Braun Sterile Container System 9-Jul - Manual (Page 8)

6
Sterile container system
Aesculap Sterile Technology
Unloading the sterilizer
Transporting the sterile container
Storing the sterile containers
Note
The sterile containers may be stored in stacks.
¾ Store sterile containers in a dry, clean and protected place.
¾ Observe 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.
¾ Make certain that the color of the indicator point has changed.
¾ Make certain that all container components, particularly the lid locks,
are intact.
¾ Ensure the container seal is intact.
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.
WARNING
Risk of burns due to a hot sterile container after
sterilization!
¾ Always wear protective gloves when unloading the
sterilizer.
CAUTION
Risk of non-sterility of container contents!
¾ Always carry the sterile containers by their handles.
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.
DANGER
Risk of contamination from improperly sterilized
materials!
¾ Prior to commissioning the sterile materials, check
to ensure that the sterilization was successful.