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Setup methods according to DIN EN ISO 17664

Sterilisation

Sterilisation in a steriliser in compliance with DIN EN 13060

CAUTION

Contact corrosion from moisture.

Damage to the product.

▶

Immediately remove the product from thesteam steriliser after the

sterilisation cycle!

The medical device has a max. temperature resistance of 138℃.

KaVo recommends for example

- STERIclave B 2200/ 2200P by KaVo

- Citomat/ K-series by Getinge

Autoclave three times with an initial vacuum for at least 4 minutes at 134°C

± 1

Содержание 1.002.2179

Страница 1: ...Instructions for use RONDOflex plus 360 ...

Страница 2: ...Sales 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: ...s and conditions 10 Safety 12 Description of safety instructions 12 Description of safety instructions Warning symbol 12 Description of safety instructions Structure 13 Description of safety instructions Description of hazardous steps 14 Safety instructions 16 Product description 20 Technical data 21 ...

Страница 4: ...RONDOflex plus Mounting 26 Changing the RONDOflex plus Disconnection 27 Filling the powder container 28 Changing the cannula 30 Changing the cannula Insertion 30 Changing the cannula Removal 32 Check for malfunctions 33 Setup methods according to DIN EN ISO 17664 34 Preparation at the site of use 34 Cleaning 35 Cleaning Cleaning the cannulas 38 ...

Страница 5: ...Contents 3 Disinfection 39 Drying 42 Care products and systems 43 Packaging 44 Sterilisation 45 Storage 47 Accessories 48 ...

Страница 6: ...opes that you enjoy your new high quality product Following the instructions below will allow you to work smoothly economically and safely Symbols See the section Safety Warning Symbol Important information for users and technicians Disinfectable with heat ...

Страница 7: ...e A product with this mark meets the requirements of the relevant EC directives i e the ap plicable standards in Europe Action request Target group This document is intended for dentists and their assistants The section on starting up is also intended for service technicians ...

Страница 8: ...lex plus is suitable for the following indications Preparation for sealing fissures Opening and expanding fissures Creating micromechanical retention for adhesive restorations to the enamel and dentin with a subsequent acid etching technique Preparing small carious defects Preparing the adhesive surfaces of brackets Cleaning and removing residual adhesive from bridges crowns etc extraoral This med...

Страница 9: ...l device may only be used for the described application by a knowledgeable user The following must be ob served the applicable 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 pat...

Страница 10: ...elf with the device Use surgical loupes or a microscope to check the minimally invasive work Note It is recommendable to use a disposable mirror during treatment To create cavities Focus on a point An intermittent powder jet can improve abrasion Working distance 1 mm Hold the powder jet perpendicular to the surface of the tooth ...

Страница 11: ... of the oral cavity When for example adhesive residue needs to be removed from crowns Remember that dust accumulates around the working field This can impair the function of nearby devices and instruments You should therefore pro vide suitable dust extraction Objects that may contact the powder jet should be protected with a cloth Otherwise the surface may become da maged if necessary removed dust...

Страница 12: ...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 connection ...

Страница 13: ...buted 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 this documen...

Страница 14: ...Safety 12 Description of safety instructions Warning symbol Warning symbol ...

Страница 15: ...ety instructions Structure DANGER The introduction describes the type and source of the hazard This section describes the potential consequences of non observance The optional step contains necessary measures for avoiding hazards ...

Страница 16: ... safety instructions with the 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 ...

Страница 17: ...Safety 15 DANGER DANGER indicates a maximum hazardous situation that can directly cause serious injury or death ...

Страница 18: ...e or longer peri ods of nonuse Reduced product life The medical device should be cleaned serviced and placed in a dry stored location according to instructions before long periods of non use CAUTION Injury or damage due to wear Irregularities in the product Stop work and seek service support ...

Страница 19: ...particle impervious clothes and a hood We recommend using a dental dam and a dust extraction system WARNING Damage from soiled and moist compressed air Contaminated and moist compressed air can cause malfunctions and lead to premature bearing wear In general ensure dry clean uncontaminated compressed air accor ding to EN ISO 7494 2 ...

Страница 20: ... contacting the gingiva and avoid the insuf flation of blown air into open wounds CAUTION Cleansers and disinfectants can attack the plastic housing This can form hairline cracks and cause other damage which can create a hazardous situation The RONDOflex plus therefore has to undergo a safety check every two years Note Never use the RONDOflex plus on patients with chronic diseases of the respirato...

Страница 21: ...sensitive surfaces Rinse parts insensitive to moisture under flowing water to remove residual powder The following individuals are authorised to repair and service KaVo pro ducts The technicians of KaVo branches throughout the world Technicians of authorised dealers specially trained by KaVo Independent technicians especially trained by KaVo ...

Страница 22: ...Product description 20 Product description RONDOflex plus 360 Mat no 1 002 2179 ...

Страница 23: ...bar Water pressure 1 5 0 1 bar Air consumption 5 11 Nl min depending on the type of cannula Water quantity 35 45 ml min Connection Attachable to all MULTIflex coup lings Note The pressure set for the turbine drive is automatically increased 20 from 2 8 to 3 2 bar ...

Страница 24: ...Product description 22 Have a service technician regularly check the manufacturer s recommen ded pressure for your unit to ensure that the instruments function properly ...

Страница 25: ...d from starting the medical device after very cold storage The medical device can malfunction Products that are very cold must be warmed to 20 C to 25 C before use Temperature 50 C to 80 C Relative humidity Non condensing Air pressure 700 hPa to 1060 hPa Protect from moisture ...

Страница 26: ...First use 24 First use WARNING Hazard from nonsterile products Infection danger to the care provider and patient Before first use and after each treatment sterilize the medical device ...

Страница 27: ...x Coupling All O rings must be present and undamaged CAUTION Missing or damaged O rings If the O rings are missing or damaged malfunctions and premature failure can occur Check that all O rings are present and undamaged on the coupling ...

Страница 28: ... the RONDOflex plus Mounting Place the RONDOflex plus precisely on the MULTIflex coupling and push it to the back until it audibly locks into place Note Pull on the RONDOflex plus to check its seat on the MULTlflex coupling ...

Страница 29: ...First use 27 Changing the RONDOflex plus Disconnection Grasp the MULTIflex coupling and pull the RONDOflex plus forward twisting slightly ...

Страница 30: ... container Unscrew the powder container to the left against the direction of the arrow Fill the powder container half way with RONDOflex powder 20 g Screw on the powder container straight on to the right in the direction of the arrow ...

Страница 31: ...eded If you do not need the powder container close it with the rubber cover Only use original KaVo RONDOflex powder Note Observe the safety datasheet for the RONDOflex 2013 powder 50 µm and 27 µm This can be found at www kavo comby searching for Safety data sheets ...

Страница 32: ...the cannula Insertion Before inserting the cannula blow out the receiving hole with com pressed air Insert the cannula into the handpiece and turn it all the way to the right with the key opposite the direction of the arrow ...

Страница 33: ...se the cannula can come loose If the cannula comes off during treatment it could substantially endanger the patient and user Pull on the cannula each time before treatment and check its seat Before each treatment make sure that the cannula operates properly ...

Страница 34: ...First use 32 Changing the cannula Removal Turn the cannula with the key all the way to the left in the direction of the arrow and remove it ...

Страница 35: ...the tooth surface is too far When preparing cavities paint with the tip The caries lesions are too large since the kinetic energy of the powder particles is lost due to the soft caries material Too little powder in the container min 20 full Too little drive pressure ...

Страница 36: ...om contaminated medical devices Observe suitable personal protective measures Remove residual cement composite or blood at the Site of use The medical device must be dry when transporting it to be prepared Do not place it in a solution or the like The medical device should be prepared as close to the treatment time as possible Remove the cannulas ...

Страница 37: ...in the product Only clean manually CAUTION Malfunction from cleaning with oils or maintenance spray Defective product Do not clean the medical device with oils or maintenance of spray Manually cleaning the outside Necessary accessories Tap water 30 C 5 C or a 60 to 70 alcohol solution Brush such as a medium hard toothbrush ...

Страница 38: ... before manually cleaning the inside To effectively set up the inside of the machine must be cleaned automati cally in a cleaning and disinfection unit in accordance with ISO 15883 1 The interior of this product is not to be cleaned manually Mechanically cleaning the exterior and interior KaVo recommends thermodesinfectors in accordance with DIN EN ISO 15883 such as the Miele G 7781 G 7881 ...

Страница 39: ... mediclean the neutraliser neodisher Z and rinse neodisher mielclear The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Directly before machine cleaning blow dry the inside and outside of the medical device or dry in a thermodesinfector ...

Страница 40: ...ning the cannulas Remove the cannulas Twist the nozzle needle from the front and then from the back into the cannula Remove the nozzle needle and blow out the cannula with compressed air or Remove the cannula and rinse it with tap water or a 60 alcohol so lution ...

Страница 41: ...Defects to the product Only clean manually or in the thermodesinfector Manually disinfecting the exterior KaVo recommends the following products based 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 ...

Страница 42: ...let it work according to the disinfectant manufacturer Note Observe the instruction for use for the disinfectant Manual disinfection of the interior To effectively set up the inside of the machine must be cleaned automati cally in a cleaning and disinfection unit in accordance with ISO 15883 1 The interior of this product is not to be disinfected manually ...

Страница 43: ...881 Validation was performed with the program VARIO TD the cleaner ne odisher mediclean the neutraliser neodisher Z and rinse neodisher mielclear The program settings and cleansers and disinfectants that must be used can be found in the instructions for use of the thermodisinfector Directly before machine cleaning blow dry the inside and outside of the medical device or dry in a thermodesinfector ...

Страница 44: ...and inside the compressed air until no water drops are visible Machine drying The drying procedure is normally part of the disinfection program of the thermodisinfector Note Please follow the instructions for use of the thermodisinfector compres sed air quality see the Warning under Startup ...

Страница 45: ...oduct care This can cause damage and malfunction Before each thermodisinfection or sterilisation unscrew the powder container empty it and thermodisinfect or sterilise it with the hand piece Likewise clean off any powder residue on the the RONDOflex es pecially the cannulas tubes and powder nozzle ...

Страница 46: ...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 packaging of the items to be sterilised must satisfy the applicable standards and be appropriate for sterilising ...

Страница 47: ...n from moisture Damage to the product Immediately remove the product from thesteam steriliser after the sterilisation cycle The medical device has a max temperature resistance of 138 KaVo recommends for example STERIclave B 2200 2200P by KaVo Citomat K series by Getinge Autoclave three times with an initial vacuum for at least 4 minutes at 134 C 1 ...

Страница 48: ...ing to DIN EN ISO 17664 46 Autoclave using the gravitation method for at least 10 minutes at 134 C 1 Autoclave using the gravitation method for at least 60 minutes at 121 C 1 Follow the manufacturer s instructions for use ...

Страница 49: ...etup methods according to DIN EN ISO 17664 47 Storage Prepared products should be stored protected germ free from dust in a dry dark and cool room Note Observe the expiration date of the sterilised item ...

Страница 50: ...Accessories 48 Accessories 1 set consists of Accessories obtainable from dental and medical suppliers ...

Страница 51: ...Accessories 49 110 o 90 o Designation Mat no cannula 110 0 64 mm 1 002 6251 cannula 90 0 64 mm 1 002 9179 cannula 110 0 46 mm 1 002 9176 ...

Страница 52: ...ntainer 27 μm 1 003 1235 Rubber cover 1 000 2678 Powder 27 μm 1000 g 1 000 5957 Powder 50 μm 1000 g 1 000 5956 Cleaning drill 1 001 3602 Nozzle tube 1 002 9920 Additional accessories Designation Mat no O ring for cannulas 0 200 6019 Powder container 50 μm 1 003 1236 Container seal 0 573 6072 ...

Страница 53: ......

Страница 54: ...1 002 6681 kb 20080311 02 en ...

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