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Treatment instructions

for reusable medical devices

DOK_0022_e_Aufbereitungsanweisung.doc version: 08.11.2006 page 1 of 2

Manufacturer: Storz am Mark GmbHEmminger Strasse 39, 78576 Emmingen-Liptingen, GermanyTelephone 07465/9260-10, fax 07465/9260-50eMail: vertrieb@stoma.de, Internet: www.stoma.de

Products: All of the reusable dental instruments marketed by STOMA, which have a solid con-struction (no movable parts) and simple jointed constructions. Where different in-structions must be followed for certain products, refer to separate instructions foruse 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: Particular attention is required when cleaning long narrow cannulasand blind holes.

Restrictions on treatment Frequent treatment has little effect on these instruments. The end ofthe products working life is normally determined by wear and damagedue to use.In general, the products should be disinfected and cleaned as soon aspossible after use to avoid blood residues from drying on, which in turnare much more difficult to clean. Blood residues can be carriers ofCreutzfeld-Jacob pathogens.

instructions:

Site of use Remove surface soiling with a disposable towel/paper towelChemical wet disinfection Chemical wet disinfection with suitable disinfectants identified for this

purpose in the DGHM list. Follow manufacturers instructions with re-gard to dosing, reaction time and temperature.

or:

Treatment in automaticcleaning/disinfection ma-chines

Disinfect and clean instruments as soon as possible after use

Arrange instruments correctly (jointed instruments opened, usespecially intended inserts for instruments with long or narrowcavities 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 instruc-tions with regard to dosing, reaction time and temperature.

Ensure thorough rinsing to remove all residues from the clean-ing process.

Remove instruments from the machine immediately after theprogramme has ended do not leave in the machine overnight

Rotary instruments (burs, cutters, abrasives) are only partially suitablefor machine treatment. Treatment in an ultrasonic bath or immersionbath is preferable.

Cleaning: automatic as Treatment in automatic cleaning/disinfection machines, see above

Cleaning: manual Equipment: cleaning agent from DGHM list, brush (never use metal

brushes), running waterMethod:

7/28/2019 DOK 0022 Aufbereitung GB

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Treatment instructions

for reusable medical devices

DOK_0022_e_Aufbereitungsanweisung.doc version: 08.11.2006 page 2 of 2

1. Rinse surface soiling from the instrument.2. Apply cleaning solution to all surfaces with a brush. Ensurethat jointed instruments are cleaned in both open and closedposition. Pay particular attention to cleaning poorly accessiblesites such as locking devices, slits etc.NOTE: a suitable brush must be used to clean cannulas andblind holes so that every part is reached.3. The instrument is held under running water until all residuesof the cleaning agent and visible surface soiling have been re-moved. The running water must flow through the cannulas andblind holes must be filled and emptied repeatedly.

We recommend demineralised water for the final rinsing.

Maintenance, inspectionand testing

Oil the joints of instruments with a paraffin-based lubricant be-fore testing their function.

Check that jointed instruments move freely. Check the functionof 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 enoughfor the instrument/tray so that the seal is not under tension.

Sterilisation Sterilisation by validated sterilisation method with moist heat in accor-dance 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 gui-delines of DIN 58953 part 7-9 depending on the type of packaging andstorage 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 theequipment, materials and staff employed in the treatment facility. This normally requires validation and rou-tine monitoring of the process. Any deviations from the provided instructions should also be evaluated care-fully 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 HealthBulletin 4 2006 and any national regulations must always be followed in conjunction with the treatment.