Safe Handling; Product Description; Intended Use; Operating Principle - B.Braun Aesculap Instrucciones De Manejo/Descripción Técnica

1.

Safe handling

Risk of contamination of sterile goods from
unsealed sterile containers!
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 container prod-
ucts with each other.
►
Prior to use, check that the product is in good working order.
►
To prevent damage caused by improper setup or use and in order not
to compromise the warranty and liability:
– Use the product only according to these instructions for use.
– Follow the safety and maintenance instructions.
– Never use damaged or faulty sterile containers. Replace any dam-
aged 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 con-
tainer thoroughly before use.
►
Ensure that only persons with the requisite training, expertise or expe-
rience will handle the product and its accessories.
►
Keep the instructions accessible for personnel.
►
Follow general guidelines and aseptic principles when handling con-
taminated 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 devices can be sterilized, stored and trans-
ported in the Aesculap optics container. The container can also be used for
transporting medical devices back to the decontamination center after
use. The Aesculap sterile container system is suitable for steam steriliza-
tion.
Note
Please contact your Aesculap representative if your Aesculap sterile con-
tainers 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 appli-
cation.
3.

Preparation and setup

3.1

First use

►
Thoroughly clean the new sterile container prior to first use.
►
After cleaning, use a suitable filter, see Filter change.
Sterile Container System PrimeLine:
The germ barrier system 16 (permanent filter) is integrated in the system.
3