Nouvag MD11 Bedienungsanleitung Seite 61

MD 11
Sterilisation of the electronic motor is performed with a fractionated pre-vacuum steam sterilisation
Sterilisation
technique (in accordance with DIN EN 556-1/DIN EN ISO 17665-1) giving due consideration to the respective
national requirements.
Minimum requirements:
1. Pre-vacuum phases: 3
2. Sterilisation temperature: At least 132°C.
3. Hold time: At least 3 minutes (full cycle).
4. Drying time: At least 10 minutes (max. 25 minutes).
When sterilising several products during one sterilisation cycle, do not exceed the maximum steriliser load.
(see manufacturer's details).
A drying cycle must be added in the case of autoclaves without a post-vacuum function. After sterilisation
the perfect sterilisation result needs to be checked using corresponding indications. According to the Robert-
Koch Institute preparation ends with the documented release for use of the medical device.
If the sterilised electronic motor is not used immediately after sterilisation, the material packaging must be
labelled with the sterilisation date.
Storage Storing the sterile packaging
The sterilised product must be stored away from dust,
humidity and contamination. During storage ensure that
there is no direct exposure to sunlight. After the expiry
date has passed, do not use the product any longer.
Information The above preparation process has been verified by a validated procedure.
for validating The following materials and machines were used:
the preparation
1. Alkaline cleaner: Neodisher® Mediclean; Chemische Fabrik Dr. Weigert GmbH & Co. KG
2. Enzymatic cleaner: Neodisher® MediZyme; Chemische Fabrik Dr. Weigert GmbH & Co. KG
3. Cleaning/disinfection unit: Miele G 7836 CD
4. Rack trolley: Miele E429
5. Autoclave: Selectomat 666-HP (MMM)
6. Sterile packaging: Sterisheet 100; Broemeda Amcor Flexibles GmbH
Chemicals and machines other than those mentioned can also be used. In such a case consult the
manufacturers or suppliers to find out whether their products confer the same performance as the products
that the procedure was validated with.
If you should opt for a different procedure for reprocessing to the one given above, you are required to
correspondingly establish the suitability.
Note There is no experience available from conducting other sterilisation procedures such as plasma sterilisation,
low temperature sterilisation procedure, etc.
Caution! Users bear full responsibility if they use a procedure which differs from the validated sterilisation procedure
described!
MD 11, V2.0, Operating Instructions, REF 31665, V22/17
Handling the sterile packaging
Before taking out the product, check that the
sterile packing is intact. When taking out the
product, follow the respective aseptic procedures.
EN
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