Update Hygiene and Maintenance according to EN ISO 176642017 Rev000 Nov 2018

Contents W&H Symbols... 4 Hygiene and maintenance... 5 Hygiene and maintenance prior to initial use... 5 General notes... 6 Limitations on processing... 8 Initial treatment at the point of use... 9 Manual cleaning... 10 Automated cleaning and lubrication*... 11 Manual disinfection... 12 Automated cleaning and disinfection*... 13 2

Drying... 14 Inspection, Maintenance and Testing... 15 Lubrication... 16 Packaging... 17 Sterilization... 18 Storage... 20

W&H Symbols

WARNING! (risk of injury)

Thermo washer disinfectable 4

ATTENTION! (to prevent damage occurring)

Sterilizable up to the stated temperature

General explanations, without risk to persons or objects

Hygiene and maintenance

Hygiene and maintenance prior to initial use

>> The medical device is sealed in PE film and not sterilized when delivered. >> The PE film and the packaging are non-sterilizable. >> Clean, disinfect and lubricate the medical device. >> Sterilize the medical device.

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Hygiene and maintenance

General notes

Follow your local and national laws, directives, standards and guidelines for cleaning, disinfection and sterilization. This hygiene update in accordance with EN ISO 17664: 2017 supplements the chapter Hygiene and maintenance of the attached instructions for use. >> Wear protective clothing, safety glasses, face mask and gloves. >> Use only oil-free, filtered compressed air with a maximum operating pressure of 3 bar for manual drying. 6

Cleaning agents and disinfectants >> Read the notes, follow the instructions and heed the warnings provided by the manufacturers of cleaning agents and/or disinfectants. >> Use only detergents which are intended for cleaning and/or disinfecting medical devices made of metal and plastic. >> It is imperative to comply with the concentrations and exposure times specified by the manufacturer of the disinfectant. >> Use disinfectants which have been tested and found effective by the Verbund für Angewandte Hygiene e.V (VAH = Association for Applied Hygiene), the Österreichischen Gesellschaft für Hygiene, Mikrobiologie und Präventivmedizin (ÖGHMP = Austrian Society for Hygiene, Microbiology and Preventive Medicine), the Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). The user is responsible for validating its process if the specified cleaning agents and disinfectants are not available.

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Hygiene and maintenance

Limitations on processing

The product lifetime and the medical device’s ability to operate correctly are mainly determined by mechanical stress during use and chemical influences due to processing. >> Send worn or damaged medical devices and/or medical devices with material changes to an authorized W&H service partner. Processing cycles >> We recommend a regular service for the W&H medical device in accordance with the attached instructions for use .

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Hygiene and maintenance

Initial treatment at the point of use

Clean the medical device immediately after every treatment, to flush out any liquid (e.g., blood, saliva etc.) and to prevent settling on the internal parts. >> Operate the medical device for at least 10 seconds at idle speed.* >> Ensure that all outlets are rinsed out.* >> Wipe the entire surface of the instrument with disinfectant. >> Remove the root canal instrument.* >> Remove the medical device.* Note that the disinfectant used during pre-treatment is only for personal protection and cannot replace the disinfectant step after cleaning. *if applicable

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Hygiene and maintenance Do not place the medical device in liquid disinfectant or in an ultrasonic bath!* >> Clean the medical device under running tap water (<35°C / 95°F). >> Rinse and brush off all internal and external surfaces. >> Move moving parts back and forth several times.* >> Remove any liquid residues using compressed air. *if applicable

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Manual cleaning

Hygiene and maintenance

Automated cleaning and lubrication*

W&H recommends automated cleaning and lubrication with W&H Assistina 3x3. >> Follow the instructions in the Assistina Instructions for use. *if applicable

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Hygiene and maintenance

Manual disinfection

>> W&H recommends wiping down with disinfectant.

Evidence of the medical device’s basic suitability for effective manual disinfection was provided by an independent test laboratory using the »mikrozid® AF wipes« disinfectant (Schülke & Mayr GmbH, Norderstedt).

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Hygiene and maintenance

Automated cleaning and disinfection*

W&H recommends automated cleaning and disinfection using a washer-disinfector (WD). >> Read the notes, follow the instructions and heed the warnings provided by the manufacturers of washer-disinfectors, cleaning agents and/or disinfectants. Evidence of the medical device’s basic suitability for effective automated disinfection was provided by an independent test laboratory using the »Miele PG 8582 CD« washer‑disinfector (Miele & Cie. KG, Gütersloh) and the »Dr. Weigert neodisher® MediClean forte« cleaning agent (Dr. Weigert GmbH & Co. KG, Hamburg). >> Cleaning at 55 °C (131 °F) – 5 minutes >> Disinfection at 93 °C (200 °F) – 5 minutes *if applicable

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Hygiene and maintenance

Drying

>> Ensure that the medical device is completely dry internally and externally after cleaning and disinfection. >> Remove any liquid residues using compressed air.

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Hygiene and maintenance

Inspection, Maintenance and Testing

Inspection >> Check the medical device after cleaning and disinfection for damage, visible residual soiling and surface changes. >> Reprocess any medical devices that are still soiled. >> Sterilize the reassembled medical device following cleaning, disinfection and lubrication*. *if applicable

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Hygiene and maintenance See enclosed Instruction for use!

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Lubrication

Hygiene and maintenance

Packaging

Pack the medical device and the accessories in sterilization packages that meet the following requirements: >> The sterilization package must meet the applicable standards in respect of quality and use and must be suitable for the sterilization method. >> The sterilization package must be large enough for the sterilization goods. >> The filled sterilization package must not be under tension.

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Hygiene and maintenance

Sterilization

W&H recommends sterilization according to EN 13060, EN 285 oder ANSI/AAMI ST79. >> Read the notes, follow the instructions and heed the warnings provided by the manufacturers of steam sterilizers. >> The program selected must be suitable for the medical device.

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Recommended sterilization procedures >> Fractionated pre-vacuum process (type B) >> Gravity displacement process (type N) >> Sterilization time at least 30 minutes at 121°C (250°F) or at least 3 minutes at 134°C (273°F) >> Maximum sterilization temperature 135°C (275°F) >> Evidence of the medical device’s basic suitability for effective sterilization was provided by an independent test laboratory using the LISA 517 B17L steam sterilizer (Firma W&H Sterilization S.r.l., Brusaporto (BG)) and the CertoClav MultiControl MC2-S09S273 gravitation sterilizer (CertoClav GmbH, Traun). >> Fractionated pre-vacuum process (type B): temperature 134°C (273°F) – 3 minutes* >> Gravity displacement process (type N): temperature121°C (250°F) – 30 minutes** * according to EN 13060, EN 285, ISO 17665 / ** according to ANSI/AAMI ST55 , ANSI/AAMI ST79

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Hygiene and maintenance >> Store sterile goods dust-free and dry. >> The shelf life of the sterile goods depends on the storage conditions and type of packaging.

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Storage