Sterilisation 47 6 8 Storage 49 7 Tools 51 Table of contents 3 ...

Page 6: ...sing this KaVo quality product Following the in structions below will allow you to work smoothly economically and safely Copyright by KaVo Dental GmbH Symbols Refer to chapter Safety Warning Important information for users and technicians User instructions 4 ...

Page 7: ...munauté 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 User instructions 5 ...

Page 8: ...pair Other claims of any 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 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 complia...

Page 9: ...consequences that can be attributed to interventions on or changes made to the product by the customer or a third party not authorised 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 c...

Page 10: ...ructions Warning symbol Structure DANGER The introduction describes the type and source of the danger This section portrays the possible consequences of non observance The optional step covers necessary measures for avoiding hazards Safety 8 ...

Page 11: ...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 or moderate physical harm WARNING WARNING indicates a hazardous situation that can cause death or serious injury Safety 9 ...

Page 12: ...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 uses Removal of carious material cavity preparation removal of fillings processing of surfaces and pol ishing and smoothing tooth and restoration surfaces A medical device according to relevant national statutory regulations Safety 10 ...

Page 13: ...cable health and safety regulations the applicable accident prevention regulations these instructions for use According to these regulations the user is required to Only use equipment that is operating correctly use the equipment for the proper purpose to protect himself the patient and third parties from danger to avoid contamination from the product Safety 11 ...

Page 14: ... CAUTION Premature 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 Safety 12 ...

Page 15: ...e cutter or grinder cannot be firmly held Stop work and seek service support CAUTION Hazard from improperly putting 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 Safety 13 ...

Page 16: ...ust be set up according to the methods described 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 in terval should take into account the frequency of use Service may only be provided by...

Page 17: ...3 Product description INTRAmatic handpiece 10 ES Mat no 1 003 1111 3 1 Technical Specification Drive speed identification 1 blue ring Product description 15 ...

Page 18: ...utters or grinders can be used Short handpiece cutters or grinders can be used after conversion The handpiece can be mounted on all INTRAmatic Lux motors and motors with a connection in accordance with ISO 3964 DIN 13940 Product description 16 ...

Page 19: ...al device after it has been stored re frigerated This can cause the medical device to malfunction Prior to start up very cold products must be heated to a temperature of 20 C to 25 C 68 F to 77 F Temperature 20 C to 50 C 4 F to 122 F Relative humidity non condensing Product description 17 ...

Page 20: ...Air pressure 700 hPa to 1 060 hPa 10 psi to 15 psi Protect from moisture Product description 18 ...

Page 21: ...provider and patient Before first use and after each use sterilise the medical device 4 1 Check the amount of water CAUTION Overheating of the tooth due to lack of cooling water Thermal damage to the pulp Adjust the water amount for the spray head to a min of 50 cm3 min First use 19 ...

Page 22: ...ient spray 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 First use 20 ...

Page 23: ... the drive motor Handpiece 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 21 ...

Page 24: ...ce 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 22 ...

Page 25: ... Place the medical device on the motor coupling and lock it into place Pull on it to make sure that the medical device is securely affixed to the coupling Operation 23 ...

Page 26: ...5 2 Remove the medical device Unlock the medical device from the LUX motor coupling and remove it by twisting it slightly on its axis Operation 24 ...

Page 27: ...s that correspond to DIN EN 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 bit stop Shaft clamping length 12 mm Shaft clamping length max 22 mm without bit stop Shaft clamping length min 30 mm Shaft clamping length max 44 5 mm Operation 25 ...

Page 28: ...instructions for use and use the cutter or grinder prop erly Only use cutters or grinders that do not deviate from the indicated data 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 Operation 26 ...

Page 29: ...zard from defective chucking system The cutter or grinder can fall out and cause injury Pull on the cutter or grinder to check if the chucking system is okay and the cutter or grinder is securely held Wear gloves or a thimble to check insert or remove the bits to prevent injury and infection Operation 27 ...

Page 30: ... all the way in the direction of the arrow and insert the handpiece cutter or grinder into the chuck Hold the grip sleeve and turn the sleeve into the initial position Check that the cutter or grinder is seated by pulling on it Operation 28 ...

Page 31: ...s rotating Do not touch soft tissue with the head tip that can heat and burn the soft tissue 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 grip sleeve in the direction of the arrow to the stop Turn the grip sleeve into the initial position Operation 29 ...

Page 32: ...ntra angle handpiece drill bits Open the handpiece chuck Insert the accompanying drill bit stop into the chuck Press the contra angle handpiece drill bit against the stop close the clamping ring and make sure that the bit is firmly seated Use the accompanying hook to remove the bit stop Operation 30 ...

Page 33: ...d medical devices Observe suitable personal protective measures Remove residual cement composite or blood at the site of use Dry the medical device to prepare it for transportation Do not place it in a solution etc Prepare the medical device directly after treatment Remove the cutter or grinder from the medical device Preparation methods according to ISO 17664 31 ...

Page 34: ...efects in the product Only clean in a thermodisinfector or manually 6 2 1 Cleaning Manual cleaning external 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 Preparation methods according to ISO 17664 32 ...

Page 35: ...tap water or clean with a 60 70 alcohol solution 6 2 2 Cleaning Automated external cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883 1 e g Miele G 7781 G 7881 Preparation methods according to ISO 17664 33 ...

Page 36: ...roducts The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Directly after automated cleaning treat the medical device with the care products and systems provided by KaVo 6 2 3 Cleaning Manual cleaning internal For a medical device with KaVo CLEANspray and KaVo DRYspray Preparation methods according to ISO 17664 3...

Page 37: ...aVo DRYspray See also Instructions for use for the KaVo CLEANspray KaVo DRYspray Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the following countries Germany Austria Switzerland Italy Spain Portugal France Luxem bourg Belgium Netherlands United Kingdom Denmark Sweden Fin land and Norway In other countries only automated interior cleaning with thermodisi...

Page 38: ... the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the material compatibility with KaVo products The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Directly after automated cleaning treat the medical device with the care products and systems provided by KaVo Preparation methods accordin...

Page 39: ...tion CAUTION Malfunctioning from using a disinfectant bath or chlorine containing dis infectant Defects in the product Only disinfect in a thermodisinfector or manually Preparation methods according to ISO 17664 37 ...

Page 40: ...ds 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 FD 322 by Dürr CaviCide by Metrex Preparation methods according to ISO 17664 38 ...

Page 41: ...tions from the disinfectant manufacturer Note Observe the instruction for use for the disinfectant 6 3 2 Disinfection Manual disinfection internal To effectively set up the inside of the machine must be cleaned automat ically in a cleaning and disinfection unit in accordance with ISO 15883 1 The inside of this product should not be disinfected manually Preparation methods according to ISO 17664 39...

Page 42: ...ediclean the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the material compatibility with KaVo products The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Directly after automated disinfection treat the medical device with the care products and systems provided by KaVo Preparation meth...

Page 43: ...mpressed 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 observe the instructions for use of the thermodisinfector Preparation methods according to ISO 17664 41 ...

Page 44: ...he medical device Injury hazard from sharp and or pointed cutters or grinders Remove the cutter or grinder CAUTION Premature weary and malfunctions from improper servicing and care Reduced production time Regularly perform proper care Preparation methods according to ISO 17664 42 ...

Page 45: ...oper use on our products 6 5 1 Care products and systems Servicing Care with KaVo 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 Remove the cutter or grinder Cover the product with the Cleanpac bag Preparation methods according to ISO 17664 43 ...

Page 46: ...ends 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 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 44 ...

Page 47: ...ansion pressure for effective 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 Remove the cutter or grinder Servicing the product Preparation methods according to ISO 17664 45 ...

Page 48: ...stretched The quality and use of the sterilisation packaging must satisfy applicable standards and be suitable for the sterilisation procedure Individually weld the medical device in the sterilised item packaging such as KaVo STERIclave bags Mat no 0 411 9912 Preparation methods according to ISO 17664 46 ...

Page 49: ...toclave EN 13060 ISO 17665 1 CAUTION Premature weary and malfunctions from improper servicing and care Reduced production time Before each sterilisation cycle treat the medical device with KaVo care products Preparation methods according to ISO 17664 47 ...

Page 50: ... remove the product from the steam steriliser after the sterilisation cycle The medical device is temperature resistant up to 138 280 4 F KaVo recommends for example STERIclave B 2200 2200P by KaVo Citomat K series by Getinge Preparation methods according to ISO 17664 48 ...

Page 51: ...F Autoclave using the gravitational method sterilise for at least 10 min at 134 C 1 C 273 F 1 8 F Autoclave using the gravitational for at least 60 min at 121 C 1 C 250 F 1 8 F Follow the manufacturer s instructions for use 6 8 Storage Prepared products must be stored protected germ free from dust in a dry dark and cool room Preparation methods according to ISO 17664 49 ...

Page 52: ...Note Observe the expiration date of the sterilized item Preparation methods according to ISO 17664 50 ...

Page 53: ...mary 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 Sterilisable spray hose 0 065 5188 Drill stop 0 524 0892 Hook 0 410 1963 KaVo CLEANspray 1 007 0579 KaVo DRYspray 1 007 0580 Tools 51 ...

Page 54: ...Material summary Mat no KaVo Spray 2112 A 0 411 9640 ROTAspray 2142 A 0 411 7520 QUATTROcare plus Spray 2108 P 1 005 4525 Tools 52 ...

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Page 56: ...1 003 7289 kb 20090922 02 en ...

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