41
5.2.7 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.
5.2.8 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.
5.2.9 Storage
¾
Store processed products under conditions as germ-free as possible, in
a dry, dark, cool and dust-protected room.
5.2.10 Maintenance
To ensure reliable operation, Aesculap recommends that maintenance be
performed after 300 reprocessing cycles, at least once per year.
For services to this end, please contact your national B. Braun/Aesculap
agency, see chapter Technical Service.
5.3 Processing the microspeed® uni shaver handpiece
GD682
5.3.1 Preparations
¾
Prior to first mechanical cleaning/disinfection: Mount ECCOS® storage
GB580R in a suitable tray (e.g. JF214R).
¾
Pre-clean the product, if necessary.
¾
Reprocess the product immediately after use.
¾
Do not immerse the shaver handpiece.
¾
Do not clean the shaver handpiece through ultrasound treatment.
¾
Use cleaning/disinfecting agents that are suitable for the product.
Always follow the manufacturer’s instructions regarding
concentration, temperature and exposure time.
¾
Avoid encrustation of residues/proteins (e.g. caused by aldehyde/
alcohol).
¾
Only use bactericidal, fungicidal and virucidal disinfecting agents.
¾
Preferably use thermal disinfecting processes.
5.3.2 Mechanical cleaning/disinfecting
¾
Place the product in its proper position in ECCOS® storage GB580R
immediately after use.
¾
Connect the rinsing tube of he washing machine at tube olive
38
of
shaver handpiece
37
.
¾
Turn suction control lever
36
of shaver handpiece
37
to the
Ι
-position.
¾
Seal all rinsing tubes of the washing machine that are not used.
¾
Carry out the processing cycle:
– Use an appropriate neutral, alkaline or mildly alkaline cleaning/
disinfecting agent according to the manufacturer’s instructions.
– Do not exceed the maximum washing temperature of 55 °C.
– Wash the product for at least 3 min.
– Neutralize if necessary.
– Carry out intermediate rinse for at least 1 min.
– Carry out intensive final rinse with distilled, demineralized or fully
desalinated water.
– For thermal disinfection: Rinse for 5 min at 93 °C, with distilled,
demineralized or fully desalinated water.
– Conclude the program with a drying period of at least 10 min at a
temperature not exceeding 120 °C.
¾
After completion of the mechanical cleaning/disinfecting cycle,
inspect the surfaces, the driver and the suction channel for visible
debris.
¾
Clean manually if necessary.
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
