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KaVo 1.001.8003, Instructions For Use Manual

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KaVo 1.001.8003 Instructions For Use Manual Download Page 12

DANGER

DANGER

indicates the maximum hazard level. indicates a directly hazardous sit‐

uation that can cause death or serious injury.

2.2   Purpose – Proper use

This medical device is

▪ Only intended for dental treatment. 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: Drying root canals before

filling them, drying cavities.

▪ A medical device according to relevant national statutory regulations.

 

 

Safety

10

Summary of Contents for 1.001.8003

Page 1: ...Instructions for use Multi FINEair 333 M REF 1 001 8003 ...

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: ...ditions 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 Specifications 15 3 2 Transportation and storage conditions 16 4 First use 18 4 1 Attach the MULTIflex coupling 18 Table of contents 1 ...

Page 4: ...3 5 3 Inserting the cannula 23 5 4 Remove the cannula 24 5 5 Use 25 6 Preparation methods according to ISO 17664 27 6 1 Preparations at the site of use 27 6 2 Cleaning 28 6 2 1 Cleaning Manual cleaning external 28 6 2 2 Cleaning Automated external cleaning 29 6 2 3 Cleaning Manual cleaning of the inside 30 Table of contents 2 ...

Page 5: ...anual disinfection external 32 6 3 2 Disinfection Manual disinfection internal 33 6 3 3 Disinfection Machine disinfection external and internal 33 6 4 Drying 34 6 5 Care products and systems Servicing 35 6 6 Packaging 36 6 7 Sterilisation 37 6 8 Storage 39 7 Tools 40 Table of contents 3 ...

Page 6: ...sing this KaVo quality product Following the in structions below will allow you to work smoothly economically and safely Copyright by KaVo Dental GmbH Symbols Refer to chapter Safety Warning Important information for users and technicians User instructions 4 ...

Page 7: ...munauté 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 ...

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 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 or cleaning non compliance with oper...

Page 9: ... can 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 device number or type and factory number or serial number must b...

Page 10: ...ructions Warning symbol Structure DANGER The introduction describes the type and source of the danger This section portrays the possible consequences of non observance The optional step covers necessary measures for avoiding hazards Safety 8 ...

Page 11: ...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 indicates a hazardous situation that can cause death or serious injury Safety 9 ...

Page 12: ...roper use This medical device is Only intended for dental treatment 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 Drying root canals before filling them drying cavities A medical device according to relevant national statutory regulations Safety 10 ...

Page 13: ...cable 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 to protect himself the patient and third parties from danger to avoid contamination from the product Safety 11 ...

Page 14: ...eek service support WARNING Hazard from contraindication If the soft tissue in the oral cavity is injured the compressed air may enable septic substances to enter the tissue Treatment must be discontinued with instruments operated by com pressed air when soft tissue is damaged in the oral cavity Safety 12 ...

Page 15: ...as well as skin emphysema Keep the jet from directly contacting the gingiva and avoid the insuf flation of blown air into open wounds CAUTION Premature wear and malfunctioning from improper storage during long periods of nonuse Reduced production time The instrument must be cleaned and stored dry if it has not been used for a long period Safety 13 ...

Page 16: ... the methods described in the KaVo instructions for use 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 terval should take into account the frequency of use Service may only be provided by repair shops that have undergone training by KaVo and that use original KaVo replacement pa...

Page 17: ...duct description Multi FINEair 333 M Mat no 1 001 8003 3 1 Technical Specifications Drive pressure max 5 bar 73 psi Air consumption without the cannu la being screwed on max 20 NL min Product description 15 ...

Page 18: ...l supplier 3 2 Transportation and storage conditions CAUTION It is hazardous to start up the medical device after it has been stored re frigerated 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 Product description 16 ...

Page 19: ...Temperature 20 C to 70 C 4 F to 158 F Relative humidity 5 to 95 non condensing Air pressure 700 hPa to 1060 hPa 10 psi to 15 psi Protect from moisture Product description 17 ...

Page 20: ...cts Infection danger to the care provider and patient Before first use and after each use sterilise the medical device 4 1 Attach the MULTIflex coupling Rub off the MULTIflex connection with a dry cloth and remove residual oil and spray First use 18 ...

Page 21: ... Screw the MULTIflex LUX coupling to the turbine hose and tighten with the key Note Since light spray water and spray air are not required for the MultiFINE air deselect these functions First use 19 ...

Page 22: ...connection to equipment Dirty and moist compressed air causes premature bearing wear Ensure dry clean and uncontaminated compressed air according to ISO 7494 2 To operate the Multi FINEair the drive pressure may not exceed 5 bar 73 PSI First use 20 ...

Page 23: ... Multi FINEair and check the following pressures Induction air 5 bar 73 psi 4 3 Check O rings CAUTION Missing or damaged O rings Malfunctions and premature failure Make sure that all O rings are on the coupling and undamaged Number of available O rings 2 white and 3 black First use 21 ...

Page 24: ... is not properly locked can release from the MUL TIflex LUX during treatment Before each use check if the medical device is securely locked onto the MULTIflex LUX Precisely attach the medical device to the MULTIflex LUX coupling and push is to the rear until the coupling audibly locks in the medical device Operation 22 ...

Page 25: ...medical device Hold the coupling tight and pull the medical device off while twisting slightly 5 3 Inserting the cannula CAUTION Only use disposable cannulas with a lockable Luer connector ac cording to DIN EN 1707 Before treatment make sure that air leaves the cannula of the in strument Operation 23 ...

Page 26: ... Insert the cannula into the handpiece and turn it all the way to the right see arrow 5 4 Remove the cannula Turn the cannula to the left and remove Operation 24 ...

Page 27: ...anal Damage or injuries due to incorrect use of the Multi FINEair Make sure that the apex is closed Never use the Multi FINEair when the apex is open Make sure that the cannula is not wedged in the canal If the cannula becomes wedged immediately stopped drying Operation 25 ...

Page 28: ...t are difficult or impossible to see when wet Very fine isthmus and inlets to pulp canals accessory canal systems Fissure sealing for example with ampoule fissures prepared with air abrasive systems Tunnelling preparations bending of the micro cannulas according to the cavity shape Adhesive cementing of the root pins and ceramic superstructures in the root canal blowing away the dentine bonding an...

Page 29: ...ard exists from contaminated medical devices Observe suitable personal protective measures Remove residual cement composite or blood at the site of use Dry the medical device to prepare it for transportation Do not place it in a solution etc Prepare the medical device directly after treatment Preparation methods according to ISO 17664 27 ...

Page 30: ...ltrasonic unit Defects in the product Only clean in a thermodisinfector or manually 6 2 1 Cleaning Manual cleaning external Required accessories Tap water 30 C 5 C 86 F 10 F Brush such as a medium hard toothbrush Preparation methods according to ISO 17664 28 ...

Page 31: ...ors in accordance with ISO 15883 1 e g Miele G 7781 G 7881 Validation was performed with the program VARIO TD the cleaner ne odisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the material compatibility with KaVo products Preparation methods according to ISO 17664 29 ...

Page 32: ...ection unit in accordance with ISO 15883 1 The interior of this product is not to be cleaned manually 6 2 4 Cleaning Automated internal cleaning KaVo recommends thermodisinfectors in accordance with ISO 15883 1 e g Miele G 7781 G 7881 Validation was performed with the program VARIO TD the cleaner ne odisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear and only refers to the ...

Page 33: ...und in the instructions for use of the thermodisinfector 6 3 Disinfection 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 31 ...

Page 34: ...sed on material compatibility The microbiological efficacy must be ensured by the disinfectant manufac turer Microcide AF by Schülke Mayr liquid or cloths FD 322 by Dürr CaviCide by Metrex Required tools Cloths for wiping off the medical device Preparation methods according to ISO 17664 32 ...

Page 35: ...fectant 6 3 2 Disinfection Manual disinfection internal To effectively set up the inside of the machine must be cleaned automat ically in a cleaning and disinfection unit in accordance with ISO 15883 1 The inside of this product should not be disinfected manually 6 3 3 Disinfection Machine disinfection external and internal KaVo recommends thermodisinfectors in accordance with ISO 15883 1 Preparat...

Page 36: ...clear and only refers to the material compatibility with KaVo products The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector 6 4 Drying Manual drying Blow off the outside and inside the compressed air until no water drops are visible Preparation methods according to ISO 17664 34 ...

Page 37: ...f the ther modisinfector 6 5 Care products and systems Servicing CAUTION Do not clean the Multi FINEair with oils or care spray Malfunction or damage to the product The Multi FINEair must not be lubricated with oil or with care spray Preparation methods according to ISO 17664 35 ...

Page 38: ...stretched The quality and use of the sterilisation packaging must satisfy applicable 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 36 ...

Page 39: ...60 ISO 17665 1 CAUTION Contact corrosion from moisture Damage to product Immediately remove the product from the steam steriliser after the sterilisation cycle The medical device is temperature resistant up to 138 280 4 F Preparation methods according to ISO 17664 37 ...

Page 40: ... following ster ilisation methods Autoclave with a triple pre vacuum for least four minutes at 134 C 1 C 273 F 1 8 F Autoclave using the gravitational method sterilise for at least 10 min at 134 C 1 C 273 F 1 8 F Autoclave using the gravitational for at least 60 min at 121 C 1 C 250 F 1 8 F Follow the manufacturer s instructions for use Preparation methods according to ISO 17664 38 ...

Page 41: ... 8 Storage Prepared products must be stored protected germ free from dust in a dry dark and cool room Note Observe the expiration date of the sterilized item Preparation methods according to ISO 17664 39 ...

Page 42: ...7 Tools Obtainable from dental and medical suppliers Material summary Mat no STERIclave bags 0 411 9912 Tools 40 ...

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