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Intended Use; General Safety Instructions; Fitting Instructions - Ossur CTI 3 Gebrauchsanweisung

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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
and protection, such as injuries to the ACL, MCL, LCL, and PCL, and
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

The healthcare professional should inform the patient about everything in
this document that is required for safe use of this device.
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, excessive pressure, or unusual reaction
occurs with the use of the device.
The device is for single patient – multiple use.
This device is not guaranteed to prevent injury.

FITTING INSTRUCTIONS

While carrying out the following instructions, please refer to the overview
figure for locating components mentioned in the text (Fig. 1).
Device Application
Correct application is vital to the proper functioning of the device.
1. While seated, bend your leg to 90°.
2. Unfasten all four straps from the lateral/outside of the device (Fig. 2).
3. Place the device on your leg so that the yellow line on the Hinge (A) is
slightly above the center of your kneecap. This will allow the device to
seat properly when you stand (Fig. 3).
Note: Use any combination of the Condyle Pads (B) supplied to widen
or narrow the width of the device at the knee (Fig. 6).
4. Attach the Lower Cruciate Strap (C) (directly below the knee) first as
this strap helps create the brace-to-bone contact required to help keep
the device in place (Fig. 4).
5. Next, snugly fasten the Bottom Strap (D) (Fig. 5).
6. Continue with the Upper Cruciate Strap (E), located just above the
knee, and then fasten the Top Strap (F) (Fig. 5).
Note: Overtightening the top two straps can cause the device
to migrate.
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