All personnel involved in the handling of these products are responsible for acquiring suitable knowledge and skills to undertake the activities linked to using this product.
STORAGE AND TRANSPORT PROCEDURES
The device must be stored at room temperature in a dry, dust-free area. The product should be kept away from humidity and water (rain, high humidity, condensation, splashing) and direct sunlight.
The product is not supplied as sterilised.
Therefore, prior to insertion, the implant and the components of the kit must be sterilised using a steam-based sterilisation unit which has been duly validated.
General instructions for sterilisation placed under vacuum (high vacuum) previously.
*The implants, instruments and surgical tray must not be removed from the autoclave until the ‘drying cycle’ has finished.
Healthcare personnel will have ultimate responsibility for ensuring that any packing method or material – including a rigid reusable bin system – is suitable for use in the sterilisation process and for maintenance within the healthcare facilities.