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

5.3.3 Manual cleaning/disinfecting

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.
Remove encrusted materials with a soft nylon brush. Do not use harsh
cleaning agents or metal brushes.
Clean difficult-to-access areas with soft round plastic brushes of
fitting diameter.
Carry out intensive final rinse with distilled, demineralized or fully
desalinated water.
Inspect surfaces and difficult-to-access areas for visible debris. If
necessary, repeat the cleaning/disinfection process.
Use a lint-free cloth or a compressed-air gun for drying the product.
Make certain that difficult-to-access areas and blind holes are dried,
too.

5.3.4 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.
Check that the suction control lever can be moved.
Spray-lubricate the friction surfaces of the unlocking sleeve and the
suction control lever, using Aesculap STERILIT® oil spray.

5.3.5 Packaging

Always follow the instructions for use of the respective packaging and
storage equipment (e.g. instructions for use TA009721 for Aesculap
ECCOS® storage system).
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.
Pack trays in a way that is appropriate 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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5.3.6 Sterilization method and parameters

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
CAUTION
motor 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.

5.3.7 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:
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.

5.3.8 Storage

Store reprocessed 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