Limitations And Restrictions On Cleaning, Disinfection, And Sterilization - KLS Martin group L1 Rib Gebrauchsanweisung

L1 Rib
Instructions for Use
5.1

Limitations and restrictions on cleaning, disinfection, and sterilization

Cleaning, disinfecting and sterilizing contaminated single-use products could result in the death of or
serious injury to patients
Unused single-use products that have come into contact with bodily fluids, blood, tissue and/or the like
should be considered used and must be discarded.
Cleaning, disinfection, sterilization and use can increase the risk of contamination, e.g. by carryover of
germs.
Re-using single-use products could result in the death of or serious injury to patients!
Unused single-use products that have come into contact with bodily fluids, blood, tissue and/or the like
should be considered used and must be discarded.
Even if the single-use product appears to be intact after use, its integrity may be compromised and minor
defects and/or internal weak spots may develop, which can lead to failures.
Cleaning, disinfection, sterilization and use may increase the risk of contamination, e.g., through bacterial
transmission.
In addition to the efforts by Gebrüder Martin in choosing and carefully processing the right materials, the
user of the osteosynthesis system components must carry out a professional and continuous maintenance
program, and the medical device must undergo the previously validated processing procedure.
Frequent reprocessing has little effect on the surgical instruments.
The product life of a surgical instrument is essentially determined by wear and possible damage during use.
This is recognized in the functional check and visual inspection to be performed in each individual
processing cycle. If required, appropriate corrective measure shall be taken. This functional check and
visual inspection are the basic prerequisite for the release of the medical device for the next processing
step, for the storage of the medical device in the validated sterile barrier system and for the application of
the medical device after sterilization.
For this reason, a general specification of maximum cycles is not possible.
Frequent cleaning, disinfection and sterilization can impair the functionality of implants. Implants that show
mechanical damage, deposits on the implant surface and/or corrosion must not be used. We recommend
removing and using implants from storage using the "First In - First Out" principle.
For this reason, a general specification of maximum cycles is not possible.
52 Revi sion 01