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KaVo INTRAmatic contra-angle 14 ES 1.003.4831, Instructions For Use Manual

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KaVo INTRAmatic contra-angle 14 ES 1.003.4831 Instructions For Use Manual Download Page 17

3.1   Purpose – Intended use

Purpose:

This medical device is

▪ intended for dental treatment only. All other types of use or altera‐

tions to the product are not permitted and can be hazardous. The

medical product is intended for the following applications: The re‐

moval of caries, preparation of cavities, removal of fillings, surface

processing as well as the polishing and smoothing of dental and re‐

storation surfaces.

▪ A medical device according to relevant national statutory regulations.

 

 

 

Product description

15

Summary of Contents for INTRAmatic contra-angle 14 ES 1.003.4831

Page 1: ...Instructions for use INTRAmatic contra angle 14 ES 1 003 4831...

Page 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...

Page 3: ...s 7 2 2 Safety instructions 9 3 Product description 14 3 1 Purpose Intended use 15 3 2 Technical Specification 17 3 3 Transportation and storage conditions 18 4 Start up and shut down 20 4 1 Check the...

Page 4: ...Troubleshooting 35 6 2 1 Troubleshooting Exchanging the O rings on the motor coupling 35 6 2 2 Troubleshooting Cleaning the spray nozzle 37 7 Preparation methods according to ISO 17664 38 7 1 Preparat...

Page 5: ...products and systems Servicing 49 7 5 1 Care products and systems Servicing Care with KaVo Spray 51 7 5 2 Care products and systems Servicing Care with the KaVo SPRAYrotor 53 7 5 3 Care products and s...

Page 6: ...7 6 Packaging 62 7 7 Sterilisation 63 7 8 Storage 65 8 Tools 67 9 Warranty terms and conditions 69 Table of contents 4...

Page 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 Import...

Page 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 se...

Page 9: ...ctions 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...

Page 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 ind...

Page 11: ...use 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...

Page 12: ...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...

Page 13: ...from dropping the instrument After treatment place the instrument properly in the cradle without the cutter or grinder CAUTION Burning hazard from hot instrument head or hot instruments cover If the...

Page 14: ...onuse 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...

Page 15: ...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...

Page 16: ...3 Product description INTRAmatic contra angle handpiece 14 ES Mat no 1 003 4831 Product description 14...

Page 17: ...ot permitted and can be hazardous The medical product is intended for the following applications The re moval of caries preparation of cavities removal of fillings surface processing as well as the po...

Page 18: ...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 oper...

Page 19: ...reen ring Transmission 4 1 With press button chuck Short handpiece cutters or grinders can be used The contra angle handpiece can be mounted on all INTRAmatic LUX motors and motors with a connector in...

Page 20: ...t 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...

Page 21: ...Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 19...

Page 22: ...e 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 m...

Page 23: ...e 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...

Page 24: ...3 Start up and shut down 22...

Page 25: ...ray 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 0931 if...

Page 26: ...device during treatment A medical device that is not properly locked in place can become dis connected from the motor coupling and fall off Carefully pull on the medical device before each treatment...

Page 27: ...ON Removing and attaching the contra angle handpiece while the drive mo tor is rotating Damage to the drive Never attach or remove the contra angle handpiece while the drive motor is rotating Operatio...

Page 28: ...connecting and removing the medical device you can damage the medical device and motor cou pling Do not connect or remove the medical device while pressing the footswitch Lightly spray O rings on mot...

Page 29: ...ttach the medical device to the motor coupling and turn it until the guide stud audibly snaps into place Pull on the medical device to make sure that it is securely affixed to the coupling Operation 2...

Page 30: ...d then pulling it along its axis 5 3 Insert the milling cutters or diamond grinders Note Only use carbide cutters or diamond drill bits that conform to EN ISO 1797 1 type 1 are made of steel or hard m...

Page 31: ...nstructions 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 bur...

Page 32: ...om 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 Wh...

Page 33: ...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 31...

Page 34: ...er 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 cont...

Page 35: ...After the cutter or grinder has stopped rotating press the press but ton with your thumb and simultaneously pull out the drill bit or bur Operation 33...

Page 36: ...g 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...

Page 37: ...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 Ha...

Page 38: ...r 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...

Page 39: ...r 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 0931 Use th...

Page 40: ...ces 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 grind...

Page 41: ...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 to...

Page 42: ...perated with alkaline cleaning agents with a pH val ue of max 10 e g Miele G 7781 G 7881 Validation was carried out with Programme VARIO TD cleaning agent neodisher mediclean neutralisation agent neod...

Page 43: ...KaVo 7 2 3 Cleaning Manual cleaning internal Validated interior cleaning residual protein removal can only be accom plished with KaVo CLEANspray and KaVo DRYspray Cover the medical device with the KaV...

Page 44: ...terior 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...

Page 45: ...1 Validation was carried out with program VARIO TD cleaning agent neodisher mediclean neutralisation agent neodisher Z and rinsing agent neodisher mielclear and only applies to the compatibility of ma...

Page 46: ...on 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 disinfectant containing chlorin...

Page 47: ...erials The microbiological efficacy must be ensured by the disinfec tant manufacturer and proven by an expert opinion Mikrozid AF made by Sch lke Mayr liquid or cloths FD 322 made by D rr CaviCide mad...

Page 48: ...ion 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...

Page 49: ...ction can be carried out in thermodisinfectors in ac cordance 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 Valida tion was car...

Page 50: ...nt 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...

Page 51: ...disinfector 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 or pointe...

Page 52: ...product life Perform regular proper care and maintenance Note KaVo only guarantees that its products will function properly when the care products used are those listed as accessories as they were tes...

Page 53: ...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 ont...

Page 54: ...servicing the chuck system once a week Remove the cutter or grinder place the INTRA spray nipple tip in the opening and spray Carry out the servicing according to the instructions in the section Care...

Page 55: ...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...

Page 56: ...rrent delivery pro gramme Follow up products QUATTROcare PLUS 2124 A QUATTROcare CLEAN 2140 A Servicing and cleaning device with expansion pressure for the interior cleaning of inorganic residues and...

Page 57: ...ch 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 th...

Page 58: ...nder 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...

Page 59: ...e no validated cleaning of the interior in accordance German RKI require ments KaVo recommends servicing the product as part of the reprocessing after each use i e after each cleaning disinfection and...

Page 60: ...s 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 hat...

Page 61: ...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...

Page 62: ...ee minutes with no service procedure running the de vice automatically switches back to normal service mode See also Care with KaVo QUATTROcare PLUS 7 5 5 Care products and systems Servicing Servicing...

Page 63: ...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...

Page 64: ...o 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 devic...

Page 65: ...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...

Page 66: ...sture 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 Preparatio...

Page 67: ...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 manu...

Page 68: ...Note Comply with the expiry date of the sterilised items Preparation methods according to ISO 17664 66...

Page 69: ...1 0 411 9501 Cleanpac 10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 Nozzle pin 0 410 0931 Silicone hose 150 mm 0 593 0252 Material summary Mat no Adaptor INTRAmatic CLEANspray and DRYspray 1...

Page 70: ...Material summary Mat no KaVo Spray 2112 A 0 411 9640 ROTAspray 2 2142 A 0 411 7520 QUATTROcare plus Spray 2140 P 1 005 4525 Tools 68...

Page 71: ...anty with a free replacement or repair Other 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...

Page 72: ...ourfastness of plastic parts All liability is excluded if defects or their consequences originate from ma nipulations or changes to the product made by the customer or a third party that is not author...

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