acumed Anatomic Radial Head System Handbuch Seite 20

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Single use instruments must be discarded after a single use.
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Reusable instruments have a limited lifespan. Prior to and
after each use, reusable instruments must be inspected
where applicable for sharpness, wear, damage, proper
cleaning, corrosion and integrity of the connecting
mechanisms. Particular care should be paid to drivers, drill
bits and instruments used for cutting or implant insertion.
SURGICAL TECHNIQUES: Surgical techniques are available
describing the uses of this system. It is the responsibility of the
surgeon to be familiar with the procedure before use of these
products. In addition, it is the responsibility of the surgeon to be
familiar with relevant publications and consult with experienced
associates regarding the procedure before use. Surgical
Techniques can be found on the Acumed website (acumed.net).
IMPLANT WARNINGS: For safe effective use of the implant,
the surgeon must be thoroughly familiar with the implant, the
methods of application, instruments, and the recommended
surgical technique for the device. The device is not designed to
withstand the stress of weight-bearing, load-bearing, or excessive
activity. Device breakage or damage can occur when the implant
is subjected to increased loading associated with delayed union,
nonunion, or incomplete healing. Improper insertion of the device
during implantation can increase the possibility of loosening or
migration. The patient must be cautioned, preferably in writing,
about the use, limitations, and possible adverse effects of this
implant. These cautions include the possibility of the device or
treatment failing as a result of loose fixation and/ or loosening,
stress, excessive activity, or weight bearing or load bearing,
PKGI-42-T Effective 08-2019
particularly if the implant experiences increased loads due to
delayed union, nonunion, or incomplete healing, and the
possibility of nerve or soft tissue damage related to either surgical
trauma or the presence of the implant. The patient must be
warned that failure to follow postoperative care instructions can
cause the implant and/ or treatment to fail. The implants may
cause distortion and/or block the view of anatomic structures on
radiographic images. The components of these systems have not
been tested for safety, heating, or migration in the MRI
environment. Similar products have been tested and described in
terms of how they may be safely used in post-operative clinical
evaluation using MRI equipment
1
Shellock, F. G. Reference Manual for Magnetic Resonance Safety, Implants, and
Devices: 2014 Edition. Biomedical Research Publishing Group, 2014.
SURGICAL INSTRUMENT WARNINGS: For safe effective use
of any Acumed instrument, the surgeon must be familiar with the
instrument, the method of application, and the recommended
surgical technique. Instrument breakage or damage, as well as
tissue damage, can occur when an instrument is subjected to
excessive loads, excessive speeds, dense bone, improper use or
unintended use. The patient must be cautioned, preferably in
writing, as to the risks associated with these types of instruments.
IMPLANT PRECAUTIONS: An implant shall never be reused.
Previous stresses may have created imperfections, which can
lead to a device failure. Protect implants against scratching and
nicking. Such stress concentrations can lead to failure. Mixing
implant components from different manufacturers is not
recommended for metallurgical, mechanical and functional
reasons. The benefits from implant surgery may not meet the
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