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general information


            Cautions before using the products
            Before every use you should carefully check the operability of the implants and operating instruments.
            They should be free of damages. If there are any cracks, fractures, discolouration, deformation or any dama-
            ges on the implants which may be due to unsuitable storing, imperfect sterilization or preliminary inefficient
            treatment, the use of the implant is prohibited. The assembly, perfect fitting and operation of the implants and
            all necessary instruments should be tested. Perfect fitting and operation, appropriate dimensions and posi-
            tions should be checked in all cases.

            requirements towards the user
            The instrument set of tools and implants can only be applied by doctors with appropriate qualifications and
            special information and experience in field of using osteosynthesis implants. The doctor who performs the
            operation is responsible for choosing the correct indication, the type and dimension of the implants and the
            operation treatment technology.

            Implantation is not recommended if the patient’s health conditions makes difficult to accept it or problems are
            expected during recovery process; e.g. decreased circulation, weak quality or quantity bone system, impossi-
            ble rehabilitation due the mental condition of the patient etc.

            general warnings
            Before the operation the patient should be informed about the possible disadvantages of the implant. By
            choosing the appropriate implant type of the bone fracture, the weight and activity of the patient should be
            taken into consideration. The solidity of the implant is restricted, so it is necessary to avoid overloading it by
            overweight. The biomechanical loading of the implant should be minimized, as much as possible. During the
            application of the implant, the process of recovering is to be controlled. By repetitive loading or by protected
            bone recovering the implants may be deformed, dislocated. This needs intervention in time. Repeated defor-
            mation of the implant should be avoided. The implants are only for one-time use (not reusable), the implants
            are declared = single used product, after re-implantation of a declared single used product, the re-implanted
            product is prohibited for next further implantation. The type and the size of the implants should be defined ac-
            cording to the specific case. Before operation, the user’s manual of the implants should be studied carefully.

            applied implant materials
            The applied high quality materials specially developed for TITANIUM IMPLANTS are made in accordance
            DIN EN ISO 5832-3 Ti6AL4V. The applied high quality materials specially developed for STAINLESS STEEL
            IMPLANTS are made in according to DIN EN ISO 5832-1. Combined use of implant products from other
            manufacturer companies my start damaging process and is prohibited, which the DIGImed can’t take respon-
            sibility for you this is also declared in the DIGImed manual.

            Protection of the product, packaging, preperation for use
            The declared non-sterile implants come clean, without any production pollution for packaging. Before using,
            circumstances are to be assured where the integrity of the packaging will be preserved. The storage should
            be in a clean, dry place-environment, avoiding extra temperature and chemicals.

            Before using, unpack the implants and sterilize according to the prescriptions, also follow strictly the Manual -
            Instruction for Use avoid touching by bare hand. The sterilization of the instruments should be done together
            with the tray, each tray should be wrapped and sterilized inside of a required and recommended closed steri-
            lization container, bottom and lid perforated.

            Interaction with medicines
            An interaction of the implants with medicines is not known.

            4           Digimed Medizintechnik • Kreutzerstrasse 1 • 78573 Wurmlingen • Germany •
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