Cleaning, Disinfection And Sterilization; Limitations And Restrictions On Cleaning, Disinfection And Sterilization - KLS Martin group marSeal5 plus Gebrauchsanweisung

6 Cleaning, Disinfection and Sterilization

Possible danger to life of the patient in case of non-sterile handling!
Products supplied in non-sterile condition must be cleaned, disinfected and sterilized before the first and
any further use.
• In case of patients with Creutzfeldt-Jakob disease (CJD), suspected CJD or possible CJD variants,
processing of the products must be carried out according to the applicable national regulations.
• The operator/processor is responsible for cleaning, disinfecting and sterilizing the products used. It is
essential that national regulations, including restrictions, be observed.
The processing procedure must be validated prior to use of the medical device. The operator/processor is
responsible for this.
Products delivered in sterile condition (blade in sterile packaging) are marked with the corresponding
symbol. They may be removed from the packaging only immediately before use. The expiration date and
the intactness of the sterile packaging must always be checked before use.
Because of potentially inadequate labeling on the product, products that have been removed from their
sterile packaging but have not been used and are not contaminated cannot be considered equivalent to
products that have been obtained as non-sterile products. In this case, the operator/processor is
responsible for use including labeling, cleaning, disinfection and sterilization.
The specific information for each reference number for the following section is available at:
www.klsmartin.com/processing
6.1

Limitations and Restrictions on Cleaning, Disinfection and Sterilization

Possible danger to life of the patient from cleaning, disinfection and sterilization of contaminated
single-use products!
Single-use products that have not been used but have come into contact with bodily fluids, blood, tissue
and/or similar are to be considered used and must be discarded.
Cleaning, disinfection, sterilization and use can increase the risk of contamination, e.g. by carryover of
germs.
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Bipolar Sealing System marSeal5 plus/ - Maryland
Instructions for Use
Revision 06