VDW.GOLD® RECIPROC® - Vdw-dental.com

VDW.GOLD® RECIPROC® - Vdw-dental.com VDW.GOLD® RECIPROC® - Vdw-dental.com

vdw.dental.com
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12.07.2015 Views

enClean the cables and the outer surfaces of thedevice using a paper towel or soft cotton clothlightly moistened with an aldehyde-free cleaningand disinfectant (bactericidal and fungicidal) solution,e.g. Mikrozid AF Liquid or Minuten SprayClassic.Remove the lip clip and the file clip from the cablesbefore cleaning. The lip clip and file clip need tobe cleaned, disinfected and sterilised before eachuse. This includes first use. Thorough cleaning anddisinfection are crucial for effective sterilisation.Follow the special instructions given in Chapter8.2 Cleaning, Disinfection and Sterilisation (inAccordance with DIN EN ISO 17664). Consult theuser‘s manuals of the devices used in yourpractice as well.Ensure that only validated cleaning/disinfectionand sterilisation methods are used, that thedevices (disinfector, steriliser) are maintained andinspected at regular intervals, and that thevalidated parameters are preserved throughoutevery cycle.608.2 Cleaning, Disinfection andSterilisation (in Accordancewith DIN EN ISO 17664)8.2.1 Pre-Treatment1. Pulp and dentine residues must be removedfrom the accessory parts immediately (within2 hours or less). Do not allow them to dry! Afterusing the accessory parts on patients, put theparts directly into a bowl filled with an appropriatecleaning and disinfectant solution for cleaning,preliminary disinfection and temporary storage(for max. 2 hours).2. Afterwards, clean the accessory parts underrunning water or in a disinfectant solution to removeall visible contaminants. The disinfectantshould be aldehyde-free (aldehyde sets bloodstains), tested for effectiveness (e.g. VAH/DGHMorFDA-approved or CE certified), appropriate fordisinfecting the accessories and compatible withthe accessory parts (see Chapter 8.2.7 MaterialDurability).Always observe the applicable governmenthygiene standards and your practice‘s or clinic‘shygiene regulations as well. This applies especiallyto guidelines for effective prion inactivation.For your own safety, always wear gloves whenhandling contaminated accessory parts.WARNINGS• The cables cannot be autoclaved.• Using substances other than those describedabove can cause damage to thedevice and the accessory parts.• Do not use hot-air or radiation sterilisation,and do not sterilise using formaldehyde,ethylene oxide or plasma.• The plastic casing is not sealed. Do notuse any liquids or sprays directly on theconsole, especially on the display or nearthe electrical sockets.Use only clean, soft brushes or cloths whenremoving contaminants manually. Do not usemetal brushes or steel wool.When cleaning the file clip, open and close it fivetimes in order to clean the inner parts more effectively.Please note that disinfectants used duringpre-treatment are only for personal protection andare not a substitute for post-cleaning disinfection.However, pre-treatment is still important.WARNINGDo not use any automatic processes orultrasonic baths to clean or disinfect theaccessories.

618.2.2 Manual Cleaning and DisinfectionWhen selecting cleaning and disinfectant solutions,make sure that:• they are intended for use in cleaning or disinfectinginstruments,• the disinfectant’s effectiveness has been tested(e.g. VAH/DGHM- or FDA-approved or CE-certified)and that it is compatible with the cleaningsolution,• the chemicals used are compatible with theaccessory parts (see Chapter 8.2.7 MaterialDurability).Combined cleaning/disinfectant solutions shouldonly be used if the instruments are only slightlycontaminated (no visible contamination).Follow the instructions provided by the manufacturersof the cleaning and disinfectant solutionsregarding concentration, application time andrinsing.Only use freshly-prepared solutions made withwater which is either sterile or contains only lowlevels of bacteria (< 10 cfu/m) and endotoxins(< 0.25 EU/ml, e.g. purified water (PW/HPW)), aswell as filtered, oil-free air for drying.Step-by-Step ProcedureCleaning1. Place the pre-cleaned accessory parts in thecleaning bath for the stipulated application time;ensure that they are covered sufficiently (if necessary,use a soft brush to carefully brush themoff). When cleaning the file clip, press it closedand release it five times in order to clean the innerparts more effectively.2. Then take the instruments out of the cleaningbath and rinse them thoroughly with water at leastthree times for one minute each; press and releasethe file clip five times when rinsing.Disinfection1. After cleaning and inspecting the accessoryparts, place them in the disinfection bath for theapplication time stipulated; make sure that theaccessory parts are sufficiently covered. Whendisinfecting the file clip, open and close it fivetimes in order to disinfect the inner parts moreeffectively.2. Then take the instruments out of the disinfectionbath and rinse them thoroughly with waterat least five times for one minute each; open andclose the file clip five times when rinsing.3. Inspect, dry and pack the accessory parts asquickly as possible after taking them out of thedisinfectant (see Chapters 8.2.3 Inspection/Maintenance and 8.2.4 Packing). Make sure thatthe accessory parts do not come into direct contactwith one another!8.2.3 Inspection/MaintenanceCheck all accessory parts after cleaning or cleaning/disinfection. Dispose of defective accessory partsimmediately. Defects may include:• Warped plastic• CorrosionAccessory parts which are still contaminated mustbe cleaned and disinfected again. Maintenanceis not required. Do not use instrument oil!8.2.4 PackingPack the accessory parts in disposable sterilisationpackaging (individual single-use packaging)which meets the following requirements:• In compliance with DIN EN ISO/ANSI AAMI ISO11607• Suitable for steam sterilisation (temperaturesafeto at least 137 °C (279 °F), sufficientlysteam-permeable)enEndo Easy Efficient ®

enClean the cables and the outer surfaces of thedevice using a paper towel or soft cotton clothlightly moistened with an aldehyde-free cleaningand disinfectant (bactericidal and fungicidal) solution,e.g. Mikrozid AF Liquid or Minuten SprayClassic.Remove the lip clip and the file clip from the cablesbefore cleaning. The lip clip and file clip need tobe cleaned, disinfected and sterilised before eachuse. This includes first use. Thorough cleaning anddisinfection are crucial for effective sterilisation.Follow the special instructions given in Chapter8.2 Cleaning, Disinfection and Sterilisation (inAccordance with DIN EN ISO 17664). Consult theuser‘s manuals of the devices used in yourpractice as well.Ensure that only validated cleaning/disinfectionand sterilisation methods are used, that thedevices (disinfector, steriliser) are maintained andinspected at regular intervals, and that thevalidated parameters are preserved throughoutevery cycle.608.2 Cleaning, Disinfection andSterilisation (in Accordancewith DIN EN ISO 17664)8.2.1 Pre-Treatment1. Pulp and dentine residues must be removedfrom the accessory parts immediately (within2 hours or less). Do not allow them to dry! Afterusing the accessory parts on patients, put theparts directly into a bowl filled with an appropriatecleaning and disinfectant solution for cleaning,preliminary disinfection and temporary storage(for max. 2 hours).2. Afterwards, clean the accessory parts underrunning water or in a disinfectant solution to removeall visible contaminants. The disinfectantshould be aldehyde-free (aldehyde sets bloodstains), tested for effectiveness (e.g. VAH/DGHMorFDA-approved or CE certified), appropriate fordisinfecting the accessories and <strong>com</strong>patible withthe accessory parts (see Chapter 8.2.7 MaterialDurability).Always observe the applicable governmenthygiene standards and your practice‘s or clinic‘shygiene regulations as well. This applies especiallyto guidelines for effective prion inactivation.For your own safety, always wear gloves whenhandling contaminated accessory parts.WARNINGS• The cables cannot be autoclaved.• Using substances other than those describedabove can cause damage to thedevice and the accessory parts.• Do not use hot-air or radiation sterilisation,and do not sterilise using formaldehyde,ethylene oxide or plasma.• The plastic casing is not sealed. Do notuse any liquids or sprays directly on theconsole, especially on the display or nearthe electrical sockets.Use only clean, soft brushes or cloths whenremoving contaminants manually. Do not usemetal brushes or steel wool.When cleaning the file clip, open and close it fivetimes in order to clean the inner parts more effectively.Please note that disinfectants used duringpre-treatment are only for personal protection andare not a substitute for post-cleaning disinfection.However, pre-treatment is still important.WARNINGDo not use any automatic processes orultrasonic baths to clean or disinfect theaccessories.

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