44
microspeed® uni motor system
Aesculap Power Systems
5.4.4 Manual cleaning/disinfecting
¾
Do not clean the product by ultrasound treatment under any
circumstances.
¾
Use an appropriate neutral, alkaline or mildly alkaline cleaning/
disinfecting agent according to the manufacturer’s instructions.
¾
Do not immerse the product in any fluid. Allow any fluid that has
penetrated the device to run out immediately.
¾
Clean all surfaces with a soft plastic brush and a suitable cleaning/
disinfecting agent.
¾
Remove encrusted debris with a soft nylon brush. Do not use harsh
cleaning agents or metal brushes.
¾
For cleaning the cannulation, use special cleaning brush TA011327.
¾
Thoroughly brush and rinse surfaces under running water.
¾
Carry out intensive final rinse with distilled, demineralized or fully
desalinated water.
¾
Inspect for visible debris all surfaces and places that are difficult to
access. If necessary, repeat the cleaning/disinfection process.
¾
Dry the product with a lint-free cloth.
¾
Make certain that lumens and channels are dried, too.
5.4.5 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 and does not show atypical
running noises, overheating or excessive vibrations.
¾
Set aside the product if it is damaged.
5.4.6 Packaging
¾
Always follow the instructions for use of the respective storage devices
(e.g. instructions for use TA009721 for the Aesculap ECCOS® storage
system).
¾
Insert the product in its proper position in the ECCOS® storage device,
or on a tray in such a way that the product is protected against
damage. Observe the weight limit for each tray/container.
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.
5.4.7 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.
5.4.8 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.
5.4.9 Storage
¾
Store processed products under conditions as germ-free as possible, in
a dry, dark, cool and dust-protected room.
CAUTION
Damage to the pistol handpiece caused by sterilization
in sterilizers of insufficient 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
