Manual Cleaning/Disinfecting; Control, Care And Inspection; Packaging; Sterilization Method And Parameters - B. Braun microspeed uni Instructions For Use Manual

Aesculap Power Systems
microspeed® uni motor system

5.4.4 Manual cleaning/disinfecting

Do not clean the product by ultrasound treatment under any
circumstances.
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. Allow any fluid that has
penetrated the device to run out immediately.
Clean all surfaces with a soft plastic brush and a suitable cleaning/
disinfecting agent.
Remove encrusted debris with a soft nylon brush. Do not use harsh
cleaning agents or metal brushes.
For cleaning the cannulation, use special cleaning brush TA011327.
Thoroughly brush and rinse surfaces under running water.
Carry out intensive final rinse with distilled, demineralized or fully
desalinated water.
Inspect for visible debris all surfaces and places that are difficult to
access. If necessary, repeat the cleaning/disinfection process.
Dry the product with a lint-free cloth.
Make certain that lumens and channels are dried, too.

5.4.5 Control, care and inspection

Allow the product to cool down to room temperature.
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.
Set aside the product if it is damaged.

5.4.6 Packaging

Always follow the instructions for use of the respective storage devices
(e.g. instructions for use TA009721 for the Aesculap ECCOS® storage
system).
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.
Package trays appropriately for the sterilization process (e.g. in
Aesculap sterile containers).
Pack the product in such a way that the packaging will prevent
recontamination of the product in the period between reprocessing
and reuse.
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5.4.7 Sterilization method and parameters

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
CAUTION
cable!
Protect the motor cable (e.g. by wrapping it in a
cloth).
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
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.
Make certain that the motor cables are not kinked or coiled up too
tightly. The coil radius has to be larger than 10 cm.
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:
Sterilization
Temp.
method
Pre-vacuum 270—275 °F
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

Store processed products under conditions as germ-free as possible, in
a dry, dark, cool and dust-protected room.
ST46-1993 and validated
Minimum exposure time
In a sterile container
Wrapped
system
4 min 4 min
in