ottobock 28U23 WalkOn Trimable Instruction Manual
- June 4, 2024
- ottobock
Table of Contents
28U23 WalkOn Trimmable
Instruction Manual
28U23 WalkOn Trimable
| Article Number | Side | Shoe Size | Height |
|---|---|---|---|
| 28U23 = L36-39 | left | L36-39 | 35 cm |
| 28U23 = R36-39 | right | R36-39 | 35 cm |
| 28U23 = L39-42 | left | L39-42 | 36 cm |
| 28U23 = R39-42 | right | R39-42 | 36 cm |
| 28U23 = L42-45 | left | L42-45 | 37,5 cm |
| 28U23 = R42-45 | right | R42-45 | 37,5 cm |
| 28U23 = L45-48 | left | L45-48 | 39 cm |
| 28U23 = R45-48 | right | R45-48 | 39 cm |
INFORMATION
Date of the last update: 2018-05-07
• Please read this document carefully
• Follow the safety instructions
Explanation of Symbols
CAUTION Warnings regarding possible risks of accident or injury.
NOTICE
Warnings regarding possible technical damage.
INFORMATION
Additional information on the fitting/use.
Description
1.1 Indications for use
The WalkOn Trimable is to be used exclusively for orthotic fittings of the
lower limbs and is exclusively suitable for contact with healthy and intact
skin.
1.2 Indications and effects
WalkOn Trimable supports the foot at drop foot conditions with no more than
mild spasticity, e.g. after stroke, traumatic brain injury, in multiple
sclerosis, neural muscle atrophy, peroneal palsy etc.
WalkOn Trimable fits patients with:
- a stable ankle
- no or only mild impairment of motor knee control
- active patients, walking indoors as well as outdoors
For foot deformities: the WalkOn Trimable is indicated when a foot deformity
can be corrected through the use of an additional insole and a lateral stop in
combination with a sturdy shoe.
The WalkOn Trimable is generally suitable for sports activities, as long as no
fast, sudden movements are executed in extreme stride sequences (e.g.
basketball, badminton or riding with high activity). In any case, activities
should be discussed with the patient, and a special fitting for high activity
levels realized where applicable.
Effects:
WalkOn Trimable provides the user with a more natural gait pattern; a faster
and more stable walk. The toes and foot are lifted up during the swing phase
(clearance) and “foot slap” is prevented. Energy restoration gives a
propelling effect at the initial swing phase.
NOTICE
The WalkOn Trimable is a dynamic ankle foot orthosis and must not be used for
the prevention of contractures etc.
The indication must be determined by the physician.
1.3 Contraindication
1.3.1 Absolute contraindication
- Moderate to severe spasticity in the lower leg
- Leg ulcers
- Moderate to severe edema
- Moderate to severe foot deformities
1.3.2 Relative contraindication
In case of the following indications, consultation with a physician is
required:
Skin diseases/-injuries, inflammatory symptoms, prominent scars that are
swollen, reddened and feel excessively warm when touched; Lymphatic flow
disorders, including unclear soft tissue, swelling distant to the body area to
which the appliance will be applied; Sensory and circulatory disorders of the
lower extremities.
1.4 Safety instructions
INFORMATION
The patient is to be instructed in the proper use/care of the product.
The initial fitting and application of the product must be carried out by
trained, qualified personnel only. The daily duration of use and period of
application is dependent on the medical indication by the physician.
CAUTION
Risk of injury as a result of improper use. The product is designed for use on
one patient only. Parts to be fitted and those parts that come directly into
contact with the skin can cause functional and hygienic risks if the orthosis
is used by another person.
An orthosis/support applied too tightly to the body can cause local pressure
and, in some cases, even restrict adjacent vessels or nerves. Do not apply the
product too tightly. Consult a physician immediately if you experience unusual
changes (such as an increase in pain). Improper changes to the product are not
permitted.
CAUTION
Risk of an accident when driving a motor vehicle. The ability to drive a
vehicle when wearing a WalkOn Trimable is determined on a case-to-case basis.
Criteria include the type of fitting (clinical picture, fitting) and the
individual abilities of the WalkOn Trimmable user.
All users are required to observe the applicable national driving laws when
operating motor vehicles.
For insurance purposes, drivers should have their driving ability examined and
approved by an authorized test center.
CAUTION
Risk of injury due to incorrect environmental conditions. The user must be
informed of the risks that exceptional situations might present. For example,
jumping down from height (more than 1 meter / 39 inches) may expose the spring
to severe overload and cause it to break.
NOTICE
Damage due to incorrect environmental conditions. This product is not flame-
resistant. Keep the product away from flames or other heat sources.
The product should not come into contact with grease or acidic agents,
unguents, and lotions. This may reduce the product‘s period of use.
1.5 Construction
Thanks to its construction with three dynamic elements (the pylon, the heel,
and the forefoot of the sole) the orthosis provides a smooth natural gait on
even and uneven grounds.
Walking in stairs by taking weight on the forefoot as well as squatting is
permitted due to its dynamic features.
NOTICE
Damage due to inadmissible handling. The orthosis is made of pre-impregnated
composite material and cannot be thermoformed. The foot of the sole and the
connection elements must be free from holes as these would interrupt the
fibers and weaken the component.
Handling
2.1 Size selection
The size selection of the orthosis is based on the shoe size. Left and right.
S – XL.
2.2 Adapting and applying the product
- Shoe selection: to obtain the best effect of the WalkOn Trimmable, the user need to wear a stable, laced shoe with a firm heel counter. The heel height should be 1,0 cm (+/-5 mm) / 0,4 inches (+/-0,2 inches).
- Pick out the correct size from the size chart.
- Adapt the WalkOn Trimmable to the correct size: If the user has a removable inner sole in his/her shoe, use that for marking the correct size on the footplate. (pic. 1), or draw a line around the user’s foot directly on the footplate.
- Cut the footplate into the correct size (according to the line on the footplate) (pic. 2). When adjusting the foot plate width; cut on the lateral side but not more than necessary, to avoid the medial part/the insert sliding in the shoe and to avoid pressure on the medial malleoli. When adjusting the length of the footplate, focus on cutting the back of the footplate, then the insert will automatically be positioned behind (posterior) the medial malleolus which prevents pressure on the ankle and malleolus (pic. 3).
- The shell can be adjusted by grinding, if necessary.
- In the event of sharp edges at the orthosis, smooth them out by grinding the edges in water, with a grinding paper.
- If the user has a foot deformity, correct it with a corrective insole or a custom molded device. (If the foot cannot be corrected by an insole, the orthosis, and a stable shoe, a WalkOn Trimable should not be used).
- Apply the textile part to the calf part of the orthosis (pic. 4).
- Cut the soft velcro part at a proper length. To assure a good attachment, the soft velcro should not be more than 2 cm longer than the hard Velcro, when the calf band is attached around the user’s calf.
2.3 Instruction for use and care
Material: Carbon fiber composite. Calf band: PCM (Phase Change Material), a
temperature regulative material, micro hook and loop, soft velcro tape.
Cleaning:
- Textile part: Machine wash at 40 °C (104 °F) is recommended when necessary but approximately twice a week. Use a standard mild detergent. Wash out thoroughly and air dry. Note: Residues of cleaning agents may cause skin irritations and wear of the material.
- Composite part: wipe off with a moistened rag when necessarily Your Orthotist can supply you with extra calf parts (art. no. 623Z39, left or right) in cases of loss, poor function of the velcro straps, worn out, etc.
Upper limit temperature: 120 °C.
Disposal after use: Combustible material.
Further usage restrictions
The product has been designed for use on only one patient. The daily duration
of use and period of application is dependent on the medical indication.
Latex Safe: To our knowledge, this product does not contain any natural
rubber.
Liability
The manufacturer’s warranty applies only if the product has been used under the conditions and for the purposes described. The manufacturer recommends that the product be used and maintained according to the instructions for use.
CE conformity
This product meets the requirements of the 93/42/EEC guidelines for medical devices. This product has been classified as a class I devise according to the classification criteria outlined in appendix IX of the guidelines. The declaration of conformity was therefore created by Ottobock with sole responsibility according to appendix VII of the guidelines.
Ottobock SE & Co. KGaA
Max-Näder-Straße 15 · 37115 Duderstadt/Germany
T +49 5527 848-0 · F +49 5527 72330
healthcare@ottobock.de
www.ottobock.com
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