Safe Handling; Product Description; Intended Use; Operating Principle - B.Braun Aesculap Mode D'emploi

1. Safe handling

Risk of contamination of sterile materials due to
sealing failure of sterile container!
The sealing of the sterile container and its germ
WARNING
barrier function will be compromised if the sterile
container is combined with components from
other manufacturers.
Only combine Aesculap sterile
products with each other.
Prior to use, check for proper condition and functioning of the product.
To avoid damaging the product through improper setup or operation
and mitigating the warranty and liability on the part of the product's
manufacturer:
– Use the product only according to these instructions for use.
– Follow the safety instructions and maintenance advisories.
– Never use damaged or faulty sterile containers. Replace any damaged
components immediately with original spare parts.
– If sterile container components are repaired in a way that could affect
the container's germproof qualities: Inspect the sterile container
thoroughly before use.
Ensure that only persons with the requisite training, expertise or
experience will handle the product and its accessories.
Keep the instructions accessible for personnel.
Follow general guidelines and aseptic principles when handling
contaminated items that have undergone or are to undergo
sterilization.

2. Product description

2.1 Intended use

The Aesculap sterile container system is a reusable sterile barrier system
that preserves the sterility of medical products until they are used or reach
their use-by date. Medical products can be sterilized, stored and
transported in the Aesculap optics container. The container can also be
used for transporting medical products back to sterile processing after use.
The Aesculap sterile container System is suitable for steam sterilization.
container
Note
Please contact your Aesculap representative if your Aesculap sterile
containers are to be used in any other steam sterilization process.

2.2 Operating principle

The Aesculap sterile container system meets the requirements of
DIN 58953-9 and EN ISO 11607.
Sterile containers with a perforated lid and a closed bottom have been
validated for steam sterilization in a sterilizer acc. to EN 285 through the:
• fractionated vacuum process.
Sterile containers with a perforated lid and a perforated bottom are also
suitable for steam sterilization in a sterilizer acc. to EN 285 through:
• gravitational procedures
Note
The suitability of any specific process must be validated at the site of
application.
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