42
microspeed® uni motor system
Aesculap Power Systems
5.3.3 Manual cleaning/disinfecting
¾ Use an appropriate neutral, alkaline or mildly alkaline cleaning/
disinfecting agent according to the manufacturer’s instructions. Do
not immerse the product in any fluid.
¾ Remove encrusted materials with a soft nylon brush. Do not use harsh
cleaning agents or metal brushes.
¾ Clean difficult-to-access areas with soft round plastic brushes of
fitting diameter.
¾ Carry out intensive final rinse with distilled, demineralized or fully
desalinated water.
¾ Inspect surfaces and difficult-to-access areas for visible debris. If
necessary, repeat the cleaning/disinfection process.
¾ Use a lint-free cloth or a compressed-air gun for drying the product.
¾ Make certain that difficult-to-access areas and blind holes are dried,
too.
5.3.4 Control, care and inspection
¾ Allow the product to cool down to room temperature.
¾ Inspect the product after each cleaning and disinfecting cycle to be
sure it is clean, functional and undamaged.
¾ Check that the suction control lever can be moved.
¾ Spray-lubricate the friction surfaces of the unlocking sleeve and the
suction control lever, using Aesculap STERILIT® oil spray.
5.3.5 Packaging
¾ Always follow the instructions for use of the respective packaging and
storage equipment (e.g. instructions for use TA009721 for Aesculap
ECCOS® storage system).
¾ Insert the product in its proper position in ECCOS® storage GB580R, or
put it on a tray in such a way that the product is protected against
damage. Observe the weight limit for each tray/container.
¾ Pack trays in a way that is appropriate 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.
5.3.6 Sterilization method and parameters
¾ Sterilize with steam, taking note of the following:
Carry out steam sterilization via an approved steam sterilization
procedure (e.g. sterilizer in conformance with EN 285/ANSI/AAMI/
ISO 11134-1993, ANSI/AAMI ST46-1993 and validated in
conformance with EN ISO 17665 or EN 554/ISO 13683). In the
fractioned vacuum process, sterilization must be carried out using the
134 °C/2 bar program with a minimum holding time of 5 minutes.
Note
Steam sterilization at 134 °C for a holding time of 18 min can adversely
affect the service life of the product.
¾ Make certain that the motor cables are not kinked or coiled up too
tightly. The coil radius has to be larger than 10 cm.
¾ When sterilizing several products at the same time in one steam
sterilizer: Make sure that the maximum allowable load capacity of the
steam sterilizer, as specified by the manufacturer, is not exceeded.
5.3.7 Sterilization for the US market
• Sterilization of the device may be accomplished by steam.
• Aesculap does not recommend the device be sterilized by “Flash” or
chemical sterilization.
• Surgical instruments may also be placed within an Aesculap rigid ster-
ilization container (sterile container) for processing under generally
accepted hospital in-use conditions.
The recommended sterilization parameters are as follows:
WARNING for the US market
If this device is/was used in a patient with, or suspected of having
Creutzfeldt-Jakob Disease (CJD), the device cannot be reused and
must be destroyed due to the inability to reprocess or sterilize to
eliminate the risk of crosscontamination.
5.3.8 Storage
¾ Store reprocessed products under conditions as germ-free as possible,
in a dry, dark, cool and dust-protected room.
CAUTION
Damage to motor cables GD672 and GD673 caused by
sterilization in sterilizers of small volume! Hot wall
surfaces (>150 °C) in the sterilizer can damage the
motor cable!
¾ Protect the motor cable (e.g. by wrapping it in a
cloth).
Sterilization
method
Temp.
Minimum exposure time
Wrapped
In a sterile container
system
Pre-vacuum 270—275 °F 4 min 4 min