B.Braun AESCULAP S4 Mode D'emploi page 23

4
S Spinal System
– Not applicable for the USA – See version for the USA –
Sterility
• The implant components are delivered unsterile.
• The implant components are delivered in individual
packaging.
!
Store implant components in their original packaging and
only remove them from such packaging immediately befor
use.
!
Prior to use, preclean and steam sterilize implants in
accordance with applicable hospital guidelines for the
preparation of sterile materials.
Sterilization method and parameters
!
Use the implant system storage trays for sterilization and
sterile preparation.
!
Sterilize with steam, taking note of the following:
The sterilization has to be done according to a validated
steam sterilization procedure (e.g. in a sterilizer according to
EN285/ANSI/AAMI/ISO11134-1993, ANSI/AAMI ST46-1993
and validated according to EN 554/ISO 13683). In case of
application of the fractionated vacuum procedure the
sterilization has to be done using the 134 °C/2 bar program
with a minimal holding time of 5 minutes.
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