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Instruction for use

Sterilization container (Container, Boxes) for steam sterilization

Geister Medizintechnik GmbH Föhrenstraße 2 78532 Tuttlingen / Germany Tel.: +49-7461-96624-0 FAX: +49-7461-96624-22 E-Mail: info@geister.com

General:

The Geister sterilisation container is a reusable sterilisation container made of metal, conforming to EN 868-1/EN 868-8, which is provided with a filter that ensures forced admission for the sterilising medium. In the sterilisation container the items can be transported and sterilised in the sterilisation chamber by trained and qualified personnel. Outside the sterilisation chamber the sterilisation container allows sterile storage taking into account the ambient conditions defined in DIN 58953-9. The product you have purchased is an accessory for apparatuses (DIN 58946 and DIN EN 285 autoclaves) which are intended for sterilisation. When using steam sterilisers which do not satisfy the requirements of DIN 58946 or DIN EN 285 the sterilisation process must be validated in conjunction with the sterilisation container in accordance with EN 554. Depending on packing and the method of steam sterilisation, sterilisation containers must be used with a filter in the lid, with a filter in the bottom, or with a filter in the lid and bottom (see DIN 58953 Part 9). The maximum load weight for instrument sterilisation is 10 kg, including perforated tray. In the case of textiles a load weight of 6.5 – 7 kg is permissible. In order to ensure that the lid of the sterilisation container can be closed properly, the container may be loaded up to a maximum of 20 mm below the brim. Any additional internal packaging used must not exceed the maximum loading height. Use:

Before every use make sure that there is no solid or liquid soiling inside the container or on the outside and check operability of the filter (visual inspection). Disposable sterilisation filters made of paper impermeable to micro-organisms (EN 868-2) must be changed before every use. Long-life filters made of cotton (as per DIN 58953 Part 6) must be changed after 60 sterilisation cycles - before the cotton gradually burns. Only use the filter materials available from Geister Medizintechnik GmbH. Only use containers which have no visible signs of damage. This particularly applies to the sealing surface of the container gasket in the lid and the brim. In addition, bent lids and filter plates must be replaced immediately or else it will not possible to guarantee sterile storage of the sterile items. Check all fittings on the sterilisation container to make sure they are secure. When the lid is completely open, the side clamp locks on the sterilisation container must close with noticeable tension in order to ensure that the container remains impermeable to micro-organisms. In order to prevent the container from being opened inadvertently after sterilisation the side locks can be secured with suitable disposable plastic seals. Containers may only be cleaned and subjected to chemical disinfection by using aluminium-compatible liquids. To clean the container, undo the filter retention plates and remove the filters. After completion of the cleaning process fit the filters, new filters if necessary, together with the filter retention plates.

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When the container has been filled with the items for sterilisation, the closed container is placed in the sterilisation chamber according to the autoclave manufacturer's instructions and sterilised according to his instructions. After the cooling phase the sterilisation container can be removed and stored with the sterilised items as follows, in accordance with the provisions of DIN 58953-9, until the sterile items are to be used:

Packaging of sterile items

Type of packaging Storage life

Sterilisation containers as per DIN EN 868-1 or DIN EN 868-8

Single packaging for sterile items Double packaging for sterile items

6 months

Since the storage period figure stated above is only for guidance under normal aseptic conditions, attention is drawn to the fact that if asepsis standards required are particularly high, shorter storage periods have to be applied or impairment of asepsis must be prevented by taking other measures, such as providing additional packaging. Ultimately it is the medical superintendent who is responsible for stipulating the storage life. The service life of the sterilisation container is 1,000 cycles in use. The gasket on the sterilisation container has the same service life as the sterilisation container and does not have to be subjected to maintenance or replaced. The product conforms to the statutory health and safety regulations provided it is used under normal operating conditions. Any modifications to the product must be agreed with the manufacturer.