Intended Use; General Safety Instructions - Ossur CTI Gebrauchsanweisung

ENGLISH
SYMBOLS
Medical Device

INTENDED USE

The device is intended for external support, stabilization and protection
of the knee.
Indications for use
• For knee conditions that may benefit from increased AP and ML
stability around the knee, such as: ACL, MCL, LCL, PCL, rotary, and
combined instabilities.
No known contraindications.
Warnings and Cautions:
• The use of the device may increase the risk of deep vein thrombosis
and pulmonary embolism.

GENERAL SAFETY INSTRUCTIONS

Read these instructions carefully before use. Keep them for future
reference.
Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
The patient should stop using the device and contact a healthcare
professional:
• If there is a change or loss in device functionality, or if the device
shows signs of damage or wear hindering its normal functions.
• If any pain, skin irritation, or unusual reaction occurs with the use of
the device.
The device is for single patient – multiple use.
This device is a supportive brace only and is not intended or guaranteed
to prevent injury.
USAGE
While carrying out the following instructions, please refer to the overview
figure for locating components mentioned in the text (Fig. 1).
Device Application
1. Unfasten all straps from the outer side of the device.
2. Bend the knee at a 90° angle, with the foot flat on the floor.
3. Ensure that the CTi logo goes on the outside of the leg. Place the
device on the leg such that the patella is centered between the
Condyle Pads (A) (Fig. 2).
Ensure proper alignment of the device on the leg:
• Height positioning: Align the center of the Hinge slightly above the
middle of the patella (Fig. 2).
4. The device is pre-assembled with thick Condyle Pads. There are also
thin and medium Condyle Pads, as well as a hook-and-loop, shim
included with the device. Use any combination of the Condyle Pads
and shim to widen or narrow the width of the device at the knee.
5. The supplied tibial wedge pads can be placed between liner to adjust
the fit around the tibia (Fig. 7). They can also be used to position the
hinge center forward slightly or removed to position the hinge further
backward (Fig. 8,9).
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