ottobock 28U11 WalkOn Prefabricated Ankle Foot Orthosis Instruction Manual

28U11/28U22/28U23/28U33-WalkOn Prefabricated Ankle Foot Orthosis
Instruction Manual

WalkOn Prefabricated Ankle Foot Orthosis

28U11
WalkOn| Article number| Side| Shoe size
EU| Calf height
---|---|---|---|---
| 28U11=L36–39| links/left| 36–39| 35 cm| 13.8 in
28U11=R36–39| rechts/right
28U11=L39–42| links/left| 39–42| 36 cm| 14.2 in
28U11=R39–42| rechts/right
28U11=L42–45| links/left| 42–45| 37,5 cm| 14.8 in
28U11=R42–45| rechts/right
28U11=L45–48| links/left| 45–48| 39 cm| 15.4 in
28U11=R45–48| rechts/right
28U22
WalkOn Flex| Article number| Side| Shoe size
EU| Calf height
---|---|---|---|---
| 28U22=L36–39| links/left| 36–39| 32,5 cm| 12.8 in
28U22=R36–39| rechts/right
28U22=L39–42| links/left| 39–42| 35 cm| 13.8 in
28U22=R39–42| rechts/right
28U22=L42–45| links/left| 42–45| 37 cm| 14.6 in
28U22=R42–45| rechts/right
28U22=L45–48| links/left| 45–48| 39 cm| 15.4 in
28U22=R45–48| rechts/right
28U22
WalkOn Flex Junior| Article number| Side| Shoe size
EU| Calf height
---|---|---|---|---
| 28U22=L24–27| links/left| 24–27| 20,5 cm| 8.0 in
28U22=R24–27| rechts/right
28U22=L27–30| links/left| 27–30| 24 cm| 9.5 in
28U22=R27–30| rechts/right
28U22=L30–33| links/left| 30–33| 27 cm| 10.6 in
28U22=R30–33| rechts/right
28U22=L33–36| links/left| 33–36| 29,5 cm| 11.6 in
28U22=R33–36| rechts/right
28U23
WalkOn Trimmable| Article number| Side| Shoe size
EU| Calf height
---|---|---|---|---
| 28U23=L36–39| links/left| 36–39| 35 cm| 13.8 in
28U23=R36–39| rechts/right
28U23=L39–42| links/left| 39–42| 36 cm| 14.2 in
28U23=R39–42| rechts/right
28U23=L42–45| links/left| 42–45| 37,5 cm| 14.8 in
28U23=R42–45| rechts/right
28U23=L45–48| links/left| 45–48| 39 cm| 15.4 in
28U23=R45–48| rechts/right
28U33
WalkOn Lateral| Article number| Side| Shoe size
EU| Calf height
---|---|---|---|---
| 28U33=L36–39| links/left| 36–39| 32,5 cm| 12.8 in
28U33=R36–39| rechts/right
28U33=L39–42| links/left| 39–42| 35 cm| 13.8 in
28U33=R39–42| rechts/right
28U33=L42–45| links/left| 42–45| 37 cm| 14.6 in
28U33=R42–45| rechts/right
28U33=L45–48| links/left| 45–48| 39 cm| 15.4 in
28U33=R45–48| rechts/right
28U33
WalkOn Lateral Junior| Article number| Side| Shoe size
EU| Calf height
---|---|---|---|---
| 28U33=L24–27| links/left| 24–27| 20,5 cm| 8.0 in
28U33=R24–27| rechts/right
28U33=L27–30| links/left| 27–30| 24 cm| 9.5 in
28U33=R27–30| rechts/right
28U33=L30–33| links/left| 30–33| 27 cm| 10.6 in
28U33=R30–33| rechts/right
28U33=L33–36| links/left| 33–36| 29,5 cm| 11.6 in
28U33=R33–36| rechts/right
Material| 28U11, 28U23, 28U33
Structural part: Carbon fiber composite; Calf strap and padding: Polyurethane
---|---
28U22
Structural part: Glas fiber composi­ te; Calf strap and padding: Polyu­rethane
Latex-free : This product does not contain natural rubber.

Foreword

INFORMATION
Date of last update: 2022-03-03

• 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 28U11 WalkOn, 28U22 WalkOn Flex/WalkOn Flex Junior, 28U23 WalkOn Trimmable, and 28U33 WalkOn Lateral/WalkOn Lateral Junior ankle-foot orthoses.

Product overview

(see fig. 1 )

Item| Designation| Item| Designation
1| Lower leg shell| 4| Calf strap with padding
2| Orthosis| 5| Sole
3| Y-hook-and-loop| |

Intended use

3.1 Indications for use
The orthosis is intended exclusively for orthotic fittings of the lower limbs and exclusively for contact with intact skin.
Ottobock recommends wearing the product with a stocking and not directly on the skin. A thin stocking made of a washable, moisture-absorbent material is suitable to wear under the product.
To avoid pressure points, make sure that the stocking is free of wrinkles.
The orthosis must be used in accordance with the indications.
3.2 Indications

• Drop foot, without or with mild spasticity

Caused for example by:

• Peroneal paralysis
• Stroke
• Traumatic brain injury
• Multiple sclerosis
• Neuromuscular atrophy

Indications must be determined by the physician.
3.3 Contraindications
3.3.1 Absolute Contraindications

• Moderate to severe spasticity in the lower leg
• Moderate to severe edema
• Moderate to severe foot deformities

3.3.2 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/body area; lymphatic flow disorders, including unclear soft tissue swelling distal to the body area to which the medical device will be applied; sensory and circulatory disorders in the lower leg and the foot area.

• Severe deviations of the leg axis (genu varum/valgum/recurvatum)
• Contractions at the knee and/or ankle joint

3.4 Lifetime
When used as intended, the product is designed for:
Junior 1 year (shoe sizes EU 24-27, 27-30, 30-33, 33-36)
Adults 2 years (shoe sizes EU 36-39, 39-42, 42-45, 45-48)
When the end of the lifetime is reached, have the product inspected for functionality by qualified personnel. Use of the product beyond the specified lifetime is the responsibility of the user.
The doctor decides the daily duration of use for the product.
3.5 Restrictions for use
The orthosis must not be used to prevent contractures.
The orthosis must not be used for sports activities that involve jumping, sudden movements or rapid step sequences (e.g. basketball, badminton, riding sports). Sports activities should gener­ ally be discussed with the patient.
3.6 Effects

• Supports dorsiflexion
• Promotes dynamic rollover
• Promotes a physiological gait pattern
• Reduces the risk of falling

3.7 Accessories
28U11, 28U22, 28U23

• 28Z10 Lateral pronation strap

Safety

4.1 Explanation of warning symbols
WARNING Warning regarding possible serious risks of accident or injury.
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 General safety instructions
CAUTION
Reuse of 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
Mechanical damage to the product
Injuries due to changes in or loss of functionality

• Use caution when working with the product.
• Check the product for proper function and readiness for use.
• In case of changes in or loss of functionality, discontinue use of the product and have it checked by authorized, qualified personnel.

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 stabilization due to loss of material functionality

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

Use

WARNING
Operation of motor vehicles
Risk of accidents due to restricted body function

• Observe the applicable legal and insurance regulations for the operation of motor vehicles and have your driving ability examined and certified by an authorized agency.

INFORMATION

• The daily duration of use and period of application is generally determined by the physi­cian.
• The initial fitting and application of the product must be carried out by qualified personnel.
• Instruct the patient in the handling and care of the product.
• Instruct the patient to see a physician immediately if any exceptional changes are noted (e.g. worsening of the complaint).

5.1 Size Selection

• Select the orthosis size based on the shoe size (see sizing table).

5.2 Adaptation
CAUTION
Improper molding or application
Injuries or damage to the orthosis due to overloading of the material and improper fit of the orthosis due to breakage of load-bearing components

• Do not make any improper changes to the orthosis.
• Always apply the orthosis according to the information in the instructions.

NOTICE
Damage due to improper handling (heat treatment, drilling holes)
Loss of orthosis functionality

• Do not carry out any heat treatment on the orthosis. The orthosis is not thermoformable.
• Do not drill any holes in the bottom of the sole or the connecting elements as holes break the fibers and weaken the component.

NOTICE
Use without suitable footwear
Restriction of functionality due to insufficient stabilization

• Only use the orthosis with closed footwear, taking the allowable effective heel height into account.

Attaching the calf strap to the lower leg shell
28U11, 28U23, 28U33

1. Open the strap and loosen it from the padding (see fig. 2, see fig. 3).
2. Pull the padding over the wings of the lower leg shell, positioning the padding on the inside and the strap on the outside of the shell (see fig. 4, see fig. 5, see fig. 6).
3. Pull the strap tight through the loop (see fig. 7, see fig. 8).

28U22

1. Open the strap and detach it from the hook-and-loop (see fig. 2).
2. Pull the padding over the long wing of the lower leg shell, positioning the padding on the inside and the strap on the outside of the shell (see fig. 4).
3. Pull the padding over the short wing of the lower leg shell (see fig. 5, see fig. 6).
4. Fasten the strap to the hook-and-loop on the short wing of the lower leg shell (see fig. 7, see fig. 8).

Selecting footwear

• Choose a sturdy lace-up shoe with a solid heel cup to ensure the optimum effectiveness of the orthosis. The effective heel height should be between 0.5 cm and 1.5  cm.

Adapting the orthosis

1. Put the orthosis on the patient’s foot.

2. If the insole in the patient’s shoe can be removed, use it as a template to transfer the correct size to the footplate or mark the contours of the foot directly on the plate with a pen (see fig. 9).

3. If using the insole, pay attention to the position of the insole on the footplate. The orthosis should not come into contact with the ankle bone, and the movement of the patient’s Achilles tendon should not be restricted.

4. 28U11: Sand the footplate up to the marking (see fig. 10).
   28U22, 28U23, 28U33: Use scissors to trim the footplate along the marking (see fig. 10).
   NOTICE! When adjusting the width of the footplate, do not remove more material than necessary on the lateral/medial side to prevent the spring from pressing against the ankle bone. If the plate needs to be narrower, remove material on both sides.

5. 28U11: To adjust the length of the footplate, focus on sanding the posterior section of the plate so that the spring is positioned behind the ankle and pressure on the ankle joint or ankle is prevented (see fig. 11).
   28U22, 28U23, 28U33: To adjust the length of the footplate, trim the posterior section of the plate so that the spring is positioned behind the ankle and pressure on the ankle joint or ankle is prevented (see fig. 11).

6. Optional: If the lower leg shell needs to be adapted to the patient, and the shell.

7. If the orthosis has sharp edges, smooth down the sanded edges.

8. For foot deformities: Correct the foot position with an insole or a custom molded device.
   INFORMATION: If the foot cannot be corrected by an insole, the orthosis, and a sturdy shoe, the WalkOn should not be used.

Optional: Shortening the calf strap

Put the orthosis on the patient.

1. Determine the length of the strap.
2. Remove the Y-hook-and-loop and shorten the strap using scissors.
3. Fasten the Y-hook-and-loop to the strap.

28U22 WalkOn Flex Junior, 28U33 WalkOn Lateral Junior

• CAUTION! The Y-hook-and-loop of the calf strap may be swallowed by young children. Sew the Y-hook-and-loop to the calf strap after fitting.

Checking the fit of the orthosis

• Check that the orthosis is fitted properly before handing it over to the patient.
• Conduct trial walking with the patient. Testing on inclines, ramps, and stairs is mandatory. Fine-tune as required.

5.3 Application
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 dam­ age.
• Do not continue using a product that is no longer functional, or that is worn or damaged.

1. Remove the insole from the shoe on the side to be fitted.
2. Open the calf strap.
3. Insert the orthosis into the shoe.
4. Put the orthosis on together with the shoe.
5. Fasten the calf strap.

5.4 Removal

1. Open the calf strap.
2. Remove the shoe together with the orthosis.
3. Optional: Remove the orthosis from the shoe and re-insert the insole of the shoe.

Cleaning

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

• Only clean the product with the approved cleaning agents.
• Ottobock recommends cleaning the orthosis twice a week.

Textile component

• NOTICE! Detergent residues may cause skin irritation and wear of the material.

1. Remove the textile component from the orthosis.
2. Fasten all hook-and-loop closures.
3. Optional: Use a mesh laundry bag.
4. Wash the textile component in warm water at 30 °C with a standard mild detergent. Rinse out detergent residues thoroughly.
5. Allow to air dry. Do not expose to direct heat (e.g. from the sun, an oven, or a radiator).

Orthosis frame

1. Wipe with a damp cloth as needed.
2. Allow airing dry. Do not expose to direct heat sources (e.g. sunlight, stove, or radiator).

Packaging

WARNING
Packaging in the hands of children
Risk of suffocation if the carrier bag is pulled over the mouth and nose, risk of strangulation by the cord

• Store the packaging out of reach of children.

The product is delivered in a carrier bag. The carrier bag is intended exclusively for transporting and storing the product.

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.
9.1 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 unauthorized modification of the product.
9.2 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.

Ottobock SE & Co. KGaA
Max-Näder-Straße 15
37115 Duderstadt · Germany
T +49 5527 848-0
F +49 5527 848-3360
healthcare@ottobock.de
www.ottobock.com
© Ottobock · 647G1530=all_INT-25-2203

References

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