KLS Martin group GENOS Mode D'emploi page 25

Instructions for use
KLS Martin GENOS Distractors (non sterile)
Following distraction
Consolidation phase following distraction: The distractor must be left in situ for approx. 12
months and may be removed only after the consolidation or "knitting" process has been com-
pleted.
Physiotherapy can already be started during the consolidation phase in order to prevent adduc-
tion contracture.
Attention: Avoid any measures that could have an adverse effect on the distractor!
Recommendation
All implant components used should be documented in the patient record, complete with item
numbers, designations and batch and/or serial numbers (if available). Note that reliable track-
ing of the implants used is guaranteed only when the serial numbers have been recorded.
Packaging
Before using the product, be sure to check the packaging for integrity.
Packages with a broken seal cannot be returned for credit.
Cleaning and sterilization
Brand-new distractors must be sent through the entire processing cycle (using suitable clean-
ing, disinfecting and sterilization methods) prior to use.
The distractors are suitable for machine processing/thermal disinfection. They can be treated
with programs released for (re)processing surgical instruments. However, be sure to observe
the instructions given by the manufacturers of your cleaning/disinfecting machines (washer-
disinfectors) and the treatment agents (cleaner, disinfectant) used. The processing cycle – in-
cluding proper loading – must guarantee adequate removal of residues.
Sterilization must be carried out according to a validated steam sterilization process, for ex-
ample in a sterilizer satisfying EN 285/ANSI/AAMI/ISO 11134-1993 and ANSI/AAMI ST46-1993
requirements and validated in accordance with DIN EN ISO 17665-1:2006 specifications.
The responsibility for proper cleaning, disinfection and sterilization of distractors lies with the
operator or product user. Be sure to observe all local regulations (including potential re-
strictions).
Documents also applying
The Instructions for Use relating to osteosynthesis implants must be observed and followed as
well when using the distractor. This user guide is supplied with the osteosynthesis screws.
Use in conjunction with other products
For metallurgic, mechanical and functional reasons, KLS Martin implants must not be used in
conjunction with implants or implant systems from other manufacturers (compatibility of com-
ponents not guaranteed).
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