Aesculap ELAN 4 Gebrauchsanweisung Seite 11

7.8 Inspection, maintenance and checks
►
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.
►
Connect ELAN 4 electro oil spray adapter GB600860 (gray) to connec-
tor for motor cable 3 and spray through the applied part for approx.
2 seconds with Aesculap-STERILIT oil spray GB600, see Fig. B.
►
Check the product for any damage, abnormal running noise, overheat-
ing or excessive vibration.
►
Inspect tools for broken, damaged or blunt edges.
►
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).
►
Place the product in the correct position in the ECCOS holder GB076R,
see Fig. A.
►
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
For further information, see Technical data.
►
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).
►
Validated sterilization process
– Steam sterilization using fractional vacuum process
– Steam sterilizer according to DIN EN 285 and validated according
to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding
time 5 min
►
When sterilizing several products at the same time in a steam sterilizer,
ensure that the maximum load capacity of the steam sterilizer speci-
fied by the manufacturer is not exceeded.
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 Temp.
method
Prevacuum 270 °F/275 °F
*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 in accor-
dance with the maintenance labeling or at least once a year.
e.g. 2016-07
For technical service, please contact your national B. Braun/Aesculap
agency, see Technical Service.
9. Troubleshooting list
Note
For further information, see instructions for use of ELAN 4 electro control
unit GA800 (TA014401).
-6 , Aesculap recommends the
Time Minimum drying time
4 min 20 min
9