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KaVo 1.003.7708, Instructions For Use Manual

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KaVo 1.003.7708 Instructions For Use Manual Download Page 18

3.1   Purpose – Proper use

Purpose:

This medical device is

▪ 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 uses: Cavity preparation and caries

excavation.

▪ A medical device according to relevant national statutory regulations.

 

 

 

Product description

16

Summary of Contents for 1.003.7708

Page 1: ...Instructions for use INTRAcompact contra angle 2068 CHC REF 1 003 7708 ...

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: ...tructions Warning symbol 7 2 1 2 Description of safety instructions Structure 7 2 1 3 Description of safety instructions Description of danger levels 8 2 2 Safety instructions 9 3 Product description 15 3 1 Purpose Proper use 16 3 2 Technical Specifications 18 3 3 Transportation and storage conditions 19 Table of contents 1 ...

Page 4: ...d grinders 25 5 4 Removing the milling tool or diamond grinder 29 6 Troubleshooting 31 6 1 Check for malfunctions 31 6 2 Troubleshooting 32 6 2 1 Troubleshooting Exchanging the O rings on the motor coupling 32 6 2 2 Troubleshooting Cleaning the spray nozzle 34 7 Setup methods according to DIN EN ISO 17664 35 7 1 Preparation at the site of use 35 Table of contents 2 ...

Page 5: ...nual disinfection external 42 7 3 2 Disinfection Manual disinfection internal 43 7 3 3 Disinfection Machine disinfection external and internal 44 7 4 Drying 45 7 5 Care products and systems Servicing 46 7 5 1 Care products and systems Servicing Care with KaVo Spray 47 7 5 2 Care products and systems Servicing Care with KaVo SPRAYrotor 49 7 5 3 Care products and systems Servicing Servicing with KaV...

Page 6: ...7 6 Packaging 52 7 7 Sterilisation 53 7 8 Storage 55 8 Tools 57 9 Terms and conditions of warranty 58 Table of contents 4 ...

Page 7: ...KaVo 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 Safety Warning symbol chapter Important information for users and service technicians User instructions 5 ...

Page 8: ... requirements of the applicable EC directive Can be steam sterilised at 134 C 1 C 4 C 273 F 1 6 F 7 4 F Thermodisinfectable 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 ...

Page 9: ...g symbol 2 1 2 Description of safety instructions Structure DANGER The 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 Safety 7 ...

Page 10: ...ted here together with 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 cause death or serious injury Safety 8 ...

Page 11: ...th or serious 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 ...

Page 12: ...ice should be cleaned serviced and stored in a dry location according to instructions before long periods of nonuse CAUTION Risk of burn injury from hot handpiece head or hot handpiece lid Burn injuries in the mouth may be caused if the instrument overheats Never touch soft tissue with the handpiece head or handpiece lid Safety 10 ...

Page 13: ... 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 without the cutter or grinder Safety 11 ...

Page 14: ...e dental treatment unit connected must have control equipment for changing the speed and direction of rotation A note is to be included in the documents accompanying the dental treatment unit referring to responsibilities arising from safety relia bility and performance The medical device may only be combined with a treatment unit re leased by KaVo Safety 12 ...

Page 15: ...ined by KaVo To ensure proper function the medical device must be set up according to the reprocessing methods 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 de...

Page 16: ...Service may only be carried out by KaVo trained repair shops using original KaVo replacement parts Safety 14 ...

Page 17: ...3 Product description INTRAcompact contra angle handpiece 2068 CHC Mat no 1 003 7708 Product description 15 ...

Page 18: ...atment 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 Cavity preparation and caries excavation A medical device according to relevant national statutory regulations Product description 16 ...

Page 19: ...le 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 protect him or herself the patient and third parties from danger and avoid contamination from the product Product description 17 ...

Page 20: ...ation 1 blue ring Speed transmission 1 1 With press button chuck Usable with contra angle cutters or grinders The contra angle handpiece can be mounted on all INTRAmatic motors and motors with a connection in accordance with ISO 3964 DIN 13940 Product description 18 ...

Page 21: ...evice after 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 temperature 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 Product description 19 ...

Page 22: ...Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 20 ...

Page 23: ...der and patient Before first use and after each use sterilise the medical device 4 1 Cooling medium supply 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 First use 21 ...

Page 24: ...l device during treatment A medical device that is not properly locked in place can become discon nected from the motor coupling and fall off Carefully pull on the medical device before each treatment to ensure that it is securely locked onto the motor coupling Operation 22 ...

Page 25: ...ly start the contra angle handpiece when the chuck is closed CAUTION Removing and attaching the contra angle handpiece while the drive motor is rotating Damage to the drive Never attach or remove the contra angle handpiece while the drive motor is rotating Operation 23 ...

Page 26: ...the medical device to the LUX motor coupling until it locks into place and twist it until the catch audibly locks Pull on it to make sure that the medical device is securely attached to the coupling Operation 24 ...

Page 27: ...d then pulling it along its axis 5 3 Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond burs that correspond to ISO 1797 1 type 1 are made of steel or tungsten carbide and meet the following cri teria shaft diameter 2 334 to 2 35 mm overall length max 22 mm Operation 25 ...

Page 28: ...structions 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 cutters or grinders Cutters or grinders could fall out during treatment and injure the patient Never use cutters or grinders with worn shafts Operation 26 ...

Page 29: ... from 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 inserting and removing use gloves or a fingerstall to prevent an injury or in fection Operation 27 ...

Page 30: ... Insert the cutter or grinder into the segment of the head drive by twisting the tool slightly and push to the stop Check that the tool is seated by pulling on it Operation 28 ...

Page 31: ...der Lacerations and damage to the chucking system Do not touch rotating cutter or grinder Never press the press button while the cutter or grinder is rotating Remove the cutter or grinder from the contra angle handpiece after treatment to avoid injury or infection while storing it Operation 29 ...

Page 32: ... After the cutter or grinder has stopped rotating press the press button with your thumb and simultaneously pull out the drill bit or bur Operation 30 ...

Page 33: ...ng or damaged O rings Malfunctions and premature failure Make sure that all O rings are on the coupling and undamaged CAUTION Heating of the product Burns or product damage from overheating Do not use the product if it is irregularly heated Troubleshooting 31 ...

Page 34: ...e When the speed drops or is uneven Caring for the medical device An O ring is missing on the motor coupling Replace O ring 6 2 1 Troubleshooting Exchanging the O rings on the motor coupling CAUTION Hazard from improper care of the O rings Malfunctions or complete failure of the product Do not use Vaseline or other grease or oil Troubleshooting 32 ...

Page 35: ...or coupling may only be lubricated with a cotton ball wetted with KaVo spray 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 Troubleshooting 33 ...

Page 36: ...Hazard from insufficient amount of spray water Insufficient spray water can cause the medical device to overheat and damage the tooth Check spray water channels and if necessary clean spray nozzles with the nozzle needle Mat no 0 410 0921 Troubleshooting 34 ...

Page 37: ...es Observe 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 Setup methods according to DIN EN ISO 17664 35 ...

Page 38: ... ultrasonic unit Defects in the product Only clean manually or in a thermodisinfector 7 2 1 Cleaning Manual cleaning external Accessories required Tap water 30 C 5 C 86 F 10 F Brush e g medium hard toothbrush Setup methods according to DIN EN ISO 17664 36 ...

Page 39: ...ed with alkaline cleaning agents at a pH of max 10 e g Miele G 7781 G 7881 validation was performed with the VARIO TD programme neodisher mediclean cleaning agent neodisher Z neu tralisation agent and neodisher mielclear rinsing agent and extends only to the compatibility of materials with respect to KaVo products Setup methods according to DIN EN ISO 17664 37 ...

Page 40: ...edical device are dry and then lubricate immediately with care agents from the KaVo care system 7 2 3 Cleaning Manual cleaning internal Can only be done with KaVo CLEANspray or KaVo DRYspray Cover the medical device 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...

Page 41: ...ual 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 thermodisinfec tors in accordance with ISO 15883 1 Setup methods according to DIN EN ISO 17664 39 ...

Page 42: ...er mielclear rinsing agent and extends only to the compatibility of materials with respect to KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector com plying 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 d...

Page 43: ...tion CAUTION Malfunctioning from using a disinfectant bath or disinfectant containing chlorine Defects in the product Only disinfect in a thermodisinfector or manually Setup methods according to DIN EN ISO 17664 41 ...

Page 44: ...on material compatibility The microbiological efficacy must be ensured by the disinfectant manufac turer Microcide AF from Schülke Mayr liquid or cloths FD 322 from Dürr CaviCide from Metrex Tools required Cloths for wiping down the medical device Setup methods according to DIN EN ISO 17664 42 ...

Page 45: ...disinfection 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 com patibility of materials e g WL cid made by ALPRO Immediately after internal disinfection lubricate the KaVo medical de vice immediately with care agents from the...

Page 46: ...nd neodisher mielclear rinsing agent and extends only to the compatibility of materials with respect to KaVo products For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector com plying 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...

Page 47: ... compressed air until water drops are no longer visible Machine drying The drying procedure is normally part of the cleaning program of the ther modisinfector Follow the instructions for use of the thermodisinfector Setup methods according to DIN EN ISO 17664 45 ...

Page 48: ... in the medical device Risk of injury from sharp or pointed cutters or grinders Remove cutter or grinder CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Perform proper care regularly Setup methods according to DIN EN ISO 17664 46 ...

Page 49: ... 7 5 1 Care products and systems Servicing Care with KaVo Spray KaVo recommends servicing the product after each time it is used i e after each automatic cleaning and before each sterilisation Remove cutter or grinder Cover the product with the CLEANpac bag Place the product on the cannula and press the spray button for one second Setup methods according to DIN EN ISO 17664 47 ...

Page 50: ...nd servicing the chuck system once a week Remove the cutter or grinder place the spray nipple tip in the opening and spray Carry out the servicing according to the instructions in the section Care with KaVo Spray Setup methods according to DIN EN ISO 17664 48 ...

Page 51: ...h sterilisation Place the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a CLEANpac bag Service the product See also Instructions for use KaVo SPRAYrotor 7 5 3 Care products and systems Servicing Servicing with KaVo QUATTROcare Cleaning and care unit with expansion pressure for effective cleaning and care Setup methods according to DIN EN ISO 17664 49 ...

Page 52: ...er each automatic cleaning and before each sterilisation Remove cutter or grinder Service the product Chuck care KaVo recommends cleaning and servicing the chuck system once a week See also Instructions for use KaVo QUATTROcare Setup methods according to DIN EN ISO 17664 50 ...

Page 53: ...er or grinder place the spray nipple tip in the opening and spray Subsequently treat with the care products and care systems specified See also Care with KaVo QUATTROcare Setup methods according to DIN EN ISO 17664 51 ...

Page 54: ...etched The quality and use of the sterilised product packaging must satisfy ap plicable 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 Setup methods according to DIN EN ISO 17664 52 ...

Page 55: ...th EN 13060 ISO 17665 1 e g KaVo STERIclave B 2200 2200 P CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Before each sterilisation cycle service the medical device with KaVo care products Setup methods according to DIN EN ISO 17664 53 ...

Page 56: ...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 Setup methods according to DIN EN ISO 17664 54 ...

Page 57: ... 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 7 8 Storage Prepared products must be stored protected from germs as far as possi ble and dust in a dry dark cool room Setup methods according to DIN EN ISO 17664 55 ...

Page 58: ... Comply with the expiry date of the sterilised items Setup methods according to DIN EN ISO 17664 56 ...

Page 59: ... 0 411 9501 Cleanpac 10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 Nozzle needle 0 410 0921 Material summary Mat no 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 57 ...

Page 60: ...er 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 compliance with...

Page 61: ...om 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 type and serial number must be clearly visible on this document Terms and conditions of warranty 59 ...

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