OSSUR CTi3 Ligament Knee Brace Instruction Manual

OSSUR CTi3 Ligament Knee Brace

Product Information

The device is a medical product designed for external support, stabilization, and protection of the knee. It is intended to provide increased AP and ML stability and protection, particularly for knee conditions such as injuries to the ACL, MCL, LCL, and PCL, and rotary and combined instabilities. The device has no known contraindications. The healthcare professional should inform the patient about everything in the user manual that is required for safe use of the 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 necessary.

Product Usage Instructions

Fitting Instructions

• Refer to the overview figure for locating components mentioned in the text.
• Control the strap length by adjusting the medial/inside hook-and-loop strap end
• If the lower liner extensions under the Lower Cruciate and Bottom Straps are too long, remove the strap from the extension and trim the extension with scissors.
• The D-rings can be changed from internal to external D-rings or replaced if a D-ring is broken. Remove the screw to disengage.
• For maximum comfort and support, wear a knee sleeve and ensure the product fits securely.

While carrying out the following instructions, please refer to the overview figure for locating components mentioned in the text

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

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
   Note : Use any combination of the Condyle Pads (B) supplied to widen or narrow the width of the device at the knee

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

5. Next, snugly fasten the Bottom Strap (D)

6. Continue with the Upper Cruciate Strap (E), located just above the knee, and then fasten the Top Strap (F)
   Note : Overtightening the top two straps can cause the device to migrate.

Note : Control the strap length by adjusting the medial/inside hook-and- loop strap end . If the lower liner extensions under the Lower Cruciate and Bottom Straps are too long, remove the strap from the extension and trim the extension with scissors.

Note : The D-rings can be changed from internal to external D-rings or replaced if a D-ring is broken. Remove the screw to disengage.

Stop Kit Installation:

1. Choose the appropriate stop size from the Stop Kit
2. Place the stop into position with the Snap  aligned to the hinge location (A), then slide the Gear Jam into the hinge.
3. Hold the stop in place as shown
4. Slowly flex the device while ensuring the landing shelf meets the upper frame as shown.
5. The stop will audibly click into place
6. Repeat for opposite side hinge, using the same size stop.

Stop Kit Removal:

1. With the device in extension, grab the tail of the stop and pull away from the frame. The Flexion Stop will snap out.
2. Repeat for opposite side hinge.

Impact Guard Set Installation:

1. Carefully peel back the liners to expose the mounting tab locations on the upper and lower brace frames
2. Place the Impact guard into the device, lining up the holes
3. Install the two T20 Torx mounting screws to secure the Impact guard.

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.

For maximum comfort and support, wear a knee sleeve and ensure the product fits securely.

Device Adjustments

Hinge Extension Stop Set Installation
The device comes equipped with a 0° Extension Stop (G) installed. Extension Stops for 5°, 10°, 20°, and 30° are also available. The specific stop angle is molded into each stop.

1. Remove the Condyle Pad from the Hinge
2. Remove the Philips screw
3. Flip the device over to see the front of the device. Bend the device slightly. Place the tip of the screwdriver under the Extension Stopand gently pry the stop from the Hinge.
4. Select your desired stop angle Angles are marked on each stop.
5. Bend the device slightly. Insert the hooked tip of the new Extension Stop into the Hinge and push down on the other side until it is flush with the front of the Hinge
6. Finish by reinstalling the screw and Condyle Pad
7. Repeat this process for the Hinge on the other side, making sure to use the matching Extension Stop.

Hinge Flexion Stop Set Installation

Installation:

1. Select the correct angle setting. 60°, 75°, and 90° Flexion Stop options are provided in the stop kit
2. Place the stop into position with the Snap (Fig. 16 A) aligned to the hinge location (A), then slide the Gear Jaminto the hinge.
3. Hold the stop in place as shown.
4. Slowly flex the device while ensuring the landing shelf meets the upper frame as shown.
5. The stop will audibly click into place.
6. Repeat for opposite side hinge, using the same size stop.

Installation of the 0° Flexion Stop:

1. Position device into full extension with 0° extension stops installed
2. Place the stop into position with Gear Jam pushed into the hinge gear teeth. An audible snap will confirm the correct position
3. Hold the stop in place as shown. Use thumb to push Snap into place.
4. The stop will audibly click into place
5. Repeat for opposite side hinge, using the same size stop.

Removal:

1. With the device in extension, grab the tail of the stop and pull away from the frame. The Flexion Stop will snap out.
2. Repeat for opposite side hinge.

Impact Guard Set Installation
Impact Guard (H) sets are available to protect the knee against impacts. To install the Impact Guard set:

1. Carefully peel back the liners to expose the mounting tab locations on the upper and lower brace frames
2. Place the Impact guard into the device, lining up the holes
3. Install the two T20 Torx mounting screws to secure the Impact guard to the upper and lower brace frames
4. Reinstall the upper and lower liners.

To replace the Impact guard set Elastic Cord (I) (sold separately) or reconnect the upper and lower panel of the guard set:

1. Fold the Elastic Cord into a loop
2. From the liner side of the upper guard, feed the loop through the rightmost hook and pull snug
3. Weave the Elastic Cord through the hooks To attach to the leftmost hook, loop the cord and pull through from the liner side.
4. Center the Elastic Cord
5. Feed both end loops through the holes on the lower guard
6. Hook the loop ends to the lower guard tabs

Device Removal

1. Sit down and bend the knee at an 80° angle with the foot flat on the floor.
2. Unfasten all posterior straps of the device and attach the straps back to themselves. This will make it easier to put the device on next time and will also prolong the life of the straps.

Accessories and Replacement Parts
Please refer to the Össur catalog for a list of available replacement parts or accessories.

USAGE

Cleaning and care

• Hand-wash using mild detergent and rinse thoroughly.
• Air dry.
• Note : Do not machine-wash, tumble dry, iron, bleach, or wash with fabric softener.
• Note : If the device is used in salt water or chlorinated water, rinse with fresh water and air dry.

Hinge
Remove foreign materials (e. g., dirt or grass) and clean using fresh water.

DISPOSAL

The device and packaging must be disposed of in accordance with respective local or national environmental regulations.

LIABILITY
Össur does not assume liability for the following:

• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or environment.

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