Validated Reprocessing Procedure; General Safety Notes - B.Braun Aesculap Mode D'emploi/Description Technique

Aesculap
Sterile Container System Edition 01/2013
Sterilization
Risk of sterilization failure!
►
Sterilize the containers only by approved and
validated sterilizing processes.
CAUTION
►
Sterilize with steam, taking note of the following: Sterilization must be
carried out through a validated steam sterilizing process (e.g. in a
steam sterilizer according to DIN EN 285, validated according to DIN
EN ISO 17665).
Unloading the sterilizer
Risk of burns due to a hot sterile container after
sterilization!
►
Always wear protective gloves when unloading
WARNING
the sterilizer.
Transporting the sterile container
Risk of non-sterility of container contents!
►
Always carry the sterile containers by their han-
dles.
CAUTION
►
Never carry or lift the sterile container at the
lid.
►
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.
►
Store sterile containers in a dry, clean and protected place.
►
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.
Risk of contamination from improperly sterilized
materials!
►
Prior to commissioning the sterile materials,
DANGER
check to ensure that the sterilization was suc-
cessful.
►
Make certain that the color of the indicator point has changed.
►
Make certain that all container components, particularly the lid locks,
are intact.
►
Ensure the container seal is intact.
6
®
5.

Validated reprocessing procedure

5.1

General safety notes

Note
Adhere to national statutory regulations, national and international stan-
dards and directives, and local, clinical hygiene instructions for reprocess-
ing.
Note
For patients with Creutzfeldt-Jakob disease (CJD), suspected CJD, or possi-
ble variants of CJD, observe the relevant national regulations concerning
the reprocessing of products.
Note
Mechanical reprocessing should be favored over manual cleaning as it
gives better and more reliable results.
Note
It should be noted that successful reprocessing of this medical device can
only be guaranteed following prior validation of the reprocessing method.
The operator/reprocessing technician is responsible for this.
The recommended chemistry was used for 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.
Note
For up-to-date information about reprocessing and material compatibility,
see also the Aesculap Extranet at www.extranet.bbraun.com.