The disinfection set complies as well with the high quality and safety standards of the EC tissue guideline 2004/23/EC of 03/31/2004, the commission guideline 2006/17/EC as per 02/08/2006, the commission guideline 2006/86/EC as per 10/24/2006, which have been implemented into German Law with the TPG-Tissue Regulation - TPG-GewV from 26/03/2008 as with the German AMWHV (German regulation for the manufacture of pharmaceuticals and active ingredients) of 11/03/2006 The disinfection set comprises an external packaging and a disinfection container.
The two-piece packaging is made of polystyrol and closes sterilely by means of a thread mechanism with an Evoprene seal.
The disinfection container is made of Makrolon and consists of two chambers, thus complying with the A standards for clean rooms.
The bottom part of the container accommodates the femoral head and is filled with the disinfection medium up to the marking line. The lid or transfer container is used for sterile closure of the bottom chamber and for taking up the disinfection liquid at the end of the process.
The disinfection container is used for thermal disinfection of allogenic femoral heads from living donors in the Lobator sd-2 device and for subsequent sterile storage in the deep freezer.
Prior to the first use of the system the operator should be thoroughly trained by a telos representative or an experienced colleague.
After use, the disinfection containers need to be discarded in accordance with category B of the hospital waste regulation
Warnings / Precautions:
The red safety thread on the external packaging needs to be fully intact.
The valve of the transfer container must only be closed (turned by 360°) after complete drainage of the liquid, otherwise the correct function of the disinfection container is not guaranteed
The disinfection sets are manufactured in lots. Each lot is only released for sale after hygienic testing of the manufacturing conditions by a ZLG accredited laboratory, confirming that the germ contamination on the disinfection sets before sterilization (bioburden) does not exceed the prescriptive limits and provided the submission of a sterility certificate issued by a certified contract sterilization laboratory.