Steam Sterilization; Sterilization For The Us Market - B. Braun Aesculap MINOP InVent Gebrauchsanweisung/Technische Beschreibung

Aesculap ®
MINOP InVent trocar 30°
►
After each complete cleaning, disinfecting and dry-
ing cycle, check that the instrument is dry, clean,
operational, and free of damage (e.g. broken insu-
lation or corroded, loose, bent, broken, cracked,
worn, or fractured components).
►
Dry the product if it is wet or damp.
►
Repeat cleaning and disinfection of products that
still show impurities or contamination.
►
Check that the product functions correctly.
►
Immediately put aside damaged or inoperative
products and send them to Aesculap Technical Ser-
vice, see Technical Service.
►
Assemble separable products, see Trocar assembly.
►
Check for compatibility with associated products.
Packaging
►
Place the product in its holder or on a suitable tray.
Ensure that all cutting edges are protected.
►
Pack trays appropriately for the intended steriliza-
tion process (e.g. in sterile Aesculap containers).
►
Ensure that the packaging provides sufficient pro-
tection against recontamination of the product
during storage.

Steam sterilization

Note
The product may only be sterilized when dismantled.
►
Check to ensure that the sterilizing agent will come
into contact with all external and internal surfaces
(e.g. by opening any valves and faucets).
►
Validated sterilization process
– Disassemble the product
– Steam sterilization using fractionated vacuum
process
– Steam sterilizer according to DIN EN 285 and
validated according to DIN EN ISO 17665
– Sterilization using fractional vacuum process at
134 °C, holding time 18 minutes for prion inac-
tivation
18
►
When sterilizing several instruments at the same
time in a steam sterilizer, ensure that the maxi-
mum load capacity of the steam sterilizer specified
by the manufacturer is not exceeded.

Sterilization for the US market

■
Aesculap advises against sterilizing the device by
flash sterilization or chemical sterilization.
■
Sterilization may be accomplished by a standard
prevacuum cycle in a steam autoclave.
To achieve a sterility assurance level of 10
recommends the following parameters:
Aesculap Orga Tray/Sterile container (perforated
bottom)
Minimum cycle parameters*
Steriliza- Temp.
tion method
Prevacuum 270 °F/27
5 °F
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accom-
plished in an Aesculap sterile container cleared by FDA
for the sterilization and storage of these products.
Other sterilization cycles may also be suitable, how-
ever individuals or hospitals not using the recom-
mended method are advised to validate any alternative
method using appropriate laboratory techniques. Use
an FDA cleared accessory to maintain sterility after
processing, such as a wrap, pouch, etc.
WARNING for the US market
If this device is/was used in a patient with, or sus-
pected of having Creutzfeldt-Jakob Disease (CJD),
the device cannot be reused and must be destroyed
due to the inability to reprocess or sterilize to elim-
inate the risk of crosscontamination.
-6 , Aesculap
Time Minimum
drying
time
4 min 20 min