Otto Bock 3R21, Instructions For Use Manual

Page: 16 / 132

Signs of changes in or loss of functionality during use
Changes in functionality can manifest themselves, for example,
through a changed gait (swing phase, stance phase), incomplete
extension, stiffness and the development of noise.
5 Scope of delivery
For the scope of delivery, see Figure
1
on page 2.
A product component without a reference number in the illustration
cannot be reordered separately.
A reference number shown in bold in the illustration stands for a
single component pack, in which the product components shown
below it can be reordered.
6 Technical data
The technical data are shown in Figure
2
on page 2.
: Proximal system height (PSH); : distal system height (DSH)
7 Preparing the product for use
7.1 Information on fabrication of a prosthesis
CAUTION
Incorrect alignment, assembly or adjustment
Injuries due to incorrectly installed or adjusted as well as damaged
prosthetic components
► Observe the alignment, assembly and adjustment instructions.
CAUTION
Initial use of the prosthesis by the patient
Fall due to lack of patient experience, incorrect alignment or incor­
rect adjustment of the prosthesis
►
For the safety of the patient, use a suitable device (e.g. parallel
bars, handrail, wheeled walker) during initial standing and walk­
ing.
16
7.2 Bench alignment of the prosthesis
CAUTION
Improper assembly of the screw connections
Risk of injury due to breakage or loosening of the screw connec­
tions
► Clean the threads before every installation.
►
Apply the specified torque values.
►
Follow the instructions regarding the length of the screws and
about how to secure the screws.
INFORMATION
The prosthetic components and prosthesis shown in the illustrations
are used as examples to illustrate the general process. The instruc­
tions for use of the prosthetic components selected for the patient
contain detailed information and have to be used for fabrication of
the prosthesis.
► To enable the patient to stand safely, align the prosthesis using
the alignment images (Figure
3 on page 3) as well as the
instructions for use of all prosthesis components used.
► Additionally, observe Figure
4
on page 4 and the following
points for the bench alignment of the prosthesis:
► Manufacture the prosthetic socket using the lamination anchor in
such a way as to ensure safe use with respect to the patient's
body weight and level of activity.
► Regarding the definitive prosthesis, observe the instructions
for securing the set screws in the lamination anchor.
►
Secure the prosthetic socket to the lamination anchor using the
screws and nuts supplied.
►
To fabricate the definitive socket, observe the section "Fabricat­
ing the definitive socket" (see Page 17).
► Create the prosthetic socket in such a way that only the
marked area is used as a flexion stop.