KLS Martin marSeal 5 Bedienungsanleitung Seite 71

Instructions for Use
Bipolar Sealing System marSeal 5 with sterile blade holder
5.8 Sterilization
WARNING
Risk of infection in case of non-sterile handling!
Improper sterilization and non-sterile handling can entail severe health risks for the patient.
Sterilization must be done using a validated steam sterilization method, e.g. according to
EN 285 in a sterilizer and validated according to EN ISO 17665.
The operator/user is responsible for cleaning, sterilizing and resterilizing the device. 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.
Prior to each sterilization, the instruments must undergo a complete visual inspection and
functional check for damage and wear, see section 5.11 "Functional Check", page 76.
Damaged instruments or their components must be immediately appraised by Gebrüder Martin
or an authorized partner, and must be repaired or replaced if required.
Repeat the cleaning if a visual check reveals tissue residues on the instrument, or if the blade
is still in the instrument.
WARNING
Danger of infection and risk of damage in case of impermissible reprocessing!
Non-sterile handling can cause severe health risks for the patient.
After each use, remove and dispose of the blade holder according to the applicable
•
regulations!
Never reprocess and/or reuse blade holders! Reprocessing of the blade holders can
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damage the instrument!
Do not sterilize with hot air or using so-called flash autoclaving methods!
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Do not use any plasma sterilization methods (NTP Sterilization)!
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Care must be taken to ensure that the instruments to be sterilized are exposed to the
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steam, including the internal surfaces.
Revision 2 71