OSSUR CTi 1034 001 Flexible CTi Knee Brace Instructions

OSSUR CTi 1034 001 Flexible CTi Knee Brace

Product Information

Specifications

• Intended Use : External support, stabilization, and protection of the knee
• Contraindications : None known

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.

Product Usage Instructions

Overview Figure
Please refer to the overview figure (Fig. 1) for locating components mentioned in the following instructions.

Strap Fastening

1. Fasten the straps in the following order. All straps can be adjusted and/or trimmed to length.
2. Fit the Lower Cruciate Strap (B) first, located directly below the knee and tighten the tibial control strap.

Extension Stop Replacement

1. To replace the extension stop, remove the condyle pad and loosen the screw securing the extension stop (Fig. 10).
2. Remove the extension stop out of the hinge.
3. Select the desired extension stop and place it into the hinge from the back with the small lip facing down (Fig. 11).
4. Position the hole in the extension stop with the screw hole in the hinge plate. Re-insert the screw and fasten, making sure not to overtighten.
5. Repeat this procedure for the opposite hinge. Note : Ensure the same extension stop is used for both hinges.

Field-Serviceable D-Ring Replacement

1. Use a size 1 Philips head screwdriver to undo the central screw (Fig. 12). Remove the D-Ring and both posts from the device (Fig. 13).
2. Select a same-sized D-Ring. Place the female post inside the D-Ring (Fig. 14).
3. The default D-Ring placement is on the inside of the device. However, the D-Rings can be moved to the outside of the frame if preferred (Fig. 14).
4. Place the D-Ring with the female post into the hole on the frame.
5. Place the male post through the outside of the frame and slide the two together. We suggest using the longer male post on all Pro Sport models or when the frame is too thick for the short male post.
6. Re-insert the central screw and fasten, making sure not to overtighten.

Strap Maintenance
To prolong the life of the straps and make it easier to put the device on next time, it is recommended to attach the Velcro straps to themselves when not in use.

Cleaning and Care

• Washing the device with the soft goods detached allows for more thorough cleaning.
• Note : Do not machine-wash, tumble dry, iron, bleach, or wash with fabric softener.
• Note : If the device is used in saltwater or chlorinated water, rinse with fresh water and air dry.

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

FAQ

• Q: Can the D-Rings be changed from internal to external configuration?
  A: Yes, the field-serviceable D-Rings can be changed from internal to external configuration in case of discomfort.

• Q: What should I do if a D-Ring is broken?
  A: If a D-Ring is broken, it can be replaced. Please reach out to Customer Service or CTi distributor for assistance.

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 not 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).
   Fasten the straps in the following order. All straps can be adjusted and/or trimmed to length.

6. Fit the Lower Cruciate Strap (B) first, located directly below the knee (Fig. 3). This strap is located above the calf muscle and aids in the correct positioning of the device as it helps create the device-to-bone contact required to help keep the device in place.

7. Next, snugly fasten the Bottom Strap (C) by inserting it through the D- Ring (Fig. 4).

8. Continue with the Upper Cruciate Strap (D), located just above the knee (Fig. 5).

9. Fasten the Top Strap (E) (Fig. 6). Make sure that the strap hook tab does not overlap the elastic insert on the strap.
   Note : Overtightening the top two straps can cause the device to migrate.

10. Last, snugly fasten the Anterior Cruciate Strap (F).

    • If the brace is too far anterior, loosen the anterior tibial strap and tighten the lower and bottom straps.
    • If the frame is too far posterior, loosen the lower and bottom straps and tighten the tibial control strap.

Device Adjustments
Range of Motion (ROM) Adjustment
The device comes with a 5-10° extension stop installed and includes the following additional stops: 0°, 5–10° (installed), 10–20°, 20–30°, and 30–40° (Fig. 15)

1. Remove the Condyle Pad from the hinge.
2. Use a short size 2 Philips head screwdriver to remove the screw securing the extension stop (Fig. 10).
3. Remove the extension stop out of the hinge.
4. Select the desired extension stop and place the stop into the hinge from the back with the small lip facing down (Fig. 11).
5. Position the hole in the extension stop with the screw hole in the hinge plate. Re-insert the screw and fasten. Making sure to not overtighten.
6. Replace the condyle pad.
7. Repeat this procedure for the opposite hinge.
   Note : Ensure the same extension stop is used for both hinges.

How to Replace or Move the Field-Serviceable D-Rings
The field-serviceable D-Rings can be changed from internal to external configuration in case of discomfort or replaced if a D-Ring is broken. If the D-Rings are riveted onto the device, please reach out to Customer Service or CTi distributor for assistance.

1. Use a size 1 Philips head screwdriver to undo the central screw (Fig. 12). Remove the D-Ring and both posts from the device (Fig. 13).
2. Select a same sized D-Ring. Place the female post inside the D-Ring (Fig. 14).
3. The default D-Ring placement is on the inside of the device. However, the D-Rings can be moved to the outside of the frame, if preferred (Fig. 14).
4. Place the D-Ring with the female post into the hole on the frame.
5. Place the male post through the outside of the frame and slide the two together. We suggest using the longer male post on all Pro Sport models or when the frame is too thick for the short male post.
6. Re-insert the central screw and fasten. Making sure not to over tighten.

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.

Refurbishing
The device should be regularly sent to Össur for refurbishing. The frequency of which depends on amount of activity by patient. Your healthcare professional should help determine frequency of service; the recommended minimum frequency is yearly. Refurbishment is provided at the cost of the customer. There is a usual turnaround time of three to five working days, plus shipping time.

Cleaning and care

Washing the device with the soft goods detached allows for more thorough cleaning.

Washing Instructions

• 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.
• Lubricate with silicone spray or dry graphite if needed.

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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