Bowa ERGO 300, Инструкция по применению

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Instructions for use, ERGO 300 - BOWA- IFU-12930- ERG0300-S0-EN-20210701 37
Sterilization The instruments are sterilized using a fractionated pre-vacuum steam sterilization process (in accordance with DIN EN
ISO 17665-1), taking into account the respective national requirements.
Minimum requirements:
1. Pre-vacuum phases: 3
2. Sterilization temperature: minimum 132°C to maximum 134°C
3. Holding time: At least 5 minutes (full cycle).
4. Drying time: at least 10 minutes ( maximum 25 minutes )
When sterilizing several products in one sterilization cycle, the maximum load of the sterilizer must not be exceeded
(see manufacturer’s instructions). In the case of autoclaves without a pre-vacuum, a drying phase must take place. After
the sterilization, the perfect sterilization result must be checked with the help of appropriate indications. According to
the Robert Koch Institute, reprocessing ends with the documented release of the medical device for use. If the sterilized
instruments are not used immediately after sterilization, the packaging must be labeled with the sterilization date.
Storage Storage of sterile packagings
The sterilized product is stored protected from dust, mois-
ture and contamination. Direct sunlight must be avoided
during storage. After the expiry date, the product must be
reprocessed.
Handling of sterile packaging
The sterilized product is stored protected from dust, mois-
ture and contamination. Direct sunlight must be avoided
during storage. After the expiry date, the product must be
reprocessed.
Information on
validation of the
Reprocessing The above reprocessing process has been verified by a validated procedure. The following materials and machines were
used:
1. Alkaline cleanser: Neodisher® Mediclean; Chemische Fabrik Dr. Weigert GmbH & Co. KG
2. Enzymatic cleanser: Neodisher® MediZyme; Chemische Fabrik Dr. Weigert GmbH & Co. KG
3. Cleaning and disinfection device: Miele G7836 CD
4. Slide-in trolley: Miele E429
5. Sieve basket / rinsing bar: 3mach (Nouvag REF 51401)
6. Steam sterilizer: Selectomat 666-HP (MMM)
7. Sterile packaging: Sterisheet 100; Broemeda Amcor Flexibles GmbH
Chemicals and machines other than those mentioned can also be used. In this case you agree with the manufacturers or
suppliers whether their products provide the same performance as the products with which the process was validated.
If you decide to use a different reprocessing method than the one mentioned above, it is your duty to prove suitability
accordingly.
Note There is no experience with the implementation of other sterilization processes, such as plasma sterilization, low-tem-
perature sterilization processes, etc.
The user bears full responsibility when using a method other than the described, validated sterilization method!
Attention! Please also observe the legal provisions applicable in your country as well as the hygiene regulations of the doctor‘s prac-
tice or hospital. This applies in particular to the different requirements for effective prion inactivation.
Preparation of grippers
The gripping pliers shown are not part of the “morcellator set”, but can be ordered as an option. The instructions required
for reprocessing are described in detail in the instructions for use supplied with the respective gripper.