ottobock 50K30 Xeleton Instructions

ottobock 50K30 Xeleton

Foreword

INFORMATION

Date of last update: 2022-01-26

• Please read this document carefully before using the product and observe the safety notices.
• Instruct the user in the safe use of the product.
• Please contact the manufacturer if you have questions about the product or in case of prob­lems.
•  Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state.
• Please keep this document for your records.
  These instructions for use provide important information on the fitting and application of the 50K30 Xeleton knee joint orthosis.

Product description

Item| Component (see fig. 1)| Item| Component (see fig. 1 )
---|---|---|---
A| Joint cover| D| Pull loop
B| Pad retainer| E| Tibia pad
C| Technogel® condyle pad| F| Screw connection

Intended use

Indications for use
The brace is intended exclusively for orthotic fittings of the lower limbs and exclusively for con­tact with intact skin.
The brace must be used in accordance with the indications.

Indications

• After ruptures of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL), collateral ligament injuries (MCL, LCL) or after capsular ligament surgery
• Conservative, pre-operative and post-operative joint stabilisation (e.g. after meniscal fixation or meniscus replacement) with limited range of motion
• Conservative therapy of chronic complex knee joint instability
  The indication must be determined by the physician.

Contraindications

Absolute Contraindications
None known.

Relative Contraindications
The following indications require consultation with a physician: skin diseases/injuries; inflamma­tion; prominent, swollen scars; reddening and hyperthermia of the treated limb; pronounced vari­cose veins, especially with impaired return flow; lymphatic flow disorders, including unclear soft tissue swelling distal to the body area where the device will be applied; sensory and circulatory disorders in the legs, e. g. associated with diabetic neuropathy.

Mechanism of Action
The brace relieves and stabilises the knee joint.

Lifetime
The product is designed for a maximum lifetime of 2 years.

Qualification
Patients may be fitted with the product only by trained qualified personnel. The qualified person­nel must be familiar with the handling of the various techniques, materials, machines and tools.

Safety

Explanation of warning symbols

CAUTION
Warning regarding possible risks of accident or injury.

NOTICE
Warning regarding possible technical damage.

General safety instructions

CAUTION
Contact with heat, embers or fire
Risk of injury (such as burns) and risk of product damage

Keep the product away from open flames, embers and other sources of heat.

CAUTION
Breakage of the brace frame or joint due to improper shaping Injuries caused by sharp edges, loss of function

• Avoid adapting the brace repeatedly.
• Do not make any improper changes to the brace.
•  Inform your patient.

CAUTION
Reuse on other persons and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs

• The product may be used by one person only.
• Clean the product regularly.

NOTICE
Contact with oils, salves, lotions or other products that contain oils or acids
Insufficient stabilization due to loss of material functionality

• Do not expose the product to oils, salves, lotions or other products that contain oils or acids.

Handling

INFORMATION

• The daily duration of use and period of application are generally determined by the physi­cian.
• The initial fitting and application of the product must be carried out by qualified personnel according to the instructions of the treating physician.
• Consult a physician if any exceptional changes are noted (such as worsening of the com­plaint).

Selecting the Size

1. Measure the circumference of the patient’s thigh 15 cm (6″) above the center of the patella and determine the orthosis size (see size table).
2. Determine the length of the orthosis based on the patient’s height (see size chart). Ottobock recommends the long version of the orthosis for a height over 1.83 m (6 ft).

Fitting and Application

Adjusting the Range of Motion (Flexion/Extension)

INFORMATION
The joint stops (medial and lateral) must have identical degree settings.

• Available extension stops (square grip): 0°, 10°, 20°, 30°, 45°
• Available flexion stops (round grip): 0°, 10°, 20°, 30°, 45°, 60°, 75°, 90°

1. Remove the condyle pads from the pad retainers (see fig. 5).

2. Remove the adjustment screws from the pad retainers (see fig. 6).

3. Remove the pad retainers (see fig. 1, item B) and the joint covers (see fig. 1, item A) (see fig. 7).

4. Insert the desired extension and flexion stops (see fig. 8).
   → The stops will engage after slight resistance.

5. Insert the joint covers with the profile edge facing forwards.

6. Attach the pad retainers (see fig. 7).

7. Insert the adjustment screws in the pad retainers and tighten them (see fig. 6).

8. Attach the condyle pads to the pad retainers with hook-and-loop material (see fig. 5).

9. Move the orthosis joints and check the position of the stops.

Adaptation to the Knee Width
Spacer pads (thickness = 5 mm and 8 mm) are included in the scope of delivery. The spacer pads can be mounted between the pad retainers (see fig. 1, item B) and the condyle pads (see fig. 1, item C) using hook-and-loop fasteners (see fig. 5). This adjustment can be carried out independently on the medial and lateral joints.

Applying the ACL Version

CAUTION
Incorrect or excessively tight application
Risk of local pressure and constriction of blood vessels and nerves due to improper or exces­sively tight application

• Ensure that the product is applied properly and fits correctly.

NOTICE
Use of a worn or damaged product
Limited effectiveness

• Before each use, check the product for functional reliability and for possible wear or dam­age.
• Do not continue using a product that is no longer functional, or that is worn or damaged.
• All straps are opened.
• The patient is sitting on the front edge of a chair. The knee is angled at 45°.

1. Position the orthosis with the middles of the joints approximately even with the top of the patel­la (see fig. 9).
   → Although the orthosis starts out being a little too high, it will quickly settle into the correct position.

2. Fasten the lower front strap for the lower leg (see fig. 10).
3. Fasten the upper rear thigh strap (see fig. 11).
4. Keep the knee bent, and push the two joints towards the back of the leg (see fig. 12).
5. Fasten the lower thigh strap (see fig. 13). Pull the joints forward slightly, and position them so they are centered relative to the knee joint. Ensure that the joints are not pulled ahead of the lateral center line of the leg (see fig. 14).
6. Fasten the upper front strap for the lower leg (see fig. 15).
7.  Fasten the rear strap for the lower leg (see fig. 16).
8. Tighten the orthosis straps so that the orthosis fits firmly but is comfortable to wear.
9. After 15 min of active movement (e.g. slight knee bends): slightly retighten the straps in the specified sequence (see fig. 2, straps 1-5).

Conversion to and application of the CI version

• The orthosis is in the as-delivered condition (ACL version).
• The CI accessory set is at hand.

1. Loosen and remove the screw connection on the lower thigh strap (strap 3) (see fig. 17).
2.  Attach the pull loop on the lower thigh strap and the additional pull loop (see fig. 1, item D; CI accessory kit) with the longer screw (see fig. 18).
3. Mount the additional strap (strap 6, CI accessory kit) as the front thigh strap.
4. Position the orthosis correctly (see the section “Applying the ACL Version”).
5. Fasten the straps in the specified sequence (see fig. 3, straps 1-6).

Conversion to and application of the PCL version

• The orthosis is in the as-delivered condition (ACL version).
• The PCL accessory kit is at hand.

1. Remove the lower thigh strap (strap 3), the rear strap for the lower leg (strap 5), and the upper front strap for the lower leg (strap 4).
2. Turn the pull loop on the lower thigh strap (see fig. 1, item D) to the front.
3. Use strap 4 without tibia pad with the pad on strap 3 as the front thigh strap.
4. Loosen the screw connection of the upper front strap for the lower leg, and remove the front pull loop (see fig. 19).
5. Mount the pull loop on the rear strap for the lower leg with the short screw (PCL accessory kit).
6. Use strap 3 with the pad on strap 5 as the rear strap for the lower leg.
7. Position the orthosis correctly (see the section “Applying the ACL Version”).
8.  Fasten the straps in the specified sequence (see fig. 4, straps 1-4).

Replacing the Straps and Pads
Straps:

• The straps are equipped with opposing hook-and-loop closures and are easy to replace.
  Strap and Frame Pads

• The strap and frame pads are attached with hook-and-loop closures and are easy to replace.

Use of liners and covers
Optional liners and covers are available for the orthosis. A liner is used as a layer between the orthosis and the skin to protect against skin damage. A cover is pulled over the orthosis, protect­ing it against damage. This also reduces the risk of injury in sports with the potential for massive body contact (e.g. collisions). The following products can be used with the orthosis (the size is specified in the reference num­ber):

Delivery

• Check that the brace fits the leg properly at the time of delivery.
• The centre of the patella and the centre of the joints are approximately aligned.

Cleaning

INFORMATION
Ensure proper alignment when inserting the tibia pad. The wide side of the pad must face up.

1. Remove the straps and pads from the brace.
2. Fasten all hook-and-loop closures.
3. Hand-wash the straps and pads in warm water at 30 °C (86 °F) using neutral detergent. Rinse thoroughly.
4. Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
5. If the brace comes into contact with salt water or dirt, rinse with clear water and allow to air dry.

Disposal

Dispose of the product in accordance with national regulations.

Legal Information

All legal conditions are subject to the respective national law of the country of use and may vary accordingly.

Liability
The manufacturer shall be liable in the event that the product is used in accordance with the descriptions and instructions in this document. The manufacturer will not assume liability for dam­age caused by disregarding the information in this document, particularly due to improper use or unauthorized modification of the product.

CE Conformity
The product meets the requirements of Regulation (EU) 2017/745 on medical devices. The CE declaration of conformity can be downloaded from the manufacturer’s website.

References

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