ottobock 28U25 WalkOn Reaction Plus and Reaction Junior Instruction Manual

28U25/28U24/28U34-WalkOn Reaction Plus and Reaction Junior
Instruction Manual

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28U24
WalkOn Reaction| Article number| Side| Shoe size
EU| Tibia height
---|---|---|---|---
| 28U24=L36–39| links/left| 36–39| 32,5 cm| 12.8 in
28U24=R36–39| rechts/right
28U24=L39–42| links/left| 39–42| 35 cm| 13.8 in
28U24=R39–42| rechts/right
28U24=L42–45| links/left| 42–45| 37 cm| 14.6 in
28U24=R42–45| rechts/right
28U24=L45–48| links/left| 45–48| 39 cm| 15.4 in
28U24=R45–48| rechts/right
28U25
WalkOn Reaction plus| Article number| Side| Shoe size
EU| Tibia height
---|---|---|---|---
| 28U25=L36–39| links/left| 36–39| 32,5 cm| 12.8 in
28U25=R36–39| rechts/right
28U25=L39–42| links/left| 39–42| 35 cm| 13.8 in
28U25=R39–42| rechts/right
28U25=L42–45| links/left| 42–45| 37 cm| 14.6 in
28U25=R42–45| rechts/right
28U25=L45–48| links/left| 45–48| 39 cm| 15.4 in
28U25=R45–48| rechts/right
28U25
WalkOn Reaction Junior| Article number| Side| Shoe size
EU| Tibia height
---|---|---|---|---
| 28U25=L24–27| links/left| 24–27| 20,5 cm| 8.0 in
28U25=R24–27| rechts/right
28U25=L27–30| links/left| 27–30| 24,5 cm| 9.65 in
28U25=R27–30| rechts/right
28U25=L30–33| links/left| 30–33| 27 cm| 10.6 in
28U25=R30–33| rechts/right
28U25=L33–36| links/left| 33–36| 29,5 cm| 11.6 in
28U25=R33–36| rechts/right
28U34
WalkOn Reaction Lateral| Article number| Side| Shoe size
EU| Tibia height
---|---|---|---|---
| 28U34=L36–39| links/left| 36–39| 32,5 cm| 12.8 in
28U34=R36–39| rechts/right
28U34=L39–42| links/left| 39–42| 35 cm| 13.8 in
28U34=R39–42| rechts/right
28U34=L42–45| links/left| 42–45| 37 cm| 14.6 in
28U34=R42–45| rechts/right
28U34=L45–48| links/left| 45–48| 39 cm| 15.4 in
28U34=R45–48| rechts/right
*28U34
WalkOn Reaction Lateral Junior| Article number| Side| Shoe size
EU| Tibia height
---|---|---|---|---
| 28U34=L24–27| links/left| 24–27| 20,5 cm| 8.0 in
28U34=R24–27| rechts/right
28U34=L27–30| links/left| 27–30| 24,5 cm| 9.65 in
28U34=R27–30| rechts/right
28U34=L30–33| links/left| 30–33| 27 cm| 10.6 in
28U34=R30–33| rechts/right
28U34=L33–36| links/left| 33–36| 29,5 cm| 11.6 in
28U34=R33–36| rechts/right
Material| Structural part: Carbon fiber composite; Calf strap and padding: Polyurethane
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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 28U24 WalkOn Reaction, 28U25 WalkOn Reaction plus, WalkOn Reaction Junior, 28U34 WalkOn Reaction Lateral, and 28U34 WalkOn Reaction Lateral Junior ankle-foot orthoses.

Product overview

(see fig. 1 )

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

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.
The doctor decides the daily duration of use for the product.

• 28U25 WalkOn Reaction Junior: The orthosis may be combined with other dynamic foot/ankle foot orthoses if the biomechanical requirements can be met more effectively as a result.

3.2 Indications

• Minor impairment of plantar flexors
• Minor impairment of knee extensors
• Drop foot, with or without mild to moderate spasticity

Caused for example by:

• Stroke
• Traumatic brain injuries
• Multiple sclerosis
• Neuromuscular atrophy
• Peroneal nerve injury
• Infantile cerebral palsy (ICP)

28U25

• Impairment of the plantar flexor muscles
• Impairment of knee extension

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
• Leg ulcers

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.
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.
3.5 Restrictions for use
The orthosis must not be used for the prevention of contractures (shortening) etc.
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

• Promotes a largely symmetrical and fluid physiological gait
• Supports knee extension and knee flexion
• Supports knee extension during toe-off
• Prevents uncontrolled foot contact and foot slap during heel strike
• Influences the statics in the frontal and sagittal plane when standing

3.7 Accessories
28U24, 28U25

• 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 physi­can.
• 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

1. Open both straps and detach them from the hook-and-loop (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).
3. Tighten the straps and attach them to the hook-and-loop on the opposite wing of the lower leg shell (see fig. 6, see fig. 7).

Selecting footwear

• Choose a sturdy shoe with laces or hook-and-loop fasteners and a solid toe cap to ensure the optimal effectiveness of the orthosis. The effective heel height should be between 0.5 cm and 1.5 cm.

Adapting the orthosis

1. If the patient uses footwear with removable insoles, take the insole out of the shoe on the fit­ ting side.
   INFORMATION: Keep the insole to use the shoe without the orthosis.

2. Have the patient sit on a chair with footwear and without the orthosis. Position the foot at a 90° angle to the lower leg (see fig. 8).

3. Mark the position of the ankle joint in the shoe with a small piece of adhesive tape (see fig. 8).

4. Have the patient sit on a chair without footwear and with the orthosis. Position the foot at a 90°  angle to the lower leg.
   INFORMATION: Apply the orthosis so the ankle bone has adequate freedom of move­ment and does not contact the spring.

5. Determine the position of the ankle bone and mark it on the orthosis frame with a small piece of adhesive tape (see fig. 9).

6. Trim the orthosis sole (see fig. 10) so the markings on the shoe and the orthosis frame line up (see fig. 11).

7. Adapt the shape of the sole according to the removable insole. In doing so, make sure that the required external rotation of the foot is maintained (see fig. 10).

8. Insert the orthosis in the shoe and optionally cover it with an insole (see fig. 12).

9. Put on the orthosis together with the shoe (see fig. 13).

10. Measure the correct a-p (anterior-posterior) position of the knee joint (e.g. on the 3D L.A.S.A.R Posture).
    INFORMATION: The load line of the knee joint in the a-p position lies approx. 15 mm in front of the compromise knee pivot point according to Nietert.

11. Optional: Use wedges as compensating elements to achieve the desired position.
    For example, place a compensating element under the forefoot (see fig. 17) if the patient stands with excessive flexion or place a compensating element under the heel (see fig. 18) if the patient stands with excessive extension.
    INFORMATION: Optionally, materials other than those supplied may also be used to build up the bottom sole.

12. Optional: Sand the upper edge and the wings of the frontal support and modify the padding accordingly.
    NOTICE! The functionality of the orthosis must not be impaired. Do not sand in the area of the spring or the surfaces!

13. Optional: If the patient has a foot deformity, correct it with an insole or a custom molded device.
    28U24, 28U25:INFORMATION: The manufacturer offers the 28Z10 lateral pronation strap as an accessory that can be attached to the lateral sole with hook-and-loop fasteners. Frontal and dorsal traction stabilizes the foot using hook-and-loop fasten­ ers in the area of the spring.

14. Close the textile component at calf height (see fig. 13).

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.

28U25 WalkOn Reaction junior, 28U34 WalkOn Reaction 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 to air 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
[email protected]
www.ottobock.com
© Ottobock · 647G816=all_INT-16-2

References

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