Braun 9-Jul manual Validated processing procedure, General notes

Aesculap Sterile Technology

Sterile container system

Unloading the sterilizer

Risk of burns due to a hot sterile container after sterilization!

¾Always wear protective gloves when unloading the

WARNING sterilizer.

Transporting the sterile container

Risk of non-sterility of container contents!

¾ Always carry the sterile containers by their handles.

CAUTION	¾	Never carry or lift the sterile container at the lid.
	¾	Transport the sterile container in such a way that

mechanical damage will not occur.

Storing the sterile containers

Note

The sterile containers may be stored in stacks.

¾Store sterile containers in a dry, clean and protected place.

¾Observe storage periods and storage conditions acc. to DIN 58953-9.

Checking and commissioning the sterile materials

The contents of a sterile container can be commissioned as sterile only if the container has been properly sterilized, stored and transported.

If this is not the case, the sterile materials must be processed again.

Risk of contamination from improperly sterilized materials!

¾Prior to commissioning the sterile materials, check

DANGER to ensure that the sterilization was successful.

¾Make certain that the color of the indicator point has changed.

¾Make certain that all container components, particularly the lid locks, are intact.

¾Ensure the container seal is intact.

6

5. Validated processing procedure

Note

Adhere to national statutory regulations, national and international standards and directives, and local, clinical hygiene instructions for sterile processing.

Note

For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible variants of CJD, observe the relevant national regulations concerning the reprocessing of the products.

Note

Up-to-date information on processing can be found on the Aesculap Extranet at www.aesculap-extra.net

Note

Successful processing of this medical product can only be ensured if processing is performed through a validated processing procedure. The user/processor is responsible for the validation.

Due to process tolerances, the manufacturer’s specifications can only serve as an approximate guide for assessing the processing procedures applied by the individual operator/processors.

5.1 General notes

Encrusted or fixated residues from surgery can make the cleaning process more difficult or ineffective, and can cause corrosion of stainless steels. To avoid this, the time interval between application and processing should not exceed 6 h, and neither fixating pre-cleaning temperatures >45 °C nor any fixating disinfecting agents (active ingredients: aldehyde, alcohol) be used.

Excessive doses of neutralizers or basic detergents can cause chemical degradation and/or fading and obliteration of laser inscriptions on stainless steel surfaces, regarding visual reading and machine-readability of the inscriptions.

Residues containing chlorine or chlorides e.g. in surgical residues, medicines, saline solutions and in the service water used for cleaning, disinfection and sterilization will cause corrosion damage (pitting, stress corrosion) and result in the destruction of stainless steel products. To remove such residues, the products must be rinsed sufficiently with fully desalinated water and dried thoroughly.