acumed Polarus Bedienungsanleitung Seite 20

EN
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.
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, 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: 2011 Edition. Biomedical Research Publishing Group, 2011.
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
PKGI-22-P Effective 05-2020
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
patient's expectations or may deteriorate with time, necessitating
revision surgery to replace the implant or to carry out alternative
procedures. Revision surgeries with implants are not uncommon.
SURGICAL INSTRUMENT PRECAUTIONS: Single use surgical
instruments shall never be reused. Previous stresses may have
created imperfections, which can lead to a device failure. Protect
instruments against scratching and nicking, such stress
concentrations can lead to failure.
ADVERSE EFFECTS: Possible adverse effects are pain,
discomfort, or abnormal sensations and nerve or soft tissue
1
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damage due to the presence of an implant or due to surgical
trauma. Fracture of the implant may occur due to excessive
activity, prolonged loading upon the device, incomplete healing, or
excessive force exerted on the implant during insertion. Implant
migration and/or loosening may occur. Metal sensitivity,
histological, allergic or adverse foreign body reaction resulting
from implantation of a foreign material may occur. Nerve or soft
tissue damage, necrosis of bone or bone resorption, necrosis of
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