Processing, Cleaning, Disinfection And Sterilization - KLS Martin group Rotterdam Instrucciones De Uso

Instructions for Use
Rotterdam Palatal Distractor
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Processing, Cleaning, Disinfection and Sterilization

Distraction systems are suitable for machine processing/thermal disinfection. They can be
processed with the same programs that have been released for surgical instruments. As
regards cleaning, be sure to follow the instructions provided by the manufacturer of your
washer-disinfector(s) as well as those provided by the manufacturers of the cleaners and
disinfectants used. The process (including loading) must guarantee sufficient removal of
residues.
WARNING
Danger of infection due to non-sterile handling!
Improper sterilization and non-sterile handling of the distraction system can lead to serious
health hazards for patients.
Sterilization must be carried out according to a validated steam sterilization process, for
example in a sterilizer complying with EN 285:2009 and ANSI/AAMI ST 79, validated in
accordance with ISO 17665-1:2006.
ANSI/AAMI ST 79 recommends a minimum cycle time of 4 minutes at 132°C (270°F) for
dynamic air removal steam sterilization cycles. Please follow the instructions of the user
manual of your steam sterilizer.
NOTICE
The responsibility for proper cleaning, disinfection and sterilization of distraction components
rests with the operator/user. Be sure to observe your national/local regulations, including
potential restrictions.
Use appropriate and approved sterile packing (e.g. in accordance with EN 868, ISO 11607)
for the sterilization, the subsequent transport and storage.
Contaminated and/or used implant components may never be reused and therefore must not
be reprocessed.
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