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7.6 Packaging

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

bag is not stretched.

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)!

Preparation methods according to ISO 17664

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Содержание 1.003.7712

Страница 1: ...Instructions for use INTRAcompact contra angle 2967 CHC REF 1 003 7712 ...

Страница 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 ...

Страница 3: ...nstructions 6 2 2 Safety instructions 8 3 Product Description 13 3 1 Purpose Proper use 14 3 2 Technical Data 16 3 3 Transportation and Storage Conditions 17 4 First use 19 4 1 Checking the amount of water 20 5 Operation 22 5 1 Attaching the medical device 22 Table of contents 1 ...

Страница 4: ...ctions 31 6 2 Troubleshooting 33 6 2 1 Troubleshooting Cleaning the spray nozzle 33 7 Preparation methods according to ISO 17664 35 7 1 Preparations at the site of use 35 7 2 Cleaning 36 7 2 1 Cleaning Manual cleaning external 36 7 2 2 Cleaning Automated external cleaning 37 7 2 3 Cleaning Manual cleaning internal 38 7 2 4 Cleaning Automated internal cleaning 40 Table of contents 2 ...

Страница 5: ...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 the KaVo SPRAYrotor 49 7 5 3 Care products and systems Servicing Care with KaVo QUATTROcare 49 7 6 Packaging 52 7 7 Sterilisation 53 7 8 Storage 56 8 Tools 57 9 Warranty terms and conditions 58 Table of contents 3 ...

Страница 6: ...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 4 ...

Страница 7: ... 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 5 ...

Страница 8: ...tions Warning symbol 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 6 ...

Страница 9: ...h 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 7 ...

Страница 10: ...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 8 ...

Страница 11: ...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 9 ...

Страница 12: ...rviced and stored in a dry location according to instructions before long periods of nonuse CAUTION Risk due to incorrectly 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 10 ...

Страница 13: ...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...

Страница 14: ...Service may only be carried out by KaVo trained repair shops using original KaVo replacement parts Safety 12 ...

Страница 15: ...3 Product Description INTRAcompact contra angle handpiece 2967 CHC Mat no 1 003 7712 Product Description 13 ...

Страница 16: ...nt 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 caries excavation endodontics A medical device according to relevant national statutory regulations Product Description 14 ...

Страница 17: ...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 15 ...

Страница 18: ... green rings Speed transmission 14 8 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 16 ...

Страница 19: ...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 17 ...

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

Страница 21: ... first use and after each use sterilise the medical device CAUTION Damage from soiled and moist cooling air Contaminated and moist cooling air can cause malfunctions and lead to premature bearing wear Make sure that the supply of cooling air is dry clean and unconta minated according to ISO 7494 2 First use 19 ...

Страница 22: ...ecking the 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 First use 20 ...

Страница 23: ...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 21 ...

Страница 24: ...cal 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 ...

Страница 25: ... attach or remove the contra angle handpiece while the drive motor is rotating CAUTION Damage If the footswitch is pressed while you are connecting and removing the medical device you can damage the medical device and motor coupling Do not connect or remove the medical device while pressing the footswitch Operation 23 ...

Страница 26: ...n the motor coupling with KAVOspray Attach the medical device to the motor coupling and twist it until the guide stud audibly locks Pull on the medical device to make sure that it is securely affixed to the coupling Operation 24 ...

Страница 27: ...nd 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 ...

Страница 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 ...

Страница 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 ...

Страница 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 ...

Страница 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 ...

Страница 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 ...

Страница 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 ...

Страница 34: ...Check the amount of cooling air The medical device is too hot while working Caring for the medical device When the speed drops or is uneven Caring for the medical device An O ring is missing on the motor coupling Replace O ring Troubleshooting 32 ...

Страница 35: ... spray nozzle CAUTION Hazard from insufficient spray water Insufficient spray water can cause the medical device to overheat and damage the tooth If the amount of spray water is insufficient unblock the spray nozzles Troubleshooting 33 ...

Страница 36: ... Use the nozzle needle Mat no 0 410 0921 to free the water passage in the spray nozzles Troubleshooting 34 ...

Страница 37: ...minated medical devices Observe suitable personal protective measures Remove all residual cement composite or blood without delay The medical device must be dry when transporting it to the site of re processing Do not place it in a solution or the like Reprocess the medical device as soon as possible after treatment Preparation methods according to ISO 17664 35 ...

Страница 38: ...nctions from cleaning in an 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 Preparation methods according to ISO 17664 36 ...

Страница 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 Preparation methods according to ISO 17664 37 ...

Страница 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...

Страница 41: ...nual 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 Preparation methods according to ISO 17664 39 ...

Страница 42: ...her 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 ...

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

Страница 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 Preparation methods according to ISO 17664 42 ...

Страница 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...

Страница 46: ... 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 For program settings as well as cleansers and disinfectants to be used please refer to the Instructions for Use of the thermodisinfector com plying wit...

Страница 47: ... with care agents from the KaVo care system 7 4 Drying Manual drying Blow off the outside and inside with 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 Preparation methods according to ISO 17664 45 ...

Страница 48: ...edical device Risk of injury from sharp and or pointed cutters or grinders Remove cutter or grinder CAUTION Premature wear and malfunctions from improper servicing and care Reduced product life Perform regular proper care and maintenance Preparation methods according to ISO 17664 46 ...

Страница 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 Preparation methods according to ISO 17664 47 ...

Страница 50: ...ng 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 Preparation methods according to ISO 17664 48 ...

Страница 51: ...e each 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 Care with KaVo QUAT TROcare Cleaning and care unit with expansion pressure for effective cleaning and care Preparation methods according to ISO 17664 49 ...

Страница 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 Preparation methods according to ISO 17664 50 ...

Страница 53: ...ter 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 Preparation methods according to ISO 17664 51 ...

Страница 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 Preparation methods according to ISO 17664 52 ...

Страница 55: ...ith 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 Preparation methods according to ISO 17664 53 ...

Страница 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 Preparation methods according to ISO 17664 54 ...

Страница 57: ...initial vacuum at least 3 minutes at 134 C 1 C 4 C 273 F 1 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 Preparation methods according to ISO 17664 55 ...

Страница 58: ...eprocessed products should be stored protected from dust with min imum exposure to germs in a dry dark and cool place Comply with the expiry date of the sterilised items Preparation methods according to ISO 17664 56 ...

Страница 59: ... 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 ...

Страница 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...

Страница 61: ...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 type and serial number must be clearly visible on this document Warranty terms and conditions 59 ...

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