baholzer - B-DYN

Page 5 / 48 Disinfection Steps 6 Rinse and finition Soak the instrument in reverse osmosis water for 1 minute. Use a syringe and 60mL of reverse osmosis water to access all difficult areas. Repeat soaking 2 additional times using fresh water - Reserve osmosis water - Syringe Minimum 1 minute 7 Final Rinse Rinse carefully with distilled water - Distilled water Minimum 1 minute 8 Final Drying Dry devise utilizing medical quality filtered air - Medical quality filtered air Until product is visually dry 9 Tidying The instruments have to be placed in the right position inside the trays as described on the position map fixed on the tray for the sterilization. Note: In case of suspection of Creutzfeld-Jakob Disease (CJD), incinerate the ancillaries and the fixation pliers In case of non respect of the instructions mentioned above, the healthcare center will have to apply a validated equivalent cleaning process for which it will be fully responsible. 11-STERILIZATION OF BDYN ANCILLARIES Sterilization is performed under the responsibility of the healthcare centers. The following prescribed method and materials must be used to reduce the risk of transmission of UTA, (French health ministry - DGS/R13/2011/449 dated 01/12/2011). In case of non respect of the instructions mentioned above, the healthcare center will have to apply a validated equivalent cleaning process for which it will be fully responsible. 1- The sterilization in autoclave is to make in a specific container (fenced basket, Tray, Plastic tray placed in a peelable pouches autoclavable). NB: It isn’t recommended to realize the sterilization with peelables pouches autoclavables without a container ➔ Ancillaries can pierce the films components the pouches. 2-A sterilization BY AUTOCLAVE is advised following this protocol: Steam sterilization parameters Values Cycle Type Pre-vacuum Set Point Temperature 134°C / 273°F Cycle Time Minimum 3 minutes Dry Time Minimum 30 minutes Cool Time (inside and outside the autoclave chambers) Minimum 40 minutes 3 - Remark: After each cycle of cleaning/sterilization, insure of all the good working of the ancillaries: verify the integrality and the correct operation, of the locking systems (clipping, prehension) without excessive play. 4- If the ancillaries utilization is different, after sterilization stock them in a tray on a peelable pouches. In case of non respect of the instructions mentioned above, the healthcare center will have to apply a validated equivalent cleaning process for which it will be fully responsible. 12-STORAGE PRECAUTIONS - The BDyn devices must be stored in a clean, dry and tempered place under atmospheric pressure, away from sunlight and rays in its original packaging. Ensure that the box is not dropped, hit or crushed. - The ancillaries must be stored in their dedicated container or equivalent packaging to prevent any deterioration. 13-EXPLANTATION AND ELIMINATION OF DEVICES Explantation and handling should be done following recommendations of ISO 12891-1:2015 « Implants for surgery – Retrieval and analysis of surgical implants » Part 1: « Retrieval and Handling ». Any explanted device must be send back, for analysis, following the current protocol. This protocol is available on demand to COUSIN BIOTECH. It is important to note that any implant that should not have been cleaned and disinfected before expedition must be contained in a sealed package. The elimination of explanted medical device must be conducted in accordance with standards in the country for the disposal of infectious hazards waste. The elimination of a non-implanted device is not the subject of specific recommendations. The surgeon will decide the necessity of the resection of the BDyn, its replacement or the rachis fusion according to the known and recognized techniques. 14-INFORMATION REQUEST AND CLAIMS Following its quality policy, COUSIN BIOTECH is committed to make every effort to produce and supply a high quality medical device. However, if a health professional (client, user, prescriber ...) had a claim or cause of dissatisfaction with a product in terms of quality, safety or performance, he must inform COUSIN BIOTECH as soon as possible. In case of failure of an implant or if it contributed to cause serious adverse effects for the patient, the healthcare center must follow the legal procedures in his country, and inform COUSIN BIOTECH in the shortest time. For any correspondence, thank you to specify the reference, batch number, the coordinates of a reference and a comprehensive description of the incident or claim. Brochures, documentation and surgical technique are available on request from COUSIN BIOTECH and its distributors. If further information is needed or required, please contact your COUSIN BIOTECH representative or distributor. Table of contents