Safe Handling; Product Description; Intended Use; Operating Principle - B.Braun AESCULAP Sistema de contenedores estériles Instrucciones De Manejo

1. Safe handling

Risk of contamination of sterile supplies due to
inadequately sealed sterile container!
The sealing of the sterile container and its functioning
WARNING
as a germ barrier will be compromised if the sterile
container is combined with components from other
manufacturers.
Only combine Aesculap sterile container 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.
Adhere to applicable standards.
Follow general guidelines and principles of hygiene 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 intended for use as sterile
packaging for instruments and textiles due for steam sterilization through
a validated steam sterilization process (e.g. in a sterilizer complying with
EN 285/ANSI/AAMI/ISO 11134-1993,
validated according to EN ISO 17665 or EN 554/ISO 13683).
After sterilization, the sterile materials are stored in the sterile container
until they are used.
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 conforms to 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:
• 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 process
Note
The suitability of any specific process must be evidenced by a validation at
the site of application.

3. Preparation and setup

3.1 First use

Thoroughly clean the new container prior to first use.
After cleaning, insert a suitable filter, see Filter change.
Sterile container system PrimeLine:
The germ retention system 16 is integrated with the system.
ANSI/AAMI ST46-1993 and
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