B.Braun Aesculap Targon FN Mode D'emploi/Description Technique page 3

Inspection, maintenance and checks
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Allow the product to cool down to room temperature.
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Inspect the product after each cleaning and disinfecting cycle to be sure it is: clean, functional, and undamaged.
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Immediately set aside damaged or inoperative products.
Packaging
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Place the product in its holder or on a suitable tray.
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Pack trays appropriately for the sterilization process (e.g. in Aesculap sterile containers).
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Make sure that the packaging will prevent a recontamination of the product during storage.
Sterilization
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Validated sterilization process
– Steam sterilization through fractionated vacuum process
– Steam sterilizer according to DIN EN 285 and validated according to DIN EN ISO 17665
– Sterilization using fractionated vacuum process at 134 °C/holding time 5 min
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When sterilizing several instruments at the same time in a steam sterilizer, ensure that the maximum load capac-
ity of the steam sterilizer specified by the manufacturer is not exceeded.
Storage
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Store sterile products in germ-proof packaging, protected from dust, in a dry, dark, temperature-controlled area.
Application
The operating surgeon shall devise an operation plan that specifies and accurately documents the following:
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Selection of the implant components and their dimensions
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Positioning of the implant components in the bone
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Location of intraoperative landmarks
The following conditions must be fulfilled prior to application:
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All requisite implant components are ready to hand.
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Operating conditions are highly aseptic.
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All requisite implantation instruments must be available and in working order, including specialized Aesculap
implantation systems.
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The operating surgeon and operating room team are thoroughly familiar with the operating technique and with
the available range of implants and instruments; information materials on these subjects must be complete and
ready to hand.
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The operating surgeon is fully conversant with the rules governing medical practice, the current state of scientific
knowledge, and the contents of relevant scientific articles by medical authors.
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The manufacturer has been consulted if the preoperative situation was unclear and if implants were found in the
area operated on.
The surgical procedure and following information has been explained to the patient, and the patient's consent has
been documented:
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Under certain circumstances it can happen that, when a fracture is treated with an implant, humerus anatomy
will not be fully restored.
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Following treatment of a fracture, shoulder and elbow joint function may be impaired.
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Pains may occur following the fracture treatment.
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The implants must not be exposed to overload due to excessive strains, hard physical work or sports activities.
Overstraining entails the risk of implant loosening or breakage.
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The patient must be informed about the limits to the allowable strain on the implant, and be given appropriate
behavior guidelines. The risks of transgressing these rules must be explained to the patient.
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Revision surgery may become necessary in cases of implant loosening or pseudarthrosis.
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The patient must undergo regular medical follow-up examinations.
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The attending physician decides when to remove, in part or completely, the osteosynthesis implants through
another surgical procedure.
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Check for correct mounting of the plate on the aiming device: Insert the drill through the drill sleeve and the
aiming hole and guide it through the plate hole.
Complications due to incorrect use and/or incorrect assessment/treatment of the
fracture!
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Use support screws of the appropriate length.
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Make certain that implants are aligned correctly.
WARNING
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Handle the implants with appropriate care.
Explantation
Note
Implant removal can give rise to complications due to implants that are locked in place, ingrown bone tissue, etc. Such
complications can lead to damage to implants and/or instruments. For such cases a set of special instruments is rec-
ommended, which can be ordered from Aesculap. This instrument set should be at hand for every explantation. Other
special instruments are available for dealing with broken implants. Note the instructions for use for such cases!
Further information on Aesculap implant systems is available from B. Braun/Aesculap or the appropriate B. Braun/
Aesculap office.
Änd.-Nr. 47046
TA-Nr. 012010 07/13 V6