B. Braun Aesculap Spine activ C FW857R Gebrauchsanweisung Seite 14

Aesculap Spine
activ C insertion instrument
Assemble dismountable
Assembling the instrument.
Check for compatibility with associated products.
Packaging
Appropriately protect products with fine working
tips.
Place the product in its holder or on a suitable tray.
Ensure that all cutting edges are protected.
Package trays appropriately for the sterilization
process (e.g. in Aesculap sterile containers).
Ensure that the packaging provides sufficient
protection against recontamination of the product
during storage (DIN EN ISO 11607).
Sterilization
Note
The product may only be sterilized in disassembled
condition.
Note
The irrigation connector must be removed from the
handle end of the insertion instrument prior to
sterilization.
Ensure that the sterilant can reach all external and
internal surfaces (e.g. by opening valves and
stopcocks).
Validated sterilization process
– Disassemble the instrument
– Steam sterilization through fractionated vacuum
process
– Steam sterilizer specified in DIN EN 285 and
validated in accordance with DIN EN ISO 17665
– Sterilization through
process at 134 °C/holding time 5 min
When sterilizing several instruments at the same
time in a steam sterilizer: ensure that the
maximum permitted load specified by the
manufacturer for the steam sterilizer is not
exceeded.
12
instruments, see
fractionated vacuum
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
recommends the following parameters:
Aesculap Orga Tray/sterile container (perforated
bottom)
Minimum cycle parameters*
Sterilization Temp.
method
Pre-vacuum 270 °F—
275 °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 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.
Storage
Store sterile products in germ-proof packaging,
protected from dust, in a dry, dark, temperature-
controlled area.
-6
, Aesculap
Time Minimum
drying time
4 min 20 min