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Verfügbare Sprachen
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5
Reprocessing, Cleaning, Disinfection and Sterilization
5.1
General Information
The operator/user is responsible for cleaning, disinfecting and sterilizing the instrument.
It is essential that national regulations and restrictions be observed.
Use appropriate and approved sterilization packing (e.g. in accordance with EN 868,
ISO 11607) for sterilization, subsequent transport and storage.
Reprocessing instructions acc. to EN ISO 17664 are attached in the form of a separate sheet
intended to be displayed in your instrument reprocessing department.
The parameters for cleaning and disinfecting the product are to be determined by the
operator/user, e.g. as part of the hygiene plan. The treatment agents must be selected to be
compatible with the component materials as well as hygienically and microbiologically
effective. A thorough final rinse must be performed to ensure that no residues are left on any
of the individual components after the treatment.
NOTICE
• Observe all applicable national regulations in regard to reprocessing of the products in case
of patients suffering from Creutzfeldt-Jakob disease, suspected CJD or possible variants of
the disease.
• Note that successful reprocessing of this medical product can be guaranteed only
after prior validation of the reprocessing process. The responsibility for this lies with
the operator/reprocessor.
• In the interest of process capability and better and more reliable cleaning results, machine
reprocessing should always be preferred to manual cleaning, unless they have to be
combined.
• Due to process tolerance, the data provided by the manufacturer serve only as reference
values for the evaluation of the reprocessing processes carried out by the operator/
reprocessor.
62
Bipolar Sealing System marSeal 5 with sterile blade holder
Instructions for Use
Revision 2
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