Aesculap Neurosurgery
MINOP TREND (TRansnasal ENDoscopy System)
14
Control, care and inspection
¾
Allow the product to cool down to room
temperature.
¾
Lightly lubricate movable parts (irrigation sheath
lock, irrigation button, handle cone) with
maintenance oil suitable for the respective
sterilization process (e.g. Aesculap STERILIT® Spray
JG600 or maintenance oil JG598).
¾
Assemble the separable product, see Assembling.
¾
Inspect the product after each cleaning and
disinfecting cycle to be sure it is clean, functioning
properly, not damaged, has intact insulation and
does not have any loose, bent, broken, cracked,
worn, or fractured components.
¾
Check for compatibility with associated products.
¾
Set aside the product if it is damaged.
Packaging
¾
Appropriately protect products with fine working
tips.
¾
Sort the product into its appropriate storage device
or put it on a suitable tray.
¾
Package trays appropriately for the sterilization
process (e.g. in Aesculap sterile containers).
¾
Pack the product in such a way that the packaging
will prevent recontamination of the product in the
period between reprocessing and reuse.
Sterilization method and parameters
Note
The product can be sterilized either in disassembled or
in assembled condition.
¾
Make certain that all external and internal surfaces
will be exposed to the sterilizing agent (e.g. by
opening all valves and faucets).
¾
Validated sterilization process
– Steam sterilization through fractionated vacuum
process
– Steam sterilizer acc. to EN 285/ANSI/AAMI/
ISO 11134-1993, ANSI/AAMI ST 46-1993,
validated acc. to EN 554/ISO 13683
– Sterilization through fractionated vacuum process
at 134 °C/holding time 5 min
¾
When sterilizing several products at the same time
in one steam sterilizer: Make certain that the
maximum allowable load capacity of the steam
sterilizer, as specified by the manufacturer, is not
exceeded.
Sterilization for the US market
•
Aesculap does not recommend the device sterilized
by flash or chemical sterilization.
•
Sterilization may be accomplished by steam auto-
clave in a standard prevacuum cycle.
To achieve a sterility assurance level of 10-6, Aesculap
recommends the following parameters:
*Aesculap has validated the above sterilization cycle
and has the data on file. The validation was accom-
plished in an Aesculap Sterilcontainer cleared by FDA
for the sterilization and storage of these instruments.
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.
Aesculap Orga Tray/Sterilcontainer (perforated
bottom)
Minimum cycle parameters*
Sterilization
method
Temp.
Time
Minimum
drying time
Pre-vacuum
132 °C
(275 °F)
4 min
20 min
Summary of Contents for Aesculap Neurosurgery
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