Directions for Use The autoclavable containers are not sterile upon delivery. They must be washed before first use and sterilized using Type B sterilization cycles. It is a good idea to wash the autoclavable containers with soap and water before each use in order to keep bacterial levels low. If the autoclavable container has not been used in a long time, or if contamination with biological material is suspected, the container should undergo a deep cleaning in which the silicon supports are removed and disinfected using the typical procedure for the preparation of instruments and surgical tools for steam sterilization. If the silicon supports have been removed, dry the container before reassembly. A visual inspection can verify the integral state of the container. Place the tools to be sterilized in their proper supports which will hold them still during the sterilization cycle. Laboratory tools should be inserted into the silicon support by their stems, leaving the area to be sterilized uncovered. Surgical tools should be inserted handle first and not by their working end. The tray with utensils should be placed inside the container which can then be closed. Autoclavable containers are not able to retain sterility; to keep them sterile, they must be placed, together with their contents, inside bags (with reference to EN 868) which are able to preserve sterility. After using the tools, the autoclavable container must be placed in a protected place to avoid unnecessary contamination until re-use.
Intended Use The autoclavable containers have been designed for the sterilization cycles of small steam sterilizers used for medical purposes or for material which can come in contact with blood or bodily fluids. The product is intended for outpatient use by Medical or Paramedical personnel familiar with the autoclave sterilization process.
The function of the autoclavable containers is to: - keep tools in the correct position for transport and storage as well as during and after the autoclave sterilization cycle; tools are held by the stem and handle with the working end face up. - enable the correct performance of the sterilization process, allowing steam to penetrate inside the container; - keep the utensils it holds uncontaminated during and after the autoclave sterilization process. The containers can therefore be sterilized together with the surgical tools. Sterilization cycles are defined by the manufacturer of the laboratory instruments and surgical tools and/or by the autoclave manufacturer.
Based on Ippi S.r.l.’s tests, the sterilization cycle for the autoclavable containers has the following characteristics: • maximum temperature of 134°C; • cycle duration of 18 minutes; The compatibility of sterilization cycles required for the autoclave, tools and container can be verified by checking the sterilization cycles as defined in their respective user manuals. The autoclavable container, complete with silicon supports, has been tested in 200 sterilization cycles. The raw material for the tray and container has been tested in 1000 sterilization cycles. There was no sign of wear and tear to the material after testing.
Warnings and Precautions The autoclavable containers are not sterile upon delivery. Autoclavable containers are not able to retain sterility. For this reason it is necessary to put the autoclavable containers with the utensils to be sterilized in special bags (with reference to EN 868). Inappropriate use, breakage and deterioration of the material can compromise the container’s resistance to sterilization or it’s ability to be sterilized; re-use is not advised in case of damage to any component. Exposure to sunlight can cause the container to change color but will not compromise its resistance to sterilization or its ability to be sterilized.