Braun Aesculap Acculan 4 Instrucciones De Manejo/Descripción Técnica página 16

Aesculap
Attachments for small drill GA344 and drill GA844
7.8 Inspection, maintenance and checks
►
Allow the product to cool down to room temperature.
►
Spray product after every cleaning and disinfection with oil spray
adapter 23 GB600880 (green) approx. 2 sec with Aesculap STERILIT
Power Systems oil spray GB600, see Fig. F.
Note
Aesculap additionally recommends occasional spraying of moving parts
(such as knobs, couplings, cover lids) with the Aesculap STERILIT-Power-
Systems oil spray.
►
Check the product after each cleaning and disinfection for the follow-
ing: cleanliness, damage, function, abnormal operation noise, exces-
sive heat or heavy vibration.
►
Set aside the product if it is damaged.
7.9 Packaging
►
Always follow the instructions for use of the respective packaging and
storage devices (e.g. instructions for use TA009721 for Aesculap-
ECCOS holder system).
►
Insert the products in the correct position into the ECCOS fixations,
see Fig. E.
►
Pack trays appropriately for the sterilization process (e.g. in Aesculap
sterile containers).
►
Ensure that the packaging will prevent a recontamination of the prod-
uct.
7.10 Steam sterilization
Note
Remove all attached components from the product (tools, accessories)
before sterilization.
►
Check to ensure that the sterilizing agent will come into contact with
all external and internal surfaces (e.g. by opening any valves and fau-
cets).
►
Use a validated sterilization method:
– Steam sterilization using fractional vacuum process
– Steam sterilizer DIN EN 285
DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 132 °C/holding
time 4 min
When sterilizing multiple products in one steam sterilizer:
►
Ensure that the maximum permitted load specified by the manufac-
turer for the steam sterilizer is not exceeded.
14
Acculan 4 / ELAN 4 electro
®
and validated
7.11 Sterilization for the US market
■
Aesculap advises against sterilizing the device by flash sterilization or
chemical sterilization.
■
Sterilization may be accomplished by a standard prevacuum cycle in a
steam autoclave.
To achieve a sterility assurance level of 10
following parameters:
Aesculap Orga Tray/Sterile container (perforated bottom)
Minimum cycle parameters*
Sterilization
method
Prevacuum
*Aesculap has validated the above sterilization cycle and has the data on
file. The validation was accomplished in an Aesculap sterile container
cleared by FDA for the sterilization and storage of these products. Other
sterilization cycles may also be suitable, however individuals or hospitals
not using the recommended method are advised to validate any alterna-
tive method using appropriate laboratory techniques. Use an FDA cleared
accessory to maintain sterility after processing, such as a wrap, pouch, etc.
7.12 Storage
►
Store sterile products in germ-proof packaging, protected from dust, in
a dry, dark, temperature-controlled area.
8. Maintenance
To ensure reliable operation, the product must be maintained at least once
a year.
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
pursuant to
-6 , Aesculap recommends the
Temp. Time Minimum drying time
270 °F/275 °F 4 min 20 min