ottobock 50K90 Agilium Softfit Knee Bracing and Support Instructions

ottobock 50K90 Agilium Softfit Knee Bracing and Support

Foreword

INFORMATION

Date of last update: 2022-03-31

• 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 50K90 Agilium Softfit and the use of the 29K338=* strap set for the treatment of lateral osteoarthritis of the knee.

Product description

50K90 scope of delivery (see fig. 1)

Item| Designation
1| Hook-and-loop closure
2| Strap guide loop
3| Donning loop
4| Thigh strap
5| Joint bars with condyle pad
6| Lower leg strap
7| Strap guide loop
8| Hook-and-loop closure
9| Patella cutout
10| Joint stops for extension limitation
11| Joint stops for flexion limitation
12| Screwdriver
13| Allen wrench
Scope of delivery

Item| Description
1| Thigh pad
2| Lower leg pad
3| Thigh bar strap holder, slotted
4| Tibial bar strap holder
5| Strap risers

Intended use

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

• Unicompartmental osteoarthritis of the knee
• Posttraumatic and postoperative instability and/or feeling of instability
• Conditions/injuries requiring unicompartmental relief (e.g. post-operative treatment following meniscus reconstruction or ligament injuries which require unilateral relief)
• Rheumatoid arthritis
  Indications must be determined by the physician.

Contraindications

Absolute Contraindications
Not known.
Relative Contraindications
The following indications require consultation with a physician: skin dis­eases/injuries, inflammation, prominent scars that are swollen, reddening and hyperthermia of the fitted limb; pronounced varicose veins, especially with return flow impairment, lymphatic flow disorders, including unclear soft tissue swelling distant to the body area to which the support will be applied; sensory and circulatory disorders in the area of the legs, e.g. in case of dia­betic neuropathy.

• Bicompartmental osteoarthritis of the knee

Lifetime
The product is designed for a maximum lifetime of 1 year.
Effects
The orthosis provides relief for the affected compartment by means of the 3-point principle and stabilises the knee joint.

Safety

Explanation of warning symbols

caution

Warning regarding possible risks of accident or injury. Warning regarding possible technical damage.

General safety instructions

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.

CAUTION

Exceeding the service life
Risk of injury due to change in or loss of functionality and damage to the product

• Ensure that the approved service life is not exceeded.

CAUTION

Use with heat-sensitive skin

Skin irritation due to overheating

• Do not use the product in case of a known heat allergy.
• Do not continue to use the product if skin irritation occurs.

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.

NOTICE

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

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

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.

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).

Size Selection 50K90 Agilium Softfit

1. Measure the circumference of the thigh 15 cm above the centre of the patella.
2. Measure the circumference of the lower leg 15 cm below the centre of the patella.
3. Determine the size of the orthosis (see size chart).

*29K338 Strap set*
The 29K338 strap set for treating lateral osteoarthritis of the knee is avail­able in five sizes.

**Application

**

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.
  • Prerequisite: The patient should be seated.
  • Prerequisite: The knee joint should be relieved of pressure and slightly bent.
  • Open all hook-and-loop closures.
  • Grasp the orthosis by the donning loops (see fig. 1, item 1) and pull it over the foot up to the knee with the large opening first (see fig. 2).
  • Adjust the orthosis until the patella is positioned in the centre of the patella cutout (see fig. 3) and the orthotic joint is at the height of the middle of the patella.
  • Guide the lower leg strap through the strap guide loop, pull it taut and close it at the hook-and-loop closure (see fig. 4).
  • Guide the thigh strap through the strap guide loop, pull it taut and close it at the hook-and-loop closure (see fig. 5).
  • Ensure that the orthosis is in the correct position.
  • Optional: Adjust the corrective force; this changes the varus/valgus angle of the orthosis (see fig. 6).

Adaptation
Adjusting the corrective force

• Prerequisite: The patient should be seated.
• Prerequisite: The knee joint should be relieved of pressure and slightly bent.
  • Set the corrective force on the socket screw above the orthotic joint (see fig. 6). This changes the varus/valgus angle of the orthosis.
  • Check the corrective force while standing and walking.
  • The corrective force can be optionally adapted until the desired adjust­ment has been made.

Optional: limiting the knee flexion and extension
The extension limitation at delivery is 0°. The flexion is not limited.

1. Move the joint bars of the orthotic joint (see fig. 1, item 5) to maximum flexion (see fig. 8).
2. Remove the condyle pad from the hook-and-loop pad (see fig. 9).
3. Pull the joint bars out of the lateral guides of the orthosis (see fig. 10).
4. To limit the extension, remove the anterior screw. To limit the flexion, remove the posterior screw.
5. Choose the joint stops appropriate for the desired flexion and extension limitation (see fig. 1, items 11 and 12).
6. Insert the joint stops into the orthotic knee joint. Insert the joint stop for extension limitation at the front and the joint stop for flexion limitation at the back. Ensure that the heads of the joint stops are pointing outwards (see fig. 12).
7. Secure the joint stop with the screw (see fig. 11).
8. Insert the joint bars into the lateral guides, observing the installation direction.
9. Re-attach the condyle pad.

Retrofitting the 29K338 strap set

1. Remove the thigh and lower leg straps from the orthosis (see fig. 13, see fig. 14).
2. Flex the joint bars in the joint and pull them out of the lateral guides of the orthosis (see fig. 15).
3. Slide the slotted strap holder over the joint bar from above, placing the hook-and-loop closure over the adjustment mechanism of the thigh bar so the hook-and-loop closure faces anterior (see fig. 16).
4. Side the unslotted second strap holder over the joint bar from below.
5. Flex the joint bars in the joint and insert them into the lateral guides, observing the installation direction (see fig. 17).
6. Turn the orthosis over from the lateral side to the medial side.
7. Fasten the strap risers to the medial pads of the orthosis using hook-and-loop (see fig. 18). INFORMATION: The shorter end of the hook-and-loop closure is on the pad for the strap riser on the thigh, and the long end is on the pad for the strap riser on the lower leg.
8. Turn the orthosis over from the medial side to the lateral side.
9. Fasten the slotted thigh strap and the lower leg strap to the strap holders on the joint bars, close to the knee. The slot in the thigh strap lines up with the slot in the strap holder (see fig. 19). The strap guide loops are positioned facing anterior.
10. Turn the orthosis over from the lateral side to the medial side and attach the thigh and lower leg straps to the medial strap risers (see fig. 20).
11. Open the orthosis on the larger side and fasten the thigh pad with hook-and-loop from the centre of the inside to the inner joint bar cover, approx. 10 mm below the upper edge of the orthosis (see fig. 21).
12. Fasten the lower leg pad so it is centred on the inner joint bar cover, approx. 10 mm below the lower edge of the orthosis (see fig. 22).

Removal

• Prerequisite: The patient should be seated.
• Prerequisite: The knee joint should be slightly bent and relieved of pres­sure.
  • Loosen the hook-and-loop closure on the thigh strap (see fig. 1, item 1) and pull it out of the strap guide loop.
  • Loosen the hook-and-loop closure on the lower leg strap and pull it out of the strap guide loop.
  • Pull the orthosis down over the foot.

Cleaning

NOTICE

Use of improper cleaning agents
Damage to the product due to use of improper cleaning agents

• Only clean the product with the approved cleaning agents.
  • Remove all metal splints.
  • Fasten all hook-and-loop closures.
  • Recommendation: Use a laundry bag or net.
  • Wash the orthosis in warm water at 30 °C with standard mild detergent. Do not use fabric softener. Rinse thoroughly.
  • Allow to air dry. Do not expose to direct heat sources (e.g. sunlight, stove or radiator).
  • Reinsert the metal splints.

Disposal

Dispose of the product in accordance with national regulations.

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
Liability
The manufacturer will only assume liability if the product is used in accord­ance with the descriptions and instructions provided 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 unauthor­ised 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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