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Subsequently treat with the care products and systems listed below.

6.8   Packaging

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

Summary of Contents for INTRA 3610 N2

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

Page 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...

Page 3: ...ty 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 supp...

Page 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 Manu...

Page 5: ...ction 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...

Page 6: ...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 Importan...

Page 7: ...munaut Europ enne 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...

Page 8: ...tructions 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 m...

Page 9: ...e 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 indicat...

Page 10: ...se 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...

Page 11: ...e 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 t...

Page 12: ...cians 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 descr...

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

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

Page 15: ...tment 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 a...

Page 16: ...plicable 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 equi...

Page 17: ...g 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 s...

Page 18: ...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 Pri...

Page 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...

Page 20: ...e 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 cau...

Page 21: ...t 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 supp...

Page 22: ...ith 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...

Page 23: ...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...

Page 24: ...797 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 diamete...

Page 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 We...

Page 26: ...tter 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...

Page 27: ...emove 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 grinde...

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

Page 29: ...fection 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 pr...

Page 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...

Page 31: ...nctions 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 1...

Page 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 fr...

Page 33: ...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 Clea...

Page 34: ...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 a...

Page 35: ...ion 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...

Page 36: ...nds 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 m...

Page 37: ...cturer 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 clean...

Page 38: ...ansers 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 s...

Page 39: ...mo 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...

Page 40: ...ing 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 Preparat...

Page 41: ...UAT 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 m...

Page 42: ...ecommends 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 Prepa...

Page 43: ...ote 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 sui...

Page 44: ...oclave 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 pr...

Page 45: ...n 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...

Page 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...

Page 47: ...ry 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...

Page 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...

Page 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 regul...

Page 50: ...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 i...

Page 51: ......

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

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