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3.1 Purpose – Proper use

Purpose:

This medical device is

▪ only for dental treatment by a dental professional. The product may not

be changed or used for any other purpose since this may be hazard‐

ous. The medical device is intended for the following use: Surgery.

▪ A medical device according to relevant national statutory regulations.

Product description

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Содержание 0.524.5610

Страница 1: ...Instructions for use INTRA surgical handpiece 3610 N2 REF 0 524 5610 ...

Страница 2: ...Distributed by KaVo Dental Corporation 11729 Fruehauf Drive Charlotte NC 28273 USA Tel 847 550 6800 Fax 847 550 6825 Manufacturer Kaltenbach Voigt GmbH Bismarckring 39 D 88400 Biberach www kavo com ...

Страница 3: ...ety instructions 6 2 2 Safety instructions 8 3 Product description 12 3 1 Purpose Proper use 13 3 2 Technical data 15 3 3 Transportation and storage conditions 16 4 First use 18 4 1 Cooling medium supply 18 5 Operation 20 5 1 Attach the medical device 20 Contents 1 ...

Страница 4: ... 25 6 Preparation methods according to ISO 17664 27 6 1 Preparations at the site of use 27 6 2 Disassemble the medical device 28 6 3 Assembling the medical device 29 6 4 Cleaning 29 6 4 1 Cleaning Manual cleaning external 29 6 4 2 Cleaning Automated external cleaning 30 6 4 3 Cleaning Manual cleaning of the inside 30 6 4 4 Cleaning Automated internal cleaning 31 6 5 Disinfection 33 Contents 2 ...

Страница 5: ...ection external and internal 36 6 6 Drying 36 6 7 Care products and systems Servicing 37 6 7 1 Care products and systems Servicing Care with KaVo Spray 38 6 7 2 Care products and systems Servicing Care with KaVo QUATTROcare 39 6 8 Packaging 41 6 9 Sterilization 42 6 10 Storage 44 7 Tools 45 8 Warranty terms and conditions 47 Contents 3 ...

Страница 6: ...r new high quality product Following the instructions below will allow you to work smoothly economically and safely Copyright by KaVo Dental GmbH Symbols See the section Safety Warning Symbols Important information for users and technicians User instructions 4 ...

Страница 7: ...mmunauté 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 ...

Страница 8: ...structions Warning symbol Structure DANGER The introduction describes the type and source of the danger This section describes the possible consequences of misuse The optional step contains necessary measures for avoiding haz ards Safety 6 ...

Страница 9: ...he three levels of danger will help avert property damage and injury CAUTION CAUTION indicates a hazardous situation that can lead to property damage or minor to moderate injury WARNING WARNING indicates a hazardous situation that can lead to serious injury or death Safety 7 ...

Страница 10: ...use serious injury or death 2 2 Safety instructions 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 8 ...

Страница 11: ...he 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 9 ...

Страница 12: ...icians specially trained by KaVo To ensure proper function the medical device must 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 terva...

Страница 13: ...Service may only be provided by repair shops that have undergone training by KaVo and that use original KaVo replacement parts Safety 11 ...

Страница 14: ...3 Product description INTRA surgical handpiece 3610 N2 Mat no 0 524 5610 Product description 12 ...

Страница 15: ...atment by a dental professional The product may not be changed or used for any other purpose since this may be hazard ous The medical device is intended for the following use Surgery A medical device according to relevant national statutory regulations Product description 13 ...

Страница 16: ...pplicable health and safety regulations the applicable accident prevention regulations these instructions for use According to these regulations the user is required to only use properly operating equipment use the equipment for the proper purpose to protect himself the patient and third parties from danger to avoid contamination from the product Product description 14 ...

Страница 17: ...ng Transmission 1 1 Maximum speed max 40 000 rpm 1 The INTRA surgical handpiece 3610 N2 can be disassembled See also 4 First use Page 18 Handpiece cutters or grinders can be inserted After conversion short handpiece cutters or grinders can be inserted Product description 15 ...

Страница 18: ...N 13940 3 3 Transportation and storage conditions CAUTION Starting up the medical device can be hazardous after it has been stored in an excessively cold location The medical device can 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 Product description 16 ...

Страница 19: ...Temperature 20 C to 50 C 4 F to 122 F Relative humidity Non condensing Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 17 ...

Страница 20: ...se and after each use sterilize the medical device 4 1 Cooling medium supply CAUTION Hazard of air embolism and skin emphysema The insufflation of irrigation in open wounds in the surgical area can cause air embolisms and skin emphysema Avoid the insufflation of irrigation in open wounds in surgical area First use 18 ...

Страница 21: ...nt unit Cool the cutter or grinder using an external supply During surgery observed the necessary guidelines concerning cool ing Use physiological sterile cooling liquid Make sure that the coolant supply is free of air Do not use a different coolant First use 19 ...

Страница 22: ...with the drive motor Lock the handpiece Only start the hand piece when the chuck is closed CAUTION Removing and attaching the handpiece while the device is rotating Damage to the catch Never attach or remove the handpiece while the device is rotating Operation 20 ...

Страница 23: ...k it into place Pull on it to make sure that the medical device is securely affixed to the coupling 5 2 Remove the medical device Unlock the medical device from the motor coupling and remove it or pull it off by twisting it slightly on its axis Operation 21 ...

Страница 24: ...1797 1 type 3 are made of steel or hard metal and meet the following criteria shaft diameter 2 334 to 2 350 mm with drill stop Overall length max 44 5 mm Shaft clamping length min 31 mm Cutting diameter max 3 mm Without drill stop Overall length max 62 5 mm Shaft clamping length min 49 mm Blade diameter max 3 mm Operation 22 ...

Страница 25: ... or grinders Cutters or grinders can fall out during treatment and injure the patient Never use cutters or grinders with worn shafts CAUTION Injury hazard from cutters or grinders Infections or cuts Wear gloves or fingerstalls Operation 23 ...

Страница 26: ...utter or grinder is securely held Fur checking inserting and removing use gloves or a fingerstall to prevent an injury or infection Rotate the grip sleeve all the way in the direction of the arrow and insert the handpiece cutter or grinder into the chuck Turn the grip sleeve back into its initial position Check that the cutter or grinder is seated by pulling on it Operation 24 ...

Страница 27: ...remove the cutter or grinder Turn the grip sleeve back into its initial position 5 5 Conversion for short handpiece cutters or grinders Note The handpiece must be converted when short cutters or grinders are used Open the handpiece chuck Insert the accompanying drill stop into the chuck Insert the handpiece cutter or grinder and push it in all the way Operation 25 ...

Страница 28: ... Remove the drill stop using the accompanying hook Operation 26 ...

Страница 29: ...nfection hazard exists from contaminated medical devices Observe suitable personal protective measures Note After each operation immediately disassemble the medical device and clean it thoroughly to prevent malfunctions Remove residual cement composite or blood at the site of use Preparation methods according to ISO 17664 27 ...

Страница 30: ... the like Prepare the medical device directly before treatment Remove cutters or burs from the medical device 6 2 Disassemble the medical device Remove cutters or burs from the medical device Grip the sleeve and remove the grip sleeve by pulling it forward Preparation methods according to ISO 17664 28 ...

Страница 31: ...unctions from cleaning in the ultrasonic unit Defects in the product Only clean in a thermodisinfector or manually 6 4 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 29 ...

Страница 32: ... 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 and let the cleaner work for one minute Then rinse for 3 5 seconds with KaVo DRYspray See also Instructions for use for the KaVo CLEANspray KaVo DRYspray Preparation methods a...

Страница 33: ...e Luxem bourg Belgium Netherlands United Kingdom Denmark Sweden Fin land and Norway In other countries only automated interior cleaning with thermodisinfectors in accordance with ISO 15883 1 6 4 4 Cleaning Automated internal cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883 1 e g Miele G 7781 G 7881 Preparation methods according to ISO 17664 31 ...

Страница 34: ...d only refers to material compatibility with KaVo products The program settings cleaners 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 according to ISO 17664 32 ...

Страница 35: ...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 33 ...

Страница 36: ...ends the following products based on material compatibility The microbiological efficacy must be ensured by the disinfectant manufac turer CaviCide by Metrex Required tools Cloths for wiping down the medical device Preparation methods according to ISO 17664 34 ...

Страница 37: ...acturer disinfectant manufacturer Note Observe the instruction for use for the disinfectant 6 5 2 Disinfection Manual disinfection internal To effectively set up an automatic inside cleaning in a cleaning and disin fection unit in accordance with ISO 15883 1 is necessary The inside of this product should not be disinfected manually Preparation methods according to ISO 17664 35 ...

Страница 38: ...eansers and disinfectants that need to be used can be found in the instructions for use for the thermodisinfector Directly after automated cleaning treat the medical device with the care products and systems provided by KaVo 6 6 Drying Manual drying Blow off the outside and inside with compressed air until no water drops are visible Preparation methods according to ISO 17664 36 ...

Страница 39: ...rmo disinfector 6 7 Care products and systems Servicing Note KaVo only guarantees that its products will function properly when the care products are used that are listed as accessories since they were tested for proper use on our products Preparation methods according to ISO 17664 37 ...

Страница 40: ...cing Care with KaVo Spray Chuck care KaVo recommends cleaning and maintaining the chucking system every evening Remove the cutter or grinder place the spray nipple tip in the opening and spray Preparation methods according to ISO 17664 38 ...

Страница 41: ...QUAT TROcare Cleaning and care unit with expansion pressure for thorough 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 sterilization Remove the cutter or grinder Preparation methods according to ISO 17664 39 ...

Страница 42: ...recommends cleaning and maintaining the chucking system once a week See also Instructions for use KaVo QUATTROcare Remove the cutter or grinder place the spray nipple tip in the opening and spray Preparation methods according to ISO 17664 40 ...

Страница 43: ...Note The sterilization bag must be large enough for the instrument so that the bag is not stretched The quality and use of the sterilized product packaging must satisfy ap plicable standards and be suitable for the sterilization procedure Preparation methods according to ISO 17664 41 ...

Страница 44: ...toclave EN 13060 ISO 17665 1 CAUTION Premature weary and malfunctions from improper servicing and care Reduced production time Before each sterilization cycle treat the medical device with KaVo care products Preparation methods according to ISO 17664 42 ...

Страница 45: ...on cycle immediately remove the product from the steam sterilizer The medical device has a maximum temperature resistance up to 138 280 4 F Autoclave with a pre vacuum for least four minutes at 134 C 1 C 273 F 1 8 F Drying time 20 min Preparation methods according to ISO 17664 43 ...

Страница 46: ... gravitational for at least 60 min at 121 C 1 C 250 F 1 8 F Drying time 30 min Follow the manufacturer s instructions for use 6 10 Storage Prepared products must be stored germ free and protected from dust in a dry dark and cool room Note Observe the expiration date of the sterilized item Preparation methods according to ISO 17664 44 ...

Страница 47: ...ary 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 0931 Spray hose sterilisable 0 065 5188 Drill stop 0 524 0892 Hook 0 410 1963 KaVo CLEANspray 1 007 0579 KaVo DRYspray 1 007 0580 Tools 45 ...

Страница 48: ...Only for the USA Material summary Mat no KAVOspray America 2113 A 0 411 9660 QUATTROcare plus Spray America 2141 P 1 005 4524 Tools 46 ...

Страница 49: ... 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 are or may be due to natural wear improper handling cleaning or maintenance non compliance with operating or ...

Страница 50: ...n 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 clearly visible on th...

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Страница 52: ...1 007 2722 kb 20100923 06 en US ...

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