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

Instructions for Use
Rotterdam-Midline Distractor / Bologna-Midline Distractor
A stereo lithographic model (STL model, available from us on request) can be very useful for
exact determination of the anatomical conditions and corresponding distractor selection.
WARNING
Do not use different materials or systems in combination!
KLS Martin distraction systems must not be combined with systems from other
manufacturers! Using instruments not specifically intended for use with implants can result in
failure of the distraction system!
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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 / product 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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