Otto Bock Lower Leg Orthosis User manual

Instructions for use
Lower Leg Orthosis (AFO)
- Custom Fabrication -

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Foreword1 4.........................................................................................................................
Description of the Design and Individual Components2 4.............................................
Areas of Application and Usage Restrictions3 4.............................................................
Medical and Therapeutic Aspects4 4................................................................................
Safety5 5...............................................................................................................................
Explanation of warning symbols5.1 5..............................................................................
General safety instructions5.2 5....................................................................................
Handling6 5..........................................................................................................................
Shoe selection6.1 5.....................................................................................................
Check6.2 6.................................................................................................................
Applying the orthosis6.3 6............................................................................................
Wearing the orthosis6.4 7.............................................................................................
Removing the orthosis6.5 7...........................................................................................
Cleaning7 7..........................................................................................................................
Maintenance8 7...................................................................................................................
Disposal9 8...........................................................................................................................
Legal information10 8...........................................................................................................
Liability10.1 8...............................................................................................................
Table of contents
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1 Foreword
INFORMATION
Date of last update: 2021-04-29
►Please read this document carefully before using the product and observe the safety
notices.
►Obtain instruction from the qualified personnel in the safe use of the product.
►Please contact the qualified personnel 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.
2 Description of the Design and Individual Components
Your orthosis primarily consists of a lower leg component and a foot component that may have an
integrated length compensation mechanism. The joints may be free-moving, limited in their move
ment or locked. Joint functionality may also be supported by spring mechanisms. The adjustment
range offered by adjusting the closure straps is limited. Please also refer to "Volume fluctuations"
in section4.
The static alignment of the foot component and lower leg component has been adapted to your
individual needs and takes the heel height of your shoe into account.
The Ottobock team has informed you about the features of your orthosis.
3 Areas of Application and Usage Restrictions
Your orthosis is an orthopaedic appliance that makes it possible or easier for you to stand and
walk, or fulfils other specific requirements relevant to your condition. The Ottobock team adapted
the orthosis to the loads expected at the time of fitting. If your activity level increases in the course
of use, adjustments may be required. Changes will also have to be made if your physical condi
tion worsens and more support from the orthosis is needed.
Please consult your doctor regarding the daily duration of use and potential therapeutic measures
(e.g. occupational therapy or physical therapy) to improve your performance. First-time users in
particular are at first unaccustomed to wearing an orthosis and have to learn how to handle their
orthosis. Applying and removing, sitting, standing and walking must be practised. Ways to handle
a potential fall must also be explained. Your doctor, physiotherapist or orthotist can provide you
with additional advice on orthosis training.
In general, you should not experience too much discomfort when wearing your orthosis. Excess
ive pressure can cause complications, e.g. pressure sores or joint problems. If you have any
questions or concerns about your orthosis, please do not hesitate to contact your orthotist.
4 Medical and Therapeutic Aspects
If problems in the region of the spinal column occur in spite of an objective improvement of stat
ics, please consult your orthotist.
Volume fluctuations
Body weight fluctuations and swelling in the leg can lead to problems with the fit, resulting in
functional deficits. The use of compression stockings can help prevent this problem. However, be
sure to consult your doctor.
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5 Safety
5.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
5.2 General safety instructions
CAUTION!
Risk of injury and risk of product damage
►Observe the maximum lifetime of the product.
►To avoid the risk of pinching, do not reach into the joint mechanism.
►Keep the product away from open flames, embers and other sources of heat.
►Do not make any changes to the orthosis or its components.
NOTICE!
Risk of product damage and limited functionality
►Do not expose the product to prohibited environmental conditions (see instructions for use of
the individual components).
►Check the product for damage if it has been exposed to prohibited environmental conditions.
►Do not use the product if it is damaged or in a questionable condition. Take suitable meas
ures (e.g.cleaning, repair, replacement, inspection by the manufacturer or a specialist work
shop).
6 Handling
6.1 Shoe selection
CAUTION
Incorrect effective heel height
Falling injuries due to loss of functionality
►When buying new shoes, be sure to observe the predetermined effective heel height.
Effective heel height
The effective heel height of the orthosis is determined during the construction of the orthosis. The
heel height of the orthosis cannot be altered and is calculated by the heel height minus the fore
foot height.
Calculation of the effective heel height:
The effective heel height (a-b) of your orthosis is:
……..
Shoe selection
When selecting shoes, ensure that the inner sole can be removed to make room for the foot com
ponent of the orthosis. The shoe's heel counter must be high enough to prevent the heel from
slipping out of the shoe.

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6.2 Check
CAUTION
Volume fluctuations of the affected limb or problems with the fit (e.g. caused by growth)
Injuries, friction, pressure sores, circulatory disorders and paralytic symptoms caused by prob
lems with the fit
►If the orthosis is fitted during the growing phase, it must be adjusted according to changing
body dimensions.
►Check the skin daily for damage and sensitivity disturbances (visually and by palpitating).
►Please consult your doctor or orthotist in case of any signs of skin damage, even if they are
only minor.
CAUTION
Use of a worn or damaged product
Restricted support or injuries due to changes in or loss of functionality
►Before each use, check the orthosis for functional reliability and for possible wear or dam
age.
►If the orthosis or a component of the orthosis shows any signs of wear (e.g. tears, deforma
tions, poor fit) or damage, the orthosis should no longer be used.
Please verify whether your orthosis is undamaged and functional prior to each use.
If you wear a stocking underneath the orthosis, it should be made of a washable and moisture-
absorbent material. Make sure that the stocking is free of wrinkles, or pressure sores may devel
op.
Also check the skin in the area of the orthosis. Skin in the area of the orthosis must be free from
grease, oils and lotions as these substances reduce the durability of the materials and cause skin
irritations due to sweat or friction. Materials used in the orthosis were tested for skin tolerance. If
skin changes develop on your leg, please consult your doctor or orthotist immediately.
6.3 Applying the orthosis
CAUTION
Incorrect or excessively tight application
Injuries, risk of local pressure and constriction of blood vessels and nerves due to improper or
excessively tight application
►Observe the instructions for applying and removing the orthosis.
►Do not over tighten the closures when applying the orthosis.
►Ensure that the orthosis is positioned correctly.
The Ottobock team instructed you in how to put on the orthosis so that a secure fit is ensured:
1) Open the orthosis wide enough to put in your leg.
2) Place your leg into the orthosis and make sure the orthosis is correctly positioned.
3) Tighten the closure straps one after the other. Do not over tighten the closure straps.
4) Verify the correct position of the joints before you put your full weight on the orthosis.
Every time you apply your orthosis, verify that the orthosis is firmly in place by pulling on it.
Please observe the following instructions:
• Before getting into the shoe with the orthosis, be sure to open it wide enough. This eases
entry and keeps the toes from curling. You can also wear a sock so you slip into the shoe
more easily.
• Avoid any pumping movement between the leg and orthosis.

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6.4 Wearing the orthosis
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 authorised agency.
CAUTION
Excessive strain on load-bearing components
Injuries due to breakage of load-bearing components
►Sports activities are only permitted after consultation with your doctor or prosthetist/orthot
ist.
►If the product has been exposed to extreme strain (e.g. due to falling), take any necessary
measures (e.g. repair, replacement, inspection by the manufacturer's customer service
etc.).
The daily duration of use of your orthosis is determined by your doctor. In general, you should not
experience too much discomfort when wearing your orthosis.
Please consult your orthotist if you experience any problems despite correct handling.
6.5 Removing the orthosis
1) Open the closure straps of the orthosis wide enough to remove your leg.
2) Remove your leg from the orthosis.
7 Cleaning
NOTICE
Use of improper cleaning agents
Loss of functionality due to damage to materials
►Do not let your orthosis come into contact with acids or alkaline solutions.
►Do not use any aggressive cleaning agents.
►Do not use any solvents such as thinner, acetone, gasoline, etc.
Your orthosis requires regular care. Clean the orthosis with a damp cloth. Ottobock Derma
Clean® is recommended for disinfecting the orthosis.
Clean the plastic surfaces with water and skin-friendly soap. Removable pads, if any, can be
washed separately at a maximum temperature of 30°C. It is important that you thoroughly dry the
cleaned surfaces (not on a heater) and make sure that no soap residue remains on the orthosis
since this could cause skin irritation.
Please consult your doctor if you have any questions on skin diseases or disinfection methods.
8 Maintenance
CAUTION
Lack of or insufficient maintenance
Injuries due to changes in or loss of functionality
►Observe the specified maintenance intervals.
In the interest of your own safety, you should keep the inspection appointments agreed with your
O&P professional in order to avoid any damage to your device.

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The Ottobock team recommends a
maintenance interval of: ……………..
Also please take note of all changes in the material of your device. Please contact your O&P pro
fessional immediately in this event.
9 Disposal
In some jurisdictions it is not permissible to dispose of the product with unsorted household
waste. Improper disposal can be harmful to health and the environment. Observe the information
provided by the responsible authorities in your country regarding return, collection and disposal
procedures.
10 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary
accordingly.
10.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descrip
tions 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.

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