Braun Aesculap Spine Instructions For Use/Technical Description page 14

Aesculap Spine
activ L chisel and chisel guides
Inspection, maintenance and checks
Damage
corrosion) to the product caused by
insufficient lubrication!
CAUTION Prior
lubricate moving parts (e.g.
joints, pusher components and
threaded
maintenance oil suitable for the
respective sterilization process
(e.g. for steam sterilization:
Aesculap STERILIT® I oil spray
JG600 or STERILIT® I drip
lubricator JG598).
Allow the product to cool down to room
temperature.
After each complete cleaning, disinfecting and
drying cycle, check that the product is: dry, clean,
operational, and free of damage (e.g. broken
insulation 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
Service, see Technical Service.
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).
12
(metal seizure/friction
to function checks,
rods) with
Ensure that the packaging provides sufficient
protection against recontamination of the product
during storage (DIN EN ISO 11607).
Sterilization
Note
The product can be sterilized either in disassembled or
in assembled condition.
Ensure that the sterilant can reach all external and
internal surfaces (e.g. by opening valves and
stopcocks).
Validated sterilization process
– Disassemble the product.
– 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 products 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.
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:
fractionated vacuum
-6
, Aesculap