Otto Bock Thoracolumbosacral orthosis User manual

Instructions for use
Thoracolumbosacral orthosis (TLSO)
– 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 4...............................................................................................................................
Explanation of warning symbols5.1 4..............................................................................
General safety instructions5.2 5....................................................................................
Handling6 5..........................................................................................................................
Check6.1 5.................................................................................................................
Application6.2 6..........................................................................................................
Wearing the orthosis6.3 6.............................................................................................
Removal6.4 6..............................................................................................................
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
The orthosis consists of 2 layers of cotton fabric. The cotton is reinforced at the seams with light
weight metal rods and at the back with a frame. The removable frame consists of a pelvic band
with paravertical rods parallel to the spine. They end in reclination bars that straighten the
thoracic spine.
The orthosis, including the proportion of elastic materials and the position and type of closures, is
customised to meet your personal needs. You can adjust the closures of your orthosis to com
pensate for slight fluctuations in weight. Greater fluctuations require a modification or even a new
orthosis. Please contact your orthotist if you have fitting problems.
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 the trunk.
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
Weight fluctuations can lead to problems with the fit and, as a result, to functional deficits. Be
sure to consult your doctor or orthotist.
5 Safety
5.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
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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.
Use an undershirt made of a washable and moisture-absorbent material. Make sure that the
undershirt is free of wrinkles, or pressure sores may develop.
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 still develop in the area of the orthosis, please consult your doctor or orthotist imme
diately.

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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.
> Check that the reclination bars pass through the plastic roll loops in the raised back section
and are fastened to the fleece at the sides of the fabric part.
1) Place the orthosis around your body from back to front and put your arms through the reclina
tion holder loops.
2) Sit down to check the correct height of the orthosis. When the legs are bent at a 90° angle,
the orthosis must end at the groin.
3) Guide the tip of the lower closure through the roll loop and close it.
4) Check whether the orthosis fits snugly.
5) Fasten the lower closures as tightly as possible so the orthosis will maintain the correct posi
tion while it is worn.
6) Fasten the other closures. Optional: Loosen the upper closure for minor activity or if you feel
uncomfortable.
7) Check the fit of the reclination bars; they must fit snugly under the arms. Optional: Loosen
the reclination bars for minor activity or if you feel uncomfortable.
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. Materials used in the orthosis were tested for
skin tolerance. Should skin changesdevelop, consult your doctor.
6.4 Removal
1) Loosen the reclination bars.
2) Unfasten all closures.

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3) Remove the orthosis from front to back and guide your arms through the reclination holder
loops.
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. The
orthosis and all detachable fabric parts can be machine washed on the gentle cycle at 30°C with
a commercially available laundry detergent.
1) Place the orthosis face down on the table.
2) Hold the frame in the frame pocket with one hand and pull the fabric back with the other
hand.
3) Pull out the frame.
4) Put the fabric part in a laundry bag or net.
5) Wash the fabric part.
6) Allow the fabric part to air dry. Do not expose to direct heat sources (e.g. sunlight, oven or
radiator).
7) It is important that you thoroughly dry the cleaned surfaces (do not put on a heater or in the
dryer).
8) Ensure that no soap residue is left on the orthosis, since this could cause skin irritation.
9) Place the fabric part face down on the table.
10) Hold the frame with one hand and pull the fabric back with the other hand.
11) Insert the frame by pushing the paravertical rods of the frame into the lower of the two pock
ets until you feel resistance.
12) Place the orthosis on the table with the back facing down and insert the pelvic band into the
frame padding.
13) Disinfect the orthosis if you have open or oozing wounds. Spray the orthosis with commer
cially available disinfectants. Disinfectant may cause the coloured hook-and-loop closures to
fade.
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.
INFORMATION
The product may be exposed to increased loads by the patient.
►Shorten the maintenance intervals according to the expected loads.
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: ……………..

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

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