Clinician's Choice Preparation and Reprocessing Instructions in accordance with DIN/EN ISO 17664

Preparation and Reprocessing Instructions in accordance with DIN/EN ISO 17664 Polishers

MANUFACTURER

METHOD

CB Ernst Healthcare Consulting EVE Vetter GmbH GmbH Am Neumarkt Neureutstr. 6 34, 22041 Hamburg, Germany Distributed by: Clinician’s 75210 Keltern, GermanyChoice Dental Products, Inc

SYMBOL

REV. STATUS

H

09

LANGUAGE

English

en

WARNINGS:

!

• Observe the manufacturer’s information on material compatibilities for cleaning, disinfection and sterilisation. • All instruments are delivered unsterile and must go through the indicated cycle before and after each use. • Strong acids and strong bases may oxidise the stainless steel shank. • Avoid temperatures >150 °C. • Ultrasonic bath must not exceed temperatures of 42 °C because of the possible coagulation of protein. • Instruments that have not completely dried after cleaning and disinfection must be dried again (e.g. with medical compressed air) to avoid compromising the success of sterilisation. • Instructions of cleaning and/or disinfecting solutions must specifically state “suitable for rubber polishers or synthetics/silicones”. The exposure time and concentration specified by the manufacturer must be followed.

RESTRICTION OF REPROCESSING: Repetitive reprocessing can slightly change both the look and feel of the product, but does not interfere with the instrument’s function. RISK ASSESSMENT AND CLASSIFICATION OF MEDICAL DEVICES BEFORE REPROCESSING: The type and scope of reprocessing is determined by the use of the medical device. Therefore, the operator is responsible for the correct classification of the medical devices and thus for the definition of the type and scope of reprocessing (see KRINKO/BfArM recommendation, point 1.2.1 Risk assessment and classification of medical devices prior to reprocessing). On the basis of this user-dependent classification, the operator can determine which of the reprocessing methods listed in this preparation and reprocessing instruction needs to be applied. PLACE OF USE:

No special requirements

STORAGE AND TRANSPORT:

It is recommended to transport the contaminated instruments in a closed container. It is recommended that instruments be reprocessed as soon as possible, within 2 hours after use at the most. Intermediate storage of used instruments with contamination such as blood residues can lead to corrosion damage.

PREPARATION:

Wear personal protective equipment (durable gloves, water-repellent coat, face protection mask or goggles and protection mask).

PRE-TREATMENT:

Pre-clean under running water with a brush (plastic) directly after use. Equipment: Plastic brush (e.g. lnterlock, #09084), tap water (20± 2 °C) (at least drinking water quality) 1. Rinse the polishers under running water for 60 seconds and brush them thoroughly with a plastic brush, particularly the difficult to access areas of the head (bristles, silicone bristle tips).

CLEANING: MANUAL

Note: Coarse surface contamination on the instruments must be removed before manual reprocessing (see pre-treatment) Equipment: Multi-stage enzymatic cleaner (e.g. Dürr Dental, ID 215), tap water/flowing water (20± 2 °C) (at least drinking water quality), ultrasonic bath (e.g. Sonorex Digital 10P) 1. Prepare the cleaning solution according to the manufacturer‘s instructions (Dürr Dental ID 215 2% solution was validated) and fill into an ultrasonic bath. 2. Completely immerse the polishers in the solution. 3. Expose the products for 1 minute to the ultrasonic bath. 4. Remove the polishers from the cleaning solution and rinse them each thoroughly (30 seconds) under running water. 5. Check for cleanliness. If contamination is still visible, repeat the above specified steps.

DISINFECTION: MANUAL (with subsequent sterilisation)

Equipment: At least limited virucidal instrument disinfectant (VAH listed - or at least listed in the IHO with testing according to DVV) e.g. based on quaternary ammonium compound(s), alkylamine(s)/alkylamine derivative(s), guanidine(s)/guanidine derivative(s) (e.g. Dürr Dental, ID 212), preferably fully deionised water (deionised water, according to KRINKO/BfArM recommendation free of facultatively pathogenic microorganisms), ultrasonic bath (e.g. Sonorex Digital 10P), lint-free sterile cloth. 1. Prepare the disinfectant solution according to the manufacturer’s instructions (Dürr Dental ID 212, 2% solution was validated) and place into an ultrasonic bath. 2. Completely immerse the polishers in the disinfectant solution. 3. Expose the products for 2 minutes to the ultrasonic bath. 4. Further exposure time to the disinfectant solution for 5 minutes according to the desinfectant manufacturer’s instructions. 5. Remove the polishers from the disinfectant solution and allow to drip off. 6. Rinse the products with deionised water for 30 seconds. 7. Wipe with a single use sterile lint-free cloth or, if necessary, dry with medical compressed air.

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