Otto Bock Scoliosis correction orthosis User manual

Instructions for use
Scoliosis correction orthosis
− 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..........................................................................................................................
Check6.1 5.................................................................................................................
Application6.2 6..........................................................................................................
Wearing the orthosis6.3 6.............................................................................................
Removal6.4 7..............................................................................................................
Cleaning7 7..........................................................................................................................
Maintenance8 7...................................................................................................................
Disposal9 7...........................................................................................................................
Legal information10 7...........................................................................................................
Liability10.1 7...............................................................................................................
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
This is a scoliosis correction orthosis consisting of a circular plastic shell that closes in front. The
orthosis has a pelvic brace that straightens the pelvis and extends the lumbar spine. Depending
on the type of scoliosis, there are compression pads in various positions that derotate and correct
the spine. There are spaces opposite these compression pads that the spine must move into
when you inhale. The orthosis is asymmetrical and has an abdominal component. It has been cus
tom designed for your diagnosis. Depending on the type of scoliosis, the orthosis may limit free
dom of movement. The closures compensate for slight weight fluctuations. Greater fluctuations
require a modification or even a new orthosis. The Ottobock team informed you about the features
of your orthosis.
3 Areas of application and usage restrictions
Your orthosis is an orthopaedic device for correcting your scoliotic (three-dimensional) spine
deformity.
The Ottobock team adapted the orthosis to the loads expected at the time of fitting.
Please consult your doctor regarding the daily duration of use and how accompanying therapeutic
measures (e.g. occupational therapy or physical therapy) can improve your physical capacity.
First-time users in particular are at first unaccustomed to wearing an orthosis and have to learn
how to handle their orthosis. Donning and doffing must be trained.
In general, you should not experience discomfort when wearing your orthosis. Excessive pressure
can lead to complications such as pressure points. If you have any questions or concerns about
your orthosis, please do not hesitate to contact your orthotist.
4 Medical and therapeutic aspects
Over time, immobilisation of the muscles can lead to weakening of the muscles. Regular physical
therapy or isometric exercises are necessary to prevent this. Your physician can provide you with
additional advice on muscle training. Your orthosis is part of a treatment concept. Adhering to the
daily duration of use, guided physical therapy anddaily therapeutic exercise at home are part of
the treatment. Contact your orthotist if you have any problems with your orthosis.
Volume Fluctuations
Body weight fluctuations and growth can lead to problems with the fit and, as a result, to function
al deficits. Be sure to consult your doctor or orthotist.
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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.
►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 Check
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.
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 sensory disorders (visually and by palpating).
►Please consult your doctor or orthotist if there are any signs of skin damage, even if they are
only minor.
Please check whether your orthosis is undamaged and functional prior to each use.
If you wear an undershirt under the orthosis, it should be made of a washable and moisture-
absorbent material with no side seams. Make sure that the undershirt is free of wrinkles, or pres
sure sores may develop.

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Check the skin in the area of the orthosis, especially in the area of the pads. The continual cor
rective pressure of the pads can easily lead to changes in the skin (darkening). No dark red or
bluish discolouration or broken skin may occur. 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. Do not use skin powder because it rubs against the skin under
the pads and dries it out even more. Avoid direct contact of injured skin with leather materials.
Materials used in the orthosis were tested for skin tolerance. Should skin changes still develop in
the orthosis area, please consult your doctor or orthotist immediately. Due to normal growth, the
orthosis may become too small or the pads may no longer be in the proper positions. Note the
position and pressure of the pads as well as your height. If a change or loosening occurs, please
contact your orthotist.
6.2 Application
CAUTION
Incorrect or excessively tight application
Risk of local pressure and constriction of blood vessels and nerves due to improper or excess
ively tight application
►Ensure that the orthosis is applied properly and fits correctly.
CAUTION
Direct skin contact with the product
Skin irritation due to chafing or sweat formation
►Do not wear this product directly on the skin.
1) Open up the orthosis at the closures.
2) Move the orthosis around your body from one side of your waist across the back.
3) Check the position of the iliac crest profile while lying on your back to determine the correct
height.
4) Fasten the closures.
5) After standing up, stretch up out of the orthosis with your hands on the iliac crests.
6.3 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, physical therapist or
orthotist.
►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 discomfort when wearing your orthosis. Since the orthosis is worn between your body
and clothing, friction, especially at the edges of the orthosis, can cause wear to clothing.

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Increased sweating can cause skin irritation under the orthosis. Your orthosis is a brace that is
prescribed during the growth phase. It leads to continual correction.
6.4 Removal
> Unfasten the closures.
1) Move the orthosis around your body from one side of your waist across the back.
2) Open the orthosis at the closures and remove it.
7 Cleaning
NOTICE
Use of improper cleaning agents
Loss of functionality due to damage to materials
►Do not use any harsh cleaning agents.
►Do not use any solvents such as thinner, acetone, gasoline, etc.
Your orthosis requires regular care. Wash the plastic or metal parts with soap and water.
Disinfect the orthosis if you have open or oozing wounds. Spray the orthosis with a commercially
available disinfectant. Disinfectant may cause the coloured hook-and-loop closures to fade.
It is important that you thoroughly dry the cleaned surfaces (do not put on a heater or in the dry
er).
Ensure that no soap residue is left 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 observe the check-up dates established with your
orthotist in order to avoid any damage to your orthosis.
The Ottobock team recommends a
maintenance interval of: ……………..
In addition, please pay attention to any changes that may become evident in the material of your
orthosis. Please contact your orthotist immediately if any changes occur.
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

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damage caused by disregarding the information in this document, particularly due to improper
use or unauthorised modification of the product.

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