Treatment instructions for reusable medical devices

Manufacturer:

Storz am Mark GmbH

Emminger Strasse 39, 78576 Emmingen-Liptingen, Germany Telephone 07465/9260-10, fax 07465/9260-50 eMail: vertrieb@stoma.de, Internet: www.stoma.de

Products:

All of the reusable dental instruments marketed by STOMA, which have a solid construction (no movable parts) and simple jointed constructions. Where different instructions must be followed for certain products, refer to separate instructions for use and/or treatment.

Please note: our instruments are supplied unsterile and must therefore undergo the complete treatment cycle prior to the first use and after each use. Warnings: Restrictions on treatment Particular attention is required when cleaning long narrow cannulas and blind holes. Frequent treatment has little effect on these instruments. The end of the products working life is normally determined by wear and damage due to use. In general, the products should be disinfected and cleaned as soon as possible after use to avoid blood residues from drying on, which in turn are much more difficult to clean. Blood residues can be carriers of Creutzfeld-Jacob pathogens. Remove surface soiling with a disposable towel/paper towel Chemical wet disinfection with suitable disinfectants identified for this purpose in the DGHM list. Follow manufacturers instructions with regard to dosing, reaction time and temperature. Disinfect and clean instruments as soon as possible after use Arrange instruments correctly (jointed instruments opened, use specially intended inserts for instruments with long or narrow cavities such as tubes and cannulas) Water inlet temperature not above 45 C Use only suitable cleaning agents/disinfectants identified for this purpose in the DGHM list. Follow manufacturers instructions with regard to dosing, reaction time and temperature. Ensure thorough rinsing to remove all residues from the cleaning process. Remove instruments from the machine immediately after the programme has ended do not leave in the machine overnight Rotary instruments (burs, cutters, abrasives) are only partially suitable for machine treatment. Treatment in an ultrasonic bath or immersion bath is preferable. as Treatment in automatic cleaning/disinfection machines, see above Equipment: cleaning agent from DGHM list, brush (never use metal brushes), running water Method:

instructions: Site of use Chemical wet disinfection

or: Treatment in automatic cleaning/disinfection machines

Cleaning: automatic Cleaning: manual

DOK_0022_e_Aufbereitungsanweisung.doc

version: 08.11.2006

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Treatment instructions for reusable medical devices

1. Rinse surface soiling from the instrument. 2. Apply cleaning solution to all surfaces with a brush. Ensure that jointed instruments are cleaned in both open and closed position. Pay particular attention to cleaning poorly accessible sites such as locking devices, slits etc. NOTE: a suitable brush must be used to clean cannulas and blind holes so that every part is reached. 3. The instrument is held under running water until all residues of the cleaning agent and visible surface soiling have been removed. The running water must flow through the cannulas and blind holes must be filled and emptied repeatedly. We recommend demineralised water for the final rinsing. Maintenance, inspection Oil the joints of instruments with a paraffin-based lubricant beand testing fore testing their function. Check that jointed instruments move freely. Check the function of locking mechanisms. All instruments: visual inspection for damage and wear. Sort out blunt or defective instruments. Preparation for sterilisation Individual items: use a standardised packaging material. Sets: sort instruments into the trays provided. Pack jointed instruments in open state. The bag must be big enough for the instrument/tray so that the seal is not under tension. Sterilisation Sterilisation by validated sterilisation method with moist heat in accordance with DIN EN ISO 17665-1 bzw. ISO 11134. Record sterilisation date (or sterile batch/LOT) on the packaging. Storage Observe the storage period in accordance with the recommended guidelines of DIN 58953 part 7-9 depending on the type of packaging and storage site.
Treatment notes produced in accordance with DIN EN ISO 17664:2004 Note: the user is responsible for ensuring that the actual treatment achieves the desired results with the equipment, materials and staff employed in the treatment facility. This normally requires validation and routine monitoring of the process. Any deviations from the provided instructions should also be evaluated carefully by the user for their effectiveness and possible detrimental consequences. Moreover, we point out that the recommendation of the Robert Koch Institute published in Federal Health Bulletin 4 2006 and any national regulations must always be followed in conjunction with the treatment.

DOK_0022_e_Aufbereitungsanweisung.doc

version: 08.11.2006

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