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KaVo INTRA 3630 N Instructions For Use Manual Download Page 47

6.9   Sterilisation

Sterilisation in a steam steriliser (Autoclave) 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 KaVo

care products.

 

 

Preparation methods according to ISO 17664

45

Summary of Contents for INTRA 3630 N

Page 1: ...Instructions for use INTRA Chirurgie shank 3630 N REF 0 534 5670...

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: ...6 2 Safety 8 2 1 Description of safety instructions 8 2 2 Purpose Proper use 10 2 3 Safety instructions 12 3 Product description 15 3 1 Technical Specification 16 3 2 Transportation and storage condi...

Page 4: ...hods according to ISO 17664 28 6 1 Preparations at the site of use 28 6 2 Disassembling the medical device 29 6 3 Assembling the medical device 30 6 4 Cleaning 30 6 4 1 Cleaning Manual cleaning extern...

Page 5: ...and internal 38 6 6 Drying 39 6 7 Care products and systems Servicing 40 6 7 1 Care products and systems Servicing Care with KaVo spray 41 6 7 2 Care products and systems Servicing Care with the KaVo...

Page 6: ...this 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 chapter Important...

Page 7: ...eets the requirements of the applicable EC directive Sterilisable in steam up to 135 C 275 F Thermodisinfectable Target group This document is intended for dentists and their assistants The section on...

Page 8: ...air 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 l...

Page 9: ...ived 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...

Page 10: ...tions Warning symbol Structure DANGER The introduction describes the type and source of the danger This section illustrates the potential consequences of non observance The optional step covers necess...

Page 11: ...he 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...

Page 12: ...nt only All other types of use or alterations to the product are not permitted and can be hazardous The medical product is designed to be used with the corresponding heads in the following application...

Page 13: ...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 c...

Page 14: ...3 Safety instructions WARNING Hazard to the care provider and patient Damage irregular noise during operation excessive vibration unusual build up of heat Stop work and seek service support Safety 12...

Page 15: ...ife The medical device should be cleaned serviced and stored in a dry location according to instructions before long periods of nonuse CAUTION Risk of burn injury if the instrument is hot Burn injurie...

Page 16: ...d 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 ser...

Page 17: ...3 Product description INTRA surgical shank 3630 N Mat no 0 534 5670 Product description 15...

Page 18: ...on Drive speed max 20 000 rpm identification 2 green rings Step down ratio 30 1 Maximum speed 650 min 1 The INTRA surgical shank can be disassembled See also 6 2 Disassembling the medical device Page...

Page 19: ...8440 INTRA head 68 CN Mat no 0 540 2030 INTRA head 67 H Mat no 0 540 8420 INTRA head 67 I Mat no 0 540 8150 INTRA head 67 IC Mat no 0 540 8430 INTRA head 67 R Mat no 0 540 8320 INTRA Kopf 67 RC Mat n...

Page 20: ...13940 3 2 Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored strongly refrigerated This can cause the medical device to malfunction P...

Page 21: ...Temperature 20 C to 70 C 4 F to 158 F Relative humidity 5 RH to 95 RH Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 19...

Page 22: ...after each use sterilise the medical device 4 1 Cooling medium supply CAUTION Hazard of air embolism and skin emphysema There is a danger that the insufflation of spray in open wounds in the surgical...

Page 23: ...Cooling the drill bit or bur via external supply During surgical interventions comply with the necessary precautions regarding cooling Use physiological sterile cooling fluid Ensure that the supply o...

Page 24: ...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...

Page 25: ...CAUTION Removing and attaching the handpiece while the drive motor is rotating Damage to the catch Never attach or remove the reducing shank while the device is ro tating Operation 23...

Page 26: ...edical device to the LUX motor coupling until it locks into place and twist it until the catch audibly locks in place Pull on it to make sure that the medical device is securely affixed to the couplin...

Page 27: ...ng its axis 5 3 Inserting the INTRA head CAUTION Loosening of the medical device during treatment If the head is not properly locked in place it can fall out during treatment Do not mount or remove th...

Page 28: ...ng in the direction of the arrow to the stop and hold it there Insert the head to the stop Make sure that the catches engage prop erly Rotate the clamping ring against the direction of the arrow and t...

Page 29: ...5 4 Removing the INTRA head Hold the clamping ring tight turn it all the way in the direction of the arrow and pull the medical device off while twisting slightly Operation 27...

Page 30: ...medical devices Observe suitable personal protective measures Note Immediately disassemble and thoroughly clean the medical device after each surgical intervention since malfunctions could otherwise...

Page 31: ...treatment Note For rehabilitation remove the head from the shank 6 2 Disassembling the medical device Remove the INTRA head from the medical device Screw the conical sleeve on in counterclockwise dire...

Page 32: ...leaning CAUTION Malfunctions from cleaning in an ultrasonic unit Defects in the product Only clean manually or in a thermodisinfector 6 4 1 Cleaning Manual cleaning external Accessories required Tap w...

Page 33: ...tap water Note Never use alkaline or chlorine containing disinfectants 6 4 2 Cleaning Automated external cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883 1 Preparation methods...

Page 34: ...ty with KaVo prod ucts 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...

Page 35: ...with KaVo DRYspray See also KaVo CLEANspray KaVo DRYspray Instructions for Use Note KaVo CLEANspray and KaVo DRYspray for manual interior cleaning are only available in the following countries Germany...

Page 36: ...the neutraliser neodisher Z and rinse neodish er mielclear and only refers to the material compatibility with KaVo prod ucts The program settings and cleansers and disinfectants that must be used can...

Page 37: ...ion 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...

Page 38: ...he following products based on material compatibility The microbiological efficacy must be ensured by the disinfectant manufac turer Microcide AF from Sch lke Mayr liquid or cloths FD 322 from D rr Ca...

Page 39: ...m the disinfectant manufacturer Note Observe the instructions for use for the disinfectant 6 5 2 Disinfection Manual disinfection internal For the effective re preparation the inside of the device mus...

Page 40: ...ediclean the neutraliser neodisher Z and rinse neodish er mielclear and only refers to the material compatibility with KaVo prod ucts The program settings and cleansers and disinfectants that must be...

Page 41: ...ssed air until water drops are no longer 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...

Page 42: ...product life Perform proper care regularly Note For care remove the head from the reducing shank Note KaVo only guarantees that its products will function properly when the care products used are thos...

Page 43: ...nds servicing the project after each time it used i e after each automatic cleaning and before each sterilisation Cover the product with the Cleanpac bag Place the product on the cannula and press the...

Page 44: ...ject after each time it used i e after each automatic cleaning and before each sterilisation Place the product on the appropriate coupling of the KaVo SPRAYrotor and cover it with a CLEANpac bag Servi...

Page 45: ...th expansion pressure for effective cleaning and care KaVo recommends servicing the project after each time it used i e after each automatic cleaning and before each sterilisation Servicing the produc...

Page 46: ...tched 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...

Page 47: ...Autoclave 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 KaVo care p...

Page 48: ...remove the product from the steam steriliser after the sterilisation cycle The medical device is resistant to temperatures up to 138 280 4 F KaVo recommends e g STERIclave B 2200 2200P from KaVo Cito...

Page 49: ...utoclave with gravitation process for least ten minutes at 134 C 1 C 273 F 1 8 F Autoclave with gravitation process for at least 60 minutes at 121 C 1 C 250 F 1 8 F Follow the manufacturer s instructi...

Page 50: ...Note Observe the expiration date of the sterilised item Preparation methods according to ISO 17664 48...

Page 51: ...ary Mat no Instrument stand 2151 0 411 9501 Cleanpac 10 units 0 411 9691 Cellulose pad 100 units 0 411 9862 Spray hose sterilisable yard ware 0 065 5188 Material summary Mat no KaVo CLEANspray 1 007 0...

Page 52: ...Material summary Mat no ROTAspray 2142 A 0 411 7520 QUATTROcare plus Spray 2108 P 1 005 4525 Tools 50...

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